CU-HD1 Instructions for use

CU-HD1
This Operation manual is intended to provide information needed to use CU-HD1 that is developed and
manufactured by CU Medical Systems, Inc.
Also this Operation manual is subject to change without prior notice.

※ All copyrights in this document are owned by CU Medical Systems, Inc.

No part of this document may be used or reproduced in any manner without written permission of the
copyright owner.

Date of latest revision: August 11, 2017

Classification No.: CUOPM1US.F
© 2015, CU Medical Systems, Inc.

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 CU-HD1 Instructions for use

◎ Table of Contents

◎ Before You Begin...................................................................................................... 9

◎ General Instructions ...............................................................................................10

◎ About This Operation manual .............................................................................11

◎ Cautions for Installing and Storing the Product .............................................12

◎ Storage and Usage Environments ......................................................................13

Chapter 1. Product Introduction ..............................................................................14

1.1 Intended Use............................................................................................................... 15

1.1.1 AED Mode ........................................................................................................................................................ 15
1.1.2 Manual Defibrillation Mode .................................................................................................................... 16
1.1.3 Pacer Mode ..................................................................................................................................................... 17
1.1.4 Patient Monitoring Mode ......................................................................................................................... 18

1.2 User-Specific Functions ............................................................................................ 20

1.2.1 Intended Users ............................................................................................................................................... 20
1.2.2 Limited Usage by Users ............................................................................................................................. 20

Chapter 2. Components of the Product .................................................................21

2.1 Exterior View of Product .......................................................................................... 22

2.1.1 Front View ........................................................................................................................................................ 22
2.1.2 Rear View ......................................................................................................................................................... 22
2.1.3 Left/ Right Side View .................................................................................................................................. 23

2.2 Switches and Buttons ............................................................................................... 23

2.3 Indicators ..................................................................................................................... 25

2.4 Screen Layout Elements............................................................................................ 27

2.4.1 Screen Layout ................................................................................................................................................. 27
2.4.2 Battery Indication Symbols ...................................................................................................................... 30
2.4.3 Soft Key ............................................................................................................................................................. 31
2.4.4 Display Symbols ............................................................................................................................................ 32
2.4.5 Symbols Used on the Operation manual and Equipment ........................................................ 33

2.5 AED Mode Voice and Text Prompts ...................................................................... 38

2.6 Alarms and Errors ...................................................................................................... 40

2.6.1 Alarm .................................................................................................................................................................. 40

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2.6.2 Errors .................................................................................................................................................................. 42

2.7 Accessories .................................................................................................................. 43

Chapter 3. Product Installation ................................................................................48

3.1 Unpacking.................................................................................................................... 49
3.1.1 Package of the Main Body ....................................................................................................................... 49
3.1.2 Package of Accessories .............................................................................................................................. 50

3.2 Peripheral Device Connection ................................................................................. 51

3.2.1 Installing Battery and Charging Battery ............................................................................................. 51
3.2.2 AC Power Module Connection............................................................................................................... 52
3.2.3 Connecting the Car Cigar Jack and AC Adapter ........................................................................... 54
3.2.4 Mounting SD Card ....................................................................................................................................... 54
3.2.5 Feeding Printer Paper ................................................................................................................................. 55
3.2.6 Connecting AC Adapter for charging CU-CM1 .............................................................................. 56

3.3 Self-test ........................................................................................................................ 56

3.4 Product Storage ......................................................................................................... 56

Chapter 4. Automated External Defibrillation (AED) Mode ...............................57

4.1 Preparing Defibrillation ............................................................................................ 58

4.1.1 Connecting to the device ......................................................................................................................... 58
4.1.2 AED Mode Layout and Setting .............................................................................................................. 59
4.1.3 Attaching the Defibrillation Pads .......................................................................................................... 64

4.2 Analyzing Patient ....................................................................................................... 66

4.2.1 Auto Analysis Mode (Auto Analysis Mode ON) ............................................................................. 66
4.2.2 Manual Analysis Mode (Auto Analysis Mode OFF) ...................................................................... 67

4.3 Performing AED ......................................................................................................... 67

4.3.1 Checking Analysis Results and Voice Instructions ........................................................................ 67
4.3.2 AED Treatment ............................................................................................................................................... 68
4.3.3 Things to Do following Defibrillation.................................................................................................. 69

4.4 AED alarm .................................................................................................................... 70

4.4.1 Type of Alarm................................................................................................................................................. 70

Chapter 5. Manual Defibrillation & Synchronized Cardioversion.....................71

5.1 Preparing Defibrillation ............................................................................................ 72

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5.1.1 Connecting to the Device ......................................................................................................................... 72

5.1.2 Manual Defibrillation Mode Layout and Setting ........................................................................... 73
5.1.3 Attaching Defibrillation Pads and Paddle ......................................................................................... 75

5.2 Manual Defibrillation (Asynchronous)................................................................... 78

5.3 Delivering Synchronized Cardiac Pacing Energy ................................................. 79

5.3.1 Steps to Deliver Pacing Energy .............................................................................................................. 80

5.4 Alarm for Manual Defibrillation Mode.................................................................. 81

5.4.1 Type of Alarm................................................................................................................................................. 81

Chapter 6. Noninvasive Pacer Mode .......................................................................85

6.1 Preparing Pacing ........................................................................................................ 86

6.1.1 Pacing Mode Layout ................................................................................................................................... 86
6.1.2 Preparing and Connecting Patient Monitoring Device .............................................................. 87
6.1.3 Attaching Pacing Pads and ECG Electrodes..................................................................................... 89

6.2 Demand Pacing Mode .............................................................................................. 90

6.2.1 Selecting Demand Pacing Mode ........................................................................................................... 90
6.2.2 Steps of Demand Pacing .......................................................................................................................... 90

6.3 Fixed Pacing Mode .................................................................................................... 91

6.3.1 Selecting Fixed Pacing Mode.................................................................................................................. 91
6.3.2 Steps of Fixed Pacing ................................................................................................................................. 91

6.4 Ending Pacing ............................................................................................................. 91

6.5 Alarm for Pacing Mode ............................................................................................ 92

6.5.1 Type of Alarm................................................................................................................................................. 92

Chapter 7. Patient Monitoring .................................................................................96

7.1 Monitoring ECG .......................................................................................................... 98

7.1.1 ECG Monitoring Setup ............................................................................................................................... 99
7.1.1.1 Connecting ECG Cable .................................................................................................................... 99
7.1.1.2 Setting..................................................................................................................................................... 99
7.1.1.3 Preparing ECG Monitoring .......................................................................................................... 101
7.1.1.4 Location of ECG Electrodes ........................................................................................................ 102
7.1.1.5 Measuring ECG ................................................................................................................................. 103
7.1.2 12-Lead ECG measurement ................................................................................................................... 104
7.1.3 Alarm for ECG Measuring ....................................................................................................................... 105

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7.1.3.1 Type of Alarm ................................................................................................................................... 105

7.1.3.2 Alarm Setting ..................................................................................................................................... 107

7.2 Measuring Pulse CO-Oximetry(SpO2) ................................................................. 109

7.2.1 Preparing to Measure SpO2................................................................................................................... 109
7.2.1.1 Connecting to the Device............................................................................................................ 109
7.2.1.2 Inputting the information for patient monitoring ........................................................... 110
7.2.1.3 Applying the SpO2 Sensor .......................................................................................................... 110
7.2.1.4 Measuring SpO2 ............................................................................................................................... 111
7.2.2 Alarm for Measuring SpO2 ..................................................................................................................... 112
7.2.2.1 Type of Alarm ................................................................................................................................... 113
7.2.2.2 Alarm Setting – SpO2 .................................................................................................................... 113
7.2.2.3 Setting Alarm – Heart Rate......................................................................................................... 114

7.3 Measuring Noninvasive Blood Pressure (NIBP) ............................................... 115

7.3.1 Preparing to Measure NIBP ................................................................................................................... 115
7.3.1.1 Connecting to the Device............................................................................................................ 115
7.3.1.2 Inputting the information for patient monitoring ........................................................... 116
7.3.1.3 Applying the Cuff to the Patient .............................................................................................. 116
7.3.1.4 Measuring NIBP ............................................................................................................................... 117
7.3.2 Alarm for NIBP Measuring ..................................................................................................................... 120
7.3.2.1 Type of Alarm ................................................................................................................................... 120
7.3.2.2 Alarm Setting ..................................................................................................................................... 122

7.4 Measuring End-tidal CO2 (EtCO2) ........................................................................ 124

7.4.1.1 Connecting to the Device............................................................................................................ 125
7.4.1.2 Setting................................................................................................................................................... 126
7.4.2 Using the Analyzer ..................................................................................................................................... 130
7.4.2.1 Using the IRMA Mainstream Analyzer .................................................................................. 130
7.4.2.2 Using the ISA Sidestream Analyzer ........................................................................................ 132
7.4.3 Alarm for EtCO2 ........................................................................................................................................... 133
7.4.3.1 Type of Alarm ................................................................................................................................... 133
7.4.3.2 Setting Alarm ..................................................................................................................................... 134

7.5 Transferring Patient Monitoring Information ................................................... 135

Chapter 8. MENU Composition ............................................................................. 136

8.1 Patient Information ................................................................................................ 137

8.1.1 Patient Information 1/3 ........................................................................................................................... 137
8.1.2 Patient Information 2/3 ........................................................................................................................... 137

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8.1.3 Patient Information 3/3 ........................................................................................................................... 138

8.2 Alarm ......................................................................................................................... 139

8.2.1 Alarm Pause Time ...................................................................................................................................... 139

8.3 Printer........................................................................................................................ 140

8.4 Device Management .............................................................................................. 140

8.4.1 Voice Recording .......................................................................................................................................... 141
8.4.2 Volume ............................................................................................................................................................ 141
8.4.3 Date & Time ................................................................................................................................................. 142
8.4.4 Bluetooth ........................................................................................................................................................ 142

8.5 Etc. ............................................................................................................................. 143

8.5.1 Self Test ........................................................................................................................................................... 144
8.5.2 Data Management ..................................................................................................................................... 144

Chapter 9. Communication and Data Management ......................................... 145

9.1 Built-in Printer ......................................................................................................... 147

9.1.1 ECG Signal Output ..................................................................................................................................... 147
9.1.2 Defibrillation Result Report.................................................................................................................... 147

9.2 Data Storage: SD Card ........................................................................................... 148

9.2.1 Voice Recording .......................................................................................................................................... 148
9.2.2 Saving ECG .................................................................................................................................................... 148

9.3 External Communications: Bluetooth Communication ................................... 149

9.3.1 Initializing Bluetooth Connection ........................................................................................................ 149
9.3.2 Unpair Device ............................................................................................................................................... 152
9.3.3 12-Lead ECG Transfer ............................................................................................................................... 153
9.3.4 Real-time Transfer ...................................................................................................................................... 153
9.3.5 Connecting Bluetooth with Smartphone (for Android) ............................................................ 154

9.4 Data Management .................................................................................................. 155

9.4.1 Event Review ................................................................................................................................................. 155
9.4.2 ECG Review .................................................................................................................................................... 156
9.4.3 Data Copy ...................................................................................................................................................... 157
9.4.4 Data Delete.................................................................................................................................................... 157

Chapter 10. Maintenance ...................................................................................... 158

10.1 Self-test ..................................................................................................................... 158

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10.1.1 Power On Self-test ............................................................................................................................... 158

10.1.2 Periodic Self-test ................................................................................................................................... 159
10.1.3 Manual Self-test..................................................................................................................................... 159

10.2 Power Management ............................................................................................... 161

10.2.1 Charging Battery ................................................................................................................................... 161

10.3 Cleaning .................................................................................................................... 162

10.3.1 How to clean and Take Precautions ............................................................................................ 162

10.4 Maintenance Activities........................................................................................... 163

10.4.1 User Maintenance Activities ............................................................................................................. 163
10.4.2 Maintenance Checklist ........................................................................................................................ 164

Chapter 11. Safety Considerations ...................................................................... 165

11.1 Considerations during Product Management................................................... 166

11.2 Considerations for Product Usage ...................................................................... 167

11.3 Considerations for Defibrillation ......................................................................... 169

11.4 Considerations for Pacer Mode ........................................................................... 170

11.5 Considerations for Patient Monitoring Mode .................................................. 171

11.6 Considerations for Handling Power and Battery ............................................. 172

Chapter 12. Troubleshooting ............................................................................... 173

12.1 General Troubleshooting....................................................................................... 174

12.2 Troubleshooting for Problems Related to Defibrillation & Pacing Treatment

175

12.3 Troubleshooting for Problems Related to ECG Measuring ........................... 176

12.4 Troubleshooting for Problems Related to SpO2 Measuring .......................... 177

12.5 Troubleshooting for Problems Related to NIBP Measuring .......................... 178

12.6 Troubleshooting for Problems Related to EtCO2 Measuring ........................ 179

12.7 Troubleshooting for Problems Related to Printing ......................................... 180

12.8 Troubleshooting for Problems Related to Using SD Card ............................. 181

12.9 Troubleshooting for Problems Related to Bluetooth Communication ....... 182

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Chapter 13. Product Specification ...................................................................... 183

13.1 Exterior of Product ................................................................................................. 183

13.2 Environmental Condition....................................................................................... 184

13.3 ECG Analysis system – ECG Database Test........................................................ 186

13.4 Defibrillation Feature ............................................................................................. 186

13.5 Delivered Defibrillating Energy according to the Load Impedance ............. 188

13.6 Manual Mode .......................................................................................................... 189

13.7 AED Mode ................................................................................................................ 190

13.8 Pacer Mode .............................................................................................................. 191

13.9 Patient Monitoring Mode ..................................................................................... 191

13.10 Display .................................................................................................................. 195

13.11 Event Storage ...................................................................................................... 195

13.12 Built-in Printer ..................................................................................................... 195

13.13 Bluetooth .............................................................................................................. 196

13.14 Battery Module ................................................................................................... 196

13.15 AC Power Module............................................................................................... 197

13.16 Car Cigar Jack ...................................................................................................... 197

13.17 AC Power Adapter .............................................................................................. 198

13.18 Internal Battery ................................................................................................... 198

13.19 Power Adapter .................................................................................................... 198

Chapter 14. Service Guidelines ............................................................................ 199

Chapter 15. Electromagnetic Compatibility ...................................................... 201

◎ EtCO2 Measuring – Interfering gas and Vapor Effects ................................ 206

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CU-HD1 Instructions for use

◎ Before You Begin

◎ Before You Begin

Thank you for purchasing CU-HD1. In order to use this product safely, it is necessary to familiarize yourself with
this introduction manual and fully understand the operation methods and cautions before using the product.

CU-HD1 and CU Medical Systems, Inc. hereinafter referred to as “the Product” and “the Company” respectively.

This device provides the Automated External Defibrillator (AED) function, Manual Defibrillator function, Non-
Invasive Pacing function and Patient Monitoring function.

High-voltage and high-current electric energy is applied to the defibrillator. Therefore, be sure to
read through this Operation manual so that you can fully understand the safety cautions, operation
methods, and general cautions before using this product.

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CU-HD1 Instructions for use

◎ General Instructions

◎ General Instructions
When using the product, be sure to follow instructions described in this Operation manual.

It is recommended to place the instruction manual near the product and refer to it when unsure about an item
or a defect has possibly occurred.

In no event, shall the company be liable for any product problems arising out of careless operation or
negligent misuse by the user.

All of the repair services for the product can provided only by CU MEDICAL SYSTEMS, INC. or its authorized
agents.

Use only parts and accessories that are recommended by the company.

When you want to use the product in connection with other devices for which no usage instructions are
provided in this Operation manual, be sure to contact us before starting operation.

If this product does not operate normally, stop using the product immediately, contact our company or a
certified agency, notify of the failure details and request a repair.

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CU-HD1 Instructions for use

◎ About This Operation Manual

◎ About This Operation manual

■ Contents of This Operation manual
This instruction manual includes necessary information for the user to operate this product correctly.
If you have any questions or have any problems using the product, please contact us.

■ Safety Instructions and Cautions

※ In this Operation manual, following terms are used to highlight safety-related cautions that must
be observed during the use of the product. You must fully understand the safety-related
cautions described in this Operation manual to safely use the product.

※ If an injury has occurred to the user or a patient due to a clear instance of user negligence or
misuse, the company or its authorized agent holds no liability.

A case that could result in dangerous situations, including death or severe injury if instructions are
not observed

Instruction that directly or indirectly addresses the company policy in order to protect people or
property

Explanation of reference terms or additional operating methods for normal product usage

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CU-HD1 Instructions for use

◎ Storage and Usage Environments

◎ Cautions for Installing and Storing the Product

For product installation and storage, be sure to refer to the following instructions and avoid damages
to the product.
Symbol Instruction

Avoid installing or storing the product in a location with high humidity where is
exposed to moisture or poor ventilation.

Avoid installing or storing the product in a location with significant temperature

variation.
• Operation environment:
Condition where both device and pads must be stored together, and are
immediately usable in an emergency case.
Temperature range: 0℃~40℃, Humidity range: 5%~95%, Non-condensing
• Storage environment:
Condition where device and pads are not stored together with device that
has been stored or transported for a long time
Temperature range: -20℃~60℃, Humidity range: 5%~95%,
Non-condensing

Avoid installing or storing the product in a location with a leak of chemicals or

inflammable gas.

Do not disassemble the product arbitrarily.

In this case, the company is under no obligation.

Avoid installing or storing the product in a location exposed to direct sunlight.

Avoid installing or storing the product in a location near an electric heating

appliance.

Avoid installing or storing the product in a location where it may receive excessive
impacts from vibrations.

Proper caution must be taken to avoid exposure to impurities.

Especially, great caution must be taken to avoid exposure to metal impurities.

When disconnecting the power cord from the wall outlet, have it gently pulled out
by grabbing the plug and not the cord.

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CU-HD1 Instructions for use

◎ Storage and Usage Environments

◎ Storage and Usage Environments

※ Check for abnormalities on the exterior of the product, and if detected, contact and have the retailer
inspect the product before using it.

※ If the product has been submerged under water, contact and have the retailer inspect the product before
using it.

※ The status of the battery charge must be periodically monitored during the storage. Ensure that the
remaining battery is sufficient (for operating the device).

※ If the battery is completely discharged while using the device, you can use the device while charging the
battery by connecting the AC power module. At this time, turn off the device, connect the AC power
module, and then turn on the device again.

※ Do not operate the device in electrically noisy environments near motors, generators, X-ray equipment,
wireless transmitters or mobile phones as these will interfere with the signals being acquired. Such
electrical noise interference may lead to a malfunction of the device.

※ After using the device, thoroughly clean the main body using a soft, dry cloth.

※ If the battery has been stored for a long period of time, charge the battery periodically. This will help
preventing the occurrence of low battery level.

 Use the AC power adapter and car cigar jack in order to only recharge the battery.
 Do not use the device with the AC power adapter and car cigar jack connected to it.
 Remove the battery if the device is not likely to be used for some time.

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 CU-HD1 Instructions for use

◎ Chapter 1_Product Introduction

Chapter 1. Product Introduction

The CU-HD1 is a medical device that is operated by battery and AC power.

This product is a medical device designed to be used by Level 1 and Level 2 emergency medical technicians
and medical professionals.

This product provides the automated external defibrillation function and the manual defibrillation function. This
product also provides the synchronized cardioversion function, transcutaneous pacing function, and patient
monitoring function.

This product also has the Synchronized Cardioversion function, Transcutaneous Pacing function, and Patient
Monitoring function. This product can be used by emergency medical technicians and medical professionals.

You can use the functions of the device with simple button operations, and check various information through
the screen while using the product.

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CU-HD1 Instructions for use

◎ Chapter 1_Product Introduction

1.1 Intended Use

The CU-HD1 monitor/defibrillator is a complete acute cardiac care response system designed for basic
life support(BLS) and advanced life support (LAS) patient management protocols.

1.1.1 AED Mode

▶Indications

The Defibrillation function delivers an electric shock to a patient showing the symptoms of
sudden cardiac arrest, such as ventricular fibrillation and ventricular tachycardia, in order to
restore the normal ECG rhythm.

AED mode is to be used only on patients in cardiopulmonary arrest.

The patient must be unconscious, pulseless, and not breathing normally before using the
defibrillator to analyze the patient’s ECG rhythm.

※ A patient with sudden cardiac arrest is a person with

① no response and
② no normal breathing.

In the Automated External Defibrillation (AED) mode, the patient's ECG obtained through the
defibrillation pads is analyzed automatically and the guidance is provided through the voice and
message, informing the user to press the electric shock button.

▶Contraindications

None known.

The product must not be used in AED Mode on patients who show any of the following
symptoms: responsiveness, normal movement, normal breathing and a detectable pulse.

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CU-HD1 Instructions for use

◎ Chapter 1_Product Introduction

1.1.2 Manual Defibrillation Mode

In the manual mode an electric shock is delivered to a patient with arrhythmias according to the
patient's status for treatment while checking the patient’s signal directly.

Manual Mode is divided into two functions such as asynchronous defibrillation and synchronized
cardioversion.

The Synchronized Cardioversion function analyzes the QRS of the patient's ECG to enable
execution of the defibrillation according to the R wave.

In the manual mode, the synchronized cardioversion treatment can be used for a patient with
unstable tachyarrhythmia, such as atrial flutter or atrial fibrillation, and a patient with cardiac
ischemia who has insufficient blood volume.

▶Indications

Manual defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such
as ventricular fibrillation and symptomatic ventricular tachycardia. Delivery of this energy in the
synchronized mode is a method for treating atrial fibrillation, atrial flutter, paroxysmal
supraventricular tachycardia and, in relatively stable patients, ventricular tachycardia.

▶Contraindications

Defibrillation is contraindicated in the treatment of Pulseless Electrical Activity (PEA), such as

idioventricular or ventricular escape rhythms, and in the treatment of asystole.

 When the product is used for asynchronous defibrillation treatment in Manual mode, do not
use it on patients who show any of the following symptoms:
- responsiveness, normal movement, normal breathing and detectable pulse.
 There is a possibility of explosion or fire if the product is used in the presence of flammable
agents or in an OXYGEN enriched atmosphere due to the arc discharged caused by electric
shock.
 Do not deliver an electric shock when the patient's ECG signal is in the asystole state. It may
lead to a failure to restore cardiac pacemaker functions in the heart, meaning the cardiac
function will not be restored.
 This product must not be applied on patients implanted with the implantable pacemaker. If
patients show all of the symptoms including no response, and abnormal breathing, use the
product in the following ways:
- Attach the pad at least 3cm away from the implantable pacemaker attached to the patient.
- Do not attach the pad right on the area implanted with the implantable pacemaker.

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◎ Chapter 1_Product Introduction

1.1.3 Pacer Mode

Pacing is a method applied to patients who had lost natural cardiac movement functions, mostly
used on patients with bradycardia.

The CU-HD1 functions to support non-invasive pacing, a way of helping maintain a patient’s pulse
by attaching its electrode to the patient’s skin and delivering artificial electric stimulation to the
heart.

Pacing mode is divided into the ‘Fixed mode’ and the ‘Demand mode’.

Consult a physician and follow the manufacturer's instructions before treating a person with a
permanent pacemaker or an implantable cardiac defibrillator. Pacing therapy should only be
performed by trained medical personnel.

▶Indications

Noninvasive pacing is indicated for symptomatic bradycardia in patients with a pulse.

▶Contraindications

Noninvasive pacing is contraindicated for the treatment of ventricular fibrillation and asystole.

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◎ Chapter 1_Product Introduction

1.1.4 Patient Monitoring Mode

Patient monitoring mode features the ECG monitoring function, the function to measure the level
of SpO2, functional oxygen saturation in the blood, the function to measure the non-invasive
blood pressure, and the function to measure the end-tidal carbon dioxide (EtCO2).

For the ECG monitoring function, you can selectively use the 3-lead, 5-lead, or 10-lead ECG cables.
If the patient's ECG is analyzed while monitoring the patient and if ventricular fibrillation or
ventricular tachycardia occurs or it exceeds or falls below the range of set ECG, the alarm function
will be activated.

▶ Indications

The electrocardiogram is used to identify, diagnose, and treat patients with cardiac disorders and
is useful in the early detection and prompt treatment of patients with acute
STelevationmyocardial infarction (STEMI).

▶Contraindications

None known

SpO2 is a noninvasive method of measuring functional oxygen saturation (SpO 2) in arterial blood.
SpO2 readings indicate the percentage of hemoglobin molecules in arterial blood which are
saturated with oxygen.

▶Indications

Pulse oximetry is indicated for use in any patient who is at risk of developing hypoxemia.
SpO2 monitoring may be used during no motion and motion conditions.

▶Contraindications

None known..

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CU-HD1 Instructions for use

◎ Chapter 1_Product Introduction

A noninvasive blood pressure measuring device is divided based on patient status (adult, child
and infant - classified as For adults, children, and infants and is used with an appropriate cuff to
measure a patient’s blood pressure.

▶Indications

Noninvasive blood pressure monitoring is intended for detection of hypertension or hypotension

and monitoring BP trends in patient conditions such as, but not limited to, shock, acute
dysrhythmia, or major fluid imbalance.

▶Contraindications

None known..

End-tidal carbon dioxide (EtCO2) provides end-tidal CO2 level of the patient to monitor breathing
or to determine whether CPR is being performed correctly.

▶Indications

The electrocardiogram is used to identify, diagnose, and treat patients with cardiac disorders and
is useful in the early detection and prompt treatment of patients with acute
STelevationmyocardial infarction (STEMI).

▶Contraindications

None known..

※ For more detailed information about the patient monitoring mode, please refer to
“Chapter 7_Patient Monitoring”.

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◎ Chapter 1_Product Introduction

1.2 User-Specific Functions

1.2.1 Intended Users
The AED mode and Patient Monitoring mode can be used by Level 1 and Level 2 emergency
medical technicians and medical professionals. The Manual Defibrillation mode and the Non-
Invasive Pacing mode should be carried out by a medical professional.

1.2.2 Limited Usage by Users

The CU-HD1 is a product featuring the defibrillation, pacer and patient monitoring functions. Such
product features are designed to apply to only one patient, and it is forbidden to use such
features on more than two patients. For the purpose of maintaining patient records, the product
must be used on only a single patient.

To apply the defibrillation or pacing functions on the emergency patient who is currently using
the implantable cardiac defibrillator (ICD) or the cardiac resynchronization therapy defibrillator
(CRT-D), you must contact a medical specialist.

 Do not use this Product on more than one patient at the same time.
 When using the storage function, initialize equipment usage time so that you can identify the
specific patient information from others. If you set the Rotary switch to OFF for about 10
seconds, the device usage time will be initialized.

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◎ Chapter 2_ Components of the Product

Chapter 2. Components of the Product

The CU-HD1 is comprised of a main body and various accessories.

This chapter is intended to provide information about the exterior view of the product, various buttons and
indicators on the main body, Bluetooth communications with linkage to the outside, a real-time printing printer,
screen symbols, texts and voice signals that intend to bring convenience to users.

Also, this chapter includes the guidelines on accessories mounted on the main body which are the power
module, ECG cable, SpO2 sensor, NIBP cuffs, and EtCO2 module, etc.

 As for the pads designed and manufactured for the therapeutic purpose, ECG cables, and other
related accessories except for disposable consumables, you must use what is provided by the
CU Medical Systems, Inc.

 When there is any damage in disposable consumables or accessories, stop using the device
and contact a customer service center for replacement. Also, if damage occurs to the
equipment cable or reusable paddles, please contact a service center.

 If your CU-HD1 does not have some of the optional functionality listed in this chapter,
disregard these controls and the related information described throughout this manual.

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CU-HD1 Instructions for use

◎ Chapter 2_ Components of the Product

2.1 Exterior View of Product

2.1.1 Front View

2.1.2 Rear View

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◎ Chapter 2_ Components of the Product

2.1.3 Left/ Right Side View

2.2 Switches and Buttons

There are ten buttons on the main body including switches to change the defibrillation mode and
energy settings.

※ Each button’s function is described below.

1) CU-HD1

Button Function

Rotary Switch (Mode / Energy Selection Switch)

This button is used to select the desired mode (AED, Monitor, Manual) and turn
the power on/off. When the mode is selected, the power is turned on
simultaneously. When Manual mode is used, the user can select the volume of
electric shock energy (1-10, 15, 20, 30, 50, 70, 100, 120, 150, 170, 200 Joule).

Charge Button
When an electricity shock needs to be done in the manual defibrillator mode, the
defibrillation energy is charged according to the setting on the Rotary switch by
pressing this button.
When the battery has been completely recharged, the orange lamp of the Shock
button will be on.

Shock Button
When a defibrillation electric shock is needed through an ECG signal analysis, the
orange lamp of the Shock button will be on.
By pressing the button at this time, the electric shock will be delivered to the
patient.

Menu Knob
This key is used to navigate around the menu and select each mode. In addition,
the entry of patient information and device setup can be done.

Soft Keys
These buttons facilitate selecting necessary functions in each mode.

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Button Function

SYNC Button
In the manual defibrillator mode and pacer mode, it is used for synchronized
cardioversion.
It analyzes the patient's ECG signal and synchronizes the transfer of defibrillation
energy with the R wave among the QRS of the ECG signal within 60ms.

• Pacer Mode Button

Selects either the ‘Fixed mode’ or ‘Demand mode’ out of pacer modes for
noninvasive cardiac pacing therapy.
• Pacer Rate Selection Button:
Controls the pacing rate. The pacer rate control buttons on right and left adjust
the pacing rate.
• Pacer Current Selection Button:
Sets up the pacing current output using the pacing current control buttons on
right and left.
• Pacer Start/Stop Button
Starts and stops the pacing therapy.

Lead Selection Button

The lead of the ECG that is indicated in the LCD can be chosen.

Print Button
Outputs the real-time ECG information or stops any printing during the printing
process.

NIBP Button
Starts/Stops noninvasive blood pressure measuring.

Home Button
While changing the settings in the menu, pressing this button exits out from the
menu screen.

Event Button
The medicine information given to patients is entered.

2) CU-CM1

Button Function

Power Button
This button is used to select power on/off of CU-CM1

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2.3 Indicators
1) CU-HD1
The indicators are located right over the main body’s LCD display as shown below. They function
to indicate the power state of the device or any problems that may happen in the device.

※ The symbols marked in the above indicators are summarized below.

Indicator Description

This indication shows whether the power is fed from the commercial power source
through an AC power module, or from the car cigar jack.

Once the battery is attached to the device, the LED lights up in green. When the
green LED is blinking, it indicates that the battery is being charged through the AC
power module and the car cigar jack. Once the charging is completed, it lights up
in green.
When there is any problem in the system, the SERVICE LED lights up.
If this happens, the device does not operate normally. Therefore, stop using it
immediately and contact an authorized service center to repair the product.

2) CU-CM1
The four indicators are located on the left side of CU-CM1.

※ The symbols marked in the indicators are summarized below.

Indicator Description

Power/Connection Indicator
The blue indicator will light up when the product turns on. If the CU-CM1 is in
communication with the CU-HD1 via Bluetooth while measuring CO2, the blue
indicator will blink in 1 second intervals.
Low Battery Indicator
The yellow indicator will light up when the remaining battery of the CU-CM1 falls
below 20%. Recharge the battery when the Low Battery Indicator turns on.
Charging Status Indicator
The green indicator will light up when the battery is charged with AC power.
The indicator will turn off when battery charging is complete

AC Power Connection Indicator

The green indicator will light up when AC power is connected to the product.

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◎ 2장_제품구성

3) IRMA Mainstream gas analyzer

※ The indications of the above indicator are summarized below.

Steady green light System OK

Blinking green light Zeroing in progress

Steady red light Sensor error

Blinking red light Check adapter

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2.4 Screen Layout Elements

The CU-HD1 screen is differently composed depending on individual modes (AED, Manual
Defibrillation, Pacer, and Patient Monitoring).

2.4.1 Screen Layout

The screen shown on the LCD of the product is sectioned as shown in the figure below.
According to the function of the CU-HD1, a different screen layout is displayed and the basic
screen layout is shown below.

1) AED Mode

(A)
(D)
(B)

(E)
(C)

Screen Layout
Device state Shows mode in use, connector state, Duration of device
(A)
indication area usage, current time, date, and power state
(B) Sector 1 Display of ECG measured through the pads
Shows text prompt guides and progress of AED
(C) Sector 2
procedure
Heart rate indication
(D) Shows beat per minute(bpm)
area
(E) SpO2 indication area Shows SpO2(%)
Menu & Soft button Soft buttons to start analyze, change CPR type,
(F)
area start/stop CPR, and menu creation

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2) Manual Defibrillation Mode, Patient Monitoring Mode, and Pacer Mode

(A)

(B) (D)

(E)
(C)
(F)

(G)

Screen Layout
Device state indication Shows mode in use, connector state, Duration of device usage,
(A)
area current time, date, and power state
(B) Sector 1 Vital signs measured through the ECG electrodes, pads, paddles
(C) Sector 2 or sensors

Heart rate indication

(D) Shows beat per minute(bpm), predefined alarm limit
area
Shows blood pressure(mmHg), Systole/diastole, mean blood
(E) NIBP indication area
pressure, predefined alarm limit
(F) SpO2 display area Shows SpO2(%),predefined alarm limit
Menu & Soft button Creates soft button menu by mode, shows alarming message,
(G)
area and Bluetooth connection

 Heart rate is expressed as the vital sign in Sector 1, while the vital sign set for Sector 2 does
not affect the heart rate display.

 When the ECG cables are not connected or when in Lead Fault condition, the ECG lead graph
is displayed in dotted lines.
 When the pads or paddles are not connected or when the pads are not attached, the pad lead
graph is displayed in dotted lines.

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3) 12-Lead Screen Layout of Patient Monitoring Mode

By connecting a 10-lead cable, Patient Monitoring Mode can be switched to a mode that
measures 12-lead ECG signals in the following screen layout.

(A)
(B)

(C)

Screen Layout
Shows mode in use, connector state, Duration of device
(A) Device state indication area
usage, current time, date, and power state
12-lead ECG indication 10-ECG signal measured form the lead ECG cable
(B)
area (I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6)
Patient vital signs & Displays heart rate, SpO2, NIBP, Bluetooth
(C) Bluetooth communication communication connection status, soft button menu, and
area alarm message

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2.4.2 Battery Indication Symbols

The product displays the battery status in the symbols depicted as follows:

Stage Symbol Description

Step1 Remaining battery is more than 90%

Step2 Remaining battery is 60~90%

Step3 Remaining battery is 40~60%

Step4 Remaining battery is 10~40%

Step5 Remaining battery is less than 10%

In addition, the icons related to the battery are summarized in the following table.

Symbol Description
AC power module input

Battery is not connected

 It is recommended that battery charging must be done if it’s Step 4, or two LEDs light at the
battery gauge at least.

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2.4.3 Soft Key

The usage of the soft keys is changed depending on individual modes the product offers. The
function of each key by mode is summarized in the table below.

Soft Key Description

Starts an ECG analysis.

Stops the ECG analysis.

Denotes that the CPR type is set to 30 : 2.

Pressing the soft key switches the type to 15 : 2.
Denotes that the CPR type is set to 15 : 2.
Pressing the soft key switches the type to 30 : 2.

Starts CPR.

Stops CPR.

The charged electric shock energy is internally discharged.

Turns off an alarm that is occurring. Pressing the soft button will turn off an
alarm and the button will change into the [Pause Alarm] button.

Stops the alarm temporarily.

Starts the 12-lead mode.

Stops the 12-lead mode.

Transfers the 12-lead data.

Transfers the information of the patient being examined to the computer in real
time. To see this, Bluetooth must be connected.

Once the pad is detached, the menu is activated. (Applied to all modes)

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2.4.4 Display Symbols

Symbol Description

Indicates the 3-lead ECG cable is connected.

Indicates the 5-lead ECG cable is connected.

Indicates the 10-lead ECG cable is connected.

Indicates the pads are connected.

Indicates the paddles are connected.

The IRMA Mainstream Analyzer is connected to the CU-CM1.

The ISA Sidestream Analyzer is connected to the CU-CM1.

Indicates whether the Bluetooth communication is connected.

(Blue: Bluetooth connected, Red: Bluetooth disconnected)

Shows it is in the R-Sync mode.

Indicates it is printing.

Indicates the alarm function is on.

Indicates the alarm function is off.

Indicates the alarm function is temporarily stopped.

Indicates heart rate at the 12-lead mode.

Indicates the ECG storage function is being executed.

Indicates the voice and ECG storage functions are being executed.

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2.4.5 Symbols Used on the Operation manual and Equipment

Any or all of the following symbols may be used in this manual or on this equipment.

1) CU-HD1 and Other accessories

Symbol Description

Consult instructions for use (Operation manual).

Conformité Européenne
Complies with the requirements of the Medical Device Directive
93/42/EEC as amended by 2007/47/EC
For EU only:
Electrical and electric equipment shall be collected and recycled in
accordance with Directive 2002/96/EC

Defibrillation-proof type BF applied part

Defibrillation-proof type CF applied part

Authorized representative in the European Community

Manufacturer

Date of manufacture

Use by date

Serial Number

General warning: Observe and follow all safety signs

Warning: Electric Shock

Do not immerse in water.

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Symbol Description

Do not break, drill, or disassemble.

Warning: Keep away from flammable materials.

Direct current

Alternating current

Do not re-use

LOT Number

Catalogue number

Temperature limit: Storage it in temperature environments ranging from

0℃ to 43℃.

Do not fold.

For Korea only:

Confirmation of declaration (for battery module)

Equipment or system which includes an RF transmitter or intentionally

applies RF energy for the purpose of diagnosis or treatment.

Protected against ingress of solid foreign objects >1.0mm in diameter.

IP43 Protected against access to hazardous parts with a wire.
Protected against spraying water

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2) CU-CM1
Symbol Description

Power Button (ON/OFF)

Indicates connection of power and product

Indicates low battery

Indicates the charging status

Indicates connection of AC power

DC power input

Serial port

Gas Inlet

Defibrillation-proof type BF applied part

Consult instructions for use (Operation manual).

Warning

For Korea only:

Certificate of Broadcasting and Communication Equipment

Serial Number

Date of manufacture

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3) IRMA Mainstream gas analyzer

Symbol Description

Serial Number

Catalog number

Complies with 93/42/EEC Medical Device Directive when connected to

medical devices approved by PHASEIN AB.

Rx only
Caution (U.S.): Federal law restricts this device to sale by or on the order
of a physician.

Consult instrunctions for use.

IP classification indicating level of protection against ingress of water and

IP44 solid foreign parts

For EU only:
Electrical and electric equipment shall be collected and recycled in
accordance with Directive 2002/96/EC.

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4) ISA Sidestream gas analyzer

Symbol Description

Serial Number

Catalog number

Complies with 93/42/EEC Medical Device Directive when connected to

medical devices approved by PHASEIN AB.

Rx only
Caution (U.S.): Federal law restricts this device to sale by or on the order
of a physician.

Gas Inlet:
Gas inlet for connecting the Nomoline Family sampling lines

Gas Outlet (evac):

Evacuation outlet

Consult instrunctions for use.

IP classification indicating level of water protection

IPX4 “Splash-proof”

For EU only:
Electrical and electric equipment shall be collected and recycled in
accordance with Directive 2002/96/EC.

Date of manufacture

Defibrillation-proof type BF applied part

Conforms to ANSI/AAMI ES60601-1:2005 Cert. to CAN/CSA-C22.2

No.60601.1:2008.

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2.5 AED Mode Voice and Text Prompts

※ Plug in pads connector
It indicates that the pads connector or the paddles adapter must be connected to the main
body.

※ Attach pads
Attach the disposable defibrillation pads to the patient’s chest skin below the right clavicle and
on the middle glands in the armpit below the left nipple, and connect the connector on the
opposite side of the defibrillation electrode to the defibrillation pad connector correctly.

※ Do not touch the patient

It indicates that contact with the patient must be avoided for the accurate ECG analysis.

※ Analyzing heart rhythm

It indicates that it is under the analysis of the patient’s ECG signal. Do not touch the patient.
Also, when analyzing the ECG signal, if a patient makes any movements, the analysis may have
errors.

※ Shock advised
It means that the patient needs to have electric shock treatment.

※ Stand clear
It means that a patient must avoid all contact with other people.

※ Charging
It indicates that sufficient energy is charged for electric shock treatment.

※ Press the flashing orange button, now

It indicates that the user must press the Shock button for electric shock treatment.

※ Shock delivered
It indicates that electric shock treatment was delivered to the patient.

※ No shock advised
It indicates that electric shock treatment is unnecessary.

※ The shock button was not pressed

It indicates that a prompt to press the Shock button has not been pressed within 15 seconds.
(The device will discharge through an internal circuit after 15 seconds)

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※ Push the chest down fast two inches

It indicates that you must administer cardiopulmonary resuscitation (chest compression).

※ Begin CPR, now

It means that you must begin CPR.

※ Give two breaths

It indicates that you must administer cardiopulmonary resuscitation (chest compression).

※ If no pulse, press “Analyze”

It indicates that there is no pulse in manual analysis mode. You must press the Analyze button.

※ If no pulse, begin CPR

If there is no pulse and not need electric shock, you must begin CPR.

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2.6 Alarms and Errors

2.6.1 Alarm
Information and alarms for the patient or device state are transferred to the user through text
messages in the LCD, beeper sounds or LED indicators of the CU-HD1. When an alarm is issued,
the alarm will continue until the user confirms it. To cancel the alarm, you need to change alarm
setting in the alarm item on the main menu or eliminate the factors causing the alarm.

※ The alarm settings can be changed under alarm list in the MENU. Default alarm settings
are restored when the product is powered off and on. To change the default alarm setting,
refer to the service manual.

Individual alarms and their description are summarized below.

• Indicator
It shows the information on the production operation and the state of the battery/AC power. For
details, refer to the description in Section 2.3 - Indicators.

• Text
If the set limit of alarm occurrence is exceeded according to the patient’s condition, an alarm of
the patient's condition will be issued and the relevant alarm text will be displayed on the top left
side of LCD. Also, if the cables, paddles or pads are not connected, a message indicating the
relevant condition is displayed on the LCD.
When it is temporarily stopped, the alarm is done so for a predetermined period of time, and the
temporal stop time is lapsed in 10-second interval until its preset time, enabling a checkup for a
temporary alarm stop.
If the alarm condition continues to happen even after discontinuing the alarm, the same alarm
continues to be issued.

• Sound alarm (Beep sound)

A beep sound is generated depending on the alarm conditions. You can mute the alarm sound
(beep sound) by pressing the Mute Alarm button. When you press the Mute Alarm button, the
alarm will be muted according to the set time, and the Mute Alarm button will change to the
Pause Alarm button. If you press the Pause Alarm button, an alarm will not be issued according
to the set time.

※ Alarm sound range: Max. 85 dB, Min 45 dB

High Priority Alarm sound : 85dB (Maximum level)
Medium Priority Alarm sound : predefined Alarm volume level (Min.45dB ~ Max.85dB)

 If the volume level of the alarm sound is lower than the ambient sound pressure level, it may
interfere with the operator’s awareness of the alarm condition.

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 If an arrhythmia (ventricular fibrillation/ventricular tachycardia) or cardiac arrest takes place, an

alarm for the patient condition shall be issued at the patient monitor mode, pacer mode and
manual defibrillation mode. If it is intended to monitor the patient, check the alarm settings on
the menu.

1) The Type of Alarm

※ The following shows type or alarms corresponding alarm settings and patient conditions.
They can be configured in the alarm section of the menu.
Alarm Item Alarm Message (Color)
Ventricular Fibrillation / Ventricular Tachycarddia VF / VT (Red)
Asystole Asystole (Red)
Extreme Brady (Red)
Extreme Tachy (Red)
Heart rate
HR High (Yellow)
HR Low (Yellow)
Pulse Low (Yellow)
Pulse
Pulse High (Yellow)
SpO2 Low (Yellow)
SpO2
SpO2 High (Yellow)
Systolic High (Yellow)
Systolic Low (Yellow)
Diastolic High (Yellow)
NIBP
Diastolic Low (Yellow)
Mean High (Yellow)
Mean Low (Yellow)
EtCO2 High (Yellow)
EtCO2 Low (Yellow)
Capnography Respiration Rate High (Yellow)
Respiration Rate Low (Yellow)
Apnea (Red)
※ Red: High priority order Alarm, Yellow: Medium priority order Alarm
※ Latch / Non-Latch Alarm
Interval between alarm signals
 Latch alarms
- Once the alarm is triggered, it will not be cleared until the [Pause Audio] or [Pause Alarm]
button is pressed even after the patient recovers to normal.
- This includes High priority order alarms.
 Non-Latch alarms

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- Once the alarm is triggered, it will clear automatically when the patient recovers to
normal.
- This includes Medium priority order alarms.

 ECG alarms (VT/VF, asystole, heart rate) are generated only when Sector 1 is lead II or pads.
 To monitor ECG alarms, Sector 1 must be changed to 'Lead II' or 'Pads'.

2) List of Default Alarm Limits

※ The following list shows the defibrillator's default alarm settings. When the defibrillator
is powered off and on, the following alarm settings are restored. To change the default
alarm settings, see the Service Manual.
Alarm
Default Alarm Limits
Item
VT / VF Alarm setting ON
Asystole Alarm setting ON
Alarm setting ON
Heart rate
Trigger condition Under 60 BPM / Over 120 BPM
Alarm setting ON
Pulse
Trigger condition Under 60 BPM / Over 120 BPM
Alarm setting ON
SpO2
Trigger condition Under 90% / Over 100%
Alarm setting ON
Alarm standard Systolic blood pressure
NIBP Systolic alarm trigger condition Under 70 mmHg / Over 200 mmHg
Diastolic alarm trigger condition Under 30 mmHg / Over 160 mmHg
Mean alarm trigger condition Under 40 mmHg / Over 180 mmHg
Alarm setting ON
EtCO2 Trigger condition (if using %) Under 2% / Over 6.7%
Capno- Trigger condition (if using mmHg) Under 15mmHg / Over 50mmHg
graphy Alarm setting ON
Respiration
Respiration rate trigger condition Under 5 BPM / Over 30 BPM
rate
Apnea alarm trigger condition Apnea for more than 20 seconds

2.6.2 Errors
The product may produce errors when there are problems during its operation in addition to
alarms, and each error is represented in the LCD screen as a code.
※ To troubleshoot the errors, refer to “Chapter 12_Troubleshooting”.

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 Setting Alarm limits to extreme values can render the Alarm system useless.

 If the rotary switch is not in the correct position, the 'Check the rotary switch.' message
appears with a periodic alert sound. If this alarm message appears, check that the rotary switch
is positioned correctly.

2.7 Accessories
The CU-HD1’s accessories are composed of disposable accessories (disposable defibrillation pads,
ECG electrodes, printing papers, etc.) as well as external defibrillation paddles used for electric shock,
ECG cables, SpO2 sensor and extension cable, NIBP cuff and NIBP connection tube, SD card, power
supply devices (AC power module, car cigar jack, and battery module), and bed rack.

Image Name Description

External
External defibrillation paddles are pressed against the patient's
Defibrillation
chest to deliver electric shock.
Paddle

Conductive gel is used to maximize electric contact between the

Conductive Gel
patient and the metal surface of the paddles.

Disposable Disposable defibrillation pads are attached on the chest to

Defibrillation measure the patient's ECG or, when necessary, to deliver electric
Pads shock. Always refer to the markings on the pads before attaching
(Adult) them.

Infant/Child Only for AED mode.

Reduced Energy Including a module that reduces the energy delivered to the
Defibrillation patient, these disposable pads can be attached on the front or
Pads back of an infant/child patient in any direction.

Only for manual defibrillation mode, pacer mode, and patient

Multifunction
monitoring mode.
Defibrillation
These disposable pads can be attached on the front or back of
Pediatric Pads
an infant/child patient in any direction.

After removing disposable defibrillation pads (for adults or for

Pads Connection
infants/children) from package, use pad connection adapter to
Adapter
connect the pads to the defibrillator.

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Image Name Description

3-Lead ECG This ECG cable is used for measuring 3-lead ECG waveforms
Cable ∙ Leads: I, II, III

5- Lead ECG This ECG cable is used for measuring 7-lead ECG waveforms
Cable ∙ Leads: I, II, III, aVR, aVL, aVF, V

10- Lead ECG This ECG cable is used for measuring 12-lead ECG waveforms
Cable ∙ Leads: I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

Disposable ECG
ECG monitoring electrodes are attached on the patient to
Monitoring
measure ECG signals.
Electrodes

The sensor is attached to the patient's fingertip, etc. to measure

SpO2 Sensor
SpO2.

SpO2 Sensor This extension cable is used to connect SpO2 sensor to the CU-
Extenstion Cable HD1.

Cuff for NIBP

Measuring This cuff is used for NIBP measurement of infants.
(Infant)

Cuff for NIBP

Measuring This cuff is used for NIBP measurement of children.
(Child)

Cuff for NIBP

Measuring This cuff is used for NIBP measurement of adults.
(Adult)

Connection This connection tube is used to connect the NIBP measuring cuff
Tube for NIBP to the CU-HD1.
Measuring

CO2 Sensor If the EtCO2 option is selected for your CU-HD1, this
Communication communication module connects the CU-HD1 with the IRMA
Module Mainstream or ISA Sidestream over Bluetooth.

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Image Name Description

IRMA
Mainstream This mainstream analyzer module measures EtCO2.
Analyzer

ISA Sidestream
This Sidestream analyzer module measures EtCO2.
Analyzer

IRMA Airway
This adapter is connected to the IRMA Mainstream to measure
Adapter
EtCO2 of an adult or child.
(Adult/
Single patient use. Disposable.
Pediatric)

IRMA Airway This adapter is connected to the IRMA Mainstream to measure

Adapter EtCO2 of an infant.
(Infant) Single patient use. Disposable.

Nomoline
This is connected to the ISA Sidestream gas analyzer to measure
(Adult/
EtCO2.
Pediatric/
Single patient use. Disposable.
Infant)
Nomoline
Adapter This is connected to the ISA Sidestream gas analyzer to measure
(Adult/ EtCO2.
Pediatric/ Multi patient use. Disposable.
Infant)
Nomoline
Airway This is connected to the ISA Sidestream gas analyzer to measure
Adapter Set EtCO2.
(Adult/ Single patient use. Disposable.
Pediatric)

This is connected to the ISA Sidestream gas analyzer to measure

Nomoline
EtCO2.
Extension
Single patient use. Disposable.

T-Adapter This is connected to Nomoline and Monoline extension to

(Adult/ measure EtCO2.
Pediatric) Single patient use. Disposable

When charged, the battery module can supply power to the CU-
HD1 without the need for an external power source.
Battery Module
※ For details on attaching, detaching and charging the battery,
see "3.2.1 Installing & Charging Battery".

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Image Name Description

This module provides power to the CU-HD1 from a commercial
100-240V AC power source. It can also charge the battery
AC Power
module.
Module
※ For details on attaching and detaching the AC power module,
see "3.2.2 AC Power Module Connection".

AC Power The power adapter can be connected to the rear of the CU-HD1
Adapter to charge it.

The car cigar jack can be connected to the rear of the CU-HD1
Car Cigar Jack
to charge it through the cigar jack in a car.

Power Adapter
The power adapter can supply power to the CU-CM1.
for CU-CM1

Cradle for holding the CU-CM1 and ISA Sidestream sensor in

CU-CM1 Cradle
place.

The bed rack allows the CU-HD1 to be secured onto the patient's
Bed Rack
bed.

SD Card
The SD card is used to save or export data generated by the
(Secure Digital
CU-HD1.
Card)

Printing paper is required for the built-in printer.

Printing Paper ※ For details on the printing paper, see "Chapter 13. Product
Specifications".

Load resistance is used to check the defibrillation function in

Self-test Load
manual self-testing mode.
Resistance
※ For details on manual self-testing, see "8.5.1 Self Testing".

Attached to the CU-HD1, the carry bag can house CU-HD1

Carrying Bag
accessories.

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 Paddles or pads designed specifically for children are recommended when using the
defibrillator on children aged 8 years or under or weighing 25 kg or below. In emergency
situations, pads for adults may be used on children.
 Using the defibrillator on an adult with pads for children (without defibrillation energy
reduction module) may cause necrosis of the cardiac muscles.

 ECG cables with AHA in the product name are generally ECG cables following the US naming
convention, while products with IEC in the product name are generally ECG cables following
the EU naming convention

Location of AHA IEC

electrode Mark Color Mark Color
RA White R Red
Limbs LA Black L Yellow
electrode LL Red F Green
RL Green N Black
V Brown C White
V1 Brown C1 Red
V2 Yellow C2 Yellow
Chest
V3 Green C3 Green
electrode
V4 Blue C4 Brown
V5 Orange C5 Black
V6 Violet C6 Violet

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◎ Chapter 3_Product Installation

Chapter 3. Product Installation

This section is intended to provide basic information about how to install the CU-HD1 and its product parts.

For details regarding the operation of CU-HD1 besides the installation of accessories, refer to Chapters 4~7.

If the product is initially installed in an emergency situation, please check out if the product components are
properly installed after the product has been used or during the periodic checkup session.

If the floor surface and your hands are wet, you may get shocked. Move to a dry location first and install the
product.

Before using, turn on the device using the Rotary switch and check the charging status visually.

If an optional charger is used, charge it for at least 4 hours.

Double check any part connected to the patient directly.

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3.1 Unpacking
Take a careful look to see if there is any damage to the package container.
Check out whether there is any obvious damage to the device, which may have been caused during
transportation.
Check if all of the components and accessories have been accurately provided according to the
package item list.

3.1.1 Package of the Main Body

As seen in the below figure, the main body package includes with the main body of CU-HD1 of
the CU-HD1, an AC power module, and the battery module, etc.

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3.1.2 Package of Accessories

The accessory package is composed of the below items, and each of the accessories are listed
below.

 Consist of accessories may be differed from an order. When unpacking, it is very important to
check to make sure all accessories you have placed an order are included

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3.2 Peripheral Device Connection

3.2.1 Installing Battery and Charging Battery
The battery module is mounted in the direction shown in the below figure. After the battery
module has been mounted, be sure to hear a “click” sound when the battery module and the
CU-HD1 are connected to each other.

-- +

Finger latch

The internal battery pack of the Product is fully charged before leaving the factory. Upon
receiving the product, please charge the battery module.

To separate the battery from the main body, press the finger latches on both sides of the battery
and pull the battery out.
Avoid exposing battery module to hot, humid or wet conditions.

If the Low Battery status is indicated, please charge the battery module. When the battery is
being recharged, the Battery Recharge indicator will blink. When the recharging process has been
completed, the Battery Recharge indicator will shows green light.

 To check the battery charging status, refer to the battery status displayed in the LCD screen.
 To check the battery status in terms of the charge level, refer to “2.4.2 Battery Indication
Symbols” or use the Battery Level Indication button in the rear side of the battery.
 For more information about the safety tips for battery usage, please refer to “11.6
Considerations for Handling Power and Battery”.
 For more detail information about the charging battery, please refer to “10.2 Power
Management“.

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3.2.2 AC Power Module Connection

The AC power module is mounted in the direction shown in the below figure. After the AC power
module has been mounted, be sure to hear a “click” sound when the AC power module and the
CU-HD1 are connected to each other. After the AC power module has been mounted, use the AC
power by plugging in the power cable.

-- +
--
-

Finger latch

To separate the AC power module from the main body, press the finger latches on both sides of
the AC power module and pull the AC power module out.
Avoid exposing AC power module to hot, humid or wet conditions.

If the SUPPLY MAINS is interrupted for more than 30 s, the subsequent operation does one of the
following:

- Connected with charged battery

The CU-HD1 continues normal operation by switching automatically to operating from its battery,
and the mode of operation, all OPERATOR settings and stored data shall not be changed.

- Non connected with battery or connected with discharged battery

The CU-HD1 reverts to the MANUFACTURER’s or previous RESPONSIBLE ORGANIZTIONS’s default
settings.

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 Vendors and users should note that the AC power module has been rated for electromagnetic
compatibility for work use (A Class). The defibrillator is appropriate for use in places other than
homes.
 Caution should be taken on the mounting position of the battery module and the AC power
module shown in the instruction manual.
 The battery module is mountable in both the A and B slots, but the AC power module is
mountable only in the B slot.

 For more information about the safety tips for the AC power module, please refer to “11.6
Considerations for Handling Power and Battery”.

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3.2.3 Connecting the Car Cigar Jack and AC Adapter

The car cigar jack is mounted in the direction shown in the figure below. The car cigar jack input
terminals are located in the left lower part (the ‘B’ slot indicating terminal) of the rear side of the
device.

The protruding part of the car cigar jack connector faces upward when mounting the car cigar
jack.

-- + -- +

 The car cigar jack and AC power adapter are designed only to charge the battery. Therefore,
do not use them for running the device.
 For more information, please refer to “11.6 Considerations for Handling Power and Battery”.

3.2.4 Mounting SD Card

The SD card mounting slot is located in the left side of the main body. Open the protection cover
from the slot and mount the SD card as shown below.

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3.2.5 Feeding Printer Paper

For feeding the printer paper, load the paper according to the below sequence.

① In the left figure, pull the lever forward on the right side of the printer from the CU-HD1.
② The front cover of the printer will be open as shown in the figure on the right.

③ Place the printer paper into the printer, and pull out some paper.
④ Push the printer cover back to the default location until it makes a “click” sound.
⑤ If the Rotary switch is set to the monitor mode, the printer power amp will be light up green.
You can use the [Feed] button to take as much printer paper as you want

⑥ When replacing the printer paper, repeat steps ① and ②, then detach the printer paper
with your hand.

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3.2.6 Connecting AC Adapter for charging CU-CM1

To charge the CU-CM1 battery, mount the charging adapter in the direction shown below.
The input port is located in the top left of the CU-CM1.

AC Adapter Port

3.3 Self-test
Whenever the product is turned on, it periodically initiates a self-test. This test is designed to ensure
that the whole system is ready for use in emergencies. The Self-test performs the battery state
checkup, the control system state checkup, and evaluates all functions provided by the product.

This product can also run a manual self-test. It is recommended to perform a manual self-test for
first-time use. For detailed contents, refer to “10.1 Self-test”.

3.4 Product Storage

Place the product in an accessible place so that it can be used readily during emergencies.

Do not disconnect the battery pack during storage. The battery must be charged fully enough to be
turned ON during emergencies through the self-test.

 If there are errors other than the battery error, contact CU Medical Systems, Inc. or an
authorized agent. If a “Low Battery” error occurs, recharge the battery pack or plug in the AC
power according to the instructions described in the Operation manual.

 For long-term storage, do not store the product in connection with the disposable
defibrillation pads.

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◎ Chapter 4_Automated External Defibrillation

Chapter 4. Automated External Defibrillation (AED) Mode

■ Overview
The Automated External Defibrillation (AED) mode designed for patients with acute cardiac
arrhythmia automatically analyzes whether the patient falls under cardiac arrhythmia like ventricular
tachycardia or ventricular fibrillation, and produces corresponding results in the form of sound or text
to help the user appropriately treat the patients.

This defibrillator supports two AED modes: Auto Analysis Mode (Auto Analysis Mode ON) which
automatically analyzes the patient's ECG, and Manual Analysis Mode (Auto Analysis Mode OFF) which
analyzes ECG when the 'Analyze' soft key is pressed. In addition, the defibrillator provides voice
guidance to facilitate performance of CPR. In addition, the product provides a voice guide to facilitate
the CPR procedure.

 Other medical devices that may be affected by defibrillation energy (strong electric shock) or
become an obstruction to the protection of defibrillator should be removed from the vicinity of
the patient.

 The CU-HD1 is not intended to be used for supplementing the abnormal functionality of the
internal pacemaker. Therefore, if needed to recover the heart function of patients using the
internal pacemaker, consult a medical specialist.
 The CU-HD1 does not have any functionality generating the alarm sound or warning message
saying whether an internal pacemaker is used for the patient or not.

 To safely shut the CU-HD1 down while in AED (Automated External Defibrillator) mode, rotate
the rotary switch to the OFF position.

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4.1 Preparing Defibrillation

4.1.1 Connecting to the device
1) Connecting the Pads connection adapter
Connect the pad connector to the main body as shown in the figure below. Check the shape of
the connector input terminal on the main body and the shape of the pad connector cradle.

When removing the defibrillation pads and paddles connector from the main body, for
disconnection, turn a cable connector terminal in the unlocking direction, and pull it out from
the main connector.

2) Connecting the Disposable defibrillation pads

Connect the disposable pad and the pad connector as shown in the figure below. There is a set
direction of groove. Caution should be taken on this direction when connecting.

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4.1.2 AED Mode Layout and Setting

1) AED Mode Layout

Shock
Cable
AED Usage Da Time Ti Power
Connection
Mode Time te m status
Status
Lead e
Informat
Heart
ion
Rate

Text
Messa SpO2
ge

Analyz CPR Type CPR

e Button Start
Button Button

AED Mode Informs which mode is running.

Usage Time Displays the total time of use of the device after turning it on.
Date Displays the date.
Shock Times Shows the number of electric shocks delivered.
Current Time Shows the current time.
Shows the input power state when using the remaining battery
Power Status
indication or the AC power module.
Heart Rate/ SpO2 Shows the heart rate and SpO2.
Shows the message telling the AED procedural information while using
Text Message
the AED mode and the battery charge state.
CPR Type Button Controls the CPR rate. (30:2, 15:2)

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2) Setting
2.1) Auto Analysis
Press the menu knob from “Auto Analysis” at the “Main Menu” and then the following screen
will be prompted, where you can change the Auto Analyzing setting at the AED mode.

 In Auto Analysis ON mode, patient ECG is automatically analyzed once the pads are correctly
connected to the patient.
 In Auto Analysis OFF mode, patient ECG is not analyzed even when the pads are correctly
connected to the patient.
To analyze ECG, press the "Start Analysis" soft key.

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2.2) CPR
Press the menu knob from “CPR” at the “Main Menu” and then the following screen will be
prompted, where you can change the CPR setting at the AED mode. From the CPR menu, you
can choose whether to turn on/off the CPR guide, or the method of CPR.

After changing the CPR settings, the changed values are applied by pressing the menu knob.
Select Exit from “CPR” menu and press the menu knob to retrieve the “Main Menu”.

 CPR Guide On/Off

You can set it to On/Off to use the CPR guide via the voice and text instruction functions.
 CPR Pause Time
. When the CPR guide is set to off, the CU-HD1 can pause the device so that the user can
perform CPR. .
 Compression: Breath
You can choose 30 : 2 or 15 : 2 for CPR.

2.3) Voice Recording

The CU-HD1 supports the voice recording function, and determines whether to use the voice
recording function in this item.
The voice recording is available on AED mode only.

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2.4) Volume
This is a sub-menu to control the speaker volume of the CU-HD1.

 Voice Volume / Alarm Volume

The device has a volume scale of 10 levels, which can be changed by 1 unit with the
menu selection button.
 QRS Beep On/Off:
You can set it to On/Off to generate the beep sound when detecting the QRS of the ECG.

2.5) Filter
At the “Filter” menu, you can set a bandwidth with which you can check out the ECG signal
detected by the CU-HD1.
Support for the function of filtering the LCD monitor and printer ECG signal, and individual
optional item is listed as follows.

 ECG For Display

You can select the filter bandwidth of EMS (1~30Hz) and Monitor (0.5~40Hz). Default
setting is EMS.
 ECG For Printing
You can select the filter bandwidth of EMS (1~30Hz), Monitor (0.5~40Hz), and Diagnostic
(0.05~150Hz). Default setting is EMS.
 AC Line Filter
This is an item to remove the power noise. Select 60Hz or 50Hz according to the power
source. Default setting is 60Hz.

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2.6) ECG Gain

This is the menu item that takes control of the ECG sensitivity degree. If the ECG signal is too
high or too low, you can change the signal level to an extent that you can easily verify it.
Default setting is 10mm/mV.

 Sector 1
As for the ECG signals displayed in the Sector 1, click the menu knob to choose the ECG
signal size from Auto Gain, 5mm/mV, 10mm/mV, and 20mm/mV.
 Sector 2
As for the ECG signals displayed in the Sector 2, click the menu knob to choose the ECG
signal size from Auto Gain, 5mm/mV, 10mm/mV, and 20mm/mV.

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4.1.3 Attaching the Defibrillation Pads

The pads are attached in the order of taking off upper-body clothes, opening the pads and
connecting the pads connectors to the main body of the CU-HD1.

※ Attach and connect the defibrillation pads in the order described below.
① Take off all the upper-body clothes including any under-garments.

② If the chest to which the pads are attached is too hairy, shave it using a razor or with
scissors.

③ Tear off the defibrillation pads package along the cutting line. Select the adult or pediatric
pads according to the patient.

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④ Attaching pads – Following the directions indicated in the figure below. Attach the pads to
the upper body of the patient. Individual pads have a drawing showing the attaching
location. It is best to follow the exact locations.

[Attaching locations for adult pads]

[Attaching locations for pediatric pads]

 If the pediatric pads are used in the AED mode, make sure they have the defibrillation energy
attenuation module.
 Maintain the position where the pads are attached dry. If the patient’s skin surface is moist or
wet, a problem may occur when the device recognizes the patient and defibrillation energy
may leak during defibrillation.
 If using the disposable pads, do not use the defibrillation-specific gel. The defibrillation-specific
gel must be used for the external defibrillation paddles.
 Check for any damage to the pads and the packages of the pads as well as the expiration date.
If damaged or expired, discard the package without using it.
 When the patient is less than 8 years old or weighs less than 25 kg (55 lb), use Pediatric
defibrillation pads. Do not delay therapy to determine the patient’s exact age or weight.

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4.2 Analyzing Patient

Once the pads are attached, the AED mode operates according to the Auto Analyzing settings.
Operating sequence is as follows.

4.2.1 Auto Analysis Mode (Auto Analysis Mode ON)

① Once attaching the pads to the patient correctly, his or her ECG is automatically analyzed.
② If the patient’s ECG analysis results require defibrillation, it delivers the defibrillation
electricity shock and reanalyzes the ECG automatically.
③ During CPR after the defibrillation electricity shock has been delivered, there is no ECG
analysis.

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4.2.2 Manual Analysis Mode (Auto Analysis Mode OFF)

① Push the soft key called “Analyze” to analyze the patient’s ECG.
② As this time, the voice and text messages that are “If no pulse, press ‘Analyze’.” shall be
displayed.
③ Using the manual analysis mode, therefore, the user must use the device according to the
patient’s ECG on the LCD screen.
④ In addition, if the ECG analysis results in requiring defibrillation, it does not automatically
reanalyze the patient’s ECG after delivering the defibrillation electricity shock. Rather, press
the “Analyze” button again to reanalyze his or her ECG.

 Do not analyze the patient ECG during patient movement. A patient must be motionless
during ECG analysis. Do not touch the patient during analysis. Cease all movement via
stretcher or vehicle before analyzing the ECG.

4.3 Performing AED

4.3.1 Checking Analysis Results and Voice Instructions
If defibrillation is necessary as a result of analyzing the patient’s ECG through the pads, the
instructions to deliver an electric shock will be provided. If the defibrillation is not necessary, the
instructions to carry out CPR and continuous ECG analysis will be provided according to the
patient's condition.

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4.3.2 AED Treatment

1) Charging Defibrillation Energy
The device automatically starts charging. The charging process can be checked through the
display shown below, and once charging has been completed, the beeper sound will starts and
the Shock button will blink.

※ Effective shock level of the CU-HD1 is set at 200J for adults and 50J for children.

 Do not allow defibrillation pads of paddles to touch each other or to touch other ECG
monitoring electrodes, lead wires, dressings, etc. Contact with metal objects may cause
electrical arcing and patient skin burns during defibrillation and may divert current away from
the heart.
 While charging or carrying out the defibrillation, do not allow the operator or other individuals
to come into contact with the patient or any device connected to the patient.

 Do not allow exposed portions of the patient’s body to come in contact with metal objects,
such as a bed frame, as unwanted pathways for defibrillation current may result.

 If the Shock button is not pressed within 15 seconds after the charge energy has been charged,
the charged energy is discharged internally.

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2) Delivering Defibrillation Energy

Pushing the Shock button delivers the defibrillation energy to the patient. Since there may be an
injury due to a leak of the energy, do not have contact with the patient. Before pressing the
button, warn people with a loud and clear warning to stand back from the patient.

The below figure displays when the defibrillation energy is delivered.

3) Performing CPR
As the function to help CPR, CU-HD1 provides the guidance on the CPR procedure with voice
and text messages.
At the AED mode, press the “Start CPR” soft button to perform CPR without defibrillation.
The CPR rate (Compression : Respiration) can be selected through the “CPR Type 30:2” / “CPR
Type 15:2” soft button.

4.3.3 Things to Do following Defibrillation

Carry out CPR 5 times (this will take approximately 2 minutes) and analyze the patient’s ECG.
Depending on the analysis results of the patient’s ECG, carry out additional defibrillation and
CPR.

 While delivering the defibrillation energy, the patient’s ECG through the pads does not show
up in the screen. When it’s delivered, the Biphasic wave is shown.
 If the patient's ECG changes to ECG that does not require defibrillation in the fully
charged state, the fully charged energy of ME equipment discharge to internal resistor
and is reanalyzed after CPR guide.

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4.4 AED alarm

The alarm occurring in the AED mode is a technical alarm. If the device operation failure and SpO2
malfunction are detected, an alarm will be issued.

4.4.1 Type of Alarm

1) Technical Alarm
Alarm Message Priority Indication Condition

Alert tone with red

Equipment An error is preventing the equipment from
High alarm message with
malfunction functioning.
alert sound

Alert tone with

turquoise alarm
SpO2 Error Low There is a problem with the SpO2 module.
message with alert
sound

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◎ Chapter 5_Manual Defibrillation & Synchronized Cardioversion

Chapter 5. Manual Defibrillation & Synchronized Cardioversion

■ Overview
The manual defibrillation mode that should be carried out by a medical personnel to deliver electric
shocks depending on the conditions of the arrhythmia patient while directly checking the patient’s
ECG signals displayed on the screen.

In the manual defibrillation mode, both paddles and pads can be used.

When the synchronized cardioversion function is used, the synchronization with the R wave will be
established and an electric shock will be delivered.

 To safely shut the CU-HD1 down while in Manual Defibrillation mode, rotate the rotary switch
to the OFF position.

 Defibrillating asystole can inhibit the recovery of natural pacemakers in the heart and
completely eliminate any chance of recovery. Asystole should not be routinely shocked. Begin
CPR.
 To avoid stress to the defibrillator or the tester, never attempt to repeatedly charge and
discharge the defibrillator in rapid succession. If a need for repetitive testing arises, allow a
waiting period of at least 2 minutes after every third discharge.

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5.1 Preparing Defibrillation

5.1.1 Connecting to the Device
1) Connection of the paddles and the pad connector
Connect the pad connector or the paddle cradles to the main body as shown in the figure
below. Check the shape of the connector input terminal on the main body and the shape of the
pad connector or the paddle cradles.

To remove the paddles and the pad connector from the main body, remove these items by
rotating them in the unlock direction on the lock figure shown in the connector input terminal
of the main body.

2) Connecting the Disposable Defibrillation Pads

Connect the disposable pad and the pad connector as shown in the figure below. There is a set
direction of groove. Caution should be taken on this direction when connecting.

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5.1.2 Manual Defibrillation Mode Layout and Setting

1) Layout

Cable Usage Current Power

Date
Connection Time Time Status

Selected
Status
Charging
Lead Shock
Status Shock Hear
Informatio Energy
Display Times Rate
n

Blood
Pressur
e

Lead
SpO
Informatio
Impedance Status 2
n
Bar

Disarm
Soft Key

Selected Status Informs which mode is running.

Cable Connection Informs connection status of cable which is using.
Usage Time Displays the total time of use of the device after turning it on.
Date Displays the date.
Current Time Shows the current time.
Shows the input power state when using the remaining battery
Power Status
indication or the AC power module.
Heart Rate Informs measured heart rate and predefined alarm limit
Blood Pressure Informs measured blood pressure and predefined alarm limit
SpO2 Informs measured SpO2 and predefined alarm limit
Disarm Soft Key Discharges the charged energy into the inside of the device.
Lead Information Informs ECG cable and lead information.
Shows the energy level being charged for pressing the Shock
Charing Satus Display
button, and disappears when the charge completes.
Shock Times Shows the number of electric shocks delivered.
Shows the symbol of the energy value being delivered to the
Shock Energy
patient.

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2) Setting

※ Manual Defibrillation Mode

The strength of the electric shock energy can be chosen among 1-10, 15, 20, 30, 50, 70, 100, 120, 150, 170
and 200J by switching the rotary switch while checking any change in the patient’s ECG signals according
to the electric shock treatment.

※ Synchronized Cardioversion
The synchronized cardioversion transfers energy in sync with the ‘R’ wave of the ECG signals measured.
Paddles and pads may be used for the synchronized cardioversion. Synchronized Cardioversion is
enabled in the manual defibrillation mode.

 When using the supplied pediatric pads which are specified for the CU-HD1, the energy level
must not exceed 50J.

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5.1.3 Attaching Defibrillation Pads and Paddle

Hair or foreign substances on the patient’s chest should be removed in order not to affect the
defibrillation.

1) Defibrillation Pads
For how to use the pads, follow the same steps as explained in Section 4.1.3, which describes
pads attachment and connecting pads for AED.

[Basic layout after attaching pads]

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2) External Defibrillation Paddle

Undress the patient's top, including inner wear. If necessary, dry the patient’s chest and remove
hair or foreign substances on the patient’s chest using a razor or scissors in order not to affect
the defibrillation. When using the external defibrillation paddles, their locations are shown in the
figure below of section 2.1), and it’s recommended to use the defibrillation-specific gel.

[Basic layout after attaching paddles]

 The impedance connection status bar must be green or above. This may not be possible
according to a patient’s physical conditions. In such cases, maintain the status bar in yellow (5
bars) or above.

 Rubbing the paddles together without applying enough conductive gel on the paddle
electrode surface may scratch or damage the surface.
 After using the conductive gel, clean off the gel that may be left on the paddles with wet
clothes or gauze. If any leftover gel dries on the pads or paddles, it may cause problems in
future use.

 Apply an ample amount of conductive gel on the paddle electrodes. Do not allow the gel to
dry or accumulate in between the chest wall and paddle electrodes. Failure to remove gel
residue from previous use may result in burns to the patient or a reduction of delivered energy.
 When the impedance connection status bar is not in the green area or above, incorrect
defibrillation or vital sign measurement may occur. The status bar must be in the green area or
above for correct defibrillation.

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2.1) Using the External Defibrillation Paddle

① Remove the paddles from the paddle cradle by pulling

the paddles straight out.

② If foreign substances exist on the surface of the

paddles, remove such foreign substances completely.

③ Apply the conductive get supplied by CU Medical

Systems, Inc. on the paddles.

④ While holding the paddle handles, adjust the paddle

pressure and positions. Watch the impedance
connection status bar and keep the level above green.

2.2) Using the Pediatric External Defibrillation Paddle

The American Heart Association recommends that small paddles be used on children weighing
less than 10 kg. Large paddles may be used if they can be kept from interfering or contacting
with one another.
The external defibrillation paddle for children is inside the external defibrillation paddle. Use it
in the following manner.

① Push the yellow switches on the paddles in ② While pressing the yellow switches, pull
the direction of the arrow as indicated. them in the direction of the arrow.

③ After separating both paddles as shown in the figure below,

use them in the same way as those of the adult paddles.

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5.2 Manual Defibrillation (Asynchronous)

Manual defibrillation is done in three stages with the CU-HD1 by rotating the rotary switch.

1) Selecting Energy( )

[Default Screen after Pad Connection] [Default Screen after Paddle Connection]

2) Charging Energy

Using Pads: Press the Charge button ( ) on the front of the defibrillator to start charging
energy.
Using Paddles: Press the yellow button next to the paddle handle to start charging.

[Charging Screen when using pads] [Charging Screen when using paddles]

3) Performing Defibrillation
Using disposable pads: Press the Shock button ( ) on the front of the defibrillator to deliver
defibrillation energy to the patient.
Using Paddles: Press the two orange buttons on the front of the paddle handles at the same time
to deliver defibrillation energy to the patient.

[Defibrillation Screen when using pads] [Defibrillation Screen when using paddles]

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 If the energy level is changed while charging the defibrillation energy, charging will be
canceled. To charge the device again at the newly selected energy level, press the Charge
button again.
 When the paddle is used and you press the Shock button while the impedance is not
recognized after charging is finished, the charged energy will be discharged internally. Charge
the device again by pressing the Charge button on the paddle handle, then carry out the
defibrillation.

5.3 Delivering Synchronized Cardiac Pacing Energy

In order to treat a patient’s unstable tachyarrhythmia, such as atrial flutter or atrial fibrillation,
defibrillation should be carried out through the synchronization with the ECG R wave. The
synchronized cardioversion is a method recommended for treating the patient’s unstable
tachyarrhythmia, such as atrial flutter or atrial fibrillation. CU-HD1's synchronized cardioversion
function detects the ECG R wave and delivers an electric shock energy according to the R wave.

 When using the synchronized cardiac pacing function, check that the marker indication,
position and heart rate are consistent.
 The white inverted triangle mark indicates the position of the R wave signal which is measured
through synchronization.

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◎ Chapter 5_Manual Defibrillation & Synchronized Cardioversion

5.3.1 Steps to Deliver Pacing Energy

① Place the rotary switch to Manual Defibrillation and press the “Sync” button on the top left
side of the rotary switch to see if the blue button light is lit.
② Check whether the R-Sync marks which is in sync with the R-wave of the measured ECG
shows up.
③ Select the desired defibrillation energy by rotating the rotary switch.
④ Pushing either the Charge button or the yellow charge button of the paddles, charging
energy is displayed on the screen. To cancel the defibrillation energy, use the “Disarm” soft
button. If defibrillation is not done within 15 seconds, the defibrillation energy is
automatically cancelled. If changing the defibrillation energy that is charged, since changing
the rotary switch to the energy level desired cancels the charged energy inside the device,
recharge energy by pressing the Charge button again.
⑤ When the defibrillation energy is fully charged, loudly and firmly instruct the patient and
surrounding individuals not to contact with an object connected to the patient.
⑥ When using the pad, press the Shock button on CU-HD1. When using the paddle, press the
orange button. When the R wave is detected, defibrillation will be delivered automatically.

 Pressing the "Sync" button above the rotary switch lights the lamp in blue and activates the
synchronized cardiac pacing mode. Pressing the "Sync" button again dims the blue light and
deactivates the synchronized cardiac pacing mode.
 If markers do not appear above the R waveform, select another ECG lead. If synchronization
markers do not appear, it means that the R wave could not be detected and therefore
synchronized cardiac pacing energy cannot be delivered.

 If there is interference generated by patient movement while attached with the paddles or pads, or
external contact, it may sense the R-wave and deliver the defibrillation energy to the patient.
Therefore, avoid any contact with the patient during pacing.
 Since defibrillation may bring harm to the performer or surrounding people. Make sure to keep a
safe distance from the patient and any electronic devices and conductive metals connected to the
patient during defibrillation.
 Poor adherence and/or air under the defibrillation pads can lead to the possibility of arcing and
skin burns.
 After pressing the Shock button, keep hands away from the electrode plates.
 Medical electrical equipment which does not incorporate defibrillator protection should be
disconnected during defibrillation.
 Do not allow defibrillation pads of paddles to touch each other or to touch other ECG monitoring
electrodes, lead wires, dressings, etc. Contact with metal objects may cause electrical arcing and
patient skin burns during defibrillation and may divert current away from the heart.

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5.4 Alarm for Manual Defibrillation Mode

For details on alarms generated in manual defibrillation mode, see alarm information for each vital
sign measurement function (ECG, SpO2, NIBP, EtCO2) in "Chapter 7_Patient Monitoring".
Details on alarm configuration and settings are available.

5.4.1 Type of Alarm

1) Physiological Alarms
Alarm
Classification Priority Indication Condition
Message

Patient's ECG measurement

Red alarm message
VT / VF High indicates ventricular fibrillation /
with alert sound
ventricular tachycardia.
Red alarm message Patient's ECG measurement
Asystole High
with alert sound indicates cardiac arrest.

Heart rate measurement exceeds

Red alarm message
Extreme Brady High the maximum set value by more
with alert sound
than 20.
Algorithm Heart rate measurement falls
Red alarm message
Extreme Tachy High below the minimum set value by
with alert sound
more than 10.
Yellow alarm
Heart rate measurement exceeds
HR High Medium message
the maximum set value.
with alert sound

Yellow alarm
Heart rate measurement falls
HR Low Medium message
below the minimum set value.
with alert sound
Yellow alarm
Pulse measurement exceeds the
Pulse High Medium message
maximum set value.
with alert sound
Yellow alarm
Pulse measurement falls below the
Pulse Low Medium message
minimum set value.
with alert sound
SpO2
Yellow alarm
SpO2 measurement exceeds the
SpO2 High Medium message
maximum set value.
with alert sound
Yellow alarm
SpO2 measurement falls below the
SpO2 Low Medium message
minimum set value.
with alert sound

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Alarm
Classification Priority Indication Condition
Message

Yellow alarm Systolic blood pressure

Systolic High Medium message measurement exceeds the
with alert sound maximum set value.
Yellow alarm Systolic blood pressure
Systolic Low Medium message measurement falls below the
with alert sound minimum set value.
Yellow alarm Diastolic blood pressure
Diastolic High Medium message measurement exceeds the
with alert sound maximum set value.
NIBP
Yellow alarm Diastolic blood pressure
Diastolic Low Medium message measurement falls below the
with alert sound minimum set value.
Yellow alarm Mean blood pressure
Systolic High Medium message measurement exceeds the
with alert sound maximum set value.
Yellow alarm Mean blood pressure
Systolic Low Medium message measurement falls below the
with alert sound minimum set value.
Red alarm message Respiration is not measured during
Apnea High
with alert sound the set duration (seconds).

Yellow alarm
EtCO2 measurement exceeds the
EtCO2 High Medium message
maximum set value.
with alert sound
Yellow alarm
EtCO2 measurement falls below
EtCO2 Low Medium message
EtCO2 the minimum set value.
with alert sound
Yellow alarm
Respiration Respiration rate measurement
Medium message
Rate High exceeds the maximum set value.
with alert sound
Yellow alarm
Respiration Respiration rate measurement falls
Medium message
Rate Low below the minimum set value.
with alert sound

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2) Technical Alarms
Alarm Message Priority Indication Condition

Turquoise alarm
Real-time Bluetooth transmission failed or
Transmission failed Low message
12-ch Bluetooth transmission failed.
with alert sound

Turquoise alarm
Low battery level. Low message Low battery level.
with alert sound

Turquoise alarm
NIBP Measurement
Low message NIBP measurement failure.
Failure
with alert sound

Turquoise alarm
NIBP signal has
Low message Oscillometric signal has noise.
noise artifacts
with alert sound

Turquoise alarm
NIBP Pneumatic NIBP operation is interrupted by bent
Low message
Blockage tubes, etc.
with alert sound

Turquoise alarm
NIBP air leak or
Low message Air is leaking from tubes, etc.
loose cuff
with alert sound

Turquoise alarm
NIBP Cuff
Low message NIBP is over-pressurized.
Overpressure
with alert sound

Turquoise alarm
There is a problem with NIBP module
NIBP Error Low message
operation.
with alert sound

NIBP Calibration Turquoise alarm

overdue Low message NIBP module calibration has expired.

with alert sound

Turquoise alarm
NIBP Equipment
Low message NIBP device is faulty.
Malfunction
with alert sound

Turquoise alarm
SpO2 Error Low message There is a problem with the SpO2 module.
with alert sound

Turquoise alarm
Unidentified
Low message Invalid accessory ID.
accessories
with alert sound

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Alarm Message Priority Indication Condition

Turquoise alarm
CO2 : Out of range Measurement value of the CO2 sensor is
Low message
accuracy outside the reference accuracy range.
with alert sound

CO2 : Out of Turquoise alarm

Internal temperature of the CO2 sensor is
range/internal Low message
outside the reference range.
temperature with alert sound

CO2 : Out of Turquoise alarm

The CO2 sensor is outside the ambient
range/ambient Low message
pressure range.
pressure with alert sound

Turquoise alarm
CO2 : Need zero
Low message The CO2 sensor requires zero calibration.
calibration
with alert sound

Turquoise alarm
Software Error Low message The CO2 sensor has a software error.
with alert sound

Turquoise alarm
Hardware Error Low message The CO2 sensor has a hardware error.
with alert sound

Turquoise alarm
Motor Speed out of The CO2 sensor motor exceeds the speed
Low message
bounds range.
with alert sound

Turquoise alarm
Factory calibration There is an error with the CO2 sensor
Low message
data loss calibration value.
with alert sound

Equipment Red alarm message An error is preventing the equipment

High
malfunction with alert sound from functioning.

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◎ Chapter 6_Noninvasive Pacer Mode

Chapter 6. Noninvasive Pacer Mode

■ Overview
This mode helps maintain a heart rate by periodically contracting the heart with electric stimuli to the
patient whose normal heart contraction is not observed.

An electric stimulus is delivered through the pads attached to the patient in a noninvasive manner.

The pacing method consists of two modes: ‘Demand mode’ that the pacing signals are transferred to
when the patient’s heart rate is slower than the preset pacing rate, and the ‘Fixed mode’ where the electric
stimulus is delivered to the patient at a fixed heart rate.

 Do not deliver any defibrillation energy to any patients using the pacing function.
 If defibrillation is necessary, remove the cables connected with the pacing electrodes before
carrying out the defibrillation.

 Do not use the noninvasive pacer to any patients using the internal pacemaker.

 The pacing controller is used in the same manner as pacer.

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6.1 Preparing Pacing

6.1.1 Pacing Mode Layout

⑥ ⑤

③ ④
① ②

Pacer Mode Shows whether the device is running in the Pacer mode.
①Pacer Mode Shows the Pacer’s mode (Fixed/Demand)
②Pacer Status Shows whether the pacer is running or stopped.
③Current Shows the current to be delivered.
④Pacing Rate Shows the pacing rate (pacing times per minute).
⑤R-Sync Mark Shows the R-Sync mark in sensing the R-wave while analyzing the ECG.
⑥Pacing Display Shows a white indication when delivering the pacing pulse to the patient.

 During pacing, heart rate is shown on the screen as '---' due to inaccurate ECG.
 Since the diagnosis function on patient conditions is not offered by pacing, continue to watch
the patient during pacing.

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6.1.2 Preparing and Connecting Patient Monitoring Device

In order to check the patient’s condition according to pacing, CU-HD1 displays vital signs
detected from the 12-lead ECG and SpO2, NIBP, EtCO2 sensor on the screen. Each item can be
selected using the lead select button and setting the Patient Monitoring mode function. It is
necessary to check the patient’s heart rate due to pacing and evaluate the patient’s vital sign
occasionally or continuously while carrying out the pacing treatment.

1) Connecting and Attaching the Pacing Pad

A disposable defibrillation pad is used for pacing.
(Refer to CUA0508O, CUA0809PM - 2.7 Accessories)

For how to connect and attach the pad, refer to "4.1.1 Connecting to the Device" and "4.1.3
Attaching and Connecting the Defibrillation Pads".

Attach the pads on the positions as shown in the figure below according to the patient’s
condition and circumstance.

[Attachment positions of pacing pads and ECG electrodes]

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2) Connecting and Attaching the ECG electrodes

To check the pacing result through the ECG electrodes during pacing, use new disposable ECG
electrodes.

For connecting the ECG cable, refer to “7.1.1.1 Connecting ECG Cable”.

Remove hair or foreign substances on the patient’s body where the electrodes are attached
using a razor or scissors.

Attach the ECG electrodes within an appropriate distance from the pads. If the ECG electrodes
are placed close to the pads, the ECG signals may be distorted due to the pacing current. For
the attachment position, refer to the figure above.

3) Measuring SpO2, NIBP, and EtCO2

To measure SpO2, NIBP and EtCO2 during pacing, refer to “Chapter 7_Patient Monitoring”.

 Maintain a proper distance between the pacing pads and the conductive part of the ECG
electrodes, so as not to attach them together.
 If the pads are detached from the patient, a confirmation alarm will be issued.

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6.1.3 Attaching Pacing Pads and ECG Electrodes

For accurate measurement of the ECG signals to check the pacing results in the Demand mode
for pacing, it is recommended to use disposable ECG electrodes ever as not used as possible. If
the skin with which the ECG electrodes contact is dirty, it may impact accurate measurement of
the ECG signals.

Disposable defibrillation pads may be used for non-invasive demand mode pacing. And for details
of how to attach disposable defibrillation pads to the patient, refer to Section “4.1.3 Attaching
the Defibrillation Pads”.

 Maintain a proper distance between the pacing pads and the conductive part of the ECG
electrodes, so as not to attach them together.
 The patient’s skin where the pads and the electrodes are attached should be kept dry. The
patient’s skin should be dry in order not to affect the measurement of the ECG signal. In such
a case, no current will leak and/or the adhesive strength of the pads will not be maintained
during pacing.
 Before using the pads and the electrodes, check the expiration date and any damage to the
packaging. If damaged or expired, discard the package without using it.
 If pacing is carried out for a long period of time, replace the pads periodically.

 If the pads are detached from the patient, a confirmation alarm will be issued.

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6.2 Demand Pacing Mode

The Demand mode pacing was adopted to maintain the patient’s heart rate when it is slower than a
predefined heart rate.

6.2.1 Selecting Demand Pacing Mode

The Demand mode pacing can be selected by the “Mode” button. The Demand mode pacing
and Fixed mode pacing can be switched back and forth by this button.

6.2.2 Steps of Demand Pacing

① To evaluate the pacing process, select the ECG by pressing the LEAD Selection button.

② If needed, measure SpO2, NIBP, or EtCO2.

③ Using the Rate and Current buttons on the pacer menu, the pacing rate and pacing current

can be adjusted.

④ To start pacing, use the Start/Stop button. To stop it during pacing, stop it using the

Start/Stop button.

⑤ Check whether pacing is in progress or displayed on the screen.

⑥ Check the patient’s heart rate with respect to pacing through the ECG, SpO2, pulse, NIBP,

and EtCO2. If the heart rate is not enough after checking his or her symptoms, increase the

strength of the pacing current as needed.

⑦ Patient conditions may require a change in the current level as time goes on. During pacing,

the performer must continue to monitor the patient.

 Do not touch the patient nor have the patient touch any devices while the pacing electric
stimulus is active. Otherwise, the ECG will be distorted, impacting the pacing.
 If touching the patient to check the heart rate of the patient while delivering the pacing energy
to him or her, it may be possible to be exposed to the pacing current.

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6.3 Fixed Pacing Mode

The Fixed mode pacing delivers the pacing current to the patient at a predefined, constant heart rate
regardless of the patient’s heart rate.

6.3.1 Selecting Fixed Pacing Mode

The Fixed mode pacing can be selected the same way as the Demand mode pacing. Push the
Mode button to select.

6.3.2 Steps of Fixed Pacing

① To evaluate the pacing process, select the ECG by pressing the LEAD Selection button.

② If needed, measure SpO2, NIBP, or EtCO2.

③ Using the Rate and Current buttons on the pacer menu, the pacing rate and pacing current

can be adjusted.

④ To start pacing, use the Start/Stop button.

⑤ Check the patient’s heart rate. If no pulse is recognized, increase the current level till the

heart rate is sensed, and gradually adjust the current to the minimum level where the pulse

is detected.

6.4 Ending Pacing

Stop pacing if defibrillation is needed while it’s in progress. Perform defibrillation and CPR according
to the AED and manual defibrillation methods described in Chapter 4 and 5.

 It’s recommended to use the Demand Pacing mode. The Fixed mode is normally used when
there is ECG interference or noise that makes it difficult to sense the reliable R-wave in the
Demand mode.

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6.5 Alarm for Pacing Mode

For details on alarms generated in pacing mode, see alarm information for each vital sign
measurement function (ECG, SpO2, NIBP, EtCO2) in "Chapter 7_Patient Monitoring".
Details on alarm configuration and settings are available.

6.5.1 Type of Alarm

1) Physiological Alarms
Classification Alarm
Priority Indication Condition
Message

Patient's ECG measurement

Red alarm message
VT / VF High indicates ventricular fibrillation /
with alert sound
ventricular tachycardia.
Red alarm message Patient's ECG measurement
Asystole High
with alert sound indicates cardiac arrest.

Heart rate measurement exceeds

Red alarm message
Extreme Brady High the maximum set value by more
with alert sound
Algorithm than 20.
Heart rate measurement falls
Red alarm message
Extreme Tachy High below the minimum set value by
with alert sound
more than 10.
Yellow alarm message Heart rate measurement exceeds
HR High Medium
with alert sound the maximum set value.

Yellow alarm message Heart rate measurement falls

HR Low Medium
with alert sound below the minimum set value.
Yellow alarm message Pulse measurement exceeds the
Pulse High Medium
with alert sound maximum set value.
Yellow alarm message Pulse measurement falls below
Pulse Low Medium
with alert sound the minimum set value.
SpO2
Yellow alarm message SpO2 measurement exceeds the
SpO2 High Medium
with alert sound maximum set value.
Yellow alarm message SpO2 measurement falls below
SpO2 Low Medium
with alert sound the minimum set value.
Systolic blood pressure
Yellow alarm message
Systolic High Medium measurement exceeds the
with alert sound
maximum set value.
NIBP
Systolic blood pressure
Yellow alarm message
Systolic Low Medium measurement falls below the
with alert sound
minimum set value.

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Classification Alarm
Priority Indication Condition
Message

Diastolic blood pressure

Yellow alarm message
Diastolic High Medium measurement exceeds the
with alert sound
maximum set value.
Diastolic blood pressure
Yellow alarm message
Diastolic Low Medium measurement falls below the
with alert sound
minimum set value.
Mean blood pressure
Yellow alarm message
Systolic High Medium measurement exceeds the
with alert sound
maximum set value.
Mean blood pressure
Yellow alarm message
Systolic Low Medium measurement falls below the
with alert sound
minimum set value.
Respiration is not measured
Red alarm message
Apnea High during the set duration
with alert sound
(seconds).
Yellow alarm message EtCO2 measurement exceeds the
EtCO2 High Medium
with alert sound maximum set value.
Yellow alarm message EtCO2 measurement falls below
EtCO2 EtCO2 Low Medium
with alert sound the minimum set value.
Respiration Yellow alarm message Respiration rate measurement
Medium
Rate High with alert sound exceeds the maximum set value.
Respiration rate measurement
Respiration Yellow alarm message
Medium falls below the minimum set
Rate Low with alert sound
value.

 While pacing is being carried out, an ECG-related alarm will not be issued.

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2) Technical Alarms
Alarm Message Priority Indication Condition

Turquoise alarm message Real-time Bluetooth transmission

Transmission failed Low with alert sound failed or 12-ch Bluetooth transmission
failed.
Turquoise alarm message
Low battery level. Low Low battery level.
with alert sound

NIBP Measurement Turquoise alarm message

Low NIBP measurement failure.
Failure with alert sound

NIBP signal has Turquoise alarm message

Low Oscillometric signal has noise.
noise artifacts with alert sound

NIBP Pneumatic Turquoise alarm message NIBP operation is interrupted by bent

Low
Blockage with alert sound tubes, etc.

NIBP air leak or Turquoise alarm message

Low Air is leaking from tubes, etc.
loose cuff with alert sound

NIBP Cuff Turquoise alarm message

Low NIBP is over-pressurized.
Overpressure with alert sound

Turquoise alarm message There is a problem with NIBP module

NIBP Error Low
with alert sound operation.
NIBP Calibration Turquoise alarm message
overdue Low with alert sound NIBP module calibration has expired.

NIBP Equipment Turquoise alarm message

Low NIBP device is faulty.
Malfunction with alert sound

Turquoise alarm message There is a problem with the SpO2

SpO2 Error Low
with alert sound module.

Unidentified Turquoise alarm message

Low Invalid accessory ID.
accessories with alert sound

Turquoise alarm message Measurement value of the CO2 sensor

CO2 : Out of range
Low with alert sound is outside the reference accuracy
accuracy
range.
CO2 : Out of Turquoise alarm message
Internal temperature of the CO2
range/internal Low with alert sound
sensor is outside the reference range.
temperature
CO2 : Out of Turquoise alarm message
The CO2 sensor is outside the ambient
range/ambient Low with alert sound
pressure range.
pressure
CO2 : Need zero Turquoise alarm message The CO2 sensor requires zero
Low
calibration with alert sound calibration.

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Alarm Message Priority Indication Condition

Turquoise alarm message

Software Error Low The CO2 sensor has a software error.
with alert sound

Turquoise alarm message

Hardware Error Low The CO2 sensor has a hardware error.
with alert sound

Motor Speed out of Turquoise alarm message The CO2 sensor motor exceeds the
Low
bounds with alert sound speed range.

Factory calibration Turquoise alarm message There is an error with the CO2 sensor
Low
data loss with alert sound calibration value.

Equipment Red alarm message An error is preventing the equipment

High
malfunction with alert sound from functioning.

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◎ Chapter 7_Patient Monitoring

Chapter 7. Patient Monitoring

■ Overview
The patient monitoring mode enables observing patient conditions by measuring the patient’s ECG,
SpO2, NIBP, and EtCO2 using the ECG cables (3-, 5- and 10-lead), SpO2 sensor, NIBP cuff, and EtCO2
measuring module.

In addition, with the alarm setting on the menu, an alarm is issued whenever an abnormality of the
patient’s ECG is detected, leading to appropriate treatment.

The 12-lead ECG measures and patient monitoring information can be checked by connecting into a
computer through the Bluetooth communication. For details of information transfer, refer to
“Chapter 9_Communication and Data Management”.

 If attaching the pads to the patient to use the defibrillation function while measuring the ECG
in the patient monitoring mode, make sure that the electrodes used in measuring the ECG and
defibrillation paddles or pads do not make any contact.
 If it is necessary to monitor for a long period of time, replace the ECG electrodes or the pads
periodically.

 To safely shut the CU-HD1 down while in Monitor mode, rotate the rotary switch to the OFF
position.

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◎ Patient Monitoring Mode Layout

Turning the Rotary switch to “Monitor” brings up the following screen. Push the LEAD Change
button on the left to change the ECG lead shown on the upside of the monitor.

Monitor Cable Connection Power

Status Usage Time Date Time
Mode Status

Lead Heart Rate

Information Alarm Sign

Heart Rate
Alarm Limit

NIBP Alarm
Sign
Systolic/Diastolic
Lead
Information NIBP Alarm
Limit
Mean Blood
Pressure
SpO2
Alarm Sign

SpO2
Alarm
Limit

Bluetooth Bluetooth 12-Lead

Connection Transmission Start
Status Start/Stop Button
Button

Monitor Mode Informs which mode is running.

Usage Time Displays the total time of use of the device after turning it on.
Date Displays the date.
Current Time Shows the current time.
Power Status Shows the input power state when using the remaining battery indication or the
AC power module.
Heart Rate Shows beat per minute(bpm), predefined alarm limit
SpO2 Shows SpO2(%),predefined alarm limit
Shows blood pressure(mmHg), Systole/diastole, mean blood pressure, predefined
NIBP
alarm limit
“Start 12-Lead”
Starts 12-Lead Mode.
Button

 While printing, pressing the lead change button in Sector 1 stops the printing.
 If only Sector 1 is printing, the lead for Sector 2 can be changed while printing.
 If both Sector 1 and Sector 2 are printing, the lead for Sector 2 cannot be changed while
printing.

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7.1 Monitoring ECG

■ Overview
The CU-HD1 can be used with 3-lead, 5-lead or 12-lead ECG patient cables, ECG electrodes, and
defibrillation pads to perform ECG monitoring.

The equipment analyzes ECG and provides alarms based on heart rate, ventricular fibrillation or
ventricular tachycardia.

For ECG monitoring over long periods or for more precise ECG measurement, make sure to select
an appropriate channel (I, II, III, aVR, aVF, aVL, V1 - V6) based on the patient's condition as
monitored with ECG electrodes.

The patient's ECG obtained through the amplification and operation of differential voltages
between minute electromotive forces occurred due to the cardiac activities measured through the
electrodes is displayed on the monitor as waveforms and values. When this value exceeds the
range of set values for alarm, an alarm will be issued, indicating the abnormal condition of the
patient.

 The monitoring alarm of CU-HD1 is set to adult by default. If it is necessary to monitor an

infant, change the alarm settings according to the circumstances of the infant. Using the
product without changing the alarm settings may result in inaccurate alarms.
 When monitoring is done on patients with pacemakers, monitoring accuracy deteriorates
significantly. In this case, asystole, etc. may not be detected. Check the operation and integrity
of the CU-HD1 and ECG cable regularly by performing the Self-test.

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7.1.1 ECG Monitoring Setup

7.1.1.1 Connecting ECG Cable
Connect the ECG cable and CU-HD1 by checking the grooves on the ECG cable connector and
the ECG terminal on the main body.

If you would like to measure ECG by using 3-lead, 5-lead, 10-lead, all of the cables must be
inserted into the ECG terminal.

7.1.1.2 Setting
1) Inputting the information for patient monitoring
In Monitor Mode, use the Menu knob to enter patient information.
For more details on entering information, see "8.1 Patient Information".

2) Filter
At the “Filter” menu, you can set a bandwidth with which you can check out the ECG signal
detected by the CU-HD1.

Support for the function of filtering the LCD monitor and printer ECG signal, and individual
optional item is listed as follows.

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 ECG For Display

You can select the filter bandwidth of EMS (1~30Hz) and Monitor (0.5~40Hz). Default
setting is EMS.
 ECG For Printing
You can select the filter bandwidth of EMS (1~30Hz), Monitor (0.5~40Hz), and Diagnostic
(0.05~150Hz). Default setting is EMS.
 AC Line Filter
This is an item to remove the power noise. Select 60Hz or 50Hz according to the power
source. Default setting is 60Hz.

3) ECG Gain
This is the menu item that takes control of the ECG sensitivity degree. If the ECG signal is too
high or too low, you can change the signal level to an extent that you can easily verify it.
Default setting is 10mm/mV.

 Sector 1
As for the ECG signals displayed in the Sector 1, click the menu knob to choose the ECG
signal size from Auto Gain, 5mm/mV, 10mm/mV, and 20mm/mV.
 Sector 2
As for the ECG signals displayed in the Sector 2, click the menu knob to choose the ECG
signal size from Auto Gain, 5mm/mV, 10mm/mV, and 20mm/mV.

 Changes made to the settings in the menu are not saved. To change the default settings, see
the Service Manual.

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7.1.1.3 Preparing ECG Monitoring

1) Attaching ECG Electrodes to patient
① Remove hair or foreign substances on the location where the electrodes are attached
using a razor or scissors as necessary.
② Use rubbing alcohol to wipe any grease off the skin.
③ Remove all moisture from the skin and allow it to dry completely before attaching
electrodes.
④ Connect electrodes to the ECG cable (3-lead, 5-lead, or 12-lead) firmly before connecting
electrodes to the patient.
⑤ Check expiry dates and condition of the electrodes, then remove electrode packaging.
Attach the electrodes to the patient one at a time.
⑥ When connecting the electrodes, check that the entire electrode is firmly attached to the
patient and that the wire is not detached outside the electrode.
⑦ For details on attachment positions of the electrodes, see “7.1.1.4 Location of ECG
Electrodes”.

 If monitoring for an extended period of time, monitoring electrodes and multifunction

electrode pads may need to be changed periodically. Refer to the manufacturer’s
documentation for replacement frequency.

 Do not allow the conductive unit of the electrodes, including the neutral electrode and relevant
connections, to come into contact with any other conductors, including the ground.

 When using ECG electrodes, always check the expiry date. Also, remove the ECG electrodes
from sealed packaging immediately before use.
 When using the expired disposable ECG electrode and the disposable ECG electrode whose
envelope is lost, the accurate ECG measurement is not guaranteed.

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7.1.1.4 Location of ECG Electrodes

1) 3-Lead
 RA/R Underneath the right shoulder collarbone, or
the right arm
 LA / L Underneath the left shoulder collarbone, or
the left arm
 LL / F Left lower abdomen or left leg

2) 5-Lead
 RA/R Underneath the right shoulder collarbone,
or the right arm
 LA / L Underneath the left shoulder collarbone, or
the left arm
 LL / F Left lower abdomen or left leg
 RL/N Right lower abdomen
 V/C Among 12-lead locations, select the desired
one from V1 ~ V6

3) 12-Lead
 RA/R Underneath the right shoulder collarbone, or
the right arm
 LA / L Underneath the left shoulder collarbone, or
the left arm
 LL / F Left lower abdomen or left leg
 RL/N Right lower abdomen
 V1/C1 Right 4th sterna intercostal

 V2/C2 Left 4th sterna intercostal

 V3/C3 Middle between V2 and V4

 V4/C4 5th sternal intercostal in the medial line of left

collarbone
 V5/C5 Anterior axillary line in the horizontal line to
V4
 V6/C6 Medial axillary line in the horizontal line to V4

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7.1.1.5 Measuring ECG

During ECG measurement, it is very important to select an appropriate lead for accurate
detection of the QRS complex through monitoring.
If necessary, select an appropriate ECG waveform size.

Cable Connection
Status

Lead
Information

Lead
Information

1) Selecting Lead
Type of ECG Type of applicable lead
3-Led I, II, III
5-Lead I, II, III, aVR, aVL, aVF, V
12-Lead I, II, III, aVR, aVL, aVF, V1, V2, V3, V4, V5, V6

 Setting "Device Management / ECG Size" to “Auto Gain” automatically shows the adequately
sized ECG waveform on the screen.
 Should a “Lead Fault” message appear, check the ECG cable or electrode connections. If the
problem persists, replace the cables and electrodes.
 Dotted lines on the ECG denote invalid ECG signals in the waveform sector.
 In this case, check that an appropriate lead has been selected, and that the pads, ECG
electrode cable and electrodes are attached correctly.
 When replacing the lead cables, dotted lines appear momentarily.
 Dotted lines appear when the “Lead Fault” error occurs.

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7.1.2 12-Lead ECG measurement

Use the lead selection button to select a lead to display from the 12-lead ECG (I, II, III, aVR, aVL,
aVF, V1, V2, V3, V4, V5, V6) shown in Section 1 and Section 2.

◎ Layout
Push the “Start 12-lead” soft key. And check the ECG signal while the patient keeps his/her
body in the same position.
If needed, press the MENU key to enter patient information.

Hear SpO2 NIBP Bluetooth 12-Lead Data 12-Lead

Connection Status Transmission Button Stop Button
Rate

Heart Rate Shows the heart rate.

SpO2 Shows the SpO2 value measured for the patient.
NIBP Shows the NIBP value measured for the patient.
Displays whether the device is connected to Bluetooth
Blutooth Connection Status communication.
(Blue: Connected, Red: Disconnected)
12-Lead Data Transfer Transfers the 12-lead data by the use of Bluetooth communication.
Stop 12-Lead Stops 12-lead measurement.

 Do not connect many devices to the patient at once. The leakage limit of the current may be
exceeded.
 Adjusting the ECG waveform size on the screen does not affect the ECG data used in
arrhythmia analysis.

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 In case of a patient implanted with a pacemaker, the heart rate meter may count the
pacemaker rate even if cardiac arrest or other arrhythmias occurs. To avoid a shock hazard and
interference from nearby electrical equipment, keep electrodes and patient cables away from
grounded metal and other electrical equipment.
 ECG monitoring of the patient can be measured accurately when the patient is motionless.
 Physiological alarms may be triggered by environmental factors.

7.1.3 Alarm for ECG Measuring

7.1.3.1 Type of Alarm
1) Physiological Alarms
Alarm Message Priority Indication Condition

Patient's ECG measurement indicates

Red alarm message
VF / VT High ventricular fibrillation / ventricular
with alert sound
tachycardia.
Red alarm message Patient's ECG measurement indicates
Asystole High
with alert sound cardiac arrest.

Red alarm message Heart rate measurement exceeds the

Extreme Brady High
with alert sound maximum set value by more than 20.

Red alarm message Heart rate measurement falls below the

Extreme Tachy High
with alert sound minimum set value by more than 10.

Yellow alarm message Heart rate measurement exceeds the

HR High Medium
with alert sound maximum set value.

Yellow alarm message Heart rate measurement falls below the

HR Low Medium
with alert sound minimum set value.

2) Technical Alarms
Alarm Message Priority Indication Condition

Turquoise alarm
Transmission Real-time Bluetooth transmission failed
Low message
failed or 12-ch Bluetooth transmission failed.
with alert sound

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 Arrhythmias-related alarms only occur when lead II of the pads or the ECG electrodes is
selected for Sector 1 in Monitor mode. To monitor the patient's ECG, set the pads or ECG lead
II for the lead section from Sector 1 (yellow box in the figure below).

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7.1.3.2 Alarm Setting

1) VT/VF
This is a screen to set it to On/Off to generate the alarm sound when detecting Ventricular
Tachycardia (VT), or Ventricular Fibrillation (VF).

2) Asystole
This is a screen to set it to On/Off to generate the alarm sound when detecting Asystole.

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3) Heart Rate
This is an item to set the alarm according to Heart Rate (HR) measured through the ECG cable
or pad.

 Alarm On/Off
You can set it to On/Off to generate an alarm sound when the patient HR goes beyond
the assigned numeric setting.
 Upper Limit
This is the maximum value of patient HR that generates an alarm sound, which can be
changed by 5bpm with the Menu selection button. Numeric values you can set range
from 35 to 300bpm.
 Lower Limit
This is the minimum value of patient HR that generates an alarm sound, which can be
changed by 5bpm with the Menu selection button. The numeric values that you can set
ranges from 30 to 295bpm.

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7.2 Measuring Pulse CO-Oximetry(SpO2)

■ Overview
The SpO2 Module measures functional oxygen saturation in the blood. The measurement
determines the oxygenated hemoglobin as a percentage of the hemoglobin that can transport
oxygen. The SpO2 Pulse Oximetry is used as one of supplementary measures, enabling to measure
SpO2 and pulse rate.

The product uses the principle of spectrophotometry. SpO2 is measured percutaneously using a
difference in the optical density occurring when two lights at a natural wavelength pass through
material with a different concentration, while pulse waveform, value of SpO2 concentration, and
heart rate are displayed on the monitor through the operation. When this value exceeds the
range of set values for alarm, an alarm will be issued, indicating the abnormal condition of the
patient.

7.2.1 Preparing to Measure SpO2

7.2.1.1 Connecting to the Device
A SpO2 alarm is issued when the measurement exceeds or falls below the range of the set
values. The SpO2 alarm is a non-latch alarm, so it will be canceled when the measurement falls
under the range of the set values.

1) Connection to the SpO2 Sensor and SpO2 Sensor Extension Cable

2) Connecting SpO2 Sensor Extension Cable to the Main body

How to connect the SpO2 connection cable and the CU-HD1 is shown below, and the groove
of the connector and input terminal prevents inaccurate connection.

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7.2.1.2 Inputting the information for patient monitoring

In Monitor Mode, use the Menu knob to enter patient information.
For more details on entering information, see "8.1 Patient Information".

7.2.1.3 Applying the SpO2 Sensor

① Position the sensor so the cable is above the finger.

② Ensure the sensor is correctly connected to the finger as illustrated.
③ After use, remove the sensor from the patient, wipe the entire sensor pad clean with 70%
isopropyl alcohol and allow it to air dry.

 On the finger to be measured, there must be the presence of normal perfusion.

 LED light must be located in the location where light can be passed through the body.
 Take caution that bright sun rays and bright light in the surgery room will be not detected by
the sensor.
 If necessary, cover the sensor site with opaque fabric or tape so that light cannot pass through
the sensor part.
 Always keep the sensor dry.
 If excessive movement occurs to the object to be measured, SpO2 cannot be measured.
 Inspect the sensor application site at least every two hours for changes in skin quality, correct
optical alignment and proper sensor application. If skin quality is compromised, change the
sensor site. Change the application site at least every four hours. More frequent checking may
be required due to an individual patient’s condition

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7.2.1.4 Measuring SpO2

When the SpO2 sensor is attached to the finger, the CU-HD1 automatically starts measurement
and displays SpO2 and pulse on the screen as illustrated.

[SpO2 Measurement Screen]

When measuring SpO2 only, the screen shows [SpO2 Measurement Screen] above, along with a
pulse. When pads, paddles, or ECG cables are connected (not in Lead Fault condition) and ECG is
measured, pulse is shown in HR bpm.

SpO2 is one of the supplementary measures to check the patient‘s status; the measurement value is
subject to change according to the patient’s status and ambient condition. Measurement values may
change in the following cases.
- Hypothermic patient or Acidotic patient
- Patients that are receiving a photosensitive drug
- Patients that are receiving vasoconstrictor medications
- Patients that have poor circulation
- Hemoglobin malfunction patient
- Severe anemia patient
- Elevated levels of bilirubin
- Interference by carboxyhemoglobin and methemoglobin
- Injected dyes such as methylene blue
- Exposure to excessive illumination such as surgical lamps, bilirubin lamps, fluorescent lights, infrared
heating lamps or direct sunlight
- Equipment with an inaccurate sensor

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 Always use DS100A sensors and extension cables approved by CU Medical Systems, Inc. Check
compatibility before use of sensors or extension cables from other manufacturers, as they may
affect defibrillator performance.
 The CU-HD1 is calibrated to display functional oxygen saturation.
 Incorrect usage of the sensors under excessive pressure for long periods may result in pressure
damage.

 Some models of commercially available bench top functional testers and patient simulators can
be used to verify the proper functionality of pulse oximeter sensors, cables and monitors. See
the individual testing device's operation manual for the procedures specific to the model of
tester that you are using.
 SpO2 measurement accuracy can only be evaluated in vivo by comparing pulse oximeter
readings with values traceable to SpO2 measurements obtained from simultaneously sampled
arterial blood using a laboratory CO-oximeter.
 Functional test equipment designed for SpO2 testing cannot be used to assess the accuracy of
the SpO2 readings.
 See the sensor’s operation manual for the maximum temperature possible at the sensor-skin
interface and other information such as intended patient population, sensor application sites
and use criteria.
 Information about wavelength range can be useful to clinicians, especially those performing
photodynamic therapy

7.2.2 Alarm for Measuring SpO2

SpO2 alarms with measurement settings are activated when the measurement exceeds or falls
below the set value. SpO2 alarms are non-latch alarms; they are automatically deactivated when
the trigger condition no longer exists.

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7.2.2.1 Type of Alarm

SpO2 measurement mode has physiological alarms and technical alarms.

1) Physiological Alarms
Alarm Message Priority Indication Condition

Yellow alarm message Pulse measurement exceeds the

Pulse High Medium
with alert sound maximum set value.
Yellow alarm message Pulse measurement falls below the
Pulse Low Medium
with alert sound minimum set value.
Yellow alarm message SpO2 measurement exceeds the
SpO2 High Medium
with alert sound maximum set value.
Yellow alarm message SpO2 measurement falls below the
SpO2 Low Medium
with alert sound minimum set value.

2) Technical Alarms
Alarm Message Priority Indication Condition

Turquoise alarm
There is a problem with the SpO2
SpO2 Error Low message
module.
with alert sound

7.2.2.2 Alarm Setting – SpO2

You can set the SpO2 measurement alarm trigger range. Available fields include "Alarm On/Off",
"Upper Limit" and "Lower Limit".
Press the Menu Knob and select Alarms → SpO2 to open the SpO2 Alarm Settings screen.

 Alarm On/Off
You can set it to On/Off to generate the alarm sound when the measured SpO2 value goes
beyond the assigned numeric range.
 Upper Limit
This is the maximum value of SpO2 that generates the alarm sound, which can be changed
by 1% with the Menu selection button. The numeric values that you can set range from 2
to 100%.

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 Lower Limit
This is the minimum value of SpO2 that generates the alarm sound, which can be changed
by 1% with the Menu selection button. The numeric values that you can set ranges from 1
to 99%.

7.2.2.3 Setting Alarm – Heart Rate

This is an item to set the alarm according to Heart Rate (HR) measured through the SpO2 sensor.

 Alarm On/Off
You can set it to On/Off to generate an alarm sound when the patient HR goes beyond
the assigned numeric setting.
 Upper Limit
This is the maximum value of patient HR that generates an alarm sound, which can be
changed by 5bpm with the Menu selection button. Numeric values you can set range
from 35 to 300bpm.
 Lower Limit
This is the minimum value of patient HR that generates an alarm sound, which can be
changed by 5bpm with the Menu selection button. The numeric values that you can set
ranges from 30 to 295bpm.

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7.3 Measuring Noninvasive Blood Pressure (NIBP)

■ Overview
The systolic and diastolic blood pressures are measured using a vibration occurring when the
blood flow resumes at the time of inflation and deflation of the cuffs. The average from the
resumption of blood flow when expanding and the mean arterial pressure is calculated and
displayed on the monitor. If the systolic and diastolic blood pressures go outside the range of set
value for alarm, an alarm will be issued, indicating the abnormal condition of the patient.
The systolic and diastolic blood pressures are measured using a vibration occurring when the
blood flow resumes at the time of inflation and deflation of the cuffs. The average from the
resumption of blood flow when expanding and the mean arterial pressure is calculated and
displayed on the monitor. If the systolic and diastolic blood pressures go outside the range of set
value for alarm, an alarm will be issued, indicating the abnormal condition of the patient.
Non-invasive blood pressure (NIBP) is displayed on the monitor in modes other than Automatic
Defibrillation mode, and in case of 12-lead ECG mode, measurements are displayed only at the
bottom of the screen. Automatic occasional NIBP measurement and manual NIBP measurement
functions are provided. Occasional time and alarm-related measurement settings can be modified
in the menu.

7.3.1 Preparing to Measure NIBP

7.3.1.1 Connecting to the Device
To mount the cuff for noninvasive blood pressure (NIBP) measuring to the CU-HD1, a separate
connection tube is needed.

1) Connecting the Cuff and the Connection Tube for NIBP Measuring

2) Connecting the Connection Tube to the Main body

To use the NIBP function, you need to mount the tube connected with the cuff to the NIBP
input port of the main body as shown below. Hold the metal connector of the tube and pull it
in the opposite direction of the product to disconnect the tube from the main body.

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7.3.1.2 Inputting the information for patient monitoring

In Monitor Mode, use the Menu knob to enter patient information.
For more details on entering information, see "8.1 Patient Information".

Before measurement, choose the correct Patient Category from the menu. It is important for the
safety of the patient that you choose the correct “Patient Category” (Adult, Pediatric, Neonate) since
the maximum expansion pressure is determined based on your selection.
For details on changing Patient Category, see Menu. The default setting is "Adult".

7.3.1.3 Applying the Cuff to the Patient

① Select an appropriate cuff for the patient.
② If there is no cuff that fits the patient well, select a larger cuff rather than a smaller one.

Adult Pediatric infant

circumference 23~33cm circumference 12~19cm circumference 8~13cm

※ Proper location of cuff

③ Ensure the patient is lying down or comfortably seated with legs uncrossed, both feet on
the floor, and back supported. The limb to be used for NIBP measurement should be
relaxed, extended, and placed on a smooth surface for support. The operator position is
not restricted during NIBP measurement.
④ Sqeeze as much air from the cuff as possible before placing it on the patient.
⑤ Place the suff 2 to 5cm above the elbow crease.

⑥ Adjust the cuff so that the artery marker on the cuff is over the artery, pointing to the
hand or foot.
⑦ Check that the cuff ends between the range lines marked on the cuff.
⑧ If they do not line up, use a different size cuff.
⑨ Wrap the deflated cuff snugly around the limb without impeding blood flow.
⑩ Ensure that the hose is routed th avoid kinking or compression.

⑪ Keep the cuff placement at the same level as the heart.

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 Avoid using the cuff on parts of the body where damage to the tissue from external air
pressure can be expected.
 Never use anything other than the cuff supplied with the defibrillator. CU Medical Systems, Inc.
will not be liable for any problems caused by the use of products other than the cuff supplied.
 Neonatal brood pressure measurements must always use a 3 meter patient hose in order to
avoid overpressure errors caused by a lack of air volume within the overall pneumatic system.

 Select and use a proper cuff according to the patient for accurate measurement of noninvasive
blood pressure (NIBP) by referring to “2.7 Accessories”. If a cuff which is too small is used, the
measured blood pressure will be higher than the actual blood pressure of the patient, and if a
cuff which is too large is used, the measured blood pressure will be lower than the actual
blood pressure of the patient.
 When the blood pressure is measured while the cuff is loose or air remains in the cuff, the
measured blood pressure may be higher than the actual blood pressure. Use the cuff by
adhering it to the patient as closely as possible while it is being deflated.
 Accuracy of any blood pressure measurement may be affected by the position of the subject,
his or her physical condition and use outside of the operating instructions detailed in this
manual. Interpretation of blood pressure measurements should be made only by a physician or
trained medical staff.
 Intended patient populations include adult, pediatric and neonate patients. Safety and
effectiveness have not been proven on pregnant women.
 For neonate populations, the clinical effectiveness of this device has not been established in
the presence of dysrhythmias. Arterial reference sites included femoral, umbilical and radial
arteries.

7.3.1.4 Measuring NIBP

① Selecting Mode
This product takes NIBP measurements in manual and automatic modes. Mode selection
(automatic or manual) can be made using the menu.

Mode Description

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Manual Mode Pressing the NIBP button starts the measurement.

When NIBP Mode is set to "Automatic", measurements can be taken
Auto Mode by adjusting the measurement interval to 1, 3, 5, 10, 15, 30, 60 or 120
minutes.

② Measuring NIBP
Pressing the “NIBP” button starts the measurement according to the selected mode. During
measurement, the cuff attached to the patient expands and pressure applied is shown on the
screen. When measurement is complete, the systolic and diastolic blood pressures (mean blood
pressure) are displayed on the screen. Pressing the NIBP button once during measurement
stops the measurement.

During measurement, press the NIBP button to stop the measurement.

 Use clinical judgment to decide whether or not to perform automatic blood pressure
measurements on patients with severe blood clotting disorders because of the risk of
hematoma in the limb wearing the cuff.
 Do not apply the cuff to a limb that has an intravenous infusion or arterial catheter in place.
This could cause tissue damage around the catheter when the infusion is slowed or blocked
during cuff inflation.
 Do not attach the cuff to a limb being used for IV infusions or any other intravascular access,
therapy or an arterio-venous (A-V) shunt. The cuff inflation can temporarily block blood flow,
potentially causing harm to the patient.
 Prolonged series of NIBP measurements in automatic mode may be associated with purpura,
ischemia and neuropathy in the limb wearing the cuff. When monitoring a patient, examine the
extremities of the limb frequently for normal color, warmth and sensitivity. If any abnormality is
observed, stop the blood pressure measurements immediately
 Care should be taken when using an NIBP measurement mode on patients with decreased
consciousness, neuropathy, irregular cardiac rhythm, labile high blood pressure, increased arm
activity, or arterial insufficiency especially if the unit is utilized for a prolonged period. Pay
particular attention to unconscious patients since they cannot alert you if the pain is present.
 Accurate measurements are not guaranteed in circumstances such as dramatically fluctuating
barometric pressure (inside airplane or elevator) or hyperbaric chamber.
 Do not allow the NIBP tube to become kinked or crushed. This could prevent normal cuff
deflation resulting in patient injury due to prolonged restriction of blood flow.
 Do not place cuff over a wound, as this can cause further injury.

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 Repeated use of SpO2 measurements on the same patient over a short time interval can affect
blood pressure readings, limit circulation to the limb, and cause injury to the patient.
 Observe the patient’s limb periodically to ensure that circulation is not impaired for a
prolonged period of time.
 Do not place the NIBP cuff on the same arm or leg as an SpO2 sensor. Inflation of the cuff
causes the SpO2 monitor to read incorrectly.
 Do not attach the NIBP cuff to the arm on the side of the body where a mastectomy has been
performed. Attach the cuff on the other arm for blood pressure measurement.


 The pulse measured during NIBP measurement is not displayed on the screen. For patient
heart rate information, use the SpO2 sensor or ECG electrodes.
 A major air leak can be preventing cuff inflation. Check hose and cuff connections, replace a
defective hose or cuff, as necessary, and reattempt NIBP measurement. Check hose for kinks.
Kinked hose can be preventing the correct measurement.
 Do not compress or restrict pressure tubes during an NIBP measurement.
 If a spill occurs and liquid appears inside the tubing, contact your service personnel.
 If the circumference of the upper arm is less than 8-13 cm, noninvasive blood pressure cannot
be measured for the patient.
 Allergic exanthema (symptomatic eruption) in the area of the cuff may result, including the
formation of urticaria (allergic reaction including raised edematous patches of skin or mucous
membranes and intense itching) caused by the fabric material of the cuff.
 Petechia (a minute reddish or purplish spot containing blood that appears in the skin)
formation or Rumple-Leede phenomenon (multiple petechia) on the forearm following the
application of the cuff, which may lead to Idiopathic thrombocytopenia (spontaneous persistent
decrease in the number of platelets associated with hemorrhagic conditions) or phlebitis
(inflammation of a vein) may be observed.

 NIBP measurement accuracy can be improved by minimizing patient movement.

 Do not talk during the measurement. Keep quiet and stay calm for the entire process.
 Patient movement, very low pulse volume, or vibration from outside sources can influence the
accuracy of blood pressure measurements.
 Blood pressure readings may be affected by the position of the patient, their physiologic
condition, the presence of arrhythmia and other factors.
 NIBP Measuring function cannot be used on AED Mode.
 Activating the pacer function or charging the defibrillation energy automatically stops NIBP
measurement in Pacer Mode or Manual Defibrillation Mode.

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7.3.2 Alarm for NIBP Measuring

A NIBP alarm is issued when the measurement exceeds or falls below the range of the set values.
The NIBP alarm is the non-latch alarm, so it will be canceled when the measurement falls under
the range of the set values.

 An NIBP alarm is issued due to an occasional measurement. Once the alarm is issued, the EXIT
button will be activated immediately.

7.3.2.1 Type of Alarm

NIBP measurement mode has physiological alarms and technical alarms.

1) Physiological Alarms

Alarm Message Priority Indication Condition

Yellow alarm message Systolic blood pressure measurement

Systolic High Medium
with alert sound exceeds the maximum set value.
Yellow alarm message Systolic blood pressure measurement
Systolic Low Medium
with alert sound falls below the minimum set value.
Yellow alarm message Diastolic blood pressure measurement
Diastolic High Medium
with alert sound exceeds the maximum set value.
Yellow alarm message Diastolic blood pressure measurement
Diastolic Low Medium
with alert sound falls below the minimum set value.
Yellow alarm message Mean blood pressure measurement
Mean High Medium
with alert sound exceeds the maximum set value.
Yellow alarm message Mean blood pressure measurement
Mean Low Medium
with alert sound falls below the minimum set value.

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2) Technical Alarms

Alarm Message Priority Indication Condition

NIBP
Turquoise alarm message
Measurement Low NIBP measurement failure.
with alert sound
Failure
NIBP signal has Turquoise alarm message
Low Oscillometric signal has noise.
noise artifacts with alert sound

NIBP Pneumatic Turquoise alarm message NIBP operation is interrupted by

Low
Blockage with alert sound bent tubes, etc.

NIBP air leak or Turquoise alarm message

Low Air is leaking from tubes, etc.
loose cuff with alert sound

NIBP Cuff Turquoise alarm message

Low NIBP is over-pressurized.
Overpressure with alert sound

Turquoise alarm message There is a problem with NIBP

NIBP Error Low
with alert sound module operation.

NIBP Calibration Turquoise alarm message

Low NIBP module calibration has expired.
overdue with alert sound

NIBP Equipment Turquoise alarm message

Low NIBP device is faulty.
Malfunction with alert sound

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7.3.2.2 Alarm Setting

You can set the NIBP-related alarm ON/OFF. You can set an item to issue an alarm among the
measured NIBP results.

1) Alarm Setting Screen

Press the Menu knob and select Alarms → NIBP to open the NIBP Alarm Setting screen.

2) Alarm On/Off
Turns the alarm on or off for noninvasive blood pressure. You can set the alarm only for the
selected items out of the results of noninvasive blood pressure measuring.

3) Systolic Blood Pressure

Ye can set the alarm range for systolic blood pressure out of the measured values.

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4) Diastolic Blood Pressure

You can set the alarm range for diastolic blood pressure out of the measured values.

5) Mean Blood Pressure

You can set the alarm range for mean blood pressure out of the measured values.

 Changes made to the alarm settings in the menu are not automatically saved. When the
equipment reboots, the default alarm settings are restored. To change the default alarm
settings, they must be changed and saved in Administrator Mode. For details on entering
Administrator Mode or changing default alarm settings, see the Service Manual.

 Calibrate the NIBP measurement device every year by contacting CU Medical Systems, Inc. for
service.
 If the device does not work properly, see Troubleshooting for Problems Related to NIBP
Measuring. For other problems, please contact the CU Medical Systems Service Center.

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7.4 Measuring End-tidal CO2 (EtCO2)

■ Overview

The CU-CM1 allows you to measure CO2, EtCO2, and RR (Respiration Rate). CO2 can be measured
in Patient Monitoring Mode, Pacer Mode and Manual Mode on the CU-HD1.

The CU-CM1 offers two methods for measuring CO2, namely Mainstream and Sidestream and it is
measured through infrared absorption of CO2.

CO2 continues to be measured through a sampling line or the adapter. EtCO 2 is measured
through the concentration of CO2 at every end of the patient's exhalation. It can be a critical
means of monitoring the respiration of the patient. For example, it allows you to see if chest
compressions were administered properly to a patient during CPR, and is used to confirm
successful intubation. It also allows you to check respiratory ailments in the lungs or bronchi.

 CU-CM1 is not compatible with any other products other than CU-HD1.
 Either Mainstream or Sidestream measurement method can be selected and used.
 When cleaning the IRMA Mainstream gas analyzer, always wipe it with a soft cloth. Remove the
airway adapter before cleaning the analyzer.
 Wipe the outside surface using a formula of 70% or less ethanol and a 70% or less isopropyl
alcohol.
 This device does not provide an automatic air pressure compensation function.

 If the zero calibration of the CO2 sensor is necessary, if correct air pressure is not set of if the
pre-heating time is not enough, the EtCO2 and RR measurements may not be accurate. A
sensor application error or environmental conditions may also affect the measurements.
 Accessories of IRMA Mainstream gas analyzer and ISA Sidestream gas analyzer can only be
used once. Do not clean, sterilize, or reuse them.
 Check if CO2 waveform (capnogram) is appropriate on the monitor screen. Always check if the
patient's ventilator is connected correctly.
 If it is loosely connected or damaged, the patient's breathing may become abnormal or the
measurement of respiratory gases may become inaccurate. Connect it securely and check the
connected part for leaks.
 If spray medicine or anesthetic gas is used, the CO2 measurement may be inaccurate.
 Carry out zero calibration while the airway adapter is not connected to the patient.

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 Preparing the Measurement of EtCO2

7.4.1.1 Connecting to the Device
1) Connecting the IRMA Mainstream to CU-CM1 (Front View)

2) Connecting the ISA Sidestream to CU-CM1 (Rear View)

 When selecting an accessory, always check the patient category (adult, pediatric, neonate),
patient airway (ventilation), and ventilation status (humidified ventilation).
 Use only accessories provided by CU Medical Systems, Inc. for correct and accurate
measurement of CO2.

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7.4.1.2 Setting
The CU-CM1 measures the amount of CO2 and transmits the measured value to the CU-HD1 via
Bluetooth. The CU-HD1 displays it on the LCD screen. CO2 can be measured in Patient
Monitoring Mode, Pacer Mode and Manual Mode on the CU-HD1.
First, pairing the CU-CM1 with the CU-HD1 is needed for using CU-CM1. For details on pairing
the CU-CM1 is shown below.

1) Pairing
If a new CU-CM1 is purchased or replaced, it can be used only after pairing with CU-HD1.

① Select "CO2 Sensor Initialization" in Bluetooth as below for pairing via Bluetooth. (“MENU”
→ “Device Management” → “Bluetooth” → “CO2 Sensor Initialization”)

 CU-HD1 may be obstructed by other devices, even if those other devices meet the KN
emission requirements.

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② When the CU-CM1 is turned on and is paired with the CU-HD1 via Bluetooth, a long
beep will sound three times. The following window will pop up on the CU-HD1 screen to
show that pairing is complete.

 Communication is not possible with devices that are not designated by CU Medical Systems,
Inc.
 Before pairing the CU-HD1, turn on the power of the device to be connected.

③ Select CO2 by pressing the lead selection (Sector 2) button on the CU-HD1. When Sector
2 is selected as CO2, the CO2 measurement screen appears and the CU-HD1 attempts to
connect to the CU-CM1.

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④ When you turn the CU-CM1 on by pressing the power button, the CU-HD1 is connected
to the CU-CM1. When the CU-HD1 is connected to the CU-CM1, the screen shows
information on the Mainstream and Sidestream connections, as well as the battery status
of the CU-CM1.

,,

,
,

2) CO2 Display
You can change the sweep speed, scale, and unit by selecting “MENU → Device Management
→ Etc. → CO2 → CO2 Display”.

2.1) CO2 Seep Speed

In Menu on the CU-HD1, you can change the sweep speed in the CO2 measurement graph.
You can change it within the following range.
- 6.25 mm/sec (default setting)
- 12.5 mm/sec
- 25 mm/sec

2.2) CO2 Scale

In Menu on the CU-HD1, you can change the scale in the CO2 measurement graph. You can
change it within the following range.
- 0~100 mmHg or 0~14 % (default setting)
- 0~50 mmHg or 0~7 %
- 0~20 mmHg or 0~4 %

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2.3) Unit
In Menu on the CU-HD1, you can change the display unit in the EtCO2. You can change it
within the following range.
- mmHg (default setting)
- %

3) CO2 Zero Calibration

When CO zero calibration is required, select "Menu → Device Management → Etc. → CO2 →
Zero Calibration" to perform zero calibration.

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7.4.2 Using the Analyzer

7.4.2.1 Using the IRMA Mainstream Analyzer
① Plug the IRMA connector into the IRMA input of CU-CM1 and switch the power on.

② Snap the IRMA probe on top of a new IRMA airway adapter. It will click into place when

properly seated.

③ If necessary, perform zero calibration for the analyzer on the CU-HD1. (MENU  Device
Management  Etc.  CO2  Zero Calibration)

④ During the calibration a message “Zero calibration in progress” will appear on CU-HD1
and the green LED on the IRMA Mainstream Analyzer will blink.

⑤ When zero calibration is completed, the message will disappear and the green LED will
be steady.

⑥ Connet IRMA airway adapter 15mm male connector to the breathing circuit Y-piece.

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⑦ Connet the IRMA airway adapter 15mm female connector to the patient’s endotracheal
tube.

⑧ Connect the patient’s endotracheal tube to the patient, and measure the CO2.

 Perform zero calibration for the analyzer while the Airway adapter is not connected to the
patient.

 For more accurate measuring CO2, perform the zero calibration whenever you replace the
Airway adapter.
 When zero calibrating the IRMA Mainstream Analyzer, additional calibration gas is not required.
 Before measuring the amount of CO2 using the IRMA Mainstream Analyzer, it is required for
the analyzer to warm-up for 10 seconds after you turn it on. For accurate measurement, use
the equipment approximately 30 seconds after the IRMA Mainstream gas analyzer has been
powered on.

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7.4.2.2 Using the ISA Sidestream Analyzer

① Connect the ISA Sidestream analyzer connector into the CU-CM1 rear connector port.
② Connet the Nomoline connetor to the ISA Sidestream analyzer.

③ After ensuring the nasal cavity is clear, insert the tip of the nasal cvity Nomoline into the
patient’s nostril for measurement.

 Before measuring the amount of CO2 using the ISA Sidestream Analyzer, it is required for the
analyzer to warm-up for 1 minutes after you turn it on. For accurate measurement, use the
equipment approximately 2 minutes after the ISA Sidestream gas analyzer has been powered
on.

 If the "Sampling line is interrupted" message appears or the measurement value begins to
show error, replace the nomoline connector.
 Disposable accessories, such as disposable nomoline adapter set and T adapter set, should be
used for only one patient.

 If the patient's nostrils are blocked partially or completely or the patient is breathing using
his/her mouth when the ISA Sidestream gas analyzer is used, the EtCO2 measurement may
become lower.
 Reflux of gastric contents, mucus, pulmonary edema fluid or endotracheal epinephrine
introduced into the detector may increase airway resistance and affect breathing. If such a case
occurs, dispose of the accessories.
 EtCO2 should be measured after ensuring the nomoline airway is not bent and a physical
blockade is not occurring as a result of the patient lying on top of nomoline airway.
 Using a flammable anesthetic mixed with air, oxygen or nitric oxide poses a danger of
explosion. If it is exposed directly to laser, the ESU device, or high heat while oxygen exists, the
nomoline airway may ignite. If a procedure using laser, an electrosurgery device, or high heat
is carried out on the patient's head and neck, special caution should be taken to prevent the
occurrence of fire in the nomoline or the surrounding environment.
 The sidestream CO2 sensor port should be ventilated to the outside. If the discharge port of
the sidestream sensor is blocked, the measurement may be significantly delayed while such a
problem is not displayed.
Place the nomoline airway carefully, so as not to choke the patient’s neck or body.

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7.4.3 Alarm for EtCO2

7.4.3.1 Type of Alarm
EtCO2 measurement mode has physiological alarms and technical alarms.

1) Physiological Alarms

Alarm Message Priority Indication Condition

Red alarm message with Respiration is not measured during

Apnea High
alert sound the set duration (seconds).

Yellow alarm message EtCO2 measurement exceeds the

EtCO2 High Medium
with alert sound maximum set value.
Yellow alarm message EtCO2 measurement falls below the
EtCO2 Low Medium
with alert sound minimum set value.
Respiration Rate Yellow alarm message Respiration rate measurement
Medium
High with alert sound exceeds the maximum set value.
Respiration Rate Yellow alarm message Respiration rate measurement falls
Medium
Low with alert sound below the minimum set value.

2) Technical Alarms

Alarm Message Priority Indication Condition

Measurement value of the CO2

CO2 : Out of Turquoise alarm message
Low sensor is outside the reference
range accuracy with alert sound
accuracy range.
CO2 : Out of Internal temperature of the CO2
Turquoise alarm message
range/internal Low sensor is outside the reference
with alert sound
temperature range.
CO2 : Out of
Turquoise alarm message The CO2 sensor is outside the
range/ambient Low
with alert sound ambient pressure range.
pressure
CO2 : Need zero Turquoise alarm message The CO2 sensor requires zero
Low
calibration with alert sound calibration.
Turquoise alarm message The CO2 sensor has a software
Software Error Low
with alert sound error.
Turquoise alarm message The CO2 sensor has a hardware
Hardware Error Low
with alert sound error.

Motor Speed Turquoise alarm message The CO2 sensor motor exceeds the
Low
out of bounds with alert sound speed range.
Factory
Turquoise alarm message There is an error with the CO2
calibration Low
with alert sound sensor calibration value.
data loss

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7.4.3.2 Setting Alarm

1) Capnography
Set the range for generating capnography-related alarms. Available alarm range options
include “EtCO2”, “Respiration Rate” and “Apnea”.

2) EtCO2
You can set the alarm range of EtCO2 out of the measured values.

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3) Respiration Rate
You can set the alarm range of respiration rate out of the measured values.

4) Apnea
You can set the alarm range of apnea out of the measured values.

 Changes made to the alarm settings in the menu are not automatically saved. When the
equipment reboots, the default alarm settings are restored. To change the default alarm
settings, they must be changed and saved in Administrator Mode. For details on entering
Administrator Mode or changing default alarm settings, see the Service Manual.

7.5 Transferring Patient Monitoring Information

The CU-HD1 supports the SD card and Bluetooth Communication as the medium to transfer or
deliver the measured patient information to other devices.
For information on the real-time printer, SD card and Bluetooth communications please refer to
“Chapter 9_ Communication & Data Management”.

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Chapter 8. MENU Composition

■ Overview
The CU-HD1 MENU key may be used to change the settings of patient information, alarm, printer,
CPR, device configuration, and automatic analysis.

To change the menu composition, use the menu knob or the soft button at the bottom of the LCD
screen.

The MENU key is activated in the condition where there is no connection to a patient with pads or
paddles in other modes than the Patient monitoring mode (Monitor mode).

[Main Menu Display]

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8.1 Patient Information

Press the Menu knob from “Patient Information” at the “Main Menu” to view the following menu
display where you can change patient information. Patient Information comprises of three sub-menus.
Use the soft keys of “Previous Page” and “Next Page” to change the sub-menu.

To change patient information, turn your Menu knob left or right to select the patient information
item. If you press the Menu knob, a text input window will be prompted at the bottom of the menu.
Also, you can change the information about the number or gender information by switching between
Increase and Decrease, On and Off using the Menu knob.

After changing the sub items of Patient Information, press the Menu knob to apply the changed data.
Select “Exit” from each of the Patient Information input menu to return to the “Main Menu”.

8.1.1 Patient Information 1/3

The following screen is a Patient Name and ID setting menu where you can change the
information fitting for each of items. (Default setting: N/A)

8.1.2 Patient Information 2/3

The following screen is the second screen of the Patient Information sub-menu where you can
change the patient category, age and gender.
Each of the detailed settings is listed as follows.

∙ Patient category includes Neonate, Pediatric and Adult.

∙ The age of a patient can be increased/decreased (0-150) by 1 using the Menu selection button.
∙ Patient gender can be changed to female or male

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8.1.3 Patient Information 3/3

The following figure displays a screen where you can change information about whether a patient
is using an Implantable Cardiac Defibrillator (ICD). It can be set to “Put on” or “Put off”
according to the patient status.

 Make sure to enter a patient category before measuring noninvasive blood pressure.

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8.2 Alarm
Press the Menu knob from the “Alarm” item at the “Main Menu”, and then the following MENUs will
be prompted so that you can change the alarm setting. For the setting of the alarm menu, you can
change the on/off status of alarm, and the maximum/minimum value of the alarming frequency.

After the detailed items have been changed, the changed values are applied by pressing the Menu
knob.
Select “Exit” from each of the alarm menus, and press the Menu knob, the “Main Menu” will be
prompted.

 Changes made to the alarm settings in the menu are not automatically saved. When the
equipment reboots, the default alarm settings are restored. To change the default alarm
settings, they must be changed and saved in Administrator Mode. For details on entering
Administrator Mode or changing default alarm settings, see the Service Manual.
 Changes made to the filter settings in the menu are not automatically saved. To change the
default settings, see the Service Manual.

8.2.1 Alarm Pause Time

This is a screen to set the amount of “alarm pause time from the time when the “Alarm Pause”
button is pressed to when to generate the next alarm sound.
Alarm Pause Time can be changed by 10 second with the Menu knob.
The amount of alarm pause time that you can set ranges from 30 seconds to 2 minutes.

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8.3 Printer
Press the Menu knob from “Print” at the “Main Menu” to view the following menu display where you
can change the printer settings.

After the detailed items have been changed, the changed values are applied by pressing the Menu
knob. Select “Exit” from the “Printer” menu, and press the Menu knob, the “Main Menu” will be
prompted.

 Auto Mode
This is a function to set it to the automatic printing mode, printing the defibrillation process
after permitting defibrillation shock. The Menu knob may be used to set the automatic mode
setting to On or Off.
 Manual Print Duration
A function to set the Manual Print Duration time, for printing after the Printer button has been
pressed. By clicking the Menu knob, the duration time can be changed by 10 seconds. The
amount of time that you can set ranges from 30 seconds to 2 minutes.
 Sector
Set the number of vital sign sectors which are printed by pressing the Print button. 'Sector 1' prints Sector 1 only
and 'Sector 2' prints both Sector 1 and Sector 2.

8.4 Device Management

Click the Menu knob from “Device Management” at the “Main Menu” and then the following screen
will be prompted, where you can change and manage the various settings of the CU-HD1.
The following screen displays the “Device Management” sub-menu which is comprised of voice
recording, volume control, time adjustment, filter function selection, self-device test, Bluetooth
communication function, and ECG gain control.

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8.4.1 Voice Recording

The CU-HD1 supports the voice recording function, and determines whether to use the voice
recording function in this item.
The voice recording is available on AED mode only.

8.4.2 Volume
This is a sub-menu to control the speaker volume of the CU-HD1.

 Voice Volume / Alarm Volume

The device has a volume scale of 10 levels, which can be changed by 1 unit with the menu
selection button.
 QRS Beef On/Off
You can set it to On/Off to generate the beep sound when detecting the QRS of the ECG.

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8.4.3 Date & Time

You can set the date and time. Date is entered in the order of year, month and date, and time is
entered in the order of hour, minute and second. After selecting an item to be changed, press the
Menu knob to enter the date and time. After finishing, press the Menu knob to change the
setting in order by pressing the Menu knob.

8.4.4 Bluetooth
The Product supports wireless communication using Bluetooth. The “Bluetooth” menu is
composed of the following menus that connect Bluetooth to external devices.

From the “12-lead send duration” on the “Bluetooth” menu, you can set the 12-lead ECG time
that is transferred when the 12-lead ECG information is transferred to other devices. The time
bracket you can set ranges from 10 seconds to 2 minutes by the 10 second unit. The following
shows the menu for “12-lead send duration”.

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If you select Initialize Bluetooth from the “Bluetooth” menu, the following window will be
prompted, waiting for the connection to Bluetooth communication.

If the Bluetooth communication device is not detected, press the “Cancel” button. The window will
be prompted, saying that Bluetooth is not connected yet.
Through the following window, you can verify that there is Bluetooth communication established
between the CU-HD1 and the computer. For information on computer and communication, please
refer to “Chapter 9_Communication and Data Management”.

 CO2 connection can be reset using a product with the EtCO2 function. For details on
connecting to a product with the EtCO2 function, see “7.4.1.1 Connecting to the Device”.

8.5 Etc.
The following screen displays the “Etc.” sub-menu which is comprised of self-test, data management,
and CO2.

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8.5.1 Self Test

The CU-HD1 performs a self-test on a periodic basis when the device is turned on. If a user
selects the menu to use the self-test function of the device, the following confirmation window
will be prompted.

After the device has been inspected, it is impossible to use the function of device treatment and
diagnosis. So, please turn off the device and turn it on again. The list of items tested in the
manual test is as follows.

Test Item Inspection Details

Normal System Test Inspects functions necessary for the system operation.
Mode Rotary Key Test Checks out the Rotary switch functions.
Charging Button Test Checks the button status to prevent unintended recharging.
Shock Button Test Checks the Shock button status.
Audio Test Inspects whether the audio function works normally.
Defibrillation Test Inspects the charging/discharging functions.
Pacer Test Inspects the pacer function.
ECG Lead Test Inspects the ECG function.
Battery (Part A/B) Test Inspects the function of battery terminals (A/B)
SpO2 Test Inspects the function of SpO2 module.
Printer Test Inspects the printer working status.

※ For more detailed information on the manual diagnosis process, please refer to Section
10.1.3 – Manual Self-test.

8.5.2 Data Management

If a user selects the menu to use the data management function of the device, the following
confirmation window will be prompted.

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Chapter 9. Communication and Data Management

■ Overview
Bluetooth communication is available in the CU-HD1 when transferring measured data externally, and
when verifying stored patient information using programs installed in an adjacent computer.

Other than communicating with an external device, you can transfer digitalized voice and patient
measurement information externally by the use of an SD Card. Also, you can use the real-time printer
to print out ECG information and device usage history.

The CU-HD1 uses a data management function to record/manage patient vital sign data in the
internal memory. Up to 100 records of context information can be stored. When storing a single data
type, data can be stored for up to 192 hours continuously.
Context information is recorded in the following modes.
- AED Mode
- Manual Defibrillation Mode
- Patient Monitoring Mode
- Pacer Mode

※ Context information in data management is displayed as date of the context, start time, duration,
and usage mode.

 General functions are unavailable while using the data management function. Entering Data
Management mode disables Normal mode. Exiting Data Management mode turns the
equipment on again.
 When 100 context information records have been stored in the internal memory, the
defibrillator will store new context information by overwriting the oldest context information.

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※ In data management, Event Review, ECG Review, Copy Data, or Data Erasing can be used for
context information.

Event Review shows the start date and time of the event and details of the event. ECG Review shows
ECG information of up to 16 seconds per page on the screen. Partial and Total Print are also
available in Event Review and ECG Review.
Copy Data allows you to select and copy context information stored in the internal memory it to
external memory (SD card).
Data Erasing erases all context information stored in the internal memory.
.

 Do not insert or remove the external memory (SD card) while the defibrillator is in use. Doing
so may cause the defibrillator to malfunction.

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9.1 Built-in Printer

The CU-HD1 printer can print out the following information.

9.1.1 ECG Signal Output

① Press the Lead Select button to select ECG for print out.
② Press the Print button to start printing.
③ Out of information displayed on the LCD, the ECG information displayed in the upper part
will be print out. Press the Lead Select button to choose the ECG to be printed from 3/7/12-
lead and pads ECG information at the upper part of the Monitor mode and Manual
Defibrillation mode LCD screen.
④ Press the Print button to print out the measured ECG.
⑤ When you want to stop the real-time ECG printing process, press the Print button.
⑥ Items to be printed include patient information, product information, printed wave
information, heart rate, print filter characteristics, data, and time.

9.1.2 Defibrillation Result Report

When it comes to automatic defibrillation or manual defibrillation results, a report will be made
on the defibrillation results after defibrillation has been implemented and it will be printed. If the
Automatic mode is turned on from the Print item on the menu, the printing job will be done
automatically.
Items to be automatically printed include the patient information, product information, patient’s
ECG measured with pads or paddles, heart rate, print filter characteristics, date and time,
defibrillation process (analysis, recharging, and defibrillation energy delivery) and SpO2
information.
If you don’t want to print out the defibrillation report, you can change a setting on the Printer
menu, or force the printer into pause by pressing the Print button when it starts into motion.

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 If there is not enough printer paper before the printing job is finished, the remaining
information will be printed out by feeding paper into the printer without turning off the device.
 For the information on how to feed printing paper into the printer, please refer to “Chapter
3_Product Installation”.
 When the noninvasive blood pressure measuring process is complete, the measured values are
printed.
 While printing, EtCO2 pauses and the "Will reconnect after printing" message appears.

9.2 Data Storage: SD Card

The CU-HD1 provides two saving functions. One functions to save the patient’s ECG, and the other
works to record and save voice uttering during the use of the product.

9.2.1 Voice Recording

If the voice recording function is turned on in the menu with a SD card inserted, a voice will be
automatically recorded on the SD card when the device is turned on.

9.2.2 Saving ECG

When an SD card is inserted on the CU-HD1, the patient’s ECG is automatically saved, and the
saved ECG information can be viewed on your personal computer.

 When using the saving function, install an SD card before turning on the product. When using
a new SD card, connect the SD card to a PC and format it in FAT32 before inserting it in the
defibrillator.

 If there are 10 MB or less of free space on the SD card, replace it or delete unnecessary data
before use. Otherwise, further data storage may not be possible or the existing data may be
damaged.
 Do not remove the SD card from the product during the usage. It may cause a malfunction.
 When verifying the saved information, close the current process and remove the SD card.

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9.3 External Communications: Bluetooth Communication

9.3.1 Initializing Bluetooth Connection
1) Searching the Device
① Select “Initialize Bluetooth Connection” from the ‘Bluetooth” menu to prepare the
Bluetooth connection as shown below. (“MENU” > “Device Management’ > “Bluetooth” >
“Initialize Bluetooth Connection”)

② Double click “My Bluetooth Places” from the desktop.

③ When executing “My Bluetooth Places”, the following screen will be prompted. Double
click “Search for devices in range” on the following screen.

 If you purchase your PC and the CU-HD1 together, Bluetooth has should already have been
completed. If you need to initialize the Bluetooth connection due to a PC problem, you must
disconnect Bluetooth first, and then initialize the Bluetooth connection.

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④ If the Bluetooth device is detected, the following screen will be prompted, and the CU-
HD1 can be identified with its serial number.

⑤ After clicking the detected Bluetooth device, right-click the device connection. And then
the following window will be prompted. At this time, type the security code.

※ For more information on how to type security code, please contact us.

⑥ Click the “OK” button after you have accurately entered the secure code. If the security
code has been typed correctly, a check mark will be displayed to the Bluetooth device
icon as shown below.

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⑦ Double click the detected Bluetooth device and check the port connected to the device.

2) Connecting the Device

If you double click the above device and make a connection, the communication connection will
be completed between the computer and the CU-HD1.

3) Verifying the Device Connection

If the Bluetooth is successfully connected, the following window will be prompted in the CUHD1
screen, notifying that the connection had been successfully made.

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9.3.2 Unpair Device

① Turn off the CU-HD1. Double click “My Bluetooth Palces” form the desktop of pc.

② Double click “Search Bluetooth Device” form “My Bluetooth Places”.

③ The Bluetooth device is searched. At this time, the name of the searched Bluetooth device
should be matched to the product serial number..

④ Click the searched device and right click.

⑤ Click “Unpair Device”. Close the “My Bluetooth Palces” window.

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9.3.3 12-Lead ECG Transfer

The sequence to send 12-lead ECG information via Bluetooth communication is shown as follows.
① Connection between a patient and the CU-HD1 10-lead ECG. (Refer to “Chapter 7_Patient
Monitoring”.)
② Press the “Send” soft button.
(The “Send” soft button is activated after 10 seconds from 12-lead starting.)

If the connection for transferring patient information is made between the computer and the
Bluetooth device, it should be possible to verify the above 12-lead measurement screen. If
Bluetooth is connected, the Bluetooth icon at the bottom of the screen appears blue, and the
“Send” soft button should be activated. If Bluetooth is disconnected, the icon should appear red,
and the “Send” soft button should disappear.

③ Press the “Send” soft button and transfer patient information via transfer program.

9.3.4 Real-time Transfer

You can verify the ECG and SpO2 information displayed on the screen in the real-time remote
mode by connecting the Bluetooth communication to the computer’s agent program.
(Real-time transfer is available only when Bluetooth is connected. If the real-time transfer is not
available, verify the Bluetooth connection status.)

① Launch the EKG Monitor Agent program on tour computer.

② Click the Bluetooth icon from the EKG Monitoring Agent program to connect Bluetooth
communication. And then verify that Bluetooth (the blue icon) is connected to the product.
③ If you press the “Real-time Transfer” soft key form the product, the patient’s information will

be transferred to the computer via the Bluetooth connection. (10 seconds later after
Bluetooth is connected, the “Real-time transfer” soft key will be created.)

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9.3.5 Connecting Bluetooth with Smartphone (for Android)

① To pair the equipment with a smart phone, download and install the ‘EMS12 Agent’ from
the Android Google Market.
② In monitor mode, select MENU > Device Management > Bluetooth > 12Ch Transmission
Initialization and wait until a connection is made over Bluetooth with the chosen smart
phone.

③ On your smart phone, go to Setting > Bluetooth and scan for available devices.
④ Add the scanned device to your smart phone. (The PIN is the same as the device serial
number.)
⑤ Launch the 'EMS12 Agent ' app, select Settings > Scan Devices, then add the registered
device to the app.
⑥ Tap the ‘Connect CU’ button to connect to the equipment over Bluetooth.

⑦ When the Bluetooth connection is established, the ‘Bluetooth connected’ message appears
on the equipment message window.

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9.4 Data Management

9.4.1 Event Review
To review the events of context information stored in the internal memory, follow the steps below.
① Rotate the rotary switch to Monitor, Pacer, Manual or AED mode. No pads should be
attached to the equipment.
② Press the Menu knob to select ‘MENU’.
③ Use the Menu knob to select ‘Device Management’ and press the Menu knob.
④ Select ‘Etc.’ and press the Menu knob.
⑤ Select ‘Data Management’ and press the Menu knob.

⑥ Press the ‘OK’ button with the Menu knob to exit normal mode.
⑦ Rotate the Menu knob left/right to select a context information record and press the Menu
knob.
⑧ Select ‘Event Review’ and press the Menu knob.

1) Partial printing in Event Review

① For partial printing, press the Menu knob once, then rotate the Menu knob left/right to
select events.

② After making the selection, press the Menu knob.

③ At the message window confirming partial printing, press the ‘OK’ button to execute partial
printing.

2) Total printing in Event Review

① Press the ‘Total Print’ (softkey) button.

② At the message window confirming total printing, press the ‘OK’ button to exectue total
printing.

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9.4.2 ECG Review

To review the ECG data stored in the internal memory, follow the steps below.
① Rotate the rotary switch to Monitor, Pacer, Manual or AED mode. No pads should be

attached to the equipment

② Press the Menu knob to select ‘MENU’.
③ Use the Menu knob to select ‘Device Management’ and press the Menu knob.
④ Select ‘Etc.’ and press the Menu knob.
⑤ Select ‘Data Management’ and press the Menu knob.
⑥ Press the ‘OK’ button with the Menu knob to exit normal mode.

⑦ Rotate the Menu knob left/right to select a context information record and press the Menu
knob.
⑧ Select ‘ECG Review’ and press the Menu knob.

1) Partial printing in ECG Review

① For partial printing, press the Menu knob once, then rotate the Menu knob left/right to
select events.
② After making the selection, press the Menu knob.
③ At the message window confirming partial printing, press the ‘OK’ button to execute partial

printing.

2) Total printing in ECG Review

① Press the ‘Total Print’ (softkey) button.
② At the message window confirming total printing, press the ‘OK’ button to exectue total
printing.

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9.4.3 Data Copy

To copy the context information stored in the internal memory, follow the steps below.
① Mount the external memory device (SD card).

② Rotate the rotary switch to Monitor, Pacer, Manual or Automatic Defibrillation Mode. The
pads must be OFF.
③ Press the Menu knob to select ‘MENU’.
④ Use the Menu knob to select ‘Device Management’ and press the Menu knob.
⑤ Select ‘Etc.’ and press the Menu knob.
⑥ Select ‘Data Management’ and press the Menu knob.

⑦ Press the ‘OK’ button with the Menu knob to exit the normal mode.
⑧ Rotate the Menu knob left/right to select a context information record and press the Menu
knob.
⑨ Select ‘Copy Data’ and press the Menu knob.
⑩ At the message confirming data copying, select the ‘OK’ button.
⑪ The selected context information is automatically copied to the external memory.

9.4.4 Data Delete

To delete the context information stored in the internal memory, follow the steps below.
① Rotate the rotary switch to Monitor, Pacer, Manual or Automatic Defibrillation Mode. The
pads must be OFF.
② Press the Menu knob to select ‘MENU’.
③ Use the Menu knob to select ‘Device Management’ and press the Menu knob.
④ Select ‘Etc.’ and press the Menu knob.
⑤ Select ‘Data Management’ and press the Menu knob.
⑥ Press the ‘OK’ button with the Menu knob to exit the normal mode.
⑦ Select ‘Data Erasing’ (soft key) button.
⑧ At the message confirming data erasing, press the ‘OK’ button to erase data.

 We advise regular back up of the context information in the internal memory and erasure of
the data for more systematic management.

 Before erasing data, copy all context information in the internal memory to the external
memory (SD card).
 Data erasing deletes all context information from the internal memory.

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◎ Chapter 10_Maintenance

Chapter 10. Maintenance

■ Overview
This chapter is intended to provide detailed information on management methods and instructions
and the product self-test functions for the maintenance and management of the CU-HD1.

Familiarize yourself with the product functions and management method introduced in this chapter
in order to maintain the product at the condition for optimal and immediate use.

You can check all of the main systems that are needed to properly run the product through the
automatic or manual self-test.

10.1 Self-test
The product is a medical device. Therefore, it performs a self-test in order to make sure that all of its
functions work normally. If an error lamp is ON, immediately stop using the device and contact CU
Medical Systems, Inc. or an authorized sales agent.

10.1.1 Power On Self-test

To ensure that the device is always ready for any emergencies, a self-test is performed by the
device. The list of items tested in this test is as follows.

 Battery Capacity Test

Verifies that the battery capacity is sufficient for proper operation.
If the battery level becomes too low, the device prompts you on the low battery condition
 Button Functionality Test
Checks whether the Charge button is pressed or not, preventing unintended recharging.
 Charging and Discharging Test
Verifies the proper functioning of the charging and discharging subsystems.

 If the “Low Battery” status is indicated, please recharge the battery.

 If there are errors other that “Low Battery”, please refers to “Chapter 13_Troubleshooting”,
and contact an authorized sales agent.

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10.1.2 Periodic Self-test

When the device is stored with a charged battery pack connected to it, it performs a periodic
self-test to ensure that it is ready for use in emergencies. There are three types of periodic self-
tests.

1) Daily Self-test
This test is done on a daily basis and the following items are checked.
 This test is the same as the battery capacity test done during the “power on” self-test.
 Checks the Charge button status to prevent unintended recharging.
 Checks the Shock button status of the device.

2) Weekly Self-test
This test is done on the weekly basis and the following items are checked.
 Checks the daily self-test items.
 Verifies the functionality of the SpO2 Pulse Oximeter.
 Verifies the functionality of the internal ECG circuit.

3) Monthly Self-test
This test is done on a monthly basis and the following items are checked.
 Weekly self-test items are tested.
 Charging and Discharging test: Tests whether the product can replenish itself with 2J energy, and checks the
functionality of charging and discharging through internal discharging.

10.1.3 Manual Self-test

The product can also run a manual self-test that requires your intervention.

The manual mode test evaluates all functions tested in all the self-test modes. To initiate a
manual self-test, use the “Self Test” in the “Device Management” menu. During the self-test
process, there is a process for the user to make sure whether the device functions properly.

① Go to “MENU” > “Device Management” > “Self Test” items.

(To check out the defibrillation energy status, please connect the test resistance to the
product.)
② A window will be prompted for verification. Please check it again.

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The Product cannot be used during the manual self-test session. The following section will give
you the step-by-step testing guidelines.

① If the mode is switched to the “Self Test” mode, product information (model name, serial
number), software version information, and the date when the self-test had been done at the
last time will be displayed on screen.
② Normal System Test : The test is run on the general system.
③ Mode Rotary Key Test : Checks the Rotary switch. If the instruction window is prompted,
move the Rotary switch to 150J of the manual defibrillator mode.
④ Charging Button Test : Process to verify the functionality of the Charge button. Press the
Charge button accoridng to the instructions.
⑤ Shock Button Test : Process to verify the functionality of the Shock button. Press the Shock
button according to the instructions.
⑥ Audio Test : Checks the speaker functions. After the voice test, there is a process to check
whether to operate the voice function by clicking the Menu knob.
⑦ Defibrillation Test : Items to check the defibrillation functionality, including the test of
automatically charging 200J and delivering the defibrillation energy. To test 200J
defibrillation operation, you must press the Shock button, and use the checkup resistance to
implement the test. If there is no resistance or simulator connection to deliver the
defibrillation energy, the device discharges the internally charged energy, leading to failure.
⑧ Pacer Test : Test about the pacer function.
⑨ ECG Lead Test : Tests 12-lead ECG measurement.
⑩ Battery Part A Test : Inspects the functionality of power terminal ‘A’.
⑪ Battery Part B Test : Inspects the functionality of power terminal ‘B’.
⑫ SpO2 Test : Inspects the functionality of SpO2 measurement module.
⑬ Printer Test : Inspects the functionality of the printer.

If the above manual test function has been finished, a message window will be prompted, saying
that the device must be closed.

In the course of the self-test process, if there is any problem with the test results, or the self-test
is put into pause during the test, or the test result indicates failure because the verification
request had not been properly performed, an additional self-test can be provided according to
the result of the power on the self-test.

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10.2 Power Management

Power supplies of the CU-HD1 include the battery module to charge, the AC power module, and a
car cigar jack adapter. For the information on how to supply power for those, refer to “Chapter
3_Product Installation”.

The CU-HD1 is an emergency medical product that must be usable even in a situation without AC
power. So it is important to check the battery status when preparing for an emergency. For the
charged battery capacity, check the remaining battery gauge or remaining battery status displayed
on the LCD screen.

10.2.1 Charging Battery

The battery can be charged with an AC power module, or car cigar jack.

The AC power module and battery must be mounted at the same time. In case where AC power
is supplied to the AC power module, the Product can be operated by the use of power supplied
by an AC power module, and the mounted battery will proceed into its charging process. It is
recommended to use the car cigar jack only for the purpose of battery charging.

If the battery is completely discharged, it takes less than 5 hours to completely charge the battery.

Battery life depends on the frequency and duration of use. When properly cared for and used in
its intended environment, the battery module has a useful life of approximately 2 years. Use
outside those conditions could significantly reduce battery life.

For details of information on battery module and power, please refer to “Chapter 13_Product
Specifications”.

 During storage, regularly ensure the battery is adequately charged. The battery is a
consumable part which requires regular inspection and replacement.

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10.3 Cleaning
For any device problems resulting from the negligence of the below cleaning instructions, the free
repair service may not be applied even during the warranty period.

Keep the main body and cables away from dust and pollution, and in the normal time, clean it using
a soft cloth.
There is a risk of device damage from forcible pressing or shock.

10.3.1 How to clean and Take Precautions

 Always keep the product clean, and check the damage status. If damaged, make a service
request.
 Check the product operation periodically to see if the product operation and functions are
carried out normally. Maintain the product performance to enable correct operation in an
emergency situation.
 Check the major terminals such as the defibrillation cable ports and DC power ports whether
they maintain normal condition without damage.
 In particular, check the expiration period of the defibrillation pads and disposable parts
among the product accessories and replace them with new parts if expired.
 Dispose used consumable parts according to the relevant regulations. Be careful not to cause
environmental pollution when disposing.
 Disposing the device while the battery is being mounted poses a risk of electric shock.
 Then dispose of the device and accessories in accordance with your country’s regulations for
equipment containing electronic parts.
 Wipe the product and accessories with a soft cloth for cleaning. Excessive force or impact
may cause a product failure.
 Do not immerse any part of the product or accessories in fluid or soap. Do not let any fluid
enter the case of the device.
 Do not use strong, acetone-based cleaners or abrasive materials in cleaning the device.
 Especially, the filter of the LCD could be damaged.
 The IRMA Mainstream Analyzer can be cleaned using a cloth moistened with maximum 70%
ethanol or maximum 70% isopropyl alcohol.
 Remove the disposable IRMA Airway Adapter prior to cleaning the IRMA Mainstream
Analyzer.
 Airway Adapter is disposable. Do not sterilize, immerse, or reuse.

※ Do not sterilize the product.

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10.4 Maintenance Activities

The user shall not repair this product at their own discretion. Basic maintenance can increase the
lifespan of the product, and maintain the normal condition of the device.

10.4.1 User Maintenance Activities

Frequency Activity Actions to be taken
Check the Product for any
error messages that might For any error messages, that you cannot handle, please
have been generated during call an authorized sales agent.
the self-test.
Ensure that there is no dirt,
water droplets, or dew at the If dirt, water droplets, or dew, remove them before use.
connector gates of defibrillator If you cannot remove them, please call us or an
Daily, pads/paddles, SpO2, ECG authorized representative.
Monthly, cables, NIBP Cuff.
or after Check supplies, accessories,
using the and spare parts for damage If any supplies have expired, replace them immediately.
product and expiration.

For any errors issued by manual testing, please call the

Perform the manual self-test.
manufacturer or its authorized sales agent.

Check the case of the device

If there is any apparent damage to the case of the
and the accessories for any
device, consult the manufacturer.
sign of apparent damage.
If there is dirt contamination, clean the case as
Check for dirt contamination.
suggested in Section 10.3.

 It is recommended to carry out periodic inspections of the product in preparation for an

emergency situation.

 Detailed technical information required for service support and servicing by certified personnel
is provided in the Service Manual.

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10.4.2 Maintenance Checklist

CU-HD1

Serial Number: __________________ Location/ Vehicle ID: ________________

Date

Schedule

Exterior Condition

Accessory Maintenance
Status

Error Correction or
Measures

Inspected by Signature
of Operator

The used supplies must be discarded according to the related law applicable to the local region.
When discarding the used defibrillation pads, special caution must be paid not to cause
environmental pollution. As for the battery replacement, please consult the manufacturer or the
authorized sales agent. If there is a need for discarding the battery, it must be discarded according to
the related law.

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◎ Chapter 11_Safety Considerations

Chapter 11. Safety Considerations

■ Overview
When using the product, you must understand the follow safety considerations.
Safety considerations are described repeatedly in many parts of this manual. The safety instructions
are repetitively described in this guide.
Each of the safety considerations displays risk factor, such risk factors are categorized as follows
according to the seriousness of potential accidents.

 A case that could result in a dangerous situation, including death or severe injury if instructions
are not observed

 Instruction that directly or indirectly addresses the company policy in order to protect people
or property

 Explanations for referential terms or additional operation tips helping you properly use the
product

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11.1 Considerations during Product Management

Safety Level Possible Risks or Risk Factors
Do not use the Product if it has been immersed in water. If the product has been
submerged in water, immediately contact us or the authorized sales agent.
If you connect a damaged device or an accessory to the device, the product may
not work properly, causing injuries to the user and the patient.
Do not immerse the product or the accessories in fluids. Do not let any fluid enter the
case of the device. Do not spill liquids on the case of the device. If a spill occurs on
the case, there is a risk of fire or electric shock. Do not sterilize the product. Do not
use abrasive materials in cleaning the product, especially on the LCD filter.
If any damage occurs to a defibrillation pad during its use or handling, replace it
with a new one.
This product is designed to resist any physical shock that may occur in the work
site. However, excessive shock may lead to damage to the product.
If damage is suspected, implement a manual self-test.
When changing the "Default Value" setting, follow the instructions of medical
professionals.
The user shall not repair this product at one’s own discretion. If the user tries to
disassemble the device arbitrarily, an electric short may be caused. This product is
in relation to high-voltage and high-current, the repair service for this product
shall go to the company or the authorized sales agent.
I t is important to carry any “must-have” accessories at all times. When unpacking,
check to make sure all of the accessories are included without omission.
To increase the product’s safety and reliability, only the accessories the company
provides must be used.
When storing the product, disconnect the defibrillation pads from the device. To
prevent the gel on the pads from drying up, do not open them before use.
If the device is continuously used, the battery must be kept connected. If the
battery and power are not connected, a self-test cannot be performed.
If there is gel left on the paddles, it may cause other problems in defibrillation
functionality in future. Check the surface of the paddles during maintenance and
clean off any leftover gel.
The product is graded as follows.
- The product’s Electric Shock Prevention is graded in Class 1.
Do not use this product with a flammable anesthetic or near a solvent.
- Noise Class by IEC/EN 60601-1 (safety of electro medical equipment) is “B”.
- Noise Alleviation Class by IEC/EN 60601-1-2 (electromagnetic compatibility) is “B”.
Carry out the maintenance according to the maintenance instructions of this
Operation manual.

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11.2 Considerations for Product Usage

Safety Level Possible Risks or Risk Factors
Do not operate the device in environments with flammable materials or gas
chemicals.
There is a possibility of explosion or fire if the Product is used in the presence of a
concentration of oxygen or inflammable anesthetics.
High-voltage and high-current electric energy is applied when using the Product.
Before using this product, gain the full knowledge on how to operate the device
from the Operation manual.

Do not modify this equipment without authorization of the manufacturer

Operation of the device below specified amplitude or value of vital sign may cause
inaccurate results.

Use with designated accessories only.

While performing maintenance, calibration, etc., without tools, once the cover,
connectors, etc. are removed, do not touch the patient at the same time as
touching any of the non-electric parts of the medical device which can be touched
in the patient environment.
For the patient’s safety, do not place the device in a location where a risk factor
may occur, such as a location where the device may fall down on top of the
patient.
If the floor surface and your hands are wet, you may get shocked. Move to a dry
location first and install the product.

If you discover any abnormality while using the product, turn off the power and
refer to the user manual.

This device should be connected to a power source with protective grounding in

order to avoid the risk of electric shock.
Only a user who is appropriately trained and certified must use the product.
The Manual mode or Pacing function must be used by medical personnel who
have knowledge on the ECG analysis.
Any electric devices that produce electric waves such as wireless devices or mobile
phones may deteriorate the performance of the product. The electric waves from
these devices may cause noises on the ECG signals measured from the patient,
and the device to malfunction.
Check the SD card direction. Do not force it to prevent any damage to the SD
card slot.

Do not use the ECG cables or connectors accompanied with the product with
other vender’s ECG monitoring devices.

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Safety Level Possible Risks or Risk Factors

Do not remove the SD card mounted while using the product.

Do not expose this product to X-ray or a strong magnetic field (MRI).

With the ECG Monitoring mode, the patient’s heart rate is measured and displayed
on the LCD screen. It neither analyzes the ECG nor delivers defibrillating shocks.
This product can be used in a place with high-frequency surgical equipment
without an additional protective device. The accuracy of this product may be
degraded temporarily during electric surgery or defibrillation but this does not
affect the safety of the product or a patient. See the electrosurgery device’s
Instructions for Use for information on reducing hazards of burns in the event of a
defect in its equipment. This product must not be exposed to X-ray or strong
magnetic fields (MRI).

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11.3 Considerations for Defibrillation

Safety Level Possible Risks or Risk Factors
When the electric shock is delivered, high voltage and currents are used so that it
may affect not only the user but also people standing nearby. Do not make
contact with the patient receiving the electric shock.
Do not have the defibrillation pads make contact with other materials including
the ECG electrode, wire, or dressing.
Do not use the gel-dried pads. Do not allow air to enter between the pads and
skin. The air entered between the pad and skin will cause skin burn.

Do not place the patient on a wet surface.

When carrying the patient in a paramedic vehicle, it is impossible to perform an

accurate ECG signal analysis so when detecting the heart rhythm needed for
electric shock, be sure to stop the vehicle and perform a reanalysis before using it.
The pediatric pads with the defibrillation energy attenuation module must be used
only for AED mode. If you use it in the Manual Defibrillator mode, contact the
manufacturer.

Do not forcibly perform the serial internal disarm.

If you do CPR during the analysis of a patient’s ECG signal analysis, you may
perform an incorrect analysis due to the interference of the patient’s ECG signal
analysis.
When attaching the defibrillation pads to the patient’s skin, following the
instructions described in the rear side of the pad. Do not use the damaged pad.
The defibrillation pad is disposable, do not reuse.
After using the conductive gel, remove the remaining gel on the paddles
completely using a wet towel or gauze.
In the course of CPR, the device provides the beep sound based on the 5 time
cycle according to the 2005 CPR Guideline Instructions (30:2, 15:2).

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11.4 Considerations for Pacer Mode

Safety Level Possible Risks or Risk Factors
Do not make contact with the patient who is receiving the Demand pacing
mode treatment. If an unintended ECG signal is created, it may affect the
pacing treatment.
Do not deliver any defibrillation energy to any patients using the pacing
function.
If defibrillation is necessary, remove the cables connected with the pacing
electrodes before carrying out the defibrillation.
If touching the patient to check the patient status, it may be possible to be
exposed to pain or other inconvenience due to the leakage of pacing current.
Do not use the gel-dried pads.
Do not allow air to enter between the pads and skin.
If long-term pacing is needed, replace pads during the periodic checkup
schedule.

Do not move a patient on a wet surface.

If you perform long-term pacing treatment using the battery, perform

periodic checks for the battery capacity.
Always check the patient’s condition while carrying out pacing. Do not leave
the patient while the product is functioning.
Check the location indicating mark displayed in the rear side of the pads
when attaching pads to the patient.

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11.5 Considerations for Patient Monitoring Mode

Safety Level Possible Risks or Risk Factors

Do not contact the patient whose ECG is being measured.

Place the ECG electrode on the accurate ECG location to be measured.

When a body part such as tissue is expected to be damaged while measuring

noninvasive blood pressure, you need to see a physician first.
Before measuring noninvasive blood pressure, make sure to classify and enter
user information.
When a patient's skin surface is wet, have the skin area dried off for the ECG
electrode, and attach the electrode.
When attaching the ECG electrode to a patient’s skin, do not use the
electrode whose shelf life has expired or whose package has been
compromised.

Make sure that the connection tube of the cuff is not twisted or folded.

This product is used to measure patient’s ECG by the use of defibrillation

pads and ECG electrodes (3-lead, 5-lead and 10-lead).
In cases when the patient is carried by a vehicle, or makes movements, it is
not possible to gain a completely accurate ECG results.

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11.6 Considerations for Handling Power and Battery

Safety Level Possible Risks or Risk Factors
Caution must be taken to prevent battery module breakage. In addition, do
not charge the battery for excessively long amounts of time.
When using this device with the AC power module, make sure to connect the
module to a power source with protective grounding to avoid the risk of
electric shock.
When using with the AC power module, always use the rated input power
specified in the user manual. For details on rated input power, see “13.15 AC
Power Module”.
If integrity of the protective grounding cable or the installed protective
grounding system cannot be ascertained, use the battery.
The AC power module is attachable only to the B slot. When using AC power,
take precautions to mount the battery.
When there is an alarm indicating low battery capacity, stop using it, and use
the AC power module to charge or replace the battery.
Use a car cigar jack and AC adapter only to charge the battery. In addition, to
prevent the vehicle battery from discharging due to the usage of a car cigar
jack, star t the vehicle engine, and use the car cigar jack.
During the use of the product, do not connect or disconnect the AC power
module. The replacing of the product power during the operation may cause
a malfunction of the device.

Check the daily self-test results on a periodic basis.

When installing this defibrillator by connecting it to the AC power module,

keep the defibrillator at least 30 cm from the wall to allow easy disconnection
of the AC power cable.

Always use the designated original charger.

Never leave the defibrillator unattended in a car during summer.

Always use the designated battery.

Do not expose the defibrillator to high temperatures of 60°C or above.

If the "Low Battery" message is indicated, please charge the battery.

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◎ Chapter 12_Troubleshooting

Chapter 12. Troubleshooting

■ Overview
This Chapter describes malfunctions caused by errors that may take place during running the CU-
HD1, and problems and their remedial actions.

When the device malfunctions, the corresponding text message(s) shall be issued to inform the
device state. If the device still malfunctions after the associated troubleshooting described in this
chapter has been carried out, contact an authorized representative.

 Any repairs on the product must be carried out by trained service personnel. When a problem
that may not be resolved takes place, do not disassemble the product arbitrarily. Otherwise, it
could result in an injury.

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12.1 General Troubleshooting

The table shown below summarizes problems that may be considered malfunctioning, their cause
and remedial action to resolve them is shown.

Error Symptom Cause Actions to be Taken

When pads or
- Check the connection to the connectors for the pads
paddles cannot No connector connected
and paddles.
be connected
- Check the cable state to see if the connection between
No pads cable the pads and the product is correct and there is any
When pads
connection damage to the cable.
cannot be
Incorrect pads - Check the pads attached to the patient.
connected
connection - Check the expiration date and state of the pads.
- Replace the pads if they are damaged.
- The charged energy is discharged by itself if the Shock
When the Auto internal button has not been pressed within 15 seconds.
message “The discharging - Recharge the energy by pressing the Charge button if
shock button the charged energy discharged.
was not - Check the connection state between the pads or paddles
No connection to the
pressed.” and the product.
patient, or permissible
“No shock - Check the connection between the patient and the pads.
range of the measured
advised.” has - Check whether the impedance is able to deliver the
patient impedance
been prompted energy at the contact point between the patient and
diverged
paddles.
Defibrillation energy - Charge the defibrillation energy again after pressing the
changed Charge button and selecting it using the Rotary switch.

When canceling - The charged energy is discharged by itself if the Shock

the charged Auto internal button has not been pressed within 15 seconds.
energy at the discharging - Recharge the energy by pressing the Charge button if
manual the charged energy discharged.
defibrillator - Use the conductive gel if the contact between the
mode paddles and the patient skin is not good.
Bad paddle contact
- Check if there is any impurity on the conductive plates
of the paddles that has contact with the patient.

"Check the
rotary switch" Rotary switch is not in
- Adjust the rotary switch to the correct position.
message with the correct position.
alert sound

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12.2 Troubleshooting for Problems Related to Defibrillation & Pacing Treatment

The table below describes the problems that may be encountered during defibrillation and pacing
therapy, their causes and remedial action to resolve them.

Error Symptom Cause Actions to be Taken

When pads or
No connector - Check the connection to the connectors for the pads
paddles cannot
connected and paddles.
be connected
- Check the cable state to see if the connection between
No pads cable the pads and the product is correct and there is any
When pads
connection damage to the cable.
cannot be
Incorrect pads - Check the pads attached to the patient.
connected
connection - Check the expiration date and state of the pads.
- Replace the pads if they are damaged.
- The charged energy is discharged by itself if the Shock
Auto internal button has not been pressed within 15 seconds.
When the
discharging - Recharge the energy by pressing the Charge button if
message “The
the charged energy discharged.
shock button was
- Check the connection state between the pads or paddles
not pressed.” No connection to the
and the product.
“No shock patient, or permissible
- Check the connection between the patient and the pads.
advised.” has range of the measured
- Check whether the impedance is able to deliver the
been prompted patient impedance
energy at the contact point between the patient and
diverged
paddles.
Defibrillation energy - Charge the defibrillation energy again after pressing the
changed Charge button and selecting it using the Rotary switch.
When canceling - The charged energy is discharged by itself if the Shock
the charged Auto internal button has not been pressed within 15 seconds.
energy at the discharging - Recharge the energy by pressing the Charge button if
manual the charged energy discharged.
defibrillator - Use the conductive gel if the contact between the
mode paddles and the patient skin is not good.
Bad paddle contact
- Check if there is any impurity on the conductive plates
of the paddles that has contact with the patient.

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12.3 Troubleshooting for Problems Related to ECG Measuring

The table below describes the problems that may be encountered while measuring the ECG, their
causes and remedial action to resolve them.

Error Symptom Cause Actions to be Taken

When the 12-lead
- Check the contact state of the 10-lead ECG cable and the
button is not Bad cable contact
device.
activated
- Check the contact state between the ECG electrodes and
the patient.
Bad ECG electrode
- Replace the ECG electrodes if they are defective or bad.
contact
- Select other leads if the patient’s skin is wet, and dry off
When excessive the location where the ECG electrodes are to be attached.
ECG noise Contact between
happens the patient and - Make sure there is no contact with the patient.
another
Excessive patient - Settle down the patient or stop the ECG measuring
movement temporarily.
ECG cable damaged - Replace the ECG cable.
Bad cable - Check the connection between the product and the ECG
connection cable.
Inappropriate cable
- Replace with the ECG cable of the CU-HD1.
use
When the ECG is
ECG cable damaged - Replace the ECG cable.
not
- Check that the ECG cable makes correct contact with the
measured
Bad ECG ECG electrodes.
connection - Check the connection state of the ECG cable.
No ECG connection - Check the state of the ECG electrodes (damage or
contamination).
When it drifts
away from the 12- - Check the state of the 10-lead cable.
10-lead cable
lead mode while - Check the connection state between the 10-lead cable
dropped
12-lead ECG and the Input terminal.
measuring

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12.4 Troubleshooting for Problems Related to SpO2 Measuring

The table below describes the problems that may be encountered during measuring the SpO 2, their
causes and remedial action to resolve them.

Error Symptom Cause Actions to be Taken

Excessive patient - Settle down the patient or move the sensors to locations
movement where no movement is possible.
Sensor failure - Replace the sensor.
Bad sensor
Measuring failure - Replace the sensor connector.
connector
Product failure - Contact an authorized sales agent.
Inappropriate cuff - Replace the NIBP cuff if it is located close to heart in a
location body par where SpO2 is measured.
When the
Inappropriate
measuring signals - Check that the sensors are appropriately located.
sensor location
are weak.

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12.5 Troubleshooting for Problems Related to NIBP Measuring

The table below describes the problems that may be encountered while measuring noninvasive blood
pressure, their causes and remedial actions to resolve them.

Error Symptom Cause Actions to be Taken

- Check if a patient moves excessively.
Excessive patient
- Settle down the patient or move the sensors to locations
movement
where no movement is possible.
- Use an appropriate cuff for a patient category.
- Check if the cuff is tightened up.
- Check if the cuff is located correctly.
- Check if the cuff size is correct.
Measuring failure Inappropriate use
- Remove any part of clothes between the cuff and the
patient’s arm.
- Check if the connection tube is twisted or folded.
- Check if the patient is pressing the cuff or the tube.
Sensor failure - Contact an authorized sales agent.
Product failure - Contact an authorized sales agent.
Accessory failure - Replace the cuff and connection tube.
- Check if the cuff, tube and equipment are connected
properly.
- Check if the cuff is tightened up.
Incorrect use or - Check if the cuff is located correctly.
Exceeded
damage of the cuff - Check if the cuff size is correct.
measuring time
and tube - Check if air is leaked from the cuff.
- Check if the tube is damaged.
- Attach the cuff to the upper arm of the patient closely
and remove air from the cuff completely before use.
- Check if the cuff size is correct.
- Check if the connection tube is twisted or folded.
Excessive pressure Incorrect use
- Check if the cuff is located correctly.
- Check if the patient is pressing the cuff or the tube.

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12.6 Troubleshooting for Problems Related to EtCO2 Measuring

The table below describes the problems that may be encountered while measuring EtCO2, their
causes and remedial actions to resolve them.

Error Symptom Cause Actions to be Taken

- Turn the CU-CM1 on.
- Connect the CU-CM1 with the CU-HD1 where there are
Paring or Bluetooth no obstructions between them, within a maximum radius
connection failure of 10 m.
- Connect the CU-CM1 to the CU-HD1 via Bluetooth, and
conduct zero calibration.
Sampling line is - Reconnect the sampling line.
twisted or - Check if the sampling line is twisted.
connection error - If the problem persists, replace the sampling line.
Poor condition of - Replace the adapter with a new airway adapter.
adapter - Connect the airway adapter.
- Reconnect the analyzer to the CU-CM1.
An error of the IRMA
- If the problem persists, replace the analyzer.
Mainstream or ISA
Measuring failure - Connect the desired analyzer to the connector on the
Sidestream Analyzer.
CU-CM1.
CO2 options are not
- If you want to add CO2 options, please contact us.
installed
CO2: Out of range - Conduct zero calibration.
accuracy - If the problem persists, replace the analyzer
- Check the operating environment.
CO2: Out of range
- Use the device in the correct operating environment by
internal temperature
referring to “Chapter 13_Product specification”
- Check the operating environment.
CO2: Out of range
- Use the device in the correct operating environment by
ambient pressure
referring to “Chapter 13_Product specification”
Motor Speed out of - Reconnect the analyzer to the CU-CM1.
bounds - If the problem persists, please contact us.
An error of the IRMA
Software or - Reconnect the analyzer to the CU-CM1.
Mainstream or ISA
hardware error - If the problem persists, please contact us.
Sidestream Analyzer.
An error of the IRMA
Factory calibration - Reconnect the analyzer to the CU-CM1.
Mainstream or ISA
data loss - If the problem persists, please contact us.
Sidestream Analyzer.

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12.7 Troubleshooting for Problems Related to Printing

The table below describes the problems that may be encountered when using the printer, their
causes and remedial action to resolve them.

Error Symptom Cause Actions to be Taken

- Open the printer cover and remove the jammed paper.
When the paper
Paper jam - Refer to “Chapter 3_Product Installation” for feeding the
does not move
paper into the printer.
- Use the recommended paper. Refer to “Chapter
When not running
Paper feeding issue 13_Product specification” for feeding the paper into the
at all (red LED
printer.
blinking)
Printer failure - Contact an authorized sales agent.
- Use the recommended paper. Refer to “Chapter
Inappropriate paper
13_Product specification” for feeding the paper into the
When the printout used
printer.
is blurry or
- No printing is done when the paper has been fed in the
unreadable
Bad paper fitting wrong way. Refer to “Chapter 3_Product Installation” for
paper fitting.
When no printing
Printer failure - Contact an authorized sales agent.
occurs

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12.8 Troubleshooting for Problems Related to Using SD Card

The table below describes the problems that may be encountered during using SD cards, their causes
and remedial action to resolve them.

Error Symptom Cause Actions to be Taken

Storage device - SD card can be installed to the CU-HD1. Other types of
When installation other than SD card storage device cannot be applies.
is not possible Installation - For information on how to install the SD card, please refer
direction error to "Chapter 3_Product Installation".
- SD card may have internal damages. Use another device.
SD card damage - If a normally working SD card is not working properly,
contact the service center.
- Free space of the storage device is less than 1MB, the
Storage failure create data is not saved. Back up the saved information or
install another empty storage device.
No free space
- If the saved files outnumber 100, storage is not possible
Back up the saved information or install another new
storage device.
- For the following error, take the following remedial
actions.
- “Insufficient capacity for external storage device”
Storage error Erros - “Too many files stored in the external storage device”
- “External storage device errors”
- Troubleshooting: Use an empty SD card. If you turn on the
device again storage process will be continued.

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12.9 Troubleshooting for Problems Related to Bluetooth Communication

The table below describes the problems that may be encountered when using Bluetooth
communication, their causes and remedial actions to resolve them.

Error Symptom Cause Actions to be Taken

- Please install (setup) the Bluetooth feature on your
No connection with
Bluetooth computer.
Bluetooth or not
connection failure - Please place your computer within an area allowing for
powered on
Bluetooth communication connectivity.
- Make sure that your computer is placed within an area
Bluetooth Bluetooth
allowing for Bluetooth communication connectivity.
disconnected disconnected
- Please reconnect Bluetooth to your computer.
- Please check the connection to Bluetooth communication.
Bluetooth - Check if the patient information transfer program works
disconnected properly on your computer.
Transfer failure
- Try reconnection.
Product feature - Contact an authorized sales agent.
error

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Chapter 13. Product Specification

■ Overview
This chapter shows you the specifications of the CU-HD1. This chapter describes specifications in
relation to the exterior view, defibrillation, ECG, SpO2, NIBP, EtCO2, battery/charging function,
communication, and data storage.

13.1 Exterior of Product

The followings are the standard exterior view specifications of this product.

CU-HD1
Dimentions (Paddle 326mm (W) x 253mm (L) x 358mm (H) (Width×Length×Height)
included)
Body: 4.7kg or below / 8.2kg or below if paddles, cables (ECG cable,
SpO2 sensor), print paper, and storage device included.
Weight
Paddle (with cables): 1.2kg or below.
Battery, AC power module: 0.5kg, 0.7kg respectively.

CU-CM1
Dimentions 128.6mm (W) x 78.7mm (L) x 32mm (H) (Width×Length×Height)
210g or below if battery included.
Weight IRMA Mainstream, ISA Sidestream analyzer: 25g, 130g or below,
respectively.

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13.2 Environmental Condition

CU-HD1
Condition where both the equipment and pads must be stored together, which are
Operation immediately usable in an emergency case
Environment Temperature: 0 ~ 40 ℃
Humidity : 5% ~ 95%, Non-condensing
Condition where the equipment and pads are not stored together, with only the
Storage equipment stored or transported for a long time
Environment Temperature: -20 ~ 60 ℃
Humidity : 5%~95%, Non-condensing
Shock/ Fall/
Abuse Satisfying the condition of IEC 60601-1 Section 21
tolerance
Vibration MIL-STD-810E Method 514.4 Category 10
Package Satisfying the condition of IEC 60601-1 Section 44
ESD Satisfying the condition of IEC 61000-4-2:2001
Satisfying the condition of IEC 60601-1-2
EMI (emission)
EN55011:1998+ A1:1999 +A2:2002, Group 1, Class B
IEC 60601-1-2 limits, method EN 61000-4-3: 2001 Level 3 (10V/m 80MHz to
EMI (tolerance)
2500MHz)
Dustproof/
Waterproof IP43 according to the condition of IEC 60529
Classification
Standby Temperature: 0 ~ 43 ℃
Pads Usage
Usage Temperature: 0 ~ 40 ℃
Environment
Humidity : 5%~95%, Non-condensing
Battery Usage Condition to store or transport only the battery for a long time
and Storage Temperature: -20 ~ 45 ℃
Environment Humidity : 5%~95%, Non-condensing

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CU-CM1
Operation Temperature: 0℃ ~ 40℃
Environment Humidity : 10% ~ 95%, Non-condensing
Storage Temperature: -20℃ ~ 60℃
Environment Humidity : 5% ~ 95%, Non-condensing
Altitude 0~4,572m
ESD Satisfying the condition of IEC 61000-4-2:1995+A1:: 1998+A2: 2001
Satisfying the condition of IEC 60601-1-2
EMI (emission)
EN 55011:2007+A2:2007, Group 1, Class B
Satisfying the condition of IEC 60601-1-2
EMI (tolerance)
EN 61000-4-3: 2006+A1:2008 Level 3 (10V/m 80MHz to 2500MHz)

Defibrillation-proof type BF
Operation Temperature: 0℃ ~ 40℃
Environment Humidity : 10% ~ 95%, Non-condensing
Storage Temperature: -40℃ ~ 75℃
Environment Humidity : 5% ~ 100%, Non-condensing
Altitude 0~4,572m
Dustproof/
Waterproof IP44
Classification

Defibrillation-proof type BF
Operation Temperature: 0℃ ~ 50℃
Environment Humidity : 10% ~ 95%, Non-condensing
Storage Temperature: -40℃ ~ 70℃
Environment Humidity : 5% ~ 100%, Non-condensing
Altitude 0~4,572m
Dustproof/
Waterproof IPX4
Classification

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13.3 ECG Analysis system – ECG Database Test

ECG Analysis system – ECG Database Test
90% One
ECG Minimum Test No
Performanc Shock Observed Sided Lower
Rhythm Rhythms test sample sample Shock
e goal Decision Performance Confidence
Class size size Decision
Limit
Coarse VF 97.26%
>90%
200 219 213 6 (213/219) 95%
sensitivity
SHOCKABL sensitivity
E Fast VT 81.02%
50 >75% 137 26
111 (111/137) 97%
sensitivity
sensitivity
Normal 100 > 99% 100%
0 100
Sinus minimum specificity 100 (100/100) 97%
Rhythm (arbitrary) specificity
AF,SB,SVT,
NON heart block, 99.54%
> 95%
SHOCKABL idioven- 30 (arbitrary) 219 1 218 (218/219) 98%
specificity
E tricular specificity
PVC’s
Asystole 96.21%
> 95%
100 132 5 127 (127/132) 93%
specificity
specificity

a. A statement for health Professionals From the AHA(American Heart Association) Task Force on AED,
Subcommittee on AED Safety and Efficacy. Automatic External defibrillators for Public Access
Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm
Performance, Incorporating New Waveforms, and Enhancing Safety. 발행 1977;95:1677-1682
b. According to AHA Recommendations (a) and AAMI-based DF80, SVT is clearly included in the non
shock able rhythm grade.

13.4 Defibrillation Feature

Defibrillation Feature
∙ Semi-automatic
Operation Mode
∙ Manual: Sync, Asynchronous defibrillation

Output Waveform
(Manual / Automatic)

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※ Parameters of waveforms are adjusted according to the patient’s

impedance.
Shock Delivery Delivers shock using paddles or disposable defibrillation pads.
Impedance Rage of
25 ~ 175 Ohms
Defibrillation Shock

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13.5 Delivered Defibrillating Energy according to the Load Impedance

(Delivered Defibrillating Energy according to the Load Impedance
Selected Load Impedance (Ohms)
Energy Accuracy
25 50 75 100 125 150 175
(Joules)

1 1 1 1 1 1 1 1 ±1 J

2 2 2 2 2 2 2 2 ±1 J

3 3 3 3 3 3 3 3 ±1 J

4 4 4 4 4 4 4 4 ±1 J

5 5 5 5 5 5 5 5 ±2 J

6 6 6 6 6 6 6 6 ±2 J

7 7 7 7 7 7 7 7 ±2 J

8 8 8 8 8 8 8 8 ±2 J

9 9 9 9 9 9 9 9 ±2 J

10 10 10 10 10 10 10 10 ±2 J

15 15 15 15 15 15 15 15 ±3 J

20 20 20 20 20 20 20 20 ±3 J

30 30 30 30 30 30 30 30 ±15 %

50 50 50 50 50 50 50 50 ±15 %

70 70 70 70 70 70 70 70 ±15 %

100 100 100 100 100 100 100 100 ±15 %

120 120 120 120 120 120 120 120 ±15 %

150 150 150 150 150 150 150 150 ±15 %

170 170 170 170 170 170 170 170 ±15 %

200 200 200 200 200 200 200 200 ±15 %

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13.6 Manual Mode

Manual Mode
∙ Less than 7 sec. : If a rechargeable battery is fully-charged.
∙ Less than 6 sec. : If an AC power module is used (only when power
is more than 90%).
Charging Time
∙ Less than 7 sec. : If the battery has been discharged more than 15
(200 Joules)
times after it had been fully charged.
∙ Less than 7 sec. : If the battery has been discharged more than 15
times after the battery module had been replaced.
Manual: 1J~4J±1J, 5J~10J±2J, 15J±3J, 20J±3J, 30J±15%, 50J±15%,
Shock Energy Selection 70J±15%, 100J±15%, 120J±15%, 150J±15%, 170J±15%, 200J±15% (50Ω
load)
Operation Keys and Soft button, LEAD Selection button, Print button, Rotary switch, Charge
Buttons button, Shock button, SYNC button, MENU key, HOME button
Indicators LCD for ECG display, Power/Error display indicators
∙ Text prompts of Charge Energy
Charing Indicator ∙ Beep when charging
∙ Shock button blinks in orange
Eenergy Selection Rotary switch
Impedance Range of
25~175 Ohms
Defibrillation Shock
Charging Manipulation Charge button
Shock Delivery Shock button
∙ Use SYNC button for synchronized cardioversion.
SYNC ∙ Analyze the patient’s ECG signals and synchronize R-wave of QRS in
ECG with shock delivery within 60ms.

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13.7 AED Mode

AED Mode
∙ Less than 7 sec. : If the battery is full-charged.
∙ Less than 7 sec. : If a new battery module is used.
∙ Less than 6 sec. : If an AC power module is used (only when power is
Charging Time more than 90%).
(200 Joules) ∙ Less than 7 sec. : If the battery has been discharged more than 15
times after it had been fully charged.
∙ Less than 7 sec. : If the battery has been discharged more than 15
times after the battery module had been replaced.
AED Energy Semiautomatic: 200J±6J fixed (50Ω load)
Gives step-by-step guidelines to the user on how to take proper
Text and Voice Prompts
measures for the emergency situation.
AED Operation Key and Analyze button, Stop Analysis button, Shock button, CPR Type 30:2 /
Button 15:2, Start/Stop CPR
LCD for ECG display etc., Text instruction, Alarm indication, Soft button,
Indicator
MENU key
∙ Progress bar of the amount of energy charged and text prompts
Charging Indicator ∙ Beep when charging
∙ Shock button blinks in orange
Analyzes the patient’s ECG to determine whether defibrillation is needed
Patient Analysis or not.
(When the automatic patient analysis feature is enabled)
Defibrillation-needed Ventricular Fibrillation or Fast Ventricular Tachycardia, 150bpm or above
Rhythm
Sensitivity and Specificity
of Algorithm that requires AHA 2010 guidelines is met.
Defibrillation
Disposable Pads for Adult Surface area: 100Cm / Length of cable: approximately 55cm or above
Disposable Pediatric Pads
Surface area: 40Cm / Length of cable: approximately 120cm or above
for AED Mode

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13.8 Pacer Mode

Pacer Mode
Pacing Type Noninvasive Pacing
Energy Waveform Monophasic Rectangular
Pacing Mode Demand mode, Fixed mode
Energy Magnitude 5 ~200 mA (±5mA)
Pulse Width 20ms (±10%)
Pacing Rate 30 ~ 180 ppm (±1.5%)
Impedance Range in
25 ~ 175 Ohms
which Pacing is possible
Mode button, Rate button, Print button, MENU key, HOME button, and
Operation Key and Button
LEAD Selection button
LCD for ECG display etc., text prompt, QRS detection display, patient
Indicator
monitoring information display, pacing signal delivery display
Analyzes the patient ECG to determine whether to deliver pacing energy
Analysis in Demand Mode
or not in the Demand mode.

13.9 Patient Monitoring Mode

ECG Monitoring
∙ ECG type: 3-Lead, 5-Lead, 10-Lead
ECG Input
∙ Able to see ECG results using LCD or an external printer.
∙ Detects when the ECG cable(s) is detached (if the ECG cable is
Lead Fault disconnected from the patient or the device)
∙ Apply 31.227nA (excluding internal resistance of cable)
Heart Rate Display 30 ~ 300 bpm (accuracy: ±3 bpm)
∙ Heart rate alarm setting range (minimum < alarm < maximum)
∙ Minimum: 30~300 bpm (though, it should be set to a value lower than
Setting of Heart Rate
the maximum)
Alarm
∙ Maximum: 30~300 bpm (though, it should be set to a value higher
than the minimum)
∙ 2.5mm/mV, 5 mm/mV, 10 mm/mV, 20 mm/mV
ECG Size ∙ AUTO: 0.3 ~ 5.5 mV, Display inputted ECG signals as 10mm on the
screen.
∙ Emergency: 1 ~ 30 Hz (-3 dB)
∙ Monitoring: 0.5 ~ 40 Hz (-3 dB)
Frequency Range
∙ Diagnosis: 0.05 ~ 150 Hz (-3 dB)
∙ Notch Filter: OFF, 50Hz, 60Hz
Patient Isolation
Defibrillation-proof type CF
(Defibrillation Check)
Sweep Speed 25mm/sec

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ECG Monitoring
Recovery time of
defibrillation-proof type 5 seconds (Recovery time after delivering the defibrillation voltage)
applied unit
Heart Rate Averaging Determined by calculation algorithm of heart rate every 2 seconds
∙ A step increase from 80bpm to 120bpm: approximately 6.52 seconds
Response Time
∙ A step decrease from 80bpm to 40bpm: approximately 18.46 seconds
Time to alarm for
Approximately 10.5 seconds, regardless of amplitude and heart rate
Tachycardia

SpO2 Monitoring
Pulse rate 20 ~ 250 bpm (± 3 bpm)
SpO2 Measuring Rage 1 ~ 100%
SpO2 Accuracy 80 ~ 100%(± 3 digit)

Perfusion 0.2%

Minimum: 1% ~ 100% (though, it should be set to a value lower than the

maximum)
SpO2 Alarm Setting
Maximum: 1% ~ 100% (though, it should be set to a value higher than
the minimum)
Display Update Interval 6 seconds

Resolution 1%

SpO2 Sensor Nellcor sensor(DS100A Sensor)

Sensor Light 660 nm(Red), 890 nm(Infrared)

Power Consumption 15mW or below

NIBP Monitoring
Patient Category Adult, Pediatric, Neonate
Measuring Method Oscillometric
Operation Mode Manual/ Auto mode
Time Interval for Auto 1, 3, 5, 10, 15, 30, 60, 120 munutes
Mode
Display Systolic / Diastolic / Mean blood pressure, Alarm setting
Error Range for Pressure ± 3 mmHg

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NIBP Monitoring
Systolic
- Adult: 40 ~ 260 mmHg
- Pediatric: 40 ~ 160 mmHg
- Neonate 20 ~ 130 mmHg
Measuring Range
Diastolic
- Adult: 20 ~ 200mmHg
- Pediatric: 20 ~ 120 mmHg
- Neonate: 20 ~ 100 mmHg
Adult: 300mmHg
Overpressure Limit Pediatric: 300mmHg
Neonate: 150 mmHg
Adult: 23~33cm
Cuff Type Pediatric: 12~19cm
Neonate: 8~13cm
Material: Polyurethane
Connection Tube
Length: approximately 3m

EtCO2 Monitoring
The result of measuring CO2 acquired from the IRMA Mainstream analyzer
Capnography Input
or ISA Sidestream analyzer is displayed on the CH-HD1 LCD.
Display Range 0 ~ 99 mmHg (0~14 %)
0~99 mmHg: ± (1.5 mmHg + 2% of reading)
EtCO2Accuracy
0~14 vol%: ± (0.2 vol% + 2% of reading)
 6.25 mm/sec (Default setting)
Sweep Speed  12.5 mm/sec
 25 mm/sec
 0~100 mmHg or 0~14 % (Default setting)
Scale  0~50 mmHg or 0~7 %
 0~20 mmHg or 0~4 %
Display Unit mmHg or %

 Minimum: 10 ~ 94 mmHg
EtCO2 Alarm Setting
 Maximum: 11 ~ 95 mmHg
Respiration Rate
± 1 bpm
Accuracy
Respiration Rate Alarm  Minimum: 1 ~ 149 bpm
Setting  Maximum: 2 ~ 150 bpm

Apnea Alarm Setting 20 ~ 60 seconds

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IRMA Mainstream Analyzer

Cable Length 2.5m ± 0.1m
Range 0 ~ 99 mmHg

Nomal Condition 0~99 mmHg : ± (1.5 mmHg + 2% of reading)

Accuracy (22 ±℃, 1013 ± 40hPa) 0~14 vol%: ± (0.2 vol% + 2% of reading)

All Condition ± (2.25mmHg + 4% of reading)

Resolution 1 mmHg

Warm-up Time 10 seconds or below

Rise Time ≤90 ms

Total Response Time <1 seconds

Isolation of Patient
Defibrillation-proof type BF
(Check Defibrillation)
Recovery time of defibrillation-proof 5 seconds (Recovery time after delivering the defibrillation
type applied unit: voltage)
Note 1. The accuracy specification is valid for the operating temperature and humidity conditions
specified, except for interference specified in the table “EtCO2 Measuring – Interfering gas
and vapor effects”.

ISA Sidestream Analyzer

Cable Length 0.5m ± 0.025m
Range 0 ~ 99 mmHg

Normal Condition 0~99 mmHg: ± (1.5 mmHg + 2% of reading)

Accuracy (22 ±℃, 1013 ± 40hPa) 0~14 vol%: ± (0.2 vol% + 2% of reading)
All Condition ± (2.25mmHg + 4% of reading)
Resolution 1 mmHg

Warm-up Time 10 seconds or below

Rise Time ≤200 ms

Total Response Time <3 seconds

Sampling Flow 50 ± 10 sml/min

Isolation of Patient
Defibrillation-proof type BF
(Check Defibrillation)
Recovery time of defibrillation-proof 5 seconds (Recovery time after delivering the defibrillation
type applied unit: voltage)
Note 1. The accuracy specification is valid for the operating temperature and humidity conditions
specified, except for interference specified in the table “EtCO2 Measuring – Interfering gas
and vapor effects”.

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13.10 Display
Display
Type TFT LCD (including backlights)
Screen Size 152.4(W) X 91.44(H) mm
Resolution 800 X 480 X 3(RGB) pixels
Dot Pitch 0.0635(W) X 0.1905(H) mm
Backlight LED Life Time 20,000hours (time when brightness is reduced to 50%)
ECG Viewing Time 6 seconds
13.11 Event Storage
Event Storage
External Storage Store up to 100 events and ECG data.
SD Card (if 1GB) Store more than 192 hours of single event or ECG data.
Or, store more than 8 hours of events, ECG data, and voice data
ECG Data Print Output ECG directly from the CU-HD1.

13.12 Built-in Printer

Built-in Printer
Print Method Thermal line printing
Resolution 203dpi X 406 dpi (dpi: dot per inch)
Print Width 48mm
Print Rate 25mm/sec
Feed Rate About 62.5mm/sec
7.2 V DC
Input Power Power consumption in a standby state: 70mA
Maximum power consumption: 2.4A
5 °C ~ 40 °C
Operation Temperature
Humidity: 30%~85%, Non-condensing
-10 °C ~ 50 °C
Storage Temperature
Humidity: 30%~90%, Non-condensing (without printer paper)

Printer Paper
Type Roll type
Width: 58mm
Size
Roll size: Maximum diameter 40mm

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13.13 Bluetooth
Bluetooth
Parani-ESD210
Applied Module
(Bluetooth – Serial Module)
Version Bluetooth v 1.2
Frequency Range 2.402 GHz ~ 2.480GHz
Send Output Max. +4 dBm
Receive Sensitivity -80 dBm(0.1%BER)
Antenna Standard antenna and dipole antenna
Communication Distance Within 30m (based on open space)
Operation Temperature -10°C ~ 55°C (Humidity: 90%, Non-condensing)
Storage Temperature -20°C ~ 70°C (Humidity: 90%, Non-condensing)
Transmission Method :
FHSS(Frequency Hopping Spread Spectrum)
Miscellaneous
Modulation Method :
GFSK(Gaussian-filtered Frequency Shift Keying)

13.14 Battery Module

Battery Module (for CU-HD1)
Battery Type Lithium Ion
Size 170mm X 116mm X 51mm (Width X Length X Height)
Weight 0.7kg or below
14.6 VDC, 4300 mAh (min. 4000 mAh) (Standard Battery)
Output
14.6 VDC, 8600 mAh (min. 8000 mAh) (Bulk: Standard Battery x 2EA)
Battery Capacity New fully-charged batteries, operating at room temperature, 25℃
1. Capacity to Shutdown
1) AED (200J): 200 ~ 230 minutes or 80 ~ 90 200J discharges
2) Pacing(at 200mA/180ppm): 180 ~ 210 minutes
3) Monitor(monitoring with ECG, SpO2, NIBP measured every 1
minute): 230 ~ 280 minutes
4) Manual: 180 ~ 220 minutes or 100 ~ 120 200J discharges
Standard
Battery
2. Capacity after low Battery
Capacity
1) AED (200J): 15 ~ 25 minutes or 6 ~ 12 200J discharges
2) Pacing(at 200mA/180ppm): 15 ~ 30 minutes
3) Monitor(monitoring with ECG, SpO2, NIBP measured every 1
minute): 20 ~ 30 minutes
4) Manual: 20 ~ 30 minutes or 10 ~ 18 200J discharges
Bulk 1. Capacity to Shutdown
Battery 1) AED (200J): 400 ~ 460 minutes or 160 ~ 180 200J discharges
(Standard 2) Pacing(at 200mA/180ppm): 360 ~ 420 minutes

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◎ Chapter 13_Product Specification

Battery x 3) Monitor(monitoring with ECG, SpO2, NIBP measured every 1

2EA) minute): 460 ~ 560 minutes
4) Manual: 360 ~ 440 minutes or 200 ~ 240 200J discharges

2. Capacity after low Battery

1) AED (200J): 20 ~ 35 minutes or 8 ~ 15 200J discharges
2) Pacing(at 200mA/180ppm): 25 ~ 38 minutes
3) Monitor(monitoring with ECG, SpO2, NIBP measured every 1
minute): 35 ~ 45 minutes
4) Manual: 25 ~ 40 minutes or 14 ~ 23 200J discharges
Approximately 5 hours to 100%. Approximately 4.5 hours to 90%.
Charging Time with
Charging the battery at temperatures above 45℃ may degrade
device off
battery life. (for standard battery)
Battery Capacity Check Level 5
Charge: 0°C ~ 40°C
Operation Temperature Discharge: -20°C ~ 60°C
Humidity: 90% of below, Non-condensing
-20°C ~ 45°C
Storage Temperature
Humidity: 90% or below, Non-condensing

13.15 AC Power Module

AC Power Module (for CU-HD1)
100 ~ 240 VAC, 50/60 Hz
Input 2.5A MAX(110 AC)
1.5A MAX(220V AC)
Output 18 V DC, 2 A
Size 170mm X 116mm X 60mm (Width X Length X Height)
Weight 0.7kg or less
-20°C ~ 40°C
Operation Temperature
Humidity: 90% of below, Non-condensing
-20°C ~ 60°C
Storage Temperature
Humidity: 90% of below, Non-condensing

13.16 Car Cigar Jack

Car Cigar Jack (for CU-HD1)
Output 12VDC, 6.3A (Max.)
Length 1800 ± 50mm
Weight 0.08kg or less
-20°C ~ 40°C
Operation Temperature
Humidity: 90% of below, Non-condensing
Storage Temperature -20°C ~ 60°C

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Humidity: 90% of below, Non-condensing

13.17 AC Power Adapter
AC Power Adapter (for CU-HD1)
Input 100~240V, 50~60Hz
Output 12V/3.6A
Length 1900 ± 50mm
Weight 0.4kg or less
-20°C ~ 40°C
Operation Temperature
Humidity: 90% of below, Non-condensing
-20°C ~ 60°C
Storage Temperature
Humidity: 90% of below, Non-condensing

13.18 Internal Battery (for CU-CM1)

Internal Battery (for CU-CM1)
Battery Type Lithium Ion
Output 7.4 VDC, 1,100 mAh
Capacity Minimum 4 hours or more
Charing Time About 3 hours

13.19 Power Adapter

Power Adapter (for CU-CM1)
Input 100~240V, 50~60Hz, 0.3A
Output 12 VDC, 1A
Test Standard Complies with IEC 60601-1:1998+A1: 1991+A2: 1995

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◎ Chapter 14_Service Guidelines

Chapter 14. Service Guidelines

■ Product Warranty
Device Name Model Name
Purchase Date (MM/DD/YY) Serial No.
Distributor Person in Charge

■ About Service
The products of CU MEDICAL SYSTEMS, INC. are designed and manufactured in compliance with the
Medical Devices Act and the relevant notifications of the Ministry of Food and Drug Safety, including
the Standards and Specifications of Medical Devices, General Requirements for Basic Electric and
Mechanical Safety of Medical Devices, and Medical Devices Manufacturing and Quality Control
Standards.

※ You are entitled to free servicing of the product for any problem that occurs during the warranty
period (2 years for the product and 1 year for the battery) under normal usage conditions.
(Warranty period shall be reduced by half if the device is used for commercial purposes.)

Problem Type Compensation Note

Requesting repairs for performance or
Product replacement or servicing
functional defects occurring under normal
free of charge
usage conditions within 1 month of purchase
Performance or Repairable defects Free repair
functional problems Non-repairable
Product replacement or refund Refund after
occurring under normal defects
straight-line
usage conditions within Replacement
Refund depreciation
warranty period unavailable
Product replacement
Problems occurring Within warranty Product replacement after paying
because service parts period the amount required for paid
are not held during the servicing
part holding period After warranty Refund of amount plus 10% after
period straight-line depreciation
Refund after
Within warranty
Product lost by service Product replacement or refund straight-line
period
provider after consumer depreciation
has requested service After warranty Refund of amount plus 10% after
period straight-line depreciation

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◎ Chapter 14_Service Guidelines

※ Even within the warranty period, the following defects are not covered by warranty.
 Failures caused by operations performed against instructions in the Operation manual or other
incorrect operation.
 Failures caused by repair or modification in service centers other than those designated by CU
Medical Systems, Inc.
 Failure or damage caused by a fall or external shock after purchase.
 Damage by natural disasters such as fire, earthquake, flood and/or lightning.
 Damage caused by use or storage of the device in environments subjected to high temperature,
high humidity, chemical compounds, microorganisms, etc. which are detrimental to use of the
device.
 Failure due to depletion of consumables.
 Failure caused by sand and/or soil getting inside the device.
 The purchase date, customer name, distributor name, batch number and other listed information
being arbitrarily changed.
 No proof of purchase provided along with the device warranty.
 Usage of accessories (such as adapter, battery, etc. and parts not recommended by the
manufacturer.
 Other failure or damage caused by inappropriate operation.

■ Product Registration
After purchasing, please register the product on our website (www.cu911.com) to receive continued
customer support and product information.

■ Technical Support and Service

Website
http://www.cu911.com

Online Support
Go to our website (www.cu911.com) -> Customer Service -> Contact Us

CU Medical Systems, Inc. / Customer Service Team

4F Cheonggye Plaza, 221, Anyangpanqyo-ro, Uiwang-si, Gyeonggi-do, Republic of Korea
Tel +82-31-421-9700 / Fax +82-31-421-9911

Europe
Authorized EU Representative / Medical Device Safety Service, GmbH
Schiffgraben 41, 30175 Hannover, Germany

Branch Office of CU Medical Systems, Inc. in Germany

Ernst-Augustin-Str.5, 12489 Berlin Germany
Tel: +49-30-6781-7804/ Fax: +49-511-6262-8633

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◎ Chapter 15_Electromagnetic Compatibility

Chapter 15. Electromagnetic Compatibility

■ Guidance and Manufacturer’s Declaration – Electromagnetic Emissions
The CU-HD1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the CU-HD1 should assure that it is used in such an environment.

Emissions Test Compliance Electromagnetic environment - Guidance

The CU-HD1 uses RF energy only for its internal function.
RF emissions
Group 1 Therefore, its RF emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic equipment.
RF emissions
Class B
CISPR 11
The CU-HD1 is suitable for use in all establishments, including
Harmonic emissions
Class A domestic establishments and those directly connected to the
IEC61000-3-2
public low-voltage power supply network that supplies
Voltage fluctuations/
buildings used for domestic purposes.
flicker emissions Complies
IEC 61000-3-3

 Do not use the product near other electronic devices. If you use the product in such an
environment, check if it is working properly.
 If cables or accessories that are not designated by CU Medical Systems, Inc. are used, the
product may be affected by EMC

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◎ Chapter 15_Electromagnetic Compatibility

■ Guidance and Manufacturer’s Declaration – Electromagnetic Immunity

The CU-HD1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the CU-HD1 should assure that it is used in such an environment.

IEC 60601 Electromagnetic

Immunity test Comliance level
Test level environment - guidance

Electrostatic ± 6 kV Contact ± 6 kV Contact Floors should be wood, concrete

discharge (ESD) ± 8 kV air ± 8 kV air or ceramic tile. If floors are
IEC 61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%.
Electrical fast ± 2 kV for power ± 2 kV for power Mains power quality should be
transient/ burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 ± 1 kV for ± 1 kV for hospital environment.
input/output lines input/output lines
Surge ± 1 kV differential ± 1 kV differential Mains power quality should be
IEC 61000-4-5 mode mode that of a typical commercial or
± 2kV common ± 2kV common hospital environment.
mode mode
Voltage dips, short <5 % UT <5 % UT Mains power quality should be
interruptions and (> 95% dip in UT): (> 95% dip in UT): that of a typical commercial or
voltage variations for 0.5 cycle for 0.5 cycle hospital environment. If the user of
on power supply the CU-HD1 image intensifier
input lines 40% UT 40% UT requires continued operation
IEC 61000-4-11 (60% dip in UT): (60% dip in UT): during power mains interruptions,
for 5 cycle for 5 cycle it is recommended that the CU-
HD1 image intensifier be powered
70% UT 70% UT from an uninterruptible power
(30% dip in UT): (30% dip in UT): supply.
for 25 cycle for 25 cycle

<5 % UT <5 % UT
(>95% dip in UT): (>95% dip in UT):
for 5s for 5s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic of
Magnetic field a typical location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE. UT is the a.c. mains voltage prior to application of the test level.

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◎ Chapter 15_Electromagnetic Compatibility

■ Guidance and Manufacturer’s Declaration – Electromagnetic Immunity (Life-

Supporting Functions)

The CU-HD1 is intended for use in the electromagnetic environment specified below. The customer
or the user of the CU-HD1 should assure that it is used in such an environment.

Immunity IEC 60601

Comliance level Electromagnetic environment - guidance
test Test level

Portable and mobile RF communications

equipment should be used no closer to any
part of the CU-HD1, including cables, than
the recommended separation distance
calculated from the equation applicable to
the frequency of the transmitter.

Recommended separation distance

3 Vrms
3 Vrms
150 kHz ~ 80
35
MHz 𝑑 𝑃
𝑉 1
outside ISM bansa 12
Conducted RF 𝑑 𝑃
𝑉 2
IEC 61000-4-6 10 Vrms
10 Vrms 𝑑 𝑃 80 MHz to 800 MHz
𝐸
150 kHz ~ 80
MHz
𝑑 𝑃 800 MHz to 2.5 GHz
𝐸
in ISM bandsa

10 V/m
10 V/m where P is the maximum output power
80MHz ~ 2.5GHz rating of the transmitter in watts (W)
Radiated RF
according to the transmitter manufacturer
IEC 61000-4-3
20 V/m and d is the recommended separation
20 V/m
80MHz ~ 2.5GHz distance in meters (m).b
Field strengthsc from fixed RF transmitters,
as deter-mined by an electromagnetic site
survey, should be less than the compliance
level in each frequency ranged.d
Interference may occur in the vicinity of
equipment marked with the following

symbol:

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◎ Chapter 15_Electromagnetic Compatibility

NOTE 1. At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2. These guidelines may not apply in all situations. Electromagnetic propagation is

affected by absorption and refection from structures, objects and people.

The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are

a 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz;
and 40.66 MHz to 40.70 MHz.

The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and
in the frequency range 80 MHz to 2.5 GHz are intended to decrease the likelihood
that mobile/portable communications equipment could cause interference if it is
b
inadvertently brought into patient areas. For this reason, an additional factor of 10/3
is used in calculating the recommended separation distance for transmitters in these
frequency ranges.

Field strengths from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM
radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To
assess the electromagnetic environment due to fixed RF transmitters, an

c electromagnetic site survey should be considered. If the measured field strength in

the location in which the CU-HD1 is used exceeds the applicable RF compliance level
above, the CU-HD1 should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting
or relocating the CU-HD1.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1]
d
V / m.

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◎ Chapter 15_Electromagnetic Compatibility

■ Recommended Separation Distances between portable and mobile RF

communications equipment and the CU-HD1 – for Life-supporting equipment and
System
The CU-HD1 is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the CU-HD1 can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the CU-HD1 as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter [m]

Rated 150kHz to 80MHz 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2,5GHz

maximum outside ISM in ISM bands

output bands

power of 35 12 12 23
𝑑 𝑃 𝑑 𝑃 𝑑 𝑃 𝑑 𝑃
transmitter
𝑉 1 𝑉 2 𝐸 1 𝐸 2

[W] E1 = E1 = E1 = E1 =
V1 = 3Vrms V2 = 10Vrms
10V/m 20V/m 10V/m 20V/m

0.01 0.06 0.12 0.12 0.06 0.23 0.16

0.1 0.11 0.38 0.38 0.19 0.73 0.36

1 0.35 1.20 1.20 0.6 2.30 1.15

10 1.11 3.79 3.79 1.90 7.27 3.64

100 3.50 12.00 12.00 6.0 23.00 11.50

For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2. The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz.
NOTE 3. An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range 80 MHz to 2.5 GHz to decrease the likelihood that mobile/portable
communications equipment could cause interference if it is inadvertently brought into
patient areas.
NOTE 4. These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and refection from structures, objects and people

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◎ EtCO2 Measuring – Interfering gas and Vapour Effects

◎ EtCO2 Measuring – Interfering gas and Vapor Effects

Gas level CO2
Gas or vapor
(vol%) IRMA Mainstream ISA Sidestream
N2O (Nitrous oxide) 60 ㅡ 1, & 2 ㅡ 1, & 3

Halothane 4 ㅡ 1

Enflurane
Isoflurane 5 +8% of reading 4

Sevoflurane
Desflurane 15 +12% of reading 4

Xenon 80 -10% of reading 4

Helium 50 -6% of reading 4

Metered dose inhaler

Not for use with metered dose inhaler propellants
propellants
C2H5OH (Ethanol) 0.3
C3H7OH (Isopropanol) 0.5
ㅡ 1
CH3COCH3 (Acetone) 1
CH4 (Methane) 3
Note 1. Negligible interference, effect included in the specification “EtCO2 Accuracy” above.
Note 2. IRMA Mainstream measures N2O.
Note 3. Negligible interference with N2O / O2 concentrations correctly set, effect included in the
specification “EtCO2 Accuracy” above.
Note 4. Interference at indicated gas level. For example, 50 vol% Helium typically decreases the CO 2
readings by 6%. This means that if measuring on a mixture containing 5.0 vol% CO 2 and 50
vol% Helium, the measured CO2 concentration will typically be (1-0.06)*5.0 vol% = 4.7 vol%
CO2.

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Operation Manual

CU Medical Systems, Inc.

130-1, Donghwagongdan-ro, Munmak-eup, Wonju-si,
Gangwon-do, Republic of Korea
Tel: +82 33 747 7657
Fax: +82 33 747 7659

[Sales]
5F Cheonggye Plaza, 221, Anyangpangyo-ro, Uiwang-si,
Gyeonggi-do, Republic of Korea
Tel: +82 31 421 9700
Fax: +82 31 421 9911

Website: www.cu911.com

Medical Device Safety Service, GmbH

Schiffgraben 41, 30175 Hannover, Germany

2460
The CU-HD1 complies with the requirements of the Medical Device Directive
93/42/EEC as amended by 2007/47/EC.

207