CN97010000-530 3502-2000008 V1.2
CN97010000-530 3502-2000008 V1.2
User Manual
(Part I)
This Manual is written and compiled in accordance with the IEC 60601-1 (Medical electrical equipment Part1:
General requirements for safety), and MDD 93/42/EEC. It complies with both international and enterprise
standards and is also approved by State Technological Supervision Bureau. The Manual is written for the current
Patient Monitor.
The Manual describes, in accordance with the Patient Monitor’s features and requirements, main structure,
functions, specifications, correct methods for transportation, installation, usage, repair, maintenance and storage,
etc. as well as the safety procedures to protect both the user and equipment. Refer to the respective chapters for
details.
This manual is applicable to the product series for all our Patient Monitors. It consists of two parts, part I covers
almost the all necessary content, except the operations for user interface, which is included separately in part II.
The Manual is published in English and we have the ultimate right to explain the Manual. No part of this manual
may be photocopied, reproduced or translated into another language without the prior written consent. We reserve
the right to improve and amend it at any time without prior notice. Amendments will however be published in a
new edition of this manual.
This manual is an integral part of the product, it should always be kept close to the equipment so that it can be
obtained conveniently when needed
Warning: must be followed to avoid endangering the operator and the patient.
☞ Note: contains some important information and tips about operations and
application.
Attention: must be followed to avoid causing damage to the monitor.
Caution:
Federal law restricts this device to sale by or on the order of a physician.
3502-2000008
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User manual for Patient Monitor
Instructions to User
Dear Users,
Thank you very much for purchasing our product. Please read the following very carefully
before using this equipment.
Read these instructions carefully before using this monitor. These instructions describe the
operating procedures to be followed strictly. Failure to follow these instructions can cause
monitoring abnormality, equipment damage and personal injury. The manufacturer is NOT
responsible for the safety, reliability and performance issues and any monitoring
abnormality, personal injury and equipment damage due to user’s negligence of the
operation instructions. The manufacturer’s warranty service does not cover such faults.
WARNING for PACEMAKER PATIENTS: Although the pacemaker pulse
inhibition function is available in this device, the heart rate meter may
continue to count the pacemaker rate during occurrences of cardiac arrest or
some arrhythmias. Do not rely entirely upon rate meter ALARMS. Keep
pacemaker patients under close surveillance. See this manual for disclosure of
the pacemaker pulse rejection capability of this instrument.
If uncertain about the accuracy of any measurement, first check the patient’s
vital signs by any alternative means, and then make sure the monitor is
functioning properly.
The monitor is not suitable for use in the presence of flammable anesthetic
mixture with air, oxygen or nitrous oxide.
The monitor is defibrillator proof. Verify that the accessories can function
safely and normally and the monitor is grounded properly before conducting
defibrillation.
Disconnect the monitor and sensors before MRI scanning. Use during MRI
could cause burns or adversely affect the MRI image or the monitor’s
accuracy.
If you have any doubt to the grounding layout and its performance, you must
use the built-in battery to power the monitor.
All combinations of equipment must be in compliance with the standard IEC 60601-1.
The SpO 2 measurement of this monitor may not work for all testees. If stable
readings cannot be obtained at any time, discontinue use.
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User manual for Patient Monitor
manufacturer.
Each time the monitor is used, check the alarm limits to ensure that they are
appropriate for the patient being monitored.
The alarm limit value shall be within the measuring range, or it may disable
the alarm system. Please refer to the related chapter for alarm limit range.
A HAZARD can exist if different alarm presets are used for the same or
similar equipment in single area.
When taking the measure of a pediatric or neonates(less than 10 years old) blood pressure,
do NOT operate in the adult mode. The high inflation pressure may cause lesion or even
body putrescence.
The monitor is prohibited from applying to those who have severe hemorrhagic tendency
or who are with sickle cell disease for they may develop partial bleeding when this
monitor is used to take the blood pressure measurement.
DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or
intubations or skin lesion area, otherwise, damages may be caused to the limb.
Continuous use of SpO2 sensor may result in discomfort or pain, especially for those with
microcirculatory problem. It is recommended that the sensor should NOT be applied to
the same place for over two hours, change the measuring site periodically if necessary.
SpO2 measuring position must be examined more carefully for some special patient. Do
NOT install the SpO2 sensor on the finger with edema or vulnerable tissue.
To prevent the risk of the short circuit and to ensure the ECG signal quality, the equipment
must be properly grounded.
Although biocompatibility tests have been performed on all the applied parts, some
exceptional allergic patients may still have anaphylaxis. Do NOT apply to those who have
anaphylaxis.
All the connecting cables and rubber tubes of the applying parts should be kept away from
the patient's cervix to prevent any possible suffocation of the patient.
All the parts of the monitor should NOT be replaced at will. If necessary, please use the
components provided by the manufacturer or those that are of the same model and
standards as the accessories along with the monitor which are provided by the same
factory, otherwise, negative effects concerning safety and biocompatibility etc. may be
caused.
DO NOT stare at the light of SpO2 sensor (infrared is invisible) when switch it on, for the
infrared may do harm to the eye.
If the monitor falls off accidentally, please do NOT operate it before its safety and technical
indexes have been tested minutely and positive testing results obtained.
The system might not meet its performance specifications if stored or used outside the
manufacturer’s specified temperature and humidity ranges.
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User manual for Patient Monitor
Reuse, disassembly, cleaning, disinfecting the single patient use CO2 cannula kits and
on-airway adapters may compromise functionality and system performance leading to a
user or patient hazard. Performance is not guaranteed if an item labeled as single
patient use is reused.
Electrical Shock Hazard: Always disconnect the CO2 Sensor before cleaning. Do NOT
use if it appears to have been damaged. Refer servicing to qualified service personnel.
Electrical Shock Hazard:No user serviceable parts inside the CO2 Sensor.
After the life cycle of the Sidestream CO2 Sensor and its accessories has been met,
disposal should be accomplished following national and/or local requirements.
Please peruse the relative content about the clinical restrictions and contraindication.
The accessories which can be used repeatedly should have a thorough cleanness before it is
used to another patient. Please refer to the related chapter for maintenance method.
When disposing of the monitor and its accessories, the local law should be followed.
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User manual for Patient Monitor
Table of Contents
Chapter 1 Overview........................................................................................................................................... 1
1.1 Product Name.............................................................................................................................................. 1
1.2 Applications and Scope............................................................................................................................... 1
1.3 Operating Environment............................................................................................................................... 1
1.4 Impact on Environment and Resources....................................................................................................... 1
1.5 Safety........................................................................................................................................................... 1
Chapter 2 Working Theories............................................................................................................................. 3
2.1 Overall Structure......................................................................................................................................... 3
2.2 Composition................................................................................................................................................ 3
2.3 Working Theories........................................................................................................................................ 3
Chapter 3 Installation and Connection............................................................................................................. 5
3.1 Installation................................................................................................................................................... 5
3.1.1 Opening the Box and Check............................................................................................................. 5
3.1.2 Connecting the AC Power Cable...................................................................................................... 5
3.1.3 Starting the Monitor.......................................................................................................................... 6
3.2 Connection................................................................................................................................................... 6
3.2.1 ECG Cable/Lead Wires Connection................................................................................................. 6
3.2.2 Cuff Connection for Blood Pressure Measurement.......................................................................... 8
3.2.3 SpO2 Probe Connection.................................................................................................................. 11
3.2.4 CO2 Sensor Connection.................................................................................................................. 15
3.2.5 TEMP Probe Connection................................................................................................................ 19
3.2.6 Loading Printing Paper................................................................................................................... 19
Chapter 4 Alarm............................................................................................................................................... 21
4.1 Alarm Description..................................................................................................................................... 21
4.1.1 Alarm Condition............................................................................................................................. 21
4.1.2 Alarm Priority................................................................................................................................. 21
4.1.3 Alarm Modes.................................................................................................................................. 22
4.1.4 Alarm Setting.................................................................................................................................. 22
4.2 Alarm Technical Specifications................................................................................................................. 22
Chapter 5 Technical Specifications................................................................................................................. 24
5.1 ECG Monitoring........................................................................................................................................ 24
5.2 RESP Monitoring...................................................................................................................................... 25
5.3 TEMP Monitoring..................................................................................................................................... 25
5.4 NIBP Monitoring....................................................................................................................................... 25
5.5 SpO2 Monitoring....................................................................................................................................... 26
5.6 Pulse Rate Monitoring............................................................................................................................... 26
5.7 CO2 Monitoring......................................................................................................................................... 26
5.8 Data Recording.......................................................................................................................................... 27
5.9 Other Technical Specifications.................................................................................................................. 27
5.10 Classification........................................................................................................................................... 27
5.11 Guidance and manufacturer’s declaration-Electromagnetic compatibility.............................................. 28
Chapter 6 Packaging and Accessories............................................................................................................. 32
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User manual for Patient Monitor
6.1 Packaging.................................................................................................................................................. 32
6.2 Accessories................................................................................................................................................ 32
Chapter 7 Working Principles......................................................................................................................... 33
7.1 Introduction to ECG Measurement............................................................................................................ 33
7.1.1 How to Obtain High Quality ECG and Accurate Heart Rate Value................................................33
7.1.2 Factors affecting ECG signal.......................................................................................................... 33
7.2 Introduction to Blood Pressure Measurement........................................................................................... 34
7.2.1 Blood Pressure Measuring Principle.............................................................................................. 34
7.2.2 Factors affecting NIBP measuring.................................................................................................. 35
7.2.3 Clinical Limitations........................................................................................................................ 36
7.3 Introduction to Oxygen Saturation Measurement...................................................................................... 36
7.3.1 SpO2 Measuring Principle.............................................................................................................. 36
7.3.2 SpO2 Measurement Restrictions (interference reason)................................................................... 37
7.4 Introduction to Respiration Measurement................................................................................................. 37
7.4.1 Respiration Measuring Principle.................................................................................................... 37
7.4.2 Factors affecting respiration monitoring......................................................................................... 38
7.5 Introduction to Temperature Measurement................................................................................................ 38
7.6 Introduction to Capnograph Measurement................................................................................................ 38
7.6.1 CO2 Measuring Principle................................................................................................................ 38
7.6.2 Mainstream vs. Sidestream Sampling............................................................................................. 38
Chapter 8 Troubleshooting.............................................................................................................................. 40
8.1 No Display on the Screen.......................................................................................................................... 40
8.2 Excessive ECG Signal Interference or too Thick Baseline....................................................................... 40
8.3 No Blood Pressure and Pulse Oxygen Measures....................................................................................... 40
8.4 System Alarm............................................................................................................................................ 40
Chapter 9 Maintenance.....................................................................................................................................41
9.1 Service and Examination........................................................................................................................... 41
9.1.1 Daily Examination.......................................................................................................................... 41
9.1.2 Routine Maintenance...................................................................................................................... 41
9.2 Battery Maintenance.................................................................................................................................. 42
9.3 Cleaning and Disinfection of the Device................................................................................................... 42
9.4 Cleaning and Disinfection of Accessories................................................................................................. 43
9.5 Storage....................................................................................................................................................... 43
9.6 Transportation............................................................................................................................................ 43
Chapter 10 Appendix............................................................................................................................................ 44
10.1 Alarm Information................................................................................................................................... 44
10.2 Default Alarming Values and Setup Range.............................................................................................. 45
10.3 Status/Error during NIBP Monitoring..................................................................................................... 47
10.4 Status/Error during CO2 Monitoring....................................................................................................... 48
10.5 Typical Pressures and CO2 Readings at Altitudes.................................................................................... 49
10.6 Accessories List....................................................................................................................................... 49
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Chapter 1 Overview
1.1 Product Name
Name: Patient Monitor
1.5 Safety
a) This device conforms to IEC60601-1, electric safety classification: Class I, with Type BF and CF
User manual for Patient Monitor
applied parts.
b) This device can resist against the discharge of defibrillator and the interference of electrosurgical unit.
c) This device can monitor the patients with pace-maker.
d) DO NOT use this device while the patient is under MRI scanning.
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User manual for Patient Monitor
Figure 2.1
2.2 Composition
1. The monitor consists of the main units and the corresponding functional components (ECG cables/lead
wires, non-invasive blood pressure cuff, SpO2 probe, temperature transducer, accessories for invasive
blood pressure and CO2 monitoring).
2. The patient monitor has multiple measurement channels including ECG/Heart Rate, NIBP, SpO2/Pulse
Rate, Respiration Rate, Temperature, and CO2 Concentration.
3. The patient monitor has output ports including networking communication and the built-in printer.
4. Basic configuration includes the functions of ECG/Heart Rate, NIBP (systolic, diastolic, mean aterial
pressure & pulse rate), SpO2/Pulse Rate, Respiration Rate, and Temperature.
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2. The SpO2 module detects the plethysmograph data via the SpO2 probe and calculates the pulse rate and
oxygen saturation (SpO2) accordingly.
3. The NIBP module measures the blood pressures including systolic, diastolic, mean arterial pressure and
pulse rate through the pneumatic system and cuff. The cuffs are designed for adult and pediatric patients
respectively, and it can work in different modes to adapt different patient categories.
4. The CO2 module detects CO2 concentration through the sampling line (side stream) or within the airway
(main stream), and calculate the respiration rate, end tidal CO2 concentration (EtCO2), and inspired CO2
concentration (InsCO2).
5. The mother board is the main controlling unit, which also connects to the interface board and key board.
The interface board inter-connects the functional modules with the mother board.
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3.2 Connection
3.2.1 ECG Cable/Lead Wires Connection
ECG measurement is to collect the ECG signal via the ECG electrodes. Electrode connects the patient and the
lead wires and/or ECG cable. The lead wires and/or cable connect to the monitor. The locations of the electrodes
are very important for obtaining accurate ECG signals.
1. Connect the cable to the connector marked with the “ECG" icon on the signal input panel.
2. Select electrodes to be used. Use only one type of electrode on the same patient to avoid variations in
electrical resistance. For ECG monitoring, it is strongly recommended to use silver/silver chloride
electrodes. When dissimilar metals are used for different electrodes, the electrodes may be subject to large
offset potentials due to polarization. Using dissimilar metals may also increase recovery time after
defibrillation.
3. Prepare the electrode sites according to the electrode manufacturer’s instructions.
4. Skin clean
Clean and scrap skin to ensure low sensor impedance if necessary. Mild soap and Water is
recommended as a skin cleanser.
Note: If alcohol is used as cleanser, it is recommended to have 30-second dry time for a better
connection.
Scraping the skin gently with a dry wash cloth, gauze, for skin preparation is helpful to remove the
non-conductive skin layer.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks and is defibrillator-proof.
The locations of the electrode are in the following Figure:
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User manual for Patient Monitor
5. After starting the monitor, if the electrodes become loose or disconnected during monitoring, the system
will display “LEAD OFF” on the screen to alarm the operator.
It might not display ECG waveform when using ECG cable with 3 lead wires while the setting of
“Cable” is set as “5” in the ECG parameter setup menu. The ECG cable with 5 leads wires should
be used to measure ECG signal at this situation.
6. The ECG leads and their corresponding locations are as follows:
Black N/RF Green RL Right Leg: Right part of the upper abdomen
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User manual for Patient Monitor
1. Connect the tube with cuff to the connector marked with “NIBP” icon on the signal input panel.
2. Unfold the cuff and wrap it around the patient’s upper arm.
Requirements of the cuff:
1) Appropriate cuff should be selected according to the age and arm circumference of the subject. Its width
should be 2/3 of the length of the upper arm. The inflatable part should be long enough to permit
wrapping appropriately 80% of the limb.
Note: the appropriate cuff should be selected according to the age and arm circumference of the patient.
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User manual for Patient Monitor
2) When putting on the cuff, unfold and wrap it around the upper arm evenly to appropriate tightness.
3) Remember to empty the residual air in the cuff before the measurement is commenced.
4) Locate the cuff in such a way that the artery mark “ ” is at a location where the clearest pulsation of
brachial artery is observed.
5) The cuff should be tightened to a degree where insertion of one finger is allowed.
6) The lower end of the cuff should be 2cm above the elbow joint.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks, and is defibrillator proof.
Pressure Accuracy Verification
Pressure Accuracy Verification is a function to inspect the accuracy of pressure measurement by the NIBP
module inside the device. Technician or equipment manager should do pressure accuracy verification every
half year or year in order to check if the pressure measurement still conforms to the requirement of product
performance. If the deviation is beyond the declared specification, it is permitted to return it to factory for
repair or calibration.
Before verification, please connect the monitor to a precision pressure meter as the reference
equipment like a mercury pressure meter
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User manual for Patient Monitor
At this mode, the monitor can activate the inflation, so the pressure will increase automatically until it
exceeds the limit value specified in table A. This pressure limit value depends on the patient type selection
as shown in table A:
Adult 240mmHg
Pediatric 200mmHg
Neonate 120mmHg
Table A
During the inflation, the Monitor will close the deflating valve, and the pressure value will be shown
during the process. If there is no manual deflation operation, the pressure will persist until deflation by
manual operation, so it is necessary to use a manual valve for doing adequate deflation in several steps
to verify the pressure accuracy in the full scale of measurement range.
Mode 2: Manual inflation for the pressure accuracy verification.
At this mode, the pressure should be increased manually by a pumping balloon, and the verification can be
done by applying different pressure value manually. If the increased pressure exceeds the given limit as
shown in table B, the Monitor will deflate automatically because of over-pressure protection.
Adult 300mmHg
Pediatric 240mmHg
Neonate 140mmHg
Table B
After the verification, do press the button again to return to normal working mode, then
continue other operation, or the NIBP key will be invalid.
Pressure accuracy verification must be operated by technician or equipment manager. Doctor or
nurse is not allowed to do the verification, it is very dangerous especially when the pressure cuff
is still on patients.
Air Leakage Check
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User manual for Patient Monitor
In order to avoid significant error of blood pressure measurement or even no measurement result caused by
air leakage in the pneumatic system including the cuff during measuring, it is recommended to check if there
is leak in the pneumatic system as well.
Please remove the cuff from patient while performing the leakage check.
Safety Instructions for NIBP Measurement
When taking the blood pressure measurement on a Pediatric or Neonate patient, do NOT
operate in the Adult mode. The high inflation pressure may cause lesion or even body
putrescence. Even though the monitor can identify the cuff type so it will stop inflation and
indicate "wrong cuff" when taking the blood pressure measurement for a pediatric or neonate
in the "adult" patient type setting. The user (doctor or nurse) should pay more attention to
select the correct patient type.
It is recommended to take the blood pressure measurement manually.
NIBP monitoring is prohibited to those who have severe hemorrhagic tendency or with sickle
cell disease, or partial bleeding will appear.
Do NOT bind NIBP cuff on limbs with transfusion tube or intubations or skin lesion area,
otherwise, damages may be caused to the limbs.
If the patient is moving or suffering tremble, hyperkinesia or arrhythmia, it may cause the
inflation time of inflatable balloon endures longer, which may not only prolong the NIBP
measurement time, but also result in the body wrapped by the cuff is troubled by purpura,
hypoxemia and neuralgia because of the friction.
Before the measurement is carried out, select an appropriate monitoring mode depending on the
patient type (adult, pediatric or neonate).
It is prohibited to wrap the cuff to a limb with skin lesion
DO NOT take blood pressure measurement from a limb receiving ongoing transfusion or
intubations. Because it may damage the limb tissue around the intubation if the transfusion
becomes slower or blocked during the cuff inflation.
The windpipe which connects the cuff and monitor should be straightway without any tangle.
When an adult subject is monitored, the machine may fail in giving the blood pressure measure
if the pediatric mode is selected.
Prior to use of the cuff, empty the cuff until there is no residual air inside it to ensure accurate
measurement.
Do NOT twist the cuff tube or put heavy things on it.
When unplugging the cuff, hold the head of the connector and pull it out.
The NIBP measurement will not be affected when the monitor is connected to the patient on
whom the electrosurgical device such as defibrillator or electrosurgical knife with high frequency
is being used.
The appearance of arrhythmia results in irregular heart beat which may affect the accuracy of
NIBP measurement data. It is recommended to take the NIBP measurement again at this
situation.
The Blood pressure measurements determined with this device are equivalent to those obtained
by a trained observer using the cuff/stethoscope auscultatory method, within the limits prescribed
by the American National Standard, Manual, electronic, or automated sphygmomanometers.
The symbol indicates that the cable and accessories are designed to have special protection against
electric shocks, and is defibrillator proof.
Creative reusable SpO2 finger clip sensor is configured by default for general purpose. For further information,
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User manual for Patient Monitor
Creative reusable SpO2 finger clip sensor can be used with a compatible patient monitor (e.g. all models of
Patient Monitors and PC-900A Vital Signs Monitor made by Creative) or pulse oximeters (e.g. PC-66B Handheld
Pulse Oximeter made by Creative).
The sensor is intended to be used for continuous, non-invasive functional arterial oxygen saturation (SpO2) and
pulse rate monitoring for adult patients weighing greater than 40kg or pediatric patients weighing between
10~40kg.
SpO2 probe is a kind of very delicate sensor. Please follow the steps and procedures in operating it. Failure to
operate it correctly can cause damage to the SpO2 probe.
Operation procedure:
1. Connect the SpO2 probe to the connector marked with “SpO2” icon on the signal input panel. When
unplugging the probe, be sure to hold the head of the connector and pull it out.
2. Insert one finger (index finger is preferred, but middle or ring finger with proper nail length is possible as well)
into the probe according to the finger mark on the probe, shown as below.
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User manual for Patient Monitor
When selecting a SpO2 probe or sensor, do consider the patient’s category, adequacy of perfusion, availability of
probe site and anticipated monitoring duration. Use only SpO2 probes provided by our company with this monitor.
Read the following table for SpO2 probe information.
Some factors may affect the accuracy of saturation measurements. Such factors include: excessive patient motion,
fingernail polish, use of intravascular dyes, excessive light, poorly perfused finger, extreme finger sizes or
improper placement of the sensor.
High ambient light sources such as surgical lights (especially those with a xenon light source), bilirubin lamps,
fluorescent lights, infrared heating lamps, and direct sunlight can interfere with the performance of a SpO2 sensor.
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User manual for Patient Monitor
To prevent interference from ambient light, ensure that the sensor is properly applied, and cover the sensor site
with opaque material if necessary. Failure to take this action in high ambient light conditions may result in
inaccurate measurements.
If patient movement presents a problem, verify that the sensor is properly and securely applied; move the sensor
to a less active site; use an adhesive sensor that tolerates some patient motion; or use a new sensor with fresh
adhesive backing.
For reusable sensors, follow the sensor directions for use, cleaning and reuse. For single-patient use sensors, use a
new sensor for each patient.
Caution: Do not disinfect any SpO2 sensor by irradiation, steaming, or ethylene oxide.
Safety Introductions for SpO2 Monitoring
Continuous use of fingertip SpO2 sensor may result in discomfort or pain, especially for those
patients with microcirculatory problem. It is recommended that the sensor should NOT be
applied to the same site for over two hours, please inspect the monitoring site every 1~2
hours for skin integrity, and change the measuring site periodically if necessary.
SpO2 measuring site must be examined more carefully for some special patient. Do NOT place
the SpO2 sensor on the finger with edema or fragile tissue.
Avoid placing the SpO2 sensor on the same extremity with an arterial catheter, blood pressure
cuff, or intravascular infusion line, otherwise the blood flow could be interrupted by the
cuff or the circulatory condition could make low blood perfusion so that would result in on
pulse found or loss of pulse during SpO2 monitoring and further cause false alarm.
Do not apply tape to secure the sensor in place or to tape it shut; venous pulsation
may lead to inaccurate oxygen saturation measurements.
For disposal SpO2 sensor, If the sterile packaging is damaged, do not use it any more.
Check the SpO2 sensor and cable before use. Do NOT use the damaged SpO2 sensor.
Before each use, surface-clean sensor and cable with a soft gauze pad by saturating it with a solution
such as 70% isopropyl alcohol. If low-level disinfection is required, use a 1:10 bleach solution.
When the temperature of SpO2 sensor is abnormal, do not use it any more.
Please do not allow the cable to be twisted or bended.
Please do not use nail polisher or other cosmetic product on the nail.
The fingernail should be of normal length.
The SpO2 sensor cannot be immerged into water, liquor or cleanser completely, because the sensor has
no capability to resist the harmful ingress water.
Carefully route cables to reduce the possibility of patient entanglement or strangulation.
Do not use the sensor or other oximetry sensors during MRI scanning.
Our company offers a 6-month warranty against manufacturing defects for the SpO2
sensors mentioned above in its undamaged condition.
If you have any question regarding any of SpO2 sensor instructions, please contact
your local dealer.
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User manual for Patient Monitor
Extending airway tube for connecting to sampling tube (Single patient use)
Wye Connector
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User manual for Patient Monitor
On-air Connector
Adapter
(2) Nasal Sidestream Cannula Kits
Adapter
CO2 sensor
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User manual for Patient Monitor
3. Position the airway adapter in the patient’s respiratory circuit (as close to the patient as possible) between the
endotracheal tube and the ventilator circuit. Next, turn on the CO2 switch at CO2 Setup Screen and then wait 2
minutes for the sensor warm-up.
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User manual for Patient Monitor
Patient Monitor has two TEMP probes to measure different body temperature.
Connecting methods:
Fig.3.9 Fig.3.10
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User manual for Patient Monitor
Power Indicator
Paper cartridge
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User manual for Patient Monitor
Chapter 4 Alarm
Once the patient is changed, please recheck if the monitor can work normally, alarm function works
properly, and alarm setting are appropriate.
Lead Off, Probe off, Poor Signal, Electrode Off, High Impedance, Stifle Time Indication, Artefact.
Medium
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5.10 Classification
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User manual for Patient Monitor
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the equipment or system should assure that it is used in such an environment.
RF emissions Patient Monitor uses RF energy only for its internal function.
CISPR 11 Group 1 Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
Voltage
fluctuations/flicker
Complies
emissions
IEC61000-3-3
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User manual for Patient Monitor
Table 2
Guidance and manufacturer’s declaration-electromagnetic immunity
for all EQUIPMENT AND SYSTEMS
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the equipment or system should assure that it is used in such an environment.
Electromagnetic environment
Immunity test IEC60601 test level Compliance level
-guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood, concrete
discharge(ESD) ±8kV air ±8kV air or ceramic tile. if floors are
IEC61000-4-2 covered with synthetic material,
the relative humidity should be at
least 30%
Electrical fast ±2kV for power ±2kV for power Mains power quality should be
transient/burst Supply lines Supply lines that of a typical commercial or
±1 kV for ±1 kV for hospital environment.
IEC61000-4-4 input/output lines input/output lines
Surge ±1kV line (s) to line(s) ±1kV differential Mains power quality should be
IEC 61000-4-5 ±2kV line(s) to earth mode that of a typical commercial or
±2kV common hospital environment.
mode
Voltage dips, short Mains power quality should be
interruptions and voltage that of a typical commercial or
variations on power hospital environment. If the user
supply input lines of the equipment or system
IEC61000-4-11 requires continued operation
during power mains interruptions,
it is recommended that the
equipment or system be powered
from an uninterruptible power
supply or a battery.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity-for
EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of Patient Monitor should assure that it is used in such an electromagnetic environment.
Compliance
IMMUNITY test IEC 60601 test level Electromagnetic environment - guidance
level
Portable and mobile RF communications
equipment should be used no closer to any part of
Patient Monitor, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Conducted RF 3 Vrms 3V
150 kHz to 80 MHz Recommended separation distance
IEC 61000-4-6
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 reflection from structures, objects and people.
a: 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, and
electromagnetic site survey should be considered. If the measured field strength in the location in which Patient
Monitor is used exceeds the applicable RF compliance level above, Patient Monitor should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating Patient Monitor.
b: Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
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Table 4
Recommended separation distances between portable and mobile RF
communications equipment and The equipment or system-
for EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
Patient Monitor is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the equipment or system can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the equipment or system as recommended below, according to the maximum output power
of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum m
output power of 150kHz to 80MHz 80MHz to 800MHz 80MHz to 2,5GHz
transmitter
W
100 12 12 23
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (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: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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6.2 Accessories
(1) ECG lead cable One set
(2) NIBP cuff One set
(3) SpO2 probe One piece
(4) Body temperature probe One piece
(5) Power supply cable One piece
(6) Equipotential grounding wire One piece
(7) Disposable electrode Ten pieces
(8) User Manual One copy
(9) Warranty One copy
(10) Quality certificate One copy
(11) Assembly report Two copies
(12) Dustproof mantle One set
(13) Printing paper (optional) Ten rolls
(14) CO2 accessories (optional)
Note: The accessories are subject to change. Detailed items and quantity see the Packing List.
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First of all, the hospital should be equipped with a 100~250V power supply system with a typical grounding wire.
If big interference in ECG continues, connect one end of the grounding wire provided with this equipment to the
grounding wire on the back panel of this monitor, and the other end to the special grounding wire, water pipe or
radiator.
A common ECG plate electrode used together with this monitor has short shelf life. Generally, the shelf life is
only one month after the package is opened. When outdated plate electrode is used, due to skin’s contact
impedance and big electrode potential, the chance of interference will be increased, and the ECG baseline will
have an unstable inclination. Therefore, always use valid plate electrodes.
7.1.2 Factors affecting ECG signal
Interference from Electrosurgical Unit;
Doesn’t filter the interference waveform;
Poor grounding;
Electrodes are not placed properly;
Use expired electrode or use disposable electrode repeatedly;
The skin placed electrode is unclean or poor contract caused by scurf and hair;
Electrode long-time used.
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As change of the blood pressure is recorded by electric sensor, which sensitivity is much higher than that of
human ears, the oscillating method uses different definitions for measurement of diastolic pressure and systolic
pressure from the Korotkoff Sound Method. When the oscillating method is used, the circuit in the measuring
apparatus will separate the amplitude of the cuff pressure from its change with pulsation. The blood pressure at
amplitude of cuff pressure forward reduced according to proper proportion is defined as systolic pressure, while
the blood pressure at amplitude of cuff pressure backward reduced according to proper proportion is defined as
diastolic pressure. The maximum change of pulse pressure occurs at these two points. They are equivalent to the
point with pulse sound and the point without pulse sound respectively in the Korotkoff Sound Method.
When the risk of invasive monitoring method outweighs its advantage of accuracy, non-invasive monitoring
method shall be used.
Blood pressure measurement by the oscillating method and Korotkoff Sound Method has good correlation with
the invasive measurement. Notwithstanding, any of the non-invasive blood pressure measurements has its
one-sidedness when it is compared to the invasive measurement. The oscillating method has its advantages over
the Korotkoff Sound Method in less error, higher reliability and stability. Their differences may be reflected in the
following aspects.
1. The measures by the Korotkoff Sound Method are liable to effect of human factors. For example,
different people may have different sound judging ability, or different reactivity when listening to heart
sound and reading mercury meter. The air release speed and subjectivity may also affect the judgment.
By the oscillating method, the computation is accomplished by the computer, thus relieving the
possibility of effect due to human factor.
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2. With the Korotkoff Sound Method, the measure is taken on the basis of appearance and disappearance of
heart sound. The air release speed and heart rate may have direct effect on the measurement accuracy. It
also has the disadvantages of rapid air release and poor accuracy. In the contrast, with the oscillating
method, the determination is calculated on the basis of cuff pressure oscillatory waveform envelope,
and the air release speed and heart rate has little effect on the measurement accuracy.
3. Statistics show that, when measuring the hypertension, the measure taken by the oscillating method is
likely to be lower than that taken by the Korotkoff Sound Method. When measuring the hypotension, the
measure taken by the oscillating method is likely to be higher than that by the Korotkoff Sound Method.
But, it doesn’t mean the advantages or disadvantages between the oscillating method and the Korotkoff
Sound Method. Comparison with the results taken by more accurate method, let’s say comparison of the
invasive pressure result with the output value by the blood pressure measuring simulator, will show
which method has more accurate results. In addition, higher or lower value should be a statistical concept.
It is recommended those used to adopt the Korotkoff Sound Method use different physiological
calibration for values determined by the oscillating method.
4. The studies have shown that the Korotkoff Sound Method has the worst accuracy when it comes to
measurement of hypotension, while the oscillating method has worse accuracy when it comes to
measurement of controlled hypertension relief.
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inflation pressure until the measure is taken, after that, up to four measures will be allowed.
6. When an adult subject is monitored, the machine may fail in giving the blood pressure measure if the
Pediatric or neonate is selected.
7. When taking NIBP measurement on pediatric patients, the operator must select correct mode depending
on different patient types (refer to NIBP menu setup) and do NOT operate in the adult mode. The high
inflation pressure for adult is not suitable for pediatric patients.
Note: Some practitioners may report big discreteness or abnormal value of the blood pressure measures
when the oscillating method is used. As a matter of fact, the so-called “big discreteness” must be a term in
the sense of statistical significance of mass data. Abnormal data may be observed in some individual cases.
It is normal in the scientific experiments. It may be caused by an apparent reason, or by an unknown
factor in some cases. Such individual doubtful experimental data may be identified and eliminated using
the special statistical technique. It is not a part of this manual. The practitioner may eliminate the
apparently unreasonable data according to the experience.
Operation Introduction:
1. Take a measurement in manual mode:
Enter into the screen of NIBP setting, select “Mode” option and set it as “MANU”, and then press
the NIBP key on the front panel to start measure. If press the NIBP key again, the measurement
will be stopped.
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current into body and measuring the change of voltage between the electrodes. The product will transmit the
high-frequency current whose frequency is much higher than ECG frequency (but with the safe current limit)
to the ECG electrodes (placed at the both sides of chest), which can be detect ECG signal and chest’s
impedance at the same time, and the respiratory rate will be measured through impedance method by the
software. So the additional electrodes for respiratory measurement are unnecessary.
Notes:
Attach the TEMP transducer to the patient; generally if the TEMP transducer and skin doesn’t contact
closely, the measured value becomes lower, so for those who have requirement for temperature, add a
proper martial to transducer and fix it with adhesive tape to make them contact firmly.
Especially for pediatric patient, they like sports, pay more attention to the transducer fixing.
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Sidestream CO2 sensors are located away from the airway, requiring a gas sample to be continuously aspirated
from the breathing circuit and transported to the sensor by means of a pump. This type of system is needed for
non-intubated patients.
When using mainstream CO2 sensors, check the window for the patient secretions pooled on periodically.
Because that condition may affect the accuracy of the measurement or even make the sensor not work.
When using sidestream CO2 sensors, there is a water trap or a part of the sampling tube with dehumidifying
function. Please periodically check the flow sensor and tubing for excessive moisture or secretion buildup.
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Chapter 8 Troubleshooting
Note: In case of trouble of this machine in service, follow the instructions below to eliminate the problem first. If
the attempt fails, contact the dealer in your local area or the manufacturer.
2. Check whether the lead wires are properly inserted. If no ECG curve displayed, check if the ECG lead wires
are broken.
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Chapter 9 Maintenance
In case of trouble of this machine in the service, follow the instructions below to eliminate the problem first.
If the attempt fails, refer to the dealer in your local area or the manufacturer. Refer to the detailed
provisions in contract for the warranty period of the main unit and the accessories of this monitor.
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set "Make" to "DownLoadMake: KRK", then the user can use this particular R-curve to test the
SpO2 function. If the SpO2 simulator does not contain "KRK" R-curve, please ask the
manufacturer for helping to download the given R-curve into the SpO2 simulator.
The adjustable units within the monitor such as potentiometers are not allowed to adjust without
permission to avoid unnecessary failures that affect normal application.
It is recommended to use the battery once a month to ensure its power capability and long service
life, and recharge it after run out of its power capacity.
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9.5 Storage
If the equipment will not be used for long period of time, wipe it clean and keep it in the packaging, which shall
be kept in a dry and good ventilation place free from dust and corrosive gases
9.6 Transportation
This monitor should be transported by land (vehicle or railway) or air in accordance with the contractual terms.
Do not hit or drop it with force.
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Chapter 10 Appendix
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No Parameter Message Barometric Pressure and/or gas compensations have not been
The host must set the Barometric Pressure and set since power on. For CO2 to be calculated with the stated
compensations to clear this error; no user intervention accuracy, these values should be set whenever the sensor is
should be required. plugged in.
“Module in Sleep Mode” This bit is set when sensor has been placed in sleep mode.
“Zero In Progress “ A Module Zero is currently in progress.
One of the following conditions exist:
“Sensor Warm Up”
Sensor under temperature
This error condition is normal at startup. This error
Temperature not stable
should clear when the warm up is complete.
Source Current unstable
“Check Sampling Line” This error occurs whenever the pneumatic pressure is outside
Check that the sampling line is not occluded or kinked. the expected range.
“Zero Required” One of the following conditions exist:
To clear, check airway adapter and clean if necessary. Zero Required;
If this does not correct the error, perform an adapter Zero Required: Zero Error
zero. If you must adapter zero more than once, a
possible hardware error may exist.
The value being calculated is greater than the upper CO2 limit
“CO2 Out of Range”
(150 mmHg, 20.0 kPa, or 19.7 %). The maximum value output
If error persists, perform a zero. is the upper CO2 limit.
Usually caused when the airway adapter is removed from the
“Check Airway Adapter” sensor or when there is an optical blockage on the windows of
To clear, clean airway adapter if mucus or moisture is the airway adapter. May also be caused by failure to perform
seen. If the adapter is clean, perform a Capnostat zero. sensor zero to when adapter type is changed.
This is prompted if the CO2 sensor is not ready for a Capnostat Zero.
If the “Zero Required” and this massage both prompt message both
The Sensor promptone or more of the following conditions may exist:
not Ready • Breaths detected
• Temperature is not stable
• Source Current unstable
• In sleep mode.
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For more information regarding the accessories, please contact your local sales representative or the
manufacturer.
Note: Part No. is subject to change without prior notice, please refer to the label of parts or package list.
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EC-Representative:
Shanghai International Holding Corp. GmbH (Europe)
Address: Eiffestrasse 80, 20537 Hamburg, Germany
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