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Axcent PAVO SERVICE MANUAL

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0% found this document useful (0 votes)
1K views48 pages

Axcent PAVO SERVICE MANUAL

Uploaded by

LAVINA DSA
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 48

PAVO

MULTI-PARAMETER PATIENT MONITOR


INSTRUCTIONS FOR MAINTENANCE
[Version 1.0]
aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Notice
Before maintaining, please read this Manual carefully to ensure proper use.
Please keep this Manual properly for future reference.

Product Name: Patient Monitor


Model: PAVO
Structure and The monitor consists of master unit, display, ECG cable,
Components: SpO2 probe, blood pressure cuff, and temperature probe.
Scope of Application: Monitors patient ECG, respiration (RESP), blood oxygen
saturation (SpO2), pulse rate (PR), noninvasive blood
pressure (NIBP), and temperature (TEMP) as well as displays,
reviews and stores the monitoring information.
Manufacturer: aXcent medical GmbH
Registered Address: Josef-Görres-Platz 2, 56068 Koblenz / Germany

Version: 1.0
Date of Issue: August, 2018
aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Intellectual Property Rights

The intellectual property rights of this Instruction for Maintenance (hereinafter referred
to as ‘Manual’) and the corresponding product belong to aXcent medical GmbH
(hereinafter referred to as “aXcent”).
This Manual contains proprietary information protected by copyright law. Without
written permission of aXcent, any organization or individual is prohibited to photograph,
copy, modify or print any part of this Manual, or translate into other languages.
However, aXcent is not liable for any incidental or consequential damages to the actual
performance and use due to errors in this Manual or the provision of this Manual.
aXcent does not provide license conferred by patent law to any other parties. aXcent
does not assume legal responsibility for the legal consequences resulting from violating
the patent law and the rights of any third party.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Statement
aXcent reserves the right of final interpretation to this Manual.
The content of this Manual is subject to change without prior notice.
Only if the following requirements are met, aXcent will be responsible for the safety,
reliability and performance of the product, i.e.:
◼ Assembly, expansion, re-adjustment, improvement and repair should only be
performed by qualified personnel approved by aXcent;
◼ All the replaced parts and supported accessories and consumables relate to the
maintenance shall be originally from aXcent or others approved by aXcent;
◼ The electrical equipment complies with relevant standards and the requirements of
this Manual;
◼ The product is operated in accordance with this Manual.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Warranty and Maintenance Services


The warranty period is 2 years for this product and 1 year for the main accessories. The
main accessories include: blood oxygen probe and extension cable, ECG cable, blood
pressure cuff and catheter, temperature probe, power cord, stent, and ground wire.
Consumables are disposable materials that should be replaced after each use or
wearing parts that should be replaced periodically. The consumables are not covered by
warranty.
The warranty period is counted from the “Installation Date” filled in the Warranty Card,
which is the only certificate to check the period of warranty. To protect your rights,
please urge your installation personnel to send the second copy of the Warranty Card
to aXcent within 30 days from the date of installation; if the Warranty Card for the
product purchased is not sent to aXcent on time, the warranty period will be calculated
after 45 days from the “Delivery Date” marked on the packing box.
aXcent will be responsible for the safety, reliability and performance of the product if
the following requirements are met:
◼ The product is used in accordance with the Manual.
◼ Product installation, repair and upgrade are carried out by personnel approved or
authorized by aXcent.
◼ The storage, operating and electrical environment meets product specifications.
◼ The S/N label or manufacturer logo of the product is clearly visible, and it is
identified and confirmed that the product is manufactured by aXcent.
◼ The damage is caused by non-human factors (human factors include accidentally
dropping, sabotage, etc.).
The products that meet the warranty regulations can enjoy free service, and the
products beyond the scope of the warranty will be charged for service. The freight
(including customs fees) for transport of this product to aXcent for maintenance is
assumed by the user. For the maintenance due to any reason other than the
abovementioned causes, aXcent will charge for service, and the user needs to pay
additional costs for maintenance and parts.
When the warranty expires, aXcent will continue to provide charged maintenance
services.
If you do not pay or delay the payment of maintenance fees, aXcent will suspend the
repair services until you pay up.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

After-sales Service Unit


Name: aXcent medical GmbH
Address: Josef-Görres-Platz 2, 56068 Koblenz / Germany
Website: www.axcentmedical.com
Email: [email protected]
Tel: +49 2621 620 246 1
Fax: +49 2621 620 246 2

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Preface

Notice
This Manual is the necessary instructions for the safe use of this product. This Manual
introduces the use, properties, method of operation, safety information and intended
use of the PAVO Multi-Parameter Patient Monitor in details. Before using the product,
please carefully read and understand the contents of this Manual and abide by the
method of operation stated in this Manual in order to ensure the safety of patients and
operators.
This Manual is a major component of the product and should always be placed near the
product for easy reference.

Object of Application
This Manual is intended for professional clinical staff or personnel with experience in
the use of monitoring equipment. The readers should have knowledge and work
experience in medical procedures, practices and terminology of patient monitoring.

Illustration
All the illustrations in this Manual are for reference only. The menus, settings and
parameters of the illustrations may be different from the monitor.

Convention
◼ [Character]: Used to represent the string in the software or characters on the
interface.
◼ →: This symbol is used to indicate operation step.

Revision History
This manual has a revision number. This revision number changes whenever the manual
is updated due to software or technical change. Contents of this manual are subject to
change without prior notice.
◼ Revision number: 1.0
◼ Release time : August, 2018

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

CONTENTS

Chapter1 Safety Precautions .................................................................................................... 9


1.1 Warning Marks ........................................................................................................... 9
1.2 Safety Symbols............................................................................................................ 9
1.3 Safety Precautions ...................................................................................................... 9
Chapter2 Device Introduction ................................................................................................ 10
2.1 Overview .................................................................................................................. 10
2.2 View of Device .......................................................................................................... 10
2.2.1. Front View......................................................................................................... 10
2.2.2. Side View .......................................................................................................... 12
2.2.3. Rear View .......................................................................................................... 13
2.3 Hardware Structure .................................................................................................. 13
2.3.1. Main Control Panel ........................................................................................... 14
2.3.2. DC Power Board ................................................................................................ 15
2.3.3. Parameter Board .............................................................................................. 16
2.3.4. Alarm Indicator Board ...................................................................................... 18
2.3.5. Key Board .......................................................................................................... 18
2.3.6. LCD Transfer Board ........................................................................................... 18
2.4 Description of Software Principle............................................................................. 19
2.4.1. Real-time Operating System ............................................................................. 19
2.4.2. Introduction to System Software ..................................................................... 19
Chapter3 Function and Principle ............................................................................................ 21
3.1. Overview .................................................................................................................. 21
3.2. Parameters and Principle ......................................................................................... 21
3.2.1. ECG Parameter.................................................................................................. 21
3.2.2. RESP Parameter ................................................................................................ 21
3.2.3. TEMP Parameter ............................................................................................... 21
3.2.4. NIBP Parameter ................................................................................................ 22
3.2.5. SpO2 Parameter................................................................................................ 22
3.2.6. Infrared Ear Thermometer ............................................................................... 22
Chapter4 Monitor Performance Tests ................................................................................... 23
4.1. System Test .............................................................................................................. 23
4.1.1. Device Appearance ........................................................................................... 23
4.1.2. Start up ............................................................................................................. 23
4.1.3. Device Configuration ........................................................................................ 23
4.1.4. Normal Operation ............................................................................................. 23
4.1.5. Recorder ........................................................................................................... 23

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

4.1.6. Network Function ............................................................................................. 24


4.1.7. Clock.................................................................................................................. 24
4.1.8. ECG Waveform Output ..................................................................................... 24
4.1.9. Factory Maintenance ........................................................................................ 24
4.1.10. Safety Test ........................................................................................................ 24
4.2. Module Performance Tests ...................................................................................... 25
4.2.1. ECG and RESP Test ............................................................................................ 25
4.2.2. SpO2 Test .......................................................................................................... 25
4.2.3. NIBP Test........................................................................................................... 25
4.2.4. TEMP Test ......................................................................................................... 26
4.2.5. Infrared Ear Thermometer Test ........................................................................ 26
Chapter5 Service of Monitor .................................................................................................. 27
5.1. Component disassembly .......................................................................................... 27
5.1.1. Front Shell Exploded View ................................................................................ 27
5.1.2. Rear Shell Exploded View ................................................................................. 28
5.2. Troubleshooting Guide ............................................................................................. 28
5.2.1. Device Failures .................................................................................................. 29
5.2.2. Display Failures ................................................................................................. 29
5.2.3. Power Failures .................................................................................................. 29
5.2.4. Operation Failures ............................................................................................ 30
5.2.5. Parameter Failures............................................................................................ 30
Chapter6 Installation .............................................................................................................. 32
6.1. Check Device Packing ............................................................................................... 32
6.2. Preparation............................................................................................................... 32
6.3. Power Supply Connection ........................................................................................ 32
6.4. Other Precautions .................................................................................................... 32
Chapter7 Basic Operations ..................................................................................................... 33
7.1. Rotary Knob .............................................................................................................. 33
7.2. Keys .......................................................................................................................... 33
7.3. Touch Screen ............................................................................................................ 33
7.4. Soft Keyboard ........................................................................................................... 33
7.5. Menu ........................................................................................................................ 33
7.6. Working Modes ........................................................................................................ 34
7.6.1. Measurement Setup ......................................................................................... 35
7.6.2. Freeze Waveform ............................................................................................. 35
7.7. Other Settings........................................................................................................... 35
7.7.1. Definition .......................................................................................................... 35
7.7.2. Language Setup................................................................................................. 36

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

7.7.3. Date and Time................................................................................................... 36


7.7.4. Volume Control................................................................................................. 36
7.7.5. Unit Setup ......................................................................................................... 37
Chapter8 Cleaning .................................................................................................................. 38
8.1. Cleaning .................................................................................................................... 38
8.2. Sterilization............................................................................................................... 38
8.3. Disinfection............................................................................................................... 38
Chapter9 Maintenance .......................................................................................................... 39
Chapter10Accessories ............................................................................................................. 40
Chapter11Residual Risks ......................................................................................................... 40
Appendix A Alarm Information................................................................................................ 41
A1. Physiological Alarm Messages.................................................................................. 41
A2. Technical Alarm Messages ....................................................................................... 43

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Chapter1 Safety Precautions


1.1 Warning Marks
The warning marks used in this manual, including DANGER, WARNING and CAUTION
involve safety and other important instructions. The warning marks and their respective
meanings are listed below. You need to clearly understand their meanings before reading
this manual.
Warning Mark Meaning
Indicates an imminently hazardous situation which, if not avoided, will
DANGER result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, could
WARNING result in death or serious injury.
Indicates a potentially hazardous situation which, if not avoided, may
NOTE result in minor or moderate injury.
Indicates a potentially hazardous situation which, if not avoided, may
CAUTION result in property damage.

1.2 Safety Symbols


Symbol Meaning
Type BF Applied Part
* Type BF when a type BF part is connected
“Attention” (Please refer to the Operating Manual)

1.3 Safety Precautions


For the sake of patients and operators’ safety, please observe the following precautions when
using this device.

DANGER: DO NOT use flammable gases (e.g. anesthetics) or flammable liquids (e.g.
ethanol) near this product in order to avoid the risk of explosion.

WARNING: Please connect the device to a socket with a separate fuse box as its
protection switch. If other equipment (e.g. life support equipment) uses the same fuse box
as the protection switch, malfunction or overcurrent of the device or instant surge current
upon startup may result in tripping.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Chapter2 Device Introduction


2.1 Overview
This monitor is suitable for bedside monitoring of adults and children. It can be used to
monitor electrocardiogram (ECG), respiration (RESP), pulse rate (PR), blood oxygen
saturation (SPO2), non-invasive blood pressure (NIBP) and body temperature (TEMP).
This monitor is equipped with a replaceable built-in battery, which facilitates patients’
movement in the hospital.
The PAVO monitor can be used for monitoring:
ECG: Heart rate;
7-lead full screen
(display of one ECG waveform by default)
Arrhythmia analysis and ST segment analysis
RESP: Respiratory rate (RR) and respiratory waveform;
SpO2: blood oxygen saturation (SpO2), pulse rate (PR);
NIBP: Systolic pressure (Sys) , Diastolic pressure (Dia), Mean pressure (Mean).
The PAVO monitor provides different configurations depending on user needs:
Basic configuration: SpO2+PR+NIBP
Optional configuration: TEMP (Infrared Ear Thermometer), TEMP (1 channel), ECG, RESP,
CO2, Printer
Screen size: 8.4”

2.2 View of Device


2.2.1. Front View

Fig. 2-1 Front View

1. Power on / off button(①)

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

◼ Power on: When the monitor has been connected to AC power


supply, press this key to turn on the monitor.
◼ Power off: In power on state, press and hold this key for two
seconds to turn off the monitor.
◼ The key integrates indicator, which is lit when the monitor is turned
on and off when the monitor is turned off.
2. Battery indicator(②)
◼ On: The battery is being charged or has been fully charged.
◼ Off: The battery has not been installed, or the battery has been
installed but the AC power is not connected and the monitor is not
turned on.
◼ Flashing: The monitor is being powered by the battery.
3. Adaptor indicator(③)
◼ On: The monitor has been connected to AC adaptor
◼ Off: The monitor has not been connected to AC adaptor
4. Silence key(④): Press this key to turn off/resume the alarm sound of the
system.
5. Freeze key or print key(⑤):
◼ Presss this key to start/stop printing waveform or data.
◼ Press this key to freeze / unfreeze the wave.
6. NIBP measurement start / stop key(⑥): Press this key to start / stop the
measurement of non-invasive blood pressure.
7. Admitting patient or menu(⑦)
◼ Admitting a patient key: Press to pop-up quick admitting patient
menu.
◼ Menu: Press to pop-up “menu”
8. Display(⑧)
9. Shuttle(⑨)
Shuttle can be used to perform the following operations:
◼ Rotate: Rotate clockwise or counterclockwise to move the focus.
◼ Press: Press the knob to perform an action, such as access to a menu
or execute a command.
10. Alarm indicator(⑩)
The alarm indicator indicates the levels of physiological alarms and technical
alarms in different colors and flashing frequencies:
◼ High: red, fast flashes
◼ Medium: yellow, slow flashes
◼ Low: yellow, lit without flashing.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.2.2. Side View

Fig. 2-2 Side View

1. Temp —— Temperature probe interface ①


2. ECG —— ECG cable interface ②
3. SpO2 or CO2 —— SpO2 cable interface ③: could connected to Masimo
SpO2, Standard SpO2 or CO2 module
4. NIBP —— NIBP cuff interface ④
5. Printer or printer plate ⑤: Could install a printer (optional).

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.2.3. Rear View

Fig. 2-3 Rear View

1. Equipotential terminal: When other devices are used in conjunction with the
monitor, you should connect the equipotential terminals of other devices
and the monitor with wires to eliminate the ground potential difference
between different devices and ensure safety.
2. AC adaptor socket: connect to AC adaptor: 16.8V, 1A, charge the battery of
the monitor.
3. USB interfaces (2): Connect an external storage device to upgrade the
monitor software.
4. Network interface
5. Signal input and output interface: standard DB9 interface, which can be
connected to the PC to output data or connected with a compatible device.
6. Speaker holes
7. Spiracle

2.3 Hardware Structure


The hardware board consists of main control panel, DC power board, parameter module,
alarm indicator board, key board and LCD transfer board. The following section briefly
introduces the basic functions and operating principle of each part.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.3.1. Main Control Panel

J71 J76 J18

J72

J4

J1

J19
J8

J7
J23

BAT71

J13
J20 J9
Fig. 2-4 Main Control Panel

No. Port Function Description No. Port Function Description


Name Name
1 J1 J1 port connects Infrared Ear 8 J7 J7 port connects ECG
Thermometer module
2 J4 J4 port connects Speaker 9 J13 J13 port is a serial port for
debugging
3 J72 J72 port connects Touch 10 J20 J20 port connects printer
screen
4 J18 J18 port connects USB0 11 J9 J9 port connects NIBP
module
5 J76 J76 port connects USB1 12 BAT71 BAT71 is for button battery
6 J71 J71 port is for power input 13 J23 J23 port connects LCD
transfer board
7 J8 J8 port connects SPO2 14 J19 J19 port connects keyboard
module

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.3.2. DC Power Board

J2 J7
J1

J4

J5

J4

Fig.2-5 DC Power Board

No. Port Name Function Description


1 J1 J1 port connects Key Board
2 J2 J2 port connects switch power
3 J3 J3 port connects power port J71 of main control panel
4 J4 Reserved
5 J5 Reserved
6 J7 J7 port connects lithium battery board

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.3.3. Parameter Board

J3 J4

J5

J6

J2 J1
Fig. 2-6 Integrate Parameter Board

No. Port Name Function Description


1 J1 J1 port connect to TEMP interface board
2 J2 J2 port connects air pump
3 J3 J3 port connects and communicates with main
control panel J7
4 J4 J4 port connects and communicates with main
control panel J9
5 J5 Reserved
6 J6 J6 port connect to ECG interface board

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

J2

J1

Fig. 2-7 Spo2 Parameter Board

No. Port Name Function Description


1 J1 J1 port connects and communicates with main
control panel J8
2 J2 J2 port connect to SpO2 interface board

Fig. 2-8 Infrared Ear Thermometer Module

No. Port Name Function Description


1 ① Probe Cover
2 ② Battery Cover
3 ③ LCD Screen
4 ④ Battery cover hole
5 ⑤ ON/OFF button
6 ⑥ Membrane
7 ⑦ Probe lens
8 ⑧ Probe
9 ⑨ Probe (diameter =5.9mm)
10 ⑩ Measure key

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.3.4. Alarm Indicator Board

J1 Fig. 2-9 Alarm Indicator Board

No. Port Name Function Description


1 J1 J1 port connects key board
J2

2.3.5. Key Board

J4 J5 J3

Fig.2-10 Key Board

J1
No. Port Name Function Description
1 J1 Rotary Knob
2 J3 J3 port connects power board
3 J4 J4 port connects alarm indicator board J1
4 J5 J5 port connects and communicates with
main control panel J19

2.3.6. LCD Transfer Board


J2

Fig. 2-11 LCD transfer Board


J1
No. Port Name Function Description
1 J1 J1 port connects and communicates with
main control panel J23
2 J2 J2 port connects LCD screen

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.4 Description of Software Principle


2.4.1. Real-time Operating System
This system is an embedded real-time multitasking system supported by a real-time
operating system. That is to say, the system consists of two parts: real-time multitasking
operating system and application program.
Features:
1. Real-time capability
2. Asynchronous event responsiveness
3. Management capability interruption
4. Definite switching time and interrupt latency
5. Preemptive scheduling
Functions: The operating system mainly fulfills task switching, task scheduling, inter-
task communication, synchronization, mutual exclusion, real-time clock management,
and interrupt management.

2.4.2. Introduction to System Software


2.4.2.1. Data Flow Diagram

Sensor

Analog circuit
processing

Sending to the main unit


via serial port

Data sorting

Waveform Module info Patient info System info


data area

Status data Parameter Data


area data area processing

Trend data Alarm info

Display Front panel

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

2.4.2.2. Task Partitioning


1. Data Sorting Task
2. Data Processing Task
3. Arrhythmia Analysis Task
4. Interface Processing Task
5. Control Command Sending Task
6. Periodic Waveform Refreshing Task

2.4.2.3. Inter-task Interface


Queue, Pipeline, Event, Message Box, Semaphore

2.4.2.4. Task Design


1. Data Sorting Task: Mainly restore data received from the serial port to original real
data, and put them in the corresponding data area, e.g. waveform data area,
parameter data area, and status data area.
2. Data Processing Task: Mainly compute parameters and discriminate alarms; in the
event of an alarm, an alarm data area will be formed, and a trend database will be
formed at the same time.
3. Arrhythmia Analysis Task: Analyze arrhythmia; store arrhythmia waveforms and
corresponding information.
4. Interface Processing Task: Fulfill man-machine interaction events, and handle system
failure events. Mainly pop up various menus, modify alarm limits of various
parameters, select alarm switch status and other options, set system functions and
patient info, display historical data of ARR and EVENT and trend data, draw
measured CO waveforms, drive the Control Command Sending Task and Recorder
Task, etc.
5. Control Command Sending Task: Send various commands, such as power-on self-test,
multifunction board switch lead, gain change, waveform change, NIBP measurement
start and stop, sending alarm message to panel, and voice message.
6. Periodic Waveform Refreshing Task: Refresh various waveforms periodically.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Chapter3 Function and Principle


3.1. Overview
The PAVO monitor takes parameter modules as the basic units to acquire signals; the
results are sent to the main control board via the adapter board, thus to realize
processing and display of data and waveforms. Commands from the main control board
and status information of modules are also transmitted via the adapter board. Besides,
the adapter board achieves power adaptation and conversion. Below is the structure of
the entire system:

Medical worker

Button Display Recorder


board
Power Main control Network
supply panel port

SPO2 Patient ECG/


RESP

3.2. Parameters and Principle


The four parameter modules respectively achieve real-time monitoring of NIBP, SpO2,
and ECG/RESP/TEMP via cuff and measurement cable. The results are sent to the main
control board for processing and display and will also be transmitted to the thermo-
sensitive recorder for outputting and printing when necessary.

3.2.1. ECG Parameter


The ECG parameter of PAVO has the following functions:
1). Lead type: 3-lead, 5-lead, 12-lead
2). ST segment analysis, arrhythmia analysis
3). Identification and judgment of ECG electrode off status

3.2.2. RESP Parameter


The PAVO monitor performs respiration measurement based on the principle of
impedance method. When a man breathes, his/her chest will move up and down, which
is equivalent to the impedance change between RL and LL. The high-frequency signal
passing through the ECG electrodes RL and LL is converted to a high-frequency
amplitude-modulated signal. After this signal is detected and amplified, it changes with
respiration and is output and sent to the analog-digital converter. The RESP parameter
module consists of respiratory circuit board and coupling transformer. The circuit
comprises oscillation, coupling, detection, first amplification and high-gain amplification
sections.

3.2.3. TEMP Parameter


Temperature measurement involves conversion of body temperature to an electric
signal via the sensor used; this signal is amplified by the amplifier and then undergoes
data processing.

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3.2.4. NIBP Parameter


NIBP measurement is based on the principle of oscillation method. Inflate the cuff
around the upper arm until the pressure generated by the cuff inhibits the flow of
arterial blood in the upper arm. Then, gradually deflate the cuff according to certain
algorithm requirements. As the cuff pressure reduces, the arterial blood generates
pulsation in the cuff as the artery pulsates. The pressure sensor connected to the cuff
inflating pipeline detects the pulsation and generates a signal. Use a high-pass filter
(about 1HZ) to filter the fluctuation signal and amplify it. This signal is converted to a
digital value through the A/D converter. After processing by the microcontroller,
systolic pressure, diastolic pressure and mean pressure can be obtained. For neonates,
children and adults, fitting cuffs should be chosen in order to avoid measurement error.
There is also a protection circuit for NIBP measurement, which can prevent excessively
high inflation pressure. Main working modes of NIBP measurement include:
1. Selection among Adult, Child and Neonate modes: Select according to each patient’s
figure, weight and age.
2. Selection among Manual Measurement, Auto Measurement and Continuous
Measurement working modes. Manual measurement is also known as single
measurement. Only one measurement is performed after each start. Auto
measurement can be performed once automatically in the selected period, and the
time interval can be selected among 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120, 240 and 480
min. When continuous measurement is enabled, fast continuous measurement will be
performed within five minutes, which can realize efficient detection of changes in blood
pressure.

3.2.5. SpO2 Parameter


SpO2 is obtained by tracing pulse waves such as fingertip waves, applying certain
algorithm and consulting clinical data. The SpO2 probe is a measurement sensor in
which two light-emitting diodes and one photocell component are built.

3.2.6. Infrared Ear Thermometer


The ear thermometer measures the infrared heat created by the eardrum and
surrounding tissues, converting this temperature into an oral equivalent. The infrared
energy falls on a thin pyroelectric crystal which develops a charge proportional to that
collected energy. Discharging the crystal sends a current pulse through filters and
conversion circuits which compare the signal to tabulated data on temperature and
calculate a body temperature for the display.
This kind of temperature from the eardrum has been found to be a clinically reliable
indicator of body core temperature. The eardrum is located close to the hypothalamus,
which is the body's temperature regulator. The membrane itself is thin and almost
transparent in the visible, so you would presume that it reliably tracks the temperature
inside the membrane so that the infrared energy it emits gives a good indication of the
inside temperature.

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aXcent medical GmbH PAVO | Instructions for Maintenance Ver.: 1.0

Chapter4 Monitor Performance Tests


4.1. System Test
For details on routine tests of the PAVO series patient monitor, please refer to the
PAVO Instructions for Use, and no detailed description will be provided in this manual.
The following information only gives key test points and contents not clarified in the
foresaid User Manual.

4.1.1. Device Appearance


1. Confirm that the housing is clean without scratches and the device is firmly
assembled, and that there is no residue inside the device when shaking it.
2. Make sure that the keys feel good when operated.
3. Confirm that all necessary signs are present with correct content.
4. Make sure that standard configuration is complete and the sockets are installed
tightly.
5. Perform a vibration test on the device before the following operational tests.

4.1.2. Start up
After startup, check if the monitor works normally and if the screen displays
information normally without showing any error message. Check all of the four
waveforms (three waveforms if the lead type in the “Factory Setup” menu is 3-lead) to
see if they can be scanned normally; check if the parameters are refreshed every
second and if the clock works normally.

4.1.3. Device Configuration


Some settings can be configurable in the “Factory Setup” menu if the monitor model is
user-defined. Such settings include recorder ON/OFF status, selection of ECG lead type,
setting of network bed number, arrhythmia analysis ON/OFF status.

4.1.4. Normal Operation


1. Operate each key. The monitor should act or respond normally as required by the
Instructions for Use, and abnormal operations should not result in system crash.
2. Rotate and press the knob. The monitor should act or respond normally as required
by the Instructions for Use, and abnormal operations should not result in system
crash.
3. Operate the monitor according to the Instructions for Use. Check if the key tone and
each level of sound-light alarm are normal, if volume control is normal, and if the
alarm mute and alarm off functions can work.
4. Check the working condition of the recorder.

4.1.5. Recorder
The recorder should record according to the conditions and contents stated in the
Instructions for Use, including
1. Record correct information that is consistent with the on-screen waveforms or other
recorded contents.
2. Stop immediately when the Stop key is pressed during recording.
3. There will be corresponding prompt message on the screen in abnormal situations
such as “Out of Paper”; it will continue working normally after paper loading.
4. Correct prompt messages will be given in case of hardware failure of the recorder.
5. It can work normally for a long period of time without paper jam problem.
6. During paper loading, the auto feed function of the recorder should be normal.

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4.1.6. Network Function


Network connection should be successful and bed number should be displayed
correctly no matter whether it is the center station or the bedside machine that is
started first.
The PAVO patient monitor and the center station can receive and transmit data
normally.
The center station can correctly receive waveform parameters, alarm levels, alarm
limits, ARR events and patient info.
The alarm levels, alarm limits and patient info sent back from the center station should
be correct.
After the PAVO patient monitor is shut down, the center station can respond correctly.
See relevant technical indicators for the required time.
After the network is disconnected from certain connection process, the center station
can correctly indicate that the bed is off. After reconnection, network will be connected
and the device can work normally. See relevant technical indicators for the required
time.

4.1.7. Clock
Correct indication, accurate timing, no abrupt change, and no stop.

4.1.8. ECG Waveform Output


Connect the monitor with ECG leads and simulator; connect the D/A output port (at the
rear of the housing) to an oscilloscope (general purpose oscilloscope); select the 5V and
1V positions, respectively. Compare the waveforms respectively from the oscilloscope
and the monitor to confirm that the output signal is normal.

4.1.9. Factory Maintenance


All menus, except the “Factory Setup” menu, are set according to the values obtained at
the first time of software loading.

4.1.10. Safety Test


1. Protective earthing resistance test
The resistance between the earth terminal of network power socket and the
equipotential earth terminal should be less than 0.1Ω.
The resistance between the earth terminal of network power cable and the
equipotential earth terminal should be less than 0.2Ω.
2. Earth leakage current test
Normal situation: When the live wire and neutral wire of network power supply
short-circuits, the current between which and the earth wire should be less than
0.5mA if voltage of an effective value as 250V is applied.
Single fault situation: The current is less than 1.0mA when voltage of an effective
value as 250V is applied between the live and earth wires of network power supply.
3. Patient leakage current test: There are three monitoring parameters, including ECG,
SpO2 and TEMP. Here, ECG will be described as an example:
Under normal conditions, connect all ECG lead wires together; the current should be
less than 10uA when voltage of an effective value as 250V is applied between the
connected wires and the ground.

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4.2. Module Performance Tests


The following tests and calibrations of parameters are performed in order to ensure the
accuracy of PAVO patient monitor. Calibration should be carried out at least once a year.
All parameters of the device should be recalibrated each time after service.

4.2.1. ECG and RESP Test


1. Test tool
Simulator of physiological signals from human body
2. Test steps:
Use the measuring cable to connect the simulator to the ECG socket on the PAVO
patient monitor.
Confirm that the number of ECG waveform on the screen is identical to that selected
in the ECG module menu and the factory menu.
In default configuration, II is selected for ECG1 lead, and I for ECG2 lead (if ECG2 is
present).
Confirm that the ECG and RESP waveforms are displayed normally.
Set the parameter values of the simulator as follows:
HR=30 (gain × 4)
RR=15
Check if the ECG and RESP waveforms and the values of HR and RR displayed are
correct.
Change the simulator configuration:
HR=240
RR=120
Check if the ECG and RESP waveforms and the values of HR and RR are consistent
with the parameter values set for the simulator.
Take the ECG lead off. In such case, the PAVO patient monitor should report the
situation immediately.

4.2.2. SpO2 Test


1. Test tool
SpO2 simulator
2. Test steps
A. Connect the SpO2 simulator to the SpO2 port on the PAVO patient monitor.
B. Set the parameter values of the SpO2 simulator as follows:
SpO2=98
PR=70
C. Check if the values of SpO2 and PR displayed on the screen of PAVO patient
monitor are consistent with those from the simulator.
(Note: To observe the PR value, “PLETH” must be selected as the heart rate source in
the ECG menu.)
D. Change the set values of SpO2 and PR in the SpO2 simulator.
E. Check if the values displayed on the screen of PAVO patient monitor are identical
to the set values.
F. Take the SpO2 probe off. In such case, the PAVO patient monitor should report
“Probe off” immediately.

4.2.3. NIBP Test


1. Test tool
NIBP simulator
2. Test steps

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Use a NIBP simulator with calibration function. Carry out calibration according to the
calibration method specified in the Instructions for Use and judge the measurement
accuracy of BP pump. Perform the following test if the calibration result is OK:
A. Select Adult mode on both the simulator and the monitor.
B. Select a set of BP values within the measurement range on the NIBP simulator.
For example:
NS=90
NM=70
ND=60
C. Check if the result measured by the PAVO patient monitor is identical to that set
on the simulator.
D. Change the BP value set on the simulator, and carry out measurement again.
E. Check if the measured result is identical to the set value.

4.2.4. TEMP Test


1. Test tool
Simulator of physiological signals from human body
2. Test steps
A. Connect one end of the temperature sensor to the simulator and the other end to
the TEMP socket on the PAVO patient monitor.
Set the value on the simulator: TEMP=34℃.
Check if the TEMP value displayed on the screen of PAVO patient monitor is 34℃.
Change the set value on the simulator: TEMP=40℃.
Check if the TEMP value displayed on the screen of PAVO patient monitor is 40℃.

4.2.5. Infrared Ear Thermometer Test


1. Test Tool
None
2. Test steps
A. Turn on the Infrared Ear Thermometer.
B. Put the probe into a healthy adult’s ear, nearby the eardrum.
C. Press the Measure Key on the infrared ear thermometer.
D. Check the Temperature Value displayed on the screen of PAVO monitor is within
36.3~37.5℃.

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Chapter5 Service of Monitor


5.1. Component disassembly
5.1.1. Front Shell Exploded View

Parts List:
No. Name or Specification No. Name or Specification
1 Front shell of PAVO 9 LCD transfer board
2 Touch screen 10 Alarm lens
3 LCD screen pressing plate 11 Alarm indicator board
4 Function key 12 Article waterproof silicone(vertical)
5 LCD screen 13 Article waterproof
silicone( horizontal)
6 Key board 14 LED dustproof trim strip(vertical)
7 Main board 15 LED dustproof trim strip(horizontal)
8 Rotary cap 16

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5.1.2. Rear Shell Exploded View

Parts List:
No. Name or Specification No. Name or Specification
1 Rear shell of PAVO 14 Recorder Cover
2 Metal plate 15 CO2 label
3 Monitoring plug-in assembly 16 Recorder cover fixing bracket
4 Network port assembly 17 ECG/NIBP Board fixing bracket
5 Speaker trim strip 18 ECG Board
6 Earth terminal 19 Battery box
7 Screw plug (horizontal) 20 Battery with four core
8 Earth terminal fixed leg 21 SD Card hole label
9 Battery Cover 22 Power board
10 Data port label 23 NIBP Board
11 Silicon floor mat 24 SpO2 board

5.2. Troubleshooting Guide


During transportation, storage and use, malfunction of the PAVO patient monitor may
occur due to various factors (e.g. unstable grid voltage, change in ambient temperature,
drop and impact, component ageing), which will affect normal use of the device. In such
case, specialized persons with certain experience in repairing electronic medical devices
should be asked to conduct part-level service according to the following classification of
failures. The “part-level service” mentioned here refers to analysis, replacement and
commissioning of parts; identify failure parts of the device, such as power board, main
control board, TFT assembly, measuring cable and parameter module. Repair of parts
and components shall be performed by experienced repair engineers dispatched by the
manufacturer with special instruments and devices under certain environment and
conditions.

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5.2.1. Device Failures


Symptom Possible Cause Solution
There is no display upon startup; ① Damage of fuse ① Replace the fuse
the power indicator does not ② Damage of power supply ② Replace the power
come on, and the fan does not ③ Short circuit of other supply
work component ③ Confirm the short-
circuited component

There is no display upon startup Fault of main control board or Refer to the “Display
or black screen occurs during display Failures” section
operation; but the power
indicator is on, and the fan works
normally
Character display is normal, but Error of data communication Replace the main
the waveform is shown between main control board control board, adapter
intermittently and parameter module plate or parameter
module according to
the error message, so
as to confirm the
failure.
Some operation or measurement Damage of main control board Further check the main
function is invalid or corresponding component control board and the
corresponding
component
Occasional system crash Strong instant interference of Check the power
power grid supply and earthing
Poor performance of power system
board Replace the power
Poor performance of main board
control board Replace the main
Connection problem of power control board
supply and main control board Replace or repair the
connector

5.2.2. Display Failures


Symptom Possible Cause Solution
The power supply for startup Damage of backlight board Connect the external VGA
is normal, but there is no display to confirm the failure
task display or black screen Problem of connecting cable Repair or replace the
occurs during normal of display connecting cable
working Damage of main control Replace the main control
board board

5.2.3. Power Failures


Symptom Possible Cause Solution
The fuse is blown upon Short circuit of power supply Start the device for further
startup or other part check
The fuse is still blown when Power failure Replace the power supply
all loads are disconnected
The fuse is blown when a Damage of this component Replace this component

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component is connected
The power indicator and the Damage of +12V DC power Replace the power supply
main control board indicator supply
come on, but the fan does
not work and the adapter
plate indicator is not on
The power indicator and the Damage of +5V DC power Replace the power supply
main control board indicator supply
are not on, but the fan works
normally and the adapter
plate indicator is on

5.2.4. Operation Failures


Symptom Possible Cause Solution
Malfunction of key or rotary ① Damage of key board or ① Replace the key board or
encoder rotary encoder rotary encoder
② Problem of connecting ② Replace or repair the
cable of key board connecting cable of key
board
Sound rustiness or ① Problem of key board ① Replace the key board
malfunction ② Problem of speaker or ② Replace the speaker or
connecting cable connecting cable

5.2.5. Parameter Failures


Symptom Possible Cause Solution
Poor contact of ECG electrode Use new electrode to ensure
No ECG waveform No square wave after CAL self- good contact
test Replace the ECG/RESP module
Suspension of RL electrode Connect the RL electrode
Damage of ECG/RESP module Replace the ECG/RESP module
Abnormal ECG ① Wrong electrode connection ① Connect the measuring
waveform or existence ② Presence of suspended electrode correctly
of interference electrode ② Remove unused electrode
No ECG waveform ③ Use 3-wire power supply
Abnormal ECG waveform or ④ Select a moderate filtering
existence of interference mode
③ No earth wire for AC power ⑤ Replace the ECG/RESP
supply module
④ Incorrect selection of ECG
filtering mode
⑤ Problem of ECG/RESP module
No RESP wave or ① Poor electrode connection ① Use RL-LL electrode;
abnormal RESP wave No RESP wave or abnormal RESP ensure correct connection
wave position
② Frequent motion of patient ② Keep the patient quiet
③ Problem of ECG/RESP module ③ Replace the ECG/RESP
module
Inaccurate measured Poor connection of measuring Connect and fix the TEMP

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value of TEMP probe probe


Inaccurate heart rate, Problem of measured ECG Adjust the connection to make
wrong arrhythmia and waveform the measured waveform
ST segment analysis normal
NIBP inflation failure Folding or leakage of gas line Adjust or repair the gas line
Occasional failure to Loosening of cuff or movement of Keep the patient still; properly
detect blood pressure patient wrap the cuff
Big error in blood ① Unsuitable cuff size ① Select a proper cuff size
pressure measurement ② Problem of NIBP module ② Replace the NIBP module
No SpO2 waveform Damage of probe or SpO2 Replace the probe to confirm
module the failure
Strong interference in ① Patient is in motion ① Keep the patient silent
SpO2 waveform ② Ambient light is too strong ② Weaken the ambient light
Inaccurate measured Patient is injected with colorant Eliminate the existence of
value of SpO2 colorant before measurement

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Chapter6 Installation
6.1. Check Device Packing
Unpack the device and take out the packing list. Check the names, quantities and
specifications of the items inside the packing box one by one to see if they are
consistent with those listed in the packing list. Note the following points:
1. Optional parts or other accessories (if any) purchased by the user should also be
checked item by item.
2. If items in the packing box are not consistent with those listed in the packing list,
please contact the supplier immediately.
3. In case of any damage during transportation, please properly keep the package for
further check and meanwhile contact the supplier immediately.

6.2. Preparation
Before connecting the three-core power cable to the power socket on the main unit of
PAVO patient monitor, please first conduct the following checks:
1. Check if the grid voltage meets the device requirement.
2. In order to protect patients and medical workers, a three-core power cable should
be used for the monitor, and the power socket should be a matching three-pin
socket, so as to ensure good earthing condition of the monitor. DO NOT use two-
core AC power supply.
3. When the monitor is used simultaneously with other medical device, the
equipotential terminal at the rear of the monitor should be reliably connected to the
equipotential terminal on the said other device in the hospital.
4. DO NOT place the monitor under an infusion bag or at a position with liquid leakage.
Care should also be taken to prevent any type of liquid from flowing into the
monitor.

6.3. Power Supply Connection


1. Insert the three-pin power plug into the AC power socket.
2. Press the power key on the monitor panel to turn on the device. Wait for about 10s;
the screen will show the startup picture and then display the waveform scanning
lines and data.

6.4. Other Precautions


When the monitor is used simultaneously with other medical device, please absolutely
observe the applicable requirements on power distribution for medical devices in order
to prevent superimposed leakage current among devices from endangering patients or
medical workers.

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Chapter7 Basic Operations


7.1. Rotary Knob
The rotary knob can be:
◼ Rotated: Rotate the knob clockwise or counter-clockwise to move the focal point.
◼ Pressed: Press the knob to execute some operation, for example, accessing a menu
or executing a command.
The rotary knob is the main control knob. In the interface or menu, the green highlight
box that moves with the rotation of the knob is called as “cursor”. The cursor can be
located by turning the knob, which will facilitate execution of the intended operation.

7.2. Keys
There are three types of keys on the monitor:
◼ Soft keys: Positions in the interface where the cursor can stay, enabling you to
quickly and conveniently access a menu or execute an operation. These keys mainly
include:
◆ Parameter hotkeys: Select a parameter area to access the corresponding
parameter setup menu.
◆ Waveform hotkeys: Select a waveform area to access the corresponding
parameter setup menu.
◆ Smart hotkeys: These are shortcut keys located at the bottom of the main screen,
which enable quick operations by the user. See the “Smart Hotkeys” section.
◼ Hard keys: They are tangible keys on the monitor, such as the Alarm and Mute keys
on the front panel.
◼ Popup keys: They are menu keys relating to tasks, which will appear on the screen of
the monitor when necessary. For example, the popup confirmation keys when you
need to confirm a change.

7.3. Touch Screen


Directly tap the touch screen to complete some operations quickly and conveniently.

7.4. Soft Keyboard


When tapping an editable box, the system will show a soft keyboard at the top of the
screen to facilitate your entry. You can enter information by turning the rotary knob or
tapping on the touch screen to select the required characters one by one. Press the
Back key to delete a single character; press the Enter key to confirm that you have
finished entry and close the soft keyboard.

7.5. Menu
Select [Menu] in the monitor interface by turning the rotary knob or directly
tapping on the touch screen, and open the [Main Menu] as shown in the figure below.
You can complete most operations and settings on the Main Menu.

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Menu Close
title

Main display
area of menu

Fig.7-1 [Main Menu]

The form of other menus is basically similar to that of [Main Menu]. A menu generally
consists of the following parts:
◼ Menu title: This summarizes the current menu.
◼ Close: It is used to close the current menu; you can exit the current menu or close
the current menu and go back to the previous menu.
◼ Main display area: This area displays options, buttons, prompt messages, etc.; “>>”
means that you can access the corresponding submenu by selecting this option.
◼ Confirmation button area: There is a confirmation button area in some menus. It is
used to confirm menu operations; there are mainly two buttons: OK and Cancel.

7.6. Working Modes


The monitor has two working modes, of which, the Demo mode is password-protected.
1. Monitoring mode (working mode)
This is the routine working mode for patient monitoring. Depending on the patient, you
can change some settings such as the alarm limit. However, when the patient is
discharged, the monitor will restore these settings to their defaults according to the
preset default configuration.
2. Demo mode
This mode is password-protected (default password: “8888”) and is only for
demonstration purpose.
◼ Enter the Demo mode:

◆ Select the [Menu] smart hotkey → [Main Menu];

◆ Select [Demo>>] → Enter and confirm the password, and the monitor will
enter the Demo mode.
◼ Exit the Demo mode:

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◆ Select the [Menu] smart hotkey → [Main Menu];

◆ Select [ExitDemo>>], and the monitor will exit the Demo mode.

WARNING
⚫ The Demo function is only used for demonstration of device performance and for
user training. In actual clinical applications, use of the Demo function should be
forbidden in order to prevent medical workers from mistaking the information
displayed on the monitor for waveform and parameters of the patient under
monitoring; such mistake will affect patient monitoring and delay disease treatment.

7.6.1. Measurement Setup


This section only introduces general settings for waveform measurement in the
Monitoring mode; as to details of other function settings for parameters, please see the
corresponding sections.
Tap on the waveform area of a certain parameter to enter the corresponding setup
menu. The setup menu defines the detailed waveform settings for this parameter, such
as wave gain and wave velocity. You can separately set different parameter waveforms
as needed.

7.6.2. Freeze Waveform


During monitoring of a patient, you can freeze the waveform on the screen and then
have a review so as to observe the condition of this patient during this period. The
Freeze/Defreeze operation is described as follows:
Select the Freeze smart hotkey to freeze the waveform displayed on the monitor.
Tap the Freeze smart hotkey to defreeze the waveform.

7.7. Other Settings


Common settings of the monitor refer to those general settings that define how the
monitor works, such as setting of alarm volume. These settings often can affect several
measurements or several settings on the display interface.

7.7.1. Definition
When the monitor is installed or when the monitor is used for a new application, the
monitor should be defined as follows:

◼ Select the [Menu] smart hotkey → [Main Menu];

◼ Select [User Maintenance>>] → Enter and confirm the password → [User


Maintenance] menu;
◆ Select [Device Name]: Enter the device name by using the soft keyboard on the
screen.
◆ Select [Department]: Enter the device user department and division by using the
soft keyboard on the screen.
◆ Select [Bed No.]: Enter the bed number by using the soft keyboard on the screen.

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7.7.2. Language Setup


Set the language on the monitor according to the following steps:

◼ Select the [Menu] smart hotkey → [Main Menu];

◼ Select [User Maintenance>>] → Enter and confirm the password → [User


Maintenance] menu;
◼ Select [Language]; select the language as per your need:
◆ [English]: Set the monitor interface language to English.
◆ [Spanish]: Set the monitor interface language to Spanish.

7.7.3. Date and Time


Set the time on the monitor according to the following steps:

◼ Select the [Menu] smart hotkey → [Main Menu];

◼ Select [User Maintenance>>] → Enter and confirm the password → [User


Maintenance] menu;
◼ Select [Time Setup>>] → Enter [Time Setup] menu;
◼ Select [Date Format]; set the date format as per your preference:
◆ [YYYY-MM-DD]: Year-Month-Day
◆ [MM-DD-YYYY]: Month-Day-Year
◆ [DD-MM-YYYY]: Day-Month-Year
◼ [Date]: Set the Year, Month and Day.
◼ [Time]: Set the Hour, Minute and Second.

7.7.4. Volume Control


1. Alarm Volume
◼ Select the Vol.Set smart hotkey → [Volume Setup] menu;
◼ Select [Alarm Vol]: Set [Y]. The value of Y is in the range of X~9; X is the minimum
volume; the value of Y increases/decreases by 1 every time the rotary knob is
rotated.
2. Key Volume
◼ Select the Vol.Set smart hotkey → [Volume Setup] menu;
◼ Select [Key Volume]: [N]. The value of N is in the range of 0~9; the value
increases/decreases by 1 every time the rotary knob is rotated. Select 0 to turn off
the key volume; select 9 to set the key volume to the maximum.
3. QRS Volume
Select the Vol.Set smart hotkey → [Volume Setup] menu;
Select [QRS Volume]: [M]. The value of M is in the range of 0~9; the value
increases/decreases by 1 every time the rotary knob is turned. Select 0 to turn off the
volume; select 9 to set the volume to the maximum.

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7.7.5. Unit Setup


You can select units as per your preference according to the following steps:

◼ Select the [Menu] smart hotkey → [Main Menu];

◼ Select [User Maintenance>>] → Enter and confirm the current password → [User
Maintenance] menu;
◼ Select [Unit Setup>>] → [Unit Setup] menu;
◆ Select [Height]; select the unit [cm]/[inch] as needed.
◆ Select [Weight Unit]; select the unit [kg]/[lb] as needed.
◆ Select [Press.Unit]; select the unit [mmHg]/[kPa] as needed.
◆ Select [Temp Unit]; select the unit [℃]/[℉] as needed.

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Chapter8 Cleaning
The PAVO series patient multi-parameter monitor should be cleaned according to
specified method. In order to avoid contamination and damage of the device, please
use recommended materials for cleaning. For the sake of patients’ safety, DO NOT use
any degraded or damaged cables, sensors or accessories.

8.1. Cleaning
1. Use soft cloth for wiping and cleaning;
2. Soap, amino or ethanol material can be used to clean the main unit and power box;
3. Soap or amino material can be used to clean ECG cables;
4. Soap, amino or ethanol material should be used to clean reusable cuffs;
5. Soap or amino material should be used to clean reusable IBP sensors;
6. Soap, amino or ethanol material should be used to clean reusable SpO2 probes;
7. Soap or ethanol material should be used to clean reusable TEMP probes.
Remarks:
1. Ammonia water: Diluted ammonia water <3%;
2. Ethanol: Ethanol 70%, isopropanol 70%;
3. DO NOT use abrasive materials such as wire brush or silver polish;
4. NEVER allow cleaning fluid to flow into the device or soak the component to be
cleaned.

8.2. Sterilization
1. After cleaning, sterilization should be carried out when necessary.
2. Ethanol or aldehyde cleaning agent should be used to clean the main unit and power
box;
3. Ethanol cleaning agent should be used to sterilize ECG cables;
4. Ethanol or aldehyde cleaning agent should be used to sterilize reusable cuffs;
5. Ethanol or aldehyde cleaning agent should be used to sterilize reusable SpO2 probes;
6. Bleaching agent should be used to sterilize reusable TEMP probes.
Remarks:
1. Ethanol cleaning agent: Ethanol 70%;
2. Bleaching agent: Sodium hypochlorite diluent (beaching agent for washing),
concentration 500ppm~5000ppm. NEVER allow the sterilizing liquid to flow into or
soak the device or its accessories. DO NOT leave any residual sterilizing liquid on any
surface.

8.3. Disinfection
After cleaning, disinfection should be carried out when necessary. Since the disinfection
process is complex, you must observe applicable hospital regulations and pay special
attention to safety. Generally, EtO gas is used for disinfection.

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Chapter9 Maintenance
The PAVO series multi-parameter patient monitor is a precise and sophisticated device.
Proper servicing and maintenance of the monitor not only can bring the device performance
into full play, but also can ensure the device accuracy during long-time work and avoid
various measurement errors. In order to avoid cross contamination, please confirm that the
device has been cleaned and disinfected before maintenance.
Frequently check the device and the cables, sensors and wires used;
Clean the device from time to time according to actual needs;
Perform the safety test once a year;
Calibrate the NIBP parameter once a year;
Calibrate the TEMP parameter once a year;
Test the device functions once a year;
Perform the safety test every time after the device is opened for repair;
In case of any problem found during maintenance, please contact the supplier immediately.

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Chapter10 Accessories
10.1 Accessories
Standard accessories are as follows (depending on configuration):
Standard
No. Name Specifications & characteristics
quantity
1 3 or 5-lead ECG cable Adult 3 or 5-lead all-in-one clip 1
2 Electrode slice 50mm×55mm, adult, disposable 1
3 SpO2 probe Adult finger clip 1
Blood pressure cuff Adult repetitive single-tube cuff 1
Blood pressure gas nozzle Metal 1
4
Blood pressure extension 3M gray
1
tube
2.25K-type temperature Adult body surface
5 1
probe
Detachable three-cell lithium battery
6 2.600mAh lithium battery 1
(11.1V 2.600mAh)
7 Ground wire V0020A 1
8 Power cord 3×0.75mm2 10A 250V L=2M 1

10.2 Maintenance of accessories


The accessories contain a rechargeable Lithium ion battery, SpO2 probe, NIBP cuff, NIBP
extension cable , ECG Cable, ECG electrodes, TEMP Probe ,
The monitor can be fitted with rechargeable battery to ensure its continuous work after
the failure of alternating current power supply. Please refer to the user’s manual about
the maintenance of rechargeable Lithium ion battery.
Meanwhile, more details about the maintenance of accessories (e.g. SpO2 probe, NIBP
cuff, CO2 probe and so on) refer to the user’s manual.

Chapter11 Residual Risks


PAVO Multi-Parameter Patient Monitor is a kind of monitoring instrument, which
monitors patients, and measures such as ECG, non-invasive blood pressure, oxygen
saturation, body temperature, respiration and pulse rate. According to the
requirements and regulations of ISO 14971:2016, the risk of this product is analyzed,
and the predicted analysis results are risk-free.
The following residual risks for patients, users and third parties have been identified
within the risk management process:
• Safety risks due to inadequate service and maintenance tasks and intervals.
• Safety risks due to inadequate transport processes and materials.
• Safety risks by using the device by unqualified staff and misunderstanding the
product and documentation.
• Safety risks by electric shock while using the patient monitor being electrically
connected to patients, users and third parties (e.g. ECG).
Please be aware of these risks by using the patient monitor. In order to minimize these
risks, the operator has to take care of checking the device before using and in intervals
according manufacturer requirements. Also, that the materials and tools for transport
and installation are suitable and approved by the manufacturer.
The staff using this product and make decisions related to patient’s health need to be
qualified and has to understand the product in function and features.

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Risks by electric shock can be minimized by using tested and approved accessories and
regulary electrical safety testings by authorized staff after installation, before using and
during lifetime of the product.

Appendix A Alarm Information


This chapter lists some important physiological and technical alarm information, and some
alarms are not necessarily listed.
Note that in this chapter: L column indicates the default alarm level: H indicates high level,
M indicates middle level, L indicates low level, and “*” indicates level set by the user.
Corresponding countermeasures are listed for each alarm message. If you operate in
accordance with the countermeasures but the problem persists, contact your service
personnel.

A1. Physiological Alarm Messages


Source Alarm message L Causes and countermeasures
HR Too High HR value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the
M* patient's physiological condition, and check if the
HR Too Low
patient category and alarm limit settings are
appropriate for the patient.
PVCs value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the
PVCS Too High M* patient's physiological condition, and check if the
patient category and alarm limit settings are
appropriate for the patient.
Asystole H The patient has arrhythmia. Check the patient's
VF/VTA H condition, electrodes, cables and lead wires.
R on T M*
Frequent PVC M*
Couplet PVC M*
Single PVC M*
ECG PVC Bigeminy M*
PVC Trigeminy M*
Tachycardia M*
Bradycardia M*
Miss Beat M*
Pacemaker Not H Pacemaker works abnormally; check the
Capture pacemaker.
Pacemaker Not work H
H The patient ECG signal is too weak, and the system
ECG Signal weak can’t analyze. Check the patient's condition,
electrodes, cables and leads.
ST-I Too High ST value is higher than the upper alarm limit or
ST-I Too Low lower than the lower alarm limit. Check the
ST-II Too High patient's physiological condition, and check if the
M* patient category and alarm limit settings are
ST-II Too Low
ST-III Too High appropriate for the patient.
ST-III Too Low

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Source Alarm message L Causes and countermeasures


RR Too High Patient PR value is higher than the upper alarm
limit or lower than the lower alarm limit. Check the
M* patient's physiological condition, and check if the
RR Too Low
patient category and alarm limit settings are
Resp appropriate for the patient.
The patient's respiratory signal is too weak, and the
Apnea(RESP) H system can’t analyze. Check the patient's condition,
electrodes, cables and leads.
RESP ARTIFACT H* Respiration heartbeat interference
T1 Too High T1/T2 value is higher than the upper alarm limit or
T1 Too Low lower than the lower alarm limit. Check the
T2 Too High patient's physiological condition, and check if the
patient category and alarm limit settings are
T2 Too Low
appropriate for the patient.
Temp M*
TD value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the
TD Too High patient's physiological condition, and check if the
patient category and alarm limit settings are
appropriate for the patient.
SPO2 Too High SpO2 value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the
patient's physiological condition, and check if the
SPO2 Too Low
patient category and alarm limit settings are
appropriate for the patient.
SpO2 M*
PR Too High SpO2 value is higher than the upper alarm limit or
lower than the lower alarm limit. Check the
patient's physiological condition, and check if the
PR Too Low
patient category and alarm limit settings are
appropriate for the patient.
NIBP signal weak NIBP value is higher than the upper alarm limit or
NIBP-Sys Too High lower than the lower alarm limit. Check the
NIBP-Sys Too Low patient's physiological condition, and check if the
NIBP M* patient category and alarm limit settings are
NIBP-Mean Too High
NIBP-Mean Too Low appropriate for the patient.
NIBP-Dia Too High

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A2. Technical Alarm Messages


Source Alarm message L Causes and countermeasures
Connect to AC power supply, and charge the
System Battery Low H battery, and power with the battery as needed
after fully charged.
ECG ECG Comm. Stop H ECG module failure, or communication failure
ECG Comm. Error H between the module and the host; please
ECG Config Error H restart the device.
ECG Self check Error H
ECG Lead Off M* The electrodes are not connected to the
ECG YY OFF (YY is a patient firmly or fall off, or lead wires and the
lead name) M* main cable fall off. Check the connection of
electrodes and lead wires.
TEMP1 Sensor Off L The temperature sensor falls off from the
Temp
TEMP2 Sensor Off L patient. Check the sensor connection.
SPO2 Comm. Stop H SpO2 module failure, or communication failure
SPO2 Comm. Error between the module and the host; please
H
restart the device.
SPO2 No Sensor L SpO2 sensor falls off from the patient or
SPO2 Sensor Off L monitor, malfunctions, or sensor other than
SPO2 Sensor Error L specified in this Manual is used. Check the
SpO2 SPO2 Search sensor mounting position, whether the sensor
Timeout L is damaged or sensor type. Reconnect the
sensor or use new sensor.
SPO2 Search Pulse L Sensor signal is poor or too weak. Check the
SPO2 Signal Unstable L patient's condition, and place the sensor in a
SPO2 Failure L suitable position. If the failure persists, replace
SPO2 Signal Weak L the sensor.
NIBP Comm. Stop H NIBP module failure, or communication failure
NIBP Comm. Error L between the module and the host; please
NIBP Self check error H restart the device.
NIBP CFG Error H
NIBP system error H If failure occurs during measurement, the
NIBP system can’t analyze and calculate. Check the
Measurement
L patient's condition, check the connections or
timeout
replace the cuff, and then re-test.
The used cuff does not match the set patient
Cuff type error L category. Verify the patient category and
replace the cuff.
NIBP cuff isn’t placed or connected properly, or
Cuff loose or no cuff L
there is gas leak.
Cuff leak L Check cuff and inflation tube.
Ambient atmospheric pressure is abnormal.
Confirm that the environment complies with
NIBP Air pressure error L the monitor's specifications, and check
whether there are special reasons affecting
ambient pressure.
The measured blood pressure of the patient
NIBP over range L
exceeds the measuring range.
NIBP signal weak L Patient's pulse may be weak or cuff is too

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Source Alarm message L Causes and countermeasures


loose. Check the condition of the patient, and
place the cuff in a suitable position. If the
failure persists, replace the cuff.
NIBP signal unstable Excessive movement may result in too much
L motion artifact or interference in the signal
during measurement.
NIBP signal saturated Motion signal amplitude is too large due to
L
movement and other reasons.
NIBP over pressure Cuff overpressure, and gas blockage may
L occur; check the gas path, and then re-
measure.
NIBP module reset error; check the gas path is
Module reset failed L
blocked, and then restart the measurement.

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NOTES:

45
aXcent medical GmbH
Josef-Görres-Platz 2
56068 Koblenz / Germany
Tel.: +49 261 3011 117
Fax: +49 261 3011 111
[email protected]
www.axcentmedical.com

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