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Contents
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Table of Contents
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BeneHeart C & BeneHeart S Series
Automatic External Defibrillator
Operator’s Manual
(BeneHeart C1/BeneHeart C1A/BeneHeart C2/BeneHeart C2A/
BeneHeart C1 Fully Automatic/BeneHeart C1A Fully Automatic/
BeneHeart C2 Fully Automatic/BeneHeart C2A Fully Automatic/
BeneHeart S1/BeneHeart S1A/BeneHeart S2/BeneHeartS2A/
BeneHeart S1 Fully Automatic/BeneHeart S1A Fully Automatic/
BeneHeart S2 Fully Automatic/BeneHeart S2A Fully Automatic)
Summary of Contents for Mindray BeneHeart C Series
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BeneHeart D6
Defibrillator/Monitor
Service Manual
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I
Intellectual Property Statement
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. (hereinafter
calledMindray) owns the intellectual property rights to this product
and this manual. This manualmay refer to information protected by copyrights or patents and
does not convey any licenseunder the patent rights of Mindray, nor the rights of others.
Mindray does not assume anyliability arising out of any infringements of patents or other
rights of third parties., , and are the registered trademarks or
trademarks owned by Mindray in China and other countries.
Revision History
This manual has a revision number. This revision number changes
whenever the manual isupdated due to software or technical specification change.
Contents of this manual are subjectto change without prior notice.
Version number 7.0
Release time: May 2011
© 2009-2011 Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
All rights reserved.Company Contact
Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co.,
Ltd.E-mail Address: [email protected]
Tel: +86 755 26582479, +86 755 26582888
Fax: +86 755 26582934, +86 755 26582500
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II
Preface
Manual Purpose
This manual provides detailed information about the assembling,
dissembling, testing andtroubleshooting of the equipment to support effective
troubleshooting and repair. It is notintended to be a comprehensive, in-depth explanation of the
product architecture or technicalimplementation. Observance of the manual is a prerequisite for
proper equipmentmaintenance and prevents equipment damage and personnel
injury.Intended Audience
This manual is for biomedical engineers, authorized technicians
or service representativesresponsible for troubleshooting, repairing and maintaining the
defibrillator/ monitorsPasswords
Passwords may be required to access different modes. The
passwords are listed below:Installation mode: 888888
Service mode: 332888
Configuration mode: 315666
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1
Contents
1
Safety…………………………………………………………………………………………………………………
1-11.1 Safety Information
…………………………………………………………………………………………….
1-11.1.1 Dangers
………………………………………………………………………………………………..
1-21.1.2
Warnings……………………………………………………………………………………………….
1-21.1.3 Cautions
……………………………………………………………………………………………….
1-21.1.4 Notes
……………………………………………………………………………………………………
1-31.2 Equipment Symbols
…………………………………………………………………………………………..
1-32 Theory of Operation
…………………………………………………………………………………………..
2-12.1 The Basics
………………………………………………………………………………………………………..
2-12.1.1
Overview………………………………………………………………………………………………
2-12.1.2 Main
Functions………………………………………………………………………………………
2-12.2 Components
……………………………………………………………………………………………………..
2-22.3 Main Unit
…………………………………………………………………………………………………………
2-22.4 Front Housing
Assembly…………………………………………………………………………………….
2-42.5 Paddle Tray
………………………………………………………………………………………………………
2-62.6 Rear Housing
Assembly……………………………………………………………………………………..
2-62.6.1 Power
System………………………………………………………………………………………..
2-62.6.2 Main Control System
……………………………………………………………………………..
2-72.6.3 Therapy
System……………………………………………………………………………………..
2-72.6.4 Parameter Measurement System
………………………………………………………………
2-72.7 External Device
Connectors………………………………………………………………………………..
2-83 Unpacking and Installation
…………………………………………………………………………………
3-13.1 Unpacking the
Equipment…………………………………………………………………………………..
3-13.2 Preparation for
Installation………………………………………………………………………………….
3-23.2.1 Preparation for Installation
Site………………………………………………………………..
3-23.2.2 Electrical Requirements
………………………………………………………………………….
3-33.3 Vehicle Mount Kit Installation
…………………………………………………………………………….
3-33.4 Installing Hook Kit or Conductive Gel Container
Kit…………………………………………….. 3-33.5 Preparation for Power
On……………………………………………………………………………………
3-33.6 User
Test…………………………………………………………………………………………………………..
3-44 Testing and
Maintenance…………………………………………………………………………………….
4-14.1
Introduction………………………………………………………………………………………………………
4-14.1.1 Test Report
……………………………………………………………………………………………
4-24.1.2 Preventative Maintenance
……………………………………………………………………….
4-24.1.3 Recommended
Frequency……………………………………………………………………….
4-34.2 Preventative Maintenance Procedures
………………………………………………………………….
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4.2.1 Visual Test
…………………………………………………………………………………………….
4-44.2.2 NIBP
Tests…………………………………………………………………………………………….
4-44.2.3 CO2 Module
Tests…………………………………………………………………………………..
4-74.2.4 Preventative maintenance test
report…………………………………………………………
4-84.3 Power On Test
…………………………………………………………………………………………………..
4-94.4 User
Test…………………………………………………………………………………………………………
4-104.5 Password for Installation Mode
………………………………………………………………………….4-114.6 Module Performance
Tests…………………………………………………………………………………4-114.6.1 Manual Defibrillation Test
……………………………………………………………………..4-114.6.2 Pacing Test
………………………………………………………………………………………….
4-134.6.3 ECG Test
…………………………………………………………………………………………….
4-144.6.4 Resp Test
…………………………………………………………………………………………….
4-154.6.5 IBP
Tests……………………………………………………………………………………………..
4-154.6.6
SpO2 Test…………………………………………………………………………………………….
4-174.6.7 Temp Test
……………………………………………………………………………………………
4-174.7 Analogue Output
Test……………………………………………………………………………………….
4-184.8 Electrical Safety Tests
………………………………………………………………………………………
4-184.9 Recorder
Check……………………………………………………………………………………………….
4-184.10 Factory Service
……………………………………………………………………………………………..
4-184.10.1 Password for Service
Mode………………………………………………………………….
4-184.10.2 Accessing Service Mode Menu
…………………………………………………………….
4-194.10.3 Calibrating
NIBP………………………………………………………………………………..
4-194.10.4 Calibrating/Zeroing
Impedance…………………………………………………………….
4-194.10.5 Device Information
…………………………………………………………………………….
4-214.10.6 Checking Failure
Code………………………………………………………………………..
4-214.10.7 Inputting Serial
Number………………………………………………………………………
4-224.10.8 Paddle Open Circuit
Display………………………………………………………………..
4-224.10.9 Selecting Recorder Type
……………………………………………………………………..
4-225 Hardware and Software
Upgrade………………………………………………………………………..
5-15.1 Hardware Upgrade
…………………………………………………………………………………………….
5-15.1.1 Upgrading MPM module
………………………………………………………………………..
5-15.1.2 MPM Module upgrade procedure
…………………………………………………………….
5-55.1.3 Upgrade the Therapy
Module…………………………………………………………………..
5-75.1.4 Upgrade the Equipment with CO2
Module………………………………………………..
5-85.1.5 Upgrade the Recorder
…………………………………………………………………………..
5-105.2 Software Upgrade through a
PC…………………………………………………………………………
5-105.2.1 Installing Mindray Patient Monitor Software Upgrade
Tool………………………..5-115.2.2 Software Upgrade Procedure
…………………………………………………………………
5-135.3 Software Upgrade through a USB Memory
…………………………………………………………
5-145.3.1
Precautions………………………………………………………………………………………….
5-145.3.2 Software Upgrade Procedure
…………………………………………………………………
5-146
Troubleshooting………………………………………………………………………………………………….
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6.1
Overview………………………………………………………………………………………………………….
6-16.2 Part Replacement
………………………………………………………………………………………………
6-16.3 Checking Defibrillator/Monitor
Status………………………………………………………………….
6-16.4 Checking Device
Information……………………………………………………………………………..
6-26.5 Checking Technical
Alarm………………………………………………………………………………….
6-26.6 Troubleshooting
Guide……………………………………………………………………………………….
6-36.6.1 Defibrillation
Problems…………………………………………………………………………..
6-36.6.2 Pacing
Problems…………………………………………………………………………………….
6-56.6.3 Power On/Off
Problems………………………………………………………………………….
6-56.6.4 Display Problems
…………………………………………………………………………………..
6-66.6.5 Alarm
Problems……………………………………………………………………………………..
6-76.6.6 Button and Knob Problems
……………………………………………………………………..
6-86.6.7 Recorder
Problems…………………………………………………………………………………
6-96.6.8 Output Interface Problems
………………………………………………………………………
6-96.6.9 CF Card
Problems………………………………………………………………………………..
6-106.6.10 Wireless Transmission Module Problems
……………………………………………… 6-106.6.11 Power Supply Problems
……………………………………………………………………….6-116.6.12 Software Upgrade
Problems…………………………………………………………………
6-126.7 Technical Alarm
Messages………………………………………………………………………………..
6-126.8 Error Codes
…………………………………………………………………………………………………….
6-136.8.1 Therapy Module Error
Codes…………………………………………………………………
6-136.8.2 Power Module Error
Codes……………………………………………………………………
6-146.8.3 Main Control Error
Codes……………………………………………………………………..
6-156.8.4 MPM Error Codes
………………………………………………………………………………..
6-157 Disassembly and Repair
……………………………………………………………………………………..
7-17.1 Tools Required
………………………………………………………………………………………………….
7-17.2 Preparations for
Disassembly………………………………………………………………………………
7-27.3 Disassembling the Main
Unit………………………………………………………………………………
7-37.3.1 Removing Hook
Mount…………………………………………………………………………..
7-37.3.2 Removing Paddle
Tray……………………………………………………………………………
7-47.3.3 Separating the Housing
…………………………………………………………………………..
7-57.3.4 Removing the Measurement Module Panel
………………………………………………. 7-67.3.5 Removing the Power Supply Assembly
…………………………………………………….
7-87.3.6 Discharging the
Capacitor……………………………………………………………………….
7-97.3.7 Removing the Therapy Module High-voltage
Board………………………………… 7-107.3.8 Disassembling the MPM
Module…………………………………………………………….7-117.3.9 Removing the CO2 Module
…………………………………………………………………..
7-127.3.10 Removing the CPU board
Assembly……………………………………………………..
7-127.3.11 Removing the Therapy Port
Assembly…………………………………………………..
7-137.3.12 Checking Waterproof Material on the Rear Housing
………………………………. 7-147.4 Disassembling the Front Housing
Assembly………………………………………………………..
7-157.4.1 Removing the Keypad
board………………………………………………………………….
7-157.4.2 Removing Display
Assembly…………………………………………………………………
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7.4.3 Removing the Speaker
………………………………………………………………………….
7-207.4.4 Removing the Indicating Lamp Board and Alarm Lamp Board
…………………. 7-207.4.5 Removing the Mode Select Knob
…………………………………………………………..
7-217.4.6 Removing the Rotary Encoder
……………………………………………………………….
7-227.4.7 Removing the
Recorder…………………………………………………………………………
7-227.5 Disassembling the MPM
Module……………………………………………………………………….
7-237.5.1 Removing the Fan
………………………………………………………………………………..
7-237.5.2 Removing the SpO2 board
…………………………………………………………………….
7-247.5.3 Removing the MPM Module Analog Board
……………………………………………. 7-257.5.4 Removing the MPM Module Digital
Board…………………………………………….. 7-267.5.5 Removing the NIBP
Module………………………………………………………………….
7-277.6 Disassembling the Power Supply Assembly
………………………………………………………..
7-287.6.1 Removing the AC/DC board
………………………………………………………………….
7-287.6.2 Removing the Power Supply Sheet Metal and the Grounding
Terminal………. 7-297.7 Disassembling the CO2 Module
………………………………………………………………………..
7-307.7.1 Disassembling the Microstream CO2 Module
…………………………………………. 7-307.7.2 Disassembling Mindray CO2
Module……………………………………………………..
7-317.8 Disassembling the Measurement Module Panel
Assembly……………………………………. 7-327.8.1 Disassembling the Measurement Module Panel with Mindray
CO2 Module.. 7-327.8.2 Disassembling the Measurement Module Panel with
Microstream CO2 Module…………………………………………………………………………………………………………………..
7-337.8.3 Disassembling the Measurement Module Panel without CO2
Module ……….. 7-337.9 Disassembling the
Recorder………………………………………………………………………………
7-347.9.1 Disassembling the TR6F
Recorder………………………………………………………….
7-347.9.2 Disassembling the TR8A Recorder
…………………………………………………………
7-357.10 Disassembling the External
Paddle…………………………………………………………………..
7-377.10.1 Disassembling the Adult
Paddle……………………………………………………………
7-377.10.2 Disassembling the Apex Pediatric
Paddle………………………………………………
7-377.10.3 Disassembling the Sternum Pediatric
Paddle…………………………………………. 7-388 Parts
………………………………………………………………………………………………………………….
8-18.1
Introduction………………………………………………………………………………………………………
8-18.2 Main Unit
…………………………………………………………………………………………………………
8-28.2.1 Exploded View
………………………………………………………………………………………
8-28.2.2 Parts List
………………………………………………………………………………………………
8-28.3 Front Housing
Assembly…………………………………………………………………………………….
8-48.3.1 Exploded View
………………………………………………………………………………………
8-48.3.2 Parts List
………………………………………………………………………………………………
8-48.4 Rear Housing
Assembly……………………………………………………………………………………..
8-88.4.1 Exploded View
………………………………………………………………………………………
8-88.4.2 Parts List
………………………………………………………………………………………………
8-88.5 Rear
Housing…………………………………………………………………………………………………..
8-108.5.1 Exploded View
…………………………………………………………………………………….
8-108.5.2 Parts List
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8.6 Measurement Module Panel
Assembly……………………………………………………………….
8-128.6.1 Exploded View
…………………………………………………………………………………….
8-128.6.2 Parts List
…………………………………………………………………………………………….
8-128.7 Power Supply Assembly
…………………………………………………………………………………..
8-148.7.1 Exploded View
…………………………………………………………………………………….
8-148.7.2 Parts List
…………………………………………………………………………………………….
8-158.8 MPM
Module………………………………………………………………………………………………….
8-168.8.1 Exploded View
…………………………………………………………………………………….
8-168.8.2 Parts List
…………………………………………………………………………………………….
8-178.9 Capacitor Assembly
…………………………………………………………………………………………
8-188.9.1 Exploded View
…………………………………………………………………………………….
8-188.9.2 Parts List
…………………………………………………………………………………………….
8-188.10 Sidestream CO2 Module Kit
……………………………………………………………………………
8-198.10.1 Exploded View
…………………………………………………………………………………..
8-198.10.2 Parts List
…………………………………………………………………………………………..
8-198.11 Microstream CO2 Module Kit
…………………………………………………………………………
8-208.11.1 Exploded View
…………………………………………………………………………………..
8-208.11.2 Parts
List……………………………………………………………………………………………
8-208.12 Paddle Tray
Assembly…………………………………………………………………………………….
8-218.12.1 Exploded View
…………………………………………………………………………………..
8-218.12.2 Parts List
…………………………………………………………………………………………..
8-218.13 External Paddle
……………………………………………………………………………………………..
8-228.13.1 Exploded View
…………………………………………………………………………………..
8-228.13.2 Parts List
…………………………………………………………………………………………..
8-228.14 Sternum Pediatric Paddle Kit
…………………………………………………………………………..
8-238.14.1 Exploded View
…………………………………………………………………………………..
8-238.14.2 Parts List
…………………………………………………………………………………………..
8-238.15 Sternum Adult Paddle Kit
……………………………………………………………………………….
8-248.15.1 Exploded View
…………………………………………………………………………………..
8-248.15.2 Parts List
…………………………………………………………………………………………..
8-248.16 Apex Pediatric Paddle Kit
……………………………………………………………………………….
8-258.16.1 Exploded View
…………………………………………………………………………………..
8-258.16.2 Parts List
…………………………………………………………………………………………..
8-258.17 Apex Adult Paddle Kit
……………………………………………………………………………………
8-268.17.1 Exploded View
…………………………………………………………………………………..
8-268.17.2 Parts List
…………………………………………………………………………………………..
8-268.18 External Paddle Cable
…………………………………………………………………………………….
8-278.18.1 Exploded View
…………………………………………………………………………………..
8-278.18.2 Parts List
…………………………………………………………………………………………..
8-278.19 Hook Mount
………………………………………………………………………………………………….
8-288.19.1 Exploded View
…………………………………………………………………………………..
8-288.19.2 Parts List
…………………………………………………………………………………………..
8-288.20 Replacement
Parts………………………………………………………………………………………….
8-298.20.1 Main Unit
………………………………………………………………………………………….
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8.20.2 Connecting Cables
……………………………………………………………………………..
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1-1
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will
result in death, seriouspersonal injury or property damage.
WARNING
Indicates a potential hazard or unsafe maintenance
practice that, if not avoided,could result in death, serious personal injury, product /
property damage.CAUTION
Indicates a potential hazard or unsafe maintenance
practice that, if not avoided,could result in minor personal injury or product/property
damageNOTE
Provides application tips or other useful information to
ensure that you can betterservice your product.
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1-2
1.1.1 Dangers
WARNING
Do not open the equipment cases to avoid shock hazard.
All servicing and futureupgrades must be carried out by the personnel trained and
authorized by ourcompany only.
1.1.2 Warnings
WARNING
To avoid high voltage shock, disconnect the
defibrillator/monitor from AC adapterand remove the batteries before disassembly.
The equipment must be connected to a properly installed
power socket withprotective earth contacts only. If the installation does not
provide a protectiveearth conductor, do not use this socket and operate the
equipment on rechargeablebatteries.
When disposing of the packaging material, be sure to
observe the applicable wastecontrol regulations and keep it out of children’s reach.
1.1.3 Cautions
CAUTION
Make sure that no electromagnetic radiation interferes
with the performance of theequipment when preparing to carry out performance tests. Mobile
phone, X-rayequipment or MRI devices are a possible source of interference
as they may emithigher levels of electromagnetic radiation.
Before connecting the equipment to the power line, check
that the voltage andfrequency ratings of the power line are the same as those
indicated on theequipment’s label or in this manual.
Protect the equipment from damage caused by drop, impact,
strong vibration orother mechanical force during servicing.
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1-3
1.1.4 Notes
NOTE
Refer to Operation Manual for detailed operation and
other information.1.2 Equipment Symbols
Attention: Please read thismanual carefully before
servicing.
Equipotential terminal
Danger: High-voltage Service indicator
Alternating current(AC) Network connector
Battery Video output
USB connector Analog input/out
ESD warning symbol for Electrostatic sensitive devices.
Type CF applied part. Defibrillator-proof protection against
electric shock.Type BF applied part. Defibrillator-proof protection against
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2-1
2 Theory of Operation
2.1 The Basics
2.1.1 Overview
BeneHeart D6 defibrillator/monitor (hereinafter called the
equipment) provides fouroperating modes: Manual Defib, AED, Pacer, and Monitor. The
equipment is for use inhospital and pre-hospital settings. It adopts the most advanced
biphasic defibrillationtechnology and can deliver up to 360J of defibrillation
energy.BeneHeart D6 has an 8.4″ LCD display.
2.1.2 Main Functions
The equipment has the following main functions:
Manual Defib Mode
In Manual Defib Mode, the operator analyzes the patient’s ECG,
and, if appropriate, followsthis procedure:
1 Select the Manual Defib mode, adjust the energy level if
necessary2 Charge; and
3 Deliver the shock.
Defibrillation may be performed through external paddles or
multifunction electrode pads. InManual Defib Mode, you can also perform synchronized
cardioversion.AED Mode
In AED mode, the equipment automatically analyzes the patient’s
ECG rhythm andindicates whether or not a shockable rhythm is detected. Voice
prompts provideeasy-to-follow instructions and patient information to guide you
through thedefibrillation process. Messages and flashing buttons are also
presented to reinforce thevoice prompts.
Pacer Mode
The Pacer Mode offers non-invasive transcutaneous pacing
therapy. Pace pulses aredelivered through multifunction electrode pads using a
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2-2
Monitor Mode
In Monitor Mode, the equipment is intended for monitoring,
displaying, reviewing,storing and printing multiple physiological parameters and
waveforms including ECG,pulse oximetry (SpO2), temperature (Temp), non-invasive
blood pressure (NIBP),invasive blood pressure (IBP) and carbon dioxide (CO2).
2.2 Components
The equipment consists of a main unit, accessories and PC
software.The main unit is the core of the equipment. It provides:
Overall system control;
System power supply;
Display;
Defibrillation and pacing;
AED ;
Man-mahcine interface;
Audible and visible alarms;
Multiple parameter measurements;
External connectors and communication; and
Recording, printing and data storage.
2.3 Main Unit
The main unit is composed of the front housing assembly, rear
housing assembly and thepaddle tray assembly. External paddles are rested in the
paddle tray.The front housing assembly mainly consists of LCD, keypad
board, recorder, speaker,microphone, Mode Select knob, navigation knob, backlight
inverter, alarm lamp board,indicating lamp board, front housing and front housing sheet
metal, etc.The rear housing assembly consists of CPU board, therapy
module, high voltagecapacitors, MPM module, CO2 module, power management board,
wireless networkadapter, fan, measurement module panel, therapy port, and rear
housing, etc.The paddle tray is for holding the external paddles.
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2-3
The main unit consists of the following subsystem:
Input subsystem: Its input includes keypad board,
microphone, Mode Select knob,navigation knob, and paddle handle controls.
Output subsystem: includes display screen, alarm lamp board,
recorder, and speakerProcessing and communication subsystem: includes CPU
board, therapy module, MPMmodule, and CO2 module.
Power management subsystem: includes batteries, AC/DC
board and powermanagement board.
External device connection subsystem: includes USB
connector, network connector,VGA connector and multifunction connector for analog output and
synchronous input.System Structure
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2-4
System Signal Flow
2.4 Front Housing Assembly
The front housing assembly consists of display assembly
(including the backlight inverter), akeypad board, a recorder, a speaker, a microphone, a Mode Select
knob, a navigation knob,an alarm lamp board, an indicating lamp board, a front housing
and front housing sheet metal,etc.
Navigation Knob
You can rotate the knob clockwise or counterclockwise and then
press it to confirm aselection. The knob is connected to the keypad board.
Mode Select Knob
A 8-position encoder is used to select the operating mode
(Monitor, Manual Defib, AED andPacer) and power-off. The unused positions are mechanically
disabled.Recorder
The recorder receives data from the CPU board and then sends the
data to a thermal head forprinting. The recorder front panel has a key for starting/
stopping the recorder and a greenindicator which is lit when working normally. The recorder is
connected to the keypad boardwhich board provides connection for the TR6F recorder. The block
diagram and functionalmodules of the recorder are shown as below.
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2-5
Module Description
Power Interface Introduces DC power supply from the CPU
board.Recorder Power Module Adjusts input voltage to run each
module.Recorder CPUCoordinates module communication, controls and
processes modulestatus.
Keypad board InterfaceServes as the data communication channel
between the keypad boardand the recorder CPU.
Motor Drive CircuitReceives control signals sent by the recorder
CPU to drive the stepmotor.
Keypad and Indicator
Interface
Sends keypad commands to CPU and receives CPU commands to
control the indicator.
FPC InterfaceSends print head information to CPU and receives
CPU commands tocontrol the print head.
Speaker
The speaker emits alarm tones, key-stroke tone, heart beats and
PR sound. It supports thefunctions of PITCH TONE and the multi-level volume. The speaker
is connected to thekeypad board.
Microphone
It provides the function of voice recording.
Alarm Lamp Board
The keypad board interfaces with the alarm lamp board. The alarm
lamp transmits signals todrive the green and yellow alarm lamp.
Indicating Lamp Board
The keypad board interfaces with the indicating lamp board. On
the equipment’s front panel,there are 3 indicators: AC power indicator, battery indicator
and service indicator, each has anicon aside.
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2-6
2.5 Paddle Tray
The paddle tray is used to hold paddles. It has a 50 Ω test
load inside. When the equipmentruns self tests, test current will pass through the test
load.2.6 Rear Housing Assembly
Rear housing assembly consists of the CPU board, the therapy
module, high voltagecapacitors, a MPM module, a CO2 module, a power management
board, a fan, a rear housing,a measurement module panel, and a therapy port, etc.
2.6.1 Power System
The power system consists of the following items:
AC/DC board: The AC mains is the input, and the outputs
is 18VDC.Battery: 14.8V, 4500mAh.
Power Management Board
It is intended for power transform and battery charge control.
The system outputs fourtypes of power supply: 18V (when AC mains is used) or 14.8V
(when a battery is used),12V, 5V, and 3.3V.
The priority of system power supply is rated in the order of AC
mains, Battery 1 andBattery 2. That is to say, when AC is not available, Battery 1
will be used; if Battery 1 isdefective or depleted, Battery 2 will be used.
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2.6.2 Main Control System
The CPU board is connected with the power management board with
stacking connectors, asshown below.
The main control module mainly consists of the CPU and FPGA. CPU
is used to provideleast required internal storage, program memory, large capacity
non-volatile storage, and thewatch dog. It connects EEPROM and other peripheral ICs such as
Ethernet PHY chip. FPGAperforms the main functions of display and audio. Besides,
it has the function of adaptinginterfaces from CPU to MPM module, the keypad board and the
recorder. CPU controlsFPGA via Flexbus.
2.6.3 Therapy System
The therapy system provides the functions of defibrillation,
pacing and AED analysis. Thetherapy module is an unseparated assembly.
The therapy module adopts DSP+MCU framework. MCU is responsible
for therapy controlwhile DSP for ECG and impedance detection, AED algorithm,
monitoring algorithm, pacingalgorithm, auxiliary therapy control, etc.
2.6.4 Parameter Measurement System
MPM modules and the CO2 module are used to provide
parameter monitoring. However,ECG monitoring can also be implemented by the therapy module.
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2.7 External Device Connectors
1. Hook
2. Battery 2
3. Battery 1
4. External power input: It connects an AC power cord or a DC/AC
adapter to run theequipment respectively on the external AC mains or DC power
supply.5. Equipotential grounding terminal: When the
defibrillator/monitor and other devices areto be used together, their equipotential grounding terminals
should be connectedtogether to eliminate the potential difference between them.
6. USB connector: It connects the USB memory for data export.
Data stored in the internalCF card can be transferred to the USB memory and then export to
a PC via the datamanagement software.
7. Network connector: It is a standard RJ45 connector, through
which software can beupgraded.
8. Multifunctional connector: provides ECG analog output and
defibrillationsynchronization input.
9. VGA connector: connects an external VGA display.
1
2
4
3
6
7
8
9
5
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3 Unpacking and InstallationThis chapter provides information
you need to install a defibrillator/monitor ready for use.3.1 Unpacking the Equipment
Open the package and take out the packing list. Check that all
the articles included in thepacking list are available and the quantity and
specification are correct.All the optional parts purchased by the customer shall
also be checked.Notify the supplier if provided components are not correct
as compared to the packinglist.
In case of damage during transportation, keep the packing
material and notify thesupplier immediately.
Keep the packing material till new equipment is
accepted.The following pictures show the defibrillator/monitor and
accessory packing.Main unit packing
Accessory packing
Main unitAccessory packing
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3.2 Preparation for Installation
3.2.1 Preparation for Installation Site
1. Ensure that the site meets all safety, environmental and
power requirements2. Check that required power sockets are available.
3. Check that a network connector is available if the
defibrillator/monitor needs to beconnected to network.
WARNING
Only power cables provided with the system may be used.
For reasons of safety,power (mains) extension cables or adapters shall not be
used.Environmental Requirements
WARNING
To avoid explosion hazard, do not use the equipment in
the presence of flammableanaesthetics, vapours or liquids.
CAUTION
The environment where the defibrillator/monitor will be
used should be reasonablyfree from vibration, dust and corrosive substances. If these
conditions are not met,the accuracy of the system may be affected and damage may
occur.The environmental specification is as follows:
Operating Temperature
0 to 45℃ (without CO2 module)
5 to 35℃ (with sidestream CO2 module)
0 to 40ºC (with microstream CO2 module)
Operating humidity 15% to 95%, (non-condensing)
Operating altitude -381m to +4575 m (-1250 ft to 15000 ft, or
106.2kPa to 57kPa)Storage temperature -30 to 70℃
Storage humidity 10% to 95%, (non-condensing)
Storage altitude -381m to +4575 m (-1250 ft to 15000 ft, or
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3.2.2 Electrical Requirements
Check cables and power cords. Make sure that:
1. All system cables, power cords and power plugs are not
damaged, and pins are not loose.Otherwise, remove it from use.2. The insulation of patient cables and leadwires is not
damaged, and connectors are notloose.
WARNING
Only power sockets with protective grounding can be
used.The electrical specification is as follows:
Line voltage: 100 to 240VAC
Current: 1.8 to 0.8 A
Frequency: 50/60Hz
3.3 Vehicle Mount Kit Installation
Refer to BeneHeart D6/D5 Vehicle Mount Kit Instructions for
Use for the detailedinformation on how to install the equipment on the vehicle mount
kit.3.4 Installing Hook Kit or Conductive Gel Container Kit
Refer to Hook Kit and Conductive Gel Container Kit
Installation Guide to install the hookkit or conductive gel container kit.
3.5 Preparation for Power On
Before connecting the power cord to the defibrillator/monitor’s
power input, check thatThe mains voltage meets the requirement.
3-wire power cord is used. The power socket should be
3-wire also. This ensures that thedefibrillator/monitor is properly grounded. Do not use 2-wire
power cord or socket.The equipotential grounding terminals should be connected
together when thedefibrillator/monitor and other devices are to be used
together.The defibrillator/monitor is not placed under the
infusion bag or placed where theirmight be liquid spillage. This protects the
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4Testing and Maintenance
4.1 Introduction
To ensure the equipment always functions normally, qualified
service personnel shouldperform regular inspection, maintenance and test. This
chapter provides a checklist of thetesting procedures for the equipment with recommended test
equipment and frequency. Theservice personnel should perform the testing and maintenance
procedures as required and useappropriate test equipment.
The testing procedures provided in this chapter are intended to
verify that the equipmentmeets the performance specifications. If the equipment or a
module fails to perform asspecified in any test, repairs or replacement must be done to
correct the problem. If theproblem persists, contact our Customer Service
Department.CAUTION
All tests should be performed by qualified service
personnel only.Care should be taken to change the settings in
[Installation Mode] and [ServiceMode] menus to avoid loss of data.
Before testing, service personnel should acquaint
themselves with the test tools andmake sure that test tools and cables are applicable.
When testing monitoring parameters, move the Mode Select
knob to Monitor toaccess the Monitor Mode.
When performing therapy function tests, move the Mode
Select knob tocorresponding mode.
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4.1.1 Test Report
After completing the tests, service personnel are required to
record test results and reportthem to Mindray Customer Service Department.
See the
Test Report at the end of this chapter.
4.1.2 Preventative Maintenance
Below are preventative maintenance tests which need to be
performed on thedefibrillator/monitor. See the following sections for detailed
maintenance procedures.Visual inspection
NIBP test and calibration
Microsteam and Sidestram CO2 test and calibration.
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4.1.3 Recommended Frequency
Test itemAfter
repair
Function
suspected
6
months
12
months
24
months
Visual inspection ×
Power-on Test ×
User test ×
Recorder check ×
Charge/
discharge
Energy disarming
Manual
defibrillation
tests Synchronous
defibrillation
Pacing test
× × ×
Performance test × × × ECG
Module calibration × ×
Resp Performance test × × ×
SpO2 Performance test × × ×
Temp Performance test × × ×
Accuracy test
Leakage test NIBP
Module calibration
× × ×
Performance testIBP
Pressure calibration
Leakage test × × × CO2
Module calibration × × ×
NIBP overpressure protection test × ×
×Analog out test ×
Earth leakage current
Patient leakage
current
Electrical
safety tests as
per
IEC60601-1 Patient auxiliary
current
× ×
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4. Compare the value of manometer with the value displayed on
the equipment’s screen.The difference should be no greater than 3 mmHg.
5. Raise the pressure in the metal vessel to 50 mmHg with the
balloon pump. Repeat steps3 and 4.
6. Raise the pressure in the metal vessel to 200 mmHg with the
balloon pump. Repeat steps3 and 4.
Note
You can replace the balloon pump and manometer with a
blood pressure simulatorto form a test system.
NIBP Leakage Test
Tools required:
An adult cuff
An air tubing
A correct sized cylinder
To perform the leakage test:
1. Connect the cuff to the equipment’s NIBP connector.
2. Wrap the cuff around the cylinder as shown below.
3. Press the Main menu button on the equipment’s front panel.
Select [Others>>]→[Installation Mode>>]→ enter the required
password→[Maintain NIBP]→ [StartLeakage Test].
After about 20 seconds, the equipment automatically deflates.
This means the leakage testfinishes.
When the accuracy test is completed, the result will be
displayed. If the message [NIBPPneumatic Leak ] is displayed, it indicates that the NIBP
airway may have leakages. Checkthe tubing and connections for leakages, and then perform a
leakage test again.Defibrillator/monitor
Connector for
NIBP cuf
Tubing
Cylinder
Cuff
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Calibrating NIBP
Tools required:
T-shape connector
Tubing
Balloon pump
Metal Vessel, volume 500±25 ml
Calibrated manometer, accuracy higher than 1 mmHg
1. Connect the equipment as shown below
2. Before inflation, the reading of the manometer should be 0.
If not, disconnect theairway and reconnect it until the readings is 0
3. Press the Main menu button on the equipment’s front panel.
Select [Others>>]→[Service Mode>>]→ enter the required
password→[Calibrate NIBP].4. Calibrate pressure. To do so, set the calibration value to
150 mmHg and adjust the pumpoutput pressure to 150 mmHg. After the system is stable, click
the [Calibrate] button tostart calibration.
5. Calibrate overpressure. To do so,
set [Patient Cat.] to [Adu/Ped] and adjust pump output
pressure to 330 mmHg.Click the [Calibrate] button and start calibration. Or
set [Patient Cat.] to [Neo] and adjust pump output
pressure to 165 mmHg. Clickthe [Calibrate] button and start calibration.
All the calibration results will be displayed in the
[Calibrating NIBP] screen. If thecalibration fails, please check the connections and then perform
a calibration again.Defibrillator/monitor
Connector for
NIBP cuff
Manometer
Tubing
Balloon pumpMetal vessel
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4.2.3 CO2 Module Tests
Leakage Check
1. Access the [CO2 Setup] menu and set [Operating
Mode] to [Measure].Wait for CO2warm-up.
2. Block the CO2 module gas inlet completely. This will
cause different reactions from theSidestream and Microstream CO2 modules.
Sidestream: Check that alarm message [CO2 Filter Line
Err] is displayed on thescreen in 3s. Block the gas inlet for another 30s, if the alarm
message does notdisappear, the module does not leak.
Microstream CO2 module: [CO2
Purging…] is displayed in 3s. Block the gas
inletfor another 30s, if the alarm message [CO2 Tubing Err] appears,
the module doesnot leak.
Module Calibration
Test tools
Gas cylinder, with 6% of CO2 and balance gas N2.
T-shape connector
Tubing
For sidestream CO2 module, zeroing is required before
calibration. Enter [CO2 Setup] menuand select [Zero] to perform zeroing.
To calibrate the CO2 module, follow this procedure:
1. Make sure that the CO2 module has been warmed up or
started up.2. Connect the gas cylinder with the tubing using a T-shape
connector as shown below.Check the airway and make sure there are no leaks.
Defibrillator
/monitor
Gas cylinder
To the air
Gas valveTubing
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3. Vent the tubing to the CO2 by opening the gas valve.
4. Access the [Maintain CO2] menu. To do so, Press the Main Menu
button on theequipment’s front panel. Select [Others>>]→[Installation
Mode>>]→enter therequired password→ [Maintain CO2].
5. In the [Maintain CO2] menu, select a CO2 value equal to the
vented CO2concentration.
6. In the [Calibrate CO2] menu, the measured
CO2 concentration is displayed. Wait tillthe measured CO2 concentration becomes stable; select
[Calibrate] to start CO2calibrate.
The message [Calibration Completed!] is displayed after a
successful calibration. If thecalibration failed, the prompt [Calibration Failed!] will be
displayed. In this case, performanother calibration.
4.2.4 Preventative maintenance test report
Customer name
Customer address
Servicing person
Servicing company
Equipment under test
(EUT)
Model of EUT
SN of EUT
Hardware version
Software version
Test equipment Model/No. Effective date of calibration
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Test items Test records Test results
(Pass/Failed)
Visual inspection
The case, display screen, buttons, knob, SMR, modules, power
cord, wall-mount bracket and accessories have no obvious
signsof damage.
The external connecting cables are not frayed and the
connectorpins are not loose and bent.
The external connectors are not loose or their pins are not
bent.The safety labels and data plate are clearly legible.
NIBP test
The difference is within ±3 mm when 0, 50 or 200 mmHg is set
for NIBP accuracy test.
There is no leakage with NIBP, or the manual leakage test
resultdoes not exceed 6mmHg/min.
Sidestream CO2 test
Block the gas inlet of the module or watertrap. The
sidestreamCO2 flowrate is slower than 10ml/min and an alarm of CO2
Filterline Err is given. It indicates that there is no
leakage.The displayed CO2 value is within 6±0.05%.
Microstream CO2 test
Block the gas inlet of the module or watertrap. An alarm of
CO2Filterline Err is given. It indicates that there is no
leakage.The displayed CO2 value is within 6±0.05%.
4.3 Power On TestThis test is to verify that the defibrillator/
monitor can power on normally. The test is passed if thedefibrillator/ monitor starts up by following this
procedure:1. Place the external paddles on paddle tray, insert the battery
(install both if two batteriesare configured) in the battery compartment, and then connect the
equipment with ACmains. In this case, both the AC indicator and battery indicator
shall light.2. Turn the Mode Select knob to Monitor. Check that the
equipment passes the self test andis turned on properly.
3. Check the display of technical alarm area, prompt area and
battery status indicator onthe upper right corner of the main screen to judge whether the
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4.4 User Test
Follow this procedure to perform user test:
1. If you use external paddles, place them on the paddle tray;
if you use a pads cable,connect it to the 50 Ω test load.2. Insert the battery (2 if configured) into the equipment.
Connect the AC mains if nobattery is available.
3. Select the Main Menu button on the equipment’s front panel.
In the Main Menu, select[User Test>>]. Then a prompt “Enter user test?” pops up.
Select “Yes” to enter the UserTest screen.
4. Check the test items you want to perform and select [Start]
to start user testThe test results indicate the condition of the system. If any
item fails, the service indicatorflashes.
If you cannot pass User Test or the message “Connect paddles
cable, and place paddles inpaddle tray” is shown when paddle cable is connected and
paddles are placed in paddle tray,check paddles status.
Select the Monitor mode. Press and hold the [Event] hardkey, and
then press the [LeadSelect] hardkey on the front panel, the following screen
appears.Observe the reading of “Lead Stat”:
0 x 382: Paddles are properly placed in paddle tray.
0 x 182: The travel switch indicating paddle status may
fail, but impedance is correct.0 x 102 :Paddles are not properly placed in paddle tray
and the impedance value is notcorrect.
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4.5 Password for Installation Mode
Accessing installation mode is password protected. The required
password is set to 888888before the equipment leaves the factory.
4.6 Module Performance Tests
4.6.1 Manual Defibrillation Test
Test tools:
Defibrillator/pacer analyzer
Charge/Discharge
1. Remove the batteries and connect the equipment with AC mains.
Turn the Mode Selectknob to Manual Defib.
2. Connect the external paddles to the equipment and place the
paddles on thedefibrillator/pacer analyzer.
3. Enter the Configuration-Main screen. From the Record Setup
menu set [Shock Event]to [On] so that shock events can be recorded automatically if
happened.4. Set the analyzer to Energy Measurement mode. In this case,
the energy value should bedisplayed as 0 or blank.
5. Select the energy level to 1J.
6. Charge/discharge the equipment to verify the energies
measured by the analyzer meetthe following accuracy:
Selected Energy (J) Measured Value (J)
1 0 to 3
100 85 to 115
360 306 to 414
7. Set the energy to 100J and 360J respectively. Repeat
Step 6.8. Disconnect the equipment from the AC mains. Run the equipment
on fully chargedbattery. Move the Mode Select knob to Manual Defib. Repeat
Steps 5 to 7.9. Use multifunctional electrode pads. Repeat Step 5 to Step
7.10. Verify that the equipment records the shock events
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7. When charging finishes, press and hold the “Shock” button to
deliver a shock.8. Verify that synchronous discharge succeeds and the delivery
energy measured by theanalyzer is 10J±2J.
9. Verify that the delay time of synchronous defibrillation
measured by the analyzer is lessthan 60ms.
10. Verify that the synchronous discharge mark appears on the R
wave.11. Verify that the prompt messages are correct during
testing.12. Select lead II as ECG source and perform charging. Repeat
steps 7 to 11.13. Use multifunctional electrode pads. Repeat steps 2 to
12.4.6.2 Pacing Test
Test tools:
Defibrillator/pacer analyzer
1. Run the equipment on fully charged battery. Move the Mode
Select knob to Pacer. Set[Pacer Mode] to [Fixed].
2. Connect the pads cable to the equipment and properly place
the pads on thedefibrillator/pacer analyzer.
3. Set the analyzer to Pacing Measurement mode. Use test load of
50Ω.4. On the equipment, set [Pacer rate] to [70ppm] and [Pacer
Output] to [30mA].5. Press the [Start Pacing] soft key. Verify that the pacer rate
measured by the analyzer is70 ppm±1ppm and the pacer output measured is 30 mA±5mA.
6. Press the “Stop Pacing” soft key, and then set [Pacer rate]
to [170ppm] and [PacerOutput] to [200mA].
7. Press the [Start Pacing] soft key. Verify that the pacer rate
measured by the analyzer is170 ppm±2ppm, and the measured current is 200 mA±10mA.
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4.6.3 ECG Test
Performance Test
Test tools
ECG simulator
1. Connect the simulator to the equipment’s ECG connector.
2. Configure the simulator as HR=80 bmp.
3. The displayed HR should not exceed 80±1 bmp;
ECG Calibration
1. Select the ECG parameter area to enter the [ECG Setup]
menu.2. Select [Others>>]→[Calibrate]. A waveform signals
appear on the screen and themessage [ECG Calibrating] is displayed in the prompt information
area in the lowerleft corner of the screen.
3. Compare the amplitude of the waveform with the wave scale.
The difference should bewithin 5%. If needed, you can also print out the waveform and
the wave scale.4. After ECG calibration is completed, select [Stop
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Pressure Calibration
Tools required:
Standard sphygmomanometer
Balloon pump
Tubing
T-shape connector
To perform a calibration:
1. Connect the 3-way stopcock, the sphygmomanometer and the
balloon pump through aT-shape connector, as shown below.
2. Zero the transducer. Then open the stopcock to the
sphygmomanometer.3. Press the Main menu button on the equipment’s
front panel. Select [Others>>]→[Installation Mode>>]→ enter the required
password→[Maintain IBP]. Thenconfigure IBP calibration value.
4. Inflate using the balloon pump until the reading of
sphygmomanometer approximatesthe preset calibration value.
5. Adjust the calibration value in the [Maintain IBP] menu until
it is equal to the readingof sphygmomanometer
6. Select the [Calibrate] button to start a calibration
7. The message [Calibration Completed!] is displayed after a
successful calibration. Ifthe calibration failed, the prompt [Calibration Failed!] will be
displayed.Sphygmomanometer
T-shape connector
3-way stopcock
Pressure transducer
Pressure adapter cable
IBP Module
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4.6.6 SpO2 Test
Test tool
Patient simulator.
1. Connect the patient simulator to the equipment’s SpO2
connector .2. Select the model and manufacturer of the SpO2 module under
test. Configure theparameter as SpO2 96% and PR 80 bmp.
3. The displayed SpO2 and PR values should be within the ranges
listed belowSpO2 (%) PR (bmp)
Mindray 96% ±2% 80±3
Masimo 96% ±2% 80±3
MAX-A, MAX-AL, MAX-N, MAX-P, MAX-I,
MAX-FAST96% ±2%
OxiCliq A, OxiCliq N, OxiCliq P, OxiCliq I 96% ±2.5%
D-YS, DS-100A, OXI-A/N, OXI-P/I 96% ±3%
Nellcor
MAX-R, D-YSE, D-YSPD 96% ±3.5%
80±3
4.6.7 Temp Test
Test tools
Resistance box
1. Connect the two pins of any Temp connector on equipment to
the two ends of theresistance box using 2 wires.
2. Set the resistance box to 1354.9Ω (corresponding
temperature is 37 ). The displayed℃value on the equipment should not exceed 37±0.2 .℃
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4.7 Analogue Output Test
Test tool:
Oscillograph
1. Connect the patient simulator to the equipment under test
using an ECG or IBP cable.2. Connect the oscillograph to the equipment’s multifunctional
connector.3. Verify that the waveforms displayed on the oscillograph is
identical with thosedisplayed on the defibrillator/ monitor.
4.8 Electr ical Safety Tests
See A Electrical Safety Inspection for electrical
safety tests..4.9 Recorder Check
Tools required:
None.
1. Print ECG waveforms. The recorder should print correctly and
the printout should beclear.
2. Simulate some recorder problems, such as out of paper, paper
jam, etc. the defibrillator/monitor should give corresponding prompt messages. After the
problem is removed, therecorder should be able to work correctly.
3. Switch automatic alarm recording for each parameter ON and
then set each parameter’slimit outside set alarm limits. Corresponding alarm recordings
should be triggered whenparameter alarms occur.
4.10 Factory Service
4.10.1 Password for Service Mode
Accessing service mode is password protected. The required
password is set to 332888before the equipment leaves the factory.
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4.10.2 Accessing Service Mode Menu
To access the factory service menu, Press the Main menu button
on the equipment’s frontpanel. Select [Others>>]→ [Service
Mode>>]→ enter the required passwords. The ServiceMode-Main menu is shown below.
4.10.3 Calibrating NIBP
Refer to 4.2.2 NIBP Tests for calibrating NIBP.
4.10.4 Calibrating/Zeroing Impedance
Normally impedance calibration and zeroing is unnecessary.
However, you can performimpedance checking after replacing the therapy module.
1. If not pre-connected, connect the pads cable to the
equipment.2. Connect a test load of 300 ohms to the pads cable.
3. Start the equipment and select the Monitor mode. Press and
hold the [Event] hardkey,and then press the [Lead Select] hardkey on the front panel, the
following screenappears.
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4. Verify that the reading of “RT Imped” is between
3000±450.NOTE
If 300 ohms test load is not available, you can use a 50
ohms test load to performimpedance checking. In this case, Verify that the reading of “RT
Imped” isbetween 500±75.
If the reading of “RT Imped” is not correct, perform impedance
calibration/zeroing.1. Press the Main menu button on the equipment’s front panel.
Select [Others>>]→ [Service Mode>>]→ enter
the required passwords→[Calibrate/Zero Impedance] toenter the Calibrate/Zero Impedance screen.
2. Connect a test load of 0 ohm to the pads cable; then select
“Zero”. A message “ZeroCompleted” shall be shown. If the message “Zero Failed” is
displayed, check theconnection of pads cable.
3. Connect a test load of 100 ohms to the pads cable; then
select “Calibrate”. A message“Calibration Completed” shall be shown. If the message
“Calibration Failed” isdisplayed, check the connection of pads cable.
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4.10.5 Device Information
Press the Main menu button on the equipment’s front panel.
Select [Others>>]→ [ServiceMode>>]→ enter the required passwords→ [Device
Information]. In the DeviceInformation list, you can view the device information such as
software version, system status,and etc, as shown below.
In the Device Information screen, you can select [Export] to
export error codes and shockdelivery data to a USB flash memory.
4.10.6 Checking Failure Code
Press the Main Menu button on the equipment’s front panel.
Select [Others>>]→ [ServiceMode>>]→ enter the required passwords→ [Failure
Code] to check error codes. This helpsthe service personnel to identify failures.
Refer to 6.8 Error Codes for the description of each error
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4.10.7 Inputt ing Serial Number
Press the Main Menu button on the equipment’s front panel.
Select [Others>>]→ [ServiceMode>>]→ enter the required passwords→ [Input
Serial Number] to input the equipment’sserial number.
After inputting the serial number, you can view it by accessing
Installation Mode and select[Version].
4.10.8 Paddle Open Circuit Display
This [Paddle Open Circuit Display] switch is for testing only.
In normal operation, it shouldbe set to [Off ]].
4.10.9 Selecting Recorder Type
BeneHeart D6 defibrillator/monitor can be configured with a 50
mm recorder or an 80 mmrecorder. You can choose the recorder type in the service mode
by selecting [ Recorder Type]and toggle between [50 mm Recorder] and [80 mm Recorder].
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Test Report
Customer name
Customer address
Servicing person
Servicing company
Equipment under test
(EUT)
Model of EUT
SN of EUT
Hardware version
Software version
Test equipment Model/No. Effective date of calibration
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Test items Test recordsTest results
(Pass/Failed)
Visual inspection
The case, display screen, buttons, knob, modules, power cord,
andaccessories have no obvious signs of damage.
The external connecting cables are not frayed and the connector
pinsare not loose and bent.
The external connectors are not loose or their pins are not
bent.The safety labels and data plate are clearly legible.
Power-on test
The power-on test is passed. The power indicator and alarm
systemwork correctly and the equipment start up properly.
Performance test
Manual Defibrillation Test
When running on AC mains and external paddles are used, the
equipment can be properly charged and discharged; the energy
delivered meets accuracy requirement, and shock information
iscorrectly recorded.
When running on fully charged battery and external paddles are
used,the equipment can be properly charged and discharged; the
energydelivered meets accuracy requirement, and shock information
iscorrectly recorded.
When running on AC mains and multifuncational electrode pads
areused, the equipment can be properly charged and discharged;
theenergy delivered meets accuracy requirement, and shock
informationis correctly recorded.
When running on fully charged battery and multifuncational
electrode pads are used, the equipment can be properly charged
anddischarged; the energy delivered meets accuracy requirement,
andshock information is correctly recorded.
When external paddles are used, charge tone is correctly issued
whenthe equipment is being charged. The prompt «Charged Removed»
isshown on the screen and charge done tone stops when the
Disarmhotkey is pressed. The equipment does not discharge
externally.When [Time to Auto Disarm] is set to [60s], the prompt
«ChargedRemoved» is shown on the screen and the charge done tone
stopsafter 60 seconds at the completion of charging. The equipment
doesnot discharge externally.
When pads are used, the charge tone is correctly issued when
theequipment is being charged. The prompt «Charged Removed» is -
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Test items Test recordsTest results
(Pass/Failed)
not exceed 6mmHg/min.
Temp test
The value displayed for each Temp channel of the monitor is
within37±0.1ºC.
IBP test
The static pressure value displayed for each IBP channel is
within200±2 mmHg.
The ART and LV waves for each IBP channel are displayed
correctly.Sidestream CO2 test
Block the gas inlet of the module or watertrap. The sidestream
CO2flowrate is slower than 10ml/min and an alarm of CO2 Filterline
Erris given. It indicates that there is no leakage.
The displayed CO2 value is within 6±0.05%.
Miscrostream CO2 test
Block the gas inlet of the module or watertrap. An alarm of
CO2Filterline Err is given. It indicates that there is no
leakage.The displayed CO2 value is within 6±0.05%
Analog output performance test
The waves displayed on the oscillograph are identical with
thosedisplayed on the monitor.
SpO2 test
The displayed SpO2 and PR values should be within the
specifiedranges.
Electrical safety tests
Refer to Appendix A Electrical Safety Inspection. All the
electricalsafety tests should be passed.
Recorder check
The recorder can print ECG waves correctly and the printout is
clear.Set the recorder to some problems such as out of paper, paper
jam,etc. the equipment gives corresponding prompt messages. After
theproblem is removed, the recorder is able to work
correctly.Automatic alarm recording for each parameter functions
correctlywhen parameter alarms occur.
Tested by: _________________________ Date:
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5 Hardware and Software Upgrade
5.1 Hardware Upgrade
After upgrade the hardware, please upgrade corresponding
software.5.1.1 Upgrading MPM module
Upgrading MPM module configured with 3/5-lead ECG only
You can upgrade MPM module from 3/5-lead ECG only to any of the
followingconfiguration:
PN Description of upgrade package Configuration after
upgrade801-0651-00117-00 Low cost MPM subassembly 12-Lead
ECG upgrade package
12-lead ECG
801-0651-00118-00 12-Lead ECG/Mindray SpO2upgrade
package
12-lead ECG/Mindray SpO2
801-0651-00049-00 NIBP upgrade package 3/5-lead ECG/NIBP
801-0651-00050-00 Mindray SpO2 upgrade package 3/5-lead
ECG/Mindray SpO2801-0651-00051-00 Masimo SpO2 upgrade package 3/5-lead
ECG/Masimo SpO2801-0651-00052-00 Nellcor SpO2 upgrade package 3/5-lead
ECG/Nellcor SpO2801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Mindray SpO2
/NIBP/TEMP
801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP
upgrade package
3/5-lead ECG/Mindray SpO2
/NIBP/IBP/TEMP
801-0651-00059-00 Masimo SpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Masimo SpO2
/NIBP/TEMP
801-0651-00060-00 NellcorSpO2/NIBP/TEMP upgrade
package
3/5-lead ECG /Nellcor SpO2
/NIBP/TEMP
801-0651-00061-00 Masimo SpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Masimo SpO2
/NIBP/IBP/TEMP
801-0651-00062-00 NellcorSpO2/NIBP/IBP/TEM upgrade
package
3/5-lead ECG/Nellcor SpO2
/NIBP/IBP/TEMP
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Upgrading MPM module configured with 3/5-leadECG/NIBP
You can upgrade MPM module from 3/5-lead ECG/NIBP to any of the
followingconfiguration:
PN Description of upgrade package Configuration after
upgrade801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Mindray SpO2
/NIBP/TEMP
801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Mindray SpO2
/NIBP/IBP/TEMP
801-0651-00059-00 Masimo SpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Masimo SpO2
/NIBP/TEMP
801-0651-00061-00 Masimo SpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Masimo
SpO2/NIBP/IBP/TEMP
801-0651-00060-00 NellcorSpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Nellcor
SpO2/NIBP/TEMP
801-0651-00062-00 NellcorSpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
Upgrading MPM module configured wi th 3/5-lead ECG/Mindray
SpO2You can upgrade MPM module from 3/5-lead ECG/Mindray SpO2 to any
of the followingconfiguration:
PN Description of upgrade package Configuration after
upgrade801-0651-00118-00 12-lead ECG/Mindray SpO2upgrade
package
12-lead ECG
801-0651-00053-00 Mindray SpO2/NIBP/TEMP upgrade
package
3/5-lead ECG/Mindray
SpO2/NIBP/TEMP
801-0651-00056-00 Mindray SpO2/NIBP/IBP/TEMP upgrade
package
3/5-lead ECG/Mindray
SpO2/NIBP/IBP/TEMP
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Upgrading MPM module configured with 3/5-lead ECG/Mindray
SpO2/NIBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/Mindray
SpO2/NIBP/TEM to any of thefollowing configuration:
PN Description of upgrade package Configuration after
upgrade801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
801-0651-00081-00 IBP upgrade package 3/5-lead ECG/Mindray
SpO2/NIBP/IBP/TEMP
Upgrading MPM module configured with 3/5-lead ECG/ Nellcor
SpO2/NIBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/ Nellcor
SpO2/NIBP/TEMP to any of thefollowing configuration:
PN Description of upgrade
package
Configuration after upgrade
801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
801-0651-00081-00 IBP upgrade package 3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
Upgrading MPM module configured with 3/5-lead ECG/ Mindray
SpO2/NIBP/IBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/ Mindray
SpO2/NIBP/IBP/TEMP to anyof the following configuration:
PN Description of upgrade package Configuration after
upgrade
801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
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Upgrading MPM module configured with 3/5-lead ECG/ Masimo
SpO2/NIBP/IBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/ Masimo
SpO2/NIBP/IBP/TEMP to anyof the following configuration:
PN Description of upgrade package Configuration after
upgrade801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
Upgrading MPM module configured with 3/5-lead ECG/Nellcor
SpO2/NIBP/IBP/TEMP
You can upgrade MPM module from 3/5-lead ECG/ Nellcor
SpO2/NIBP/IBP/TEMP to anyof the following configuration:PN Description of upgrade package Configuration after
upgrade801-0651-00116-00 12-lead ECG upgrade package 12-lead ECG
5.1.2 MPM Module upgrade procedure
1. Remove the MPM module assembly and parameter panel assembly
as described in 7.3.8Disassembling the MPM Module.
2. Replace the old parameter panel assembly and MPM module
assembly with those in theupgrade package.
3. Remove the watertrap receptacle unit, or microstream CO2
connector assembly, or CO2panel as described in 7.8 Disassembling the Measurement
Module Panel Assembly.4. Reassemble the watertrap receptacle unit, or microstream CO2
connector assembly, orCO2 panel on the replacement parameter panel assembly in the
upgrade package.NOTE
If you need to upgrade 3/5-lead ECG to 12-lead ECG,
insert the 12-lead ECGboard into the MPM module. Make sure that the 12-lead ECG board
should be incorrect direction. Then fix the clip in place.
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5-6
5. Reassemble the equipment.
6. Stick correct parameter panel overlay on the parameter panel
according to theconfiguration you upgrade.If the upgrade MPM module is equipped with Masimo SpO2,
you need to stick aMasimo label on the lower left corner of the front housing and a
No ImpliedLicense label below the parameter panel, as indicated in the
following pictures.If the upgraded MPM module is equipped with Nellcor SpO2,
you need to stick aNellcor label at the lower left corner of the front
housing, as indicated in thefollowing pictures.
7. Perform the tests as described in 4.6 Module Performance
Tests.Masimo label No Implied License label
Nellcor label
12-lead ECG board
Clip 1Cli 2
Clip here in place Clip here in place
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5.1.3 Upgrade the Therapy Module
You can use 801-0652-00039-00 pacer function upgrade kit to
upgrade the therapy module sothat equipment has pacing function. After upgrading the therapy
module, choose Mode label(with pacing function) with the language you need.
Follow this procedure to upgrade the therapy module:
1. Remove therapy module as described in 7.3.7 Removing the
Therapy ModuleHigh-voltage Board . Be noted that you need not to
remove the parameter panelassembly and MPM module assembly.
2. Take off the Mode Select knob. Peel off the Mode label.
3. Replace the old therapy module with the one configured with
pacing function in theupgrade package.
4. Replace the old Mode Select knob and Mode label with those in
the upgrade package.5. Reassemble the equipment.
6. After upgrade the therapy module, perform the tests described
in 4.6 ModulePerformance Tests.
Mode Select knob
Mode label
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5-8
5.1.4 Upgrade the Equipment with CO2 Module
You can use the following CO2 upgrade package to upgrade the
equipment so as to have aCO2 monitoring function.
PN Description of upgrade package
801-0651-00079-00 M02B CO2 upgrade package (for adult/pediatric)
(FRU)801-0651-00082-00 M02B CO2 upgrade package (for neonate)
(FRU)801-0651-00080-00 Microstream CO2 upgrade package (for neonate)
(FRU)Follow this procedure to upgrade the equipment:
1. Remove the parameter module panel assembly as described in
7.3.4 Removing theMeasurement Module Panel .
2. Remove the left capacitor sheet metal as described in 7.3.9
Removing the CO2 Module.3. Install the required M02B CO2 module or microstream CO2
module on the leftcapacitor sheet metal.
Mindray CO2 module Microstream CO2 module
4. Apply the CO2 insulating sheet on the MPM module mounting
plate. Be careful to alignthe edge of insulating plate with the edge of the metal plate
when stick the insulatingplate to the metal sheet. Do not stick the screw holes on
the metal sheet. Then bent theinsulating plate properly to avoid being cut by the insulating
plate during later assemblyprocess.
Make sure that the part number of
connecting cable for the microstream
CO2 connector fixing plate should
be 0651-20-77166.
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5-9
5. Peel off the overlay on the parameter module panel and
install the connector fixing partof the microstream CO2 module or the watertrap receptacle kit
and the gas outlet of theMindray CO2 module on the parameter module panel. Choose an
appropriate overlayfrom the upgrade package and apply it on the
parameter module panel.6. Install the left capacitor metal sheet with CO2 module in the
machine.7. Reassemble the machine. Route the gas pipes to avoid blocking
them.8. Perform the tests as described in 4.2.3 CO2 Module
Tests.Gas outlet
Mindray CO2
watertrap kit
Microstream CO2
connector fixing part
CO2
insulating plate
Align the edge of
insulating plate with the
edge of the metal plate
Bent here
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5.2.1 Installing Mindray Patient Monitor Software Upgrade
Tool1. Find the installation program and double click it to
startinstallation.
2. Select installation language.
- Автоматический
- Импульс дефибрилляции: бифазная усеченная экспоненциальная кривая
- Режим работы: АНД
- Каналы для измерения: ЭКГ
- Разряды энергии: 200 Дж/400, 360 Дж/200
- Дисплей: нет
- Работа от встроенной батареи: 900 мин (15 ч)
- Для взрослых и детей
- Регистрационное удостоверение
Арт. 8129
Дефибриллятор Mindray BeneHeart C1A
- Описание
- Характеристики
- Комплектация
- Данные для транспортировки
- Документация
- Дефибриллятор Mindray BeneHeart C1A — автоматическое наружное устройство с подтверждением разряда нажатием кнопки, предназначенный для экстренного оказания помощи пациенту с нарушениями ритма сердца и проведения дефибрилляции при внезапной остановке сердца у взрослых и детей
- Может быть использован в стоматологических клиниках, общественных местах, общеобразовательных учреждениях, тренажерных залах
- В дефибриллятор встроен алгоритм анализа шокового ритма, с помощью которого можно получать сигналы с последующим анализом электрокардиограммы (ЭКГ) пациента для выявления необходимости разряда дефибрилляции. В случае обнаружения шокового режима прибор запрашивает подтверждение разряда, затем подает этот разряд, если обнаружен нешоковый ритм — аппарат переходит к режиму сердечно-легочной реанимации
- Особенности дефибриллятора BeneHeart C1A:
— импульс дефибрилляции: бифазная усеченная экспоненциальная (BTE) кривая с автоматической компенсацией в зависимости от импеданса пациента
— диапазон энергии разряда от 10 до 360 Дж, энергия автоматически выставляется в зависимости от типа пациента и его импеданса (сопротивления)
— возможность использования как для взрослых, так и для детей (выбор детского режима осуществляется переводом переключателя в соответствующее положение и не требует ключа)
— функция самотестирования и индикации состояния дефибриллятора
— встроенная память на 1 Гб с возможностью сохранения основных данных пациента и параметров дефибриллятора
— автоматическая настройка громкости в соответствии с уровнем окружающего шума
— неперезаряжаемая батарея обеспечивает до 200 разрядов с максимальной энергией 360 Дж или до 400 разрядов с энергией 200 Дж
— возможен обмен данных по USB порту и не зависит от ОС на ПК
— срок службы батареи в режиме ожидания до 5 лет
— автоматическая отмена разряда при импедансе пациента менее 25 Ом и при импедансе более 300 Ом
— срок годности электродов 3 года
— режим СЛР (сердечно-легочная реанимация) может быть настроен на 30:2, 15:2 и только непрямой массаж сердца
— простое переключение между режимом «взрослый/ребенок»
— метроном СЛР
— обратная связь в режиме реального времени
— поддержка процесса сердечно-легочной реанимации: постоянная помощь спасателю в достижении цели спасения жизни
— голосовые подсказки по проведению реанимационных действий на русском языке, выполняют роль персонального инструктора, который всегда находится рядом
Перед применением необходимо ознакомиться с инструкцией по применению (паспортом изделия) или получить консультацию специалиста
Способ управления
автоматический
Импульс дефибрилляции
бифазная усеченная экспоненциальная кривая
Режим работы
АНД (не синхронизирует разряды с ритмом сердца)
Энергия импульса воздействия для взрослых, Дж
100, 150, 170, 200, 300, 360
Энергия импульса воздействия для детей, Дж
10, 15, 20, 30, 50, 70, 100
Разряды энергии 200 Дж от заряженной батареи
400 (каждую мин 3 разряда)
Разряды энергии 360 Дж от заряженной батареи
200 (каждую мин 3 разряда)
Набор энергии 200 Дж, не более, с
8
Набор энергии 360 Дж, не более, с
15
Программное обеспечение
нет
Электроды
взрослые/детские одноразовые многофункциональные
Работа от встроенной батареи, мин
900 (15 ч)
Электропитание от сети переменного тока, В/Гц
нет
Электропитание от встроенной батареи, В
12
Возможность питания от сети автомобиля
нет
Гарантия производителя, мес.
12
Дефибриллятор Mindray BeneHeart C1A
Перед применением необходимо ознакомиться с инструкцией по применению (паспортом изделия) или получить консультацию специалиста
- Блок основной BeneHeart C1A — 1 шт.
- Батарея LM34S002A — 1 шт.
- Электроды для дефибрилляции модель MR62 (взрослые/детские) — 1 пара
- Руководство по эксплуатации
Габариты в упаковке, м
0,4х0,24х0,15
Количество изделий в упаковке
1
Упаковка
картонная коробка
Дополнительная упаковка
требуется