1.1 Safety Information ...................................................................................................................................................................... 1-1
2 Theory of Operation ..................................................................................................................................... 2-1
2.1 The Basics ....................................................................................................................................................................................... 2-1
2.1.2 Main Functions .................................................................................................................................................................. 2-1
2.3 Main Unit ........................................................................................................................................................................................ 2-2
2.3.1 System Structure .............................................................................................................................................................. 2-3
2.3.2 System Signal Flow .......................................................................................................................................................... 2-4
2.3.3 Signal Sequence of Power-On/Off ............................................................................................................................. 2-5
2.4 Front Housing Assembly .......................................................................................................................................................... 2-5
2.6.1 Power System .................................................................................................................................................................... 2-6
2.6.2 Main Control System ....................................................................................................................................................... 2-7
2.6.3 Therapy System ................................................................................................................................................................. 2-8
3.3 Preparation for Power On ......................................................................................................................................................... 3-3
3.4 User Test.......................................................................................................................................................................................... 3-3
4 Testing and Maintenance ............................................................................................................................ 4-1
4.1.1 Test Report .......................................................................................................................................................................... 4-2
4.1.2 Recommended Frequency ........................................................................................................................................... 4-2
4.2 Visual Test ....................................................................................................................................................................................... 4-3
1
Page 6
4.3 Power On Test ............................................................................................................................................................................... 4-3
4.4 User Test.......................................................................................................................................................................................... 4-4
4.5 Password for Installation Mode.............................................................................................................................................. 4-5
4.6.1 Manual Defibrillation Test ............................................................................................................................................. 4-5
4.6.2 Pacing Test .......................................................................................................................................................................... 4-7
4.6.3 ECG Test ................................................................................................................................................................................ 4-7
4.6.4 Resp Test .............................................................................................................................................................................. 4-8
4.6.5 SpO2 Test .............................................................................................................................................................................. 4-9
4.9 Factory Service .......................................................................................................................................................................... 4-13
4.9.1 Password for Service Mode ........................................................................................................................................ 4-13
4.9.2 Accessing Service Mode Menu ................................................................................................................................. 4-13
4.9.4 Device Information ....................................................................................................................................................... 4-15
4.9.6 Inputting Serial Number ............................................................................................................................................. 4-16
4.9.7 Paddle Open Circuit Display ...................................................................................................................................... 4-16
5 Hardware and Software Upgrade ............................................................................................................... 5-1
5.1.2 Upgrade the Therapy Module...................................................................................................................................... 5-2
5.2 Software Upgrade through a PC ........................................................................................................................................... 5-3
5.3 Software Upgrade through a USB Disk ............................................................................................................................... 5-7
6.2 Part Replacement ........................................................................................................................................................................ 6-1
6.3 Checking Defibrillator/Monitor Status ................................................................................................................................ 6-1
6.4 Checking Device Information ................................................................................................................................................. 6-2
6.8.2 Power Module Error Codes ........................................................................................................................................ 6-17
6.8.3 Main Control Error Codes ........................................................................................................................................... 6-18
7.2 Preparations for Disassembly ................................................................................................................................................. 7-1
7.3 Disassembling the Main Unit .................................................................................................................................................. 7-2
7.3.1 Removing Hook Mount (if configured) .................................................................................................................... 7-3
7.3.3 Separating the Housing ................................................................................................................................................. 7-5
7.3.4 Discharging the Capacitor ............................................................................................................................................ 7-6
7.3.5 Disassembling the MPM Module Assembly ........................................................................................................... 7-6
7.3.6 Removing the Parameter Panel Assembly .............................................................................................................. 7-7
7.3.7 Removing the Therapy Module ................................................................................................................................... 7-7
7.3.8 Disassembling the Power Base Assembly ............................................................................................................... 7-8
7.3.9 Disassembling the AC/DC Power Supply Board .................................................................................................... 7-9
7.3.10 Disconnecting the Therapy Port Cable ............................................................................................................... 7-10
7.3.11 Removing the Main Board Assembly .................................................................................................................. 7-11
7.3.12 Checking Waterproof Strips before Reassembling ......................................................................................... 7-12
7.4 Disassembling the Front Housing Assembly ................................................................................................................. 7-14
7.4.1 Removing the Keypad Board .................................................................................................................................... 7-14
7.4.3 Removing the Alarm Lamp Board and Assistant Keypad Board .................................................................. 7-16
7.4.4 Removing the Speaker ................................................................................................................................................ 7-17
7.4.5 Removing the Mode Select Knob ........................................................................................................................... 7-17
7.4.6 Removing the Encoder ................................................................................................................................................ 7-18
7.4.7 Checking Waterproof Material on the Front Housing ...................................................................................... 7-18
7.5 Removing the Recorder ......................................................................................................................................................... 7-19
7.6 Disassembling the Recorder ................................................................................................................................................ 7-19
8 Parts .............................................................................................................................................................. 8-1
8.2 Main Unit ........................................................................................................................................................................................ 8-2
8.2.2 Parts List ............................................................................................................................................................................... 8-2
8.3 Front Housing Assembly .......................................................................................................................................................... 8-3
8.3.2 Parts List ............................................................................................................................................................................... 8-3
8.4.2 Parts List ............................................................................................................................................................................... 8-5
8.5.2 Parts List ............................................................................................................................................................................... 8-6
8.6.2 Parts List ............................................................................................................................................................................... 8-7
A Electrical Safety Inspection ......................................................................................................................... A-1
4
Page 9
NOTE
1 Safety
1.1 Safety Information
DANGER
Indicates an imminent hazard that, if not avoided, will result in death, serious personal 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 damage
Provides application tips or other useful information to ensure that you can better service your
product.
1-1
Page 10
1.1.1 Dangers
DANGER
The equipment delivers up to 360 J of electrical energy. Unless properly used as described in
these Operating Instructions, this electrical energy may cause serious injury or death. Do not
attempt to operate this defibrillator unless thoroughly familiar with these operating
instructions and the function of all controls, indicators, connectors, and accessories.
Defibrillation current can cause operator or bystander severe injury or even death. Keep
distance with the patient or metal devices connected to the patient during defibrillation.
Do not disassemble the defibrillator. It contains no operator serviceable components and
dangerous high voltages may be present. Contact authorized service personnel for repair.
To avoid explosion hazard, do not use the equipment in the presence of oxygen-rich
atmospheres, flammable anesthetics, or other flammable agents (such as gasoline). Keep the
equipment and the operating environment dry and clean.
1.1.2 Warnings
WARNING
Before putting the system into operation, the operator must verify that the equipment,
connecting cables and accessories are in correct working order and operating condition.
Make sure the synchronous input system is applied to this equipment and the input signal is
correct if necessary.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with
protective earth. If the installation does not provide for a protective earth conductor,
disconnect it from the power line and operate it on smart lithium-ion batteries.
Ensure that the equipment is supplied with continuous electric power during work. Sudden
power failure leads to the loss of patient data.
Use and store the equipment in specified environmental condition. The equipment and
accessories may not meet the performance specification due to aging, stored or used outside
the specified temperature and humidity range.
This equipment is used for single patient at a time.
Medical electrical equipment which does not incorporate defibrillator protection should be
disconnected during defibrillation.
Do not defibrillate a patient who lies on the wet ground.
Do not touch the patient and live parts simultaneously.
Do not touch the patient when connecting the peripheral equipment via the I/O signal ports to
prevent patient leakage current from exceeding the requirements specified by the standard.
1-2
Page 11
Do not rely exclusively on the audible alarm system for patient monitoring. Adjustment of
alarm volume to a low level or off may result in a hazard to the patient. Remember that alarm
settings should be customized according to different patient situations and always keeping
the patient under close surveillance is the most reliable way for safe patient monitoring.
Do not perform any functional check if the equipment is connected with a patient; otherwise
the patient might be shocked.
Remain attentive to the patient during applying therapy. Delay in delivering a shock may
result in a rhythm that was analyzed as shockable converting spontaneously to non-shockable
and could result in inappropriate delivery of a shock.
For the treatment of patients with implantable pacemakers, place therapy pads or paddles
away from internal pacemaker generator if possible to help prevent damage to the pacemaker.
To avoid inadvertent disconnection, route all cables in a way to prevent a stumbling hazard.
Wrap and secure excess cabling to reduce risk of entanglement or strangulation by patients or
personnel.
Do not touch device connectors, recorder print head, battery connector or other live
equipment if in contact with the patient; otherwise patient injury may result.
To ensure patient safety, use only parts and accessories specified in this manual.
Package material may contaminate the environment. Properly dispose of the package material
according to applicable waste control regulations and keep it out of children’s reach.
1.1.3 Cautions
CAUTION
Use of Manual Therapy security password requires the clinician to know and remember the
password. Failure to enter correct password will prevent the delivery of manual defibrillation,
synchronized cardioversion and pacing therapy.
At the end of its service life, the equipment, as well as its accessories, must be disposed of in
compliance with the guidelines regulating the disposal of such products to avoid
contaminating the environment.
Magnetic and electrical fields are capable of interfering with the proper performance of the
equipment. For this reason make sure that all external devices operated in the vicinity of the
equipment comply with the relevant EMC requirements. Mobile phones, X-ray equipment or
MRI devices are a possible source of interference as they may emit higher levels of
electromagnetic radiation.
Before connecting the equipment to the power line, check that the voltage and frequency
ratings of the power line are the same as those indicated on the equipment’s label or in this
manual.
Always install or carry the equipment properly to avoid damage caused by drop, impact,
strong vibration or other mechanical force.
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NOTE
Dry the equipment immediately in case of rain.
Never charge and deliver shock frequently in non-clinical situations. Otherwise equipment
damage could occur.
1.1.4 Notes
The equipment use a mains plug as isolation means to the mains power supply. Do not locate
the equipment in a place difficult to operate the mains plug.
During normal use, the operator shall stand in front of the equipment.
Keep this manual in the vicinity of the equipment so that it can be obtained conveniently when
needed.
If the equipment is run on a DC power supply, a DC/AC adapter we supply should be used.
This manual describes all features and options. Your equipment may not have all of them.
1.2 Equipment Symbols
See the BeneHeart D3/ BeneHeart D2 Defibrillator/Monitor Operator’s Manual (P/N: 046-010599-00)
for information about the symbols used on this product and its packaging.
1-4
Page 13
2 Theory of Operation
2.1 The Basics
2.1.1 Overview
The BeneHeart D3/BeneHeart D2 defibrillator/monitor (hereinafter called the equipment) provides four
operating modes: Manual Defib, AED, Pacer, and Monitor. The equipment is for use in hospital and
pre-hospital settings. It adopts the most advanced biphasic defibrillation technology and can deliver up
to 360J of defibrillation energy.
The equipment has an 7.0 inch color TFT LCD display with LED Backlight.
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, follows this procedure:
1 Select the Manual Defib mode, adjust the energy level if necessary
2 Charge; and
3 Deliver the shock.
Defibrillation may be performed through external paddles or multifunction electrode pads. In Manual
Defib Mode, you can also perform synchronized cardioversion.
AED Mode
In AED mode, the equipment automatically analyzes the patient’s ECG rhythm and indicates whether or
not a shockable rhythm is detected. Voice prompts provide easy-to-follow instructions and patient
information to guide you through the defibrillation process. Messages and flashing buttons are also
presented to reinforce the voice prompts.
Pacer Mode
The Pacer Mode offers non-invasive transcutaneous pacing therapy. Pace pulses are delivered through
multifunction electrode pads using a monophasic square waveform.
Monitor Mode
In Monitor Mode, the equipment is intended for monitoring, displaying, reviewing, storing and printing
multiple physiological parameters and waveforms including ECG and pulse oximetry (SpO2),
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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 the paddle tray
assembly. External paddles are rested in the paddle tray.
The front housing assembly mainly consists of LCD, keypad board, speaker, microphone, Mode Select
knob, navigation knob, alarm lamp board, front housing and front housing sheet metal, etc.
The rear housing assembly consists of CPU board, therapy module, high voltage capacitors, MPM
module, power management board, fan, measurement module panel, therapy port, recorder and
rear housing, etc.
The paddle tray is for holding the external paddles.
2-2
Page 15
B13 knob
B14 speaker
Keypad board
LCD
backlight
Indicator
Therapy
module
Paddle tray
assembly
External paddle
in-position
detection
Multi-
parameter
module
CPU and power management board
External paddle
tray
Therapy connector
50-ohm discharging
resistor
Multi-
parameter
connector panel
External paddles
Self-discharging
resistor
W8
W1
F
r
o
n
t
h
o
u
s
i
n
g
a
s
s
e
m
b
l
y
External component
W13
W14
RJ45
USB
Externally
extended IO
W2
W4
W5
W6
B15 microphone
W3
AC/DC
module
C3
C4
Recorder (D3)
Battery
W11
W9
W10
R
e
a
r
h
o
u
s
i
n
g
a
s
s
e
m
b
l
y
indicates
connection cable.
indicates hard
connection socket.
High-voltage
capacitor
B12 mode
selection switch
LCD
control
C2
CPR
module
W19
M02D
D6 interface
board
C1
Inductor
Pacing board
W20
W18
W12
W17
Alarm lamp
W7
W15
CO2
watertrap
W16
Recorder (D6)
W11
Notes:
1. The D3 recorder is placed on the rear housing while the D6 recorder is placed on the
front housing.
2. For D6, the multi-parameter module and the parameter connector panel are connected
directly in hard connection mode; for D3, the multi-parameter module and the parameter
connector panel are connected through wires.
3. The D6 needs to be connected to an external interface through the D6 interface board.
2.3.1 System Structure
2-3
Page 16
CPU and power
management board
Power
management
Main
control
AM3352
MSP430
UART
Lithium
batteries
ACDC
module
Power
Therapy
module
GPIO
M51C
Module
UART+GPIO +Power
GPIO
Navigation
knob
Mode
switch
Alarm
lamp
MicrophoneSpeaker
LCD
CPR sensor
Recorder
module
M02D
module
UART+ Power
M0
Keypad board
RS232+Power +GPIO
URAT+Power
GPIO+Power
GPIO+ Power
LVDS+ Power
GPIO+ Power
UART+ GPIO+Power
LVDS+Power+GPIO
SmBUS+ GPIO+ Power
2.3.2 System Signal Flow
The system uses the CPU and power management board as the core. The CPU and power management
board is divided into the power management part and the main control part. The processor of the power
management part is MSP430, which mainly implements communication with external lithium batteries
and power management. The processor of the main control part is AM3352, which communicates with
and controls other subsystem modules (including the therapy module, M51C module, M02D module,
recorder module, CPR sensor, and keypad board on the front housing). The main control module
communicates with other subsystems through asynchronous serial ports. The keypad board on the front
housing implements the transit between man-machine interaction interfaces and signal display. The
processor is M0, which controls input and output signals of keys, knobs, module switches, and alarm
lamps.
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Page 17
Keypad
board
MCU
TPS2490
Dual-line
DC/DC
PCON
ENABLE
RUN
CPU and power management board
EXTLD
Single-line
DC/DC
VCC_EN
2.3.3 Signal Sequence of Power-On/Off
The power-on/off action is triggered by the naviagation knbo on the keypad board of the front housing.
The power-on/off process is controlled by the power management processor as follows:
Power-on process: When you rotate the mode switch on the front panel of the defibrillator/monitor to a
mode other than "Off", the PCON signal value is changed from 1 to 0 to awake the MCU. The MCU
immediately outputs the ENABLE control signal to the TPS2490 enabling the VBUS. Then, the MCU enables
the RUN signal control of the dual-line DC-DC module to output 5 V (VBB) and 12 V signals.
Power-off process: When your rotate the mode switch to "Off", the PCON signal value is changed from 0 to
1, and the MCU outputs the ENABLE=0 and RUN=0 signals to shut down the VBUS and the DC-DC module.
2.4 Front Housing Assembly
The front housing assembly consists of display assembly, a keypad board, a speaker, a microphone, a
Mode Select knob, a navigation knob, an alarm 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 a selection. 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 and Pacer) and
power-off. The unused positions are mechanically disabled.
Speaker
The speaker emits alarm tones, key-stroke tone, heart beats and PR sound. It supports the functions of
PITCH TONE and the multi-level volume. The speaker is connected to the keypad board.
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Page 18
AC-DC
BAT1
BAT2
Dual-battery management
system
Charging circuit
3.3V
LDO
MCU
Vbus
5V DC-DC
12V DC-DC
Multi-function
port (reserved)
Speaker
LCD
M51C module
CPR Sensor
USB flash drive
Main control
3G/4G module
Keypad boards
on left and right
electrode pads
Keypad board
on front housing
3.3V DC-DCBluetooth
Wifi
M02D module
Recorder
Therapy board
VAC
BC
SMBC
SMBD
AC and battery in-position and energy detection
EXTLD
AD sampling
Overvoltage
protection
Buzzer
alarm
3.3V, 5V, 12V
AD sampling at 3.3 V, 5 V, 12 V, and 18 V
3.3 V, 5 V, and 12 V overvoltage
protection
18V
18V
12-17V
Dual-battery switching control
Overcurrent and power
protection
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 to drive the
green and yellow alarm lamp. The drvie current 60mA.
2.5 Paddle Tray
The paddle tray is used to hold paddles. It has a 50 ohm test load and position detective switch inside.
When the equipment runs self tests, test current will pass through the test load.
2.6 Rear Housing Assembly
The rear housing assembly consists of the CPU and power management board, therapy module, high
voltage capacitors, M51C module, recorder, rear housing, parameter receptacle panel, and therapy port.
2.6.1 Power System
2-6
Page 19
CPU and power management board
Power management
Main control
AM3352
MSP430
UART
AC/DC board
It has AC mains as an input and outputs 18VDC.
Battery
Its rated voltage is 14.8V, 3000mAh. Or, its rated voltage is 15.1V, 5600mAh.
CPU and power management board
It manages the system power input, supplies different system power, and monitors the power status. The
power management part implements battery charging and status information management.
The priority of system power supply is AC mains, Battery. That is to say, when AC is not available, Battery is
used.
2.6.2 Main Control System
Serving as the core of the system, the main control system implements the display, storage, printing, and
review of parameters and waveforms, as well as parameter algorithm processing.
The integrated CPU and power management board consists of the MSP430 for power management and
the AM3352 for main control. The MSP430 monitors the power status and controls the power-on/off; the
AM3352 implements man-machine interaction, screen display, and AED algorithm. The main control
module part and the power management part communicate with each other through asynchronous serial
ports.
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Page 20
MCU
Defibrillation
charging and
discharging
Cable type
identification
ASIC
Pace detection
High-pass +
amplification
Anti-
defibrillation
Hardware
low-pass
Impedance
coupling
p-lead
Keypad
identification/lamp
8IO
High voltage portion of
defibrillation and pacing
2CH current
detection
2CH voltage
detection
2CH relay
1 wire
50-ohm self-
discharging resistor
2CH relay
MCU
Uart
AD
2CH relay
ECG input
Keypad board interface
Recorder keypad board
Power interface
Signal interface
Button & indicator interface
Recorder power module
Recorder CPU
Motor drive circuit
Power control
Motor control
FPC interface
Thermal print head
2.6.3 Therapy System
The therapy system implements the measurement of P-lead input ECG and human body impedance, as
well as the defibrillation and pacing functions. The pacing function is implemented by the optional pacing
module.
2.6.4 Recorder
The recorder implements the parameter and waveform printing function by using the universal TR6F
recorder module.
The recorder receives data from the CPU board and then sends the data to a thermal head for printing.
The recorder front panel has a key for starting/ stopping the recorder and a green indicator which is lit
when working normally. The recorder is connected to the keypad board which board provides connection
for the TR6F recorder. The block diagram and functional modules of the recorder are shown as below.
2-8
Page 21
Module Description
Power Interface Adjusts input voltage to run each module.
Recorder CPU Coordinates module communication, controls and processes module status.
Keypad board Interface
Motor Drive Circuit Receives control signals sent by the recorder CPU to drive the step motor.
Keypad and Indicator
Interface
FPC Interface
Serves as the data communication channel between the keypad board and
the recorder CPU.
Sends keypad commands to CPU and receives CPU commands to control the
indicator.
Sends print head information to CPU and receives CPU commands to control
the print head.
2.6.5 Parameter Measurement System
The M51C multi-parameter module implements the parameter measurement function. It mainly
implements 3/5-lead ECG, SpO2, NIBP, and RESP measurement functions.
2.7 External Device Connectors
1
2
3
4
5
6
7
2-9
Page 22
1. Hook
2. Battery
3. Equipotential grounding terminal: When the defibrillator/monitor and other devices are to be used
together, their equipotential grounding terminals should be connected together to eliminate the
potential difference between them.
4. External power input: It connects an AC power cord or a DC/AC adapter to run the equipment
respectively on the external AC mains or DC power supply.
5. Multifunctional connector: It connects a CPR sensor, provides ECG output and defib synchronization
input.
6. USB connector
7. Network connector: It is a standard RJ45 connector.
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Page 23
3 Unpacking and Installation
This 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 the packing 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 packing list.
In case of damage during transportation, keep the packing material and notify the supplier
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
3-1
Page 24
CAUTION
3.2 Preparation for Installation
3.2.1 Preparation for Installation Site
1. Ensure that the site meets all safety, environmental and power requirements
2. Check that required power sockets are available.
3. Check that a network connector is available if the defibrillator/monitor needs to be connected 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 flammable
anaesthetics, vapours or liquids.
The environment where the defibrillator/monitor will be used should be reasonably free 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 environment
0 to 45℃ (at least 60 minutes of working time when the temperature
Operating Temperature
Operating humidity 10% to 95%, (non-condensing)
Operating altitude
Storage environment
Storage temperature
Storage humidity 10% to 95%, (non-condensing)
Storage altitude
reduces from room temperature to – 20℃)
(5 to 40℃ for CO
-381mmHg to + 4575mmHg (106.2kPa to 57kPa)
430mmHg to + 790 mmHg for CO
-30 to 70℃(-20 to 60℃ for CO2 module)
-381mmHg to +4575 mmHg (106.2kPa to 57kPa)
430mmHg to + 790 mmHg for CO
module)
2
module (57.3kPa to 105.3kPa)
2
module (57.3kPa to 105.3kPa)
2
3-2
Page 25
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 not loose.
WARNING
Only power sockets with protective grounding can be used.
The electrical specification is as follows:
Line voltage: 100 to 240VAC (±10%)
Current: 1.8 A
Frequency: 50/60Hz (±3Hz)
3.3 Preparation for Power On
Before connecting the power cord to the defibrillator/monitor's power input, check that
The mains voltage meets the requirement.
3-wire power cord is used. The power socket should be 3-wire also. This ensures that the
defibrillator/monitor is properly grounded. Do not use 2-wire power cord or socket.
The equipotential grounding terminals should be connected together when the defibrillator/monitor
and other devices are to be used together.
The defibrillator/monitor is not placed under the infusion bag or placed where their might be liquid
spillage. This protects the defibrillator/monitor from liquid ingress.
3.4 User Test
A user test shall be performed after the defibrillator/monitor is installed. Follow this procedure:
1. Connect AC mains or install the battery.
2. Connect the external paddles. If pads are used, connect the test load.
3. Select the Main Menu button on the equipment’s front panel and select [User Test >>]. Select all test
items and press [Start] to perform user test.
NOTE
Install the battery and properly place the external paddles in the paddle tray or connect the
pads cable and 50 Ω test load. Otherwise the User Test will fail.
3-3
Page 26
See the BeneHeart D3/ BeneHeart D2 Defibrillator/Monitor Operator’s Manual (P/N: 046-010599-00)
for the detailed information on user test.
3-4
Page 27
4 Testing and Maintenance
4.1 Introduction
To ensure the equipment always functions normally, qualified service personnel should perform regular
inspection, maintenance and test. This chapter provides a checklist of the testing procedures for the
equipment with recommended test equipment and frequency. The service personnel should perform the
testing and maintenance procedures as required and use appropriate test equipment.
The testing procedures provided in this chapter are intended to verify that the equipment meets the
performance specifications. If the equipment or a module fails to perform as specified in any test, repairs
or replacement must be done to correct the problem. If the problem 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 [Service Mode] menus
to avoid loss of data.
Before testing, service personnel should acquaint themselves with the test tools and make sure
that test tools and cables are applicable.
When testing monitoring parameters, move the Mode Select knob to Monitor to access the
Monitor Mode.
When performing therapy function tests, move the Mode Select knob to corresponding mode.
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4.1.1 Test Report
After completing the tests, service personnel can record test results by referring the Test Report at the end
of this chapter.
4.1.2 Recommended Frequency
Test item After
repair
Visual inspection
√
Function
suspected 6 months
12
months
24
months
Power-on Test
User test
Function Checks Recorder check
ECG Cable Test
Manual
defibrillation
tests
Pacing test
Preventive
Maintenance
(Only Performance
Tests)
Performing Tests in
the Installation
Mode
ECG Performance test
Resp Performance test
SpO2 Performance test
Maintain NIBP Performs the NIBP
Maintain CO2 Calibrates the CO2
Version Displays the
CPR Displays the
Format Data
Card
Watchdog Test Checks if the
Modify
Password
Charge/
discharge
Energy disarming
Synchronous
defibrillation
Module calibration
leakage test and
NIBP accuracy test
module.
equipment
information
battery information
of the CPR sensor
Formats the
storage card.
equipment can be
normally restarted.
Modifies the
password for
√
√
√
√ √
√ √
√ √
√ √
√ √
√
√
∕
∕
√
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√
√
√
√
√
√
√
√
∕
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Test item After
repair
Performing Tests in
the Installation
Mode
Electrical safety
tests as per
IEC60601-1
entering the
installation mode.
Earth leakage
current
Patient leakage
current
Patient auxiliary
current
√
4.2 Visual Test
Inspect the equipment for obvious signs of damage. The test is passed if the equipment has no obvious
signs of damage. Follow these guidelines when inspecting the equipment:
Carefully inspect the housing, the display screen and the buttons for physical damage.
Inspect accessories for signs of damage.
Inspect all external connections for loose connectors, bent pins or frayed cables.
Function
suspected 6 months
12
months
√
24
months
Inspect all connectors on the equipment for loose connectors or bent pins.
Make sure that safety labels and data plates on the equipment are clearly legible.
4.3 Power On Test
This test is to verify that the defibrillator/ monitor can power on normally. The test is passed if the
defibrillator/ monitor starts up by following this procedure:
1. Place the external paddles on paddle tray, insert the battery in the battery compartment, and then
connect the equipment with AC mains. 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 and is turned on
properly.
3. Check the display of technical alarm area, prompt area and battery status indicator on the upper right
corner of the main screen to judge whether the equipment runs normally.
If a power-on self test error happens, the service indicator is illuminated, and alarm messages are
displayed in the technical alarm area.
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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
test load.
2. Insert the battery into the equipment. Connect the AC mains if no battery 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 User Test screen.
4. Check the test items you want to perform and select [Start] to start user test
The test results indicate the condition of the system. If any item fails, the Red Cross status indicator flashes.
If you cannot pass User Test or the message “Connect paddles cable, and place paddles in paddle 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 [Lead Select] 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 not correct.
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4.5 Password for Installation Mode
Accessing installation mode is password protected. The required password is set to 888888 before 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 Select knob to
Manual Defib.
2. Connect the external paddles to the equipment and place the paddles on the defibrillator/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 be displayed as
0 or blank.
5. Select the energy level to 1J.
6. Charge/discharge the equipment to verify the energies measured by the analyzer meet the 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 charged battery. Move the
Mode Select knob to Manual Defib. Repeat steps 5 to 7.
9. Use multifunctional electrode pads. Repeat steps 5 to 7.
10. Verify that the equipment records the shock events automatically and correctly.
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Energy Disarming
1. Run the equipment on fully charged battery. Move the Mode Select knob to Manual Defib.
2. Connect the external paddles to the equipment and place the paddles on the defibrillator/pacer
analyzer.
3. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as
0 or blank.
4. Select the energy level to 360J.
5. Charge the equipment.
6. Verify that the charge tone is issued during charging.
7. Press the “Disarm” soft key to discharge the energy internally.
8. Verify that a prompt “Charge Removed” appears and the charge done tone stops.
9. Verify that the value measured by the analyzer is 0J or blank.
10. Enter the Configuration-Main menu, select [Manual Therapy Setup] and set [Time to Auto Disarm]
to [60s].
11. Exit “Configuration Management”. The equipment restarts automatically.
12. Set the analyzer to Energy Measurement mode. In this case, the energy value should be displayed as
0 or blank.
13. Select the energy level to 360J.
14. Charge the equipment. Count time after charging is completed.. Verify that the prompt “Shock
Removed” appears on the equipment and the energy measured by the analyzer is 0J or blank after 60
seconds.
15. Use multifunctional electrode pads. Repeat steps 3 to 14.
Synchronous Defibrillation
1. Connect the external paddles and ECG cable to the equipment. Place the paddles ECG electrodes on
the defibrillator/pacer analyzer.
2. Set the analyzer to Measurement Mode and output normal sinus rhythms, e.g. amplitude value 1mV
and HR 60bpm.
3. Enter Configuration Management. In the [Manual Therapy Setup] menu, set [Sync After Shock] to
[On].
4. Adjust the energy setting of the equipment to be 10J.
5. Press the [Sync On] soft key to start synchronous defibrillation. If Remote Sync is switched on, press
the [Sync On] soft key and select [Local] to start synchronous defibrillation
6. Select [Pads] or [Paddles] as the ECG source and begin charging.
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 the analyzer is
10J±2J.
9. Verify that the delay time of synchronous defibrillation measured by the analyzer is less than 60ms.
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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 the defibrillator/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 is 70
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 [Pacer Output] to
[200mA].
7. Press the [Start Pacing] soft key. Verify that the pacer rate measured by the analyzer is 170
ppm±2ppm, and the measured current is 200 mA±10mA.
4.6.3 ECG Test
Performance Test
Test tools
ECG simulator
1. Connect the simulator to the equipment’s ECG connector with ECG leadwires.
2. Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitude as 1mV.
3. Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ±
1 bpm.
4. Disconnect the simulator from the equipment’s ECG connector. Verify that ECG Lead Off alarm
behaves correctly.
5. On the equipment, set [Paced] to [Yes], the simulator is configured as pace signals. Verify that pace
signals are detected and pace pulse marks are displayed.
6. Connect the simulator to the equipment’s therapy module with pads.
7. Set the patient simulator as follows: ECG sinus rhythm, HR=80 bpm with the amplitude as 1mV.
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8. Check the ECG waves are displayed correctly without noise and the displayed HR value is within 80 ±
1 bpm.
9. Disconnect the simulator from the equipment’s therapy module. Verify that ECG Lead Off alarm
behaves correctly.
10. On the equipment, set [Paced] to [Yes], the simulator is configured as pace signals. Verify that pace
signals are detected and pace pulse marks are displayed.
ECG Calibration
Tool required:
Vernier caliper
1. Connect the simulator to the equipment’s ECG connector with ECG leadwires.
2. Select the ECG parameter area to enter the [ECG Setup] menu.
3. Select [Others>>] → [Calibrate]. A waveform signals appear on the screen and the message [ECG
Calibrating] is displayed in the prompt information area in the lower left corner of the screen.
4. Compare the amplitude of the waveform with the wave scale. The difference should be within 5%. If
needed, you can also print out the waveform and the wave scale.
5. After ECG calibration is completed, select [Stop Calibrating].
6. Connect the simulator to the equipment’s therapy module with pads.
7. Repeat steps 3–5.
4.6.4 Resp Test
Test tools
Resp Patient simulator
1. Connect the patient simulator to the ECG connector on the module.
2. On the defibrillator/monitor, select the Resp widow to enter the Resp Setup menu. Set [Lead] to [II].
3. Configure the simulator as follows: set Lead to II, base impedance line to 1500 Ω; delta impedance to
0.5 Ω, and respiration rate to 40 rpm.
4. Check that respiration waveform is not distorted and the displayed Resp value does not exceed 40±2
rpm.
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Defibrillator/monitor
Connector for
NIBP cuff
Balloon pump
Metal
4.6.5 SpO2 Test
Test tool
Patient simulator.
1. Connect the patient simulator to the equipment’s SpO
2. Select the model and manufacturer of the SpO
2
connector.
2
module under test. Configure the parameter as SpO
96% and PR 80 bmp.
3. The displayed SpO
Mindray
Masimo
and PR values should be within the ranges listed below
2
SpO2 (%) PR (bmp)
96% ±2% 80±3
96% ±2% 80±3
MAX-A, MAX-N, MAX-P, MAX-I 96% ±2%
Nellcor
DS-100A, OXI-A/N, OXI-P/I 96% ±3%
80±3
4.6.6 NIBP Tests
Accuracy Test
The NIBP accuracy test is required at least once every two years or whenever you doubt the NIBP reading.
Tools required:
T-shape connector
2
Tubing
Balloon pump
Metal Vessel, volume 500±25 ml
Calibrated manometer for reference, accuracy not lower than 1 mmHg
To perform the accuracy test:
1. Connect the equipment as shown below.
Manometer
Tubing
vessel
2. Before inflation, the reading of the manometer should be 0. If not, disconnect the airway and
reconnect it until the readings is 0.
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monitor
onnector for
NIBP cuff
Cuff
3. Press the Main menu button on the equipment’s front panel. Select [Others>>] →[Installation
Mode>>] → enter the required password →[Maintain NIBP] →[Start Accuracy Test].
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 steps 3 and 4.
6. Raise the pressure in the metal vessel to 200 mmHg with the balloon pump. Repeat steps 3 and 4.
Note
You can replace the balloon pump and manometer with a blood pressure simulator to form a
test system.
NIBP Leakage Test
The NIBP leakage test checks the integrity of the system and of the valve. It is required at least once every
two years or whenever you doubt the NIBP reading.
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.
Defibrillator/
C
3. Press the Main menu button on the equipment’s front panel. Select [Others>>] →[Installation
Mode>>] → enter the required password →[Maintain NIBP] →[Start Accuracy Test].
After about 20 seconds, the equipment automatically deflates. This means the leakage test finishes.
When the accuracy test is completed, the result will be displayed. If the message [NIBP Pneumatic Leak]
is displayed, it indicates that the NIBP airway may have leakages. Check the tubing and connections for
leakages, and then perform a leakage test again.
Tubing
Cylinder
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onnector for NIBP
Metal
When you select the [Start Leakage Test] button, it turns to be [Stop Leakage Test]. Select [Stop Leakage
Test], leakage test stops and the button turns to be [Start Leakage Test] again.
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
Defibrillator/monitor
C
Tubing
Manometer
cuff
Balloon pump
vessel
2. Before inflation, the reading of the manometer should be 0. If not, disconnect the airway 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 pump output
pressure to 150 mmHg. After the system is stable, click the [Calibrate] button to start 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. Click the [Calibrate]
button and start calibration.
All the calibration results will be displayed in the [Calibrating NIBP] screen. If the calibration fails, please
check the connections and then perform a calibration again.
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Gas cylinder
as valve
4.6.7 CO2 Module Tests
Leakage Check
1. Access the [CO2 Setup] menuand set [Operating Mode] to [Measure]. Wait forCO
2. Block the CO
and Microstream CO
Sidestream: Check that alarm message [CO2 Filter Line Err] is displayed on the screen in 3s.
module gas inlet completely. This will cause different reactions from the Sidestream
2
modules.
2
warm-up.
2
Block the gas inlet for another 30s, if the alarm message does not disappear, the module does
not leak.
Microstream CO
module: [CO2 Purging…]isdisplayed in 3s.Block the gas inlet for another 30s,
2
if the alarm message [CO2 Tubing Err] appears, the module does not leak.
Module Calibration
Test tools
Gas cylinder, with 6% of CO
and balance gas N2.
2
T-shape connector
Tubing
For sidestream CO2 module, zeroing is required before calibration. Enter [CO2 Setup] menu and select
[Zero] to perform zeroing.
To calibrate the CO
module, follow this procedure:
2
1. Make sure that the CO
module has been warmed up or started up.
2
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.
To the air
Tubing
G
Defibrillator/
monitor
3. Vent the tubing to the CO
by opening the gas valve.
2
4. Access the [Maintain CO2] menu. To do so, Press the Main Menu button on the equipment’s front