Cu Medical Systems - Life Gain, Disfibrilador - Manual Tecnico

Edition 1
LiFEGAIN CU-HD1
Service Manual
CU Medical Systems, Inc.

Notice
LiFEGAIN CU-HD1 Service Manual
CU Medical Systems, Inc. reserves the right to make changes to the device specifications contained in this manual
at any time without prior notice or obligation to customers.
Edition 1
Printed in the Republic of Korea
Publication Date: August, 2008
Service Manual Part No.:
Service Manual Version: 1.00.232
Software Version
> Main Processor Software Version:
> Therapy Processor Software Version:
© 2008 CU Medical Systems, Inc.
All rights are reserved. Permission is granted to copy and distribute this document for educational use.
No part of this manual may be reproduced without the permission of CU Medical Systems, Inc.
Table of Contents
1. INTRODUCTION ....................................................................................................................... 4
1.1 Introduction of Product ................................................................................................. 4
1.2 Overview of Service Manual ......................................................................................... 5
1.3 Warning, Caution, and Notice ....................................................................................... 5
1.4 Abbreviations ................................................................................................................. 5
2. DEVICE DESCRIPTION ........................................................................................................... 6
2.1 Description of Appearance ........................................................................................... 6
2.2 Accessories .................................................................................................................... 9
2.3 Configuration of Product Screen ............................................................................... 13
2.4 Dependence and Independence of Internal Devices ................................................ 16
3. MAINTENANCE ...................................................................................................................... 17
3.1 Basic Maintenance ....................................................................................................... 17
3.1.2 Maintenance of Accessories .................................................................................... 17
3.1.2.1 Paper Replacement ........................................................................................ 17
3.1.2.2 Battery Maintenance ....................................................................................... 18
3.1.2.3 ECG Cable Maintenance ................................................................................ 18
3.1.2.4 Maintenance of SpO2 Sensors and Connection Adapters .......................... 18
3.1.2.5 Maintenance of External Defibrillation Paddles .......................................... 19
3.1.3 Cleaning .............................................................................................................. 19
3.2 Maintenance Checklist ................................................................................................ 20
4. PERFORMANCE VERIFICATION/INSPECTION ................................................................... 21
4.1 Target for Verification .................................................................................................. 21
4.2 Tools or Equipment ...................................................................................................... 21
4.3 Performance Verification (Visual Inspection)............................................................ 21
4.4 Performance Verification (Functional Check) ........................................................... 21
4.4.1 Self Test (Daily, Weekly, Monthly) .................................................................... 22
4.4.2 Manual Self Test ................................................................................................. 23
4.4.3 Self Test Result (Error Code Interpretation) .................................................... 24
4.4.4 Defibrillation Shock Test ................................................................................... 25
4.4.5 Disarm Function Test ........................................................................................ 26
4.4.6 ECG Measuring Function Test .......................................................................... 27
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4.4.7 Pacer Test ........................................................................................................... 28
4.4.8 SpO2 Test ............................................................................................................ 29
4.4.9 Text, Voice Prompt Test ..................................................................................... 29
4.4.10 Printer Test ....................................................................................................... 33
4.4.11 Bluetooth & Data Transmission Test.............................................................. 35
4.4.12 Menu Operation Test ....................................................................................... 36
5. Troubleshooting .................................................................................................................... 42
5.1 Power-on Test ............................................................................................................... 42
5.2 Periodic Automatic Self Test ....................................................................................... 43
5.3 Manual Self Test ........................................................................................................... 44
5.4 Possible Common Problems during Operation of Product and Solutions ............ 45
5.5 Defibrillation Function Problems and Solutions ...................................................... 45
5.6 Problems with ECG Measurement Function and Solutions .................................... 47
5.7 SpO2 Problems and Solutions .................................................................................... 48
5.8 Pacer Problems and Solutions ................................................................................... 48
5.9 Printer Problems and Solutions ................................................................................. 48
5.10 Problems in Information Transmission Function and Solutions .......................... 49
5.11 Problems in Information Saving Function and Solutions ...................................... 49
5.12 Audio Function Problems and Solutions ................................................................ 49
5.13 LCD Function Problems and Solutions ................................................................... 50
5.1.4 Key and Button Problems and Solutions ............................................................... 50
6. Repair ..................................................................................................................................... 51
6.1 Repair Philosophy ........................................................................................................ 51
6.2 Precautions for Repair ................................................................................................. 51
6.2.1. Handling Problem ............................................................................................. 51
6.2.2 Disposal & Recycling ........................................................................................ 52
6.3 Safety Considerations ................................................................................................. 52
6.3 Product Configuration ................................................................................................. 53
6.4 Internal Assemblies Disassembly .............................................................................. 58
6.6 Product Assembly ........................................................................................................ 68
7. Operation................................................................................................................................ 70
7.1 AED ................................................................................................................................ 70
7.2 Manual Defibrillation .................................................................................................... 70
7.3 Pacer.............................................................................................................................. 71
7.4 Patient Monitoring........................................................................................................ 71
8. Specifications ........................................................................................................................ 72
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Body .................................................................................................................................... 72
Defibrillation Feature ......................................................................................................... 72
Sensitivity & Specificity..................................................................................................... 73
Defibrillation Energy Variation Corresponding to the Impedance ................................ 73
Manual Defibrillation .......................................................................................................... 74
AED ...................................................................................................................................... 74
Pacer.................................................................................................................................... 75
ECG Monitoring .................................................................................................................. 75
SpO2 ..................................................................................................................................... 75
Display: 7” TFT LCD .......................................................................................................... 76
Data Storage ....................................................................................................................... 76
Printer .................................................................................................................................. 76
Bluetooth............................................................................................................................. 77
Battery ................................................................................................................................. 77
AC Power Module, SMPS .................................................................................................. 78
Cigar Jack. .......................................................................................................................... 78
AC Adapter .......................................................................................................................... 78
Appendix 1 ................................................................................................................................. 79
Appendix 2 ................................................................................................................................. 82
Appendix 3 ................................................................................................................................. 84
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1. INTRODUCTION
1.1 Introduction of Product

LiFEGAIN CU-HD1 is a medical device that provides integrated functions such as patient
monitoring, a pacer, and an automatic/manual defibrillator.
- AED (Automated External Defibrillator) Function

In the Automated Defibrillation Mode, the LiFEGAIN CU-HD1 provides the ability to
measure and analyze the patient’s ECG, to charge the defibrillator with energy, and to
deliver the charged energy to a patient and guide CPR. In the Auto Defibrillation Mode,
the LiFEGAIN CU-HD1 informs the user whether electric shock is required through the
analysis of the ECG, and guides the operator through the process using voices and texts
for efficient defibrillator therapy.
- Manual Defibrillator Function
In the Manual Defibrillation Mode, the operator may read the ECG of the patient and, if
defibrillation therapy is deemed necessary, the operator may perform charging and
defibrillation at their discretion. Also, in the Manual Defibrillation Mode, the operator may
deliver defibrillation energy to the patient using disposable electrodes and reusable
paddles.
- Pacer Function
The LiFEGAIN CU-HD1 has a noninvasive, percutaneous pacing function. In the pacer
menu, the size of the current, the pacing current rate, and the pacing method (Fixed
Mode or Demand Mode) may be selected.
- Patient Monitoring Function (ECG and SpO2)
In the Patient Monitoring Mode, the SpO2 and ECG of the patient may be measured
noninvasively. The ECG information is displayed on a 7-inch TFT LCD in various types
such as the 3-lead, 5-lead, and 12-lead types.
- - Communication and Patient Information Transfer Function
The LiFEGAIN CU-HD1 has a function for the transfer of information on the patient’s
biometric signals, such as the SpO2 and ECG measured in the Patient Monitoring Mode in
real time, to external terminals through Bluetooth communication.
- Internal Printer
The printer, built into the front part of the product, prints a patient’s information, a patient’s
ECG information, and the contents of the events inputted by the user.
4
1.2 Overview of Service Manual
This Service Manual provides information on the use and maintenance of the product and
information for device managers on the repair and performance maintenance of the product.
The LiFEGAIN CU-HD1 may not include all the options described in this manual, depending on
the purchase options. The purchase options therefore need to be checked through the purchase
staff, or the device management documents need to be checked before repairing the product.
For information on the operation of the LiFEGAIN CU-HD1 which is not described in this Service
Manual, refer to the User’s Manual.
1.3 Warning, Caution, and Notice

In this manual, the following terms are used to highlight safety-related cautions that must be
observed when using of the product.
In the event of a user or a patient incurring an injury due to a user's negligence or obvious
incorrect operation, the company or its authorized agents are under no obligation for such
accidents.
WARNING Dangerous situations, including death or severe injury may occur if
instructions are not observed.
CAUTION Instruction that directly or indirectly addresses company policy in order to
protect people or property.
NOTICE Description of terms or additional description to be referred to.
1.4 Abbreviations
AED: Automated External Defibrillator
VF: Ventricular Fibrillation
VT: Ventricular Tachycardia
ECG: Electrocardiography
SpO2 : Saturation of oxygen in arterial blood flow
NSR: Normal Sinus Rhythm
HR: Heart Rate
MST: Manual Self Test
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2. DEVICE DESCRIPTION
2.1 Description of Appearance
Front
6
Right Side
Left Side
7
Back
8
2.2 Accessories
Accessories are shown in the table below and each accessory may be replaced when old or
worn. When disposing of an accessory, follow the waste disposal guidelines, depending on the
kind of waste.
Accessory List
Part Number Accessory Name
External Paddles
Internal Paddle Adapter
Disposable Defibrillation Pads (for Adults)
Disposable Defibrillation Pads (Pediatric)
9
Pads Connection Adapter
ECG Measurement Cable (3-Lead), US Type

ECG Measurement Cable (3-Lead), European Type


SpO2 Measurement Sensor
10
Extension Cable of SpO2 Measurement Sensor
AC Power Module
Battery Module
Car Cigar Lighter Jack
AC Power Adapter
Bed Rack
11
SD Card
Disposable ECG Monitoring Electrodes
Printer paper
Self-Test Load Resistance
Conductive Gel
Carrier Bag
12
2.3 Configuration of Product Screen
In the product, a 7-inch TFT LCD is used, and the ECG of the patient and various kinds of
information are differently displayed on the LCD depending on the mode. The screen displayed
in each mode is shown below.
- Configuration of Screen in AED Mode
- Configuration of Screen in Manual Defibrillation Mode
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- Configuration of Screen in Pacer Mode
- Configuration of Screen in Patient Monitoring Mode

In the Patient Monitoring Mode, the screens may be configured into three kinds, depending
upon the information on the patient’s biometric signals, and is displayed, depending on function,
as shown below: SpO2 Measurement, ECG and SpO2 Measurement, and 12-Lead ECG
Measurement.
SpO2 Measurement Mode
14
ECG & SpO2 Measurement Mode
12-Lead ECG Measurement Mode
15
2.4 Dependence and Independence of Internal Devices
The information on the dependence and independence of the internal and external components
of the LiFEGAIN CU-HD1 is as described below. When repairing the product, dependent parts
should be replaced together.
The classification of dependence and independence of boards, modules, and devices
constituting the product is shown in the figure. The components in the solid lines do not
influence other modules or boards; however, the main board and the therapy board should be
replaced together because they require calibration before shipment.
Since each instance that necessitates the replacement of the component is not additionally
explained in this Manual, the information described above should be remembered when
repairing the product, in order to solve any problems.
Diagram of dependence and independence of components

(the modules in the solid lines are independent modules).
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3. MAINTENANCE
3.1 Basic Maintenance

3.1.1 Operation Check
The operation check is performed in order to ascertain whether there is a problem with the
power supply or with operation..
A power supply problem can be verified by checking the power-related indicator lamps or the
relevant icons on the LCD display when either the AC power module or the battery module is in
use. If no error is found with regards to the power supply when the equipment is operated
according to the User’s Manual, it may be assumed that there is no power supply problem.
In order to check the recognition of accessories other than the power supply, as well as the
recognition of normal operation, each mode has to be checked and verified with relation to the
product.
3.1.2 Maintenance of Accessories

3.1.2.1 Paper Replacement
For feeding the printer paper, load the paper according to the sequence below. .
1. As indicated in the figure on the left, pull the lever on the right hand side of the
LiFEGAIN CU-HD1 printer forward. .
2. The front cover of the printer will be open as shown in the figure on the right.
UI 에 있는 한글 바꾸기
3. Put the printer paper into the printer in the direction shown in the following figures, and
pull out some of the paper.
4. Push the printer cover back to its default setting, until it makes a "click" sound.
5. If the Rotary switch is set to the monitor mode, the green printer power lamp will be on.
You can use the “Feed” button to take as much printer paper as you want.
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3.1.2.2 Battery Maintenance
Rechargeable batteries should always be maintained at a certain charge level, or above, in
case of a situation arising where AC power is unavailable. The charge level may be checked
using the Battery Capacity Indication Button at the back of the battery module.
CAUTION Avoid any short circuits caused by the insertion of metallic materials into
the terminals of the battery modules.
3.1.2.3 ECG Cable Maintenance

Three kinds of cables, namely 3-Lead, 5-Lead and 12-Lead cables, may be used with the
LiFEGAIN CU-HD1 to measure ECGs.
ECG cables are designed to be used with the LiFEGAIN CU-HD1 only, and cannot be used with
other equipment from CU Medical Systems or other companies. ECG Cables have unique
codes for automatic recognition when they are connected with the terminals of the LiFEGAIN
CU-HD1. Therefore, ECG Cables should not discretionally be modified or changed.
If the coatings of the ECG Cables are damaged, do not use them and dispose of them
according to disposal guidelines.
3.1.2.4 Maintenance of SpO2 Sensors and Connection Adapters

SpO2 Sensors measure SpO2 by analyzing the transmission and absorption levels of light, and
thus the sensor part that generates light should always be kept clean. If the LED generating light
is covered with foreign substances, the foreign substances should be removed before using the
equipment for patients. Avoid possible damage to the connection terminal of the adapter when
connecting the product with a SpO2 sensor.
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3.1.2.5 Maintenance of External Defibrillation Paddles
External Defibrillation Paddles are used in defibrillation therapy and require continuous
maintenance. When the External Defibrillation Paddles are used, their conductive gel should be
wiped off of the metallic electrodes. The External Defibrillation Paddles should also be wiped
clean before use, in the same manner. If the metallic plates dry with a coating of foreign
substances or conductive gel, the patient may get burnt when defibrillation therapy is performed,
and the contact between the External Defibrillation Paddles and the patient may not be
recognized.
3.1.3 Cleaning
For any device problems resulting from negligence of the below cleaning instructions, the free
repair service may not be applicable, even during the warranty period.
Keep the main body and cables away from dust and pollution, and under usual circumstances,
clean them with a soft cloth. There is a risk of device damage from forcible pressure or shock.
How to Clean and Take Precautions

Always keep the product clean, and check the damage status. If damaged, make a
service request.
Check out the product operation status on a periodic basis, whether it works normally
and functions to maintain the product’s performance readiness for an emergency
situation or not.
When cleaning the product, be careful not to damage major terminals such as the
defibrillation cable port and the DC power port etc.
Check the expiration dates of the defibrillation pads and the disposable parts in
particular, and if expired, replace them.
Used disposable supplies must be discarded according to the related law. When
discarding them, be careful not to cause environmental pollution.
When cleaning the product and its accessories, please use a soft cloth. Forcible
pressure or shock may cause a device malfunction.
Do not immerse any part of the product or its accessories in fluid or soap. Do not let
any fluid enter the casing of the device.
Do not use strong, acetone-based cleaners or abrasive materials when cleaning the
device.
The filter of the LCD in particular, could be damaged.
Do not sterilize the product.
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NOTICE When cleaning the product with a common cleaner, avoid possible corrosion of
the terminals and electrodes and melting of the resin of the main body through an
organic solvent or a basic substance.
3.2 Maintenance Checklist

A checklist for the maintenance of the LiFEGAIN CU-HD1 should be prepared, referring to the
User’s Manual. The items needed for its management should be prepared according to the
internal rules of the entity operating the product.
The maintenance checklist recommended in the User’s Manual is shown below.
Maintenance Checklist
LiFEGAIN CU-HD1
Manufacturing No.: __________________ Location/Vehicle ID:
Date
Schedule
Exterior Condition
Accessory Maintenance
Status
Error Correction or
Measures
Inspected by Signature
of Operator
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4. PERFORMANCE VERIFICATION/INSPECTION
4.1 Target of Verification

Performance verification may be performed when an additional inspection or an unscheduled
inspection is required in addition to the periodical inspections. Proper working order of the
accessories and any errors generated in the major functions of the product may be identified
through performance verification and inspection.
4.2 Tools or Equipment

The tools or equipment that is needed to check performance, depending upon the major
functions of the product, is shown below:
- Defibrillation Simulator/Analyzer
- ECG Simulator
- Pacer Simulator/Analyzer
- SpO2 Simulator (if available)
- Computer for Bluetooth Communication
WARNING Use a Simulator/Analyzer that has been inspected and calibrated by authorized
personnel.
4.3 Performance Verification (Visual Inspection)

The items to be inspected in the performance verification are as shown below:
A. Is the product the LiFEGAIN CU-HD1?
- Check whether the shape and configuration of the product are same as those of the
LiFEGAIN CU-HD1.
B. Can any problems be found with regards to the appearance of the components of the
product?
- If they are damaged, it may result in a functional influence on the exterior of the main body.
- Check whether the exterior of the battery or the AC power module is damaged.
- Check whether the exterior of the ECG cables or the SpO2 sensors/cables are damaged.
- Check whether the printer paper is dry.
- Check whether the appearance and cleanliness of the exterior paddles are acceptable.
- Check that the appearance, exposure, and shelf life of pads and ECG electrodes are
not problematic.
- Check whether exposed metallic electrodes are corroded or damaged.
4.4 Performance Verification (Functional Check)

Functional checks may not be applicable to some functions of the LiFEGAIN CU-HD1,
depending upon the options requested by the user. After gaining sufficient knowledge as to the
options of the purchased product, perform the functional check as described below.
21
4.4.1 Self Test (Daily, Weekly, Monthly)
The self test is automatically performed by the LiFEGAIN CU-HD1, depending on the situation.
A description of the items in the self test is given below.
Power-on Self Test

To ensure that the device is always ready for any emergency, a self test is performed by the
device. The list of items tested in this test is as follows:
- Battery Capacity inspection: Verify that the Battery Capacity is sufficient for proper
operation. If the Battery Capacity becomes too low, the device prompts you on the low
battery condition.
- Button Status Check: Checks whether the charge button is pressed or not, preventing
unintended recharging.
- Charge/Discharge test: Verifies the proper functioning of the charging and discharging
subsystems.
Daily Self Test

This test is done on a daily basis and the following items are checked:
- This test is the same as the battery capacity test done during the "power on" self test.
- Checks the Charge button status of the device to prevent unintended recharging.
- Checks the Shock button status of the device.
Weekly Self Test

This test is done on a weekly basis and the following items are checked:
- Checks the daily self test items.

- Verifies the functionality of the SpO2 Pulse Oximeter.
- Verifies the functionality of the internal ECG circuit.
Monthly Self Test

This test is done on a monthly basis and the following items are checked:
- Checks the weekly self test items.
- Tests whether the product can replenish itself with 2J energy, and checks the functionality
of charging and discharging through internal discharging.
22
CAUTION For a proper self test of the LiFEGAIN CU-HD1, the AC power module or the
battery module should be installed.
4.4.2 Manual Self Test

The manual mode test evaluates all the functions tested in all the self test modes.
To initiate a manual self test, use the "Self Test" in the "Device Management" menu. Self test is
the process with which the user checks the proper operation of the major functions needed
when operating the product.
The process of the manual self test is as described below.
Manual Self test
A. Go to Menu > Device Management > Self Test items.

(To check out the defibrillation energy status, please connect the test resistance to the
product.)
B. A window prompting for verification will appear. Please check it again.
The product cannot be used during the manual self test session. The following
section will give you the step-by-step testing guidelines.
C. If the mode is switched to the "Self Test" mode, product information (model name,
serial number), software version information, and the date when the self test was last
done, will be displayed on the screen.
D. System Test: A common system test is performed.
E. Mode Rotary Key Test: The rotary switch is checked. If the instruction window appears,
move the rotary switch to 150J of the manual defibrillator mode.
F. Charge Button Test: The operational status of the Charge button is checked. Press
the Charge button according to the instructions.
G. Shock Button Test: The operational status of the Shock button is checked. Press the
Shock button according to the instructions.
H. Audio Test: Checks the speaker functions. After the voice test, there is a process to
check whether to operate the voice function by pressing the menu selection switch.
I. Defibrillation Test: Checks the defibrillation functionality, including a test for the automatically
23
charging 200J and the delivery of defibrillation energy. To test the 200J defibrillation
operation, you must press the shock button, and use the checkup resistance to implement
the test. If there is no resistance or simulator connection to deliver the defibrillation energy,
the device discharges the internally charged energy, leading to failure.
J. Pacer Test: Pacer function is checked.
K. ECG Lead Test: The ECG measuring part (12 Lead ECG) is checked.
L. Battery Part A Test: Power terminal « A » is inspected.
M. Battery Part B Test (Battery Part B Test): Power terminal « B » is checked.
N. SpO2 Test: Inspects the functionality of the SpO2 measurement module.
O. Printer Test: Inspects the functionality of the printer.
If the above manual test function has been completed, a message window will appear, stating
that the device must be closed.
If the test results are indicative of a problem during the self test, solve the problem by referring
to the Manual Self Test in “Chapter 5 Troubleshooting.”
4.4.3 Self Test Result (Error Code Interpretation)

The codes of the errors that may be generated during manual/automatic self tests and use of
the product are shown below. Each error code is displayed on the left upper part of the LCD and
may be referred to when solving a problem with identification of the cause of an error.
Error Item Code Cause of Error

Battery Battery voltage is less than 14.7V.
1
Insufficiency (When only battery module is used)
Communication
2 No proper communication with high-voltage board
Error
Charge Error 4 No proper high-voltage charge.
Discharge Error 8 No proper high-voltage discharge.
High-voltage energy is not properly delivered.
Defibrillation Error 10
(Is found only in the high-voltage test during manual test.)
Mode Change Error 20 Mode change is not properly done.
Each accessory has a unique code: Accessory code does
not fit.
Accessory Error 40
(Corresponding accessories: 3-Lead, 5-Lead, and 12-
Lead ECG Cable, Pads, Paddles)
24
Error Item Code Cause of Error
Pacing Current No proper pacing current control communication with the
80
Control Error high-voltage board.
Charge Button When pressing the charge button, the line condition is
100
Error abnormal.
When pressing the shock button, the line condition is
Shock Button Error 200
abnormal.
The mode rotary is not operating properly.
Mode Rotary Error 400
(Is found only in the MST Mode Rotary Test.)
Audio Current is not normal.
Audio Current Error 800
(Is found only in the MST Audio Current Test)
ECG Board is not operating properly.
ECG Control Error 1000
(Is found only in the MST ECG Board Test)
SpO2 Module Error 2000 No proper communication with the SpO2 Module.
Impedance Error 4000 Stored Impedance is abnormal.
4.4.4 Defibrillation Shock Test

A dual defibrillation energy delivery performance test should be performed, using AC Power and
using Battery Power. The process of each test is described below.
1. Defibrillation Shock Test Using AC Power (200J) 알파벳 이상함

C. Turn off the power of the LiFEGAIN CU-HD1 and remove the battery from the main
body.
D. Mount the AC Module and connect the AC Power.
E. Connect the defibrillation simulator and the LiFEGAIN CU-HD1 using pad connectors.
F. Set the Defibrillation Simulator to meet the energy calculation.
G. Turn the rotary switch to 200J so as to charge the defibrillation energy to 200J.
H. Push the “Charge” button to charge the defibrillation energy.
I. When charging is completed, push the “Shock” button to deliver the defibrillation
energy.
J. Check the delivered defibrillation energy.
The energy should be in the range of 200J±30J.
2. Defibrillation Shock Test Using Battery Power (200J)

A. Turn the power of the LiFEGAIN CU-HD1 off, and remove the AC Power Module from
the main body.
25
B. Mount the Battery Module.
C. Connect the defibrillation simulator and the LiFEGAIN CU-HD1 using pad connectors.
D. Set the defibrillation simulator to meet the energy calculation.
E. Turn the rotary switch to 200J so as to charge the defibrillation energy to 200J.
F. Push the “Charge” button to charge the defibrillation energy.
G. When charging is completed, push the “Shock” button to deliver the defibrillation
energy.
H. Check the delivered defibrillation energy.
The energy should be in the range of 200J±30J.
In relation to defibrillation energy delivery, synchronized cardioversion energy delivery may be

tested as described below.
A. Adjust the mode of the defibrillation simulator to the ‘Synchronized Cardioversion

Evaluation Mode’.
- Adjust the LiFEGAIN CU-HD1 to have 30J in Manual Defibrillation Mode.
- Push the “SYNC” button to change the mode to the Synchronized Cardioversion
Mode.
B. Select NSR for the ECG waveform simulator and connect the pads to the LiFEGAIN
CU-HD1.
C. Select “Pads” using the lead selection button and check the measured ECG.
Check whether the R-sync mark is displayed in the R-wave of NSR.
D. Push the “SYNC” button to set Synchronized Cardioversion and push the “Charge”
button.
E. When the “Shock” button is lit, continuously push the “Shock” button until
Defibrillation Energy is delivered with synchronization with the R-wave.
F. Check the Delay Time at which the defibrillation energy is displayed after delivery
with synchronization with the R-wave of the simulator.
The delay time should be within 60ms.
4.4.5 Disarm Function Test

The LiFEGAIN CU-HD1 is designed so that, if the “Shock" button is not pushed within a certain
period of time (15 seconds) after charging with defibrillation energy, internal discharge is
automatically performed. Also, when the defibrillation energy charge is complete, the soft key for
internal discharge is activated for manual performance of internal discharge.
The process of each test is described below.
26
1. Automatic Disarm Test
A. Connect the pads with the defibrillation simulator.
B. Turn the rotary switch to 200J.
C. Push the “Charge” button to charge the defibrillation energy.
D. When the “Shock” button is turned on, indicate that charging with defibrillation
energy is finished for automatic discharge, and wait for 15 seconds.
E. Internal discharge may be identified by turning-off of the “Shock” button.
F. Check that defibrillation energy is not delivered to the defibrillation simulator.
Check if the value is zero (0) or that there is no change in the display of the
simulator.
2. Manual Disarm Test

A. Connect the pads with defibrillation simulator.
B. Turn the rotary switch to 200J.
C. Push the “Charge” button to charge the defibrillation energy.
D. Check whether the LCD of the “Disarm” soft key is activated.
E. Perform internal discharge of the defibrillation energy by pushing the “Disarm” key.
F. Internal discharge may be identified by turning-off of the “Shock” button.
G. Check that defibrillation energy is not delivered to the defibrillation simulator.
Check if the value is zero (0) or that there is no change in the display of the
simulator.
4.4.6 ECG Measuring Function Test

To check the ECG Measuring Function, you should use a simulator that generates ECG signals.
Compatible ECG measuring leads may be different depending on the kind of product. The
LiFEGAIN CU-HD1 is compatible with three kinds of ECG measuring modes (3-Lead, 5-Lead,
and 12-Lead) and the ECG information is displayed on the divided upper and lower sections of
the LCD. Also, in the case of a 12-Lead ECG, 12-Lead information may be displayed on the
screen.
The process for checking the ECG measuring function is as described below.
A. Set the ECG waveform of the simulator as NSR (Normal Sinus Rhythm) and set
the electric potential as 1mV.
B. Connect the simulator and the main body using a 3-Lead, 5-Lead, or 12-Lead ECG
measuring cable depending on the kind of ECG to be measured.
C. Turn the rotary switch of the LiFEGAIN CU-HD1 to the ‘Monitor’ position.
D. Check the ECG displayed on the LCD screen.
Check whether the ECG is clearly displayed.
Check whether a normal waveform is displayed for each lead with changing
leads by pushing the lead selection buttons.
27
Check whether the HR (Heart Rate) is 30bpm.
E. Change the alarm setting to a minimum of 30bpm and check whether the alarm
sounds.
F. Re-check items D and E in terms of the ECG Waveform NSR at 60bpm of HR and
1mV of electric potential.
G. Re-check items D and E in terms of the ECG Waveform NSR at 200bpm of HR
and 1mV of electric potential. (Set the alarm’s maximum alarm generation HR to
no higher than 200bpm.)
H. Remove each lead from the simulator and check whether they recognize the
connection status of the ECG cable.
Check whether a removed lead is recognized, using the lead selection buttons.
I. Remove the ECG cable from the terminal of the product and check whether
removal of the ECG cable is recognized by the product.
Check whether a message, « Connect ECG Cable, » is displayed.
Check, when the ECG cable is connected to the upper part of the LCD, whether
the icon disappears.
J. Set the ECG Waveform of the simulator as Aystole.
K. Check whether the paper is loaded into the built-in printer of the LiFEGAIN CU-
HD1.
L. Print the ECG by pushing the “Print” button and check the printed result.
Check whether the baseline is clearly printed.
Check whether the items shown below are printed on the paper.
Details of print: Patient Information, Product Information, Information of Printed
Waveform, HR, Attributes of Printer, and Date & Time.
4.4.7 Pacer Test

The process for checking pacer function is as described below.
A. Remove the connection of the AC Power Module and connect the main body with
the battery only. (Pacer function may be checked when at least two columns’
capacity is secured on the battery when checking the battery.)
B. Connect the pads with the simulator equipped with an analysis function.
C. Connect the pads with the main body of the LiFEGAIN CU-HD1.
D. Turn the rotary switch to ‘Pacer Mode’.
E. Set pacer as shown below.
Pacer Setting: Fixed Mode, Rate of 70ppm, and Current of 30mA
F. Push “Start/Stop” soft button.
G. Check the result analyzed by the simulator.
Pacer Speed: 70ppm±1.5%
Current: 30±5mA
28
H. Set Pacer as shown below.
Pacer Setting: Fixed Mode, Speed of 180ppm, and Current of 200mA
I. Check the result analyzed by the simulator.
Pacer Speed: 180ppm±1.5%
Current: 200±5mA
4.4.8 SpO2 Test

To check the SpO2 measuring function, you may use an SpO2 Simulator or check the function
using your finger.
The process for checking the SpO2 measuring function is as described below.
A. Turn the rotary switch of the LiFEGAIN CU-HD1 to the ‘Monitor’ position.
B. Connect the main body and the SpO2 sensor with an SpO2 Cable.
C. Connect the sensor to a finger, or to the simulator, and perform the measurement. .
(Set the SpO2 as 98 %.)
Check whether the measurement curve of the SpO2 is clearly displayed.)
If the range of the SpO2 exceeds a 95%~100% range when measuring with a
finger, re-check the position of the finger by referring to the User’s Manual.)
Check whether the pulse and SpO2 are displayed on the LCD.
4.4.9 Text, Voice Prompt Test

The LiFEGAIN CU-HD1 may use common texts, symbols, icons, voices, and beepers in AED
Mode, Manual Defibrillation Mode, Pacer Mode, and Monitor Mode and may also use different
texts or voices to guide the use of the product.
The voices and texts provided in each mode are shown below.
Soft Key Symbols & Description
AED Mode Starts an ECG analysis.
AED Mode Stops the ECG analysis.
Denotes that the CPR type is set to 30:2.

AED Mode
Pushing the soft key switches the type to 15:2.
Denotes that the CPR type is set to 15:2.

AED Mode
Pushing the soft key switches the type to 30:2.
29
Soft Key Symbols & Description
AED Mode Starts CPR.
AED Mode Stops CPR.
AED Mode /
The charged electric shock energy is internally
Manual
discharged.
Defibrillation Mode
Common Stops the alarm temporarily.
Monitor Mode
Starts the 12-lead mode.
(12-Lead ECG)
Monitor Mode
Stops the 12-lead mode.
(12-Lead ECG)
Monitor Mode
Transfers the 12-lead data.
(12-Lead ECG)
Transfers the information of the patient being examined
Monitor Mode to the computer in real time.
To see this, Bluetooth must be connected.
Common Once the pad is detached, the menu is activated.
The symbols on the screen are common and show the accessories and specific status.
Display Symbols
Indicates that the 3-lead cable is connected.
Shows that the pads are connected.
Shows that the paddles are connected.
Shows that the internal paddle is connected.
30
Display Symbols
Indicates that the SpO2 sensor is connected.
Indicates whether Bluetooth communication is connected.
(Blue: Bluetooth connected, Red: Bluetooth disconnected)
`` Shows it is in the R_Sync mode.
Indicates it is printing.
Indicates that the alarm function is on.
Indicates that the alarm function is off.
Indicates that the alarm function is temporarily stopped.
Indicates heart rate in the 12-lead mode.
Indicates that the ECG storage function is being executed.
Indicates that the voice and ECG storage functions are being executed.
In AED Mode, the processes of AED and CPR are guided with the use of voice messages and
texts on the screen.
The voice and text messages to guide the AED process are shown below.
Plug in pads connector.
Indicates that the pads connector or the paddles adapter must be connected to the main body.
Attach pads.
Denotes that the disposable defibrillation electrode must be adhesively attached to the skin area where
the clavicle ison the right side of the chest, and the last rib bone on the left side, and the opposite
connector of the electrode must be accurately connected to the defibrillation electrode connector hole.
Do not touch the patient.
31
Indicates that contact with the patient must be avoided for an accurate ECG analysis.
Analyzing heart rhythm.
Indicates that the patient's ECG signal is being analyzed. Do not touch the patient. Also, when
analyzing the ECG signal, if a patient makes any movements, the analysis may contain errors.
Shock advised.
It means that the patient needs to have electric shock treatment.
Stand clear.
It means that a patient must avoid all contact with other people.
Charging
Indicates the energy is charged for electric shock treatment.
Press the flashing orange button, now.
Indicates that the user must press the shock button for electric shock treatment.
Shock delivered.
Indicates that electric shock treatment was delivered to the patient.
No shock advised.
Indicates that electric shock treatment is unnecessary.
The shock button was not pressed.
Indicates that a prompt to press the shock button was given, but that the shock button was not
pressed within 15 seconds.
(The device will discharge through the internal circuit after 15 seconds.)
Check pulse.
Indicates that the patient’s pulse must be checked.
Push the chest down fast two inches.
Indicates that cardiopulmonary resuscitation (thoracic compression) must be administered.
If no pulse, begin CPR.
32
If there is no pulse, CPR must be started.
Give two breaths.
Indicates that respiration must be given to the patient.
Breathe.
Guide with respect to the correct respiration delivery rhythm.
If no pulse, press "Analyze"
Indicates that there is no pulse in manual mode, and that the analyze button must be pressed.
4.4.10 Printer Test

The printer function may be checked by means of test printing.
The process for checking the printer function is described below.
A. Turn the rotary switch to the “OFF” position and stop the operation.
B. When the “Power” LED of the printer is turned off, keep the “FEED” button pushed
in.
C. When the “FEED” button of the printer is pushed in, turn the rotary switch of the
LiFEGAIN CU-HD1 to ‘Monitor’.
D. Check printed result.
When checking, refer to the test print result (Figure) shown below.
33
34
4.4.11 Bluetooth & Data Transmission Test
The information transmission function using Bluetooth may be checked by connecting Bluetooth
communication and actually transmitting information.
The process for sending information using Bluetooth is described below.
A. Connect the ECG cable with the ECG simulator.

B. Set the ECG simulator as NSR 60bpm and 1mV.
C. Connect the 3-Lead ECG cable with the ECG cable terminal of the main body.
D. Connect the SpO2 sensor and cable to the index finger and the LiFEGAIN CU-HD1.
E. Turn the rotary switch of the LiFEGAIN CU-HD1 to the ‘Monitor’ position.
F. Make the adjustment using the lead buttons so that the ECG of lead 2 is displayed
on the upper section and the SpO2 graph is displayed on the lower section on the
LCD.
G. Select “Initialize” after moving from Menu > Device Management > Bluetooth.
H. Connect the communication with the Bluetooth of an external terminal and run the
real-time transmission program.
(For installation of external terminal transmission program and setting Bluetooth,
refer to the User’s Manual.)
I. Check whether the ECG signals are transmitted from LiFEGAIN to the external
terminal in real time.
35
4.4.12 Menu Operation Test
The menu has a branch structure as shown below, and each menu is described in the table
below. Check whether the menus described below correspond with the product.
Main Menu (Branch Structure)
성
이름
ID
환자 정보 환자분류
나이
성(sex)
페이서 유/무
심박수
맥박
SpO2
알람
VT/VF
무수축
알람 일시정지 시간
Main Menu 프린터
자동분석
심폐소생술
데이터관리
음성녹음
볼륨
날짜와 시간
장비관리 필터
자가 진단 테스트
블루투스
심전도 크기
36
Menu Category Menu Screen
Main Menu
Patient
Information
Patient
Information
Patient
Information
Alarm
Main Menu
37
Alarm
Alarm
Alarm
Alarm
Alarm
38
Alarm
Printer
Automatic
Analysis
CPR
Device
Management
Main Menu
39
Device
Management
Device
Management
Device
Management
Device
Management
Device
Management
Device
Management
(Bluetooth
Main Menu)
40
Bluetooth
Device
Management
41
5. Troubleshooting
In this chapter, the symptoms and solutions in case of instances where errors are generated in
the modules configuring the LiFEGAIN CU-HD1 and each function are suggested.
Among the problems found during use, minor errors are not described in this chapter. For the
solutions of the problems that may occurr during operation of the product due to inexperienced
method of use, refer to the problem solving items in the User’s Manual.
The LiFEGAIN CU-HD1 checks the status of the product by itself and lets the user identify the
occurrence of a problem.
- Identification when an error is found in the Power-on Test
- Identification when an error is found in the Daily/Weekly/Monthly Self Tests
- Identification with use of the result of the manual self test - Pass or Fail
- Identification when an error is found during use of the product
If a problem is generated, a service lamp is turned on after all kinds of tests; if an error is found
in the self test, when the rotary switch is turned off, the mode changes to manual self test mode
and inspection of the major functions of the product is performed.
If the product fails to pass the manual self test, the product should be repaired.
5.1 Power- on Test

If, when the power is turned on, the rotary switch of the LiFEGAIN CU-HD1 is turned from the
‘Off’ position, the tests shown below are performed; the symptoms and solutions when any
problem is found are described below.
Symptom at Occurrence of a
Inspection Item Troubleshooting
Problem
Battery Capacity - Occurrence of Low Battery - Charge the battery using AC power module or
Test: Error replace the battery with a charged battery.
- Use the product with AC power.
Button Functionality - Charge Button Error - Check whether the button is pushed through
Test: - Shock Button Error external pressing.
- Exterior of the button may be damaged; if not
damaged, replace the keyboard.
A A charging and - Charge Error - Replace therapy board.

Discharging test: - Discharge Error - Replace main board.
- Internal Discharge Error
- Communication Error
42
5.2 Periodic Automatic Self Test
The Periodic Automatic Self Test is performed daily, weekly, and monthly at the same time. The
Periodic Automatic Self Test is performed under conditions where power is supplied and the
rotary switch is set to the ‘Off’ position at 02:00 am. If the product is in use at the time that the
Periodic Automatic Self Test performs, the test is omitted.
The details of troubleshooting to be performed when a problem is found in the Periodic

Automatic Self Test are shown below.
- Daily Automatic Self Test: The test is performed on the same inspection items as those of the
Power-on Test.
- Weekly Automatic Self Test

Problem
Including details of Daily Automatic Self Test
SpO2 Test - SpO2 Module Error - Check whether SpO2 Module Cable is
damaged; if damaged, replace it.
- Replace SpO2 Module.
ECG Circuit Test - Incorrect ECG measurement - Replace ECG Board.
- Monthly Automatic Self Test

Problem
Including details of Weekly Automatic Self Test
A charging and - Communication Error - Perform System Test by performing MST to
Discharging test: check the trouble with main board or system.
- Check the damage and connection status of
therapy board cable and, if any problem is
found, replace it.
- If the problem is not solved after above-
described procedure, replace therapy board.
- Charge Error - Replace therapy board.
- Discharge Error - Replace therapy board.
43
5.3 Manual Self Test
MST may be performed to check the functions of LiFEGAIN and may also be performed to
check all the functions in the process of turning on and off the product when a problem is found
in the Periodic Automatic Self Test.
The solutions corresponding to the results of MST are described below.
Problem
System Test - System Stop / Abnormal - Send the product to the company to be
Operation repaired.
Rotary Switch Test - Mode Rotary Error - Replace rotary switch
Charge Button Test - Failure in Charge Button Test - Check whether the button is pushed by
external pressing.
- Exterior of the Button may be damaged; if not
damaged, replace Keyboard.
Shock Button Test - Failure in Shock Button Test - Check whether the Button is pushed by
external pressing.
- Exterior of the button may be damaged; if not
damaged, replace the keyboard.
Audio Test - No Voice - Replace speaker.

- Excessive Noise - If the problem is still found after replacing the
speaker, check the status and connection of
keyboard and connector.
- If the problem still exists in spite of no problem
in the two cases described above, contact A/S
Center.
Defibrillation Test - Charge Error - Check the status and connection of the therapy
- Discharge Error board cable.
- If cable has no problem, replace therapy
board.
Pacer Test - Pacer Error - If therapy board cable has no problem, replace
therapy board.
ECG Lead Test - ECG Control Error - Check whether ECG board cable is damaged;
if damaged, replace it.
- Replace ECG board.
Power Input Terminal - - Check the cable status of power board.

Part A Test - If cable has no problem, replace power board.
44
Problem
Power Input Terminal - Check the cable status of power board.

Part B Test - If cable has no problem, replace power board.
SpO2 Test - SpO2 Error - Check the status and connection of SpO2
module cable.
- If cable has no problem replace SpO2 module.
Printer Test - Printer Failure - Check whether printer paper is loaded and
perform printer function test.
- If no problem is found, check the status and
connection of printer cable.
- If function test and cable connection shows no
problem, replace the printer.
5.4 Possible Common Problems during Operation of Product and Solutions

Symptom Expected Cause Troubleshooting
Mode Change to Not Identified. - Perform MST process.
MST Mode after - Identify problematic function and refer to
Turning on the corresponding troubleshooting.
Product
Button Key does not Incorrect Contact - Perform MST to check any problem with key.
work. - Repair depending upon the rest of test.
Deterioration or Damage - If deteriorated or fastening has a problem, replace

that cannot be identified by it.
self test
5.5 Defibrillation Function Problems and Solutions

Charge/Shock button - Pushed status - Check whether charge button is pushed in.
does not work.
- Mechanical Damage - Check keyboard connection and cable status..
- Replace keyboard.
-Therapy Board Failure - Replace therapy board.
- Main Board Failure - Replace main board.
External Paddle is -Incorrect Fastening - Check the connection between external paddles
not recognized. and main body and, if fastened wrong, fasten
correctly.
45
External Paddle - Incorrect Fastening - Check the connection between external paddles
Charge/Shock button and main body and, if fastened wrong, fasten
does not work. correctly.
- Incorrect Connection of - Replace the connector of electric shock cable.

Electric Shock Cable
- External Paddle Electrode - Clean external paddle electrodes.

Contamination
- Paddle Defect - Replace paddle.
- Paddle/Pad Connection - Replace paddle/pad connection terminal.

Terminal Damage
- Therapy Board Failure - Check therapy board cable damage and, if no

problem is found, replace therapy board.
Internal Discharge is - Incorrect Attachment - Check the attachment status of pads and external
spontaneously done paddles.
in the status that If they are not attached within the permitted range,
Paddles and Pads internal discharge is done.
are attached.
- External Paddle - Clean the metallic electrode parts of external
Contamination paddles.
- Incorrect Fastening - The repeated attachment/ detachment due to

incorrect fastening may be evident. In this case,
check the contact status the terminals.
- Cable Defect - Replace pad connection adapter and external

paddles.
- Therapy Board Failure - Replace therapy board.
Defibrillation Energy - Charge Button Failure - Perform MST to check button status.
Charging is not (Manual Defibrillator - If needed, check the status of keyboard and
done. Mode) keyboard cable.
- Charge Error - Perform MST to check defibrillation function.

- Replace therapy board depending upon the result.
Low Charge Speed - Battery Capacity - Check battery level and, if insufficient, charge it.
- Power Board Failure - Check the status of the power board.

- Replace power board.
Synchronized Cardio - Therapy Board Failure - Replace therapy board.

version Time is
exceeded.
46
Defibrillation Energy - Wrong Connection of - Replace the connector of the electric shock cable.
is not delivered. Electric Shock Cable
Defibrillation Energy - Therapy Board Failure - Replace therapy board.

Exceeds the range
of Specification.
Energy is discharged - Therapy Board Failure - Replace therapy board.

smaller than charged
quantity.
5.6 Problems with ECG Measurement Function and Solutions

ECG Waveform is - ECG Measurement Cable - Replace ECG cable.

not displayed. (3-Lead, 5-Lead, and 12-
Lead) Defect
- ECG Cable Connector - Replace ECG cable connector terminal.

Terminal Defect
- ECG Board Failure - Replace ECG board.
ECG Measurement - Incorrect Attachment of - Check the attachment status of ECG electrode on
is wrong. ECG Electrode. the skin.
- Incorrect Skin Status - If the skin to be measured is wet, dry the skin.
- ECG Cable Defect - Replace ECG cable.
- Incorrect Connection of - Replace ECG cable connector terminal.

ECG Cable
Lead Fault Message - Incorrect Attachment of - Check the attachment status of ECG electrode on
is repeatedly ECG Electrode. the skin.
generated.
- Incorrect Skin Status - If the skin to be measured is wet, dry the skin.
- ECG Cable Defect - As ECG cable may be cut, replace ECG cable.
- Incorrect Connection of - Replace ECG cable connector terminal.

ECG Cable
- Main Board Failure - Replace Main board.
47
5.7 SpO2 Problems and Solutions
Impossible - Sensor Failure - Replace sensor.

Measurement - Inappropriate Sensor - Check the kind of sensor.
- SpO2 Extension Cable - Check the SpO2 extension cable.
Defect
- SpO2 Cable Connector - Replace SpO2 cable connector erminal.
Terminal Failure
- SpO2 Module Failure - Perform MST.
- If any trouble is found in SpO2 inspection, replace
SpO2 module.
Inaccurate - Sensor Failure - Replace sensor.

Measurement Result - Inappropriate Sensor - Check the kind of sensor.
- SpO2 Module Failure - Replace SpO2 module.
5.8 Pacer Problems and Solutions

Inaccurate Current - Therapy Board Failure - Replace therapy board.

Delivery - Main Board Failure - Replace main board.
Inaccurate Pacing - Therapy Board Failure - Replace therapy board.

Rate - Main Board Failure - Replace main board.
5.9 Printer Problems and Solutions

Printer does not - Paper Jam - Check whether paper is jammed in the printer.
work.
- Cable Defect - Check printer cable connection.
Printing is not done. - Paper Placing Direction - If printer is set so that the paper moves in the
Error reverse direction, printing is not done; setting
should be checked.
Printed status is - Inappropriate Paper is - Use recommended printing paper.

wrong. used.
- Printer Head Defect - Clean printer head part with a cotton bud as if
sweeping the part.
- Printer Failure - Replace printer.
48
5.10 Problems in Information Transmission Function and Solutions
Bluetooth is not - Access Release - Retry Bluetooth connection according to User’s
initialized. Manual.
- Bluetooth Setting Error - Contact A/S Center and ask Bluetooth connection
setting method.
- Bluetooth Module - Replace main board.
Failure
Transmission is not - Connection Release - Retry Bluetooth connection according to User’s
done. Manual.
- Bluetooth Module - Replace main board.
Failure
5.11 Problems in Information Saving Function and Solutions

Saving in external - Inappropriate Storage - Use the recommended storage device.
storage device is not Device is used.
done. - Storage Device Defect - Replace storage device.
- Writing is prohibited. - Check whether the storage device is set as “Writing
Prohibited.”
- Main Board Defect - Replace main board.
5.12 Audio Function Problems and Solutions

No Voice - Incorrect Speaker - Check speaker cable connection.
Connection
- Speaker Failure - Replace speaker.
Unequal and Rough - Speaker Failure - Replace speaker.

Voice - Main Board Failure - Replace main board.
Voice is not - Main Board Failure - Replace main board.

controlled.
49
5.13 LCD Function Problems and Solutions
Screen is not - No Power Supply - Check LCD power cable connection.
activated. - Rotary Switch Failure - Replace rotary switch
- LCD Failure - Replace LCD.
Stripes/Blurs on the - LCD Failure - Replace LCD.

Screen and Screen - Main Board Failure - Replace main board.
Failure
5.14 Key and Button Problems and Solutions

Improper - Mechanical Switch - Replace keyboard.
(Sensitive/Dull) Function Failure

Action of Key and - Incorrect Device - Replace sensor.
Button Fastening - Replace keyboard.
50
6. Repair
6.1 Repair Philosophy

The product should be repaired by a qualified technician. Since parts related to high voltage
uses are included, when disassembling the product, a technician qualified in the repair of the
product in particular, should make the repairs.
The repair philosophy of the product is to replace modules and cables in principle. That is, the information
on the repair of parts, such as the IC elements inside the module, is not provided and, in the case of any
discretional repairs made to modules, the performance of the product is not guaranteed.
A repair service is not provided for accessories and such accessories should be replaced with
new ones.
For matters pertaining to repair and servicing, visit http://www.cu911.com to request a service or
contact the department listed below, and request the required information.
A/S Department
1647-1 Donghwa, Munmak,
Wonju, Gangwon, Republic of Korea
(Factory and Head Office)

Tel +82-33-747-7657
Fax +82-33-747-7659
(Sales Department)
Tel +82-31-421-9700
Fax +82-31-421-9911
6.2 Precautions for Repair

6.2.1. Handling Problem
The product is an electronic product and is weak against the static electricity generated by
human bodies every day. When opening the main body, wear anti-static bracelets etc to prevent
static electricity.
Also, since the inside of the product may be charged with a high voltage and a high electrical
current, disconnect the power supply before opening the product and, after opening the product,
high voltage electricity should be discharged to make the environment safe before starting
repair work.
51
The tools and equipment required for repairing LiFEGAIN are as listed below:
- (+) Driver
- High-voltage energy discharge tool
(Is not supplied. If required, make a request. )
- A sharp tool to remove the labels and rubber from the product.
WARNING Before opening the product to commence repairs, all the power supplies, including the
AC Power Module and the Battery Module should be removed from the main body.
6.2.2 Disposal & Recycling

Disposal of main body and accessories should be done according to the disposal and reuse
guidelines of the corresponding area.
NOTICE Labels are damaged during disassembly. Prepare spare labels.
6.3 Safety Consideration
WARNING 1. The product should be repaired by a technician who is qualified in the

repair of the product.
2. When disassembling the product for repair, remove the power supply
from the main body. Also, when starting assembly of the product, make
sure to confirm this instruction. If power is connected, serious injury may
occur (burn and electric shock), resulting in a life-threatening situation.
- Remove Battery Module.
- Remove AC Power Module.
3. Make sure to use the supplied AC Power Accessories only. Also, do not
connect the product with any power that is not stated in the specification.
4. The inside of the product is weak against static electricity. When
disassembling the product, be careful of the generation of static electricity.
5. In the environment is exposed to explosive gas, do not assemble the
product. (Ex. High-pressure oxygen)
NOTICE 1. To repair the product, the person should have good knowledge and
understanding of the Service Manual and the product repair process.
Therefore, the equipment manager should keep a Service Manual and a
User’s Manual close at hand to be referred to during repair.
2. The problems that may occur during use of the product are described in the
User’s Manual. The solutions to the problems that may occur during repair
of the product are described in this Manual.
3. The components of the product may be different depending upon the
purchaser’s option. When evaluating the functions of the product, check the
functions installed in the product.
52
6.3 Product Configuration
The product is configured with devices consisting of labels, metal, and plastic injection-molded
materials, cables, connecting boards and accessories, parts to support fastening of devices,
and PCB boards and various accessories containing IC elements.
The connections of the various parts are shown in the figure below.
<Product Configuration>
53
The connections and names of parts are described below in detail. The front part containing the Paddle Cradle and the Main Board, and the rear part containing the
Therapy Board are shown.
<Components of Paddle Cradle>
54
<Front Part containing Therapy Board of
Main Body>
55
<Rear Part containing Therapy Board>
56
Parts List Table
57
6.4 Internal Assemblies Disassembly
The product disassembly process is described with respect to disassembling the entire modules,
including devices other than the disassembly of a specific module. Therefore, to disassemble a
specific module, the product disassembly process should be referred to.
Separation of Main Body
To detach the main body, follow the instructions described below.
1. Remove labels from the back of product.
2. Loosen the screws on the paddle cradle and separate the paddle cradle as shown in
the photos below.
Separation of Screws Separation of Paddle Cradle
58
3. Disassemble the screws from the back of the main body as shown in the photos. Under
the damage-preventive sticker, one more screw is inserted. Disassemble the product
as shown in the photos below.
Screw separation from power Input section Screw separation from upper section
Screw separation from bottom section
4. Remove the label from the upper side of the grip.
59
5. Separate the front part and the rear part by pulling forward and backwards, respectively.
Do not pull with excessive power. If the screws are not completely removed, the front
part and the rear part are not separated.
6. Detach the AC adapter and the car power jack connection terminal from the power
board.
60
7. Separation of the front part and the rear part of the product.
8. Remove the screws from the power board and the ECG board.
61
9. Detach the power board cable.
10. Detach the ECG board cable.
62
11. Remove the screws from the left/right of the aluminum panel.
12. Detach the cable connecting the main board and the therapy board.
13. Photo showing the detached main board and therapy board
(Do not touch the therapy board with hands.)
63
14. Detach the LCD module flat cable and the LCD module power.
15. Remove the screws connecting the SpO2 module and the main board.
16. Loosen the screws of the main board and separate the main board.
17. Remove the screws fixing the aluminum plate and remove the aluminum plate.
64
18. Detach the screws fixing the LED onto the bracket.
19. Detach the LCD.
65
20. Loosen the screws of the keyboard and detach the keyboard.
21. Discharge the high-voltage condenser using a high-voltage discharge device. The
arrow is shown below the high-condenser connection terminal and is used to ground
the discharge device.
66
22. Loosen the screws on the aluminum plate covering the high-voltage condenser and
remove the aluminum plate.
23. The speaker, the defibrillation paddle and pad connection terminal, the ECG cable
terminal, and the SpO2 probe connection terminal are shown in the photos below.
67
Separation of Built-In Printer
1. Open the cover of the printer and remove the paper.

2. Rotate the screws in the printer two rounds and release the fastening as shown in the
photos below.
3. When pulling the built-in printer forward, it is detached from the main body. To detach
the built-in printer, the printer cable should be detached.
6.6 Product Assembling

Assemble the product in the reverse order of the product disassembly process.
The LiFEGAIN CU-HD1 has various components and assembly should be done in order. Make
sure to perform assembly accurately in the reverse order.
68
The kinds of connector cables connected with the PCB board and the connector terminals
constituting the product and their connection positions on the PCB are shown in the table below.
Part No. Description Connection Position
AC Adapter Connector Power Board J3 AC Adapter

Connection Cable (2-pin) Connector
Connection Terminal
Main Board Power Cable Power Board J4 Main Board J1
(6-pin)
Power and Control Cable Power Board J5 Main Board J22
(13-pin)
Therapy Board Power Cable Power Board J6 Therapy Board J9
(5-pin)
ECG Cable Connector ECG Board J2 ECG Cable
Terminal Cable (12-pin) Connector Terminal
ECG Board Cable A (14-pin) ECG Board J26 Main Board J32
ECG Board Cable B (12-pin) ECG Board J27 Main Board J33
Pacer Cable (3-pin) Therapy Board J17 Therapy Board J13
Therapy Board Control Cable Main Board J29 Therapy Board J17
(12-pin)
- SpO2 Module Connection Main Board J4, J6 SpO2 Module
Terminal
- Rotary Switch Connection Main Board J2 Rotary Switch
Cable
- Pad/Paddle Connection Main Board J28 Pad/Paddle
Connector Cable Connection
Connector
- SpO2 Connection Connector Main Board J5 SpO2 Connection
Cable Connector
- LCD Flat Cable Main Board J31 LCD
- LCD Power Cable Main Board CON6 LCD
- Speaker Connection Cable Keyboard J4 Speaker
69
7. Operation
For a detailed operational method, refer to the Operator’s Manual. In this chapter, the description
of the operational method is summarized.
7.1 AED
AED Mode is applied to patients who are exhibiting the symptoms of SCA (Sudden Cardiac
Arrest) including ventricular fibrillation and ventricular tachycardia, in order to bring them back to
life by applying electric shock and restoring the normal ECG rhythm.
SCA patient means the person is showing no response, no movement, no normal breathing, and
no pulse.
When setting the product to AED Mode, it must be used by medical professionals or paramedics
with Class 2 or a higher level.
In the AED mode, the defibrillation pads must be used. The defibrillation pads work to obtain the
ECG signal of patients and deliver electric shock according to the patient’s condition.
The AED Mode’s function is to treat patients with acute cardiac arrhythmia, analyzing the ECG of
the patient to determine whether the patient is in the cardiac arrhythmia state, including ventricular
tachycardia and ventricular fibrillation. In this mode, the product provides you with voice and text
prompts.
The performance process of the AED is as shown below.

A. Turn the rotary switch to the AED mode
B. Attach the pads on the chest of the patient
- Take off the patient’s upper garment
- Open the pads
- Attach the pads
- Connect the pad connectors with the equipment
C. Analyze the ECG waveform
D. Charge with defibrillation energy (automatic charge depending on analysis result)
E. Deliver defibrillation energy
F. Perform CPR depending on the situation (voice and message instructions)
7.2 Manual Defibrillation

Manual Mode is the process whereby the user discretionally selects energy and charge and
performs defibrillation. It is divided into two functions, namely asynchronous defibrillation and
synchronous cardio version.
For the asynchronous defibrillation treatment in the manual mode, the user is able to choose the
70
level of electric shock energy from a range of 1-200 joules for the use of pads or paddles.
On the other hand, when used for synchronous cardio version, it is used on patients with the
symptoms of atrial fibrillation. It is designed to analyze the R-wave of the ECG QRS and apply the
R-wave synchronized electric shock.
In the manual mode, synchronous cardio version treatment can be applied to patients with rapid
atrial fibrillation, ventricular tachycardia, and cardiac ischemia.
7.3 Pacer
Pacing is a method applied to patients who have lost the natural cardiac movement functions, and
is mostly used on patients with bradycardia. The LiFEGAIN CU-HD1 supports noninvasive pacing,
a way of helping to maintain the patient’s pulse by attaching an electrode to the patient’s skin and
delivering artificial electric stimulation to the heart.
Pacing mode is divided into the fixed mode and the demand mode.
The currents that can be delivered from the pacing mode ranged from 5 to 200mA (±5mA); its
pacing rate is 30~180 PPM (±1.5%), the pacing time is 20ms, and the pacing wave appears in a
monophasic rectangular form.
7.4 Patient Monitoring

Patient monitoring mode features the ECG monitoring function and the function to measure the
level of the SPO2, functional oxygen saturation in the blood.
For the ECG monitoring function, you can selectively use the 3-lead, 5-lead, and 12-lead ECG
cables. During the patient monitoring session, it is possible to analyze the ECG results and to use
the alarm function according to conditions such as the number of pulses, ventricular fibrillation or
ventricular tachycardia etc..
If using an ECG cable, turn the "Rotary Switch" to Monitor Mode before usage. Also, the ECG
cable provided by the company is specifically designed only for the LiFEGAIN CU-HD1, so other
cables from other manufactures won’t work properly.
When it comes to the ability to measure the level of SpO2, it was designed to take measurement
of SpO2 more accurately by mounting the SpO2 module of Nellcor, Inc.
71
8. Specifications
The specifications of the LiFEGAIN CU-HD1 are as shown below.
Body
Size 326mm (W) x 253mm (L) x 358mm (H)
(Paddle included) (Width×Length×Height)
Body: 4.6Kg or below / 8.1Kg or below if paddles, cables (ECG cable,
SpO2 sensor), print paper, and storage device are included.

Weight
Paddle (with cables): 1.2kg or below.
Battery, AC power module: 0.5Kg, 0.7Kg respectively.
Defibrillation Feature
▪ Semi-automatic
Operation Mode
▪ Manual: Sync, Asynchronous Defibrillation
Output Waveform
(Manual / Automatic)
※ Parameters of waveforms are adjusted according to

the patient's impedance.
Delivers shock using paddles or internal paddles,

Shock Delivery
disposable defibrillation pads.
Patient Impedance Scope 25 ~ 175 Ohms25 ~ 175 Ohms
72
Sensitivity & Specificity
ECG Test 90% One Sided
Minimum test Performance Shock No Shock Observed
Rhythm Rhythms
sample size goal
sample
Decision Decision Performance
Lower Confidence
Class size Limit
97.26%
Coarse >90%
SHOCKABL
200 219 213 6 (213/219) 95%

VF sensitivity
sensitivity
E
81.02%
>75%
Fast VT 50 137 111 26 (111/137) 76%
sensitivity
sensitivity
Normal 100 100%
> 99%
Sinus minimum 100 0 100 (100/100) 97%
specificity
Rhythm (arbitrary) specificity
NON SHOCKABLE
AF,SB,S
VT,
heart 99.54%
30 > 95%
block, 219 1 218 (218/219) 98%
(arbitrary) specificity
idioven- specificity
tricular
PVC’s
96.21%
> 95%
Asystole 100 132 5 127 (127/132) 93%
specificity
specificity
Defibrillation Energy Variation Corresponding to the Impedance
Load Impedance (Ohms)

Selected
Energy Accuracy
(Joules)
25 50 75 100 125 150 175
1 1 1 1 1 1 1 1 ±1 J
2 2 2 2 2 2 2 2 ±1 J
3 3 3 3 3 3 3 3 ±1 J
4 4 4 4 4 4 4 4 ±1 J
5 5 5 5 5 5 5 5 ±2 J
6 6 6 6 6 6 6 6 ±2 J
7 7 7 7 7 7 7 7 ±2 J
8 8 8 8 8 8 8 8 ±2 J
9 9 9 9 9 9 9 9 ±2 J
10 10 10 10 10 10 10 10 ±2 J
15 15 15 15 15 15 15 15 ±3 J
20 20 20 20 20 20 20 20 ±3 J
30 30 30 30 30 30 30 30 ±15 %
50 50 50 50 50 50 50 50 ±15 %
70 70 70 70 70 70 70 70 ±15 %
100 100 100 100 100 100 100 100 ±15 %
120 120 120 120 120 120 120 120 ±15 %
150 150 150 150 150 150 150 150 ±15 %
170 170 170 170 170 170 170 170 ±15 %
200 200 200 200 200 200 200 200 ±15 %
73
Manual Defibrillation
▪ Within 7 seconds: When rechargeable battery is completely charged
▪ Within 6 seconds: When an AC power module is used (only when power is
more than 90%).
Charging Time
(200 Joules)
▪ Within 7 seconds: When the battery has been discharged more than 15
times after full charging.
▪ Within 7 seconds: When the battery has been discharged more than 15
times after replacement of battery module with a new one.
Shock
1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, 20, 30, 50, 70, 100, 120, 150, 170, 200 Joules
Energy Selection
Indicator LCD for ECG display, Power/Error display indicators
▪ Text prompts for charge energy
Charging Indicator ▪ Beep when charging
▪ Shock button flashes orange
Patient Impedance
▪ 25~175 Ohms
Recognition Range
▪ Use SYNC button for synchronous cardioversion.
SYNC ▪ Analyze the patient's ECG signals and synchronize R-wave of QRS in
ECG with shock delivery within 60ms.
AED
▪ Within 7 seconds: When Battery Module is completely charged
▪ Within 7 seconds: When a new Battery Module is used
▪ Within 6 seconds: When an AC power module is used (only when power is
Charging Time more than 90%).
(200 Joules) ▪ Within 7 seconds: When the battery module has been discharged more than
15 times after full charging.
▪ Within 7 seconds: When the battery has been discharged more than 15 times
after replacement of battery module with a new one.
AED Energy 200 Joules, fixed
Text and Gives step-by-step guidelines to the user on how to take proper
Voice Prompts measures for an emergency situation.
AED Operation Key Analyze button, Stop Analysis button, Shock button, CPR Type 30:2 / 15:2,
and Button Start/Stop CPR
▪ Progress bar of the amount of energy charged and text prompts
Charging Indicator ▪ Beep when charging is finished
▪ Shock button flashes orange
▪ Analyzes the patient's ECG to determine whether defibrillation is needed or
Patient Analysis
not. (When the automatic patient analysis feature is enabled)
Defibrillation-needed
Ventricular Fibrillation or Fast Ventricular Tachycardia, 150bpm or above
rhythm
Algorithm Sensitivity
and Specification That AHA 2005 guidelines are met.
Requires Defibrillation
74
Pacer
Pacing Type Non-invasive Pacing
Energy Waveform Monophasic Rectangular
Pacing Mode Demand mode, Fixed mode
Energy Magnitude 5 ~200 mA (±5mA)
Pulse Width 20ms (±10%)
Pacing Rate 30 ~ 180 ppm (±1.5%)
Impedance Range
In Which Pacing is 25 ~ 175 Ohms
Possible
Operation Key and Mode button, Rate button, Print button, MENU key, HOME button, and
Button LEAD Selection button.
LCD for ECG display etc., text prompt, QRS detection display, patient monitoring
Indicator
information display, pacing signal delivery display.
Demand Mode Analyzes the patient ECG to determine whether to deliver pacing energy or not in
Analysis the Demand mode.
ECG Monitoring
▪ Kinds of ECG measurement: 3-Lead, 5-Lead, and 12-Lead
ECG Input
▪ Able to see ECG results using LCD or an external printer.
Detects when the ECG cable(s) is detached (if the ECG cable is
Lead Fault
disconnected from the patient or the device)
Heart rate display 30 ~ 300 bpm (Accuracy: ±3 bpm)
▪ Heart rate alarm setting range
▪ Lower Limit: 30~300 bpm (it should be set to a value lower than the
Heart rate Alarm Setting maximum, however)
▪ Upper Limit: 30~300 bpm (it should be set to a value higher than the
minimum, however)
▪ 5 mm/mV, 10 mm/mV, 20 mm/mV
ECG Size
▪ Auto: 0.3 ~ 5.5 mV, Display inputted ECG signals as 10mm on the screen.
▪ Emergency: 1 ~ 30 Hz (-3 dB)
▪ Monitor: 0.5 ~ 40 Hz (-3 dB)
Frequency Range
▪ Diagnosis: 0.05 ~ 150 Hz (-3 dB)
▪ 50Hz, 60Hz Notch Filter
Patient Isolation
CF Type
(Defibrillation Check)
SpO2
Pulse Rate 20 ~ 250 bpm (± 3 bpm)20 ~ 250 bpm (± 3 bpm)
SpO2 값SpO2 value 70 ~ 100 % (± 3 digit) 70 ~ 100 % (±3 digit)
Perfusion 0.2%
▪ Lower Limit: 70% ~ 100% (it should be set to a value lower than the
maximum, however)
SpO2 Alarm Setting
▪ Upper Limit: 70% ~ 100% (it should be set to a value higher
than the minimum, however)
Display Update Interval 6 secs.
75
Resolution 1%
SpO2 Measuring Sensor: Nellcor Sensor (DS100A Sensor)
660 nm (Red), 890 nm (Infrared) 660 nm (Red), 890 nm
Sensor Light
(Infrared)
Power Consumption 15mW or below
Display: 7” TFT LCD

Type TFT LCD (including backlights)
Screen Size 152.4(W) X 91.44(H) mm
Resolution 800 X 480 X 3(RGB) pixels
Dot Pitch 0.0635(W)X0.1905(H) mm0.0635(W) X 0.1905(H) mm
Backlight LED Life Time 20,000 hours (time when brightness is reduced to 50%)
ECG Viewing Time 6 secs.
Data Storage
External Storage
Store more than 192 hours of events and ECG data.
SD Card
Or, store more than 8 hours of events, ECG data, and voice data
(if 1GB)
Output ECG directly from LiFEGAIN CU-HD1 or output ECG data by
CG Data Print
transferring it through Bluetooth communication.
Printer
Thermal line
Print Method
printing
2
Resolution 203dpi X 406dpi (dpi: dot per inch )
Print Width 48mm
Print Rate 25mm/sec
Feed Rate About 62.5mm/second
7.2 V DC
Input Power Power consumption in a standby state: 70mA (maximum power
consumption: 2.4A)
5 °C ~ 40 °C
Operation Temperature
Humidity: 30%~85%, Non-condensing
-10 °C ~ 50 °C
Storage Temperature
Humidity: 30%~90%, Non-condensing (without printer papers)
Printer paper
Type Roll Type
Width: 58mm
Size
Role Size: Minimum diameter 40mm
76
Bluetooth
Applied Module Parani-ESD210 (Bluetooth – Serial Module)
Version Bluetooth v 1.2Bluetooth v 1.2
Frequency Range 2.402 GHz ~ 2.480GHz2.402 GHz ~ 2.480 GHz
Send Output Max. +4 dBm
Receive Sensitivity -80 dBm(0.1%BER)-80 dBm(0.1%BER)
Antenna Standard antenna and dipole antenna
Communication
Within 30m (Based on open space)
distance
Operation
10°C ~ 55°C (Humidity: 90%, Non-condensing)
Temperature
Storage Temperature 20°C ~ 70°C (Humidity: 90%, Non-condensing)
Transmission Method:
FHSS (Frequency Hopping Spread Spectrum)
Miscellaneous Modulation Method:
GFSK (Gaussian-filtered Frequency Shift Keying)
Battery
Battery Type Lithium Polymer
Size 170mm X 116mm X 51mm (Width X Length X Height)
Weight 0.5kg or less
14.8 VDC
Output
3100 mAh
100 shocks (based on 150Joules) or at least 4 hours of patient

Capacity
monitoring (25°C)
Charging Time About 5 hours
Battery Capacity Check Level 5
Charge: 0°C ~ 40°C

Operation Temperature Discharge: -20°C ~ 60°C
Humidity: 90% or below, Non-condensing
-20°C ~ 45°C
Storage Temperature
77
AC Power Module, SMPS
Input 100 ~ 240 VAC, 50 ~ 60 Hz
18 VDC, 5 A
Output
12 VDC, 0.5 A
Size 170mm X 116mm X 60mm (Width X Length X Height)
-20°C ~ 40°C
-20°C ~ 60°C
Storage Temperature
Cigar Jack
Output 12VDC, 6.3A (Max.)
Length 1800 ± 50mm
-20°C ~ 40°C
-20°C ~ 60°C
Storage Temperature
AC Adapter
Input 100~240V, 50~60Hz
Output 12V/3.6A
Length 1900 ± 50mm
-20°C ~ 40°C
-20°C ~ 60°C
Storage Temperature
78
Appendix 1
Defibrillator Shock Waveform
Defibrillating waveform at 200J to 25-ohm load
79
80
81
Appendix 2
Pacing Waveform
Pacing waveform at 200mA to 50-ohm load

Pacing waveform at 200mA to 100-ohm

load
82
Pacing waveform at 200mA to 125-ohm Pacing waveform at 200mA to 150-ohm
load load
Pacing waveform at 200mA to 175-ohm

load
83
Appendix 3
Additional Notice
Approvals & Certifications

KFDA Approval 07-699
MDD (Medical Device Directive)
MDD 93/42/EEC Compliance
CE0470
Manufacturer
1647-1 Donghwa, Munmak,
Wonju, Gangwon, Republic of Korea
+82-33-747-7657
84

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Edition 1

CU Medical Systems, Inc.

at any time without prior notice or obligation to customers.

Printed in the Republic of Korea

Publication Date: August, 2008

Service Manual Part No.:

Service Manual Version: 1.00.232

> Main Processor Software Version:

> Therapy Processor Software Version:

© 2008 CU Medical Systems, Inc.

1.1 Introduction of Product

- AED (Automated External Defibrillator) Function

1.3 Warning, Caution, and Notice

WARNING Dangerous situations, including death or severe injury may occur if

instructions are not observed.

CAUTION Instruction that directly or indirectly addresses company policy in order to

protect people or property.

NOTICE Description of terms or additional description to be referred to.

2.1 Description of Appearance

Internal Paddle Adapter

Disposable Defibrillation Pads (for Adults)

Disposable Defibrillation Pads (Pediatric)

ECG Measurement Cable (3-Lead), US Type

ECG Measurement Cable (5-Lead), US Type

ECG Measurement Cable (12-Lead), US Type

SpO2 Measurement Sensor

Car Cigar Lighter Jack

Disposable ECG Monitoring Electrodes

Self-Test Load Resistance

- Configuration of Screen in AED Mode

- Configuration of Screen in Manual Defibrillation Mode

- Configuration of Screen in Patient Monitoring Mode

SpO2 Measurement Mode

12-Lead ECG Measurement Mode

Diagram of dependence and independence of components

3.1 Basic Maintenance

3.1.2 Maintenance of Accessories

the terminals of the battery modules.

3.1.2.3 ECG Cable Maintenance

3.1.2.4 Maintenance of SpO2 Sensors and Connection Adapters

How to Clean and Take Precautions

organic solvent or a basic substance.

3.2 Maintenance Checklist

Manufacturing No.: __________________ Location/Vehicle ID:

4.1 Target of Verification

4.2 Tools or Equipment

4.3 Performance Verification (Visual Inspection)

4.4 Performance Verification (Functional Check)

Power-on Self Test

Daily Self Test

Weekly Self Test

- Checks the daily self test items.

Monthly Self Test

4.4.2 Manual Self Test

The process of the manual self test is as described below.

Manual Self test

A. Go to Menu > Device Management > Self Test items.

4.4.3 Self Test Result (Error Code Interpretation)