Operation

Service Manual
Manual

Medical Supply Co., Ltd.

Care Vision OM-100

Pulse Oximeter
 Table of Contents

1 System Block Diagram 5

1.1. Total System Block Diagram 5

2 Factory Mode 10

2.1. Overview 10

2.2. Enter the Factory Mode 10

2.3 Demo Mode 11

3 Firmware Download 12

3.1. Overview 12

3.2. Necessary Equipment 12

3.3. How to Download Firmware 13

4 Maintenance 18

4.1. Regular Safety and Performance Check 18

4.2. Cleaning Equipment 19

4.3. Battery Maintenance 20

4.4. Environment Protection 20

5 Operation Verification 21

5.1. Overview 21

5.2. Necessary Equipment 21

5.3. Operating Test 21

5.4. Safety Test 26

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6 Disassembly 32

6.1. Overview 32

6.2. Disassembling Case 33

7 Troubleshooting 35

7.1. Overview 35

7.2. Troubleshooting 36

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 For your information

Thank you for purchasing Care Vision OM-100. This product is a medical device that
is designed to check the physiological condition of a patient by measuring the oxyg

en saturation level and pulse rate of the patient.

This document is provided for service person, it contains device system configuration,

disassembling, maintenance and troubleshooting etc.

Warranty Period

l This device is manufactured under the strict quality management and insp

ection system of the manufacturer.

l Compensation criteria for the repair and exchange shall follow “Customer

Reward Policy” notified by the Economic Planning Board.

l The warranty period of this device is one year.

l Any damages incurred while using the device under normal operating condi

tion shall be repaired in the repair center of the manufacture free of cha

rge within the warranty period.

l When the device is damaged during the warranty period, send us the prod

uct with the model number, serial number, purchase date and description

of the damage.

l The manufacturer or sales agency is not liable for any damages or loss inc

urred due to improper use of the device or customer negligence.

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Contact Information

Medical Supply Co. Ltd gladly provides our customers with various services and

information of the product. If you have any questions, contact following number or

visit our website.

110, Donghwagongdan-ro, Munmak-eup, Wonju-si, Gangwon-do

Purchase Inquiry
(in the Dongwha Medical Device Complex)
Repair & Maintenance

TEL : +82-70-7438-6034
Technical Support
FAX : +82-33-742-4385

Website http://www.medicalsupply.co.kr/

Note

l This document is a property of Medical Supply Co., Ltd and protected by

copyright.

l Changing the information of this document is not allowed without permission.

Medical Supply Co., Ltd is not liable for any problems that are incurred due to

improper use the contents of this document.

Revision History

This document contains its revision history, which is updated when the contents of

the document are changed. The contents of this document, which do not seriously

affect the performance of the device, are subject to change without prior notice.

l Revised Date : 2014. 7. 11

l Revision : 1.0

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 1 System Block Diagram

1.1. Total System Block Diagram

Figure 1. Total System Block Diagram

(1) Power

- AC power

Care Vision OM-100/Care Vision OM-100 contains SMPS (Switch Mode Power Supply)

to transform AC power to DC power. Input specification of SMPS is 100-240VAC, 50-

60Hz. There are two fuses for AC input (line and neutral) to protect the equipment

from overcurrent.

- AC-DC converter

AC input is converted to DC power using AC-DC converter. It consists of transformer,

transistor and inductor etc. AC input and DC output is isolated for protect
equipment and users from electric shock.

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 - Battery

Care Vision OM-100/Care Vision OM-100 includes an internal power source, Ni-MH

battery. The capacity is 7.2V/2000mAh and the battery can operate the device for

approximately 5 hours when measuring SpO2 continuously. The battery can be

recharged connecting power code. This device includes a battery charge circuit that

controls charging state. If battery level increases over the threshold, battery

charging will be stopped automatically.

- 3.3Vdc

3.3Vdc is generated from the battery or adapter power. It is used for operating MCU,

EEPROM, Sound driver etc. It is also used for operating RTC (Real Time Clock) in

power off condition.

- 5Vdc

5Vdc is used for operating LCD and SpO2 isolation power circuit.

In order to prevent undesired effects from power and main module, SpO2 module

uses separated power generated from isolation DC-DC converter.

(2) Main

- Main MCU

MCU is used for controlling the user interface and saving trend data etc. It displays

the SpO2 and pulse rate results to 7-segment and SpO2 graph to LCD. Alarm and

beep sounds are generated through speaker. In addition, it receives the input of

user’s key operation.

- EEPROM

EEPROM is a non-volatile memory used for storing trend data, user settings etc. It

can maintain the data stored during power off. So, the trend data and user settings

can be maintained after initializing the system or replacing the battery.

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 - RTC(Real-time clock)

After setting time, RTC counts and maintains time and date.

The power of RTC is provided continuously so, time is moving on during power off.

However, if the battery is replaced, time setting should be reset.

- Sound Driver

Sound driver is used for making the auditory signals such as alarm sound, beep

sound etc.

It consists of DAC (digital to analog converter), digital potential meter and audio

power amplifier. It converts from digital signals to analog sound, and amplifies the

volume of sound according to volume setting.

(3) SpO2

- Isolation DC-DC converter

To protect the patients from electric shock, SpO2 module, the applied part should

be isolated. This circuit consists of transformer, transistor and capacitors etc. It

converts 5Vdc to 5Vdc and 3.3Vdc used to SpO2 module.

- LED Driver

LED driver circuit is used for controlling the electrical current of Red and IR

(infrared) LED in light emitting part of SpO2 sensor. Red and IR LED repeat to turn

on and off alternately and the detector of SpO2 sensor, photodiode, receives the

red and IR light which pass through patient’s finger.

Light intensity is controlled by DAC (digital to analog converter).

- Analog Signal Process

Photodiode converts from the light signal to the current signal. Analog signal

processing circuit contains ‘IV converter’, ‘sample and hold circuit’, and ‘low pass

filter’.
‘IV converter’ converts from the current signal to the voltage signal and ‘sample
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 and hold circuit’ separates Red and IR signal from a photodiode. Low pass filter

rejects high frequency noise.

- ADC

ADC (analog to digital converter) is used for converting analog signal to digital signal.

Digital signal is easy to calculate than analog signal. So, for SpO2 algorithm

operation, analog signal is converted to digital signal.

- SpO2 MCU

It is used for controlling SpO2 circuit and running SpO2 algorithm. It calculates SpO2

and pulse rate from ADC output and determines alarm status. SpO2 MCU transmits

the data to Main MCU to display.

(4) Key

Keys are used for user input function. According to push key button, user can operate

the device such as power on/off, system setting, alarm audio pause etc. This device

contains 7 keys.

(5) LCD

LCD (liquid crystal display) is used for displaying SpO2/PR result, graph, trend data,

user setting, battery status, alarm status, etc. The display size is 240 X 64 dots, LCD

type is FSTN negative blue LCD.

(6) 7-segment

3-digits 7-segment is used to display SpO2 and pulse rate with numeric character.

SpO2 result is displayed in red color, pulse rate result is displayed in green color. In

alarm status, SpO2 or pulse rate result is flashed.

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(7) Speaker

Sound driver circuit makes the sound signal and speaker generates sound according to

the signal. The speaker has 8Ω, 1W specification.

(8) Sensor

SpO2 sensor consists of two LEDs(Red and IR) and a photodiode. It contacts to

patient’s finger and detecting SpO2 signal.

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 2 Factory Mode

2.1. Overview

This chapter mentions factory mode which enables for authorized persons to review and

check information of Care Vision OM-100 including checking the F/W version, EEPROM

etc.

2.2. Enter the Factory Mode

Enter the Factory Mode as follows:

1) Enter the Menu screen and select [Factory].

2) Enter the password [1130] and press Enter button.

PASSWORD

1111

UP DOWN EXIT ENTER

Figure 2. Password Input to access service mode

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 Table 1. Service mode Items and Functions

Items Functions

Firmware Displaying firmware version of Main BD

SpO2 ver Displaying algorithm version of SpO2 BD

System vol Adjusting the system volume level

Limit Changing minimum value of SpO2 low limit (ON : 85 à 60)

Display Transmitting the system information through a serial port

Trend clear Deleting all trend data

EEPROM check Self-testing of EEPROM

System reset Changing all parameters to default values

2.3. Demo Mode

In the demo mode, Care Vision OM-100 displays the pre-set value.

1) In power off condition, press ‘power button’ hold on ‘alarm button’ to start

displaying Demo Mode.

2) When you restart the device, the system is returned to the initial screen.

Note : Don’t Use This Function Except Special Purposes (ex : Demo or Testing)

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 3 Firmware Download

CAUTION: You must download the firmware through a representative who is in

charge of the service distributed by Medical Supply Co., Ltd. The problems

caused by downloading any other firmware presented, not from Medical

Supply Co., Ltd., are not responsible.

CAUTION: You must connect power cord to the equipment when download the

firmware.

CAUTION: After firmware download run operation test of SpO2 performance.

3.1. Overview

This chapter is to load firmware distributed for Care Vision OM-100 when a previous

firmware may have error or the firmware is updated with a new system. Request the

latest firmware and utilities to manufacturer.

3.2. Necessary Equipment

Table 2. Equipment for Downloading Firmware

Equipment Description

Firmware Downloading Cable USB to serial cable

Firmware Firmware to be downloaded

Personal Computer (PC) USB Port

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3.3. How to Download Firmware

CAUTION: Use only dedicated USB cable to prevent unexpected damage to

Care Vision OM-100 or to the PC.

1) Turn on the PC. Prepare firmware download to the device.

2) Turn off the power of the device.

3) Connect USB to serial cable to the device and to the PC.

4) Check whether the PC succeeds in searching for the USB connected to the

equipment.
5) In the window OS, Select Start – All programs – Misc program – Telecommunication –

Hyper Terminal (if using window version above XP, search trial program of

HyperTerminal in the internet.).

6) Run HyperTerminal. Input the proper name on the New Connection window like the

figure below.

Figure 3. New connection of Hyper terminal

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7) If the Connection to… screen appears, select COM Port where Care Vision OM-100

is connected as ‘the modem for connection’ and click OK.

8) When the configuration window for initial telecommunication appears, configure

the values below and click OK.

- Bit/sec: 115200

- Data bit: 8

- Parity: No

- Stop bit: 1

- Flow control: No

Figure 4. Configuring Telecommunication

9) The Hyper terminal window appears like the figure below.

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 Figure 5. Hyper Terminal Window

10) Return to the device, push the power button holding ▲ button and alarm button.

***********************
Wait Firmware Update
***********************

Figure 6. Software upgrade mode

When the window displays like Figure 6, press [▶] button. Then, display changes to

below Figure 7.

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 ***********************
Firmware Update Mode
***********************

PRG1 PRG2 PRG3 EXIT

Figure 7. Choosing Software upgrade

On the display of Figure 8, please press the Menu button on the front case and

choose [PRG3]. Then the down preparation window on the hyper terminal screen

appears like the figure below.

Figure 8. Download Preparation

11) Type ‘1’ button on the keyboard. ‘Waiting for the file to be sent (press ‘a’ to
abort)’ message and ‘CCC…’ keep appearing.

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12) Click send files ( ) on the menu bar and the ‘file send’ window appears. Select
the protocol ‘Ymodem’.

Figure 9. Send File Window

13) Select the file to send and click Send. Then, the file is downloaded like the

Figure below.

Figure 10. File Transfer Window

14) When the file transfer is completed, type the ‘2’ on the keyboard or push the
power button on Care Vision OM-100 to reboot. And then, check the normal operation.

Remove USB connection after verification of operation.

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 4 Maintenance

WARNING: Take care not to spray or spill water on Care Vision OM-100

equipment and other cables, connectors, switches and cases.

WARNING: Care Vision OM-100 complies with the waterproof regulation (IPX0)

in IEC 60529.

CAUTION: Disconnect the power code from the equipment before cleaning it.

CAUTION: Disconnect the adapter before cleaning the equipment

CAUTION: Take care for liquids or detergents not to penetrate into the
equipment through connector or duct while cleaning the equipment

CAUTION: If the battery shows signs of damage, leakage or crack, let the

service personnel authorized by the manufacturer replace it with the

authorized one.

CAUTION: When you scrap or recycle parts used for replacement, this may

lead explosion while burning up. Therefore, recycle them based on regulations

on scrapping/recycling.

4.1. Regular Safety and Performance Check

(1) Regular Safety Check

Check list below for every 24 months.

- Check external damage of the equipment

- Check whether labels are clearly visible. Otherwise, contact the service center of
Medical Supply Co., Ltd.

- Please refer to the ‘Operation Verification’ chapter for accurate verification on the

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 equipment.

- Please refer to the ‘Operation Verification’ chapter in the service manual for further

electricity safety test. If you fail the electric stability test, do not try to repair it and

contact the customer support division of Medical Supply Co., Ltd.

(2) Performance Check

Certified personnel should check based on the performance verification method for

every 2 years.

- If the equipment has visible damage or gets mechanical shock (ex, falling), the

personnel should check based on the ‘Operation Verification’ chapter in the service

manual.
- Please refer to the ‘Safety Test’ chapter in the service manual for electric safety

tests. If the equipment fails to pass the electric safety test, please refer to the

‘Troubleshooting’ chapter in the service manual.

- Check proper fuses and ranges.

- Electric source of AC power: 250V, 5A

- Internal battery power: 250V, 5A

4.2. Cleaning Equipment

Follow items below to keep the product surface clean.

- Apply detergents in markets or non-polished detergents to the smooth cloth and wipe

the top, the bottom and the front of the equipment to clean Care Vision OM-100.

Note: If a liquid like water or cleaning agent is spilt, please wipe it well and dry

completely before using the equipment.

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 4.3. Battery Maintenance

ARGUS OXM plus uses Ni-MH battery only. If you do not use the equipment for more than

2 months, please charge the battery before using the equipment. Please refer to the

‘Operation Verification’ chapter in the service manual or the ‘Battery Operation’ chapter

in the user manual to charge the battery through connecting the power cord.

Medical Supply Co., Ltd. recommends to replacing the battery for every 2 years. If you

need to store your ‘ARGUS OXM plus’ for more than 2 months, remove the battery before

storage. Please refer to the Disassemble chapter for detail about replacing and removing

the battery.

Note: If you store your ‘ARGUS OXM plus’ for a long time without removing the battery,

this causes poor performance of it. Battery is required to be fully charged/discharged to

recover its normal capacity. Fully charge the battery for about 4 hours while turning off

the equipment. Medical Supply Co., Ltd. recommends to replacing the battery for every

2 years to guarantee ARGUS OXM plus.

4.4. Environment Protection

You may reuse the battery. Do not dispose of it into the trash can.

Treat the battery based on local regulations.

Never burn the battery up for the danger of explosion.

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 5 Operation Verification

5.1. Overview

This chapter mentions the operation verification test when the user repairs or maintains

the equipment. All the tests except charging battery and battery test should be done

before the equipment returns to the user. If Care Vision OM-100 fails to pass the tests in

the manual, the equipment should be repaired through proper methods before it returns

to the user.

5.2. Necessary Equipment

Table 3. Necessary Equipment for Test

Error Code Description

Digital Multi Meter (DMM) Fluke Model 87 or equivalent equipment

SpO2 Sensor and Extension Cable DOC-10

SpO2 Simulator FLUKE Biomedical Index2 or equivalent

Safety Analyzer METRON QA-90 or equivalent

Stopwatch Manual or automatic

5.3. Operating Test

Charging battery and its operation test should be done before repairing the equipment
whenever battery seems to cause troubles. All the other tests follow repair or check

methods. Batteries should be fully charged before performing battery operation test.

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This chapter mentions the configuration values with factory default. If the user

arbitrarily configures the values, they will appear on the screen.

(1) Electric Source

- Use proper power code for Care Vision OM-100 and connect the power cord to power

source.

- Push the power button for 1 second and check whether the equipment is turned on.

- Check that the equipment shows normal mode after Self-test.

- Verify that the charging operation signal is on (or blinking).

- Disconnect the AC power cord from the equipment after it works normally.

- Check Battery status/operation indicators turn on.

- Check the equipment power is turned off after pushing the power switch for more

than 3 seconds.

(2) Battery Charge

- Connect Care Vision OM-100 to AC power with proper power code.

- Check whether charging indicators are blinking.

- If the battery is fully charged, the indicator just shows the status of stopping. If the

battery is charging, the indicator shows the status with its 4 lights.

- Disconnect the AC power cord when the batter is fully charged. Then, enter the

service mode and check battery power.

Note: Keeping normal capacity of the battery depends on user’s habits. Therefore,

battery is required to keep fully charge/discharge period.

Note: Care Vision OM-100 uses Ni-MH battery.

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(3) Battery Discharge

- When the Ni-MH battery is fully charged, disconnect the power cord from the power

source.

- Connect the equipment to the SpO2 simulator.

- Start SpO2 measurement.

- When the battery power remains for about 20 minutes after operating the equipment

for about 4 hours, check that there is an alarm showing the need to charge the battery

and the battery indicator is blinking.

- If the battery power is still low and when turned it on, the power is automatically

turned off after 5 seconds.

- If the test is passed, please charge the battery immediately.

(4) General Operating Test

- Alarm and Stop Alarm

1. Connect the equipment to power cord and turn on the equipment

2. Set the lower limit of oxygen saturation as 90% in alarm limit menu.

3. Connect the oxygen saturation (SpO2) simulator.

4. Configure the oxygen saturation (SpO2) simulator below.

-oxygen saturation 80%, PR 70 BPM

5. Start measuring the oxygen saturation.

6. Check responses below.

- Check whether oxygen saturation and pulse on the LED segment of the

equipment are the same with configuration values on the simulator.

- Check whether alarm sounds, alarm message and SpO2 value is blinking.

7. Push the alarm audio paused button.

8. Check items below.

- Alarm becomes muted
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 - Alarm generation indicator changes to alarm stop.

- The lower limit of oxygen saturation and oxygen saturation alarm limit are still

blinking.

9. Check the items in 6 appear again after 30 seconds.

10. Set up the oxygen saturation simulator below.

- oxygen saturation 98%, PR 70 BPM

11. Check if the oxygen saturation on the equipment is shown the same with the

configuration value on the simulator.

12. Check if alarm sound and signal stop

13. Remove the oxygen saturation simulator.

14. Check whether the ‘No finger’ message appears on the LCD screen of the

equipment and alarm sounds.

15. Press the alarm audio paused button and check below.

- Alarm stops.

- Adjusting System Sound

1. Connect the power cord to the equipment and turn on the equipment.

2. Set the lower limit of oxygen saturation as 90% in alarm limit menu.

3. Connect the oxygen saturation (SpO2) simulator.

4. Set up the oxygen saturation (SpO2) simulator below.

- oxygen saturation 98%, PR 70 BPM

5. Start the measurement of the oxygen saturation.

6. Push the ▼ button to adjust the beep sound and check the volume of button

and pulse while adjusting the system volume from 0 to 10.

- Adjusting Alarm Sound

1. Connect the equipment to the power cord and turn on the equipment.
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 2. Set the lower limit of oxygen saturation as 90% in alarm limit menu.

3. Connect the oxygen saturation (SpO2) simulator.

4. Set up the oxygen saturation simulator below.

- oxygen saturation 80%, PR 70 BPM

5. Start the measurement of the oxygen saturation.

6. Push the ▲ button to adjust the alarm sound and check the volume of button

and pulse while adjusting the system volume from 1 to 10.

- Time Test

1. Connect the equipment to the power cord and turn on the equipment.

2. Check if the time goes through the right top of the LCD screen on the

equipment.

- Flash Memory test

1. Connect the equipment to the power cord and turn on the equipment.

2. Change alarm limit below.

- PR high limit: 180, oxygen saturation low limit: 85

3. Turn off the equipment by pushing the power button for more than 3 seconds.

4. Turn of the equipment again.

5. Check if the changed values are stored/shown.

6) Measurement Parameter Operating Test

- Oxygen Separation (SpO2) test

1. Turn on the equipment and connect the SpO2 simulator.

2. Set up the simulator below.

- SpO2 98/70 %, PR 60/100/200 BMP

3. Check the SpO2 and the PR values on the equipment.
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 - Check the pulse bit sound.

- Check if the SpO2 has the range of error of ±2%.

- Check if the pulse has the range of error of ±2% or ±3BPM.

- Check if the pulse value appears.

4. Disconnect the SpO2 sensor from the equipment and check if the SpO2 sensor

error appears on the screen.

Note : the SpO2 simulator cannot be used to assess the accuracy of a pulse

oximeter probe or a pulse oximeter monitor.

5.4. Safety Test

ARGUS OXM plus complies with the safety regulations in the Class I of the IEC 60601-1

and Type BF.

1. Protection Earth

This test checks the protection of the power code earth from the earth of the AC plug.

The current in this test is less than 4V/50Hz - 60Hz/25A.

(1) Connect the AC power cord to the equipment and connect the power code to the

hazard analyzer based on its operation manual.

(2) Connect the resistance input lead of the hazard analyzer to the contactable earth

part of the equipment. The resistance should not be over 0.2Ω.

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2. Electric Leakage

- Earth Leakage Current

This test complies with the earth leakage current regulation in the IEC 60601-1. The

applied voltage based on the IEC 60601-1 is 264 V/50Hz – 60Hz AC. All the

measurements should be done for turning on and off the power.

(1) Connect the AC power code based on the instruction of the electric hazard

analyzer.

(2) Test the hazard analyzer with the recommended methods.

Table 4. Earth Leakage Current Value

Test Status Permitted Leakage Current (㎂)

Normal Condition (NC) 500

SFC Open Supply (SFC OS) 1000

Normal Condition RM (NCRM) 500

SFC Open Supply (SFC OSRM) 1000

Note: The earth leakage current measures AC main power and the conductor in the

protection earth. The values from the earth leakage current test should not be over the

permitted leakage current range in the Table 4.

Note: NC-normal condition / SFC-single fault condition / RM-reverse mains/line voltage

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- External Leakage Current

This test is based on the regulations on the external leakage current in the IEC 60601-

1. This test measures external leakage current not earthed between the external part

and the earth part. The applied voltage based on the IEC 60601-1 is 264 V/50Hz – 60Hz

AC voltage.

Table 5. External Leakage Current Value

Test Status Permitted Leakage Current (㎂)

Normal Condition (NC) 100

SFC Open Supply (SFC OS) 500

SFC Open Earth (SFC OE) 500

Normal Condition RM(NCRM) 100

SFC Open Supply RM (SFC OSRM) 500

SFC Open Earth RM (SFC OERM) 500

Note: The values from the external leakage current test should not be over the

permitted leakage current range in the Table 5.

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- Patient Leakage Current

This test complies with the patient leakage current standards in the Article 19 for the

Class I, Type BF in the IEC 60601-1. This test measures the patient leakage current

from the earthed patients.

(1) Connect the AC power code to the hazard analyzer based on the recommendations.

(2) Turn on ARGUS OXM plus.

(3) Measure the patient leakage current of the hazard analyzer based on the

recommendations.

(4) Measure the patient leakage current of the oxygen saturation (SpO2) with the same

method.

Table 6. Patient Leakage Current Value

Test Status Permitted Leakage Current (㎂)

Normal Condition (NC) 100

SFC Open Supply (SFC OS) 500

SFC Open Earth (SFC OE) 500

Normal Condition RM(NCRM) 100

SFC Open Supply RM (SFC OSRM) 500

SFC Open Earth RM (SFC OERM) 500

Note: The earth leakage current measures AC main power and the conductor in the

protection earth. The values from the earth leakage current test should not be over the

permitted leakage current range in the Table 6.

Note: This test requires cable tests connected to each patient.

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- Patient Leakage Current (Main voltage on the applied parts)

WARNING: The AC main voltage appears while the test is applied. Take care of

prohibiting electric shock through careful exercise.

WARNING: There may be electric shock. Therefore, do not touch clips or

simulator connected to the patient while test.

The test is based on the patient leakage current in the Article 19 for the Class I, Type BF

in the IEC 60601-1. The test is applied to the part where 110% of the main voltage is

connected to the patient and the earth. The patient leakage current is measured from

the earths connected to each patient.

Note: Keep the length of the patient test cable as short as possible in the leakage test.

Note: This test requires the connector connected to the patient as explained in the

patient leakage current.

(1) Connect the AC power code based on the recommendations of the electric hazard

analyzer.

(2) Turn on ARGUS OXM plus.

(3) Measure the patient leakage current based on the recommendations of the hazard

analyzer.

(4) Measure the patient leakage current of the oxygen saturation (SpO2) with the same

way.

Note: The patient leakage current measures forward and backward directions of the

main electrodes. The values of the patient leakage current test should not be over the

permitted leakage current range.

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 Table 7. Patient Leakage Current Value – Main voltage application

Test Status Permitted Leakage Current (㎂)

Normal polarity (SFC) 5000

Reverse polarity (SFCRM) 5000

- Patient-assistance Current

The test complies with the patient-assistance current in the Article 19 of the Class I,

Type BF in the IEC 60601-1. The applied voltage to the IEC 60601-1 is 264 V/50Hz –

60Hz AC voltage. The patient-assistance current measures all the connectable

connectors and cables.

(1) Connect the AC power code based on the recommendations of the electric hazard

analyzer.

(2) Form the SpO2 connector and connect to the input terminals of the hazard analyzer.

(3) Turn on the equipment.

(4) The values of the hazard analyzer should not be over the values in the Table 8.

Table 8. Permitted Leakage Current

Test Status permitted leakage current (㎂)

Normal Condition (NC) 100

SFC Open Supply (SFC OS) 500

SFC Open Earth (SFC OE) 500

Normal Condition RM(NCRM) 100

SFC Open Supply RM (SFC OSRM) 500

SFC Open Earth RM (SFC OERM) 500

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 6 Disassembly

WARNING: Disconnect the AC power and battery connector first in opening or

disassembling Care Vision OM-100 due to electric shock.

6.1. Overview

This chapter mentions how to disassemble Care Vision OM-100.

6.2. Disassembling Case

1. Disassemble the rear side of the device.

2. Disassemble the handle.

3. Open the top case.

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 Figure 11. Disassembling

1 Front Cover 2 SpO2 Connector 3 Key rubber

4 Speaker 5 LCD Board 6 Segment LED

7 Key Board 8 Front Bracket 9 Front Rubber Leg

10 Rear Rubber Leg 11 Main Board 12 SpO2 Board

13 Power Board 14 Battery 15 9pin Connector

16 Ground Pin 17 AC Inlet 18 Bottom Cover

19 Top Cover

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Note: The rear speaker is connected to the power board on the bracket. Therefore,

disassemble the case completely after disconnecting the connector for disassembling the

case.

Note: After disassembling the case, disconnect the internal battery connector first.

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 7 Troubleshooting

WARNING: When you judge that the measurement of the equipment is not

accurate, verify the state of the patients with other verified methods. Also, be

sure to check if the equipment works properly.

WARNING: Only the authorized personnel for repairing the equipment may
disassemble and inspect Care Vision OM-100. Users may not repair the

equipment inside by themselves.

7.1. Overview

The equipment shows error codes when it does not work properly due to error of the

system. Please refer to troubleshooting chapter.

Table 9. System Error Codes

Error Code Description

System Error 1 Error of communication data between the Main BD and SpO2 BD

System Error 2 Error of internal memory

System Error 3 Key failure

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 7.2. Troubleshooting

1. No response to the Power On/Off

Figure 12. Power Problem – No Power

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Figure 13. Power Problem –Not working by Battery

- 37 -
2. LCD or LED display is dim and hard to read

Figure 14. Display Problem – FND Problem

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Figure 15. Display Problem – LCD Problems

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3. Measuring Problem

Figure 16. Measuring Problem – No SpO2/PR/waveform Display

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4. No response to the button or no sound

Figure 17. Other Problem – Sound Problem

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Figure 18. Other Problem – Key Button Problem

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