209 MDE Lecture

8/8/2019 209 MDE Lecture

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Biomedical EquipmentTroubleshooting

1st Semester 1428-1429



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Medical Device

any instrument, apparatus, appliance, material or otherarticle, whether used alone or in combination, including

the software necessary for its proper applicationintended by the manufacturer to be used for humanbeings for the purpose of: — diagnosis, prevention, monitoring, treatment or alleviation of

disease, — diagnosis, monitoring, treatment, alleviation of or compensationfor an injury or handicap,

— investigation, replacement or modification of the anatomy or of aphysiological process,

— control of conception, and which does not achieve its principalintended action in or on the human body by pharmacological,immunological or metabolic means, but which may be assisted inits function by such means



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Troubleshooting

• (trub´&l-shoot´´) (v.) To isolate the source of a

problem and fix it, typically through a process ofelimination whereby possible sources of theproblem are investigated and eliminatedbeginning with the most obvious or easiestproblem to fix.

• In the case of computer systems, the termtroubleshoot is usually used when the problem issuspected to be hardware-related. If the problemis known to be in software, the term debug ismore commonly used.

http://www.webopedia.com/TERM/T/hardware.html


http://www.webopedia.com/TERM/T/software.html

http://www.webopedia.com/TERM/T/debug.html

http://www.webopedia.com/TERM/T/debug.html

http://www.webopedia.com/TERM/T/software.html





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How can a medical device be

Troubleshooted?• Be able to read and understand the

Service’s and User’s Manuals• Be able to use biomedical hand tools.

• Be able to use multimeter (Voltmeter,Ammeter, Ohmmeter..)

• Be able to use Oscilloscope



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Service’s and User’s Manuals

• Service’s Manual provides useful

information to Qualified Service Personal(QSP) to understand, troubleshoot,service, maintain and repair a medicalequipment (device)

• User’s Manual helps the medical staff to

operate a medical device



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Sections of Service’s Manual

• General

• Maintenance• Troubleshooting

• System Test• Board description

• Disassembly and Assembly

• Replaceable Parts List

• How to reach the manufacturer



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Conventions in Service’s Manual

• WARNING: a warning alerts the user to the possibleinjury or death associated with the use or misuse of the

instrument.• CAUTION: a caution alerts the user to possible injury or

problems with the instrument associated with its use or

misuse such as instrument malfunction, instrumentfailure, damage to the instrument, or damage to otherproperty.

• NOTE: a note provides specific information, in the formof recommendations, prerequirements, alternativemethods or supplemental information.



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1. General



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2. Maintenance

• Replacement: (Periodic Replacement Schedule)

Part Recommendation

Battery If it cant last for 30 Min.

Thermal head After 30 km of recording

LCD Module After 10000 hours

Motor ASSY After 1000 hoursLithium battery After 7 years



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• Cleaning and Greasing: Schedule



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Cleaning the Paper MarkSensor and Paper Empty

Sensor



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Cleaning the Motor Rotation Sensor and Greasing theMotor Gear and Gear Meshed With Motor Gear

1. Detach the top casing from the bottom casing as described in the“Disassembly and Assembly” section.

2. Remove the two screws holding the motor assy to the bottom

casing and remove the motor assy.3. Remove the two screws to expose the motor rotation sensor andphotodiode.

4. Use a piece of cotton moistened with alcohol to clean the sensorand photodiode.

5. Use a brush to clean the holes in the gear.6. Use grease to grease the motor gear and the gear which directly

meshes with the motor gear as shown below.7. Reattach the MOTOR SENS board to the motor with the two

screws.8. Reattach the motor assy to the bottom casing with the two

screws.9. Reattach the top casing to the bottom casing as described in the

“Disassembly and Assembly” section.



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3. Troubleshooting and System Error Message

3.1 Troubleshooting Flowchart:Use the troubleshooting flowchart to find the possible sourcesof a problem.



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3.2 Troubleshooting TableUse the troubleshooting table to locate, identify and solve aproblem in the instrument. The problems are divided intogeneral operation and recording Each category has its own

troubleshooting table for fast and easy troubleshooting.

How to use the troubleshooting table

1. Determine which troubleshooting table to use.2. In the “Problem” column find the trouble item that matches the

problem.

3. Do the action recommended in the “Corrective Action” column.

4. If the problem is not solved, do the action for the next possiblecause or criteria.

5. If none of the actions solve the problem, contact dealer



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3.3 System Error Message

During power-up and operation the instrument

continuously checks itself for system failure. If afailure is detected, system information and errorhistory are printed on the recording paper and all

operations are stopped. System information anderror history are also displayed or printed due totransient noise. After printing the system

information and error history, the power of theinstrument is automatically turned off.



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4. System Test, Adjustment, And Setting

4.1 System Test:Test level 1 Test level 2• Demonstration • Recorder• Recorder • Thermal head• Key* • Recording resolution setting• Memory* • Key*• LCD* • Memory (single)*

• Input unit* • Memory (continuous)• Calibration* • LCD*• Communication* • Input unit*• CRO/EXT1* • Calibration*

• System Setup Initialization* • Communication*• ECG Findings List Recording • CRO/EXT1*• System Setup Initialization*

• Cue mark adjustment



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DemonstrationThis is used to

learn or teach

instrumentoperation.

While executing

this test item, theinstrumentgenerates dummy12 lead ECG



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Recorder

This is used to check the condition of therecorder by printing test patterns. Therecording test patterns consist of the followingand are printed in the following order:

1. Diagonal lines (Check Thermal Head )

2. Characters H and X (Check Thermal Head )

3. Grid (Check ECG control B .)

4. Paper speed scales (10, 12.5, 25 and 50 mm/s)(Check Motor, Gear, Sensor )

5. Paper mark detection (Check Sensor )



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12

3 4

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Thermal Head

This is used to check the condition of the thermal head byprinting out the characters “H” and “X” continually.



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Key

This is used to check the condition of the keys onthe operation panel.



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Memory

This is used tocheck thecondition of

the memory bycomparing thedata of the test

patternswritten to andread fromeach memoryarea.

LCD



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LCD

The LCD displays the following four types of testpatterns every two seconds in the following order:

1. Diagonal lines are displayed.2. Entire LCD lights up.3. LCD is completely dark but backlight lights.4. Backlight does not light.



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Calibration

• Amplitude when CAL waveform is risen: 10 mm±2%• Amplitude of point which is 25 mm : more than 7.3 mmfrom the rising point of the CAL waveform



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5. Board/Unit Description

• Power Unit

The Power unit consists of the power source, batterycharging and control circuits. The Power unit uses theswitching regulation method to produce the powerrequired for the instrument.

• Flash ROM Board

The Flash ROM board has a 2 MB flash ROM for writing

the control program, analysis program, Japanese fontand English font to the ROM. Also, there is a space formounting an EEPROM.



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6. Disassembly and Assembly

The procedures inthis section tell

how to remove,replace and installmajor

components in theinstrument.

Example:

Removing theMotor Assy.

209 MDE Lecture

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