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Module 10: Technical Safety Inspection

and Preventive Maintenance Part 4
Setting into Service and Documentation

Technical Support International

DialogP SW9.xx_std_Module 10_TSI and PM Part 4_Presentation
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Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.1 Applied Accessories/Disposables

 The tubing used during the Setting Into Service has to be documented in the Check List.
 A full AV tubing set with dialyzer shall be used to achieve realistic results.

5.2 Switch on Machine

 The machine has to be switched on and pass all steps of the self test.
 Start the therapy with the following settings:
 Time – 4h
 Ultra Filtration Volume – 2 l
 Conductivity – 14,3 mS/cm
 Temperature – 37°C

5.2.1 Self test passed

 The tubing used during the Setting Into Service has to be documented in the Check List.
The self-test will be explained in the next module
Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.3 Power Fail Function

 The Power Fail Function has to be tested before therapy is selected.

 Switch on machine for approx. 5 minutes and then disconnect mains plug.

 5.3.1 The machine must give a buzz from the power supply for 1 minute.
Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.4/5 Temperature and Conductivity

 An external reference meter for temperature and
conductivity has to be connected to the blue
dialyzer coupling.
 Enter the Therapy and run stable for 10 minutes.

 Make a comparison with the reference device

and the displayed values on the monitor:
 5.4.1 Comparison measurement {at dialyzer
coupling} at 37ºC (-1.5 ºC; +0.5 ºC)
 5.5.1 Comparison measurement {at dialyzer
coupling} at 14.3 mS/cm (±0,2 mS/cm)
Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.6 Safety Air Detector (SAD)

 The Safety Air Detector has to be

tested with air.

 Lower the level in the Venous

Chamber (e.g. with level regulation
pump) until air reaches the sensor.

 5.6.1 The machine has to make a:

 visual alarm
 audible alarm

 The function in noted in the Check

List
Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.7 Monitor

 5.7 /.1/.2 All the functions related to the screen

have to be tested:
 Function of the keys
 Display illumination
 OSDs
 Touch screen OK
 Image display OK

 The results are documented in the Check List

Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.8 UF Comparison Measurement

 5.8.1 A UF comparison measurement is made with:

 15 min
 500 ml/h UF Rate
 125 ml ±15 ml
 The test has to be completed without any alarms
 The levels in the blood line chambers shall not be changed
 Air bubbles can compromise the result

 The procedure is described in the Service Manual

 All values are documented in the Check List

Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.9 /.1 Battery Option

 Has to be tested if the option is present.

 The test is done in therapy mode.

 5.9.1 Disconnect mains plug, ensuring the monitor and blood pump are still working.

 Buzzer from SMPS gives three signaling tones.

 Machine is running in battery mode.

 Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

5.10 Disinfection

 The machine has to be disinfected after a TSI and PM.

 5.10.1 This can be performed by responsible organization {user}. In this case

the user has to be informed that the disinfection needs to be done.

 5.10.2 Alternatively the service technician has to perform a disinfection

 This is documented in the Checklist.

 Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

7.2 Applied Measurement Equipment

 All measuring equipment used in during the STI and PM have to be

documented in the Check List.

 Measurement equipment is subject to the calibration service.

Training Center

Functional Electrical Safety Setting Into

Introduction Visual Inspection Documentation
Inspection Analysis Service

Check Results
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