Appendix B - Medela Thopaz Mode D'emploi

Appendix B

DIN EN 62353: 2008-8
Hospital
Location:
Visual checks
Cracks, brittle areas, discolouration on housing and display
Covers for ports are present and can be clicked in
Standard rail and bed holders are present and can be opened
Seal is present, is clean and not brittle
Release button can be pressed, canister can be clicked in
Thopaz is clean with no dirty areas
Tests
Safety test
Carry out test as described in Instructions for use.
Thopaz must be disconnected from the mains (battery
operation). Required test equipment: vacuum gauge
~0-10 kPa Class 2.5 % or better (E.G.077.1456)
Acoustic signal (beep)
Audible?
Battery
Connect Thopaz to mains adapter or place it in docking sta-
tion.
Overall evaluation
No safety or functional technical errors were detected.
Errors that are not safety relevant were detected. No direct risk.
Safety relevant errors were detected.
Tester / Signature:
480 |
Technical documentation
Thopaz serial number:
Firmware version:
Run time (Settings 2/2):
OK


 Battery is being
charged.
Errors

 1 ______________
2 ______________
3 ______________
 1 ______________
2 ______________
3 ______________
Next test: __ __ / __ __ / __ __ __ __
Place / Date:
h
NO YES
Not OK


 Battery is not
being charged.
Actions
Thopaz is ready
for use.
Thopaz is ready for
use, errors must be
corrected by
_ __ / _ __ / _ __
Do not use Thopaz
until the errors are
corrected. Send
Thopaz to Medela
Service Centre.