Appendix B - Medela Thopaz+ Gebrauchsanweisung

Appendix B

EN / IEC 62353: 2008
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
FPT 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
station.
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:
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:

Appendix B

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.
| 397