SECTION 10 APPENDIX I
_______________________________________________________________________
10-3
Safety
Tester
Electrode
#
1 2 4 3
Acceptance
Range in
Kohms
4 - 6
8 - 17
3 - 5
2 - 4
Figure 9 - BIS Sensor Simulator individual electrode impedance range
Safety Testing: Leakage Current
Leakage current testing should be performed by a qualified Engineering Technician or authorized personnel
only.
Connect the BIS Sensor Simulator to the patient
interface cable of the BIS monitor as if it was a sensor
connection.
Short the two terminals at the end of the simulator
using conventional methods such as jumpers or
alligator clips.
Connect the test signal to the shorted terminals. Make
sure that you are not touching the BIS Sensor Simulator beyond this point.
Proceed to test instrument for Leakage current as per established facility protocols and
procedure for safety testing of medical devices.
Simulator Cleaning
Wipe simulator surfaces with a wet cloth soaked in lukewarm tap water containing
bleach solution of 10% by volume.
Wipe simulator surfaces with a wet cloth of lukewarm tap water
Dry with a clean cloth and allow to dry.
10.3
Test Sensor
Use the following procedure to make a Test Sensor:
1.
Remove a new sensor from its plastic carrier sheet and place on flat surface with the
adhesive facing up.
NOTE:
Be careful that gel does not leak onto hands or connector during this
procedure.
Содержание BIS VIEW
Страница 2: ......
Страница 4: ......
Страница 10: ...iii ...
Страница 78: ...SECTION 8 SERVICING THE BIS VIEW MONITORING SYSTEM 8 16 ...
Страница 99: ......