Steps
Functionality check - Language check (performed after each patient use)
22
Record set language.
(If language is changed during functionality check,
set to original language once checks are complete).
Functionality check - Modes of operation check (performed after each patient use)
23
Device starts operating, status/alarm indicator
illuminates solid green, and the screen displays
"Continuous" and therapy set-point.
24
Device stops operating, status/alarm indicator is no
longer illuminated and the screen displays
"Standby" and therapy set-point.
25
Intermittent operation selected.
26
Device starts operating, status/alarm indicator
illuminates solid green, and the screen displays
"Intermittent" and therapy set-point.
27
Device operates for 5 minutes ± 30 seconds and
then stops operating.
28
Device does not operate for 2 minutes
± 30 seconds, status/alarm indicator remains illu-
minated and the screen displays "Intermittent" and
therapy set-point.
Functionality check - Keypad lock check (performed after each patient use)
29
Device starts operating, status/alarm indicator
illuminates solid green, and the screen displays
"Continuous" and the therapy set-point".
30
The blue indicator light above the KEYPAD LOCK
button illuminates solid blue and the screen dis-
plays "Keypad Locked", then changes to "Continu-
ous" and the therapy set-point.
31
Verify device does not stop operating when the
SELECT button is pressed and the screen displays
"Keypad Locked".
32
The indicator light above the KEYPAD LOCK button
is no longer illuminated and the screen displays
"Keypad Active".
Functionality check - Homecare lock check
33
Verify indicator above KEYPAD LOCK button illumi-
nates solid blue, screen displays "Keypad Locked",
"Continuous" and the therapy set-point on upper-
line, followed by "***" on lower line.
34
Verify device does not stop operating when the
SELECT, UP and DOWN buttons are pressed and the
screen displays "Keypad Locked".
35
Verify indicator light above KEYPAD LOCK button is
no longer illuminated and screen displays "Keypad
Active".
Yes No
Comments
Language:
16