Braun Infusomat Space - Functional Test Acc. to §5, Section 1, Mpbetreibv (German Medical Devices Operator Ordinance)

System Overview
1
Infusomat® Space 6.0 1 - 17EN
Functional test acc. to §5, Section 1, MPBetreibV
(German Medical Devices Operator Ordinance)
*
This functional test is to be performed with every individual de-
vice prior to first use.
* Mandatory in some countries in which medical product laws apply, and strongly recommended in all other countries.
Item OK Item OK
1. Completeness, Integrity 3. Functional Test (see Instructions for Use)
1.1 Instructions for Use is available. ❒ 3.1 Open pump door, insert a primed line, close pump
door
.
❒
1.2 Final Inspection Sheet is available. ❒
1.3 Not applicable. 3.2 Confirm line. ❒
1.4 No mechanical damage detected at Infusomat®
Space.
❒ 3.
3 Deny priming. ❒
3.4 Select rate 1.1 ml/h and st
art Infusomat® Space.
Green LED is shining, arrows are moving from right to
left.
❒
1.5 Name plate. ❒
1.6 Read serial number from name plate and note this be-
low on this page.
❒
3.5 Give a bolus by pre selecting a volume of 3 ml – bolus
will be deliv
ered.
❒
1.7 S
eal is fixed on device and is not damaged. ❒
3.6 Close roller clamp – red LED lights up, alarm text is
display
ed.
❒
1.8 Infusomat® Space is clean. ❒
1.9 Battery is available and in place. ❒ 3.7 Confirm alarm by pressing the OK button, open the
roller clamp, and
start Infusomat® Space again.
❒
2. Switching on and Self Test
3.8 Press Clear key - the main menu opens. ❒
2.1 Switch on Infusomat® Space (see Instructions for
Use).
❒ 3.9 Press blue key – a screen message appears ❒
2.2 Display shows: “Self test active”. ❒
4. Finalize Test
2.3 Two signal tones are audible. ❒
2.4 LEDs flash alternately (yellow, red/green, blue). ❒ 4.1 Remove Infusomat® Space line and dispose of it.
Switch of
f Infusomat® Space.
❒
2.5 Not applicable.
2.6 Is the battery charged? If not: Connect device to
mains (see Instructions for Use).
❒ 4.
2 Place instructions for use with the Infusomat® Space. ❒
2.7 Is the desired language correctly displayed? If not: Set
language (see Instructions fo
r Use).
❒ 4.3 Complete this form and file properly. ❒
4.4 Also file the Final Inspection Sheet. ❒
Functional test performed on Infusomat® S
pace with serial number
by on (date).
Infusomat® Space has been handed out without any dama
ge and in proper
working order.
Date Signature B. Braun Signature Hospital
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