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

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