7 Technical Safety Check – Infusomat® Space

Checklist for TSC – Infusomat® Space

Edit Acc. to Service Manual Version 7.0 (Master – to be added to the documentation)

Checklist for Technical Safety Check – Every 24 Months Owner

Unit: Infusomat® Space

Manufacturer: B. Braun Melsungen AG

Observe the Service Manual and the Instructions for Use. All measured values are to be documented. Year of Procurement
Accessories used should be included in testing. Make exclusive use of calibrated measuring
equipment. The check numbers of failed checks have to be listed in the "Checks not passed" fields.

Article No. (REF) Serial No. (SN) Software Version (SW) Inventory No. (of the Owner)

1. Visual Inspection
Infusomat® Space Accessories: Visual Inspection of ❍ ❍
1. Cleanliness, completeness, no damage and defects affecting safety, integrity and Pass Fail
Accessories:
readability of the label. Checks not passed: _________________

Infusomat® Space:
1. Cleanliness, completeness, no damage and defects affecting safety, integrity and readability of the labels.

Particularly:
2. Connectors “P2” and “P3” 6. Screw covers
3. Safety clamp 7. Air inline sensor Visual Inspection of ❍ ❍
Pass Fail
4. Device membranes 8. Washers/Nyseal screws Infusomat® Space:
5. Check for restricted combination 9. Pictogram on front panel Checks not passed: _________________

Electrical Safety (According to EN 60601-1 or EN 62353)

The patient and equipment leakage current of the The Technical Safety Checks of the power supply SP or of the
Infusomat® Space is caused exclusively by the operating voltage SpaceStation serve to check whether both limit values are met.
supply (Power Supply SP or SpaceStation).

2. Mechanical Inspection

1. Locking with second unit 3. Slide guide Mechanical Inspection: ❍ ❍

Pass Fail
2. Battery compartment cover Checks not passed: _________________

3. Functional Inspection
Determine Age of Battery Connect unit with power supply, with Switch on unit:
the unit turned off and the service plug 2. Indicator LEDs
Age of battery max. 8 years ❍ ❍
YES NO connected: 3. Self-test
1. Status display 4. Audible alarm
If "NO" (battery is older than 8 years):
5. Lightning
Perform Battery Check
Battery Check: ❍ ❍
Pass Fail

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EN Infusomat® Space 7.0 7-1

 7 Technical Safety Check – Infusomat® Space
Acc. to Service Manual Version 7.0 (Master – to be added to the documentation)

3. Functional Inspection (Cont.)

Operation Pressure limitation, mechanical Air inline sensor
6. Yellow warning light 16. Pmax (1.8 … 2.5 bar) ____ bar 22. Water value
7. Infusion (or 26 … 36 psi) ____ psi (1100 … 2250 mV) ____ mV
8. Buttons on the operating unit 17. Pmin (> 1.5 bar) ____ bar 23. Difference of temperature
9. Staff call (or > 22 psi) ____ psi sensors (< 3 °C) ____ °C
10. Trigger bolus at the device 24. Air alarm
11. Trigger bolus by pressing the PCA ❒ Safety clamp 25. Air value (< 100 mV) ____ mV
N/A 18. Pmin (> 1.2 bar) ____ bar
button (check N/A if not available) Note: If the water or air value is not
12. Open the operating unit. (or > 17 psi) ____ psi reached immediately, these values must be
read again after 120 seconds.
Pressure cut-off, electronic Delivery accuracy
Delivery rate: 250 mL/h, test without drop Ambient temperature 20 … 25°C Gap of safety clamp
sensor 19. Divergence (± 5 %) ____ %
26. Gap of safety clamp is between 0.3 mm
13. Upstream Alarm and 0.6 mm
Drop sensor ❒
N/A
Downstream 20. Drop sensor alarm, flow Switch on unit without power supply
14. Pressure stage 2 21. Drop sensor alarm, occlusion 27. Self-test
(0.1 … 0.7 bar) ____ bar 28. Magnetic function of the battery
(or 1.5 … 10 psi) ____ psi compartment cover
15. Pressure stage 9
Remove battery module
(0.8 … 1.4 bar) ____ bar 29. Piezo test
(or 11 … 20 psi) ____ psi

Functional Inspection: ❍ ❍
Pass Fail
Checks not passed: _________________

4. Check Battery Status

1. Battery is charged (min. 1/3) Check Battery Status: ❍ ❍

Pass Fail

Mech. Aids and Measuring Equip. Used

N/A
❒ Manometer
Ident. No.: ____________________
Calibrated until: _______________
❒ Scales
Ident. No.: ____________________
Calibrated until: _______________
N/A
❒ Graduated cylinder
❒ Stop watch
❒ Service Plug SP
❒ Infusomat® Space Line, standard
Ref. No.: ____________________
❒ Infusomat® Space Line, SafeSet
Ref. No.: ____________________
N/A
❒ Disposables
Type: _______________________
Ref. No.: ____________________
___________________________
___________________________

Accessories Used
N/A N/A
❒ Power supply SP ❒ Battery module ______________________________
❒ Power supply cable 12 V ❒ Space PCA kit (PCA button) ______________________________
❒ Connection cable staff call SP ❒ Drop sensor

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7-2 Infusomat® Space 7.0 EN
 7 Technical Safety Check – Infusomat® Space
Acc. to Service Manual Version 7.0 (Master – to be added to the documentation)

Test result: Defects found which could endanger patients, personnel or third parties: Inspection performed by:
❍ Yes
❍ No

TSC was passed:

❍ Yes Unit handed over on:
❍ No
To
Measures to be taken:
❍ None
❍ Repair

Special features / documentation: Date / Signature:

________________________________________________________________________
________________________________________________________________________
Note: If the unit has successfully passed the TSC, it is assured that the unit has met all safety- Next TSC deadline:
relevant criteria according to the technical specification at the time of inspection. The unit may
be used on patients further on!

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EN Infusomat® Space 7.0 7-3