spr2-000.835.01.02.02

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Surgery/Mobile Units
SP
Report
System
Startup, repair and maintenance
System:
System material number:
System serial number:
Customer:
Country/city:
Customer-spec. ID number
C-arm movements
© Siemens 2009
Protective earth resistance The reproduction, transmission or use
of this document or its contents is not
Equipment leakage current permitted without express written
10409105
10187803
10187800
08620010 authority. Offenders will be liable for da-
mages. All rights, including rights crea-
ted by patent grant or registration of a
utility model or design, are reserved.
Print No.: SPR2-000.835.01.02.02 English

Replaces: SPR2-000.835.01.01.02 Doc. Gen. Date: 06.10
Protocol
1Revision / Disclaimer
Document revision level

The document corresponds to the version/revision level effective at the time of system
delivery. Revisions to hardcopy documentation are not automatically distributed.
Please contact your local Siemens office to order current revision levels.
Disclaimer
The installation and service of equipment described herein is to be performed by qualified
personnel who are employed by Siemens or one of its affiliates or who are otherwise autho-
rized by Siemens or one of its affiliates to provide such services.
Assemblers and other persons who are not employed by or otherwise directly affiliated with
or authorized by Siemens or one of its affiliates are directed to contact one of the local
offices of Siemens or one of its affiliates before attempting installation or service proce-
dures.
Surgery/Mobile Units SPR2-000.835.01.02.02 Page 2 of 56 Siemens

06.10 CS PS SP
Protocol
0Table of Contents
1 _______ General ________________________________________________________ 5
Validity of the protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Definition of tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Startup ME equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Startup of ME system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
2 _______ C-arm movements protocol ______________________________________ 20
C-arm movements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
3 _______ Visual inspection - Protocol ______________________________________ 21
Visual inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
4 _______ Safety of accessories - Protocol __________________________________ 23
Safety of accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
1. Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
2. Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
3. Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
4. Accessories. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5 _______ Measurements - Protocol ________________________________________ 27
Protective earth resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Equipment leakage current. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Applied part leakage current . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Insulation resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
6 _______ Functional checks - Protocol _____________________________________ 37
Functional checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
7 _______ Evaluations - Protocol ___________________________________________ 41
Overall evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Deficiencies identified . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Signature of the tester: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Siemens SPR2-000.835.01.02.02 Page 3 of 56 Surgery/Mobile Units

06.10 CS PS SP
Protocol
Next recurrent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Acknowledgement of responsible organization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Evaluations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
8 _______ Changes from the previous version________________________________ 55

06.10 CS PS SP
Protocol
1-
Validity of the protocol
1General
This protocol is valid for the system (ME equipment or ME system per IEC 62353):
System: ...............................................................................................................................
Material number: .................................................................................................................
Serial number: ...................................................................................................................
Protection class: Q I/Q II
With applied part: Q No / Q Yes, Type Q B; Q BF; Q CF
Customer-specific ID number: ..............................................................................................
In accordance with IEC Standard 62353, the system is consistent with
a single piece of ME equipment Q Yes Q No
an ME system Q Yes Q No,
consisting of the above-mentioned ME equipment and the following additional pieces of
equipment:
(Fill out only for ME system)
2. ME equipment or equipment with functional connection to the ME equipment: .................
Material number: ...............................................................................................................
Serial number: ...................................................................................................................
Customer-specific ID number: .............................................................................................
The functional connection consists of:...............................................................................
Is the second piece of equipment located within the patient environment? Q Yes Q No
Remarks:..........................................................................................................
............................................................................................................................................
3. Equipment with functional connection to ME equipment: ................................................
Material number: .................................................................................................................
Serial number: ...................................................................................................................
Customer-specific ID number: ............................................................................................
The functional connection consists of:...............................................................................
Is the third piece of equipment located within the patient environment? Q Yes Q No
Remarks:..........................................................................................................
............................................................................................................................................
Date:........................... Signature:.................................................................................

06.10 CS PS SP
Protocol
Definition of tests 1.1
The scope of tests must be defined prior to their execution.
Startup ME equipment 0
This section not applicable, protocol is valid for the defined ME system Q
(See sections on validity of the protocol and startup of the ME system)
Scope of tests defined by:
Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Check documents for completeness and currency H Yes
- Check all externally accessible fuses Q Yes Q n.a.
- Safety-related labels H Yes
- Safety-related signs H Yes
- Safety-related markings H Yes
- Damage H Yes
- Dirt H Yes
Safety of accessories Q Yes Q n.a.
Measurements
- Protective earth resistance H Yes
- Equipment leakage current H Yes
- Applied part leakage current Q Yes Q n.a.
- Insulation resistance Q Yes Q n.a.
Functional checks H Yes
Results report H Yes
Evaluation H Yes
Notification of evaluation H Yes
Protocol handover H Yes
Remarks:..........................................................................................................
............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Startup of ME system 0
This section not applicable, protocol is valid for the ME equipment Q

(See sections on validity of the protocol and startup of the ME equipment)
Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Check documents for completeness and currency Q Yes Q n.a.
- Safety-related labels Q Yes Q n.a.
- Safety-related signs Q Yes Q n.a.
- Safety-related markings Q Yes Q n.a.
- Damage H Yes
- Dirt H Yes
Measurements
- Protective earth resistance Q Yes Q n.a.
- Equipment leakage current Q Yes Q n.a.
Evaluation H Yes
- Notification of evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
Only for testing of ME system:
- Changes to ME system Q Yes Q n.a.
- Damage H Yes
- Dirt H Yes
Measurements
Functional checks Q Yes Q n.a.
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Repair 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Safety of accessories H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
Servicing 0

Name of tester:...............................................................................................................
Department...........................................................................................................................
Company:.............................................................................................................................
Test point To do:

Visual inspection
- Damage H Yes
- Dirt H Yes
Measurements
Evaluation H Yes
Remarks:..........................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
Date:.................................. Signature:.................................................................................

06.10 CS PS SP
Protocol
2-
C-arm movements
2C-arm movements protocol
Perform this test only on the following systems:

¹ ARCADIS Varic and SIREMOBIL Compact L
Skip this test if MOBILETT XP system present
Tab. 1
Movement OK Name Date Signa-

Yes/No ture
Releasing/locking the brakes

Downward movement, position 1
Downward movement, position 2
The warning signals sound as
described.
Function of
EMERGENCY_STOP_button
Remarks:
Tab. 2
Date Comment Name Signature
Name: ...............................Date: ................................... Signature: ...............................

06.10 CS PS SP
Protocol
3-
Visual inspection
3Visual inspection - Protocol
Tab. 3 Visual inspection
Test point Startup

refer-
Recurrent tests
ence
value
ME equipment/ME sys-
tem matches configura-
tion indicated in Validity
of Protocol section Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
Q No Q No Q No Q No Q No Q No Q No
The documents are Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
complete: Q No Q No Q No Q No Q No Q No Q No
Externally accessible Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
fuses match manufac- Q No Q No Q No Q No Q No Q No Q No
turer specifications:
Q n.a. Q n.a. Q n.a. Q n.a. Q n.a. Q n.a. Q n.a.
Safety-related labels Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
are present and legible: Q No Q No Q No Q No Q No Q No Q No
Safety-related signs Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
are present and legible: Q No Q No Q No Q No Q No Q No Q No
Safety-related mark- Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
ings are present and Q No Q No Q No Q No Q No Q No Q No
legible:
There are no damages Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
that would affect safety: Q No Q No Q No Q No Q No Q No Q No
There is no dirt that Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
would affect safety: Q No Q No Q No Q No Q No Q No Q No
There are no other Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
safety-related defects: Q No Q No Q No Q No Q No Q No Q No
Date:
Name:
Signature

06.10 CS PS SP
Protocol
Tab. 4 Remarks on visual inspection
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
Name: ........................ Date: .................... Signature: .........................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
4-
Safety of accessories
4Safety of accessories - Protocol
Q The test of the safety of accessories not applicable, since there are no accessories.
1. Accessories 0
Designation: ..........................................................................................................
Material number: ..........................................................................................................
Serial number: ..........................................................................................................
Test point 1: ..........................................................................................................
Test point 2: ..........................................................................................................
Test point 3: ..........................................................................................................
Tab. 5
Startup reference value Recurrent tests

Test point 1:
There are no Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
Test point 2:
Test point 3: Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
There are no Q No Q No Q No Q No Q No Q No Q No
safety-related defects:
Date:
Name:
Signature
Tab. 6 Remarks on tests of 1st accessory
Remarks on test
dated: ......................... ............................................................................................
................................................................................................................................................................
................................................................................................................................................................

06.10 CS PS SP
Protocol
2. Accessories 0
Designation: ..........................................................................................................
Material number: ..........................................................................................................
Serial number: ..........................................................................................................
Test point 1: ..........................................................................................................
Test point 2: ..........................................................................................................
Test point 3: ..........................................................................................................
Tab. 7

Test point 1:
Test point 2:
Date:
Name:
Signature
Remarks on test
dated: ......................... ............................................................................................
................................................................................................................................................................
................................................................................................................................................................
3. Accessories 0
Designation: ..........................................................................................................
Material number: ..........................................................................................................
Serial number: ..........................................................................................................

06.10 CS PS SP
Protocol
Test point 1: ..........................................................................................................

Test point 2: ..........................................................................................................
Test point 3: ..........................................................................................................
Tab. 9

Test point 1:
Test point 2:
Date:
Name:
Signature
Remarks on test
dated: ......................... ............................................................................................
................................................................................................................................................................
................................................................................................................................................................
4. Accessories 0
Designation: ..........................................................................................................
Material number: ..........................................................................................................
Serial number: ..........................................................................................................
Test point 1: ..........................................................................................................
Test point 2: ..........................................................................................................
Test point 3: ..........................................................................................................

06.10 CS PS SP
Protocol
Tab. 11

Test point 1:
Test point 2:
Date:
Name:
Signature
Remarks on test
dated: ......................... ............................................................................................
................................................................................................................................................................
................................................................................................................................................................

06.10 CS PS SP
Protocol
5-
Protective earth resistance
5Measurements - Protocol
Tab. 13 Protective earth resistance

Reference
Repeat measurement values
value
Measuring point 1:
.................................................
Measuring point 2:
.................................................
Measuring point 3:
.................................................
Measuring point 4:
.................................................
Measuring point 5:
.................................................
Measuring point 6:
.................................................
Measuring point 7:
.................................................
Measuring point 8:
.................................................
Measuring point 9:
.................................................
Measuring point 10:
.................................................
Measuring point 11:
................................................
Measuring point 12:
..................................................
.........
Measuring point 13:
.................................................
Measuring point 14:
.................................................

06.10 CS PS SP
Protocol

Reference
Repeat measurement values
value
Measuring point 15:
.................................................
Measuring point 16:
.................................................
Measuring point 17:
.................................................
Measuring point 18:
.................................................
Measuring point 19:
.................................................
Measuring point 20:
.................................................
Measuring point 21:
................................................
Measuring point 22:
.................................................
Measuring point 23:
.................................................
Measuring point 24:
.................................................
Measuring point 25:
.................................................
(*1) Measuring circuit:
Measuring device, type:
Meas. device ser. no.:
Measuring device, calibrated up
to:
Date:
Name:
Signature
(*1) Measuring circuit entered per IEC62353. See related documentation.

06.10 CS PS SP
Protocol
Tab. 14 Remarks on protective earth resistance test
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Name: ........................................... Date: .................... Signature: .........................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Name: ............................................ Date: .................... Signature: .........................

06.10 CS PS SP
Protocol
Equipment leakage current 5.1
Tab. 15 Equipment leakage current
Equipment leakage current

Reference Repeat measurement values
value
Equipment leakage current
(Highest measured value)
[mA]
Line voltage during the mea-
surement
[V~]
Equipment leakage current,
corrected value [mA]
Measuring device,
calibrated to:
Date:
Name:
Signature:

Tab. 16 Remarks on equipment leakage current test
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Applied part leakage current 5.2
Q Measurement not applicable due to applied part type B or no applied part present.
Tab. 17 Applied part leakage current
Applied part leakage current

value
1. Applied part:
Leakage current from
applied part (highest value
measured [mA]
2. Applied part:
Leakage current from
applied part (highest value
measured [mA]
Measuring device, calibrated
up to:
Date:
Name:
Signature:

Tab. 18 Remarks on applied part leakage current test
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Name: .......................................... Date: .................... Signature: .........................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Insulation resistance 5.3
Q Measurement of insulation resistance not applicable since not required by manufac-

turer.
Tab. 19 Insulation resistance
Insulation resistance
value
Insulation resistance
[MOhm]
Measuring device,
calibrated to:
Date:
Name:
Signature:

Tab. 20 Remarks on insulation resistance test
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
Remarks on test
dated: ......................... ...............................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................
..........................................................................................................................................

06.10 CS PS SP
Protocol
6-
Functional checks
6Functional checks - Protocol
Tab. 21 Functional checks per manufacturer's specifications
Functional checks per manufacturer's specifications

Before start up and during recurrent tests
The functional checks were per- Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
formed in accordance with the Q No Q No Q No Q No Q No Q No
specifications in the startup or
maintenance instructions:
Result of functional checks: The functions were tested successfully.
No defects found:
Q Yes Q Yes Q Yes Q Yes Q Yes Q Yes
Q No Q No Q No Q No Q No Q No
Date:
Name:
Signature:
Tab. 22 Functional checks defined by tester
Functional checks defined by tester

The following functional check(s) was/were defined and carried out: Result of checks. The
functions were tested
successfully.
No defects found:
Function(s):................................................................................................. Q Yes
Date: ........................................ Signature:.............................................. Q No
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes

06.10 CS PS SP
Protocol

Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes

06.10 CS PS SP
Protocol

Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes

06.10 CS PS SP
Protocol

Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes
Function(s):................................................................................................. Q Yes

06.10 CS PS SP
Protocol
7-
Overall evaluation
7Evaluations - Protocol
Of test on _______________________________ (date)
Deficiencies identified 0
Q No deficiencies were identified.
Q The following deficiencies were identified:

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0
The results of the tests were evaluated.

Q No safety and/or functional deficiencies were identified.
¹ The ME equipment or ME system can be put into operation.
Q Minor deficiencies were identified.

¹ The deficiencies identified present no direct risk.
¹ The deficiencies identified must be corrected in the near-term.
Q Safety and/or functional deficiencies were identified.

¹ The ME equipment or ME system presents the following risks:
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
¹ The ME equipment or ME system cannot be identified as safe and must be taken
out of operation until the deficiencies identified are corrected.
Q The equipment does not meet specifications.

¹ The equipment must be taken out of operation.
Signature of the tester: 0
Date: ............................. Name: ........................... Signature: .....................................

06.10 CS PS SP
Protocol
Next recurrent test 0
The next recurrent test must be performed no later than in ______ months.
Acknowledgement of responsible organization 0
Responsible organization: ............................................................................................

............................................................................................................................................
............................................................................................................................................
Responsible person: ............................................................................................................
............................................................................................................................................
.............................................................................................................................................
The result of the test and risks presented by the ME equipment or ME system was commu-
nicated.
The test protocol was distributed.
Date: ...............................Name: ........................... Signature: ......................................

06.10 CS PS SP
Protocol
Overall evaluation 7.1
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
Of test on _______________________________ (date)

..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
..............................................................................................................................................
Evaluations 0



........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................
........................................................................................................................


06.10 CS PS SP
Protocol

............................................................................................................................................
............................................................................................................................................
............................................................................................................................................
.............................................................................................................................................
nicated.

06.10 CS PS SP
Protocol
8Changes from the previous version 8-
The protocol was completely revised and modified to comply with the new IEC Standard
62353.

06.10 CS PS SP
Protocol

06.10 CS PS SP

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Print No.: SPR2-000.835.01.02.02 English

Document revision level

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 2 of 56 Siemens

1 _______ General ________________________________________________________ 5

Validity of the protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

2 _______ C-arm movements protocol ______________________________________ 20

3 _______ Visual inspection - Protocol ______________________________________ 21

4 _______ Safety of accessories - Protocol __________________________________ 23

5 _______ Measurements - Protocol ________________________________________ 27

Protective earth resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

6 _______ Functional checks - Protocol _____________________________________ 37

7 _______ Evaluations - Protocol ___________________________________________ 41

Siemens SPR2-000.835.01.02.02 Page 3 of 56 Surgery/Mobile Units

Next recurrent test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

8 _______ Changes from the previous version________________________________ 55

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 4 of 56 Siemens

Siemens SPR2-000.835.01.02.02 Page 5 of 56 Surgery/Mobile Units

Definition of tests 1.1

The scope of tests must be defined prior to their execution.

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 6 of 56 Siemens

This section not applicable, protocol is valid for the ME equipment Q

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 7 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 8 of 56 Siemens

Scope of tests defined by:

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 9 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 10 of 56 Siemens

Scope of tests defined by:

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 11 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 12 of 56 Siemens

Scope of tests defined by:

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 13 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 14 of 56 Siemens

Scope of tests defined by:

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 15 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 16 of 56 Siemens

Scope of tests defined by:

Test point To do:

Siemens SPR2-000.835.01.02.02 Page 17 of 56 Surgery/Mobile Units

Scope of tests defined by:

Test point To do:

Surgery/Mobile Units SPR2-000.835.01.02.02 Page 18 of 56 Siemens

Scope of tests defined by:

1 _ General __________________________________________________ 5

2 _ C-arm movements protocol ________________________________ 20

3 _ Visual inspection - Protocol ________________________________ 21

4 _ Safety of accessories - Protocol ____________________________ 23

5 _ Measurements - Protocol __________________________________ 27

6 _ Functional checks - Protocol _______________________________ 37

7 _ Evaluations - Protocol _____________________________________ 41

8 _ Changes from the previous version__________________________ 55