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XP-Products
XP
Safety Information
System
Performing the checks in accordance with IEC 62353
© Siemens, 2011
01818850
08847543
03074502
04781204
10021770
00475541
00475509
08395381
10569023
08080017
10048590
08081080
05531103
01157200
01158059
10746667
01818447
01818363
08645967
08645959
08620010
08620002
08357613
08645983
08645975
10094910
05756122
08355088
10143407
10143408
10143406
10746666
10746665
© Siemens, 2011
All documents may only be used for rendering
services on Siemens Healthcare Products. Any
document in electronic form may be printed
once. Copy and distribution of electronic docu-
ments and hardcopies is prohibited. Offenders
will be liable for damages. All other rights are re-
served.
Print No.: XP00-000.860.01.01.02 English

Replaces: SPR2-000.860.01.01 / SP00-000.860.05.02 Doc. Gen. Date: 10.11
CS PS XP WH SG
n.a.
2011
2 Copyright / Version / Disclaimer
1Copyright / Version / Disclaimer
Copyright
“© Siemens, 2011“ refers to the copyright of a Siemens entity such as Siemens Aktienge-
sellschaft - Germany, Siemens Shenzhen Magnetic Resonance Ltd. - China, Siemens
Shanghai Medical Equipment Ltd. - China, Siemens Medical Solutions USA Inc. - USA,
Siemens Healthcare Diagnostics Inc. - USA and/or Siemens Healthcare Diagnostics Prod-
ucts GmbH - Germany.
Document Version
Siemens reserves the right to change its products and services at any time.
In addition, manuals are subject to change without notice. The hardcopy documents corre-
spond to the version at the time of system delivery and/or printout. Versions to hardcopy
documentation are not automatically distributed. Please contact your local Siemens office
to order current version or refer to our website http://www.healthcare.siemens.com.
Disclaimer
Siemens provides this documentation “as is“ without the assumption of any liability under
any theory of law.
The installation and service of equipment described herein requires superior understand-
ing of our equipment and may only be performed by qualified personnel who are specially
trained for such installation and/or service.
XP-Products XP00-000.860.01.01.02 Page 2 of 34 © Siemens, 2011

10.11 CS PS XP WH SG
Table of Contents 3
0Table of Contents
1 _______ General information and product-specific information _________________ 4
Information regarding this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Purpose of the document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Validity of this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Application of this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Required measurement devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Information regarding the standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Scope of validity of the IEC 62353:2007 or EN 62353:2008 standard . . . . . . . . . . . . 7
Measurement circuits according to IEC62353:2007 . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Check sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Product-specific Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Affecting all listed ME equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Lithotripsy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Urology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Mammography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Surgery and mobile units . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Workstations/workplaces/monitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Optionally used ME equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
2 _______ Recordings ____________________________________________________ 19
Customer and product data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Customer data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Check object . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Reason for the checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Check sequence. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Definition of checks. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Visual inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Measurements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Functional checks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Safety evaluation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
3 _______ Changes from the previous version________________________________ 33
4 _______ List of Hazard IDs ______________________________________________ 34
© Siemens, 2011 XP00-000.860.01.01.02 Page 3 of 34 XP-Products

4 General information and product-specific information
1-
Information regarding this document
1General information and product-specific information
Purpose of the document 0
This document describes the sequence of checks according to the IEC 62353:2007 or EN
62353:2008.
Validity of this document 0
This document replaces documents SP00-000.860.05... and SPR2-000.860.01...

This document supplements the safety instructions in the product-specific documentation
and is valid for the following products:
ME equipment permanently connected to the supply mains

Fluoroscopy and radiography
• This document and corresponding protocol XP00-000.835.02... can be used for fluo-
roscopy and radiography products for checks in accordance with IEC 62353:2007.
Lithotripsy
• LITHOSKOP, material no. 08355088
Mammography
• MAMMOMAT 1000, material no. 06522002, 06522010, 06522028, 06522036,
06607902
• MAMMOMAT 3000 Nova, material no. 06431832, 06431840, 06431857, 06431865,
06431873, 06431881, 06431899, 06431907
• MAMMOMAT Balance, material no. 08383114
• MammoTest, material no. 10144185
Urology
• UROSKOP ACCESS, material no. 05756122, 05756130
ME equipment/other equipment with power supply cord (mains plug)

Lithotripsy/urology:
• MODULARIS Variostar, material no. 01157200
• LITHOSTAR Modularis Vario, material no. 01158059
• LITHOSTAR Modularis 140, material no. 01159107
• MODULARIS Uro, material no. 05531012
• MODULARIS Uro II, material no. 10142940
Mammography
• Table for MammoTest, material no. 10144752
Surgery and mobile units
• ARCADIS Varic, material no. 08080017
• ARCADIS Orbic, material no. 08081080

General information and product-specific information 5
• ARCADIS Avantic, material no. 10048590

• MOBILETT XP, material no. 01818363
• MOBILETT XP Hybrid, material no. 01818454
• MOBILETT XP Digital, material no. 01818447
• MULTIMOBIL 2.5, material no. 08620002
• MULTIMOBIL 10, material no. 08620010
• MULTIMOBIL 5C, material no. 08645959
• POLYMOBIL III, material no. 10187803
• POLYMOBIL Plus, material no. 10187800
• SIREMOBIL Compact L, material no. 03780629
Workstations/workplaces and related monitors
• AES workplace, material no. 10400000
• iCAD Tower, material no. 08646155, 08646163, 08646320
• R2 ImageChecker D-Basic System, material no. 08646403
• Syngo MammoReport, material no. 08646460
Application of this document 0
This document is to be used as a supplement to the existing documents of the products

indicated in the "Validity of this document" section.
A corresponding protocol XP0-000.835.02... for checks in accordance with IEC
62353:2007 was created for these instructions.
¹ Observe all potentially deviating national regulations, standards and laws of your
country.
Startup and maintenance

¹ Perform the checks in accordance with IEC 62353:2007 according to these
instructions and the startup instructions and maintenance instructions of the ME
equipment/ME system and record the check in the corresponding protocol for
checks in accordance with IEC 62353:2007, print no. XP00-000.835.02....

Repair
¹ Perform the checks in accordance with IEC 62353:2007 according to these
instructions and record the check in the corresponding protocol for checks in
accordance with IEC 62353:2007, print no. XP00-000.835.02....
In the case of repairs, the recording of checks in the corresponding protocol for checks in
accordance with IEC 62353:2007, print no. XP00-000.835.02... can be omitted if:
¹ No checks in accordance with IEC 62353:2007 are necessary.
(For example, repairs without an intervention in the ME equipment, such as pro-
gramming of a DICOM node).
¹ Checks in accordance with IEC 62353:2007 are necessary but these are
recorded in the service report.
(For example, recording of the protective earth measurement with evaluation on
the basis of the reference values and specifications for the used measurement
device in the service report)
In the case of repairs including redetermination of the reference values (e.g., replacement
of parts in the primary circuit of the mains voltage supply, replacement of the on/off module,
replacement of applied parts, or expansion of the ME equipment by adding options), use
the corresponding protocol for checks in accordance with EC 62353, print no.
XP00-000.835.02....
Required measurement devices 0
The used measurement devices must be suitable for the necessary measurements accord-
ing to IEC 62353:2007/EN 62353:2008.
¹ Protective earth resistance measurement
¹ Leakage current measurement - if required.
¹ Insulation resistance measurement - if required.
¹ Observe the information in the "General information and product-specific informa-
tion" chapter below.
country.

Information regarding the standard 1.1
Scope of validity of the IEC 62353:2007 or EN 62353:2008 standard 0
The IEC 62353:2007 or EN 62353:2008 standard applies to the checks

¹ Prior to STARTUP
¹ During SERVICING
¹ During INSPECTION
¹ During MAINTENANCE
¹ After REPAIR
¹ During RECURRENT CHECKS
Of MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT) or MEDICAL ELECTRICAL
SYSTEMS (ME SYSTEMS) or parts thereof, developed and built and marketed according
to standard IEC 60601-1.
¹ This scope of validity relates to the products specified in the "Validity of this doc-
ument" chapter.
country.
NOTE Since the scopes of validity, measurement circuits, and

requirements regarding checks in accordance with stan-
dards IEC 62353:2007 and EN 62353:2008 are almost identi-
cal, only standard IEC 62353:2007 is mentioned in the
following references to standards.
Measurement circuits according to IEC62353:2007 0
NOTE The measurement circuits according to IEC 62353:2007 are

represented in the standard.
Use the figure numbers specified in standard IEC 62353:2007
for defining the used measurement circuit.
Also observe the work guidelines of your service organiza-
tion.
Protective earth resistance measurement

Two measurement circuits are represented in the standard:
¹ "Figure 1: Measurement circuit for measuring the PROTECTIVE EARTH RESIS-
TANCE of ME equipment disconnected from the supply mains."
(Example: ARCADIS Varic, SIREMOBIL Compact L (plug-in equipment)

¹ "Figure 2: Measurement circuit for the measurement of the PROTECTIVE

EARTH RESISTANCE" in ME equipment or ME systems that cannot be discon-
nected from the supply mains for operational reasons or in the case of ME equip-
ment or ME systems that are permanently connected to the supply mains.
(Example: UROSKOP Access, LITHOSKOP (permanently connected ME equip-
ment)
Equipment leakage current measurement

3 measurement procedures are specified in the IEC 62353:2007 standard for measuring
the equipment leakage current in ME equipment of class II.
¹ Figure 3 - measurement circuit for measuring the equipment leakage current -
equivalent measurement - class I
equivalent measurement - class II
direct measurement - class I
direct measurement - class II
¹ Figure 5 - measurement circuit for measuring the equipment leakage current - dif-
ferential measurement - class I
¹ Figure 5 - measurement circuit for measuring the equipment leakage current - dif-
ferential measurement - class II
Measuring the leakage current of type F applied part

2 measurement procedures are specified in the IEC 62353:2007 standard for measuring
the leakage current of the type F applied part in ME equipment of class I and II.
¹ Figure 6 - measurement circuit for measuring the leakage current of type F
applied parts - equivalent measurement - class I
applied parts - equivalent measurement - class II
applied parts - direct measurement - class I
applied parts - direct measurement - class II
In addition, a measurement procedure is specified in standard IEC 62353:2007 for the
measurement of the leakage current of the type F applied part in ME equipment with an
internal power supply.
applied parts - direct measurement

Insulation resistance measurement

A measurement procedure is specified in standard IEC 62353:2007 for measuring the insu-
lation resistance between a mains part and protective earth in equipment of class I and for
measuring the insulation resistance between a mains part and ungrounded, accessible,
conductive parts in equipment of class I and II.
¹ Figure 9 - measurement circuit for measuring the insulation resistance between

a mains part and protective earth - class I
a mains part and ungrounded, accessible, conductive parts - class I and II
A measurement procedure is specified in standard IEC 62353:2007 for measuring the insu-
lation resistance between a mains part and all patient connections of the applied parts.
a mains part and all patient connections of applied parts
Another measurement procedure is specified in standard IEC 62353:2007 for measuring
the insulation resistance between all patient connections of type F applied parts and pro-
tective earth - class I and for measuring the insulation resistance between all patient con-
nections of type F application parts and ungrounded, accessible, conductive parts - class
I and II.

all patient connections of type F application parts and protective earth in equip-
ment of class I and between all patient connections of type F applied parts and
(ungrounded) accessible, conductive parts in equipment of class I and II.

Check sequence 1.2
The IEC 62353:2007 standard establishes the following check sequence:

¹ Selection of checks
¹ Visual inspection
¹ Protective earth resistance
¹ Leakage currents
Watch for any hazards which may arise during the check.
¹ Insulation resistance
Insulation resistance measurement does not need to be performed for the equip-
ment described in this document.
¹ Function test
The functions must be performed according to the information in the documents
accompanying the product as well as the documents published in the CB docu-
ment of the equipment (e.g. servicing instructions/maintenance instructions).
¹ Results report
¹ Evaluation
The check results have to be evaluated.
The evaluation must be documented.
¹ Control and preparation for proper use.

Product-specific Information 1.3
Please observe the following information regarding the checks of ME equipment/ME sys-
tems mentioned in this section.
Affecting all listed ME equipment 0
Protective earth resistance
Initial startup, transfer of measured values from manufacturing protocols

In the case of ME equipment checked completely at the factory (plug-in equipment): During
startup the measurement points and measured values of the protective earth resistance
test from the manufacturing protocol may be transferred if the following requirements are
met:
¹ The ME equipment was already programmed at the factory for the correct, on-site
mains voltage and checked with this mains voltage.
¹ The mains plug installed at the factory fits the on-site mains outlet.
¹ No adapters for adapting the mains plug installed on the equipment side to the
on-site mains outlet.
¹ No housing parts were opened.
¹ No additional components were installed.
¹ No ME equipment damage can be detected.
Measurement points
The protective earth resistance measurement must be measured at all accessible, electri-
cally conductive parts and all components of the ME equipment.
During startup the measurement locations can typically be taken from the specifications in
the supplied manufacturing protocol or the startup instructions.
If measurement point specifications are missing, the measurement points must be defined.
In the case of repeat measurements, transfer the measurement points from the protocol
with the reference values to the new protocol.
During checks after a repair, define the measurement points according to the repair work.
Protective earth resistance measurement device

Make sure the measurement device complies with the requirements of standard IEC
62353:2007.
When using a measurement device with direct current, the measurements of the protective
earth resistance must be repeated with reversed polarity. The higher measured value
should be recorded.
ME equipment/other equipment with flexible power supply cords

During the protective earth resistance measurement, move flexible power supply cords
section-by-section over their entire length to check for any possible wire breaks.

¹ Varying measured values arising during moving of the power supply cord indicate
breakage of the protective earth conductor.
¹ If necessary, replace the power supply cord.
Protective earth resistance measurement of ME systems with multi-socket outlet

The protective earth resistance of ME systems connected to the supply mains by means
of a multiple-socket outlet must be tested with inclusion of the multiple-socket outlet.
¹ The protective earth resistance of the entire ME system must not exceed 500
mohms.
¹ ME equipment with a removable power cord must not exceed the following partial
protective earth resistances:
Multiple-socket outlet: max. 200 mohms;
Removable power cord: max. 200 mohms;
ME equipment: max. 100 mohms.
¹ ME equipment with a non-removable power cord must not exceed the following
partial protective earth resistances:
Multiple-socket outlet: max. 200 mohms;
ME equipment (incl. non-removable power cord): max. 300 mohms.
Equipment leakage current
Initial startup, transfer of measured values from manufacturing protocols

In the case of ME equipment checked completely at the factory (plug-in equipment): During
startup the measurement points and measured values of the leakage current measure-
ment from the manufacturing protocol may be transferred if the following requirements are
met:
¹ The ME equipment was already programmed at the factory for the correct, on-site
mains voltage/mains frequency and checked with this mains voltage/mains fre-
quency.
¹ No mains adapters for adapting the mains plug installed on the equipment side to
the on-site mains outlets.
Equipment leakage current measurement of ME equipment/ME systems of class I

The IEC 62353:2007 standard specifies that the measurement of equipment leakage cur-
rent must be performed separately on accessible conductive parts not connected to the
protective earth conductor.
The ME equipment/other equipment listed in the section "Validity of this document" does
not have any accessible conductive parts that are not connected to the protective earth
conductor.

Permanently installed ME equipment

In the case of ME equipment permanently connected to the supply mains, equipment leak-
age current measurement can be omitted if the protective measures against electrical
shock within the supply mains are in accordance with IEC 60364-7-710 ("Medical loca-
tions"), and related check are performed regularly. Also refer to the following product-spe-
cific information.
ME equipment or equipment with power supply cord (with mains plug)

An equipment leakage current measurement is to be performed for the ME equip-
ment/other equipment with power supply cord (mains plug) specified in the "Validity of this
document" section.
All specified ME equipment/other equipment has an electronic on/off module or a
switched-mode mains part.
Measurement procedure restrictions
Measurement of the equipment leakage current using the equivalent measurement proce-
dure can lead to incorrect measured values in the case of electronic on/off modules or
switched-mode mains parts of the device under test.
Therefore, the equipment leakage current must be measured via differential current mea-
surement or direct measurement in accordance with IEC 62353:2007 for the ME equip-
ment/other equipment specified in the "Validity of this document" section.
Since the protective earth conductor cannot fulfill its function during direct measurement,
there is a potential hazard to the tester or other personnel.
When direct measurement is used as a measurement procedure for equipment leakage
current, the following conditions and safety precautionary measures must be taken prior to
testing.
¹ The ME equipment or other equipment must be isolated in order to avoid mea-
surement errors.
¹ Access to the ME equipment or other equipment by personnel other than the
tester must be prevented (blocking, measurement in a separate room).
¹ During the measurement, the tester may not touch the ME equipment or other
equipment.
¹ In the case of ME equipment/ME systems with an electronic switch-on circuit, the
measurement device is set to manual measurement to prevent measurement
errors.
During differential current measurement, no hazard to the tester or other personnel can
arise during the measurement, since the protective function of the protective earth conduc-
tor remains intact. During differential current measurement, the ME equipment does not
have to be isolated.

Applied part leakage current

Some of the ME equipment specified in the "Validity of this document" section has a type
B applied part.
In the case of the equipment specified in the "Validity of this document" section, it is not
necessary to measure the leakage current of the applied part.
If ME equipment specified in the "Validity of this document" section is combined with other
ME equipment not specified in the "Validity of this document section to form one ME system
and if the ME equipment that is not specified has an applied part requiring a check of the
applied part leakage current, the applied part leakage current for this ME equipment must
be measured and recorded, and the measurement result must be evaluated.
Insulation resistance measurement

The insulation resistance measurement does not need to be performed for the products
specified in the "Validity of this document" section.
If ME equipment specified in the "Validity of this document" section is combined with other
ME equipment not specified in the "Validity of this document section to form one ME system
and if the manufacturer requires an insulation resistance measurement for the ME equip-
ment that is not specified, the insulation resistance measurement for this ME equipment
must be performed and recorded, and the measurement result must be evaluated.
Functional checks
Startup
The scope of the functional checks is normally defined in the accompanying papers, such
as the startup instructions.
In this case, additional functional checks do not need to be defined.
Maintenance
The scope of the functional checks during maintenance is normally defined in the mainte-
nance instructions of the ME equipment.
In these cases, additional functional checks do not need to be defined.
Repair
Observe the specifications in the "Application of this document" section.
The scope of the functional checks is to be defined according to the performed repair work.
In addition, safety-relevant functions, such as emergency off, emergency stop, warnings,
X-ray collimation, should be checked.
Lithotripsy 0
LITHOSKOP
The LITHOSKOP is permanently connected to the supply mains.

¹ The equipment leakage current measurement is not required if the protective

measures against electrical shock in the supply mains are in accordance with IEC
60364-7-710 and the tests for this are performed regularly.
LITHOSKOP table top

The LITHOSKOP table top is fixedly connected to the LITHOSKOP basic unit and does not
contain a separate power supply cord to the supply mains.
¹ The LITHOSKOP basic unit and table top are to be checked as one ME equip-
ment unit.
¹ Protective earth resistance test of LITHOSKOP basic unit and table.
During this check any flexible lines are to be moved in sections in order to ascer-
tain wire breaks.
¹ The shock wave head und table top are type B applied parts.
The applied part leakage current does not have to be measured
LITHOSKOP in combination with ultrasound and/or ECG monitor ME equipment

If the LITHOSKOP is operated in combination with the ACUSON X150 ultrasound unit (+
transducers) or in combination with the Infinity Gamma/Gamma XL ECG monitor, the
resulting combination comprises an ME system.
The individual ME equipment units and the combination of ME equipment are to be
checked as an ME system.
¹ The ultrasound unit is to be checked according to product-specific requirements.
Use the product-specific documents and protocols.
¹ The ECG monitor is to be checked according to product-specific requirements.
Use the product-specific documents and protocols.
¹ No additional leakage current measurements are required when testing the ME
system consisting of the combination of the LITHOSKOP and ACUSON X150
ultrasound unit. Refer to the LITHOSKOP CE declaration of conformity.
Urology 0
UROSKOP access
The UROSKOP Access is permanently connected to the supply mains.
¹ The UROSKOP Access is to be checked as ME equipment.
¹ The protective earth resistance test is to be performed.
¹ The table top is a type B applied part.

Mammography 0
MAMMOMAT 1000, MAMMOMAT 3000, MAMMOMAT Balance, MammoTest

The MAMMOMAT 1000, MAMMOMAT 3000, MAMMOMAT Balance und MammoTest ME
equipment is permanently connected to the supply mains.
MammoTest table top

The MammoTest table is separately connected to the supply mains by means of a flexible
power supply cable.
The table comprises a separate ME equipment unit that must be checked separately.
In addition to checks, the following measurements are to be performed:
¹ Protective earth resistance test of the power supply cable and table. During this
check flexible lines are to be moved in sections in order to ascertain wire breaks.
¹ Equipment leakage current measurement.
¹ The table top is a type B applied part.
MammoTest isolating transformer to workstation and monitor voltage supply

The workstation and monitor(s) were developed and produced in accordance with EN
60950-1.
The MammoTest workstation with related monitor is operated using an isolating trans-
former that is developed and produced in accordance with IEC 60601-1.
The isolating transformer is provided with a power supply cord and is connected separately
to a mains outlet of the supply mains.
The isolating transformer as well as the power supply cord are to be included in the checks.
¹ The workstation/monitor(s) and the isolating transformer are likewise to be
checked in accordance with IEC 62353:2007 (protective earth resistance and
equipment leakage current).
¹ An increased limit value of max. 3.5 mA in accordance with EN 60950-1 applies
to the equipment leakage current measurement of the workstation/monitor(s)
without inclusion of the isolating transformer.
¹ The limit value of max. 0.5 mA in accordance with IEC 62353:2007 applies to the
equipment leakage current measurement of the isolating transformer with work-
station and monitor(s) connected on the secondary side.

Surgery and mobile units 0
ME equipment with a max. permissible equipment leakage current of 0.5 mA

Standard IEC 62353:2007 allows a maximum equipment leakage current of 0.5 mA during
direct measurement or differential measurement for ME equipment of class I.
An equipment leakage current limit value of max. 0.5 mA during direct measurement or dif-
ferential current measurement is specified for the following equipment:
ME equipment with a maximum permissible equipment leakage current of 5.0 mA

Standard IEC 62353:2007 allows a maximum equipment leakage current of 0.5 mA during
direct measurement or differential measurement for ME equipment of class I. According to
comment 2, the standard allows other limit values in the case of "special requirements".
Standard IEC 60601-1 edition 3.0 2005-12 allows an earth leakage current of 5 mA under
normal conditions and 10 mA in the case of the first malfunction for ME equipment of class
I.
Therefore, an equipment leakage current of max. 5 mA during direct measurement or dif-
ferential measurement was defined at the factory as a limit value for the following ME equip-
ment.
• MOBILETT XP, material no. 01818363
• MOBILETT XP Hybrid, material no. 01818454
• MOBILETT XP Digital, material no. 01818447
• MULTIMOBIL 2.5, material no. 08620002
• MULTIMOBIL 10, material no. 08620010
• POLYMOBIL III, material no. 10187803
• POLYMOBIL Plus, material no. 10187800

Mobilett XP Digital
The MOBILETT XP Digital detector is a type B application part.
The detector manufacturer does not specify any leakage current measurement of the
applied part.
Therefore, a leakage current measurement does not need to be performed for the applied
part of the detector for the MOBILETT XP Digital.
Workstations/workplaces/monitors 0
The workstations/workplaces and related monitors used with Mammo/Uro/Litho products

are not produced in accordance with standard IEC 60601-1.
According to factory specifications (project planning guide), a minimum distance of 1500
mm between the workstations/workplaces and ME equipment is therefore to be main-
tained. In this way, the workstations/workplaces are operated outside the patient environ-
ment.
¹ The workstations/workplaces and monitors are likewise to be checked in accor-
dance with IEC 62353:2007 (protective earth resistance und equipment leakage
current).
¹ An limit value of max. 3.5 mA in accordance with EN 60950-1 applies to equip-
ment leakage current measurement of workstations/workplaces which are not
produced in accordance with IEC 60601-1 and which are located outside the
patient environment.
¹ If a multiple-socket outlet is used to connect to the supply mains, protective earth
resistance and equipment leakage current measurements are to be performed for
this outlet.
¹ If an isolating transformer is used, it must be included in the checks.
Optionally used ME equipment 0
In the case of ME equipment or other devices not listed in the "Validity of this document"
section, but which are combined with these ME equipment units (e.g. ultrasound devices,
ECG monitors, endoscopy cameras), the relevant operator manuals and product-specific
requirements are to be followed.

Recordings 19
2-
Customer and product data
2Recordings
Customer data 0
P Enter the customer data in the cover sheet of the associated protocol.
Check object 0
P Enter the identification data for the check object (ME equipment/ME system) in the associ-
ated protocol.
P If the protocol is used for recording checks of ME equipment, mark the "ME equipment"
checkpoint.
P If the protocol is used for recording checks of an ME system, mark the "ME system" check-
point and enter the additional ME equipment/other equipment forming the ME system. In
the protocol mark the "class" and "applied part" checkpoints for each additional piece of
ME equipment/other equipment. If a multiple-socket outlet is used, this is part of the ME
system. Enter the identification data of the multiple-socket outlet (e.g. manufacturer, inven-
tory number, etc.) in the corresponding protocol.
If the ME equipment or ME system was changed in the meantime, the previously defined
reference values are invalid and must be redefined.
Reason for the checks 0
P Mark the appropriate checkpoint.

"During startup" or
"After repair" or
"During maintenance".

20 Recordings
Check sequence 2.1
Definition of checks 0
The following table is used to help define the scope of the check.

Recordings 21
Checks Startup Repair *10

and mainte-
nance
Visual inspection
- Completeness/currentness of documents H Q *9
- Externally accessible fuses H *1 Q *1 / *9
- Safety-related labels H *2 Q *2 / *9
- Safety-related signs H *2 Q *2 / *9
- Safety-related markings H *2 Q *2 / *9
- Check for damage H H *9
- Check for contamination H H *9
Relevant accessory
- Check safety of accessories H *3 Q *3 / *9
Measurements
- Protective earth resistance H *4 Q *9
- Equipment leakage current H *5 Q *9
- Applied part leakage current H *6 Q *6 / *9
- Insulation resistance H *7 Q *7 / *9
Functional checks
- Functional checks according to manufacturer H *8 Q *8 / *9
specifications
- Define functional checks H *8 Q *8 / *9
- Perform functional checks H *8 Q *8 / *9
Safety evaluation
- Perform safety evaluation H H
Acknowledgement of responsible organization
- Report check results/evaluation H H
- Transfer protocol H H
*1 Omitted if there are not externally accessible fuses. Fuses that are only accessible after
removal of the covers do not need to be checked.
*2 Refer to corresponding ME equipment/ME system operator manual.
*3 Omitted if there are no accessories.
*4a) In the case of plug-in equipment completely checked at the factory, the measurement

22 Recordings
points and measured values can be taken from the manufacturing protocol if the following
conditions are met:
¹ The ME equipment was programmed at the factory for the correct mains volt-
age/mains frequency and checked with this mains voltage/mains frequency.
¹ No adapters are used for adapting the mains plug installed on the equipment side
to the on-site mains outlet.
*4b) Stationary ME equipment must be check on-site.
*5a) In the case of plug-in equipment completely checked at the factory, the measurement
points and measured values can be taken from the manufacturing protocol if the following
conditions are met:
¹ The ME equipment was programmed at the factory for the correct mains volt-
age/mains frequency and checked with this mains voltage/mains frequency.
¹ No adapters are used for adapting the mains plug installed on the equipment side
to the on-site mains outlet.

Recordings 23

*5b) Equipment leakage current measurement is not required for stationary ME equipment
if the protective measures against electrical shock in the supply mains are in accordance
with IEC 60364-7-710 and the tests for this are performed regularly.
*6 Omitted in the case of type B applied parts or if there is no applied part.
*7a) Omitted for all ME equipment specified in the "Validity of this document" section.
*7b) In the case of a check of ME equipment not listed in the "Validity of this document"
section, observe the specifications in the corresponding operator manuals.
*8a) In the case of the startup of ME equipment specified in the "Validity of this document"
section, the necessary functional checks are included in the corresponding startup instruc-
tions. Additional functional checks do not need to be performed.
*8b) In the case of the maintenance of ME equipment specified in the "Validity of this doc-
ument" section, the necessary functional checks are included in the corresponding main-
tenance instructions. Additional functional checks do not need to be performed.
*8c) During startup or maintenance or after repair of ME equipment not listed in the "Valid-
ity of this document" section, any necessary functional checks must be defined. Please
also observe the specifications in the corresponding operator manuals.
*8d) During startup, maintenance, or servicing of an ME system, any necessary functional
checks must be defined. Please also observe the specifications in the corresponding oper-
ator manuals.
*9 For service calls, the necessary checks depend on the previously performed repair work.
The scope of the check must be defined accordingly. Please also observe the specifica-
tions in the corresponding service instructions.
*10 Also observe the information in the "Application of this document" - "Repair" section.
Visual inspection 0
Check documents for completeness and currentness

The documents contained in the delivery volume are to be checked for completeness and
currentness.
¹ A review of the completeness is to be performed using the "Listing of documents"
contained in the system folder.
¹ In addition, the test protocols created at the factory must be present.
NOTE If, in the course of using the ME equipment, ME system or

accessories, documents originally present in the delivery
volume not containing information for the responsible orga-
nization or operators are missing, they do not have to be sup-
plemented (e.g. unpacking instructions, installation
instructions).

24 Recordings
¹ Missing documents containing information for the responsible organization or

operator, especially with respect to basic safety and essential performance char-
acteristics, must be supplemented.
NOTE The check for completeness or approvals based upon coun-

try-specific standards, regulations and laws, such as accep-
tance test, consistency tests, local radiation protection,
approvals, rests with the responsible organization and is not
a component of this test.
P ¹ Document the results of the checkpoint in the protocol.
Check of externally accessible fuses

Check all externally accessible fuses.
¹ The activation currents and activation characteristics of the fuses must meet the
manufacturer specifications.
P ¹ Document the results of the checkpoint in the protocol.
P ¹ If there are no externally accessible fuses, document this checkpoint in the pro-
tocol as "not applicable".
Legibility of safety-related identifiers, labels, and markings

Check the labeling of the ME equipment according to the data in the operator manual.
Also check the labeling of any installed options according to the related operator manual
(e.g. laser light localizer, etc.).
¹ All safety-related identifiers, labels and markings must be legible and complete.
P ¹ Document the results of the check in the protocol.
Check of the ME equipment for damage and contamination

Check the ME equipment/ME system for damage. The ME equipment/ME system must not
be operated in the case of damage that affects the safety of the ME equipment/ME system.
¹ Tolerable damage might include, for example, slight mechanical damage of a
cover that does not present a functional limitation or affect the safety of the ME
equipment/ME system.
¹ Intolerable damage would include, for example, a protruding cover that could
result in injury to personnel or allow access to components inside the ME equip-
ment/ME system.
¹ Intolerable damage would also include, for example, damage limiting the intended
use of the ME equipment/ME system, such as broken control elements.
In the case of ME equipment with flexible power supply cords, also check these for dam-
age.

Recordings 25
¹ The flexible power supply cords must be moved section-by-section over their
entire length to check for any possible insulation damage.
Check the ME equipment/ME system for contamination. Contamination, especially blood
or other bodily fluids, must be removed. The safety instructions of your service organization
and also the country-specific and customer-specific hygiene regulations must be strictly
observed.
P ¹ Document the results of the checkpoint in the protocol. (Visible condition of the
ME equipment: No identifiable damage, no identifiable contamination or damage;
damage or contamination entered with information regarding location and risk)
Evaluation of relevant accessories

The safety of relevant accessories must be evaluated together with the ME equipment.
NOTE Any additional functional checks and checks of the accesso-

ries are to be found in the related documents (operator man-
ual/ startup instructions/maintenance instructions) of the
accessory or ME equipment; these must be followed.
P ¹ In the test protocol, document the relevant accessories included in the evaluation
(designation, material number, serial number)
P ¹ Document the checkpoint (e.g. condition of the radiographic cassette, mechanical
securing of an optional laser light localizer, etc.)
P ¹ Document the results of the checkpoint of the relevant accessories in the test pro-
tocol
Measurements 0
Protective earth resistance

Observe the information in the "General information and product-specific information"
chapter.
Measurement
P Transfer the measurement points for the protective earth resistance measurements from
the manufacturing protocol (or startup instructions) in the case of startup or from the pro-
tocol with the reference values in the case of repeat checks to the IEC 62353:2007 proto-
col.
If no measurement points are specified, these must be defined.
P Measure the protective earth resistance at the specified measurement points.

26 Recordings
Recording
P Document the measurement device manufacturer, the measurement device type, and the
serial number.
P Record the applied measurement procedure according to IEC 62353:2007.
P Check the measurement points and their corresponding protective earth resistance values.
Limit values
Permanently connected ME equipment: Power cord protective earth resistance: Max 0.1
ohms; ME equipment protective earth resistance: Max. 0.1 ohms.
ME equipment with flexible, plug-in power cord: Power cord protective earth resistance:
Max 0.2 ohms; ME equipment protective earth resistance: Max. 0.1 ohms.
ME equipment with flexible, non-pluggable power cord: Protective earth resistance of the
ME equipment: Max. 0.3 ohms.
ME systems with multiple-socket outlet: The protective earth resistance of the multi-
ple-socket outlet is max. 0.2 ohms; together with the permissible limit values for the protec-
tive earth resistance of the ME equipment incl. the power cord, this yields a maximum
protective earth resistance of 0.5 ohms.
Equipment leakage current

chapter of these instructions.
Requirements
To prevent measurement errors during direct measurement of the equipment leakage cur-
rent, the ME equipment/other equipment must be isolated during the measurement.
WARNING Since the protective earth conductor cannot fulfill its func-
tion during direct measurement of the equipment leakage
current, there is a potential hazard to the tester or other per-
sonnel during the measurement.
Observe the following safety precautions:
¹ The leakage current measurement may only be per-
formed after the protective earth test is passed suc-
cessfully.
¹ Access to the ME equipment or other equipment by
personnel other than the tester must be prevented
(blocking, measurement in a separate room).
¹ During the measurement, the tester may not touch the
ME equipment or other equipment.
If the equipment leakage current is measured after the differential current measurement
procedure, the protective function of the protective earth conductor is maintained. There is
no danger for the tester or other persons.

Recordings 27
Equipment leakage current measurement device, measurement procedure, and

measurement
62353:2007.
In the case of repeat measurements of the equipment leakage current, use the same mea-
surement procedure as in the previous measurements.
We recommend using measurement devices allowing differential current measurement
procedures according to IEC 62353:2007. This avoids the disadvantages of direct mea-
surement.
The equipment leakage current measurement must be performed twice: 1st Measurement
-> L and N at mains plug, 2nd measurement -> L and N reversed at mains plug.
¹ Refer to the equipment leakage current measurement circuits in the "General
information and product-specific information" chapter.
Recording
P If the equipment leakage current measurement can be omitted, mark the corresponding
checkpoint in the protocol.
When measuring the equipment leakage current, record:
P ¹ The measurement device manufacturer, the measurement device type, and the
serial number.
P ¹ The measurement procedure used.
P ¹ The higher value of the two measured equipment leakage currents.
P ¹ The mains voltage measured during the measurement.
Limit values
Observe the permissible equipment leakage current limit values of the particular ME equip-
ment/other equipment specified in the "Product-specific information" section (0.5 mA or 5.0
mA).
The following tables provide the limit values according to IEC 62353:2007. Observe the
specifications in the "Product-specific information" section
Tab. 1 Permissible equipment leakage current values - equivalent measurement in accordance with IEC62353:2007.
Equipment leakage current - equivalent mea- Applied part

surement *1
Type B Type BF Type CF
Equipment leakage current for accessible, con- 1.0 mA 1.0 mA 1.0 mA
ductive ME equipment parts of class 1
Equipment leakage current for ME equipment of 0.5 mA 0.5 mA 0.5 mA
class II
*1 The measurement procedure for equipment leakage current - equivalent measurement
cannot be used for the ME equipment listed in the "Validity of this document" section.

28 Recordings
Tab. 2 Permissible equipment leakage current values - direct measurement or differential measurement in accordance
with IEC62353:2007-
Equipment leakage current - direct measure- Applied part

ment or
Equipment leakage current - differential mea-
surement
Equipment leakage current for accessible, con- 0.5 mA 0.5 mA 0.5 mA
ductive ME equipment parts of class 1 *2 *2 *2
Equipment leakage current for ME equipment of 0.1 mA 0.1 mA 0.1 mA
class II
*2 Observe the limit values defined at the factory in the "Product-specific information"
section.
Applied part leakage current

Prerequisite
WARNING Since voltage is applied to the applied part during measure-

ment of the applied part leakage current, there is a potential
hazard to the tester or other persons during the measure-
ment.
Observe the following safety precautions:
¹ The leakage current measurement may only be per-
formed after the protective earth test is passed suc-
cessfully.
¹ Access to the ME equipment or other equipment by
personnel other than the tester must be prevented
(blocking, measurement in a separate room).
¹ During the measurement, the tester may not touch the
ME equipment or other equipment and applied part.

Recordings 29
Measurement device, measurement procedure, and measurement

62353:2007.
Define the measurement procedure according to the class and type of ME equipment
applied part.
In the case of repeat measurements of the leakage current of the applied part, use the
same measurement procedure as in the previous measurements.
When using direct measurement as the measurement procedure, the applied part leakage
current must be measured twice: 1st Measurement -> L and N at mains plug, 2nd measure-
ment -> L and N reversed at mains plug.
¹ Refer to the applied part leakage current measurement circuits in the "General
information and product-specific information" chapter.
If several applied parts requiring measurement of the applied part leakage current are
present, the measurement is to be performed for each applied part and recorded.
Recording
P If the applied part leakage current measurement can be omitted, mark the corresponding
checkpoint in the protocol.
When measuring the applied part leakage current, record:
serial number.
P ¹ The measurement procedure used.
P ¹ The higher value of the two measured applied part leakage currents.
Limit values
The following table shows the permissible limit values.
Tab. 3 Permissible applied part leakage currents according to IEC 62353:2007.
Measurement procedure Applied part

Applied part leakage current - equivalent measurement - 5.0 mA 0.05 mA
(alternating current)
Applied part leakage current - direct measurement (alter- - 5.0 mA 0.05 mA
nating current)
Insulation resistance

30 Recordings
Requirements
The ME equipment is disconnected from the supply mains for the measurement.
The insulation resistance between the applied part and protective earth conductor or hous-
ing may only be measured if the ME equipment is designed for this.
Measurement device, measurement procedure, and measurement

62353:2007.
Define the measurement procedure. The measurement procedures are described in the
"General information and product-specific information" chapter.
The following measurements are to be performed and recorded:
In the case of equipment of class I between -
¹ Mains part and protective earth (Figure 9).
¹ All patient connections of type F applied parts and protective earth (Figure 11).
In the case of equipment of class I and II between -
¹ Mains part and (ungrounded) accessible, conductive parts (Figure 9).
¹ Mains part and all patient connections of the applied parts (Figure 10).
¹ All patient connections of type F applied parts and all (ungrounded) accessible,
conductive parts (Figure 11).
Recording
P If the insulation resistance measurement can be omitted, mark the corresponding check-
point in the protocol.
When measuring the insulation resistance, record:
serial number.
P ¹ The measurement points (between which parts were measured).
P ¹ The measured values of the insulation resistance measurements.

Recordings 31
Limit values
Standard IEC 62353:2007 does not specify any limit values for the insulation resistance.
If the measurement of the insulation resistance is required by the ME equipment manufac-
turer, take the limit value from the ME equipment documentation.
If an insufficient insulation resistance is suspected, measurement of the equipment leak-
age current is recommended.
The limit values specified in standard VDE 0701-0702 can serve as reference points:
Class I: Insulation resistance > 1.0 mohms at a test voltage of 500 V;
Class I: Insulation resistance measured for accessible, conductive parts without protective
earth connection > 2.0 mohms at a test voltage of 500 V.
Class II Insulation resistance > 2.0 mohms
For evaluation, the measured insulation resistance values are to be compared to the refer-
ence values.
Functional checks 0

Definition of checks
If no specifications for the functional checks are provided in the startup instructions or
maintenance instructions, define the necessary functional checks.
Recording
P If the functional checks are performed on the basis of the startup instructions or mainte-
nance instructions of the ME equipment, mark the "Functional checks were performed
according to the specifications in the startup instructions (or maintenance instructions)"
checkbox
P Record the defined functional checks in the protocol.
P Record the results of the functional checks in the protocol.

32 Recordings
Safety evaluation 0
All test results are entered in the test protocol.

P If there were no reference values or the reference values are no longer valid, mark the cor-
responding checkbox.
P In the case of repeat checks, previously determined reference values are to be compared
to the currently determined values and the result is to be documented.
P Any detected defects are to be recorded.
Evaluate the safety of the ME equipment/ME system on the basis of the test results.
P The evaluation must be documented.
P If there are defects, the resulting risk must be documented and the responsible organiza-
tion must be informed verbally and in writing.
Unsafe ME equipment must be labeled as such and must be taken out of operation until
the defects are corrected.
P Sign the protocol.
P Confirm acknowledgement by obtaining the signature(s) of the responsible person(s).

Changes from the previous version 33
3Changes from the previous version 3-
Not applicable -> new issue

34 List of Hazard IDs
4List of Hazard IDs 4-
There are no Hazard IDs in this document.


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Performing the checks in accordance with IEC 62353

Print No.: XP00-000.860.01.01.02 English

XP-Products XP00-000.860.01.01.02 Page 2 of 34 © Siemens, 2011

1 _______ General information and product-specific information _________________ 4

Information regarding this document . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

2 _______ Recordings ____________________________________________________ 19

Customer and product data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

3 _______ Changes from the previous version________________________________ 33

4 _______ List of Hazard IDs ______________________________________________ 34

© Siemens, 2011 XP00-000.860.01.01.02 Page 3 of 34 XP-Products

Purpose of the document 0

Validity of this document 0

This document replaces documents SP00-000.860.05... and SPR2-000.860.01...

ME equipment permanently connected to the supply mains

ME equipment/other equipment with power supply cord (mains plug)

XP-Products XP00-000.860.01.01.02 Page 4 of 34 © Siemens, 2011

• ARCADIS Avantic, material no. 10048590

Application of this document 0

This document is to be used as a supplement to the existing documents of the products

Startup and maintenance

© Siemens, 2011 XP00-000.860.01.01.02 Page 5 of 34 XP-Products

Required measurement devices 0

XP-Products XP00-000.860.01.01.02 Page 6 of 34 © Siemens, 2011

Information regarding the standard 1.1

Scope of validity of the IEC 62353:2007 or EN 62353:2008 standard 0

The IEC 62353:2007 or EN 62353:2008 standard applies to the checks

NOTE Since the scopes of validity, measurement circuits, and

Measurement circuits according to IEC62353:2007 0

NOTE The measurement circuits according to IEC 62353:2007 are

Protective earth resistance measurement

© Siemens, 2011 XP00-000.860.01.01.02 Page 7 of 34 XP-Products

¹ "Figure 2: Measurement circuit for the measurement of the PROTECTIVE

Equipment leakage current measurement

Measuring the leakage current of type F applied part

XP-Products XP00-000.860.01.01.02 Page 8 of 34 © Siemens, 2011

Insulation resistance measurement

¹ Figure 9 - measurement circuit for measuring the insulation resistance between

¹ Figure 11 - measurement circuit for measuring the insulation resistance between

© Siemens, 2011 XP00-000.860.01.01.02 Page 9 of 34 XP-Products

Check sequence 1.2

The IEC 62353:2007 standard establishes the following check sequence:

XP-Products XP00-000.860.01.01.02 Page 10 of 34 © Siemens, 2011

Product-specific Information 1.3

Affecting all listed ME equipment 0

Protective earth resistance

Initial startup, transfer of measured values from manufacturing protocols

Protective earth resistance measurement device

ME equipment/other equipment with flexible power supply cords

© Siemens, 2011 XP00-000.860.01.01.02 Page 11 of 34 XP-Products

Protective earth resistance measurement of ME systems with multi-socket outlet

Equipment leakage current

Initial startup, transfer of measured values from manufacturing protocols

Equipment leakage current measurement of ME equipment/ME systems of class I

XP-Products XP00-000.860.01.01.02 Page 12 of 34 © Siemens, 2011

Permanently installed ME equipment

ME equipment or equipment with power supply cord (with mains plug)

© Siemens, 2011 XP00-000.860.01.01.02 Page 13 of 34 XP-Products

Applied part leakage current

Insulation resistance measurement

XP-Products XP00-000.860.01.01.02 Page 14 of 34 © Siemens, 2011

¹ The equipment leakage current measurement is not required if the protective

LITHOSKOP table top

1 _ General information and product-specific information ___________ 4

2 _ Recordings ______________________________________________ 19

3 _ Changes from the previous version__________________________ 33

4 _ List of Hazard IDs ________________________________________ 34