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Siemens Mobilett XP Products Safety Information PDF
Siemens Mobilett XP Products Safety Information PDF
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XP-Products
XP
Safety Information
System
© Siemens, 2011
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© 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.
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.
This document describes the sequence of checks according to the IEC 62353:2007 or EN
62353:2008.
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....
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.
¹ Observe all potentially deviating national regulations, standards and laws of your
country.
Please observe the following information regarding the checks of ME equipment/ME sys-
tems mentioned in this section.
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.
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.
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.
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 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.
¹ The table top is a type B applied part.
The applied part leakage current does not have to be measured
Mammography 0
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
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.
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.
Definition of checks 0
The following table is used to help define the scope of the check.
*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
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 The mains plug installed at the factory fits the on-site mains outlet.
¹ No adapters are used 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.
*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 The mains plug installed at the factory fits the on-site mains outlet.
¹ No adapters are used 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.
Visual inspection 0
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)
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
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.
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.
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.
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.
Prerequisite
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:
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 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.
Insulation resistance
Observe the information in the "General information and product-specific information"
chapter of these instructions.
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.
Recording
P If the insulation resistance measurement can be omitted, mark the corresponding check-
point in the protocol.
When measuring the insulation resistance, record:
P ¹ The measurement device manufacturer, the measurement device type, and the
serial number.
P ¹ The measurement points (between which parts were measured).
P ¹ The measured values of the insulation resistance measurements.
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.
Safety evaluation 0