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ARTD Part 2
Safety regulations for installation
and maintenance

Date of issue: ARTD-002.731.17.01.02

March 1st, 1996 Replacing: RA0-000.012.20.02.02 (TI 236) dated.

02.92

This guideline is a safety instruction.

The content of this document deals with the relevant safety principles which are required to per-
form after-sales service.
In any case, the safety of the products and of the entire system must be ensured following all
service calls in order to protect patients, operators and third persons.

The individual steps required are described in the pertaining technical documents.

Table of contents
2FFXSDWLRQDO6DIHW\ 
1.1 General 2
1.2 Working with equipment under power 2
1.3 Reporting deficiencies in connection with on-the-job safety 3
$FWLRQRQGLVFRYHU\RIVDIHW\GHILFLHQFLHVLQRXU
SURGXFWV 
2.1 Installation/startup 3
2.2 Maintenance 3
2.3 Mandatory reporting/products 4
5HVSRQVLELOLW\IRUUHSDLUZRUNRQPHGLFDOHTXLSPHQW 
3.1 General 4
3.2 Service performed by our personnel on Siemens and
non-Siemens products 4
3.3 Service performed by customer personnel or employees of
outside companies with subsequent service performed by
Siemens employees 4
7HVWLQJUHTXLUHGLQWKHILHOG 
4.1 Introduction 5
4.2 Principles 5
4.2.1 General 5
4.2.2 Tests 6
4.3 Documentation of tests 13
4.4 Testing as per DIN VDE 0753 14
(IIHFWLYHGDWH 
&KDQJHVDVFRPSDUHGZLWKWKHSUHYLRXVYHUVLRQ 

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1 Occupational Safety

1.1 General
The installation or maintenance of medical products and systems may be entrusted only to trained per-
sonnel.

Only persons who can provide evidence of appropriate training, e.g. relevant technical training courses,
self-study or equivalent training, may be regarded as technically qualified to install and repair our products.
Completion of occupational training alone, e.g. as a journeyman, master craftsman, technician or engineer
is not sufficient without product-specific training.

The employee shall be provided with all required knowledge of pertaining safety regulations through
product training, Technical Service documentation, general and workplace-specific safety instructions and
radiation protection briefings. (For service companies commissioned by us to perform pre-installation
work, the pertaining conditions apply).

The supervisor (Technical, Service or Installation Manager) shall decide whether the employee concerned
has due regard for safety and is reliable enough to satisfy the particular demands placed on him.

All work performed within the scope of installation, repair and maintenance must comply with the safety
instructions appearing in the various technical documents, as well as with the laws, regulations, specifica-
tions etc. governing occupational safety and accident prevention.

The personal protection equipment required for the given work shall be provided and used.

Only those measuring and auxiliary instruments, tools and auxiliary devices (ladders, scaffolding, hoists
and jacks, ropes etc.) which are prescribed for the work being performed in the pertaining instructions
(e.g. ARTD 3) shall be used.

These tools, instruments and pieces of equipment must always be kept in serviceable condition and
checked for signs of safety-relevant damage prior to use. The use of damaged equipment is prohibited. In
addition to the daily checks performed by the responsible employee, all electrical and measuring equip-
ment must be subjected to periodic inspections at regular time intervals. These intervals shall be deter-
mined according to the pertaining regulations.

1.2 Working with equipment under power

• With the exception of measuring and test procedures, no work may be performed on live parts at
voltages > 50 V AC or > 120 V DC.
• Always take special care when performing troubleshooting measurements and testing (involving
connection of testing and adjusting equipment). In addition to low voltages, dangerous high voltages
are also present.
It must be possible to gain access to the test and adjustment points without endangering the em-
ployee. If this is not the case, the system must be switched off so that the measuring instrument can
be connected without risk.
• Where voltages of more than 1000 V are being measured, the products must always be switched off
before connecting the measuring instruments. Suitable high-insulation measuring instruments with
appropriate test leads and testing terminals must be used.
Attention:

∗ Following switch-off, any possible residual charges from the high-voltage circuits discharge to
chassis ground. Follow pertaining instructions in product documentation.
∗ Make sure that the measuring instrument is properly grounded.
∗ The ground connection of the measuring instrument must be connected first and removed
last.
∗ To the extent that they are applicable to our measuring and auxiliary power circuits, the 5 fa-

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miliar safety rules of electrical engineering must be observed:

1) Switch equipment off.
2) Secure equipment against being switched back on.
3) Make sure that no voltages are present!
4) Ground and short cut.
5) Cover or block access to any neighboring live parts so that they can not be inadvertently
contacted.
• Any obligation to comply with these safety regulations is always indicated in the pertaining technical
documentation. However, in most cases the responsible employee in the field must decide which of
these regulations apply depending on the work being performed.
• In cases involving live systems or equipment, it must be ensured that there is no danger of contact
by other persons with live parts of our products. This also applies to spatially separated systems. Ap-
propriate action (e.g. attachment of warning signs) must be taken.
• Regardless of these regulations, any product-specific safety instructions contained in the pertaining
documentation must be observed.
• In cases where the presence of a second person is prescribed for certain work: For instance, a sec-
ond person is generally required whenever measuring and testing must be performed under particu-
larly difficult conditions (e.g. in moist, wet surroundings). In such cases, this second person must at
least be instructed by the trained expert on how the product (system) can be switched off and which
additional technical and firs-aid measures must be taken in the event of danger or an accident.
Definition:
An instructed person is defined as anyone who has received instruction and, if necessary, been
trained on the job regarding his duties, the dangers possibly resulting from improper action, and the
required protective equipment and measures.

1.3 Reporting deficiencies in connection with on-the-job safety

• The use of any safety-relevant parts (e.g. tools, ladders, hoists/jacks etc.) not in perfect condition is
prohibited.
• If the safety of any work equipment or procedures is questionable, all deficiencies must be elimi-
nated without delay.
• If this is not possible, the deficiencies must be reported to the supervisor in charge without delay.

This also applies if:

− Work materials, e.g. dangerous materials, have not been packaged, marked or made in compliance
with safety regulations,

− Work processes or procedures are improperly planned or regulated,

− Safety equipment, protective clothing, tools etc. are not available.

2 Action on discovery of safety deficiencies in our products

If it is discovered before or during work that acute hazards exist in connection with products, the follow-
ing applies:

2.1 Installation/startup

The system may be turned over to the customer only after the detected safety deficiencies have been
eliminated.

2.2 Maintenance

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Where safety deficiencies are discovered which pose a considerable risk (e.g. danger of injury), the sys-
tem must be shut down. The customer must then be informed of the type and extend of the risk in-
volved.

The decision as to whether the system must be shut down until the hazard has been eliminated or work
shall be continued despite the danger involved must be made by the customer on his own responsibility
for the system.

2.3 Mandatory reporting/products

All accidents or hazards discovered in connection with our products are subject to mandatory reporting.

All domestic and foreign employees are therefore obliged to report to their responsible supervisors with-
out delay any deficiencies or accidents which would or might endanger equipment or persons.

The correct form and the procedure for filling it out and submitting it are described in the instructions for
processing complaints (see circular of 08/95 and C-MQR 4.14/01).

3 Responsibility for repair work on medical equipment

3.1 General
• All work performed on our products must be in compliance with the pertaining instructions.
• All work performed on Siemens or non-Siemens products must be clearly outlined in the service
report (service slip).
• All work performed must be properly described so that exact evidence concerning who is responsi-
ble for what work can be produced at any time.

3.2 Service performed by our personnel on Siemens and non-Siemens products

• The employee concerned must have the required knowledge of an experience in his field of work.
The technical supervisors are obliged to ensure that the electrical equipment and systems are in-
stalled, modified or repaired only by trained electrical personnel and in compliance with the pertaining
electrical regulations.
• The equipment concerned must be designed in accordance with the generally recognized engineer-
ing regulations.
• The technical documents and measuring equipment required to properly perform repairs (e.g. wiring
diagrams, service instructions) must be available both for Siemens and non-Siemens products. In
cases involving non-Siemens products, the manufacturer should be contacted, if necessary.
• After performing a repair, the required safety measurements must be taken (e.g. protective ground
wire resistance, leakage current, etc.).
• The maintenance report (service slip) must include the following information:

∗ Work performed

∗ Date

∗ Name and signature of service technician.

3.3 Service performed by customer personnel or employees of outside compa-

nies with subsequent service performed by Siemens employees

The operator is responsible for deciding who performs service on his unit. In any case, the operator
should be advised to demand a certificate for all work performed from the service technician.

We are not legally liable or responsible for work performed by third parties where neither the customer

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nor said third parties have received authorization from us.

• If, after work has been performed by non-Siemens customer service personnel, the customer again
wishes to exclusively employ Siemens customer service personnel, a test must be run to determine
whether any deficiencies exist which could lead to an accident.
For products requiring a Siemens-internal work permit, the responsible customer service department
at the plant must in any case be informed prior to the beginning of the test. This is necessary to de-
termine whether this product may again be serviced by Siemens customer service personnel.
• Even in cases where only a single repair contract is awarded, the repair may be carried out only after
the above test has been performed.
• If, however, the customer refuses to allow the above test to be performed, a narrowly restricted
repair contract must be concluded in writing before the repair begins. The repair work performed
must be documented in the service report.

No servicing may be performed which does not conform to the above requirements!

Only in this way it is possible to differentiate between the legal responsibility of the operator, Siemens
and third parties.

4 Testing required in the field

4.1 Introduction

Principle:

The tests specified in the technical documents must in any case be performed to
ensure the safety of all patients, operators and third parties.

The following basic safety instructions are intended as a supplement to the above literature. As such,
they should provide you with background information for several important tests which are mandatory
during customer service. These and other product-related test procedures are described in the pertaining
technical documentation.

4.2 Principles

4.2.1 General

The following points must be observed during all service calls:

• No structural or functional features may be modified.
• Make sure that no unauthorized persons are located near the products during servicing; this is par-
ticularly important in cases involving a possible risk due to voltage/current, mechanical danger, or ra-
diation.
• On completion of the work, the safety of the product/system must be ensured.
• It can be guaranteed that the safety of the products has not been reduced only if OEM spare parts
are used.
• Fuse links may be replaced only with links having the same current rating and cutoff characteristic.
• Use only the lubricants, cleaning agents, and other accessories specified in ARTD 3 or in the pertain-
ing product documents.
• When installing and/or removing parts, use only the special tools and/or devices described in the
technical documentation.
• On replacing connecting leads, all connections must be reestablished and all strain relief clamps, cord
guards and locating straps must be properly refitted.

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Important:

When making the line connection, make sure that the ground lead
is longer than the conducting leads.
• The ends of strand-type conductors used for connections to screw terminals must not be soldered.
Use cable end sleeves.
• Safety-relevant labels must remain intact following repairs.
• No dirt or grime which might impair the product’s safety should be present.

This list lays no claim to completeness, and is intended only as an example containing several
essential points which must be observed.

4.2.2 Tests

The following tests must be performed in addition to the measures mentioned in the general instructions
given above.

For the protection of the persons conducting them, the following tests must be performed in the speci-
fied order:
• Visual inspection
• Protective ground wire resistance test
• Equivalent leakage current/leakage current
• Final operational test.

4.2.2.1 Visual inspection

The product/assembly must be checked both inside and outside for visible/detectable errors prior to
servicing. Any defects thus found should be eliminated and/or reported.

4.2.2.2 Fundamentals of protective ground wire resistance testing

I. General

a) Protective ground wires must not be unclamped or unsoldered for testing purposes.

b) The protective ground wire resistance must be tested between the protective ground bus bar of the
entire systems or the protective contact of the unit plugs and any connectable, conductive part of the
product.

The line cords must be moved for at least 5 seconds during the measurement, during which time no
changes in the resistance should occur.

If higher values result, corrective measures to reduce them are required. In such a case, inform the
technical supervisor so that a fault report can be written.

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II. Installation/startup

a) For the protection of our employees, a protective ground wire test must be performed before the
product/unit is switched on. This test is to ensure that all connectable and conducting parts are prop-
erly connected to the ground wire during the required customer service activities.

b) On completion of the required work, all of the ground wire connections provided by the manufacturer
must be properly connected prior to the final operational test (attach all covers).

This applies e.g. to all metal covers which could conduct a contact voltage in the event of a fault. It is
essential for these to be connected to the protective ground wire. This must be done either by con-
necting these covers to the protective ground wire using the screwed connectors provided by the
manufacturer and suitable lock washers or by using the protective ground wire connectors provided
for that purpose. Once this has been done, a protective ground wire resistance test must be per-
formed again.

c) No testing of the protective ground wire resistance is necessary for newly delivered products which
are operated via a detachable line cord (electric outlet units) and for which no service is required dur-
ing installation and startup.

III. Maintenance (Service)

On completing maintenance of individual units or systems which might influence the protective function
of the ground wire (e.g. following removal of metal covers), the ground wire resistance test must be re-
peated. Furthermore, in cases involving detachable line cords, the protective ground wire must generally
be checked following any service work.

a) Protective ground wire resistance for products

Manufactured Manufactured
before 1984 after 1984

Block diagram

2KP 2KP

The protective ground wire resistance is measured between the product’s central protective ground ter-
minal and all of its connectable parts.

b) Max. protective ground wire resistance for our systems

The total resistance measured between the system protective ground bus bar and every connectable,
conductive part of the products must not exceed 0.2 c.

- Non-detachable products/systems

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Protective ground bus bar

(Mains box)

Block diagram
2KP

- Protective ground wire resistance for electric outlet unit

2KP
Block diagram

- Series connection of products

Addition of the specified limiting values is not allowed even in cases where several products are con-
nected in series.

The max. value of 0.2 c must not be exceeded even with such a combination.

c) Off-limit condition

Check to determine cause of off-limit condition. In any case, the value must be reduced before continuing
work. If a product defect exists, a claim report must be written in accordance with CMQR 4.14/01.

4.2.2.3 Leakage current/equivalent leakage current - principles

I. General

Leakage currents occur in all electrical equipment. They are caused e.g. by coupling capacitance’s or high-
frequency filters as well as by insulation capacitance’s.

The individual leakage current limits are defined for different products depending on their given applica-
tion. The max. leakage current permissible for a particular medical product depends on its medical appli-
cation. For some types of products, leakage current testing is prescribed in the interest of patient safety.

The leakage currents are checked at the factory based on the manufacturer’s specifications. Testing un-
der these conditions is often either impossible or realizable only at considerable expenditure in the field.

For this reason, the so-called „equivalent leakage current measurement“ must be performed in the field.
This measurement is described by the German Federal regulation VDE 0751, which governs the repair of
medical equipment. This regulation stipulates that the equivalent leakage current measurement may be
performed only by trained experts. Its main purpose is the early detection of deviations from an „initial
measurement“, and hence, of any changes in the product’s safety structure.

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An additional test based on the customer’s national regulations may also be performed. Nevertheless, the
equivalent leakage current measurement must be performed primarily. The procedure for performing the
leakage current/equivalent leakage current test is described in the pertaining technical documents.

A distinction is made between:

a) Ground leakage current

The current which flows from the power pack through or over the insulation to the protective ground
wire.

b) Housing/equipment leakage current / equivalent housing/equipment leakage current

The current which flows from the housing or any part thereof through any external, conductive con-
nection other than the protective ground wire to ground or another part of the housing.

c) Patient leakage current / equivalent patient leakage current

The current which flows from the applicator through the patient to ground, or is caused by an acci-
dental external voltage occurring at the patient and flows through the patient and an insulated (off-
ground) applicator (type F) to ground.

d) Patient auxiliary current (cardiographs)

e) Patient auxiliary current (caused by interference suppression amplifiers)

The current which flows in the patient between the parts of the applicator during normal operation
and should have no physiological effects, e.g. input current from amplifiers.

II. Equivalent leakage current

Important!

The leakage and equivalent leakage current measurements are generally required
only in products connected to the electrical power system via connecting leads an
plugs. In the case of stationar
y and permanently connected products of protection
class I, testing of the equivalent housing leakage current may be omitted.

Equipment of this kind includes e.g. stationary and permanently connected:

- X-ray equipment for diagnosis and therapy

- Gamma irradiation systems

- Electron accelerator systems.

If the equivalent equipment leakage current also must be checked for any of the above types of products,
the correct procedure is described in the pertaining technical documents.

a) Initial measurement (equivalent leakage current)

The equivalent leakage current measurement involves an initial measurement and so-called „repeat
measurements“. The purpose of these repetitions is to recognize any deviations from the so-called „initial
measurement“, thus detecting changes in the safety aspects of the equipment as early as possible.

During the measurement of the initial value, the specified max. values must not be exceeded. If they are
exceeded, the equipment must not be operated.

The initial measurement is used for comparison with subsequent leakage current
measurements and must be documented in written form.

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Note: Determination of initial measurement.

In the case of new products, the initial value may already be measured and documented during startup.
Measurement of the initial value in the field may be omitted in cases where this was already done at the
plant. In any case, the initial value must be documented to ensure that it is subsequently available for
comparison with repeat measurements.

If a product is already in operation, but still has no known initial value, measurement and documentation
shall be performed during the first repair call.

b) Repeat measurements

The value measured must not exceed the max. permissible value (see product document). In addition, the
initially measured value must not be exceeded by more than 10 mA or 50 %, whichever value is higher.

The results must be documented.

If higher values are measured, the unit must be classified „unsafe“. Appropriate measures must then be
taken to decrease these values.

If the required values can not be maintained, contact the factory.

c) Equivalent housing/equipment leakage current measurement

Warning!

This measurement must be performed with the unit disconnected from the power
supply. The switches in the power pack must be operationally closed during meas-
urement in order to measure all power pack insulation.

This equipment housing/equipment leakage current is measured between the temporarily and conduc-
tively interconnected pins of the power plug (with the exception of ground contacts) and the connectable,
conductive parts of the housing (Fig. 1).

1
. .
2

.
~ 5

1 - Unit connecting cable (power pack)

uA 4 2 - Patient connecting cable (insulated applicato
3 - Contactable, conductive parts (unit housing)
4 - Measuring circuit
5 - Line-frequency measuring voltage source

Fig. 1 - Equivalent leakage current measurement

For units in which the switches can not be operationally closed, the measurement must be performed
with the unit switched on and in both polarities (Fig. 2).

The sum of both values and the measuring circuit must be documented.

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1
Power
Supply
(N) L
(L) N
(
(
.
2

.
1 - Test outlet
2 - Applicator
uA 4 3 - Unit housing
4 - Measuring circuit

Fig. 2 - Measurement of leakage currents with units in operation

d) Equivalent patient leakage current measurement

Warning!

This measurement must be performed with the unit disconnected from the power
supply. It can be conducted only in units with an insulated applicator (BF/CF).

The equivalent patient leakage current is measured between conductively interconnected patient connec-
tors leading to insulated applicators and the connectable, conductive parts of the units. The latter are also
connected to the pins of the power plug.

Measurement of equivalent patient leakage current (only in units with an insulated applicator).

Block circuit diagram

. 1
2
.
.
~ 5
1 - Unit connecting cable (power pack)
uA 4 2 - Patient connecting cable (insulated applicato
3 - Contactable, conductive parts (unit housing)
4 - Measuring circuit
5 - Line-frequency measuring voltage source

BF and CF units with intracardiac pick-ups (e.g. pressure measuring catheter).

The equivalent patient leakage current is measured in these units with the applicator connected.

Measurement of the equivalent patient leakage current with intracardiac pick-ups (example: pressure
measuring catheter)

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Area not designated for insertion

3
2 1

Transducer
Saline solution

Metal container uA 4 1 - Unit connecting cable (power pack)

2 - Patient connecting cable (insulated applicator)
~5 3 - Contactable, conductive parts (unit housing)
4 - Measuring circuit
5 - Line-frequency measuring voltage source

• Place the intracardiac pick-up to be inserted into the relevant part of the patient’s body in a metal
container filled with a physiological saline solution.
• Fill the cavities of the intracardiac pick-up used to hold body fluid with this conductive, bubble-free
solution.
• Place the metal container on an insulated base and connect it accordingly.

III. Explanations for determining the permissible leakage currents

The maximum leakage currents permissible for the individual product groups depend on their classifica-
tion by class and degree of protection.

a) Explanation of protection classes

Products are assigned to protection classes depending on the type of protection against electrical shock
which they require:

PROTECTION CLASS I → Protective ground terminal

The unit is connected to the ground conductor, e.g. for x-ray diagnosis, CT, MR, etc.

PROTECTION CLASS II → Protective insulation

Double insulation - double or reinforced insulation, the housing has no protective ground terminal, e.g.
CARDIOSTAT 703 FI etc.

PROTECTION CLASS III → Protective low voltage

b) Explanation of degrees of protection

Products are divided up into the following categories according to the degree of protection against elec-
tric shock they require:

Type B labeling:

Type BF labeling:

+ for defibrillator

These are type B devices equipped with an insulated (ungrounded) applicator (F). Some of the devices
belonging to this type also have an electrostimulation or monitoring function, however, none of them are
applied directly in or on the heart.

Explanation:

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The letter „F“ denotes an applicator which is completely insulated (i.e. also against ground). Fault cur-
rents running through the patient should thus be reduced or eliminated altogether.

Type CF labeling: for defibrillator

+ for defibrillator

These are devices or parts of devices designed especially for applications in which a conductive connec-
tion is made directly to the heart, e.g. high-pressure injection needles, CAD products, etc.

Explanation:

Due to the high sensitivity of the heart to electric current, this equipment has an especially low leakage
current.

4.2.2.4 Final and operational tests

In addition to the prescribed tests (e.g. protective ground wire resistance/leakage current), all parts of the
system which might be influenced or affected by the work performed must be subjected to a visual
check and an operational test upon completion of servicing.

It must e.g. be ensured that:

• all safety devices/circuits are operative
• all moving parts move freely and easily
• there is no danger of collision between moving parts
• safe distances are always maintained
• all parts are properly fastened
• no signs of damage can be found, especially on supporting parts.

Evaluation of tests
• If the device is not safe, e.g. because:
• it can not be repaired or
• it did not pass the tests performed or

the user refuses to have the necessary repair work performed,

the user must be informed in writing of the danger posed by the device in its present state. In addition, a
label to that effect (e.g. a warning label) must be attached to the device.

4.3 Documentation of tests

In the FRG, all results of measurements and tests performed following customer service must be docu-
mented in accordance with the pertaining regulations.

We recommend that our foreign subsidiaries also prepare and keep such documentation so that the
flawless condition of our products can always be verified in the event of damage.

The following information must be documented:

 a) Company/department

 b) Name/signature of person performing service

 c) Device designation (e.g. type, serial no., etc.)

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 d) Date, type and scope of work performed

e) Results of tests (record of measurements, e.g. in service report or measuring instrument printout).

4.4 Testing as per DIN VDE 0753

In the FRG, regular testing in accordance with DIN 57 753/VDE 0753 is required for:
• High-frequency surgical equipment
• Electromedical equipment for intracardiac surgery
• Defibrillators.

The operator is responsible for the initiation of these tests.

The contents of the tests is specified in these regulations and included in our maintenance checklists.

5 Effective date
These safety instructions are effective as of May 1st, 1996, and replace the previous version mentioned
above.

6 Changes as compared with the previous version

Edited in order to agree with the new format in addition with changes in the text.

Erlangen, March 25th, 1996 Erlangen, March 25th, 1996

signed Dr. Essig, TD signed Mr. Hofmockel, TDS

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