System, General Safety Notes CSTD SPR2-230.805.01 TD00-000.860.01

Medical Products
Safety Information
System
General Safety Notes
2 Document Version / Disclaimer / Copyright
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 cor‐
respond to the version at the time of system delivery and/or printout. Versions to hard‐
copy documentation are not automatically distributed.
Please contact your local Siemens office to order a 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 content described herein requires superior understanding of our equipment and may
only be performed by qualified personnel who are specially trained for such installation
and/or service.
Copyright
“© Siemens, 2001” refers to the copyright of a Siemens entity such as:
Siemens Healthcare GmbH - Germany
Siemens Aktiengesellschaft - Germany
Siemens Shenzhen Magnetic Resonance Ltd. - China
Siemens Shanghai Medical Equipment Ltd. - China
Siemens Healthcare Private Ltd. - India
Siemens Medical Solutions USA Inc. - USA
Siemens Healthcare Diagnostics Inc. - USA and/or
Siemens Healthcare Diagnostics Products GmbH - Germany
Medical Products TD00-000.860.01.06.02 Page 2 of 25 © Siemens, 2001

06.16 HC SV CS SLM DOC
Table of Contents 3
1 Purpose of the document 4
2 Changes to medical products 5
3 Technical documentation 6
3.1 Hazard information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

3.2 Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
4 Occupational safety 11
4.1 Unpacking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
4.2 Working on electrical systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
4.3 Replacement of damaged or lost installation accessories. . . . . . . . . . . . . . . 14
4.4 Safety gear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
4.5 Radiation protection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
4.6 Threaded connections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
4.7 Laser radiation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
4.8 Batteries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
4.9 Working with heavy loads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20
4.10 Handling hazardous substances and dangerous goods . . . . . . . . . . . . . . . . 21
5 Using the ESD grounding wrist strap 22
6 Changes to the previous version 23
7 List of Hazard IDs 24
© Siemens, 2001 TD00-000.860.01.06.02 Page 3 of 25 Medical Products

4 1 Purpose of the document
This document provides general safety information for service activities. The meanings of
warnings and symbols are described in this document.
The following must also be observed:
n Product-specific safety information in the technical documentation and in the user
manual for the specific products.
n Country-specific regulations that are either legally stipulated or were created on the
basis of internal General Guidelines for Customer Services (ARTD).

Changes to medical products 2 5
Medical products can only be modified if approved by the responsible business area/line.
This is a fundamental product safety requirement. The business area/line as the manufac‐
turer must ensure that modifications and combinations are checked for technical compat‐
ibility and are approved for operation.
The installation, combination, or modification of components of a medical product is only
allowed in the course of an approved change (update/upgrade) by the business area/busi‐
ness line.
For corrective maintenance, CSEs may only use service parts that are approved for the
product and provided by global materials logistics.

6 3 Technical documentation
Always use the current technical documentation released by the manufacturer to ensure
that all measures and information are included.

Technical documentation 3 7
3.1 Hazard information

The use of signal words and the hazard classification are based on ANSI standard Z535.4.
Text emphasis and its meaning in the technical documentation.
Tab. 1 GEFAHR / DANGER
Bei einer unmittelbar drohenden Gefahr, die bei Nichtvermeidung

zum Tod oder zu einer schweren Körperverletzung führt.
Indicates when there is an immediate danger that leads to death

or serious physical injury.
Tab. 2 WARNUNG / WARNING
Bei einer Gefahr, die bei Nichtvermeidung zum Tod oder zu einer
schweren Körperverletzung führen kann.
Indicates a risk of danger that may lead to death or serious physi‐

cal injury.
Tab. 3 VORSICHT / CAUTION
Bei einer Gefahr, die bei Nichtvermeidung zu einer leichten oder

mittleren Körperverletzung und/ oder zu einer Sachbeschädigung
führt oder führen kann.
Indicates a risk of danger that leads to slight or moderate physical

injury and/or damage to property.
Tab. 4 ACHTUNG / NOTICE
Bei einer Gefahr, die bei Nichtvermeidung zu einem uner‐

wünschten Ergebnis oder Zustand führt oder führen kann (nicht
Tod, Körperverletzung oder Sachbeschädigung).
Indicates a risk of danger that if disregarded leads or may lead to

a potential situation which may result in an undesirable result or
state (not death, physical injury or property damage).

Tab. 5 HINWEIS / NOTE
Ist als Tipp zu verstehen. Der Anwender muss diese Anweisung

nicht unbedingt beachten. Er erfährt jedoch Vorteile, wenn er
dies tut.
Should be understood as a tip. The user does not absolutely have

to observe these instructions. However, there will be advantages
if he does.
Tab. 6 Hazard information on paper and online
Paper (black/white) Online version (color)
! DANGER (white type on red background)
! WARNING (black type on orange background)
! CAUTION (black type on yellow background)
NOTICE (black type on blue background)
NOTE (black type on green background)

Technical documentation 3 9
3.2 Symbols
Symbols are shown in black/white on paper and in color online.
Tab. 7 Symbols on paper and online
Name Paper Online Name Paper Online

Training Torque
ESD Caution
Magnetic Field X-ray
Voltage Laser
Biohazard Moving parts
High-Tempera‐ Chain-Entan‐
ture-Part glement
Protocol
Meaning of symbols:
Biological hazard
B Biohazard
Warning about biologically hazardous materials or a biologically hazardous working envi‐
ronment.
Chain drive
A Chain entanglement
Warning about hand injuries caused by the chain drive.
Hot surfaces
I High-Temperature-Part
Warning about hot surfaces or hot parts.
Moving parts
O Moving
Warning about hand injuries caused by moving parts.

Ionizing radiation
X X-ray
Warning about ionizing radiation (such as X-ray radiation) or radioactive materials.
Caution
C Caution
In older documentation, this symbol was also used to indicate a torque value.
Warning about a general hazard location.
Torque value
T Torque
Note about a threaded connector with a torque value.
Enter a measurement result
P Protocol
Note about an entry in a protocol.
Laser
L Laser
Warning about laser beam.
Voltage
V Voltage
Hazardous electrical voltage > 25 VAC or > 60 VDC.
Magnetic field
M Magnetic field
Warning about a strong magnetic field
Electrostatic-sensitive devices
E ESD
Warning regarding electrostatic-sensitive devices
Training
U n
Required mechanical or electrical work, whose performance is not described in the
document. All work must be performed by personnel who have been trained accord‐
ingly and who have the proper manufacturer authorization.
n Additionally required installation materials have to be obtained on site. These materi‐
als and all necessary procedures have to comply with the regulations that are applica‐
ble at the installation location.
n All work must be performed by personnel who have been trained accordingly and
who have the proper manufacturer authorization.
Changes
R Note about changes.

Occupational safety 4 11
Regulations regarding occupational safety and accident prevention must be observed.

The following information is provided as an overview of or supplement to the information
in the technical documentation and local regulations.
All accidents and all sources of danger that can cause an accident must be reported im‐
mediately to the responsible supervisor.
Moreover, the regulations regarding the handling of potential complaints must be ob‐
served.

12 4 Occupational safety
4.1 Unpacking
n When unpacking, look for any transport damage that could later have an adverse ef‐
fect on function and safety.
n Use only proper tools in order to prevent accidents and to protect against damage to
the contents.
n Each crate is additionally secured with straps. There is a serious risk of accident, par‐
ticularly for the eyes, when cutting the straps. The cut ends can lash back unexpect‐
edly.
n Pull only nails with a cardboard or metal disk under the head out of the crate boards.
Pull the nails out completely and dispose of them properly. Wear sturdy shoes.
n Always observe the directional markings on crates during transport, storage and un‐
packing.
n Transport safety devices are usually marked with red paint. They may be removed only
as instructed in the technical documentation.

4.2 Working on electrical systems

When voltage is being switched off, the five safety rules must be strictly observed.
Rules Remarks
1. Disconnect completely e.g. by switching off the main switch, by re‐
moving fuses properly, by pulling plugs, etc.
2. Secure against re-connection
3. Verify that the power is switched off
4. Ground and short circuit (only for sys‐
tems over 1000 V)
5. Cover or block any adjacent live equip‐
ment
Do not work on any parts where voltages of > 25 VAC or > 60 VDC are present. This does
not apply to measurement and adjustment activities. Extreme caution is required when
performing these activities. However, only tools and measurement devices suited to
these activities may be used.
Measurement and adjustment points have to be accessible to personnel without the risk
of danger. If this is not possible, the equipment has to be shut down.
If power has to be applied during a work procedure e.g., to perform system movements,
use caution when dealing with moving and rotating parts. Upon conclusion of such pro‐
cedures, the power to the system must be immediately switched off.
 WARNING
Risk of injury!
When working in the hazardous areas around products, there is a significant risk
of injury due to unintentional system movements.
 Press the service or EMERGENCY STOP switch.

4.3 Replacement of damaged or lost installation accessories

Damaged or lost installation accessories (such as steel cables, washers, etc.) may only be
replaced by original parts.

4.4 Safety gear

If there is a possibility of injury, safety gear should be worn. The information in the tech‐
nical documents should always be observed.

4.5 Radiation protection

If not handled properly, ionizing radiation can cause radiation damage. The required pro‐
tective measures must always be observed when using radiation.

4.6 Threaded connections

n All threaded connections must be sufficiently tightened without being over-stressed.
The listed torque values must always be maintained!
n The text will state whether Loctite is to be used to secure screws.
Example:
 CAUTION
Establish correct screw connections!
Incorrectly established screw connections can result in physical injury and/or
property damage.
 All screws are to be secured in accordance with the information in the docu‐
mentation.
n All screws are to be secured in accordance with the information in the documenta‐
tion.
n Damaged or lost screws must be replaced only with screws of the same type and the
specified hardness rating.
n Unless another value is stated in the instructions, all Allen screws must always have a
hardness rating of at least 8.8.

4.7 Laser radiation

Depending on the classification, laser radiation can result in damage to eyes and skin
(classes 1 to 4). Proper handling must be observed:
Tab. 8 Laser classes according to EN 60825-1, 11.2001
Class Basic concept Remarks

1 The radiation emitted by the laser device No additional protective equipment
is harmless. is required.
1M Safe for eyes when used without optical No additional safety equipment is re‐
instruments; not safe when optical in‐ quired as long as optical instruments
struments are used. are not used.
2 Safe for eyes due to the natural reaction No additional protective equipment
to look away and the blinking reflex. is required.
2M The light that can penetrate the pupil of No additional safety equipment is re‐
the eye corresponds to a class 2 laser. quired as long as optical instruments
Depending on whether a divergent or are not used.
widened laser beam is present, it may
however not be safe when optical in‐
struments are used.
3R Exceeds the MPE values 1 Hazardous to the eyes. Safety glasses
The radiation is a maximum of five times are recommended.
higher than the GZE values of class 1 (or
class 2). The risk is slightly less than in
the case of class 3B.
3B Old class 3B without 3R Hazardous to the eyes. Safety glasses
Looking into the laser is hazardous. Dif‐ are mandatory.
fuse reflections are considered harmless.
4 Old class 4 Personal safety equipment is required
Diffuse reflections are hazardous to the (safety glasses, shielding)
eyes. In addition, there is a risk of burn‐
ing and a risk for the skin.
1. MZB-Werten (MZB: Maximal zulässige Bestrahlung; engl. MPE: Maximum permissible exposure)
 Observe the relevant information in the technical documentation!

4.8 Batteries
When replacing batteries, use the same battery type and make certain the batteries are
inserted correctly.
Lithium batteries can explode when they are not installed correctly.
Batteries may only be disposed of at the specified collection sites. The terminals of lithium
batteries must be insulated for disposal.

4.9 Working with heavy loads

In addition to wearing the required protective gear, e.g., safety shoes and gloves, ensure
that heavy loads are lifted and carried properly to prevent physical injury (e.g., to the
spine).
Heavy or awkward loads should be moved using technical aids or by more than one per‐
son. The relevant information must be observed.

4.10 Handling hazardous substances and dangerous goods

Hazardous substance is the designation for materials that can burn or explode, are toxic
or hazardous to health or are caustic or irritating.
The properties associated with the hazards and protective measures are described by
their labeling with symbols and the remarks corresponding to the hazardous substance.
Hazardous substances are substances presenting a particular risk. Substances that are
subject to special transport conditions are referred to as hazardous goods. Observe the
information regarding handling, storage, transport, emergency measures, and disposal in
the safety data sheets and/or material safety data sheets.
This information must be read prior to handling hazardous substances. The necessary pro‐
tective measures must be observed:

22 5 Using the ESD grounding wrist strap
The integrated circuits and boards that are equipped with electronic components require
particularly careful handling because of their very sensitive electrostatic structures and
because of their extremely high input resistance.
Proper handling of ESD (electrostatic sensitive devices) during service work is necessary
to prevent components and modules from being damaged by electrostatic discharge.
In accordance with statutory requirements and standards, manufacturers of electronic
medical products, devices or systems must ensure that all measures recommended to
provide protection against destruction or damage caused by electrostatic discharge are
implemented.
Requirements:
n A grounding wrist strap must be worn.
ESD components can be transported in ESD-safe packaging and may only be returned for
repair or quality inspection in such packaging (see ARTD-001. 715 03 “Transport, Packag‐
ing and Storage of Service Parts”).
n It is forbidden to eat, drink or smoke in areas containing ESD and also for the duration
of the repair assignment.
n Do not wear a grounding wrist strap during high voltage measurements or inspections
(e.g. when installing high voltage generators)! The safety regulations for working
with high voltage installations take precedence.
Function check of the personal ESD protection kit:
Before every use, check the anti-static mat for damage, particularly at the contact point
between the mat and cable. Replace the mat if you notice any damage. The grounding
wrist strap and cable connection can be tested with an ohmmeter. If the contact resist‐
ance value is not between 1 mohms and 35 mohms, the wrist strap and cable must be
replaced.

Changes to the previous version 6 23
Chapter Change
Charm TD-00015174 The document was fully revised.

24 7 List of Hazard IDs
There are no Hazard IDs in this document.

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 elec‐
tronic documents and hardcopies is
prohibited. Offenders will be liable
for damages. All other rights are re‐
served.
healthcare.siemens.com/services
Siemens Healthineers Headquarters

Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Telephone: +49 9131 84-0
siemens.com/healthineers
Print No.: TD00-000.860.01.06.02 | Replaces: TD00-000.860.01.05.02

Doc. Gen. Date: 06.16 | Language: English
© Siemens Healthcare GmbH, 2001
siemens.com/healthineers

System, General Safety Notes CSTD SPR2-230.805.01 TD00-000.860.01

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

System, General Safety Notes CSTD SPR2-230.805.01 TD00-000.860.01

Uploaded by

Copyright:

Available Formats

Medical Products

Medical Products TD00-000.860.01.06.02 Page 2 of 25 © Siemens, 2001

1 Purpose of the document 4

2 Changes to medical products 5

3.1 Hazard information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

6 Changes to the previous version 23

7 List of Hazard IDs 24

© Siemens, 2001 TD00-000.860.01.06.02 Page 3 of 25 Medical Products

Medical Products TD00-000.860.01.06.02 Page 4 of 25 © Siemens, 2001

© Siemens, 2001 TD00-000.860.01.06.02 Page 5 of 25 Medical Products

Medical Products TD00-000.860.01.06.02 Page 6 of 25 © Siemens, 2001

3.1 Hazard information

Bei einer unmittelbar drohenden Gefahr, die bei Nichtvermeidung

Indicates when there is an immediate danger that leads to death

Tab. 2 WARNUNG / WARNING

Indicates a risk of danger that may lead to death or serious physi‐

Tab. 3 VORSICHT / CAUTION

Bei einer Gefahr, die bei Nichtvermeidung zu einer leichten oder

Indicates a risk of danger that leads to slight or moderate physical

Tab. 4 ACHTUNG / NOTICE

Bei einer Gefahr, die bei Nichtvermeidung zu einem uner‐

Indicates a risk of danger that if disregarded leads or may lead to

© Siemens, 2001 TD00-000.860.01.06.02 Page 7 of 25 Medical Products

Tab. 5 HINWEIS / NOTE

Ist als Tipp zu verstehen. Der Anwender muss diese Anweisung

Should be understood as a tip. The user does not absolutely have

Tab. 6 Hazard information on paper and online

Paper (black/white) Online version (color)

! DANGER (white type on red background)

! WARNING (black type on orange background)

! CAUTION (black type on yellow background)

NOTICE (black type on blue background)

NOTE (black type on green background)

Medical Products TD00-000.860.01.06.02 Page 8 of 25 © Siemens, 2001

Name Paper Online Name Paper Online

Magnetic Field X-ray

Biohazard Moving parts

© Siemens, 2001 TD00-000.860.01.06.02 Page 9 of 25 Medical Products

Medical Products TD00-000.860.01.06.02 Page 10 of 25 © Siemens, 2001

Regulations regarding occupational safety and accident prevention must be observed.

© Siemens, 2001 TD00-000.860.01.06.02 Page 11 of 25 Medical Products

Medical Products TD00-000.860.01.06.02 Page 12 of 25 © Siemens, 2001

4.2 Working on electrical systems

© Siemens, 2001 TD00-000.860.01.06.02 Page 13 of 25 Medical Products

4.3 Replacement of damaged or lost installation accessories

Medical Products TD00-000.860.01.06.02 Page 14 of 25 © Siemens, 2001

4.4 Safety gear

© Siemens, 2001 TD00-000.860.01.06.02 Page 15 of 25 Medical Products

4.5 Radiation protection

Medical Products TD00-000.860.01.06.02 Page 16 of 25 © Siemens, 2001

4.6 Threaded connections

© Siemens, 2001 TD00-000.860.01.06.02 Page 17 of 25 Medical Products

4.7 Laser radiation

Class Basic concept Remarks

 Observe the relevant information in the technical documentation!

Medical Products TD00-000.860.01.06.02 Page 18 of 25 © Siemens, 2001

© Siemens, 2001 TD00-000.860.01.06.02 Page 19 of 25 Medical Products

4.9 Working with heavy loads

Medical Products TD00-000.860.01.06.02 Page 20 of 25 © Siemens, 2001

4.10 Handling hazardous substances and dangerous goods

© Siemens, 2001 TD00-000.860.01.06.02 Page 21 of 25 Medical Products

Medical Products TD00-000.860.01.06.02 Page 22 of 25 © Siemens, 2001

© Siemens, 2001 TD00-000.860.01.06.02 Page 23 of 25 Medical Products

There are no Hazard IDs in this document.