040

MAGNETOM
MR
Planning & Installation
Safety
Vision Vision plus

Register 2 Print No.: M2-050.021.22.01.02
Replaces: n.a.
S ie me ns A G 1 99 8
The reproduction, transmission or use of this document or its contents is not permitted without express written authority. Offenders will be liable for damages. All rights, including rights created by patent grant or registration of a utility model _or_ design,_are_ reserved.
English Doc. Gen. Date: 04/99
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Safety
MAGNETOM Planning & Installation
Register 2
M2-050.021.22 Rev. 01 04/99
Page 2 of 4 TD SD 23
Siemens AG Medical Engineering
Contents
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Page
1 _______Safety guidelines _______________________________________________ 1 - 1

General . . . . . . . . . . . . . . . . . . . . . . . . . . Electrical installation. . . . . . . . . . . . . . . . . . . . Installation of medical electrical installations and systems Occupational safety guidelines . . . . . . . . . . . . . . Working with electrically conductive parts . . . . . . . Protective clothing . . . . . . . . . . . . . . . . . . . Accident reporting . . . . . . . . . . . . . . . . . . . . . Screw connections . . . . . . . . . . . . . . . . . . . . Securing screws . . . . . . . . . . . . . . . . . . . . . . Laser . . . . . . . . . . . . . . . . . . . . . . . . . . . Definition of class II laser devices according to TI 242 Safety precautions . . . . . . . . . . . . . . . . . . . Operation of the laser . . . . . . . . . . . . . . . . . Service/maintenance . . . . . . . . . . . . . . . . . Attaching the labels . . . . . . . . . . . . . . . . . . Points of injury between the table and the table guide . . Prerequisites for ramping up the magnet . . . . . . . . . Fire prevention . . . . . . . . . . . . . . . . . . . . . . Fire extinguishers . . . . . . . . . . . . . . . . . . . Smoke detectors. . . . . . . . . . . . . . . . . . . . Prior to system start-up . . . . . . . . . . . . . . . . . . General requirements for handling heavy loads. . . . . . Transporting the magnet and the MR electronics cabinet . Handling liquid cryogenic gases. . . . . . . . . . . . . . Protective clothing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-1 .1-3 .1-3 .1-3 .1-3 .1-3 .1-4 .1-4 .1-4 .1-5 .1-5 .1-5 .1-6 .1-6 .1-6 .1-9 1 - 10 1 - 11 1 - 11 1 - 11 1 - 12 1 - 13 1 - 14 1 - 15 1 - 15
2 _______Changes to previous version _____________________________________ 2 - 1
Register 2
M2-050.021.22 Rev. 01 04/99
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Contents
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Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
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The activities and tests described are to be performed in accordance with the product-specific safety instructions included in the attached documentation as well as the general safety guidelines which are described on the next pages.
General
In addition to the general safety instructions, the following TIs apply:
TI 206 TI 215 TI 219 TI 232 TI 235 TI 236 TI 237 TI 238 TI 240 TI 242
Flexible cable connections, connection of neutral conductor Working with vacuum tubes Handling and storage static-sensitive components VDE 0107 - New Edition 1981 Safety aspects for MR-installations Safety-related instructions for installation and maintenance Health hazards associated with Be-Cu tool dressing Ice formation in cryostat Safety equipment Laser radiation
Register 2
M2-050.021.22 Rev. 01 04/99
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Safety guidelines
NOTICE
The project manager is responsible for informing Siemens as well as non-Siemens employees in detail about the hazards involving activities in the vicinity of the magnet. These instructions cannot be ignored. Introduction of ferromagnetic materials or tools in proximity to the magnet results in such objects becoming projectiles which could present a lethal risk to personnel working in the vicinity of the magnet. It is the responsibility of the customer/user that patients with cardiac pacemaker implants or other implanted electronic devices remain outside the 5 Gauss exclusion zone. The exclusion zone must be identified by the user/customer and access to this zone must be restricted prior to energizing the magnet.
NOTICE
Information for the Federal Republic of Germany The project manager is responsible for ensuring that all OR cryostat magnets are inspected by TV personnel after installation and for keeping the protocol with the system paperwork. Refer to TI 235 item 2, dated 11/93.
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
Electrical installation
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1
In the Federal Republic of Germany, the electrical lay-out for medical facilities must comply with VDE guidelines 0107. For all other countries, the applicable guidelines (national or VDE regulations) are included in the installation instructions provided for the respective project.
Installation of medical electrical installations and systems
These activities are to be performed in accordance with the installation instructions and the information provided on microfilm. During the installation procedure it is required that the protective conductor connections as specified by the manufacturer are established prior to system start-up. For example, metal covers which may conduct hazardous contact voltages during fault conditions have to be connected to the protective conductor with screws and lock washers or via the provided protective conductor terminal. identifies protective conductor terminals
Equipotenial bonding
Occupational safety guidelines
It is both required and in the best interest of the technical personnel to strictly observe the occupational safety and accident prevention guidelines. The additional information provided below is an in-house addendum to these regulations.
Working with electrically conductive parts

Service Engineers should not handle or work on parts conducting voltage levels of >50V or >l20V-. This limitation does not apply to measurement and adjustment procedures. However, only tools and measurement instruments suitable for these activities should be used.
If the power has to be switched on for e.g. testing system movements, the power must be switched off immediately after the test has been completed (refer to TI 236).
Protective clothing
Protective clothing must be worn as specified in the safety instructions included in the TI folder.
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M2-050.021.22 Rev. 01 04/99
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Accident reporting
Safety guidelines
1
All accidents or potentially hazardous conditions must be reported immediately to the technical supervisor (refer to TI 236).
Screw connections
Torque applied to Screw Connections Screw connections should be sufficiently tightened without applying undue tension.
The torques for safety-relevant screw connections are listed in the enclosed instructions and are identified with the symbol
in the text margin. These screw connections have to be secured for safety reasons with a torque wrench and the torque listed (Nm).
Securing screws
All screws should be secured as described in the attached instructions which also list the screws to be secured with "Loctite." The drawing shown below illustrates the washers, disks, and rings for shafts and boreholes.
lock washer
contact disc
star washer
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
Laser
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1
The semiconductor lasers used for the MR installations function as light localizers. Each laser light localizer has an output power of less than 1 mW at a wavelength of approximately 670 nm. These specifications categorize the device as a class II laser.
Definition of class II laser devices according to TI 242
NOTICE
A class II laser product means any laser emitting a maximum output power of 1 mW and permitting human access during operation to levels of laser radiation which are part of the visible light spectrum (540 nm to 700 nm). During a short exposure to the laser beam (approximately 0.25 seconds), the eyelids natural winking reflex to light provides sufficient protection for the eye.
Safety precautions
NOTICE
Each laser device must be clearly identified by the two warning labels shown below.
For the purpose of maintenance and service, the "danger symbol" label as well as the "explanatory text" label have to be permanently affixed to a location easily visible to the service personnel. One set of labels should be attached to the RF panel close to the laser. The other set should be attached to the front magnet cover below the right laser. The explanatory text should be provided in either English, French, or German according to the language of the country of destination.
LASERSTRAHLUNG NICHT IN DEN STRAHL BLICKEN LASER KLASSE 2
WARNS
Fig. 1
Warning logotype consisting of"Danger symbol " and "explanatory text"
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M2-050.021.22 Rev. 01 04/99
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Operation of the laser
Safety guidelines
1
NOTICE
Instruct the patient to avoid looking into the laser beam and to keep his/her eyes closed.
NOTICE
Ensure that patients without a natural winking reflex wear protective glasses prior to patient positioning.
The item number for ordering the protective glasses is 70 52 947 F1114 .
Service/maintenance
NOTICE
If one of the laser light localizers is defective, replace the entire module.
Attaching the labels

There are two different label configurations.
- Label configuration for the USA: Aperture label (USA) Certification label (USA) Identification label - Label configuration for all other countries: Warning logo type (in English, German, Spanish or French) Identification label
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
1-7
LABELS
This product complies with DHHS regulations 21 CFR Subchapter J. applicable at date of manufacture.. Data of manufacture.. Siemens Aktiengesellschaft Wittelsbacherplatz 2.D - 8 Mnchen 2 Germany
Certification label (USA)
SIEMENS
ModelNo. SerialNo. MADE IN GERMANY
Identification label
Fig. 2 Safety labels
LASERSTRAHLUNG NICHT IN DEN STRAHL BLICKEN LASER KLASSE 2
Warning logotype
Register 2
M2-050.021.22 Rev. 01 04/99
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Safety guidelines
tubus
Aperture label (USA) Identification label
*
Bottom cover
Certification label only fo USA
patient table
Warning logotype
*
SHINWN
cover
Fig. 3
Position of the safety labels
NOTICE
One warning logo has to be placed behind the tubus next to one of the lasers.
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
Points of injury between the table and the table guide
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1
Although the distance between the table and table guide is 5 mm only, 4 warning labels should be attached pointing out the possibility of getting ones fingers caught between the table and the table guide. Affix the warning labels at the locations shown in Fig. 4.
LABFING
Magnet
Patient Table Patient Table
Fig. 4
Location of the four warning labels
Register 2
M2-050.021.22 Rev. 01 04/99
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Prerequisites for ramping up the magnet
Safety guidelines
1
- The exclusion zone ( 0.5 mT ) has been identified according to the planning guide - Identification and restriction of this zone ( 0.5 mT ) has been verified - Energization of the magnet has been authorized by the project manager - The project manager has informed employees working in the vicinity of the magnet about the pending magnet energization - All magnetizable material has been removed from the magnet and examination room prior to ramping up the magnet - The prescribed non-magnetizable tools are available on-site - The functionality of the Magnet STOP has been tested prior to ramping up the magnet - Access to the magnet and examination room must be restricted when starting up or servicing an energized magnet. Access is restricted by a plastic chain attached to two poles. A flashing light must be attached to each pole, and the following warning sign in the language of the respective country must be attached to the chain:
Flashing Light
Chain
Strong magnetic field Warning ! Hazardous conditions Do not enter !
ABSPER
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
Fire prevention
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1
Constructional fire prevention methods should be in accord with local regulations and guidelines. The following apply in Germany: - Richtlinien des Verbandes fr Sachversicherungen e.V. Kln - DIN 4102 - DIN 18082 It is the responsibility of the user to inform the local fire department of the equipment installed and to comply with the safety requirements specified.
Fire extinguishers
The fire-fighting equipment used must comply with the specifications of the local fire department and consist of non-magnetizable material. Non-magnetizable fire extinguishers, type KA 6, may be procured, for example, through Total/Walther Feuerschutz GmbH Vertriebsbereich HW Postfach 340 68199 Mannheim 24 Tel. 0621 / 852018
Smoke detectors
Both the type and the location of smoke detectors should prevent that the functions of the smoke detectors are not adversely affected by the magnetic field. The electrical cable of smoke detectors installed in the examination room must be routed through RF wave guides.
When installing smoke detectors close to the magnet, precautions have to be taken to avoid vapor settling on the smoke detectors (removal of boil-off lines, refilling of helium).
Register 2
M2-050.021.22 Rev. 01 04/99
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Prior to system start-up
Safety guidelines
1
The MAGNETOM installation will be inspected by various agencies in view of (refer to Register 9 of the System Manual as well as the system logbook):
Availability of on-site operating instructions? Easy accessibility of Magnet STOP? Completeness of warning signs and symbols?
The warning signs should be posted as follows: - Next to doors leading to the RF-room - Next to areas which lead to zones where the magnetic flux density exceeds 0.5 mT.
On-site availability of non-magnetizable fire extinguishers? Functionality of EMERGENCY SHUT-DOWN buttons Completed measurement of the magnetic fringe field throughout the magnet room as well as in the
floors above and below the magnet room?
Visual inspection of the system components regarding

- Ground connections at the doors - Secured line voltage cables
Review of the system logbook
NOTICE
Install and operate in medical facilities only systems and components which fulfill the general safety requirements for medical electrical systems according to DIN VDE 0750 / EN 60601 / IEC 601- series.
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
General requirements for handling heavy loads
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1
NOTICE
Always
Wear protective clothing, such as

- safety gloves ( made from leather or equivalent ) - non-magnetizable safety shoes - safety helmet, DIN 4840 - ZH 1/242 (refer to data sheet)
Inspect tools for visual damage prior to using them

The tools and auxiliary tools must be in satisfactory working condition and meet with manufacturers specifications (adhere to legal regulations).
Inform the supervisor about incidents of damage Inform temporary personnel about the hazards and the safety measures to be taken when handling
heavy loads
Use only the transport and lifting devices specified Secure the transport device and load before moving the load
NOTICE
Never
Use defective or damaged tools Block emergency exits Stretch ropes by twisting them Knot ropes or chains Stand under heavy loads Exceed the load capacity of devices Route or stretch ropes, chains, or bands over sharp edges Allow personnel to stay in areas where heavy loads are being moved
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Safety guidelines
1
Transporting the magnet and the MR electronics cabinet

WARNING
All transport activities including delivery of the magnet and the system components into the MR-suite should be performed by a licensed carrier only.
Register 2
M2-050.021.22 Rev. 01 04/99
Safety guidelines
Handling liquid cryogenic gases
Note the manufacturers safety instructions affixed to the dewars.
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1
Inform the manufacturer immediately if the dewars are damaged or covered with ice. Do not attempt
to repair or deice the dewar.
Observe the safety instructions for handling cryogenic gases. The instructions are included in the
technical and safety-related documentation.
Protective clothing Wear the protective cothing prescribed for handling liquid gases.
GASSICH
Face shield
ZETEX gloves or equivalent leather gloves Lab coat
He dewar
Non-magnetizable safety shoes
Non-magnetizable folding step ladder
Brake
Register 2
M2-050.021.22 Rev. 01 04/99
1 - 16
The non-magnetizable folding step ladder can be ordered through: Zarges Leichtbau 82362 Weilheim Tel.: 0881 / 87-1 ( 687-1 ) Order 40919 Technical data for step ladder:
Safety guidelines
surface area of platform/m floor clearance/m base/m size when folded up/m weight/kg
0.65 x 0.32 0.8 0.8 x 0.82 1.12 x 0.80 x 0.20 8.7
Register 2
M2-050.021.22 Rev. 01 04/99
Changes to previous version

No previous version exists.
2-1
Register 2
M2-050.021.22 Rev. 01 04/99
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Changes to previous version
Register 2
M2-050.021.22 Rev. 01 04/99

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MAGNETOM

Planning & Installation

Vision Vision plus

English Doc. Gen. Date: 04/99

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

1 _______Safety guidelines _______________________________________________ 1 - 1

2 _______Changes to previous version _____________________________________ 2 - 1

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Installation of medical electrical installations and systems

Occupational safety guidelines

Working with electrically conductive parts

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Definition of class II laser devices according to TI 242

LASERSTRAHLUNG NICHT IN DEN STRAHL BLICKEN LASER KLASSE 2

Warning logotype consisting of"Danger symbol " and "explanatory text"

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

Attaching the labels

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Certification label (USA)

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

Aperture label (USA) Identification label

Certification label only fo USA

Position of the safety labels

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Patient Table Patient Table

Location of the four warning labels

Siemens AG Medical Engineering

M2-050.021.22 Rev. 01 04/99

MAGNETOM Planning & Installation

Strong magnetic field Warning ! Hazardous conditions Do not enter !

MAGNETOM Planning & Installation

M2-050.021.22 Rev. 01 04/99

Siemens AG Medical Engineering

Siemens AG Medical Engineering

1 _Safety guidelines _________________________________________ 1 - 1

2 _Changes to previous version _______________________________ 2 - 1