HM

International Medical Systems

SECTION # 2
SAFETY

IMS2760
Service Manual
SAFETY

TO T H E USER

THE SAFETY OF B O T H PATIENT A N D OPERATOR HAS B E E N A MAJOR CONSIDERATION

DURING T H E D E V E L O P M E N T OF THE INTERNATIONAL M E D I C A L SYSTES, INC.
M O B I L E S U R G I C A L C - A R M SYSTEM. PROPER C A R E , USE, A N D O B S E R V A N C E OF A L L
PRECAUTIONS W I L L INSURE SAFE A N D R E L I A B L E OPERATION OF THE EXPOSCOP
PLUS. MISUSE, HOWEVER, C A N RESULT IN D A M A G E TO THE EQUIPMENT A N D / O R
SERIOUS PATIENT OR OPERATOR INJURY.

RADIATION WARNING

X - R A Y S A N D G A M M A - R A Y S A R E DANGEROUS TO BOTH OPERATOR A N D OTHERS IN

THE PROXIMITY UNLESS ESTABLISHED S A F E T Y E X P O S U R E GUIDE LINES A R E
STRICTLY COMPLIED WITH.

USEFUL A N D SCATTERED B E A M S C A N C A U S E SERIOUS OR F A T A L INJURIES TO A N Y

PERSONS IN T H E SURROUNDING A R E A IF USED B Y U N S K I L L E D OPERATORS.
APPROPRIATE PRECAUTIONS MUST B E T A K E N TO AVOID EXPOSURE TO T H E
RADIATION B E A M A N D L E A K A G E F R O M THE SOURCE HOUSING.

O N L Y AUTHORIZED PERSONNEL SHOULD OPERATE OR DIRECT THE OPERATION OF

THE EQUIPMENT. T H E Y ALSO SHOULD B E C O M P L E T E L Y FAMILIAR A N D C O M P L Y
WITH A L L ESTABLISHED SAFETY EXPOSURE FACTORS A N D PROCEDURES OUTLINED
IN SUBCHAPTER J OF TITLE 21 OF THE CODE OF F E D E R A L REGULATIONS,
(DIAGNOSTIC X - R A Y A N D THEIR MAJOR COMPONENTS). A L S O THE N A T I O N A L
COUNCIL ON RADIATION PROTECTION (NCRP) NO. 33 " M E D I C A L X - R A Y A N D G A M M A -
R A Y PROTECTION FOR ENERGIES UP TO 10 MEV-EQUIPMENT DESIGN A N D USE".

INDIVIDUALS I N V O L V E D WITH PLANNING OF X - R A Y EQUIPMENT A N D ITS

INSTALLATION MUST B E C O M P L E T E L Y FAMILIAR A N D C O M P L Y WITH THE NCRP
NO. 49 ( S T R U C T U R A L SHIELDING DESIGN A N D E V A L U A T I O N FOR M E D I C A L USE OF
X - R A Y S A N D G A M M A - R A Y S OF ENERGIES UP TO 10 M E V ) .

STATE A N D L O C A L REGULATIONS ALSO M A Y A P P L Y THAT M A Y DIFFER SLIGHTLY

F R O M F E D E R A L REGULATIONS.

F A I L U R E TO O B S E R V E THESE WARNINGS C A N RESULT IN SERIOUS OR F A T A L

BODILY INJURIES TO THE OPERATOR OR PERSONS IN THE A R E A .

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MECHANICAL-ELECTRICAL WARNING

DIAGNOSTIC SURGICAL C - A R M SYSTEMS.

A L L THE M O V A B L E ASSEMBLIES A N D PARTS OF THIS EXPOSCOP 7000 S H O U L D B E

OPERATED WITH CAUTION A N D INSPECTED R E G U L A R L Y IN A C C O R D A N C E WITH THE
RECOMMENDATIONS STATED IN THE USERS A N D SERVICE M A N U A L S .

O N L Y P R O P E R L Y TRAINED A N D QUALIFIED SERVICE PERSONNEL SHOULD B E

A L L O W E D ACCESS TO A N Y INTERNAL PARTS. L I V E E L E C T R I C A L T E R M I N A L S A R E
D E A D L Y . B E SURE THAT LINE DISCONNECT SWITCHES A R E OPEN (OFF) A N D THAT
PRECAUTIONS A R E T A K E N BEFORE OPENING ACCESS DOORS, R E M O V I N G
ENCLOSURES A N D PANELS, OR A T T A C H I N G ACCESSORIES.

DO NOT R E M O V E ACCESS COVERS F R O M THE GENERATOR, CONTROL UNIT, OR M A I N

POWER A S S E M B L Y UNTIL THE M A I N A N D A U X I L I A R Y POWER SUPPLIES H A V E B E E N
DISCONNECTED.

F A I L U R E TO OBSERVE THE AFOREMENTIONED M A Y RESULT IN SERIOUS O R

POSSIBLY F A T A L INJURY TO THE OPERATOR OR PERSONS IN T H E A R E A .

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TO T H E INSTALLER
The information in this section is intended to help the service engineer establish safe practices for
installation and maintenance of the EXPOSCOP 7000 C-ARM.

Potential hazards exist in the operation and the service of medical electronic devices and x-ray
systems. A l l users and operators must understand the safety and emergency procedures, and know
how to take adequate precautions to protect themselves and others from possible injury. A l l operators
and service engineers must be familiar with and understand the safety and emergency procedures,
operating instructions, and preventive maintenance schedules and procedures given in the operator's
manual.

Operators must know how to recognize hazardous and potentially hazardous conditions, and know
how to protect adequately themselves and others from possible injury.

The EXPOSCOP 7000 C-ARM X-Ray system presents no hazards unusual for mobile C-Arm
equipment and meets all safety requirements applicable to medical electronic equipment of this type.

RESPONSIBILITY
It is the responsibility of the owner to ensure that only trained and qualified personnel operate
the system. The operators must have obtained credentials from local, state and federal authorities
where required.

If the system fails to operate properly or fails to respond to system controls as outlined in the
operators manual, the local authorized International Medical Systems, Inc. Dealer
representative should be called to evaluate and repair the system.

The user (Hospital Administration) is responsible for verifying continued compliance of: calibration
of mA, kV, Time/mAs, and alignment of the useful beam. This must be accomplished according to
the maintenance schedule. The owner must make sure that only trained and qualified service
personnel perform installation, maintenance, calibration, and repair of the system.

Compliance with applicable local and federal statutory and regulatory requirements is the
responsibility of the user hospital administration. The user must consult with local, state, and federal
agencies regarding requirements and regulations applicable to the use.

International Medical Systems, Inc. assumes no responsibility or liability for after

sale operating and safety practices: nor can it be responsible for personal injury or
damage resulting from misuse of its systems.

Address questions and comments regarding safety to the appropriate International Medical
Systems, Inc. Dealer representative.

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Hazards

Possible hazards associated with unsafe operation of this type equipment are described below with
the safety precaution that should be taken.

1. X-ray Tube / Housing Hazards

A l l persons working with or who are exposed to X-ray tubes must take precautions to protect
themselves against serious injury. ( Be alert as carelessness can cause serious or even
fatal injuries).

The operation of X-ray tubes may involve the following hazards:

a. High voltage: Normal operating voltages can be deadly.

b. Hot oil: Tube housings contain dielectric oil which can reach high temperatures. If the tube
housing ruptures due to overload the hot oil can cause serious burns.

c. X-ray radiation: X-ray tubes produce X-radiation that is dangerous, possibly fatal.

2 . Mechanical Movement Hazards

The operator should always be alert observing the motorized movement of the vertical tube arm
assembly, or rotation of the C-Arm portion to avoid collision with any person or object.

3. Flammable Gas Hazard

The system must never be used in the presence of flammable anesthetics, or other flammable gasses,
liquids, or vapors. Gasses and vapors can be ignited by electrical arcs that can occur during normal
operation of power contactors, switches, circuit breakers, and other circuit components.

If flammable liquids, gasses, or vapors are present before the system is turned on, do not unplug
it and do not turn it on.

If flammable substances are detected after the system has been turned on, Do not turn the system
off; do not touch any of the controls, switches, or knobs; do not unplug it.
Remove all personnel immediately. Then ventilate the room to clear room of
flammable vapor or gas. Remove any flammable liquids that are producing
flammable vapors to a safe storage area.

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G E N E R A L SAFETY
Under no circumstances should any of the safety interlocks in the system be
removed, bypassed, jumpered or otherwise disabled.

Before cleaning the equipment always unplug the A C power cable from the wall.
Water, liquid soap, or other liquids, if allowed to drip into the equipment will cause
electrical short circuits possibly leading to electrical shock or fire hazards. For this
reason food or beverages containers should never be allowed on any parts of the equipment. They can
tip over and introduce conductive substances into the electrical circuitry.

The EXPOSCOP 7000 should never be operated in a location where conductive fluids such as water,
saline solution etc. may spill on any part of the equipment unless the equipment is covered by a
protective waterproof draping.

E L E C T R I C A L SAFETY

High voltage is present in the equipment always. Disconnect the power supply from the source
of power before removing any of the covers. Serious or fatal injuries can result from accidental
contact with high voltage circuits. To avoid this hazard, operators should never under any
circumstances remove any of the unit's covers.

Hazardous voltage areas:

1. High voltage transformer and X-ray tube assemblies —upwards of 110,000 volts.

2. Power transformers — 220Vac and 120Vac.

3. Image power supply control assemblies — 220Vac~ 120Vac.

4. Generator invertor control up to 300Vdc at 20Khz

If equipment must be serviced with the covers removed, then observe the following precautions:

Observe the two-person rule when working around or near lethal voltages. A person who is familiar
with the emergency power removal procedure must be present. This person must remain clear
of the machine and be prepared to turn of the machine in an emergency.

Do not perform maintenance in any area without fully understanding the circuits and voltages present.
Maintenance and repair of the EXPOSCOP 7000 should only be done by a trained and qualified
service person. Never assume a capacitor is discharged. Use a grounded shorting device when
working on circuits with capacitors, even when power is disconnected. Be sure the connections to
the system are proper as described in the installation section of this manual.

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Electrical Safety Continued:

Do not remove the Ground wire from the Generator and High Voltage Tank. Failure to ground the
Generator and High Voltage Tank properly can create a shock hazard that could cause serious bodily
injury or death. It is essential that a proper earth ground be provided as specified in the installation
section. These protective grounds should be inspected periodically.

Radiation Safety
The X-ray tube assembly produces X-radiation when energized. Never operate this device without
proper X-ray shielding in place.

The owner must designate areas suitable for safe operation and service of the system. The owner
must ensure that it is used only in these designated areas.

Radiation protection surveys and X-ray system calibration checks must be completed by trained
and qualified experts. The radiation survey reports must show that the installed equipment meets
requirements of the U.S. Department of Health and Human Services and all local, state, and federal
regulations before the system may be routinely used.

The system must be operated only by trained qualified personnel who understand the use of X-ray
tubes, collimation devices, patient positioning, and radiation safety procedures.

With the installation of X-ray systems consideration of room shielding (lead), ability of floor, ceiling,
and walls to attenuate scatter radiation. The use of lead draping and other necessary precautions to
provide necessary protection for personnel should be observed.

Physician in charge of a radiological procedure must ensure that all personnel in the room are
provided with protective clothing that must be worn with radiation monitoring devices.

X-RAY TUBE SAFETY

The X-ray tube can generate extremely high temperatures in its anode portion during operation.
The heat generated in the anode is radiated to the dielectric oil inside the tube housing. This heat is
conducted through the housing and radiates to the air. Misuse of the tube can result in a rupture of the
tube housing causing hot oil to escape, potentially resulting in serious burns. (Operators of the
system should take all necessary precautions to avoid a rupture and hot oil
leakage).

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MAIN POWER FAILURE

Main A C power can be interrupted by loss of service outlet, overloads that blow fuses or trip circuit
breakers. The owner should have a dedicated, properly rated power line installed for this system
helping to avoid these problems. Should power failure occur, do not use emergency lighting circuit if
the system is operated with a line plug. The system should remain off until power is restored.

SYSTEM P R O B L E M

Repeated circuit breaker tripping or blown fuse after resetting or replacment, may suggest an
equipment malfunction. Do not attempt to operate the system until a qualified service technician can
evaluate the system and repair if needed.

If any of the system controls fail to respond as described in the Operators Manual, the operator
should if the circumstances allow:

1. Turn system off

2. Disconnect the system from outlet power or turn off wall breaker..

3. Contact a qualified trained service engineer immediately.

EQUIPMENT OR E L E C T R I C A L FIRE

The owner should develop emergency policies and procedure for the operator in the area the system
is installed. This will included the following safety measures:

1. Turn off equipment and disconnect the system from the main A C power.

2. Evacuate everyone from the area.

3. Call for help

4. Use only a fire extinguisher approved for electrical fires.

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EQUIPMENT MODIFICATIONS

The owner is responsible for maintaining the system and must not allow any unauthorized
modifications to the system.

Modifications or additions to the equipment must be made according to statutory requirements

and generally accepted engineering regulations.

As manufacturers, assemblers, installers or importers, we cannot regard ourselves responsible in

particular for safety, reliability and performance of equipment if:

-Installation, extensions, readjustments, modifications or repairs are not performed by persons

authorized by International Medical Systems Inc.

-Components affecting the safety of the equipment are not replaced on failure by original spare
parts.

-The electrical installation of the room concerned does not comply with requirements specified in
the DHHS-Supplement and Adjusting Instructions.

-The equipment is not used in conformity with the instructions for installation, or for use.

UNAUTHORIZED MODIFICATIONS

Unauthorized changes or modifications to any part of the system may have hazardous results.
Changes or modifications of the system must not be made unless specifically authorized by
International Medical Systems, Inc. and performed by qualified trained dealer service representatives
of International Medical Systems, Inc..

When properly assembled and installed this diagnostic source assembly will fully meet the Federal
Performance Standards of Diagnostic X-Ray Systems and their components (21CFR 1020.30 - 32),
provided no unauthorized modifications, components or parts are removed from this unit and no
unauthorized adjustments are made in the beam limit device.

No adjustments or any parts may be removed from the beam-limiting device unless under the
direction of International Medical Systems, Inc. or their authorized dealers.

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