SMS

International Medical Systems

SECTION # 1
INTRODUCTION

IMS2760
Service Manual
INTRODUCTION

INFORMATION TO ASSEMBLERS

How to Use This Manual

This manual is intended for the properly trained service engineer who will perform the
installation, maintenance, and calibration on the Exposcop Plus IMS2760 C - A R M system.
The procedures in this manual should not be attempted by someone who is not properly trained
to work on X-ray systems of this type.

Reading this manual does not alone qualify the reader to maintain or service the system.
This manual is intended to compliment classroom training normally required of a service
technician or field engineer familiar with this type of equipment.

This manual does not contain procedures that can be performed by the system operator.

The contents of this manual are believed accurate at the time of publication. However, changes
in design and additional features may be incorporated in the hardware or software that are not
reflected in this version of the manual.

This manual contains the accepted procedures that must be performed to insure system
compliance with the CDRH requirements. The tests outlined must be performed by a
qualified service engineer during a system's installation and prior to customer acceptance.

These tests should be performed for CDRH certified systems prior to any known upcoming
C D R H inspections.

A list of approved test equipment has been incorporated into the manual. This equipment,
or equivalent, must be used to perform these tests successfully. A record of the equipment
used, containing model number, serial number, and calibration date, should be kept with
the results.

Testing conditions, precautions and prerequisites listed must be considered.

Each test must be followed to insure proper system compliance. Whenever more than one
procedure is applicable, other acceptable test methods are incorporated in the manual.

Check sheets are provided when necessary. As the test procedure is accomplished, the
measurements or calculations must be annotated on the appropriate check sheet. When the
final step of the test procedure is accomplished, the data gathered on the check sheet must be
used to verify compliance.

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 DO NOT DESTROY THE CHECK SHEETS.

They should be retained with the system's documents for future reference. Whenever the
system is tested by a C D R H inspector, the data contained on these check sheets will be
valuable in the event of any system compliance questions.If any non-compliance cannot be
corrected, contact an authorized International Medical Systems, Inc. representative
immediately.

INFORMATION FOR USER AND ASSEMBLERS

RESPONSIBILITY FOR MAINTENANCE

This maintenance manual contains procedures by which a properly trained and qualified
service technician can keep the system operating properly and repair it should it
malfunction.

It is the responsibility of the owner of the system to ensure that installation, calibration,
modification, and repair of the system are performed only by qualified service technicians.

Circuits inside the equipment use voltages that can cause serious injury or death from
electrical shock. To avoid this hazard, operator should never be expected or allowed to
perform any type of service task except as specifically instructed in the Operator's Manual.

If a mechanical or electrical problem is encountered by the operator during the operational

check procedure or during use of the system, a qualified service technician must be notified
immediately and system should not be used until repairs have been completed.

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RECORD KEEPING RESPONSIBILITIES

Detailed records must be kept when the system is installed, calibrated, and repaired. It is
the responsibility of the service technician who performs these procedures to complete the
forms listed below and send copies of the forms directly to the interested parties.

RECORD W H E N REQUIRED

Service Log When any service is performed on the system.

When a calibration is performed on the system.

FDA Form 2579 Report of When a system is installed, or when any

Assembly of Diagnostic of the following certified components are
X-ray System ( Four copies replaced or added:
are provided).

X-ray Tube Housing and High-Voltage

Generator.
Beam Limiting Assembly.
Image Receptor.
X-ray Control Unit.

One copy to International Medical Systems, Inc.

One copy to FDA.
One copy to State.
One copy to Hospital.

FDA Equipment Locator Card When system installation is completed. This

( Page Rev. 1-4 ) form is the last page in this section.
Return copy of form to I.M.S.

In-Hospital Check-out When system is installed.

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 International Medical Systems, Inc.
4181 Latham Street, Riverside, CA 92501 (909) 781-6660 FAX (909) 781-6457

FDA EQUIPMENTLOCA TOR CARD

EQUIPMENT: FINAL DESTINATION:

MODEL NO.: ADDRESS: _

SERIAL NO.: CITY/STATE/ZIP:

INSTALL. DATE: CONTACT PERSON:

PHONE:

DEALER:

ADDRESS:

CITY/STATE/ZIP:

CONTACT PERSON:

PHONE NO:

WITHIN TWO (2) WEEKS FOLLOWING INSTALLATION, PLEASE RETURN COMPLETED FORM
TO:

INTERNATIONAL MEDICAL SYSTEMS, INC.

4181 LATHAM STREET
RIVERSIDE, CA 92501
909/781-6660
909/781-6457 FAX

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