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This page is to provide information related to service manuals that are being withheld from In-House Biomedical Service Departments by a manufacturer of a medical device. NFPA states that service manuals are to be provided that include schematics, parts list, circuit description, calibration and troubleshooting procedures. It is my belief that manufacturers who do not supply this information are not following the requirements of the NFPA. Note: NFPA is not law in all 50 states in the USA, see list below.
If there are any errors or false information on this page please email me by clicking here. I will correct them quickly.
|
Company |
Product Description |
Model Affected |
Information not provided |
Company Rep. Contact |
Info Rec'd By |
Date Updated |
Misc Info |
|
Quinton |
Cardiac Rehab Transmitters |
|
Service manuals with
schematics do not exist. |
Richard Denu 1-800-426-0337 Option #1 |
Joe
Emmel |
11/5/02 |
Quinton does not supply transmitter
parts, only full exchange. |
|
SIMS Deltec |
CADD Pump |
6100 |
Schematics, calibration
procedures, parts. |
Jim Bruno |
Mike Kauffman Reading, PA |
12/10/02 |
All repairs must be done
by the manufacturer. |
|
Given
Imaging |
Video
Imaging System |
M2A |
Mfg will not support in-house software reloads to
hard drive. Factory exchange only. |
Bill
Garner |
Larry
Rochowicz, Reading,
PA |
2/12/2003 |
Depot repair only. |
|
Fersenious
The ONLY service options |
Peritoneal Dialysis Cycler. |
IQCard |
The
manufacturer has is to exchange the unit. No service manuals. No Field |
|
Bill
Knight |
10/24/2003 |
Mfg will only exchange unit. |
|
Boston Scientific |
HTA Therapy Unit |
|
Schematics, calibration procedures, parts. |
|
Joe Emmel Reading, PA |
08/14/2004 |
A waiting list is being compiled for those who want manuals. J |
|
Smith Nephew Dyonics |
Video Tower Equipment |
|
Operators manual only. |
|
Michael Sturgis, Sr.Tech |
08/24/2004 |
|
|
Alaris |
Digital holter recorder. |
5218 |
|
|
Mike Mappes CBET |
|
It is all digital, surface mount component, I would assume
they are basically one large RAM device. When it breaks the staff sends them
into the manufacturer for repair and their is no service manual. |
|
SR Instruments |
Scale |
SR241 |
Must be sent into the company for calibration. |
|
Mike Mappes CBET |
|
Their price for this service is reasonable, so I'm not sure it
would be worth the time and effort to do in-house repair on the scale. |
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|
Luxtec Corporation |
Light Source |
9300 |
They will provide me an Operator's Manual free of charge, but a Service Manual is not available. |
Jim Sniffen |
Carl Lemon 603-332-5211 x8285 Fax 603-332-3774 |
08/24/2004 |
|
If you have information about a manufacturer who is not supplying service information, please enter the data below and submit the information. I will update the list. This issue is one of the biggest situations affecting our field today. Anyone who does not insist that manufacturers follow the NFPA guidelines are not helping to keep hospital service costs at a minimum. We must unite in this area in order to be effective. Please help me in this endeavor. Recently cooperative manufacturers have asked to have their page as well. Please click here to see manufacturers who supply service information to in-house service departments.
Just for the record, 1 manufacturer has changed their stance on not providing service manuals as detailed in NFPA99. They have been added to the cooperative manufacturers list. (Click here.)
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Section
9-2.1.8.1 Manuals. The manufacturer of the device shall furnish operator's,
maintenance, and repair manuals with all units. These shall include operating
instructions, maintenance details, and testing procedures.
The manuals shall include the following where applicable:
(a) Illustrations that show location of controls
(b) Explanation of the function of each control
(c) Illustrations of proper connection to the patient and other equipment
(d) Step-by-step procedures for proper use of the appliance
(e) Safety considerations in application and in servicing
(f) Difficulties that might be encountered, and care to be taken if the
appliance is used on a patient simultaneously with other electric appliances
(g) Schematics, wiring diagrams, mechanical layouts, parts lists, and other
pertinent data for the appliance as shipped
(h) Functional description of the circuit
(i) Electrical Supply requirements (volts, frequency, amperage and watts), heat
dissipation, weight, dimensions, output current, output voltage, and other
pertinent data
(j) The limits of electrical supply variations - performance specifications of
the appliance shall be given for the applicable limits of electrical supply
variations.
(k) Technical performance specifications including design levels of leakage
current
(l) Instructions for unpacking (readily available upon opening), inspecting,
installing, adjusting and aligning
(m) Comprehensive preventive and corrective maintenance and repair procedures
Where appropriate, the information itemized shall be permitted to be supplied
in the form of a separate operating manual and a separate maintenance manual,
except that the separate maintenance manual shall also include essentially all
the information included in the operators manual.
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For those of
you interested, NFPA99 is law in; Alaska, Arkansas, Connecticut, Delaware,
Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Maryland, Maine,
Michigan, Mississippi, North Carolina, Nebraska, New Hampshire, New Jersey, New
York, Ohio, Rhode Island, South Carolina, Tennessee, Virginal, Vermont, West
Virginia, and Wyoming.
Darn Pennsylvania!