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Amendment 1 2005-03-09
This Report includes the following parts, in addition to this cover page:
1. Specific Technical Criteria
2. Clause Verdicts
3. Test Results
4. Enclosures
a. National Differences
b. Photographs
c. Manuals
d. Miscellaneous
The original report was modified on 2005-03-09 to include the following changes/additions:
Suffix -E, which indicates optional slotted cover was added to the model/type reference on the report cover
page.
New factory location, Shanghai GES Information Technology Co., Ltd was added to the cover page.
Suffix -E was added to the model/type reference in the Test Report.
Output Rating was revised to include maximum output rating for model numbers with suffix -E with no airflow.
General Information was revised to add slotted cover under "options included".
Engineering Considerations was revised to include optional slotted cover in the "accessories investigated for
use with the product".
Sub-clause 6.1f was revised to include suffix -E for optional slotted cover.
Table 42 was revised to add temperature test data for Models GPFM115-5-E, GPFM115-12-E and
GPFM115-28-107.
Enclosure, National Differences was revised to include National Differences for additional countries.
Enclosure, Photographs was revised to include photo of power supply with optional slotted cover.
Enclosure, Miscellaneous was revised to include list of test equipment.
Enclosure, Manuals was revised to include the latest version of Installation Instructions.
All applicable tests according to the above standard(s) have been carried out.
Test results are valid only for the tested equipment.
This Test Report can be reproduced only in whole.
Amendments and corrections can be reproduced only with the original CB Test Report.
Written permission from Underwriters Laboratories Inc. is required if the test report is copied in part.
TEST REPORT
IEC 60601-1
Medical Electrical Equipment
Part 1: General requirements for safety
Report Reference No ......................: E116994-A7-CB-1
This publication may be reproduced in whole or in part for non-commercial purposes as long as the IECEE is
acknowledged as copyright owner and source of the material. IECEE takes no responsibility for and will not
assume liability for damages resulting from the reader's interpretation of the reproduced material due to its
placement and context.
Test item description .......................: Power Supplies
Trade Mark .......................................: Condor
Model/Type reference ......................: GPFM115-X, where X represents the output voltage, which may be
any number from 3.3 to 48. May be followed by suffix -C to indicate
optional cover/fan or -E to indicated optional slotted cover is
provided.
Manufacturer ....................................: CONDOR D C POWER SUPPLIES INC
2311 STATHAM PKY
OXNARD CA 93033
Rating ...............................................: Input: 100-240 V ac, 2.3 A, 50/60 Hz
GENERAL INFORMATION
Test item particulars (see also clause 5):
Classification of installation and use.......................... : Permanently installed
Supply connection...................................................... : Header Connector
Accessories and detachable parts included in the
evaluation................................................................... : None
Options included ........................................................ : Optional cover/fan or slotted cover
Possible test case verdicts:
- test case does not apply to the test object ............. : N/A
- test object does meet the requirement ................... : P(Pass)
- test object does not meet the requirement ............. : F(Fail)
Abbreviations used in the report:
- normal condition ............................................ : N.C. - single fault condition .................: S.F.C.
- operational insulation ..................................... : OP - basic insulation .........................: BI
- basic insulation between parts of opposite BOP - supplementary insulation .........: SI
polarity:
- double insulation ............................................ : DI - reinforced insulation .................: RI
General remarks:
This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and
appended to a CB Test Certificate issued by a NCB in accordance with IECEE 02.
The test results presented in this report relate only to the object tested.
This report shall not be reproduced, except in full, without the written approval of the Issuing testing
laboratory.
List of test equipment must be kept on file and be available for review.
Report Summary
The original report was modified on 2005-03-09 to include the following changes/additions:
Suffix -E, which indicates optional slotted cover was added to the model/type reference on the report cover
page.
New factory location, Shanghai GES Information Technology Co., Ltd was added to the cover page.
Suffix -E was added to the model/type reference in the Test Report.
Output Rating was revised to include maximum output rating for model numbers with suffix -E with no airflow.
General Information was revised to add slotted cover under "options included".
Engineering Considerations was revised to include optional slotted cover in the "accessories investigated for
use with the product".
Sub-clause 6.1f was revised to include suffix -E for optional slotted cover.
Table 42 was revised to add temperature test data for Models GPFM115-5-E, GPFM115-12-E and
GPFM115-28-107.
Enclosure, National Differences was revised to include National Differences for additional countries.
Enclosure, Photographs was revised to include photo of power supply with optional slotted cover.
Enclosure, Miscellaneous was revised to include list of test equipment.
Enclosure, Manuals was revised to include the latest version of Installation Instructions.
Product Description
The equipment (DC Power Supplies) covered by this report, are components, which are intended for use in
end-product equipment used in a hospital or related health care facility, evaluated to standard for Medical
Equipment.
Model Differences
GPFM115 Series models are similar to each other and differ only on secondary circuitry.
Additional Information
The schematics for these models are kept in file at the CB Testing Laboratory mentioned in the first page of
this test report, and can be provided by the applicant upon request by CBTL's.
Technical Considerations
The product was investigated to the following EN 60601-1: 1990 + A1:1993 + A2:1995 + A13:1996
additional standards: (except EMC limitations, EN 60601-1-2,
Biocompatibility, EN 10993-1, Programmable
Electronic Systems, IEC 60601-1-4)
The product was not investigated to the following Clause 52.1, Programmable Electronic Systems (IEC
standards or clauses: 601-1-4) Clause 48, Biocompatibility (ISO 10993-1)
Clause 36, Electromagnetic Compatibility (IEC 601-1-
2)
The product is Classified only to the following Fire, Shock
hazards:
The degree of protection against harmful ingress of Ordinary
water is:
The following accessories were investigated for use Optional cover/fan and slotted cover.
with the product:
The mode of operation is: Continuous
Software is relied upon for meeting safety No
requirements related to mechanical, fire and shock:
The product is suitable for use in the presence of a No
flammable anesthetics mixture with air or oxygen or
with nitrous oxide:
2000-03-22
REPORT
ON
DESCRIPTION
PRODUCT COVERED:
ELECTRICAL RATINGS:
ENGINEERING REFERENCES:
1. This component has been judged on the basis of the required spacings in
the Second Edition of the Standards for Medical Electrical Equipment,
Part 1: General Requirements for Safety, UL 2601-1, which covers the
end use product for which the component is designed.
5. The output circuits have not been evaluated for direct patient
connection (Type B, BF or CF).
10. The power supply was evaluated as Reinforced insulation between primary
and secondary; basic insulation between primary to ground.
11. This power supply has been evaluated as Class I, continuous operation,
ordinary equipment and has not been evaluated for use in the presence
of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
12. These power supplies have been evaluated for patient care equipment,
but not patient connected.
13. Under normal and single fault conditions, the outputs do not exceed 25
V ac or 60 V dc.
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