Patient Safety Checks
Warnings, Cautions, and Safety Precautions
• The tests described in the following paragraphs are recommended to be performed every
two years and following any installation, major repair or upgrade procedure as a proven
means of detecting abnormalities that if undetected could prove dangerous to either the
patient or the operator.
• All tests can be performed using commercially available Safety Analyzer test equipment.
Basic measurements may also be performed with widely available multifunction instru-
ments like the HP 3469A multimeter or equivalent.
• The consistent use of a Safety Analyzer as a routine step in closing a repair or upgrade is
emphasized as a mandatory step if approval agency status is to be maintained. The Safety
Analyzer also proves to be an excellent troubleshooting tool to detect abnormalities of line
voltage and grounding plus total current loads.
• For Europe and Asia/Pacific according to:
IEC60601-1:1988 + A1:1991 + A2:1995 = EN60601-1:1990 +A1:1991 + A2:1995
For USA according to:
• Additional tests may be required according to local regulations.
• Normally, a Safety Analyzer is used to perform these procedures. Popular testers include
the DEMPSEY 232D, or for use in Europe, testers like the Rigel, Metron or Gerb. Follow
the instructions of the Instrument manufacturer.
If the Dempsey is used for an extended length of time, it could be damaged by the high amp
current draw of the system
It is recommended that you file the results of annual tests. This may help to identify a
problem early particularly if the test results deteriorate over a period of time.
Safety Test Procedures
The test procedures outlined in this appendix are to be used only for verifying safe
installation or service of the product in question. The setups used for these tests and the
acceptable ranges of values are derived from local and international standards but may not be
equivalent. These tests are not a substitute for local safety testing where it is required for an
installation or a service event. If using the Metron Safety tester use your local regulation to
perform the test, for example in Europe IEC601-1/IEC601-1-1 and in the US UL2601-1. The
Metron Report should print results with the names listed below, along with other data.
Testing the Instrument
Patient Safety Checks