Filter
Top Products
Safety Testing
100 Chapter 9 Preventive Maintenance, Care and Cleaning
The Toco display shows 0.
TOCO int, time, date and paper speed are printed on the paper.
3. Gently apply pressure to the syringe plunger. Check that the value on the display and
paper shows this change in pressure.
If the test fails, repeat using another transducer. If it still fails, refer to
Chapter 8, “Troubleshooting Flowcharts.”
Note— The Intrauterine Pressure Values can be between -99 and 127 units.
Safety Testing
This section defines the test and inspection procedures applicable to the Series 50 A and
Series 50 IP fetal monitors. Use the tables in the following section to determine what test
and inspection results must be reported after an installation or repair has been carried out.
Test Blocks in Table 9-2 tells you when to carry out the safety tests
Test and Inspection Matrix in Table 9-3 tells you how to carry out the safety tests.
Warning
Apply the safety test limits set by the local standards and statutes applicable to the
country of installation, such as IEC 60601-1, UL2601-1, CAN/CSA-C22.2 No. 601.1-
M90.
The safety tests defined in this chapter are derived from local and international
standards but may not be equivalent. They are NOT a substitute for local safety
testing.
Caution
Successful completion of the patient safety tests does not ensure the correct
and accurate functioning of the equipment.
Safety Test
Procedures
The test procedures outlined in this section are to be used only for verifying the safe
installation or service of the product. “Safety checks at installation refer to safety aspects
directly related to the installation and setup activities and not to intrinsic safety features that
have already been checked during final acceptance testing at the factory.”
[FDA 97-4179 Medical Quality Systems Manual: A Small Entity Compliance Guide (QSR
manual). First Edition December 1996. Chapter 14: Storage, Distribution and Installation.
This document may be viewed at http://www.fda.gov].
When running safety tests on the peripheral components of the system, refer to the