Philips M1353A, M1351A manual Safety Testing, Procedures

Models: M1353A M1351A

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Safety Testing

nThe 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.

nTest Blocks in Table 9-2tells you when to carry out the safety tests

Test and Inspection Matrix in Table 9-3tells 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

The test procedures outlined in this section are to be used only for verifying the safe

Procedures

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

100

Chapter 9 Preventive Maintenance, Care and Cleaning

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Philips M1353A, M1351A manual Safety Testing, Procedures