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

M1353A, M1351A specifications

Philips M1351A and M1353A are advanced medical monitoring devices designed to enhance patient care in various healthcare settings. These monitors are widely recognized for their precision, reliability, and user-friendly interface, making them essential tools for clinicians and healthcare providers.

The Philips M1351A is a compact portable monitor specifically tailored for adult, pediatric, and neonatal care. It is equipped with multiple physiological parameters, enabling healthcare professionals to track vital signs such as heart rate, respiratory rate, non-invasive blood pressure, and temperature. One of its standout features is the ability to display real-time waveforms, providing clinicians with instant access to critical patient information.

On the other hand, the Philips M1353A builds on the M1351A's robust capabilities, integrating advanced features that enhance monitoring capabilities. This model includes additional measurement modalities such as invasive blood pressure and capnography, allowing for comprehensive patient management. Its larger screen provides clear, easy-to-read data, and its intuitive interface ensures quick navigation through the various monitoring functions.

Both monitors utilize state-of-the-art technologies to ensure accurate and reliable measurements. The smart algorithm used in these devices minimizes the possibility of false readings, providing healthcare professionals with the confidence needed for effective clinical decision-making. The Philips M1351A and M1353A also feature an integrated alarm system that notifies caregivers of critical changes in patient conditions, ensuring timely interventions.

In terms of connectivity, these models facilitate seamless integration with hospital networks and electronic medical records (EMR) systems. This interoperability enhances the overall workflow in a clinical environment, allowing patient information to be shared efficiently amongst healthcare teams.

Additionally, the Philips M1351A and M1353A are designed with patient comfort in mind. They are lightweight and portable, making them suitable for diverse environments, from emergency departments to patient transport. Their rugged design ensures durability in high-paced settings, meeting the rigorous demands of modern healthcare.

In summary, the Philips M1351A and M1353A monitors serve as essential tools in contemporary medical practice, offering comprehensive monitoring capabilities, advanced technologies, and a user-centric design. These features collectively contribute to improved patient outcomes and enhanced overall healthcare delivery.