Spillage

Spillage

If liquid enters the monitor, you must cease using it immediately. Contact an authorized engineer for a safety inspection.

Electromagnetic Compatibility

The electromagnetic compatibility (EMC) validation includes testing performed according to the international standard for EMC with medical devices. See the Manufacturer’s Declaration for details.

EMC Testing During the test program the monitor was subjected to international standard and Philips proprietary EMC tests. During most of the testing no anomalies were observed. Some reduced performance was observed with the IEC 801-3 Radiated Immunity and IEC 801- 4 Fast Transient/Bursts Immunity tests.

IEC 801-3 specifies that the product must be subjected to a field of 3V/m over a frequency range of 26 to 1000 MHz with no degradation of performance. At many of the test frequencies over the specified range no anomalies were observed. However increased jitter of SpO2 values and DECG derived fetal heartrate values was observed at a number of test points. For these test points the radiated field was reduced to the level at which the trace returned to normal. These reduced levels are shown in the table below.

Parameter

Sensor

Frequency Range

Immunity

Level

IUP

M1333A

26 MHz to 1000 MHz

0.5V/m

IEC 801-4 specified that the product is subjected to high speed pulses up to 1000 V applied to the power cord and all I/O cables. During and after most of the test pulses, no anomalies were observed. However in rare cases the ultrasound channel had been triggered.

Parameter

Sensor

Burst Immunity Level

Ultrasound

M1356A

600 V

System

The phenomena discussed above are not unique to the monitor but are characteristic of

Characteristics

patient monitors in use today. This performance is due to very sensitive high gain front

 

end amplifiers used to process the physiological signals from the patient. Among the many

 

similarly performing monitors already in use by customers, interference from

 

electromagnetic sources is rarely a problem.

Appendix B Safety and Environment

173

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Philips M1351A, M1353A manual Spillage, Electromagnetic Compatibility, System, Characteristics

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.