Mindray DPM 1 Wartungshandbuch PDF herunterladen (Seite 23)

Specifications

3-3 Pulse oximeter Service Manual

3.7. Physical Characteristics

Maximum Size: 65×140×32mm (W×H×D)

Maximum Weight: 130g (not include battery and sensor)

3.8. Environment and Safety

Temperature

Operation:

0°C to 50°C

Transportation and

storage:

-20°C to 60°C

Humidity

Operation: 15% to 95%（noncondensing）

Transportation and

storage:

10% to 95%（noncondensing）

Altitude (above sea level)

Operation: -500 to 4,600 m (-1,600 to 15,000 feet)

Transportation and

storage:

-500 to13, 100 m (-1,600 to 43, 000 feet)

Transportation

While packaged as designed, the oximeter meets the 1A requirements of the ISTA

transportation test procedure (for the goods to be transported in a container). The required

temperature, humidity and altitude must appear on the carton.

Shock

The oximeter shall be exposed a half sinusoidal pulse that is 15g and 11ms, as required by

IEC 68-2-27. After the test, the oximeter meets all the specifications.

Vibration

After being subjected to sinusoidal or random vibration (see FDA Reviewer Guidance for

Pre-market Notification Submission, November 1993 - draft), the oximeter meets all the

specifications.

Sinusoidal

vibration:

As required by IEC 68-2-6

1g or 0.07mm, 57-62 Hz crossover frequency

10 - 500Hz, 10 sweep cycles for every axis.

Random vibration:

As required by IEC 68-2-37.

0.02 g2/Hz

20 - 500 Hz

Low reproducibility.

9 minutes for every axis.

Falling:

The oximeter meets the requirements of IEC 60601-1, clause 21.6 and

of ECRI PB-296 892, AIII 3.3 (the part against Class III instruments).

Impact:

The oximeter meets the requirements of ECRI PB-296 892, AIII 3.2 (the

part against Class III instruments).

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