Mindray DPM 1, Operator'S Manual

Page: 47 / 54

A-3
Paper: A4
Content: ID data and trend data
6. Physical Characteristics
Maximum Size: 65
×
140
×
32mm (W
×
H
×
D)
Maximum Weight: 130g (not include battery and sensor)
7. Environment and Safety
7.1 Temperature
Operation: 0
°
C to 50
°
C
Transportation and storage: -20
°
C to 60
°
C
7.2 Humidity
Operation:
15% to 95%
（
noncondensing
）
Transportation and storage:
10% to 95%
（
noncondensing
）
7.3 Altitude
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)
7.4 Transportation
Meets the 1A requirements of the ISTA transportation test procedure.
7.5 Shock
Meets all the specifications after being exposed a half sinusoidal pulse that is 15g and 11ms, as
required by IEC 68-2-27.
7.6 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 to 500 Hz
Low reproducibility.
9 minutes for every axis.
Falling:
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).