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Breg Polar Care Wave Instrucciones De Uso página 12

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PRODUCT SPECIFICATIONS
Electrical Specifications (Also see Electromagnetic Immunity Test Table on page 21)
Unit Rated: 12VDC, 1A
Power supply is specified as part of ME Equipment
Manufacturer: HDP
Model: HDP12-MD12010C
Back up supply: FRIWO
Model: FW8000M/12
Rated Input: 100-240VAC, 50-60Hz
Standards Compliance:
Designed to conform to applicable requirements of: EN 60601-1,
Edition 3.1 and 60601-1-2, 4th Edition
Electrical Classifications:
Class II, Continuous Operation. Not suitable with flammable
anesthetics. Group 1, Class B.
Environmental Requirements
Transport & Storage:
–25°C to 5°C, and
5°C to 35°C at a relative humidity of 10% to 90%, non-condensing;
>35°C to 70°C at a water vapor pressure up to 50 hPa
Operating:
5°C to 40°C (41°F to 104°F )15-90% RH non-condensing,
700 hPa to 1060 hPa
Indoor use only up to 2000m altitude
There is no warm up time required from when the Wave is stored at
the minimum storage temperature and when the product is used.
Performance Specifications
Expected Service Life:
1 year from date of first use (unit and accessories).
Average operating temperature of a Polar
≥45°F at the colder setting
Care Wave cold compression pad:
≥50°F at the cold setting
Note: The Foot/Ankle pad at the cold setting may operate at temperatures above 60°F which only
provides a cooling sensation.
Average peak compression pressure of the
50 mmHg at the regular setting
25 mmHg at the low setting
cold compression pad:
20
Output: 12VDC, max. 1.0A
Output: 12VDC, max. 1.0A
PRODUCT SPECIFICATIONS
Physical Specifications
Weight:
5 lbs (2.3 kg) Empty, 16 lbs (7.3 kg) Filled
Electromagnetic Immunity Test Table
Immunity Test
Basic EMC Standard
Electrostatic discharge (ESD)
IEC 61000-4-2
Radiated RF EM fields
IEC 61000-4-3
Proximity fields from RF wireless
IEC 61000-4-3
communications equipment
Rated power frequency
IEC 61000-4-8
magnetic fields
Electrical fast transients/bursts
IEC 61000-4-4
Surge
IEC 61000-4-5
Conducted disturbances induced
IEC 61000-4-6
by RF fields
Voltage dips
IEC 61000-4-11
Voltage interruptions
IEC 61000-4-11
Note: UT is the mains voltage prior to application of the test level
IEC 60601 Test Level (Home Healthcare)
+/- 8 kV contact
+/- 2kV, +/-4kV, +/-8 kV, +/- 15kV air
10V/m
80 MHz - 2.7 GHz
80% AM at 1 kHz
Reference IEC 60601-1-2 table 9
30 A/m 50Hz or 60Hz
+/- 2 kV for power supply lines
100 kHz repetition frequency
+/- 0.5 kV, +/- 1 kV line-to-line
+/- 0.5 kV, +/- 1 kV, +/- 2 kV line-to-ground
3V
0.15MHz - 80 MHz
6V in ISM and amateur radio bands between
0.15 MHz and 80 MHz
80% AM at 1 kHz
0% UT 0.5 cycle
At 0, 45, 90, 135, 180, 225, 270, and
315 degrees
0% UT: 1 cycle
70% UT: 25/30 cycles
Single phase: at 0 degrees
0% UT: 250/300 cycles
21

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100577-000