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Breg VPULSE Manual Del Usuario página 11

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Specifications
MODEL
VPULSE, C00001
PHYSICAL
9.8" x 14.3" x 11.25"
Size (approximately)
(249mm x 364mm x 286mm)
Weight (dry)
5 lbs. (2.27 kg)
Dual Tubing Set
10 ft. (2.4m)
CONTROLS
Keypad interface
42°F minimum (5.5°C )
THERMAL SYSTEM
Operating limit
Ice or frozen Ice Bottles
will last for 2-6 hours
Operating period
Submersible pump
Circulating System
Reservoir Capacity
1.2 gallons (4.4 liters)
water
Reservoir Fluid
Water Flow Rate
3.2 gph (12 lph) typical
PNEUMATIC SYSTEM
50mmHg (6.6kPa) ± 10%
Dynamic Compression
peak pressure
Sequential Compression
60mmHg (8.0kPa) ± 10%
peak pressure
ELECTRICAL SYSTEM
System
TPU Polyether bladder,
Voltage
Polyurethane foam with
Frequency
100% Polyester fabric
Power
lamination
Leakage Current
PVC plastic bladder, Polyu-
rethane foam with 100%
Polyester fabric lamination
12VDC, 100-240Vac
50/60Hz
15W max
300μA max
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Wall Adapter
UE24WCP1-120200SPA
Input
100-240Vac, 800μA max
Frequency
50/60Hz
Output
12VDC, 2.08A
OPERATING
525 to 795 mmHg
ENVIRONMENT
(700hPa – 1060hPa)
Atmospheric Pressure
15% to 93% relative non-
condensing
Humidity
41°F – 104°F (5°C – 40°C)
Temperature
TRANSPORT & STORAGE
ENVIRONMENT
Atmospheric Pressure
179 to 795 mmHg
(240hPa – 1060hPa)
Humidity
up to 93%
Temperature
-13°F – 158°F (-25°C –
70°C)
Expected Service Life:
300 hours from date of
first use.
REGULATORY
Classification
Class II Equipment
Type of Equipment
Type BF
REGULATORY
IEC 60601-1, Edition
APPROVALS
3.2 Medical electrical
equipment - Part 1:
General requirements for
basic safety and essential
performance.
CAN/CSA-C22,2 no
60601-
1-08 (R2008): Medical
Electrical Equipment Part1:
General Requirements
for Medical Electrical
Equipment.
IEC 60601-1-
2:2014+AMD1:2020
edition 4.1 Medical
electrical equipment
- Part 1-2: General
requirements for basic
safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances -
Requirements and tests.
VPULSE is a trademark of
Breg, Inc.
A brief summary of the tests carried out in accordance with IEC 60601-1-2:2014+AMD1:2020 is
shown below.
The VPULSE is suitable for use in the specified electromagnetic environment. The consumer and/or user of the VPULSE
should ensure that it is used in an electromagnetic environment as described below:
Emissions Test
Compliance
RF Emissions
Group 1
CISPR 11
RF Emissions
Class B
CISPR 11
Harmonic Emissions
Class B
IEC 61000-3-2
Voltage fluctuations / flicker emissions
Complies
IEC 61000-3-3
IEC 60601-1-2
Immunity Test
Test Level
Conducted Disturbances
3V
induced by RF Fields
0.15MHz – 80MHz
IEC 61000-4-6
6V in ISM & amateur radio
bands between 0.15Mz –
80MHz
80% AM at 1kHz
Radiated RF EM fields
10 V/m
IEC 61000-4-3
80 MHz – 2.7 GHz
80% AM at 1 kHz
The VPULSE is suitable for use in the specified electromagnetic environment. The user of the VPULSE should ensure that
it is used in an electromagnetic environment as described below:
IEC 60601-1-2
Immunity Test
Test Level
Electrostatic
± 8 kV contact
discharge (ESD)
± 2 kV, ± 4 kV, ± 8 kV, ± 15
kV air
IEC 61000-4-2
Electrical fast
± 2 kV
transient/burst
100 kHz repetition frequency
IEC 61000-4-4
± 0,5 kV, ± 1 kV
Surges (line to line)
IEC 61000-4-5
Reference IEC 60601-1-
Proximity Fields from RF
2:2014+AMD1:2020 table 9
Wireless Communica-
tions Equipment
IEC 61000-4-3
Electromagnetic Environment Guidance
The VPULSE uses RF energy only for its internal function. Therefore,
its RF emissions are very low and are not likely to cause interference
in nearby electronic equipment.
The VPULSE is suitable for use in all establishments, including
domestic establishments and those directly connected to the public
low-voltage power supply network that supplies buildings used for
domestic purposes.
Electromagnetic Environment Guidance
Portable and mobile RF communications equipment should be
used no closer to any part of the VPULSE, including cables, than the
recommended separation distance calculated from the equation
appropriate for the frequency of the transmitter.
Recommended Separation Distance
d=1,2√P
d=1,2√P 80 MHz to 800 MHz
d=2,3√P 800MHz to 2,5 GHz
where P is the maximum output power rating of the transmitter in
watts (W) according to the transmitter manufacturer and is the
recommended separation distance in metres (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey (a), should be less than the compliance
level in each frequency range (b).
Interference may occur in the vicinity of equipment marked with the
following symbol:
Electromagnetic Environment Guidance
Floors should be wood, concrete, or ceramic tile. If floors are
covered with synthetic material, the relative humidity should be at
least 30%.
Main power quality should be that of a typical commercial and/or
hospital environment.
Main power quality should be that of a typical commercial and/or
hospital environment.
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