Breas Z2 User Manual

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The Z2 CPAP System uses RF energy only for
its internal function. Therefore, its RF emissions
are very low and are not likely to cause any
interference in nearby electronic equipment.
The Z2 CPAP System is suitable for use in all
establishments, including domestic establish-
ments and those directly connected to the public
low-voltage power supply network that supplies
buildings used for domestic purposes.
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions & Immunity
Medical electrical equipment needs special precautions regarding EMC and needs to be installed
and put into service according to EMC information provided in this document.
The Z2 System does not have Essential Performance within the meaning of IEC 60601-1. However,
immunity testing was conducted in accordance with IEC 60601-1-2 and compliance was
confirmed as summarized in this document.
Guidance and manufacturer’s declaration - electromagnetic emissions
The Z2 CPAP System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Z2 System should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment — guidance
RF emissions Group 1
CISPR 11
RF emissions Class B
CISPR 11
Harmonic emissions Class A
IEC 61000-3-2
Voltage fluctuations/ Complies
flicker emissions
IEC 61000-3-3
WARNINGS:
• The device should not be used adjacent to or stacked with other equipment. If adjacent or
stacked use is necessary, the device should be observed to verify normal operation in the
configuration in which it will be used.
• The use of cables and accessories (eg, humidifiers) other than those specified for the device is not
recommended. They may result in increased emissions or decreased immunity of the device.
Mask Cushion is Vibrating Stop treatment. Remove and reposition the mask and, if necessary, adjust
Against the Skin and and the headgear. Resume treatment.
Air Leak is Occurring
Follow mask manufacturer’s instructions.
Z2 Has Been Left in a Hot Allow Z2 to cool before use. Disconnect the power cord and then reconnect
Environment it to restart the Z2.
Electromagnetic The Z2 and PowerShell meet all applicable electromagnetic compatibility
Compatibility standards. However, if you suspect performance of the device is affected
by interference from wireless sources, move the Z2 and PowerShell
further away from those sources.
Guidance and manufacturer’s declaration — electromagnetic immunity
The Z2 CPAP System is intended for use in the electromagnetic environment specified below. The
customer or the user of the Z2 CPAP System should assure that it is used in such an environment.
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±8 kV air
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in
UT) for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95 % dip in
UT) for 5 sec
<5 % UT
(>95 % dip in
UT) for 0.5 cycle
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95 % dip in
UT) for 5 sec
Mains power quality
should be that of a typical
commercial or hospital
environment. If the user
of the Z2 CPAP System
requires continued
operation during power
mains interruptions, it is
recommended that the Z2
CPAP System be powered
from an uninterruptible
power supply or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical
commercial or hospital
environment.
Immunity test
IEC 60601
test level
Compliance level Electromagnetic
environment – guidance
NOTE: UT is the a.c. mains voltage prior to application of the test level.
.

Breas Z2 Specifications

General

Pressure Range	4-20 cm H2O
Sound Level	26 dBA
Type	CPAP
Dimensions	6.48 x 3.30 x 2.02 inches
Power Supply	100-240V AC, 50/60Hz
Humidification	Optional
Therapy Modes	CPAP
Ramp	0-45 min
Operating Altitude	Up to 8, 000 feet