Inova Labs Inc. LifeChoice User manual

Operator’s Manual
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XYC276 REV F Nov 2011 | i
Inova Labs Inc.
3500 Comsouth Drive, Suite 100
Austin,TX 7 744 USA
www.LifeChoiceOxygen.com
Phone: [phone]
0459
Represented in Europe by:
QNET BV
Hommerterweg 286
6436 AM Amstenra e
The Netherlan s
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ii
T A B L E O F C O N T E N T S
Introduction 2
Application 2
Warnings 3
User Controls 4
LifeChoice Mobility Package 5
LifeChoice Part Names 5
Operating Instructions 6
Powering the LifeChoice 7
Resetting the External Battery 9
Battery Charging 9
Operating Procedure 10
Alarms/Light Indicators 13
Routine Maintenance 16
Specifications 17
Warranty 21
Accessories 23
Disposal 25
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Th s pat ent manual w ll fam l ar ze you w th the L feCho ce Portable Oxygen Concentrator
(POC) and ts accessor es. Be sure to thoroughly read all of the nformat on n th s manual n
ts ent rety before us ng the L feCho ce POC. The L feCho ce POC s an nternally powered,
type BF dev ce when powered by the nternal battery and a Class II, Type BF dev ce when
connected to the external AC power supply, DC power supply or rechargeable battery. The
essent al performance of the L feCho ce POC s to prov de oxygen at a volume that rema ns
w th n tolerance (the tolerance was def ned based on techn cal judgement from w th n the
manufacturer’s expert se n th s spec f c med cal appl cat on). In add t on, the dev ce’s ab l ty
to detect certa n error cond t ons (such as low concentrat on or no breath) and create an
alarm s also cons dered a part of essent al performance.
APPLICATION
Th s manual appl es to the L feCho ce POC XYC100.
INDICATIONS FOR USE: The L feCho ce Oxygen Concentrator s used on a prescr pt ve bas s by
pat ents who are d agnosed as requ r ng supplemental oxygen. Th s oxygen concentrator w ll prov de
supplemental, h gh concentrat on oxygen to these pat ents. It s not l fe support ng nor l fe susta n ng. It
may be used cont nuously n a home, nst tut on or travel env ronment. The L feCho ce s also portable.
The L feCho ce POC s FAA approved for a r travel. The requ red FAA
st cker s located on the bottom of the L feCho ce POC. FAA approval
s l sted as Inova Labs L feCho ce. Every a rl ne has spec f c nformat on
requ red for travel ng w th oxygen. Before travel ng, rev ew your a rl ne’s
spec f c requ rements.
2
REF
REF
General Warn ng,
Caut on,
R sk of Danger
Danger, No Smok ng
or Open Flame
Waste D sposal
Hum d ty
L m tat on
Temperature
L m tat on
Keep Dry
!
Symbol Description Symbol Description Symbol Description
Type BF
Appl ed Part
Dev ce that has
conduct ve contact
w th pat ent
Class II Equ pment
Gas Flow
DC Power
Rad o
Frequency
INTRODUCTION
SYMBOL DESCRIPTIONS
GAS FLOW
Manufacturer
Catalogue Number CE Mark ng
of Conform ty
EU Author zed
Representat ve
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3
LifeChoice Portable Oxygen Concentrator
1. This device is NOT INTENDED to be life-sustaining or life-supporting.
2. This device should be used only when prescribed by a physician.
3. In certain circumstances, oxygen therapy can be hazardous. Please seek medical advice before
using the LifeChoice POC.
4. U.S. Federal law restricts this device to sale by or on the order of a physician.
5. The LifeChoice POC is designed to provide a flow of high purity oxygen. Patients with a
fast breathing rate or requiring high oxygen flow may require more oxygen than the LifeChoice
POC can produce and, therefore, may not be a suitable candidate.
6. This device is not suitable for patients who are unable to hear or see alarms or communicate discomfort.
If the patient shows any signs of discomfort, a physician should be consulted immediately.
7. It is the responsibility of the patient and/or provider to make back-up arrangements for an
alternative oxygen supply when traveling; Inova Labs Inc. assumes no liability for persons
choosing not to adhere to manufacturer recommendations.
8. Availability of an alternate source of oxygen is required in case of power
outage or mechanical failure. Consult your physician or medical equipment
supplier for the type of back-up system required.
9. The LifeChoice POC is designed to be used in the provided/approved
carry case.
10. The LifeChoice should be located so as to avoid pollutants or fumes.
11. Do not use oil, grease or petroleum-based products on or near the LifeChoice
POC. Do not use power supplies/adapters, carry bags or accessories
other than those which come with the LifeChoice POC. The use of
non-specified accessories may impair equipment performance and
will void all warranties.
12. The LifeChoice POC produces enriched oxygen gas which accelerates
combustion. DO NOT ALLOW SMOKING OR OPEN FLAMES
within 10 feet (3 meters) of this device while in use. Cigarette/cigar/pipe
SMOKING while using the LifeChoice POC will VOID all warranties.
13. Never operate the LifeChoice POC in the accessory bag.
14. Do not submerge the LifeChoice POC or any of the accessories in liquid. Do not
expose to water or precipitation. Do not operate in rain. This could lead to damage.
15. Portable and mobile RF communications equipment can effect medical electrical equipment.
16. The LifeChoice POC should not be used adjacent to or stacked with other equipment. If
adjacent or stacked use is necessary, the POC should be observed to verify normal operation
in the configuration in which it will be used.
!
W A R N I N G S
!
DANGER No smoking or
open flame.
Carry Case
Accessory Bag
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U S E R C O N T R O L S
The user controls on the LifeChoice POC are specifically designed to be pressed by a finger.
Never press any of the buttons with a pen, screwdriver, stylus or any other object. Pressing the
buttons with any hard, sharp and/or small object can damage the user controls and void all warranties.
Indicator Li hts: Colored lights indicate either
a change in operating status or a condition that
may need response (alarm).
Audible Si nals: An audible signal (beep) indicates
either a change in operating status or a condition
that may need response (alarm).
Gross Particle Filter: A filter mesh is in place
inside the intake vents on the front and back of
the concentrator during operation to keep large
particles and debris out of the intake air. See
Section Air Intake Filter Cleaning for cleaning
instructions.
Nasal Cannula: A standard single lumen nasal
cannula or equivalent must be used with the
LifeChoice POC to provide oxygen from the
concentrator. A standard single lumen type cannula,
7-foot (2 meter), is recommended for use. An Adult
Nasal Cannula like # 1107 by Ventlab Corporation
is supplied with each LifeChoice POC purchase.
For replacement cannulas, please contact your local
medical equipment supplier.
Cannula Nozzle Fittin : The nasal cannula
connects to the oxygen output nozzle at the top
of the LifeChoice POC. Do not place cannula
into nasal passages until the LifeChoice POC is
fully powered on. Breathing through the cannula
during start-up will prevent the system from
powering on.
Breath Auto Mode LED: There are two inhalation
sensitivity modes on the control panel: Active-High
and Sleep-Low, which automatically adjust based on
oxygen requirements.
Pulse Settin Controls: There are three individual
pulse flow controls on the panel: 1, 2 and 3 which
are equivalent to 1, 2 or 3 liters per minute settings
on a continuous flow device.
4
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5
LifeChoice Portable Oxygen Concentrator
REF
LifeChoice
Accessory Ba
LifeChoice
Portable
Oxy en
Concentrator
with 2-hour
internal battery
AC power adapter
(universal 100v – 240v;
50hz – 60hz)
DC power adapter
(12v) with standard “car”
adapter plug
4
5
6
7
4-Way Carry Case
Use as a convertible
backpack, over the
shoulder strap, briefcase
or waist pack
(1) Three-hour
external battery
with carry case
(1) Standard sin le
lumen 7-foot
(2 meter) lon
nasal cannula
1
2
3
L I F E C H O I C E P O C M O B I L I T Y P A C K A G E ( X Y C 1 0 0 )
The LifeChoice POC can be operated using AC power, DC power or battery power
during transport while inside the approved carry case.
Battery Char e
Level Gau e
Battery Check
Pulse Settin s
1, 2, 3
Intake Vents
Vents located on
front and back
FAA Approval
Sticker
(located on bottom)
7
Cannula Nozzle
Fittin
Power
Alarm Indicator
Li ht
Breath Auto Mode
Active-Hi h
Breath Auto Mode
Sleep-Low
Exhaust/Fan
Vents
1
2
3
LIFECHOICE POC PART NAMES
4
5
6
9
10
11
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6
OPERATING INSTRUCTIONS
BEFORE USING THE LIFECHOICE POC FOR THE FIRST TIME
The LifeChoice POC and external battery
should be charged for a minimum of 6 hours
before initial use. Connect the external battery
to the LifeChoice POC, connect the AC
adapter to the external battery and plug the
AC adapter into an electrical outlet.
Make sure to verify the green LED light above
the Battery Check is solid green. This indicates
the system recognizes the external power source.
If the external battery is plugged into the Life-
Choice POC and the green LED light above the
Battery Check does not turn solid, the source is
not recognized. If charging the unit through the
external battery when this occurs, the charge will
not reach the internal battery. This may be an
indication the external battery needs to be reset.
Instructions for resetting the battery are provided in the Powerin the LifeChoice POC section.
When more than two hours battery operation is needed, the LifeChoice POC should be
powered using the external battery first and then the internal battery. The LifeChoice POC
will automatically switch to the internal battery once the external battery has been depleted.
The LifeChoice POC is recommended and
designed to be operated and stored in its carry
case at all times.
Verify that the intake vents are clean and free
from obstruction.
Connect the nasal cannula securely to the
LifeChoice POC cannula nozzle fitting.
Carry Case
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POWERING THE LIFECHOICE
The LifeChoice POC can be powered in four different ways – the internal battery, an AC power supply,
DC power supply or the external battery. The rechargeable batteries are maintenance-free and can
only be exchanged at the factory.
1. Internal Battery: A rechargeable internal
battery is located within each LifeChoice
POC unit. When it is fully charged, it supplies
power to the Life Choice POC for up to 2+
hours. When using internal battery power,
the green LED light above the Battery Check
will illuminate and flash slowly.
When the AC, DC or external battery is plugged into the LifeChoice POC, whether powered
on or off, the green LED light above the Battery Check will illuminate solid green. This is
verification that the external source has been recognized. When using an external source to
power the LifeChoice POC, verify that the green LED light above the Battery Check is solid
green indicating the system is being powered by the external source. If not connected to an
AC or DC adapter, the internal battery will slowly discharge over time even when not in use.
Always check the battery level prior to use to ensure adequate charge level.
2. AC Power Supply: An AC power supply
allows the LifeChoice POC to be connected
to a 100-240 volt, 50/60 Hz outlet. The
power supply converts 100-240 volt AC to a
DC voltage for the LifeChoice POC unit.
When the unit is operated with the AC power
supply, power from the AC outlet powers the
unit and recharges the internal and/or the
external battery simultaneously.
When using an external source to power
the LifeChoice POC, verify that the green LED light above the Battery Check is solid green
indicating the system is being powered by the external source.
3. DC Power Supply: A DC power supply can
be connected from the LifeChoice POC unit
to an automobile’s (boat, motor home, etc.) 12-volt
DC outlet. When the system is connected
to the automobile’s/vehicle’s DC outlet,
power from the automobile/vehicle
battery powers the LifeChoice POC unit
and recharges the internal and/or external
battery simultaneously.
When using an external source to power the
LifeChoice POC, verify that the green LED
light above the Battery Check is solid
7
LifeChoice Portable Oxygen Concentrator
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green indicating the system is being
powered by the external source. The AC,
DC and external battery are each connected
to the receptacle on the top of the
LifeChoice POC. (External battery shown as
example.) If the external battery is connected
to the LifeChoice POC, the AC or DC
adapter can be connected to the external battery and will charge both batteries and operate the
LifeChoice POC simultaneously.
4. External Battery: A rechargeable external
battery is included with every LifeChoice
POC XYC100 unit. When fully charged, it
supplies power to the Life Choice POC for
up to 3+ hours.
When using external battery power, the green
LED light above the Battery Check will
illuminate solid green. When using the external
battery to power the LifeChoice POC, the
system will automatically switch to internal
battery power when the external battery has
been depleted - approximately 3 hours. When
this occurs, the green LED light above the
Battery Check will turn from solid green to
flashing green. When the external battery is
required for extended time away from an AC
or DC power source, it is recommended to
power the LifeChoice POC with the external
battery first and then the internal battery for
maximum combined battery time.
Charge time for a depleted external battery is
a minimum of 6 hours with either the AC or
DC adapter. To check charge level on the
external battery, disconnect from AC or DC
adapters, press and hold yellow button on the
top of the external battery. LED lights will
illuminate indicating charge level.
When the LifeChoice POC is in use and the
external battery is plugged into the unit,
verify that the green LED light above the
Battery Check turns solid green. If the LED
light does not illuminate solid green when the external battery is connected to the LifeChoice
POC, this indicates that the LifeChoice POC is not being powered by the external battery, and
the external battery may have “tripped” due to a power surge.
To prolong the level of charge when not in use, it is hi hly recommended that the external
battery be plugged into itself. This is done by inserting the male end of the plug into the female
receptacle on the battery pack.
Reset the external battery as indicated in the following steps.
8
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B A T T E R Y C H A R G I N G
To charge the internal battery, connect LifeChoice
POC to either an AC power supply and a 100-240
volt, 50/60 Hz AC power outlet, or connect it to a
DC power outlet in an automobile (boat, motor home,
etc.). It takes a minimum of 4 hours for a discharged
internal battery to fully charge. It is recommended
to recharge the battery, even if only partially
depleted, as often as possible. To check the
battery charge level, disconnect the LifeChoice
POC from all external power sources and
power the LifeChoice POC on. Once fully
powered on, press the Battery Check to verify
internal battery charge level.
If not charged for the correct amount of time,
a 100% battery charge indicator green LED
light may be illuminated, but the actual charge
could be between 85-100%.
The internal battery cannot be overcharged, and
it is recommended to leave the LifeChoice POC
plugged in via the AC or DC adapter as often as
possible.
When charging the LifeChoice POC from the supplied AC or DC adapter,
confirm that the green LED light above the Battery Check is solid green.
This indicates the LifeChoice has recognized an external power/charging
source. The green LED light will be solid green if the system is on or off.
9
LifeChoice Portable Oxygen Concentrator
1. Unplug the external battery from the
charger and the LifeChoice POC.
2. Remove the battery from the case.
3. Look at the end of the battery with the cable
for a lit red LED light. If lit, press and hold
the “pink” button until the red LED light
turns off to reset.
4. Put the battery back in the case.
RESETTING THE EXTERNAL BATTERY
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10
If charging the internal and external battery at
the same time, powered on or off, first connect
the external battery to the LifeChoice POC,
and verify that the green LED light above the
Battery Check illuminates solid green. If the
green LED light is not solid green, follow
steps in battery charging section to
determine if the external battery has tripped.
If the green LED light is solid green, connect
the AC or DC adapter to the external battery,
and charge for 6 hours. The LifeChoice POC
can be used while charging with AC /DC power.
OPERATING PROCEDURE
1. Locate and position the LifeChoice POC so that the intake vents and exhaust fan vents
are not obstructed. The unit, particularly the air intake vents and the exhaust fan vents,
should be located in a well-ventilated space.
2. The unit may be powered by the internal battery, external battery, DC power supply
or AC power supply using the DC or AC adapters.
If you are in an automobile
(boat, motor home, etc.),
connect one end of the DC
adapter into the LifeChoice
POC power inlet and the
other end into the DC
outlet; or
If you are near an AC
outlet, connect one end
of the AC adapter into
the LifeChoice POC
power inlet and the other
end into the AC outlet; or
Connect one end of the
external battery into the
LifeChoice POC power
inlet.
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Plugging the AC or DC adapter directly into the
Lifechoice POC will charge the internal battery
and operate the system at the same time.
The external battery pack can be connected to
the LifeChoice POC, and the AC or DC adapter
can then be plugged into the external battery.
This configuration will charge the internal and
external batteries and operate the system at the
same time.
If the LifeChoice POC is powered off and the
external battery, AC or DC adapters are connected
to the system, the internal fans will operate for
approximately 4 hours to help keep the internal
battery cool during charging.
3. Press Power once to turn on. An audible beep
will occur, and the green LED light above the
Power, Active-High Mode and Pulse
Setting of 1will illuminate. This indicates
that LifeChoice POC is powered on, is ready
for use, and settings may now be changed.
Pressing Power for extended time after the
audible beep will cause the system to cycle
back to the off position.
Do not place cannula into nasal passa es until the
LifeChoice POC is fully powered on. Breathin
throu h the cannula durin start-up will prevent
the system from powerin on.
4. There are two inhalation sensitivity modes
on the control panel: Active-High and Sleep-
Low, which automatically adjust based on
oxygen requirements. No action is required
to start this feature.
11
LifeChoice Portable Oxygen Concentrator
!
CAUTION
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12
5. Select the flow setting 1, 2 or 3 as prescribed
by your doctor. These settings are equivalent
to 1, 2 or 3 LPM settings on a continuous
flow device. Place the nasal cannula in the
nasal passages and breathe normally. When
the LifeChoice POC senses inhalation,
oxygen is supplied through the cannula.
The duration of this pulse flow and size of
the pulse is dependent upon the pulse flow
setting (1, 2, or 3) selected. The green LED
light above the selected number (1, 2, or 3)
illuminates and will flash each time
inhalation is detected indicating that a pulse
of oxygen has been delivered.
6. Check to make sure your unit’s battery is fully
charged (minimum of 4 hours charge time for fully
depleted battery) before venturing out with
LifeChoice POC for the first time or upon
subsequent use. To accurately measure the
internal battery charge the unit must be
powered “on” and disconnected from the
AC/DC power supply or external battery.
The battery gauge/indicator LED lights next
to the Battery Check will illuminate to
indicate the level of battery charge (25% to
100%). The battery charge indicator LED
lights are a reference only. If a fully depleted
internal battery is not charged for a minimum
of 4 hours, it will not supply 2+ hours of use.
If not charged for the correct amount of time,
a 100% battery charge indicator LED light
may be illuminated, but the actual charge
could be less than 100%.
7. To turn the LifeChoice POC off, press Power
and hold for 2 seconds until the green LED
light above Power goes out and the unit shuts
off. When the LifeChoice POC is powered
off, the internal fans will continue to operate
for approximately 30-45 seconds for additional
cooling.
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ALARMS/LIGHT INDICATORS
Start-Up: A brief audible beep sounds at start-up when Power is pushed.
Release Power as soon as the tone sounds. Pressing Power for extended time
after the audible beep will cause the system to cycle back to the off position.
The LifeChoice POC will not power on if the cannula is being moved or
inserted in the nasal passages during start-up.
Low Battery Alarm: As the internal battery power approaches a low level
(less than10 minutes of battery power remaining), the green LED light next
to the Battery Check turns red and flashes slowly. There is also an
audible long, loud beep that will sound once every 65 seconds. When this
occurs, connect the LifeChoice POC to a DC power outlet, an AC power
outlet, a fully charged external battery, or change to another source of
oxygen immediately.
When there is approximately 10 seconds of battery power remaining, the red
LED light above the Battery Check that was slowly flashing will begin
flashing quickly, and a fast audible beep will sound, after which the unit will
shut off. When this occurs, connect the LifeChoice POC to a DC power
outlet, an AC power outlet, a fully charged external battery, or change to
another source of oxygen immediately.
When the LifeChoice POC is connected to a DC power outlet or to an
AC power outlet, the unit operates while recharging the internal battery
simultaneously. The level of battery charge is indicated by disconnecting
the LifeChoice POC from the AC or DC adapters while powered on
and pressing Battery Check. The battery charge indicator LED lights are
for reference only. If a fully depleted internal battery is not charged for a
minimum of 4 hours, it will not supply 2+ hours of use.
No Inhalation/No Breath Alarm: When the LifeChoice POC is powered
on but does not sense breathing within a predetermined time period,
approximately 75 seconds, an audible alarm beeps and the red LED light
next to Alarm flashes. If this occurs, check the connection from the cannula
to the LifeChoice POC, make sure that the nasal cannula is positioned
properly on your face and ensure that you are breathing through your nose.
Once the system detects a breath, the alarm will automatically turn off. If
the alarm continues to sound, change to an alternate source of oxygen, and
contact your equipment provider.
General Malfunction Alarm: If the LifeChoice POC has a general
malfunction, a continuous audible alarm sounds, and the red LED light
next to Alarm will continuously illuminate. When this occurs, the
concentration of oxygen that LifeChoice POC is supplying is outside of
specifications. You should change to another source of oxygen and
contact your equipment provider.
13
LifeChoice Portable Oxygen Concentrator
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14
NORMAL OPERATION INDICATORS
Normal A dible LED Light Alarm Action
Operation Alarm
LifeChoice
POC
turned on
Brief
Audible
Tone Green LED lights of Power,
Active-High Mode and Pulse Setting of 1
are illuminated
You may begin
to use your
LifeChoice
POC unit
LifeChoice
POC
has detected
an inhalation/
breath and
is delivering
a pulse of
oxygen
LifeChoice
POC
powered
by
internal
battery
No
LifeChoice POC
is functioning
normally
LifeChoice POC
is functioning
normally
No
LifeChoice
POC
plugged into
or powered
by external
source
(AC, DC or
external battery)
No
LifeChoice POC
is functioning
normally
Green LED light of selected pulse
setting flashes with each breath
Green LED light above
Battery Check
slowly flashes
Green LED light above
Battery Check is solid green
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15
LifeChoice Portable Oxygen Concentrator
A L A R M T A B L E
Problem A dible LED Light Alarm Action
Alarm
No breath
detected by
the unit for
approximately
75 seconds
Intermittent:
Beep
Red LED light next
to Alarm flashes
Check the cannula
connection. Ensure
that you are breathing
through your nose.
Once the system
detects a breath, the
alarm will shut off.
If the alarm persists, contact
your equipment provider.
Low Battery
Alarm
(Approximately
10 minutes of
battery power)
Critical Low
Battery Alarm
(Approximately
10 seconds of
battery power)
Fast audible
beep (Unit
shuts down)
Connect the
LifeChoice POC
unit to a DC adapter,
an AC adapter,
or change to
another source
of oxygen.
Turn off the unit.
Change to another
source of oxygen,
and contact your
equipment provider.
Continuous
audible
alarm
General
malfunction
of the
LifeChoice
POC
Single, loud,
long, beep
every 65
seconds
Connect the
LifeChoice POC
unit to a DC adapter,
an AC adapter,
or change to
another source
of oxygen.
Red LED light above
Battery Check slowly flashes
Red LED light above
Battery Check
begins flashing quickly
Red LED light next to Alarm
continuously illuminates
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16
R O U T I N E M A I N T E N A N C E
The LifeChoice has no end user repairable parts.
Intake Vent Cleanin : One vent located on each side of the LifeChoice POC. At least once a
week or anytime the gross mesh air filter intakes appear dirty, use a cotton swab (Q Tip® or similar)
to clean the mesh filter media in the intake vents on the front and back of the unit. Follow these steps
to properly clean the air intake filter:
Gently rub the cotton swab along the intake vents (front and back of unit) to clean and remove any
debris from the intake filter mesh. Do not poke or gouge the mesh filter; just gently rub the cotton
swab cleaner along the intake vent areas. The LifeChoice POC does not need to be removed from
the carry case to clean the air intake filter as described above.
Nasal Cannula Inspection: At least once a week, visually inspect the nasal cannula. Make sure
there are no kinks or obstructions. Replace as needed with a standard 7-foot (2 meter) single lumen
type cannula from your local medical equipment supplier.
Reserve Oxy en Supply: Your equipment provider should provide or suggest an alternative source
of supplemental oxygen therapy in case there is a mechanical failure or power outage.
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17
LifeChoice Portable Oxygen Concentrator
LIFECHOICE SPECIFICATIONS
Maximum outlet pressure: 19 psi (131 kPa)
Device Electrical Classification: Class II
Oxygen Concentration: 90% (+/ 3%)1
Oxygen Concentration Sensor Alarm: 85% or Less
Flow Control Pulse Settings: 1, 2 & 3 LPM (Equivalent to Continuous Flow) ±20%
Mode of Operation: Continuous equipment and mobility: portable
Weight: 4.9 Pounds (2.2kg)
Dimensions: Height - 9.5" (24cm), Width - 7.5" (19cm) at widest point, Depth - 3.125" (7.9cm)
Power Supply: AC 100 to 240 VAC, 50 to 60 Hz cycles, DC 12 to 19 VDC
LifeChoice Oxygen Concentrator, XYC100-Input: 19Vdc, 6A
External AC Power Adapter, XYC103AC-Input: 100-240V, 2.5A Output: 19V, 6.3A
External DC Power Adapter, XYC104DC-Input: 11.5-16VDC, 5.6A Output: 19V, 6.3A
External Rechargeable Battery, XYC102-Input: 14.2-23.7V, Output: 14.2-23.7V
Approximate Internal Battery Duration: 2+ Hours
Minimum Internal Battery Recharge Time: 4 Hours
Approximate External Battery Duration: 3+ Hours
Minimum External Battery Recharge Time: 6 Hours
Warm-up Time: 2 Minutes with an LED Signal
Sound: Less than 50 Decibels at 10 ft (3.05m), 54.4 Decibals at 3.3ft (1m)
Operational Humidity Range: 20% to 95%, Non-condensing
Operational Altitude Max: 10,000 Feet (3km)
Environmental Conditions for Use, Storage and Transport:
1 When powered by the external AC adapter, external DC adapter, or external or internal battery.
20%
95%
Operational
41 F
(5°C)
104 F
(40°C)
Storage
-4 F
( 20°C)
140 F
(60°C)
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18
Medical electrical equipment
needs special precautions
regarding EMC and needs to
be installed and put into
service according to the EMC
information provided in the
accompanying documents.
Immunity Requirements
Guidance and Manufacturer’s Declaration - Electromagnetic Immunity
The Model XYC100 is intended for use in the electromagnetic environment specified below. The customer or the user
of the Model XYC100 should assure that it is used in such an environment.
Immunity Test
IEC 60601 Test Level Compliance Level Electromagnetic Environment-
Guidance
Electrostatic Discharge
(ESD) IEC 61000-4-2
+/-6 kV contact
+/-8 kV air
+/-6 kV contact
+/-8 kV air
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
+/-1kV for input/output
lines
+/-2 kV for power
supply lines
Not applicable for
input/output lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
+/-1 kV line-to-line
+/-2kV line-to-earth
+/-1 kV line-to-line
+/-2kV line-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% U
T
(>95% dip in
U
T
) for 0.5 cycle
40% U
T
(60% dip in
U
T
) for 5 cycles
70% U
T
(30% dip in
U
T
) for 25 cycles
< 5% U
T
(>95% dip in
U
T
) for 5 seconds
< 5% U
T
(>95% dip in
U
T
) for 0.5 cycle
40% U
T
(60% dip in
U
T
) for 5 cycles
70% U
T
(30% dip in
U
T
) for 25 cycles
< 5% U
T
(>95% dip in
U
T
) for 5 seconds
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the Model
XYC100 requires continued operation
during power mains interruptions, it is
recommended that the Model XYC100
be powered from an uninterruptible
power supply or a battery.
Power Frequency
(50/60Hz) 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.
NOTE: U
T
is the a.c. mains voltage prior to application of the test level.
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