Precision Medical EasyPulse POC PM4150 Series User manual
USER MANUAL
PORTABLE OXYGEN CONCENTRATOR
Model: PM4150 Series
SAVE THESE INSTRUCTIONS
Federal (USA) law restricts this device to sale by or
on the order of a physician.
300 Held Drive Tel: (+001) 610-262-6090
Northampton, PA 18067 USA Fax: (+001) 610-262-6080
www.precisionmedical.com
1
Portable Oxygen Concentrator
CONTENTS
RECEIVING / INSPECTION .......................................................1
INTENDED USE .........................................................................1
READ ALL INSTRUCTIONS BEFORE USING ..........................1
EXPLANATION OF ABBREVIATIONS ......................................2
SAFETY INFORMATION - WARNINGS AND CAUTIONS .........2
SPECIFICATIONS ......................................................................4
COMPONENT DESCRIPTION ...................................................5
OPERATING INSTRUCTIONS ...................................................6
Using the EasyPulse POC .....................................................6
Operating Position .................................................................7
Using the Carry Bag ..............................................................7
POWER SUPPLY ..................................................................9
ACCESSORIES / REPLACEMENT PARTS .............................10
ALARM / INDICATORS / TROUBLESHOOTING ..................... 11
MAINTENANCE / CLEANING ..................................................13
RETURNS ................................................................................13
DISPOSAL INSTRUCTIONS ....................................................13
LIMITED WARRANTY ..............................................................14
DECLARATION OF CONFORMITY .........................................15
RECEIVING / INSPECTION
Remove the Precision Medical, Inc. EasyPulse Portable Oxygen Concentrator
(POC) from the packaging and inspect for damage. If there is any damage, DO
NOT USE and contact your Provider.
INTENDED USE
The Precision Medical EasyPulse POC (model PM4150) is intended to provide
supplemental oxygen to persons requiring oxygen therapy. The Precision Medical
POC can be used in a home, institution, vehicle and for transportable use.
READ ALL INSTRUCTIONS BEFORE USING
This manual is provided for your safety and to prevent damage to the POC. If
you do not understand this manual, DO NOT USE the POC and contact your
Provider.
DANGER
This product is not intended as a life-sustaining or life-supporting device.
2
Portable Oxygen Concentrator
EXPLANATION OF ABBREVIATIONS
mL/min Milliliters Per Minute
LED Light Emitting Diode
POC Portable Oxygen Concentrator
SAFETY INFORMATION - WARNINGS AND CAUTIONS
DANGER Indicates an imminently hazardous situation which, if not avoided,
will result in death or serious injury.
WARNING Indicates a potentially hazardous situation which, if not avoided,
could result in death or serious injury.
CAUTION Indicates a potentially hazardous situation which, if not avoided,
may result in minor or moderate injury.
CAUTION
Used without the safety alert symbol indicates a potentially hazardous
situation which, if not avoided, may result in property damage.
62NA
PM4150 WITH RESPECT TO ELECTRICAL SHOCK, FIRE AND
MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI
ES60601-1 (2005, 3rd ed), CAN/CSAC22.2 No. 60601-1 (2008) 62NA
Caution! U.S. Federal Law restricts this device to sale by or on
the order of a physician.
This device may contain electrical components that are hazardous
to the environment. DO NOT dispose device into standard trash.
Contact your local waste Management for disposal of Electronic
Equipment.
Symbol indicates the device complies with the requirements of
Directive 93/42/EEC concerning medical devices and all applicable
International Standards. (On CE marked Devices ONLY)
Authorized by FAA for Use Onboard Aircraft
Docket #: FAA-2012-0928
General Warning Sign NO SMOKING
Follow Instructions for Use DO NOT
Disassemble
General Mandatory Action Sign
NO Oil or Grease
Excessive Heat Warning
Class II Equipment
Type BF Equipment
General Alarm Direct Current
Power OFF Drip Proof Equipment
Red Warning - Immediate response by the OPERATOR is required
Amber Caution - Prompt response by the OPERATOR is requiired
Green Ready for use
3
Portable Oxygen Concentrator
DANGER
•
DO NOT
when in use.
•
DO NOT
•
DO NOT
•
Excessive heating of the Carry Bag can occur if intake vents are blocked.
•
TO REDUCE THE RISK OF ELECTRICAL SHOCK:
•
DO NOT use while bathing.
•
DO NOT reach for the POC that has fallen into water. Unplug immediately.
•
DO NOT attempt to repair POC. Any attempt could result in electrical shock.
WARNING
•
•
This POC contains magnetic, ferrous material that may affect the results of an MRI.
•
In the event of an equipment alarm or if you are experiencing any signs of
discomfort, connect to another source of oxygen and contact your Provider
and / or Health Care Professional immediately.
•
In certain circumstances oxygen therapy can be hazardous; any user should
seek medical advice prior to using this POC.
•
Where the prescribing Health care professional has determined that an interruption
in the supply of oxygen, for any reason, may have serious consequences to the
user, an alternative source of oxygen should be available for immediate use
.
•
accidental damage to the POC.
• ALWAYS keep at least 6 in. (15.24 cm) away from walls, furniture, and especially
• DO NOT place the POC in a small closed space such as a closet.
•
DO NOT use extension cords or electrical adapters.
•
The POC is designed to operate with a single lumen, adult cannula with a
maximum length of 7 ft (2.1 m).
•
. Rotating the knob less than the
“OFF ( ) position” or over “setting 5” will damage the Concentrator.
•
DO NOT use Components / Accessories not approved by Precision Medical,
•
The POC delivers oxygen in a concentrated form when a breath is taken. An
oxygen enrichment of the surrounding area is unlikely.
TO REDUCE RISK OF BURNS, ELECTROCUTION, FIRE, OR INJURY TO PERSONS:
•
•
DO NOT use an AC or DC Power Adapter with a damaged power cord or plug
.
•
DO NOT use if POC has been dropped or damaged.
•
DO NOT use oil or grease on the POC.
•
DO NOT cover the air vents, the POC requires proper ventilation.
•
DO NOT remove the cover on the POC. Servicing must be performed by a
trained professional.
CAUTION
•
The POC is designed to be used indoors or outdoors, in the outdoors
•
POC is designed to be used in dry conditions, the POC is not to be
submerged or operated under water.
4
Portable Oxygen Concentrator
CAUTION
DO NOT place any liquids on or near the POC. If any liquid gets on the POC,
SPECIFICATIONS
Dimensions: Height: 10.1 in (25.7 cm)
Width: 6.5 in (16.5 cm)
Depth: 4.5 in (11.4 cm)
Weight: 6.8 lbs (3.08 kg)
Shipping Weight: 13.1 lbs (5.94 kg)
Altitude: Sea level to 9000 ft (2743 m)
Operating Temperature:
Storage / Transport Temperature:
Relative Humidity: Up to 95% Non-Condensing
Oxygen Concentration: 87% to 95%
Start Up Time 87% O2
Oxygen Minute Volume*: 240 +/-15% mL/min
380 +/-15% mL/min
520 +/-15% mL/min
660 +/-15% mL/min
780 +/-15% mL/min
Mode of Delivery: Pulsed Dose only
Trigger Sensitivity: 0.50 cmH2O maximum
Trigger Delay: 0.11 seconds typical
Power: AC Power Adapter: 100-240 VAC (1.0 A @ 120 VAC)
DC Power Adapter: 11-16 VDC (5.0 A @ 12 VDC)
Battery Duration: 4.5 hrs
(
Approximate)
3.2 hrs
2.5 hrs
1.8 hrs
1.5 hrs
Sound
(@ Setting 2)
: 44 dBA
Cannula:
Maximum 7 ft (2.1 m) long standard adult single lumen nasal cannula.
Class II - with respect to protection from electrical shock
Type BF - degree of protection against electrical shock
IPX1 - degree of protection against ingress of liquids
Mode of Operation - Continuous
Volatile Organic Compound (VOC) and Particulate Requirements:
The oxygen delivered from the EasyPulse POC meets the following requirements for particulate
levels, VOC levels, carbon monoxide levels, carbon dioxide levels and ozone levels.
EPA PM2.5 Particulate Matter
ASTM D5466 Ozone Levels
21 CFR 801.415 Carbon Monoxide Levels
EPA NAAQS - Carbon Monoxide Carbon Dioxide Levels
OSHA Permissible Exposure Limits
Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres
(Canister Sampling Methodology)
* At Sea level
5
Portable Oxygen Concentrator
CAUTION
Missing or illegible labels must be replaced, contact Precision Medical, Inc.
COMPONENT DESCRIPTION
Product
Serial # Label
Inlet Filter
Setting
Indicator
Power Input
Jack
Handle Setting Knob
Oxygen Outlet
Fitting
Internal Battery
Level Indicator
Alarm Indicator
OPERATING INSTRUCTIONS
WARNING
•
Read this User Manual before operating the POC.
•
The POC shall be used by an adult or supervised by an adult when
being used by a child.
•
Additional monitoring or attention may be required for patients using this
POC who are unable to hear or see alarms or communicate discomfort.
•
. Rotating the knob less than
the “OFF ( ) position” or over “setting 5” will damage the Concentrator.
CAUTION
•
ALWAYS
and monitor on a frequent basis.
•
For Proper Oxygen Flow, be sure that cannula is not kinked or
obstructed before or during use.
•
DO NOT
•
DO NOT
the POC.
6
Portable Oxygen Concentrator
CAUTION
•
Inspect the POC for visual damage before use, DO NOT USE if damaged.
•
To prevent damage to the POC, DO NOT operate the POC without
Using the EasyPulse POC
1. Verify battery status (level) prior to each use, charge as necessary.
2. Connect the end of a standard adult single lumen oxygen nasal cannula
To ensure proper device operation, use only
an adult single lumen cannula maximum 7
ft (2.1 m).
3. Place the cannula over your ears and position
the prongs in your nose as instructed by your
Equipment Provider or cannula manufacturer.
OR
4. Prior to operation, ensure the inlet and exhaust vents on the POC are clear.
Any blockage of the vents can inhibit performance.
5. Choose one of the 3 power options: AC Power Adapter, DC Power Adapter or
for details on these 3 options).
6.
until the knob points
7. Breathe normally through your nose. A measured pulse of oxygen will be
delivered each time the POC senses an inhalation. To show the POC is
time it senses an inhalation.
to the
) position.
WARNING
ISO 8359 (Standard for Oxygen Concentrators) highly recommends
that the patient cannula that delivers gas to the patient from the oxygen
gas towards the patient in the case that the cannula becomes ignited.
The Fire Stop Check Valve should be located as close to the patient as
reasonably practicable.
Fire Stop Check Valve - Precision Medical Part # 507706
7
Portable Oxygen Concentrator
Operating Position
The POC can be operated in an upright position with or without the
carry bag as shown below.
Using the Carry Bag
The carry bag is intended to make the POC easier to transport, prevent
movement due to vibration and protect the device from minor mishaps.
CAUTION
The carry bag is not intended to make the POC waterproof, or to
protect the device from major falls or accidents/abuse.
When inserting the POC into the carry bag make sure of the following:
•
Before placing POC inside bag make sure bag is clean and
empty.
•
Make sure the control knob and control panel are aligned with
the clear window on the bag.
•
Make sure bottom exhaust vents are aligned with the mesh
opening along the bottom of the bag.
The POC can be operated lying on its back ONLY while in the carry
bag as shown below.
8
Portable Oxygen Concentrator
The carry handle can be placed in either of the positions below with
WARNING
•
The mesh on the carry bag must be aligned with the
exhaust vents on the POC to keep the POC cool and
operating properly.
•
Be sure the exhaust vents are facing away from body
while being carried.
•
If the outside of the bag feels hot or causes any discomfort,
set the POC down and check to be sure all vents are
unobstructed.
•
DO NOT cover Air Vents, the POC requires proper
ventilation.
•
DO NOT allow the POC to come in direct contact with
skin while in the carry bag.
Control panel and clear window properly aligned
Exhaust vents and mesh area properly aligned Proper carrying position
9
Portable Oxygen Concentrator
POWER SUPPLY
To prevent damage to the device, use only
Precision Medical approved external power sources.
AC Power Adapter:
The AC power adapter connects the POC to a 100-240 VAC,
50/60 Hz wall outlet. The power adapter converts AC voltage to DC
voltage in order to power the POC. The AC adapter will power the POC
and simultaneously charge the internal battery.
To connect the AC Power Adapter to the POC, insert the
DC plug connector into the power input jack on the POC and insert the
AC wall plug into a wall socket.
North American Cord (Shown)
110 Volt / 10 Amp ONLY
AC Wall PlugDC Plug
DC Power Adapter:
The DC power adapter connects the POC to an automobile’s 12 VDC
outlet. The DC adapter will power the POC and simultaneously charge
the internal battery.
To connect the DC Power Adapter to the POC, insert the
DC plug connector into the power input jack on the POC and insert the
other end into your automobile’s 12 V accessory jack.
DC Plug
Auto Accessory Plug
10
Portable Oxygen Concentrator
Internal Battery Pack:
The POC contains an internal rechargeable lithium ion battery pack. When fully
charged, the battery will power the POC for up to 4.5 hours dependent upon
setting. The Battery Level Indicator in the upper right corner of the control panel
continuously displays the charge level of the internal battery while the POC is
on. When the battery charge level drops to 15%, the last LED will turn solid red
and a brief audible beep will be emitted once every minute. When the battery
is emitted once every 20 seconds to signal that the battery is almost depleted
and you will need to connect the POC to another power source.
ENSURE BATTERY IS FULLY CHARGED PRIOR TO FIRST USE.
The internal battery can be charged by connecting either the AC
Power Adapter or DC Power Adapter to the POC. The internal battery will begin
charging as soon as power is connected. You will also be able to run the POC
while the internal battery charges.
In order to prolong life of the battery, it
is best to charge the battery frequently
rather than waiting until the battery is
fully discharged.
When storing for long periods of time
without use (> 1 month) be sure to
charge the battery to around 50%
charge level to prolong life of battery.
ACCESSORIES / REPLACEMENT PARTS
Only the items listed below are to be used with the POC.
Inlet Filter 505847
AC Power Cord 506961
AC Power Supply 506629
DC Power Supply 506750
Carry Bag 506707
Backpack Carry Bag 507303
Cannula 504833
Other Power Cord / Plug combination for the AC Power Adapter available
thru Precision Medical, Inc. ONLY.
11
Portable Oxygen Concentrator
ALARM / INDICATORS / TROUBLESHOOTING
Green Ready for use
Amber Caution - Prompt response by the OPERATOR is required
Red
Warning - Immediate response by the OPERATOR is required
The Audible Alarm and LED Indicators are listed in the chart.
Visual Indicator/
Problem
Audible
Alarm Probable Cause Remedy
The last LED on
the internal Battery
Level Indicator turns
red
Repetitive beep Internal battery has
dropped below 15%
charge remaining
Connect the POC to the AC Power Adapter,
DC Power Adapter, or external battery pack
The last LED on
the internal Battery
Level Indicator
Repetitive beep Internal battery has
dropped below 5%
charge remaining
1. Connect the POC to the AC Power
Adapter, DC Power Adapter, or external
battery pack
2. Change to alternate oxygen source if
power source is not available
Amber alarm
indicator is
illuminated and
setting number is
inhalation to signal a
detected breath
Repetitive beep No breath detected for
1 minute
1. Verify the cannula is not kinked
2. Verify the cannula is properly connected
to oxygen outlet
3. Verify the cannula is properly positioned
in the nose
Red alarm indicator
is illuminated and
setting number is
inhalation to signal a
detected breath
Repetitive beep No breath detected for
2 minutes
1. Verify the cannula is not kinked
2. Verify the cannula is properly connected
to oxygen outlet
3. Verify the cannula is properly positioned
in the nose
4. If alarm persists change to alternate
oxygen source and contact your
Equipment Provider
Amber alarm
indicator is
illuminated
Repetitive beep Breath rate exceeding
35 breaths / minute
Reduce level of activity to allow breath rate
to slow
Red alarm indicator
is illuminated
Repetitive beep
Breath rate exceeding
35 breaths / minute
for longer than 1 minute
1. Reduce level of activity to allow breath
rate to slow
2. If alarm persists, change to alternate
oxygen source and contact your
Equipment Provider
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 1 &
Repetitive beep Abnormal compressor
operation detected
1. Turn the POC to the “OFF” position
2. Turn the POC back “ON” to prescribed
setting
3. If alarm persists, change to alternate
oxygen source and contact your
Equipment Provider
12
Portable Oxygen Concentrator
Visual Indicator/
Problem
Audible Alarm Probable Cause Remedy
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 1 &
Repetitive beep Internal battery is
outside its operating
temperature range
1. Turn off the POC and disconnect any
power supplies
3. Ensure inlet and exhaust vents are not
blocked in any way
4. Verify you are operating the POC within
range.
5. It may be necessary to allow the POC
to warm up or cool before turning back
“ON”
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 1 &
Repetitive beep Motor is above its
maximum operating
temperature
1. Turn off the POC
3. Ensure inlet and exhaust vents are not
blocked in any way
4. Verify you are operating the POC within
range
5.
It may be necessary to allow the POC to
cool before turning back “ON”
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 1 &
Repetitive beep Pressure outside of
normal operation
1. Turn the POC to the “OFF” position
2. Turn the POC back “ON” to prescribed
setting
3. If alarm persists, change to alternate
oxygen source and contact your
Equipment Provider
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 2 &
Repetitive beep Fan malfunction 1. Turn the POC to the “OFF” position
2. Turn the POC back “ON” to prescribed
setting
3. If alarm persists, change to alternate
oxygen source and contact your
Equipment Provider
Red alarm indicator
is illuminated, unit
is not running and
setting numbers 2 &
Repetitive beep Failed electrical
connection
1. Turn the POC to the “OFF” position
2. Turn the POC back “ON” to prescribed
setting
3. If alarm persists, change to alternate
oxygen source and contact your
Equipment Provider
Amber alarm
and unit is running
NA Service Needed 1. Continue to use POC
2. Contact Equipment Provider
Red alarm indicator
is running
NA Service Needed 1. Switch to another source of oxygen
2. Contact Equipment Provider
Red Alarm and 3 &
4 Setting Numbers
Illuminated and
device Shuts Down
Single Beep Cannula Occluded/
Kinked
1. Ensure the Cannula and/or Outlet are
Not Blocked
2. Turn the POC to the “OFF” position for at
least 15 seconds.
3. Turn the POC back “ON” to prescribed
Setting
4. If Alarm persists, change to alternate
Oxygen source and Contact your
Equipment Provider.
All other Alarm
Conditions
Unknown
1. Switch to another
source of Oxygen.
Unknown
1. Switch to another
source of Oxygen.
1. Switch to another source of Oxygen.
2. Contact Equipment Provider.
13
Portable Oxygen Concentrator
MAINTENANCE / CLEANING
WARNING
•
Prior to cleaning, ensure the POC is turned off and unplug any
external power sources.
•
DO NOT disassemble or attempt to repair. There are no user
serviceable parts inside. Contact your Equipment Provider for service.
•
DO NOT spray or apply any cleaners directly onto the case.
•
DO NOT allow any liquids to drip inside any case openings.
•
DO NOT
Perform cleaning as required.
Cabinet:
1. The patient should connect to an alternate Oxygen source.
) position.
3. Unplug the external power source before cleaning.
4. Clean exterior surfaces of the POC with a cloth dampened with
disinfectant solution. Example: Sporicidin® Brand Disinfectant Solution.
5. Allow POC to air dry.
6. DO NOT place inside carry bag or run the POC until it is thoroughly dry.
7. When not in use, store the POC in a clean area free from grease, oil and
other sources of contamination.
Inlet Filter:
dry completely.
protruding.
Inlet Filter
Tab
RETURNS
Returned products require a Returned Goods Authorization (RGA) number,
contact Precision Medical, Inc. All returns must be packaged in sealed containers
to prevent damage. Precision Medical, Inc. will not be responsible for goods
damaged in transit. Refer to Precision Medical, Inc. Return Policy available on
the Internet, www.precisionmedical.com.
DISPOSAL INSTRUCTIONS
This device may contain electrical components that are hazardous to the
environment. DO NOT dispose device into standard trash. Contact your local
waste Management for disposal of Electronic Equipment.
14
Portable Oxygen Concentrator
LIMITED WARRANTY
AND
LIMITATION OF LIABILITY
Precision Medical, Inc. warrants that the Portable Oxygen Concentrator
POC, (the Product), will be free of defects in workmanship and/or
material for the following period:
Portable Oxygen Concentrator three (3) years from date of shipment
Battery 180 days from date of shipment
Precision Medical, Inc. is NOT responsible for normal wear and tear, or any
neglect or abuse of the product.
Precision Medical, Inc. is NOT responsible for the shipping cost of the repair.
Should any failure to conform to this warranty appear within the
thereof and substantiation that the goods have been stored, installed,
maintained and operated in accordance with Precision Medical, Inc.’s
substitutions, or alterations have been made to the goods, correct
such defect by suitable repair or replacement at its own expense.
ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES.
The representatives of Precision Medical, Inc. or any retailers are not
authorized to make oral warranties about the merchandise described
in this contract, and any such statements shall not be relied upon
complete and exclusive statement of the terms of that contract.
THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR
PURPOSE OR OTHER WARRANTY OF QUALITY, WHETHER
EXPRESS OR IMPLIED.
Precision Medical, Inc. shall not under any circumstances be liable for
special, incidental or consequential damages including but not limited
all liabilities of Precision Medical, Inc. whether based on contract,
negligence, strict tort or otherwise. Precision Medical, Inc. reserves
the right to discontinue manufacture of any product or change product
materials, designs, or
Precision Medical, Inc. reserves the right to correct clerical or
typographical errors without penalty.
DECLARATION OF CONFORMITY
Precision Medical, Inc.
300 Held Drive
Northampton PA 18067, USA
Molenstraat 15
2513 BH, The Hague
The Netherlands
Phone: +31 (0) 70.345.8570
Fax: +31 (0) 70.346.7299
PM4150
IIa
Clause 3.2 Rule 11 of Annex IX of MDD
We hereby declare that an examination of the under mentioned production quality
assurance system has been carried out following the requirements of the UK national
legislation to which the undersigned is subjected, transposing Annex II, 3 of the Directive
93/42/EEC and Directive 2007/47/EC on medical devices.
We certify that the production quality system conforms to the relevant provisions of the
aforementioned legislation, and the result entitles the organization to use the CE 0473
marking on those products listed above.
Applied Standards:
EN 1041, EN ISO 14971, EN 60601-1, EN 60601-1-2, EN 60601-1-4,
EN 60601-1-8, EN 62366, EN ISO 3744, EN ISO 8359, EN ISO 15001,
ISO 13485, ISO 15223-1, 2006/66/EC
0473
Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK
1126 A CE
Date of Expiry: 26 July 2017
Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 31 August 2012 to Date of Expiry
Manufacture Representative:
Quality Manager
Position: Quality Systems/ISO Representative
Date of Issue: 31 August 2012
Tell us how we are doing!
Visit us at www.precisionmedical.com
506640 Rev10 9/14 (??) Printed in USA
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