Precision Medical PM4150, PM4130P, PM4150P User Manual
USER MANUAL
PORTABLE OXYGEN CONCENTRATOR
Model: PM4100 Series
PM4130
PM4150
PM4150P
SAVE THESE INSTRUCTIONS
PM4130P
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
ISO 13485 Certied www.precisionmedical.com
CONTENTS
RECEIVING / INSPECTION ....................................................... 1
INTENDED USE ......................................................................... 1
READ ALL INSTRUCTIONS BEFORE USING ..........................1
EXPLANATION OF ABBREVIATIONS ...................................... 2
SAFETY INFORMATION - WARNINGS AND CAUTIONS .........2
SPECIFICATIONS ...................................................................... 6
COMPONENT DESCRIPTION ...................................................8
OPERATING INSTRUCTIONS ................................................... 8
Using the EasyPulse POC ..................................................... 9
Operating Position ...............................................................10
Using the Carry Bag ............................................................10
Power Supply.......................................................................12
ACCESSORIES / REPLACEMENT PARTS .............................14
ALARM / INDICATORS / TROUBLESHOOTING
PM4130 and PM4150 .......................................................... 15
PM4150 ...............................................................................16
MAINTENANCE / CLEANING .................................................. 17
RETURNS ................................................................................17
DISPOSAL INSTRUCTIONS ....................................................17
LIMITED WARRANTY .............................................................. 18
DECLARATION OF CONFORMITY .........................................19
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 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.
Portable Oxygen Concentrator
1
EXPLANATION OF ABBREVIATIONS
mL/min Milliliters Per Minute
LED Light Emitting Diode
POC Portable Oxygen Concentrator
Indicator light Colors and Meaning
Red
Amber Caution - Prompt response by the OPERATOR is required
Green Ready for use
Warning - Immediate response by the OPERATOR is required
SAFETY INFORMATION - WARNINGS AND CAUTIONS
DANGER
WARNING
CAUTION
CAUTION
Indicates an imminently hazardous situation which, if
not avoided, will result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, may result in minor or moderate injury.
Used without the safety alert symbol indicates a
potentially hazardous situation which, if not avoided, may
result in property damage.
PM4130 AND 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.
Authorized by FAA for Use Onboard Aircraft
Docket #: FAA-2012-0928
The patient cannula is intended for single patient use
only. Use on more than one patient may cause cross
contamination.
2
Portable Oxygen Concentrator
SAFETY INFORMATION - WARNINGS AND CAUTIONS
(continued)
General Warning Sign
Follow Instructions for Use
General Mandatory Action Sign
The Oxygen Concentrator, gas pathways, components
and accessories do not contain any natural
rubber latex.
Protected from touch by ngers and objects greater
than 12 millimeters. \ Protected from condensation.
Class II
Equipment
General Alarm Direct Current
Power OFF
DANGER
This product is not intended as a life-sustaining or life-supporting
device.
•
DO NOT smoke, allow others to smoke or have open ames near the
POC when in use.
•
DO NOT use near any type of ame or ammable/explosive
substances.
•
DO NOT allow POC to exceed “Operating or Storage Temperature
Specications”.
•
Excessive heating of the Carry Bag can occur if intake vents
are blocked.
•
Equipment not suitable for use in the presence of ammable
anesthetic.
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.
•
POC is designed to be used in dry conditions, the POC is not to be
submerged, operated under water or used while swimming.
Type BF Equipment
Excessive Heat Warning
NO
SMOKING
DO NOT
Disassemble
NO Oil or
Grease
Portable Oxygen Concentrator
3
WARNING
• Use the POC for its “Intended Use” as described in this manual.
•
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
•
Place the POC on a secure at surface when not transporting to
avoid accidental damage to the POC.
• ALWAYS keep at least 6 in. (15.24 cm) away from walls, furniture, and
especially curtains that could prevent adequate airow to the POC.
• 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).
•
DO NOT use Components / Accessories not approved by Precision
Medical, see “ACCESSORIES / REPLACEMENT PARTS”.
•
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:
•
Keep away from heat or open ame.
•
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.
•
Use only water-based lotions or salves that are oxygen-compatible
before and during oxygen therapy. Never use petroleum or oil-based
lotions or salves to avoid the risk of re and burns.
•
Do not lubricate ttings, connections, tubing, or other accessories of
the oxygen concentrator to avoid the risk of re and burns.
4
Portable Oxygen Concentrator
WARNING (continued)
•
Use only spare parts recommended by Precision Medical to ensure
proper function and to avoid the risk of re and burns.
•
Use of this device at an altitude above or below sea level to 14,000
ft (4267 m) or outside a temperature of 41°F to 104°F (5°C to 40°C)
or a relative humidity above 95% Non-Condensing is expected to
adversely affect the owrate and the percentage of oxygen and
consequently the quality of the therapy.
•
Geriatric, pediatric or any other patient unable to communicate
discomfort can require additional monitoring and or a distributed
alarm system to convey the information about the discomfort and or
the medical urgency to the responsible care giver to avoid harm.
•
Smoking during oxygen therapy is dangerous and is likely to result
in facial burns or death. Do not allow smoking within the same room
where the oxygen concentrator or any oxygen carrying accessories
are located. If you intend to smoke, you must always turn the oxygen
concentrator off, remove the cannula and leave the room where the
oxygen concentrator is located. If unable to leave the room, you must
wait 10 minutes after you have turned the oxygen concentrator off
before smoking.
•
Open ames during oxygen therapy are dangerous and is likely to
result in re or death. Do not allow open ames within 2 m of the
oxygen concentrator or any oxygen carrying accessories.
•
To ensure receiving the therapeutic amount of oxygen delivery
according to your medical condition, the Oxygen Concentrator must
be used with the specic combination of parts and accessories that
are in line with the specication of the concentrator manufacturer and
that were used while your settings were determined.
•
To ensure receiving the therapeutic amount of oxygen delivery
according to your medical condition, the Oxygen Concentrator must
be used only after one or more settings have been individually
determined or prescribed for you at your specic activity levels by
your healthcare provider.
•
If you feel discomfort or are experiencing a medical emergency while
undergoing oxygen therapy, seek medical assistance immediately to
avoid harm.
•
There is a risk of re associated with oxygen enrichment during
oxygen therapy. Do not use the oxygen concentrator or accessories
near sparks or open ames.
Portable Oxygen Concentrator
5
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