U S E R M A N U A L
PORTABLE OXYGEN CONCENTRATOR
Model: PM4130 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 |
ISO 13485 Certified |
www.precisionmedical.com |
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CONTENTS |
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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...................... |
15 |
MAINTENANCE / CLEANING................................................... |
16 |
RETURNS................................................................................. |
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DISPOSAL INSTRUCTIONS.................................................... |
16 |
LIMITED WARRANTY............................................................... |
17 |
DECLARATION OF CONFORMITY.......................................... |
18 |
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 PM4130) 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.
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EXPLANATION OF ABBREVIATIONS
mL/min |
Milliliters Per Minute |
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LED |
Light Emitting Diode |
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POC |
Portable Oxygen Concentrator |
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Indicator light Colors and Meaning |
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Red |
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Warning - Immediate response by the OPERATOR is |
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required |
Amber |
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Caution - Prompt response by the OPERATOR is required |
Green |
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Ready for use |
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 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.
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Portable Oxygen Concentrator |
SAFETY INFORMATION - WARNINGS AND CAUTIONS
(continued)
General Warning Sign |
NO |
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SMOKING |
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Follow Instructions for Use |
DO NOT |
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Disassemble |
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General Mandatory Action Sign |
NO Oil or |
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Grease |
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The PM4130 Oxygen Concentrator, gas pathways, components and accessories do not contain any natural rubber latex.
Protected from touch by fingers and objects greater than 12 millimeters. \ Protected from condensation.
Class II |
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Type BF Equipment |
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Equipment |
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General Alarm |
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Direct Current |
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Power OFF |
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Excessive Heat Warning |
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DANGER
This product is not intended as a life-sustaining or life-supporting device.
•DO NOT smoke, allow others to smoke or have open flames near the
POC when in use.
•DO NOT use near any type of flame or flammable/explosive substances.
•DO NOT allow POC to exceed “Operating or Storage Temperature
Specifications”.
•Excessive heating of the Carry Bag can occur if intake vents are blocked.
•Equipment not suitable for use in the presence of flammable 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.
Portable Oxygen Concentrator |
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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 flat 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 airflow 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 flame.
•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 fire and burns.
•Do not lubricate fittings, connections, tubing, or other accessories of the oxygen concentrator to avoid the risk of fire and burns.
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Portable Oxygen Concentrator |
WARNING (continued)
•Use only spare parts recommended by Precision Medical to ensure proper function and to avoid the risk of fire and burns.
•Use of this device at an altitude above or below sea level to 9000 ft (2743 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 flowrate 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 flames during oxygen therapy are dangerous and is likely to result in fire or death. Do not allow open flames 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 PM4130 Oxygen
Concentrator must be used with the specific combination of parts and accessories that are in line with the specification 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 PM4130 Oxygen Concentrator must be used only after one or more settings have been individually determined or prescribed for you at your specific 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 fire associated with oxygen enrichment during oxygen therapy. Do not use the oxygen concentrator or accessories near sparks or open flames.
Portable Oxygen Concentrator |
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