USER MANUAL
Contents
1. It is normal for this to occur occasionally such as during severe weather however if this condition persists connect to another source of oxygen and contact your Provider GREEN Power Indicator is ON YELLOW Oxygen Concentration and RED General Alarm Indicators are flashing and device is running Repeated beeping Device overheating Internal temp above 109 Move Concentrator to a cooler location Ensure Concentrator is positioned away from curtains or drapes hot air registers or heaters Be certain to place the Concentrator so all sides are at least 6 in 15 24 cm away from a wall or other obstruction DO NOT place concentrator in a confined area Continued on next page 9 Visual Indicator Problem Audible Alarm Probable Cause Remedy RED General Alarm Indicator is flashing while beeping device stops functioning Repeated beeping Device overheating Move Concentrator to a cooler location Ensure Concentrator is positioned away from curtains or drapes hot air registers or heaters Be certain to place the Concentrator so all sides are at least 6 in 15 24 cm away from a wall or other obstruction DO NOT place concentrator in a confined area PM4351 ONLY YELLOW Oxygen Concentration Indicator is ON steady None Low oxygen concentration Continue to use concentrator but contact your Provider PM4351 ONLY YELLOW Oxygen Concentration and RED General Alarm In2. Flow Setting Knob does not rotate 360 degrees 6 Oxygen should be flowing through the cannula If it is not refer to the ALARM INDICATORS TROUBLESHOOTING 8 7 Place the cannula over your ears and position the prongs in your nose as instructed by your Provider or cannula manufacturer OR 8 When the Concentrator is not in use press the power On Off switch to OFF position 9 Unplug Concentrator from electrical outlet for complete disconnection from Power Source ALARM INDICATORS TROUBLESHOOTING The Audible Alarm and LED Indicators are listed in the chart below Visual Indicator Problem Audible Alarm Probable Cause Remedy When device is turned ON device does not function and the GREEN Power Indicator does not light Continuous Concentrator is not properly plugged into electrical outlet Make sure Concentrator is properly plugged into the electrical outlet RED General Alarm Indicator is ON steady or continuously blinking device stops functioning Repeated beeping System malfunction Turn power switch OFF and wait 5 minutes then turn back ON If condition persists turn the concentrator OFF connect to another source of oxygen and contact your Provider RED General Alarm Indicator flashes once device momentarily stops functioning then automatically restarts Single beep Momentary AC power interruption
3. IEC 60601 1 4 and Safety Requirements for ISO 8359 Specifications are subject to change without prior notice 6 COMPONENT DESCRIPTION CAUTION Missing or illegible labels must be replaced contact Precision Medical Inc PM4351 shown Model PM4351 Model PM4350 Inlet Filter Access Cover Product Serial Label 4 Casters AC Power Cord Carry Handle Front View Back amp Side View Low Oxygen Concentration Alarm Indicator Hour Meter Power Indicator General Alarm Indicator Oxygen Outlet Flow Setting Knob ON OFF Switch Serial Model Label Action Required Power Indicator General Alarm Indicator Oxygen Outlet Flow Setting Knob ON OFF Switch Hour Meter Serial Model Label 7 OPERATING INSTRUCTIONS WARNING Read this User Manual before operating the Concentrator Additional monitoring or attention may be required for patients using this Concentrator who are unable to hear or see alarms or communicate discomfort CAUTION Inspect the Concentrator for visual damage before use DO NOT USE if damaged To prevent damage to the Concentrator DO NOT operate the Concentrator without the inlet filter 1 Place the Concentrator in a location where room air can be drawn in without being restricted NOTE There must be at least six 6 in 15 24 cm of space around the Concentrator when operating 2 P
4. AZARDS ONLY IN ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 No 601 1 Caution U S Federal Law restricts this device to sale by or on the order of a physician CONSULT ACCOMPANYING DOCUMENTS Degree of protection against ingress of liquids General Mandatory Action Sign Class II Equipment Type BF Equipment General Alarm Alternating Current Power ON Power OFF NO SMOKING Dangerous Voltage NO Oil or Grease DO NOT Disassemble 4 DANGER DO NOT smoke allow others to smoke or have open flames near the Concentrator when in use DO NOT use near any type of flame or flammable explosive substances DO NOT allow Concentrator to exceed Operating or Storage Temperature Specifications The Concentrator is 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 a Concentrator that has fallen into water Unplug immediately DO NOT attempt to repair Concentrator Any attempt could result in electrical shock WARNING Use the Concentrator for its Intended Use as described in this manual In the event of an equipment audible 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 s
5. U S E R M A N U A L PM4351 Shown 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 ISO 13485 Certified www precisionmedical com Federal USA law restricts this device to sale by or on the order of a physician SAVE THESE INSTRUCTIONS Model PM4300 Series 1 CONTENTS RECEIVING INSPECTION 2 INTENDED USE 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 SPECIFICATIONS 5 COMPONENT DESCRIPTION 6 OPERATING INSTRUCTIONS 7 ALARM INDICATORS TROUBLESHOOTING 8 MAINTENANCE CLEANING 10 RETURNS 10 DISPOSAL INSTRUCTIONS 10 REPLACEMENT PARTS 10 LIMITED WARRANTY 11 For latest revision of this User Manual go to www p
6. are no user serviceable parts inside Contact your Provider for repairs 1 Patient should connect to an alternate Oxygen source 2 Turn the Concentrator to the OFF position 3 Unplug the Power Cord from electrical outlet 4 Clean exterior surfaces of the Concentrator with a cloth dampened with water and mild detergent 5 Wipe the Concentrator dry with a clean cloth 6 When not in use store the Concentrator in a clean area free from grease oil and other sources of contamination Tell us how we are doing Visit us at www precisionmedical com REPLACEMENT PARTS DESCRIPTION PART Humidifier Adapter 507324 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 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Oxygen Concentrator the Product will be free of defects in workmanship and or material for the following period Oxygen Concentrator thre
7. dicators are ON while beeping device stops functioning Repeated beeping Very low oxygen percentage Turn the concentrator OFF connect to another source of oxygen and contact your Provider No flow from nasal cannula None 1 Kinked tubing 2 Nasal cannula has become disconnected from oxygen outlet on concentrator or from extension tubing 3 Connection between bubble humidifier and oxygen outlet on concentrator has become loose 1 Check tubing and nasal cannula for kinks 2 Check cannula and tube fittings for proper connection 3 Tighten bubble humidifier bottle Limited or no oxygen flow None Dirty or obstructed bubble humidifier or leak present Remove the bubble humidifier bottle and if flow is restored clean or replace the bubble humidifier Condensation collects in the oxygen tubing when you use a bubble humidifier bottle None Concentrator not properly ventilated elevated operating temperatures Ensure Concentrator is positioned away from curtains or drapes hot air registers or heaters Be certain to place the Concentrator so all sides are at least 6 in 15 24 cm away from a wall or other obstruction DO NOT place the Concentrator in a confined area DO NOT OVERFILL bubble humidifier Allow the oxygen tubing to dry out or replace with new tubing 10 MAINTENANCE CLEANING WARNING DO NOT remove cover or attempt to repair There
8. e 3 years from date of purchase 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 applicable period Precision Medical Inc shall upon written notification thereof and substantiation that the goods have been stored installed maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications 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 and are not part of the contract for sale Thus this writing is a final 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 to lost profits lost sales or injury to p
9. eek medical advice prior to using this Concentrator 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 ALWAYS keep the Concentrator in an upright position ALWAYS keep at least 6 in 15 24 cm away from walls furniture and especially curtains that could prevent adequate airflow to the Concentrator DO NOT place the Concentrator in a small closed space such as a closet DO NOT use extension cords or electrical adapters The Concentrator is designed to operate with a single lumen adult cannula Flow is available ONLY at the listed settings There is NO FLOW between settings Flow Setting Knob does not rotate 360 degrees TO REDUCE RISK OF BURNS ELECTROCUTION FIRE OR INJURY TO PERSONS Keep the Concentrator away from heat or open flame DO NOT use if Concentrator has a damaged power cord or plug DO NOT use if Concentrator has been dropped or damaged DO NOT use oil or grease on the Concentrator DO NOT cover the air vents the Concentrator requires proper ventilation DO NOT remove the cover on the Concentrator Servicing must be performed by a trained professional 5 CAUTION DO NOT place any liquids on or near the Concentrator If any liquid gets on or in the Concentrator immediatel
10. erson or property Correction of non conformities as provided above shall constitute fulfillment of 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 specifications without notice Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty 506767 Rev2 03 13 Printed in USA
11. lug the power cord into an electrical outlet NOTE The Concentrator is equipped with a polarized plug one blade is wider than the other As a safety feature this plug will fit in a polarized outlet only one 1 way If the plug does not fully fit in the outlet reverse the plug If it still does not fit contact a qualified electrician DO NOT attempt to defeat this safety feature To use without a bubble humidifier 3 Attach the Cannula to the Oxygen Outlet To use with a bubble humidifier 3 Attach humidifier adaptor to Oxygen Outlet fill the bubble humidifier bottle and connect as per bubble humidifier instructions NOTE Be sure not to cross thread this may cause a leak Concentrator can be used with or without Humidifier 3a Attach the Cannula to the bubble humidifier bottle 4 Push the Power On Off switch to ON position The Power Indicator light below the On Off switch will illuminate green when the Concentrator is powered ON NOTE If there is no electrical power or the device has not been plugged into the electrical outlet correctly turning the Concentrator ON will cause an Audible Alarm for up to two 2 minutes 5 Set the flow to the prescribed setting by turning the flow setting knob on the Concentrator to the prescribed flow NOTE There is NO FLOW between settings The Flow Setting Knob must point to a specific number in order to obtain flow
12. recisionmedical com 2 RECEIVING INSPECTION Remove the Precision Medical Inc PM4300 Series Oxygen Concentrator from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The Precision Medical Inc Stationary Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy The device is not intended to be life supporting or life sustaining READ ALL INSTRUCTIONS BEFORE USING This manual is provided for your safety and to prevent damage to the Oxygen Concentrator If you do not understand this manual DO NOT USE the Concentrator and contact your Provider EXPLANATION OF ABBREVIATIONS l min Liters Per Minute LED Light Emitting Diode DANGER This product is not intended as a life sustaining or life supporting device 3 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 PM4300 WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL H
13. y turn OFF the power switch unplug from the electrical outlet and contact your Provider SPECIFICATIONS Dimensions Length 17 1 in 43 5 cm Width 12 3 in 31 1 cm Height 17 0 in 43 2 cm Weight 29 6 lbs 13 4 kg Shipping Weight 33 9 lbs 15 4 kg Altitude Sea Level to 10 000 ft 3 048 m Operating Temperature 50 F to 95 F 10 C to 35 C Storage Transport Temperature 29 F to 140 F 34 C to 60 C Operating Storage Transport Relative Humidity Up to 95 Non condensing Outlet Pressure 8 0 psi 10 Oxygen Concentration and Flow Tolerance Altitude Flow Tolerance l min Oxygen Up to 6 500 ft 10 of settings 2 5 200 ml settings 0 5 1 5 87 95 6 501 10 000 ft 20 of settings 1 5 200 ml settings 0 5 85 90 When checking the concentrator s performance the oxygen analyzer used should comply with ISO 21647 standard Start up time 87 O2 Concentration 3 min Electrical AC Power 115 VAC 10 60 Hz 3 2 Amps 350 Watts Tubing Limitations 7 ft cannula with a maximum 40 ft of Crush Proof Tubing 47 ft total Equipment Classification 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 This Concentrator meets the requirements of IEC 60601 1 IEC 60601 1 2
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