EasyFlow5 User Manual (SN 51004999 and
Contents
1. OSS QuSco si c Bre does desees ess LV NVV VWN V V y W EVUU V VV VV VV VU VV VU VUUUWNCEVVUUUUV VU VV VUE VISE VISE VN VINE VUE UNS ANSE UNS UNS ANS AMANT ANS My se ANS AMAN s VROIA SE RONAN Ay MSAN SOC SOC POSSE SSH NSRDRCAA BSEC ABRE CLAUSSDRCCLAA S SS SEA SBER AS EANTA AX OO X00 9000 0 OQ XXX QU XQ OQ KOC QS XO QTL SK QL OCC EXC SI CSS S ANSON ONE NOL NO OLE NN SOLE NN OO JL COO aL MN SOL NISL NIST NIST SSNS SLT ISSIR SSL SS 000 um 9 9 4 NSS amm 9 950 0 9 amen 956 0 0 9 amm SST 6 954 0 9 NSS 050 5 aun 9 954 08 SOLS 959 ETIES EIIE IISTI SSG SSS SSCL ABD 9 959 018 SSR 017 ABD 9 9 SLT OSORIO SSSI SSS SSS NS SSG SSCSES CoS oe C O CSS Ls SS or oS ASLO SLES SOOO SOS SSS SSS ISS I ESS SCS ISO ISOC ILS OILS SIS ISG SOG SSG OS OD 2 3598 BOS 599964 S099 4 S eue S IG S9899 S600 SSSR LSS oo SSSL 335252 o SSS SSCS GOSS ROSSI SSS SSS S92 SSS 99424 SSSI SSSR SESS SSCS S LSS SIS LSS LSC SSS ODS RSS SSS SSS 506767rev4 9 13 Printed in USA2. TROUBLESHOOTING 7 Place the cannula over your ears and position the prongs in your nose as instructed by your Provider or cannula manufacturer 8 When the Concentrator is not in use press the power On Off I O switch to OFF O position 9 Unplug Concentrator from electrical outlet for complete disconnection from Power Source AWARNING ISO 8359 Standard for Oxygen Concentrators highly recommends that the patient cannula that delivers gas to the patient from the oxygen concentrator should include a Fire Stop Check Valve to stop the flow of 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 De i Nm Fire Stop Check Valve Precision Medical Part 507706 ALARM INDICATORS TROUBLESHOOTING The Audible Alarm and LED Indicators are listed in the chart below Visual Indicator Audible Probable Cause Remedy Problem Alarm YELLOW indicator Repeated Flow to patient is Remove occlusion kink or block flashes beeping occluded in patient cannula When device is Continuous Concentrator is not Make sure Concentrator is turned ON device properly plugged into properly plugged into the electrical does not function electrical outlet outlet and the GREEN Power Indicator does not light RED General Repeated System malfunction Turn power switch OFF and Alarm Indicator b
3. USER MANUAL EASYFLOWS Oxygen Concentrator Model PM4300 Series EASYFLOW5 E Q 5 o j FE A AO a 1 jn ex CL PM4351 Shown SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale by ONLY or on the order of a physician PRECISION MEDICAL 300 Held Drive Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 ISO 13485 Certified www precisionmedical com CONTENTS ISECEPATIG E INOPEO HOPB s amens ert tn NUS osi ener 2 INTENDED UCE erroaren ET 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS iteisenccnsssdasssmenseetansnniwesets 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 SPECIFICATION 5 COMPONENT DESCRIPTION rs icrtupdusetutu merbez iE PR OS IURd Rui m nrEdus 6 OPERAMNGAINSTRUYC MONS cocsunt buda da um E 0e FUA REDDE OO T ALARM INDICATORS TROUBLESHOOTING 8 MAINTENANCE CLEANING duxere eecranaiteexneedenntensuttanons 10 RETURN c 10 DISPOSAL INSTEUCD TIED pnadessau daa ri erdiren 10 REPLACEMENT PAIS 9 uiuescinsnutita p nnt ht nti rei p etna n 10 LIMITED WARRAN T Y osectasestismenurtunpud enen EEN a 11 For latest revision of this User Manual go to www precisionmedical com Oxygen Concen RECEIVING INSPECTION Remove the Precision Medical Inc PM4300 Series Oxygen Concentrator from the pack
4. 25 QOO CO A ACER So a e i lt ro C S050 oA Ce ky PAY VEN SeS stored installed maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice Precision Medical Inc is NOT responsible for the shipping cost of the Should any failure to conform to this warranty appear within the 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 authorized to make oral warranties about the merchandise described in this contract and any such statements shall not be relied upon 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 person 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 neglect or abuse of the product THIS WARRANTY IS EXCLUSIVE AND WARRANTY OF MERCHANTABILITY Precision Medical Inc applicable period Oxygen Concentrator The representatives of Precision Medical Inc or any retailers are not
5. Lm a 9 C2 HE Cary VADER lt oC gt o Ke PRR LY EN upon written S e e C2 C e re N IN LIEU OF ANY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED C ST ess C2 eo OHA AN Ce 3 i NER IS Guu Se 2 TOS ate QOO QUUC NM OQ DANA A EAN C Co SLS A S SCIO VOCE Inc shall Q Q i 2 SLS cC SoS Soy OS Or VALDE C PX KX V gt e535 e TH OOTY NOSE 2 lt lt 2 S gt QS Mn i Co Sos C ee LS TS ARR CN we S 25 7 TALS OZ OA AY NONN s Z eS 2 Se ET PN AA f LAI NN n So C2 S2 S SD So n C co reserves the right to correct clerical or three 3 years from date of purchase typographical errors without penalty Se 3 Co gt te e n i x C SSD Precision Medical C O ZS 52 DY ae XX OW Se 9 eo cC 264 X2 wee OY DNV y 5 C f i LIMITED WARRANTY 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 Co oS SeS lt vo OSes 2505 TS OON fife NN DV VIENI 2 te t Se eo j C Se Co x C Se 25 QM
6. 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 EASYFLOW5 A Oxygen Concentrator CAUTION DO NOT place any liquids on or near the Concentrator If any liquid gets on or in the Concentrator immediately turn OFF the power switch unplug from the electrical outlet and contact your Prov
7. disposal of Electronic Equipment PX REPLACEMENT PARTS DESCRIPTION PART Humidifier Adapter 507324 Tell us how we are doing Visit us at www precisionmedical com 10 ts TERN LEEREN ES ES ES PS SF HERE L S SESS PEE FEE FEE POE EEF PEEP PEE BEEBE BEEBE G0 SOS 2690 0 SOS 0995 2 905095 290 0 PSP OS OS SSS SPSS 05 25690 5 2S ROS ROS ROG ROS Re POSS MSS RSS LI OIE ISIS ISOS IO SS ISS NS NO SS GOSS CSS OC SCIONS Oo EE 01200 OG LRS Og EN 000 Org CN 01 0 0 00g LS Sor SOOO DSS LO LSS OOS LOOT GOS LOO LORI NL BOOS ooo Z0 KOS LOS 5 R w LOSS OOO AZ ete SQ KOO SZ eee PRINZ ROO KK X KKK X9 ORS SRK SOKO TOK ORA OD RA SLR OO Doc DOE x ow we Os PA A OX OX TINTS TARR ONTO HOOP Mos i SSAA AS NM SSNIANES SSIES SNL SN MES SANUUNNLE SNL SSIUINARESSIUINARESSIIUINARESSITIINNBESSITUINMEESSIIINMEESSMMIIMDESSMNIIADESSANIIAPERNITIINARERNINIIN BERN eren J MOARNEN M NV CENTS NENNEN NAM ZR VAS S22 CoA 59 9 9 um e o um FH OTRO ROSSI TINK 5 S e 2 cJ Occ OHO A SDRC PRESEN o COCR ICEL CCP UON OCA OCC OCEAN ROPER AT REO U OC IET NN VEA TAY YY TAYE XE SS i WAN f A SN MES AASS SAA Co NAE MCN AA COONAN a O ENNAN 9 SUM SOX SU oS LER QU UU SS gt O Ce gt 2 SR gt C2 TIO MATERA uU an NN Se o2 Re OO QU UU C x ro Sie ZR STK AY OAN CENA Co es 29S Xx So fi gt 05 S gt
8. L60601 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 Il Equipment Type BF Equipment General Alarm Alternating Current Power ON O Power OFF NO SMOKING AN Dangerous Voltage NO Oil or Grease DO NOT Disassemble FASYFLOW5 Oxygen Concentrator ADANGER 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 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 seek medical advice prior to using this Concentrator
9. T DESCRIPTION Missing or illegible labels must be replaced contact Precision Medical Inc Flow Setting Oxygen Flow Setting Oxygen Knob Outlet Knob Outlet ON OFF N ON OFF Switch EASY Switch Power R Power Indicator Indicator Action S AE SETOR Alarm Indicator General G Alarm Feds Indicator eim Indicator Hour Meter Serial Model Hour Meter Serial Model Label Label Model PM4350 Model PM4351 Inlet Filter Carry Handle Access Cover lo s 9 oo DA w EASYFLONS T I A i e Product Serial SE aor N E Label B a PM4351 shown AC Power Cord 4 Casters Back amp Side View Front View EASYFLOW5 6 Oxygen Concentrator OPERATING INSTRUCTIONS AWARNING e 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 e 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 Plug the power cord into an electrical outlet NOTE The Concentrator is equipped with a polarized plug
10. aging 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 f you do not understand this manual DO NOT USE the Concentrator and contact your Provider ADANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS l min Liters Per Minute LED Light Emitting Diode EASYFLOW5 2 Oxygen Concentrator SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION ASSIA Y o Vus o R o BH IPX1 0 o Y 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 PM4300 WITH RESPECT TO ELECTRICAL SHOCK FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH U
11. eeping wait 5 minutes then turn back is ON steady ON If condition persists turn or continuously the concentrator OFF connect blinking device to another source of oxygen and stops functioning contact your Provider RED General Alarm Single beep Momentary AC power It is normal for this to occur Indicator flashes interruption occasionally such as during once device severe weather however if this momentarily stops condition persists connect to functioning then another source of oxygen and automatically contact your Provider restarts Continued on next page EASYFLOWS Visual Indicator Audible GREEN Power Indicator is ON YELLOW and RED General Alarm Indicators are flashing and device is running Repeated beeping RED General Alarm Indicator is flashing while beeping device stops functioning Repeated beeping PM4351 ONLY YELLOW Oxygen Concentration Indicator is ON steady PM4351 ONLY YELLOW Oxygen Concentration and RED General Alarm Indicators are ON while beeping device stops functioning Repeated beeping No flow from nasal cannula Limited or no oxygen flow EASYFLUWS Oxygen Concentrator Device overheating Device overheating Low oxygen concentration Very low oxygen percentage Kinked tubing Nasal cannula has become disconnected from oxygen outlet on concentrator or from extension tubing Connecti
12. ider 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 Ibs 13 4 kg Shipping Weight 33 9 Ibs 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 29F to140 F 34C 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 10 of settings 2 5 SD ID DISUONE 200 ml settings 0 5 1 5 itin 20 of settings 1 5 6 501 10 000 ft 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 lt 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 ll 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 IEC 60601 1 4 and Safety Requirements for ISO 8359 Specifications are subject to change without prior notice Oxygen Concentrator 5 COMPONEN
13. on between bubble humidifier and oxygen outlet on concentrator has become loose Dirty or obstructed bubble humidifier or leak present 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 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 Continue to use concentrator but contact your Provider Turn the concentrator OFF connect to another source of oxygen and contact your Provider 1 Check tubing and nasal cannula for kinks 2 Check cannula and tube fittings for proper connection 3 Tighten bubble humidifier bottle Remove the bubble humidifier bottle and if flow is restored clean or replace the bubble humidifier Visual Indicator Audible Probable Cause Remedy Problem Alarm Condensation Concentrator not properly Ensure Concentrator is collects in the ventilated elevated positioned away from curtains oxygen tubing operating temperatures or drapes hot air registers or when yo
14. 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 I O switch to ON 1 position The Power Indicator light below the On Off 1 O 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 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
15. u use a heaters Be certain to place the bubble humidifier Concentrator so all sides are at bottle 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 MAINTENANCE CLEANING AWARNING DO NOT remove cover or attempt to repair There 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 O 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 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
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