USER MANUAL - MedToYou.com
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1. USER MANUAL FASYFLOW5 Oxygen Concentrator Model PM4300 Series IEEE ae um EASYFLOW5 Oxygen Concentrator ir 3 2 35 J 4 1 5 i 5 5 LPM O Amer oe 0 9 Of PM4351 Shown SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by 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 RECEIVING INSPECTION sicsstecsesnazaneetcastaxcuadientigeaceauasctdenseeatense 2 INTENDE D US E Le 2 READ ALL INSTRUCTIONS BEFORE USING oseese 2 EXPLANATION OF ABBREVIATIONS rnvnevvvnrrrnnnrrrvvvennrrnnnsrreen 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 PE PTBN 5 COMPONENT PES PIN 6 OPERATING INSTRUG HONS susen 7 MAINTENANCE CLEANING hvvvvvvvvnrrnnnvrrvvvvnrrnnnnrererennrrrnnsennnn 10 FM I LE 10 DISPOSAL INSTRUCTIONS snvuunrvnrrrnnvrrnvvvnnrnnnnnernrrennrrnnnennnnne 10 REPLACEMENT PARTS een 10 LIMITED VARNA 11 Oxygen Concen 1 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 to2. Humidifier Adapter 507324 Tell us how we are doing Visit us at www precisionmedical com LOWS5 1 0 Oxygen Concentrator gt yy e O RR RE REE RS SS SSS SSE SSE SESS TEEPE IEEE 2 OS IK gt gt IRS gt ISI KAKE gt I OS GASK 06 0 gn 0 0 DE gin 0 0 ny gt SSS SSRS RSS OOS TOO OOS HOO VOC TOO POC DOO POR TOO POA THO PORT OTOP OTTO OTRO DIY ATR ATR Ot TK DAT OTRA Or HY OT Or HY OTH Or 7 SSA STIRS TITAS TALK KS FRIST VIKNA STIER SST STIER STAT ATTER STIRRER SOOO OOO SOOO TO NOOO ATE SOTO STIKK SETERS STIKK SATIRE TISSA OTIS STK ATO TI INA SN R A SN SSR SA FR RS IS INNEN ERNST ESN PO ANS NESEN OE NN COVALENT AY PTR AFR AA AS SN AA SA AA SSN SANN ANNAN NANNA ENN SANMAAZSANM W h oO SS So SeS VV esas SOS SOS 253 OQ gt gt eS SOS KR Sorte SF KAN MAR o NKS SS 52 SSS KO ES A mut R on So XX SSX VV VW WN OTERO KO IS 2 ss SS 2 2 RR 7 2 V N X 29 V VVV NO NERY TI PISS 2 SS EE Q O 3 2 FSL V VVV NEA ASD LI ISS 55 gt V N 2 pa 2 3982 VN V NEED LIISA FLIS SO SAS lt T UV VAN DA TN SG A I gt 2S SS S SeS eS O So AND LIMITATION OF LIABILITY S SSe SES 202 2 Se 3 Sos SC gt 2 gt y 0 2 U DV SN amet TI SSG AS S2 18 months or 12 000 hours which ev
3. IPX1 A NO SMOKING AN Dangerous Voltage EASY NO Oil or Grease Q DO NOT Disassemble Oxygen Concentrator gt 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 Use the Concentrator for its Intended Use as described in this manual Inthe 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 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 es
4. PE ASS Y nN SL Ke EL RE O Y O ND XXx905 RR MENE a EN GS x ete ji N LS O a8 4 il IS 2 OD ZE XS soley ERS O SERN D ESS re D SS O Seal a C EZAN ELN ERRAN LSN OP S N E S YNENE EAN NNN NS NONE NOU ONE NNN S844 NES YA SAN nse i j i Seay ese SAAN NN NNN ENN EN S NNENE NENNE J se WYNN NNN NNN NE 7 SSS SSA SSE TO SS START OLE OS SSS KSSE KES SOS SSE ASIII JE ST OSSES EN ENN RT RLY SOOT OST OOS OT OST OT OI SOOT SOIL ILI SSO ILI SOILS LI SOLIS QI SSIS IQ LI SSS SSS RTS LS RSS SL SSL SOL SLL SSS 25 SSSR SSS SESS RSS SOE LISS ESS LISS ESOS SESSLER ES SSCS SOLES SRL SSC SSS SSS SSS SSS LSS NL SSS SSS SRS EE SSS SSS SS SSS SSS SS SOS SSS SSS EE En SB SB SSS SSSR SR SSS SSS SO ES SSS So Tmnamv __IOwoROoOO2 DWT7 onananaoo DrQQOQan om am mm gt mm mmmr33mm gt m gt E 506767 RevO 05 01 12 Printep in USA
5. bubble humidifier instructions NOTE Be sure not to cross thread this may cause a leak e 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 I position The Power Indicator light below the On Off T 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 e 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 EASYFLOW Oxygen Concentrator gt 7 Place the cannula over your ears and position the prongs in your nose as instructed by your Provider or cannula manufacturer DNR 8 When the Concentrator is not in use press the power On Off 1 O switch to OFF O position 9 Unplug Concentrator from electrical outlet for complete disconnection from Power Source ALARM INDICATORS TROUBLESHOOTING The Audible Alarm and LED Indicators are listed i
6. T S as r EASYFLONS a q J kh el Product i Serial i i Label Back Side View 5 5 Front View 4 Casters AG Power Cord Oxygen Concentrator gt OPERATING INSTRUCTIONS AWARNING e Read this User Manual before operating the Concentrator e 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 e 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 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
7. 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 A DANGER 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 2 Oxygen Concentrator gt SAFETY INFORMATION WARNINGS AND CAUTIONS A DANGER Indicates an imminently hazardous situation which if not avoided will result in death or serious injury AWARNING Indicates a potentially hazardous situation which if not avoided could result in death or serious injury ACAUTION 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 PM4300 WITH RESPECT TO ELECTRICAL SHOCK i T 4 FIRE AND MECHANICAL HAZARDS ONLY IN US ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 No 601 1 Caution U S Federal Law restricts this device to ONLY sale by or on the order of a physician Ci an N CONSULT ACCOMPANYING DOCUMENTS Degree of protection against ingress of liquids Class Il Equipment Type BF Equipment General Alarm Alternating Current Power ON O Power OFF
8. er comes first hours which ever comes first lt SD o Ss Q2 S 29 75 vi eo SeS 2 LIMITED WARRANTY 29 2 ZK x S9 y uy v gt gt VU V NEED WS LEA SEES Se 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 A complete and exclusive statement of the terms of that contract OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR 8 OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED all liabilities of Precision Medical Inc whether based on contract maintained and operated in accordance with Precision Medical Inc s instructions and standard industry practice and that no modifications applicable period Precision Medical Inc shall upon written notification q thereof and substantiation that the goods have been stored installed ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES materials designs or specifications without notice amp authorized to make oral warranties about the merchandise described a THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY g typographical errors without penalty gd Of non conformities as provided above shall constitute fulfillment of 5 u ka a AX aie O 4 XK ESSN Oo Ps ER SSA O Er a y HT Si aes 4 I SL SS ED OO OD SSK va n Q ESS 7 O An ES HM Q pr D s sf
9. n Concentrator 2D Visual Indicator Audible YELLOW Oxygen Concentration Indicator is ON steady YELLOW Oxygen Concentration and RED General Alarm Indicators are ON while beeping device stops functioning No flow from nasal cannula Limited or no oxygen flow Condensation collects in the oxygen tubing when you use a bubble humidifier bottle Oxygen Concentrator gt Repeated beeping Low oxygen concentration Very low oxygen percentage Kinked tubing Nasal cannula has become disconnected from oxygen outlet on concentrator or from extension tubing 3 Gonnection between bubble humidifier and oxygen outlet on concentrator has become loose Dirty or obstructed bubble humidifier or leak present Concentrator not properly ventilated elevated operating temperatures 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 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 f
10. n the chart below Visual Indicator Audible When device is turned ON device does not function and the GREEN Power Indicator does not light RED General Alarm Indicator is ON steady or continuously blinking device stops functioning RED General Alarm Indicator flashes once device momentarily stops functioning then automatically restarts RED General Alarm Indicator is flashing while beeping device stops functioning Continuous Concentrator is not properly plugged into electrical outlet Repeated beeping system malfunction Momentary AC power interruption Repeated beeping Device overheating Continued on next page 8 Make sure Concentrator is properly plugged into the electrical outlet 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 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 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 24cm away from a wall or other obstruction DO NOT place concentrator in a confined area Oxyge
11. pecially 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 4 Oxygen Concentrator gt 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 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 Ibs 13 4 kg Shipping Weight 33 9 Ibs 15 4 kg Altitude Sea Level to 10 000 ft 8 048 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 Sto
12. rage 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 po 200 ml settings 0 5 1 5 ke 20 of settings 1 5 R 6 501 10 000 ft 200 ml settings 0 5 ER When checking the concentrator s performance the oxygen analyzer used should comply with ISO 21647 standard Start up time 87 Oz 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 Il 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 EASYFLOW Oxygen Concentrator gt COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc Flow Setting Knob Oxygen Concentrator 5 2 5 Oxygen Outlet ON OFF Switch Power Low Oxygen Indicator Concentration Alarm Indicator General Alarm Indicator Hour Meter Carry Handle inlet Filter me Carry Handle Se Access Cover T
13. rom 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 Manuals available on our Website 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 SZ a sy REPLACEMENT PARTS
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