USER MANUAL - Vienna Medical
Contents
1. USER MANUAL EASYPLISE POL PORTABLE OXYGEN CONCENTRATOR Model PM4150 Series E wm oe Se D em mmm Lem emm 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 www precisionmedical com CONTENTS RECEIVING NPE TN 2 NIENDEDUSE 2 READ ALL INSTRUCTIONS BEFORE UGING 2 EXPLANATION OF ABBREVIATIONS ruervrrrrrnnnnrrnnnvrnvrrrnnnnnnn 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 2 FEIN 4 COMPONENTDE SS RPTON kvener 5 OPERATING INSTRUC MONS eres 6 Using the EasyPulse PIN Lu 6 PFOS T Using the Carry Bag E T POWER SUPPLY EE 9 ACCESSORIES REPLACEMENT DARTS 10 ALARM INDICATORS TROUBLESHOOTING 04 10 MAINTENANCE CLEANING emsrrrrrnnnrrrrvvnvrrrrnnnnnrnnnvnennrrrnnnnnnn 12 RETURNO erria acess oaetete tetra E E E R 13 DISPOSAL INSTRUCGTIONS Lue 13 LIMITED RR 15 EASYPLISE POC Portable Oxygen Concentrator 1 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 PM4150 is intended to provide supplemental oxygen to persons requiring oxygen therapy The Precision Medical POC can be used in a2. 345 8570 Fax 31 0 70 346 7299 Product Portable Concentrator Model s PM4150 MDD Class IIb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD As delivered the object of the declaration described above is in conformity with the requirements of MDD 93 42 EEC Annex II 3 and Directive 2007 47 EC of The European Parliament and the following documents BS EN 60601 1 BS EN 60601 1 2 BS EN 60601 1 8 EN 980 EN 1041 IEC 60601 1 4 IEC 60601 1 6 ISO 3744 IEC 62366 ISO 3744 ISO 8359 ISO 14971 ISO 15001 ISO 15223 1 Notified Body for Product Safety TUV Rheinland Products Safety GmbH C 0197 Certification Registration No s HD 60019110 0001 Date of Expiry 03 08 2012 PRECISION MEDICAL ISO 13485 Certified Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Be 001 610 262 6090 9 001 610 262 6080 www precisionmedical com 506640 Rev1 07 27 11 PRINTED in USA
3. H O Kr CO E b 8 pe S Sc S D 8 lt a S Le 8 Q Q O 8 3 Q Mn O G gt D C materials designs or specifications without notice material for the following period Portable Oxygen Concentrator XXS d Ce KKK Kees Sch VS SAK Wie za e EZ AS ENN Xe OO0 LAN ee O00 LN Ne dees S Oh DOSS SVO re SPP Ee aid Dees AS Z e LA Ac d ZHAO KSS Gredt OSS OO V ESX VES SOK GS TG OI As D Ke ONY LN Ae St Lt LAN el Weit 4 typographical errors without penalty we SS Ses THIS WARRANTY 8 EXPRESS OR IMPLIED SEV NNN ANNE NNN NNN NSS NSE NSE Se NS NSO MESSER o LAV Arash tten Q LN TN NN me me rms rms LN ENER X mth Wr Se NS OO NS EN ES EEE ES SG EN CEES EC CS NC OE ORS FF ST SS SSS x CG ee EE Ee Co KEE SSS SSS SSS SS SSS SES SL ESS SSS SSS SS 058 LSS SR SR SR SSS See Ge 50522 50529 SSBB SSS SSS SSS SS OS OSS OFF OOS OS SSSR LU D PER OOO NN TL SSG A 3 wat OIRA 8 Li KL Kj L 8 e SSL SS SSS LISS KG ON Eh 2 a Le L pp i gt O 2 Q L 2 Q 2 SS SESS EASYPLISE PIC Portable Oxygen Concentrator 14 DECLARATION OF CONFORMITY Manufacturer Authorized European Representative Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Emergo Europe European Office Molenstraat 15 2513 BH The Hague The Netherlands Phone 31 0 70
4. It may be necessary to allow the POC to warm up or cool before turning back on Turn off the POC Check that the inlet filter is clean 3 Ensure inlet and exhaust vents are not blocked in any way Verify you are operating the POC within the specified operating temperature range It may be necessary to allow the POC to cool before turning back ON Turn the POC to the OFF position Turn the POC back ON to prescribed setting If alarm persists change to alternate oxygen source and contact your Equipment Provider Turn the POC to the OFF position Turn the POC back ON to prescribed setting If alarm persists change to alternate oxygen source and contact your Equipment Provider Turn the POC to the OFF position Turn the POC back ON to prescribed setting If alarm persists change to alternate oxygen source and contact your Equipment Provider Amber alarm NA Service Needed 1 Continue to use POC indicator is flashing 2 Contact Equipment Provider and unit is running Red alarm indicator NA Service Needed 1 Switch to another source of is flashing and unit oxygen is running 2 Contact Equipment Provider EASYPLISE POC Portable Oxygen Concentrator 11 MAINTENANCE CLEANING Prior to cleaning ensure the POC is turned off and unplug any external power sources DO NOT disassemble or attempt to repair There are no
5. is on When the battery charge level drops to 15 the last LED will turn solid red and a brief audible beep will be emitted once every minute When the battery charge level drops to 5 the last LED starts to flash red and a brief audible beep is emitted once every 20 seconds to signal that the battery is almost depleted and you will need to connect the POC to another power source Charging The internal battery can be charged by connecting either the AC Power Adapter or DC Power Adapter to the POC The internal battery will begin charging as soon as power is connected You will also be able to run the POC while the internal battery charges EASYPLISE PDC Portable Oxygen Concentrator 9 ACCESSORIES REPLACEMENT PARTS Precision Medical Inc recommends that only the items listed below be used with the POC Inlet Filter 505847 AC Power Supply 506629 DC Power Supply 506750 Carry Bag 506707 504833 Other Power Cord Plug combination for the AC Power Adapter available thru Precision Medical Inc ONLY ALARM INDICATORS TROUBLESHOOTING The Audible Alarm and LED Indicators are listed in the chart Visual Indicator The last LED onthe Repetitive beep Internal battery has Connect the POC to the AC internal Battery Level dropped below 15 Power Adapter DC Power Indicator turns red charge remaining Adapter or external battery pack The last LED on Repetitive beep Internal battery has 1 Connect the POC to the AC the intern
6. 5 94 kg Sea level to 9000 ft 2743 m 41 F to 104 F 5 C to 40 C 4 F to 140 F 20 C to 60 C Operating Storage Transport Relative Humidity Oxygen Concentration Up to 95 Non Condensing 87 to 95 Start Up Time 87 O2 Concentration lt 10 min Oxygen Minute Volume Setting 1 240 15 mL min Setting 2 380 15 mL min Setting 3 520 15 mL min Setting 4 660 15 mL min Setting 5 780 15 mL min Mode of Delivery Pulsed Dose only Trigger Sensitivity 0 50 cmH O maximum Trigger Delay 0 11 seconds typical Power AC Power Adapter 100 240 VAC 1 0 A Q 120 VAC DC Power Adapter 11 16 VDC 5 0A 12 VDC Battery Duration Setting 1 4 5 hrs Approximate Setting 2 3 2 hrs Setting 3 2 5 hrs Setting 4 1 8 hrs Setting 5 1 5 hrs Sound Setting 2 44 dBA Cannula Maximum 7 ft 2 1 m long standard adult single lumen nasal cannula 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 Volatile Organic Compound VOC and Particulate Requirements The oxygen delivered from the EasyPulse POC meets the following requirements for particulate levels VOC levels carbon monoxide levels carbon dioxide levels and ozone levels EPA DM Particulate Matter ASTM D5466 Ozone Levels 21 CFR 801 415 Carbon Monoxide Levels EPA NAA
7. QS Carbon Monoxide Carbon Dioxide Levels OSHA Permissible Exposure Limits Standard Test Method for Determination of Volatile Organic Chemicals in Atmospheres Canister Sampling Methodology At Sea level Specifications are subject to change without prior notice EASYPLISE PIC 4 Portable Oxygen Concentrator COMPONENT DESCRIPTION Missing or illegible labels must be replaced contact Precision Medical Inc Ge ee EES 8 gt Setting Knob Oxygen Outlet Fitting Internal Battery Level Indicator Ke Power Input Jak gt Precision MP Alarm Indicator Setting Indicator Exhaust Vents len wem Inlet Filter tad UPTON PA 18087 E MADE Product ret Serial Label AEE LOGO gt 95 EASYPLISE PUC Portable Oxygen Concentrator 5 OPERATING INSTRUCTIONS AWARNING Read this User Manual before operating the POC The POC shall be used by an adult or supervised by an adult when being used by a child Additional monitoring or attention may be required for patients using this POC who are unable to hear or see alarms or communicate discomfort The Setting Knob does not rotate 360 Rotating the knob less than the OFF position or over setting 5 will damage the Concentrator For Proper Oxygen Flow be sure that cannula is not kinked or obstructed before or during use DO NOT use humidifier bottles with the POC DO NOT use pediatric low flow nasal cannulas or oxygen m
8. S S D ete go Ee Lat SS IN LIEU OF ANY g eo ee lt 2 Pn 4 SSS Qi EE I SSS gt SS x t 29 e EE e NIE FD GE KANN Gei E Ge 2 S2 gt SRR EE RR ENN LE NN f d WK ss SRR NIR NN AAN Q dek t M Q2 de SSeS Gei ei ei Go d mv a S de Kast cS ge gt Gei V se 2 2 2 d 2 SS S2 gt 2 W t gt Se SS OR LAL RAM S t LIMITED WARRANTY three 3 years from date of shipment 90 days from date of shipment 2 H de e NA XS 22 SS ge gt SS Se RR SF INN VANN Gei KO OSS de ae oS Le cht K C gt ei Ze 7 AA ANN AN 5 2 lt O lt 2 E e Ac e en Ke gt X Ke Z AE e SN ra A Lu BAM SS d Q V lt 2 So IS EXCLUSIVE AND Se NG ES eeng ee Ge d i L L 5 K gt O ER 3 Se EE KC EN Odd SANN SLS lt Kei SES TO SoS CH Zei KA DEZ MENN So Ze 2 Sos HO ANT EO WI an DAN D Gef A CO IS Le lt 3 2 Ka Se SD A LIMITATION OF LIABILITY oe Q Li A Dh 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 LO O ws 2 Em em dy d O E Q C S 3 LO K S LO
9. a single lumen adult cannula with a maximum length of 7 ft 2 1 m The Setting Knob does not rotate 360 Rotating the knob less than the OFF O position or over setting 5 will damage the Concentrator DO NOT use Components Accessories not recommended by Precision Medical see ACCESSORIES REPLACEMENT PARTS TO REDUCE RISK OF BURNS ELECTROCUTION FIRE OR INJURY TO PERSONS Keep away from heat or open flame DO NOT use anAC 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 The POC is designed to be used indoors or outdoors in the outdoors environment the POC should be used in a dry location with Battery only POC is designed to be used in dry conditions the POC is not to be submerged or operated under water EASYPLISE PIC Portable Oxygen Concentrator 3 CAUTION DO NOT place any liquids on or near the POC If any liquid gets on the POC immediately turn OFF the power switch and unplug from the electrical outlet SPECIFICATIONS Dimensions Weight Shipping Weight Altitude Operating Temperature Storage Transport Temperature Height Width Depth 10 1 in 6 5 in 4 5 in 25 7 cm 16 5 cm 11 4 cm 6 8 Ibs 3 08 kg 13 1 Ibs
10. al Battery dropped below 5 Power Adapter DC Power Level Indicator charge remaining Adapter or external battery flashes red pack Change to alternate oxygen source if power source is not available Amber alarm indicator Repetitive beep No breath detected 1 Verify the cannula is not kinked is illuminated and for 1 minute 2 Verify the cannula is properly setting number is connected to oxygen outlet not flashing during Verify the cannula is properly inhalation to signal a positioned in the nose detected breath Red alarm indicator Repetitive beep No breath detected 1 Verify the cannula is not kinked is illuminated and for 2 minutes 2 Verify the cannula is properly setting number is connected to oxygen outlet not flashing during Verify the cannula is properly inhalation to signal positioned in the nose a detected breath If alarm persists change to alternate oxygen source and contact your Equipment Provider Amber alarm Repetitive beep Breath rate Reduce level of activity to allow indicator is exceeding 35 breath rate to slow illuminated breaths minute Red alarm indicator Repetitive beep Breath rate 1 Reduce level of activity to is illuminated exceeding 35 allow breath rate to slow breaths minute 2 If alarm persists change to for longer than alternate oxygen source and 1 minute contact your Equipment Provider Red alarm indicator Repetitive beep Abnormal 1 Turn the POC to the OFF is illuminated u
11. asks with the POC e Inspect the POC for visual damage before use DO NOT USE if damaged e To prevent damage to the POC DO NOT operate the POC without the inlet filter or while the inlet filter is wet Using the EasyPulse POC 1 Connect the end of a standard adult single lumen oxygen nasal cannula with a maximum length of 7 feet 2 1 m to the POC s oxygen outlet fitting J OR j A 3 Prior to operation ensure the inlet and exhaust vents on the POC are clear Any blockage of the vents can inhibit performance 4 Choose one of the 3 power options AC Power Adapter DC Power Adapter or Internal Battery Refer to the POWER SUPPLY section of the user manual for details on these 3 options 5 Turn ON the POC by rotating the setting knob clockwise until the knob points to your prescribed flow setting number and the number is illuminated green 6 Breathe normally through your nose A measured pulse of oxygen will be delivered each time the POC senses an inhalation To show the POC is triggering properly the illuminated setting number will turn off briefly each time it senses an inhalation 7 To turn OFF the POC rotate the setting knob counterclockwise to the OFF 0 position 2 Place the cannula over your ears and position the prongs in your nose as instructed by your Equipment Provider or cannula manufacturer EASYPLISE PC 6 Portable Oxygen Concentrator Operating Position The POC can b
12. e operated in an upright position with or without the carry bag as shown below The POC can be operated lying on its back ONLY while in the carry bag as shown below Using the Carry Bag The carry bag is intended to make the POC easier to transport prevent movement due to vibration and protect the device from minor mishaps CAUTION The carry bag is not intended to make the POC waterproof or to protect the device from major falls or accidents abuse When inserting the POC into the carry bag make sure of the following e Before placing POC inside bag make sure bag is clean and empty e Make sure the control knob and control panel are aligned with the clear window on the bag e Make sure bottom exhaust vents are aligned with the mesh opening along the bottom of the bag EASYPLISE PIC Portable Oxygen Concentrator T Control panel and clear window properly aligned ees CHE Exhaust t d h area properly aligned e er propeny alg Proper carrying position AWARNING e The mesh on the carry bag must be aligned with the exhaust vents on the POC to keep the POC cool and operating properly Be sure the exhaust vents are facing away from body while being carried Ifthe outside of the bag feels hot or causes any discomfort set the POC down and check to be sure all vents are unobstructed DO NOT cover Air Vents the POC requires proper ventilation DO NOT allow the POC to come in direct contact with skin whi
13. erating 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 e DO NOT use while bathing e DO NOT reach for the POC that has fallen into water Unplug immediately e DO NOT attempt to repair POC Any attempt could result in electrical shock 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 ALWAYS keep the POC in an upright position during operation 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
14. 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 A DANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS mL min Milliliters Per Minute LED Light Emitting Diode OC Portable Oxygen Concentrator SAFETY INFORMATION WARNINGS AND CAUTIONS mr EH roster ee EES SI Oy PM4150 WITH RESPECT TO ELECTRICAL SHOCK FIRE L y AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH UL60601 1 IEC60601 1 CAN CSA C22 2 No 601 1 R Caution U S Federal Law restricts this device to sale by or on ONLY the order of a physician Wen CONSULT ACCOMPANYING DOCUMENTS This device may contain electrical components that are hazardous to the Le environment DO NOT dispose device into standard trash Contact your local waste Management for disposal of Electronic Equipment Excessive Heat Warning A El Class II Equipment Type BF Equipment General Alarm Direct Current O Power OFF IPX1 Drip Proof Equipment DO NOT NO SMOKING SN ETT amp NO Oil or Grease 2 Portable Oxygen Concentrator DANGER 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 Op
15. ilable 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 EASYPLISE PIC Portable Oxygen Concentrator 13 gt gt gt Se gt gt Pas Ss gt gt gt e gt gt gt gt gt gt SJ SSS ef RSS RE RRS RRS PRR REE RS RENE O S SS RRS RES di lt 22008 SS 225056 2255 25 mete 2 lt 2 ZS 2255 HRS RSS 2 deg Ge SSRS COLS LSR SOS RRSO ROSS RRSO RNS TRIST O Q OOOO OOOO TRS OSS a OOOO ON LOCOCO OC OOOO SOOO OO COON ARNE RNA SS e SS S5 22 cs 22 S5 SE SATS SST LK SSSI SSS FRE SS w CZ FIIN FIN OR e SR oO TERR a em HOO FS SNE ENN ENN EU ENN ENN OQ O SSS PARR SEER SO SAMAN LA O x oer a ERIE DI V Ka 2 SG a Q f Se Q ee v Y D 2 ag RO Ge s me gt S ZH Ss STE KAN ANNA NSA 4 Ge RS 2 Se gt Se I R535 Q d it Ce Go it o Ss 8 gt WE d dh ere BRYCE ENNEN de ei OSes 5 XS 4 d d CS ete IT and YS SS Echt d 2 d i So Zeg I R KS MR PAN NN MENN N oO 2 SHO Orr HOY LCE ONS HASAN A LL AN N D gt Ge O
16. le in the carry bag The carry handle can be placed in either of the positions below with the flap secured FASYPULSE POC 8 Portable Oxygen Concentrator POWER SUPPLY AC Power Adapter The AC power adapter connects the POC to a 100 240 VAC 50 60 Hz wall outlet The power adapter converts AC voltage to DC voltage in order to power the POC The AC adapter will power the POC and simultaneously charge the internal battery Connection To connectthe AC PowerAdapter to the POC insert the DC plug connector into the power input jack on the POC and insert the AC wall plug into a wall socket North American Cord Shown 110 Volt 10 Amp ONLY Red DC Plug AC Wall Plug gt DC Power Adapter The DC power adapter connects the POC to an automobile s 12 VDC outlet The DC adapter will power the POC and simultaneously charge the internal battery Connection To connect the AC PowerAdapter to the POC insert the DC plug connector into the power input jack on the POC and insert the other end into your automobile s 12 V accessory jack _ x Ja Auto Accessory Plug Internal Battery Pack The POC contains an internal rechargeable lithium ion battery pack When fully charged the battery will power the POC for up to 4 5 hours dependent upon setting The Battery Level Indicator in the upper right corner of the control panel continuously displays the charge level of the internal battery while the POC
17. nit compressor position is not running and operation detected 2 Turn the POC back ON to setting numbers 1 amp prescribed setting 2 are flashing 3 If alarm persists change to alternate oxygen source and contact your Equipment Provider EASYPULSE PIC 1 0 Portable Oxygen Concentrator Visual Indicator Audible Alarm Probable Cause Remedy Problem Red alarm indicator is illuminated unit is not running and setting numbers 1 amp 3 are flashing Red alarm indicator is illuminated unit is not running and setting numbers 1 amp 4 are flashing Red alarm indicator is illuminated unit is not running and setting numbers 1 amp 5 are flashing Red alarm indicator is illuminated unit is not running and setting numbers 2 amp 3 are flashing Red alarm indicator is illuminated unit is not running and setting numbers 2 amp 4 are flashing Repetitive beep Repetitive beep Repetitive beep Repetitive beep Repetitive beep Internal battery is outside its operating temperature range Motor is above it s maximum operating 2 temperature Pressure outside of normal operation Fan malfunction Failed electrical connection 1 Turn off the POC and disconnect any power supplies Check that the inlet filter is clean Ensure inlet and exhaust vents are not blocked in any way Verify you are operating the POC within the specified operating temperature range
18. user serviceable parts inside Contact your Equipment Provider for service DO NOT spray or apply any cleaners directly onto the case DO NOT allow any liquids to drip inside any case openings Perform cleaning as required Cabinet 1 The patient should connect to an alternate Oxygen source 2 Turn the POC to the OFF position 3 Unplug the external power source before cleaning 4 Clean exterior surfaces of the POC with a cloth dampened with disinfectant solution Example Sporicidin Brand Disinfectant Solution 5 Allow POC to air dry 6 DO NOT place inside carry bag or run the POC until it is thoroughly dry When not in use store the POC in a clean area free from grease oil and other sources of contamination N Inlet Filter 1 Remove the inlet filter by pulling on the protruding tab 2 Wash filter with mild detergent Rinse thoroughly with water and allow to dry completely 3 Once filter is dry push the filter back into the case so only the small tab is protruding e e P lt e Inlet Filter wf Tab 4 e ua aa Hm EASYPULSE PIC 1 2 Portable Oxygen Concentrator 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 ava
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