USER MANUAL - Medical Dynamics, Inc.
Contents
1. NEVER use near any type of flame or flammable explosive substances vapors or atmosphere DO NOT use oils greases lubricants or any combustible materials on or near this product Wash hands properly prior to usage DO NOT touch liquid oxygen or parts that have been in contact with liquid oxygen Liquid oxygen is extremely cold 297 F 183 C When touched liquid oxygen or parts of the equipment that have been carrying liquid oxygen can freeze skin and body tissue TO AVOID INCREASED RISK OF FIRE Keep this equipment away from electrical appliances Use and store Reservoir and Portable units at least five feet from electrical appliances that may cause heat or sparks Keep oxygen equipment away from open flames Use and store Reservoir and Portable at least five feet away from equipment such as furnaces water heaters and stoves that may contain open flames Keep equipment in a well ventilated area at all times These devices periodically release small amounts of oxygen gas that must be ventilated to prevent buildup DO NOT store liquid oxygen equipment in a closet car trunk or other confined area DO NOT place blankets draperies or other fabrics over equipment High concentrations of oxygen can cause rapid burning of other substances ALWAYS confirm prescribed dose before administering to patient and monitor on a frequent basis DO NOT carry the Portable device under your clothing These devices normally vent oxyge2. NOTES S e dated o did mte tu nds 16 WARRANTY tete ke yt e tri id ap m i E er RID RAE 17 DECLARATION OF 18 RECEIVING INSPECTION Remove product from package and inspect for damage If there is any damage DO NOT USE and contact your Equipment Provider READ ALL INSTRUCTIONS BEFORE USING Read and understand this manual before using the device This manual is provided for your safety and to prevent damage to the device If there is anything you do not understand DO NOT USE and contact your Equipment Provider EASYMATE SAFETY SYMBOL DESCRIPTION ADANGER AWARNING ACAUTION CAUTION 0197 TT 0035 gt ede E eer fis 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 could result in property damage Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning medical devices and all applicable International Standards On CE marked Devices ONLY Symbol indicates the pressure ve
3. to keep the device steady and maintain proper filling position 9 Release the Vent to Fill lever on the Portable System as soon as you notice a change in the sound of venting gas followed by a dense white vapor coming from the Reservoir cover NOTE The maximum time to fill a PM2200 PM2202 PM2203 PM2201 30 seconds 15 seconds ACAUTION operation If the Vent to Fill lever fails to close and the hissing continues remove the Portable from the Reservoir by depressing the release button on the Reservoir unit The Portable will stop venting in a few minutes The Portable may require as much as 30 minutes to restore normal 10 Disengagement PM2200 PM2203 Disconnect the Portable System from the Reservoir by pulling in an upright motion Always hold the device with at least one hand when attempting to disconnect it Figure 2 PM2201 PM2202 Figure 2 Disconnect the Portable System from the Reservoir by rotating it in counterclockwise direction until the device separates The device may now be removed from the Reservoir NOTE 1 Itis common to hear a hissing sound after the Portable System has been filled This is the relief valve venting excess gas pressure Upon disengaging the Portable System from the Reservoir it is common to see condensation on or near the fill connector 2 Itis common to have a few small droplets of liquid ox
4. as you inhale 6 Insert Portable System into the carry bag 3 Place the cannula in position by inserting the two tips into your nostrils running the tubing over your ears and then routing the cannula as shown in Figure 5 Jj AWARNING Carry bag may become saturated with oxygen which could cause it to burn rapidly if exposed to sparks or flames It may take several hours for the oxygen levels in fabric to return to normal Liquid Oxygen System 1 1 Positioning Device Figure 6 Always keep the Portable System in an upright position while in use as illustrated in Figure 6 Placing the device on its side or upside down will shorten the usage time device Using the Carry Bag Figure 7 illustrates how the device should be placed in its bag Ensure the device is oriented so there are no obstructions to the cannula connection The options on how to use the carry bag with the device are illustrated below Figures 8 10 Figure 7 Precision Mo Figure 9 12 SCO CLEANING 1 As needed clean exterior of the device with a clean lint free cloth dampened with water Allow device to dry prior to use 2 Store device in a clean area free from grease oil and other sources of contamination 3 Replace Carry Bag Liner as needed A WARNING DO NOT allow water
5. liters 2000 volume part 3 opertional requirements EN 13544 2 Respiratory Therapy Equipment Part 2 Tubing And Connectors 2002 EN 1418 Welding personnel approval testing of welding operators for fusion welding and 1998 resistance weld setters for fully mechanized and automatic welding of metallic materials ENISO 10993 1 Biological Evaluation of Medical Devices Part 1 2003 ENISO 10993 5 Biological Evaluation of Medical Devices Part 5 1999 EN ISO 10993 10 Biological Evaluation of Medical Devices Part 10 2002 A1 2006 EN ISO 15001 Compatibility of Medical Equipment with Oxygen 2003 ISO 14971 Medical Devices Application of Risk Management to Medical Devices 2000 A1 2003 ISO 18779 Medical Devices for Conserving Oxygen and Oxygen Mixtures Particular 2005 Requirements Notified Body for Product Safety TUV Rheinland Products Safety GmbH C 0197 Certification Registration No s HD 60009110 0001 Notified Body for Pressure Equipment TUV Rheinland Pressure Equipment GmbH Certification Registration No s 01 202 USA 06 2888 TT 0035 18 Liquid Oxygen Systom u PRECISION MEDICAL ISO 13485 Certified Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Toll Free Tel 800 272 7285 Toll Free Fax 800 353 1240 Tel 001 610 262 6090 Fax 001 610 262 6080 www precisionmedical com 0197 TT 0035 504635 Rev8 E 9 14 09 M Printed in USA
6. the ice has melted 11 Checkthe approximate oxygen contents in the Portable System using the contents scale NOTE The Portable Liquid Oxygen System will make a hissing noise when venting This is a normal occurrence AWARNING Never open the Vent to Fill Lever when Portable System is not connected to Reservoir If Vent to Fill Lever is inadvertently opened when not connected to Reservoir a burst of cold oxygen will be emitted It may take as much as 30 minutes to restore to normal operation Checking the Approximate Amount of Liquid Oxygen Remaining 1 Remove cannula from Portable System s outlet cannula connection 2 Remove Portable System from carry bag 3 Attach the ball end of the contents scale to the Portable System s engagement location Figure 3 by sliding ball into slot above the fill connector 4 Holdthe content scale with one hand pull down the Portable with the other hand and release This method will result in a consistent contents measurement 5 Readthe contents indicator of the scale to determine the approximate amount of liquid oxygen contents in the device To ensure you have enough oxygen to meet your needs check the indicator periodically 6 DO NOT use contents scale for any purpose other than specified doing so may damage the scale and void the warranty NEVER pull the ball end of the contents scale and allow it to snap back into the scale doing so will damage the sc
7. EASYMATE Liquid Oxygen System PM2200 SERIES SAVE THESE INSTRUCTIONS ACAUTION Federal USA law restricts this device to sale by or on the order of a physician i Your local distributor PRECISION MEDICAL N Medical Dynamics 300 Held Drive 866 624 3952 Northampton PA 18067 USA www thinkMDI net www precisionmedical com CONTENTS RECEIVING INSPECT ION iiciin 1 SAFETY SYMBOL DESCRIPTION sess 2 INTENDED USE e e petito Padi d Pa eg ERR 3 SPEGIFIGATIONS eq ea Re e Ei di ees 3 WARNINGS amp CAUTIONS sessssessssessseeeeeeeennenneneenneeennr trennen tente 4 PRINCIPLES OF OPERATION een a enne 6 PORTABLE SYSTEM DESCRIPTION sese 6 OPERATING INSTRUCTIONSG sse 6 FILLING THE PORTABLE de oer ea 7 e CHECKING THE APPROXIMATE AMOUNT OF LIQUID OXYGEN REMAINING 10 BREATHING FROM THE PORTABLE SYSTEM 10 5 POSITIONING ettet et orate t etre bc id 12 USING THE CARRY BAG 12 GEEANINQ rr tee ree te b net cet ei e es 13 REPLACEMENT PARTS pectet pt i dede dtes 13 MAINTENANCE Soasi erdt peer en inqui d ded ue erede tin 13 irit e ee t e e e eerie 13 TROUBLESHOOTING weit eee ad t e a e i te ns 14 DISPOSAL er He e D P a REED 15
8. ale and void the warranty Thetable below shows approximate use times for the Portable System after it has been completely filled The table has been constructed using a typical breathing pattern for oxygen patients Your use time may vary from the use times listed below We recommend that you learn through experience how long the Portable System will last under your circumstances Approximate use time of a Full Portable System Pulse Setting Approximate Use Time 1 9 Hours 2 8 Hours 3 5 3 Hours 4 4 3 Hours Breathing from the Portable System 1 Attach a standard adult single lumen oxygen nasal cannula no longer than 7 feet to the device s cannula connection according to the cannula manufacturer s instructions ACAUTION DO NOT use pediatric low flow nasal cannulas or oxygen masks with this device 2 Align the Pulse Selector to the prescribed setting Figure 4 The pulse setting value should be clearly visible in the center of the window AWARNING NO OXYGEN is delivered in between settings x 4 When your Portable System is set to setting 1 or above oxygen will be delivered only while you inhale You should notice a small pulse at the beginning of each breath Oxygen is delivered during this pulse It is normal for the device to occasionally skip a breath or to pulse twice in one breath 5 Breathe through the nose and feel a pulse of oxygen
9. g the inspiratory effort delivers a bolus of oxygen at the prescribed rate using the various pulse settings The device should be filled just before use PORTABLE SYSTEM DESCRIPTION Carry Handle Product Serial Label Scale Engagement location Cannula Connection Pulse n Selector w Label Connector Appearance may vary per Canister Label model The handle of this device has been left out from most illustrations in this manual for clarity purposes Serial of Vacuum Vessel AWARNING Using a clean dry cloth wipe the fill connector dry on both the Reservoir and Portable System before filling to prevent freezing OPERATING INSTRUCTIONS Prior to each use Inspect product for visible damage DO NOT use if any damage is found NOTE If any device labels are missing or illegible contact your Equipment Provider OPERATING INSTRUCTIONS continued Filling the Portable System from the Reservoir 1 Check the contents indicator on the Reservoir to ensure liquid oxygen is available for filling purposes When the Reservoir is low inform your Equipment Provider 2 Remove the cannula from the Device if attached Remove the Device from the carrying bag 4 Remove protective cap on reservoir fill coupler if applicable AWARNING 4 DO NOT fill the device while it is in the carrying bag The Portable System is intended to be used with any compatible reservoir with a maximu
10. into any of the controls or the fill connector DO NOT use cleaning solutions DO NOT immerse device in any kind of liquid DO NOT use alcohol solvents polishes or any oily substance on oxygen equipment REPLACEMENT PARTS Cannula 504833 Carry Bag Liner 504488 Carry Bag with Liner 504392 Contents Scale 504393 or 505669 Graphic MAINTENANCE ATTENTION Equipment Provider This device contains several field serviceable components Contact Precision Medical Customer Service to obtain service procedures and related service items RETURNS Returned products require a Returned Goods Authorization RGA number To obtain an RGA number contact Precision Medical Inc All returns must be packaged in sealed containers to prevent damage The Portable device must be fully depleted of liquid oxygen prior to shipping 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 Liquid Oxygen System 13 TROUBLESHOOTING If the Portable Liquid Oxygen System fails to function consult the Troubleshooting guide below If problem cannot be corrected consult your Equipment Provider Problem A No pulse Probable Cause 1 Device Empty 2 Pulse Selector set to g 3 Pulse selector positioned between settings 4 Device not sensing breath 5 Cannula disconnected 6 Ki
11. lled Start using device Hissing should reduce in a few seconds Device will continue to vent until depleted This is a normal operation Dispose of the Portable Liquid Oxygen System in accordance with the LPS local regulations Please Recycle MS 15 NOTES DEVICE SERIAL IN SERVICE DATE LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Precision Medical Liquid Oxygen System the Product and the following component parts thereof will be free of defects in workmanship and or material for the following period EasyMate Liquid Oxygen System 1 year from date of shipment Vessel Vacuum Five 5 years from date of shipment This limited warranty does not cover 1 Normal routine service items 2 Defects due to the wear and tear caused by mating components 3 Repair or replacement necessitated by misuse abuse or accident Replacement parts or repaired products shall be free from defects in workmanship and materials for the duration of the unexpired portion of the original warranty or ninety 90 days from the date of reshipment whichever is longer 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 ins
12. m working pressure of 53 PSI 3 65 bar 5 Using a clean dry cloth wipe the fill connector on the Reservoir and Device 6 Carefully position the Portable ensuring that the fill connector of the Portable System aligns with the fill connector of the Reservoir 7 Engagement PM2200 Tyco Puritan Bennett Top Fill PM2203 Taema Topfill Connect the Portable amp Reservoir by pressing down to the fill position being careful not to depress the release button on the Reservoir During filling maintain a slight downward pressure on the Portable System with one hand to keep the device steady and maintain proper filling position PM2201 Mark Series Top Fill with Twist Rotate the Portable System clockwise until the device is locked into position approximate rotation 90 DO NOT USE EXCESS FORCE WHEN LOCKING INTO POSITION PM2202 Chart Caire Side Fill Rotatethe Portable System counterclockwise until the pin of the device engages with the slot of the reservoir connector approximate rotation 45 Carefully and firmly rotate the Portable System back to the upright position until the Device and Reservoir are locked together 8 While holding the Portable System in the fill position pull the Vent to Fill lever to the open position Figure 1 A hissing noise should be noticeable NOTE PM2200 amp PM2203 maintain a slight downward pressure on the Portable System with one hand
13. n Wearing a Portable device under clothing may saturate fabrics with oxygen and cause them to burn rapidly if exposed to sparks or flame It may take several hours for oxygen levels in fabric to return to normal ALWAYS keep tubing or oxygen supply line away from path of walking to avoid potential trip or fall DO NOT use if dirt or contaminants are present on or around fill connectors on the Portable device or Reservoir NO OXYGEN is delivered when the Pulse Selector is at the 0 Setting NO OXYGEN is delivered in between settings AWARNING NEVER attempt to repair or disassemble this device Disassembling or unauthorized repair of this device could create a hazardous condition or cause equipment failure If you have problems questions or are unsure if equipment is operating properly call your Equipment Provider ALWAYS follow CGA P 2 7 standard Guide for the safe storage handling and use of Portable Liquid Oxygen Systems in Health Care Facilities This device is NOT to be used by patients who breathe through their mouths DO NOT use while sleeping without consulting your Equipment Provider DO NOT connect the Portable System to a gas source other than Oxygen Doing this will cause inhalation of hazardous substances The cannula is for single patient use only ACAUTION Consistent with the recommendations of the medical community on the use of conserving devices it is recommended that the P
14. nked or blocked cannula 7 Device overfilled Device not in upright position Refill device Set to prescribed setting Rotate Pulse selector to your prescribed setting Check position of cannula in nose b Do not breathe through mouth Reconnect cannula Remove kink obstructions Replace cannula Wait approximately 30 minutes until device returns to normal operating conditions Position device upright B Device not filling Not pulling Vent to Fill lever Not connecting fill connectors completely Reservoir empty Pull out Vent to Fill lever Makes sure fill connector are fully engaged Contact Liquid Oxygen Supplier to refill Reservoir Troubleshooting continued on next page AA 000 HR EASYMATE Oxygen System Troubleshooting continued Problem C Unable to disconnect Portable from Reservoir Probable Cause 1 Fill connectors frozen from moisture on fill connectors a Depress the release button on the Reservoir PM2200 ONLY b Allow time for device to warm D Device frosted amp no pulse Device overfilled Wait approximately 30 minutes until unit returns to normal operating conditions E Device is making a hissing noise venting NOTE VENTING IS NOT A LEAK DISPOSAL Device was just filled Device was turned on its side Patient is not using device after fi
15. ortable Liquid Oxygen System be qualified on patients in the situations it will be used rest exercise sleep This device is designed to operate with a single lumen adult nasal cannula with a maximum length of 7 feet or less Only individuals instructed and trained in its use should operate this device This device contains magnetic ferrous material that may affect the results of an MRI DO NOT use liquid leak detector to test for leaks DO NOT autoclave DO NOT gas sterilize DO NOT clean with aromatic hydrocarbons DO NOT immerse device in any kind of liquid Store device in a clean area when not in use Only use Precision Medical Inc s Liquid System carrying bag Avoid dropping the device or placing it in a position where it could fall and become damaged DO NOT block the outlet fitting or kink the cannula tubing when the device is in use Inspiratory efforts vary from patient to patient The Portable Liquid Oxygen System may not be able to detect respiratory efforts of all patients PRINCIPLES OF OPERATION The Portable Liquid Oxygen System is designed to store and deliver oxygen while maximizing your freedom of movement The Portable System is used as a Supplemental oxygen source which is filled from a reservoir containing liquid oxygen The device converts the liquid oxygen to a gas whichis then available to the patient when triggered by the inspiratory effort of the patient The Portable System sensin
16. roduct is not intended as a life sustaining or life supporting device SPECIFICATIONS Dimensions Are approximate and may vary by Model Weight Empty 2 9lbs 1 32 kg Full 3 6 lbs 1 63 kg Full including all accessories 4 6 lbs 2 09 kg Length 4 81 in 12 2 cm Width 3 63 in 9 2 cm Height 8 19 in 20 8 cm Operating Conditions Temperature 35 F to 110 F 1 7 C to 43 3 C Altitude 500 ft 152 m below Sea Level to 10 000 ft 3048 m Storage Conditions Temperature 10 F to 140 F 23 C to 60 Humidity 95 Non condensing Pulse Setting 0 1 2 3 4 LPM Equivalents Maximum Capacity 0 32 liters Maximum Working Pressure 53 psi 3 65 bar Cannula Requirement Maximum 7 foot long standard or high flow adult single lumen oxygen nasal cannula Pulse Volume Accuracy Within 15 of the nominal bolus value at each breath rate Trigger Method Inspiratory effort negative pressure from patient inhalation Breathing Frequency 1 to 30 Breaths Per Minute Specifications subject to change without prior notice Liquid Oxygen System AWARNING Oxygen supplied from this device is for supplemental use and is not intended to be life supporting or life sustaining This device is not intended for use by patients who would suffer immediate permanent or serious health consequences as a result of an interruption in the oxygen supply NEVER smoke in an area where oxygen is being administered
17. sion Medical Inc reserves the right to correct clerical or typographical errors without penalty Liquid Oxygen System 17 DECLARATION OF CONFORMITY Manufacturer Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Authorized European Representative Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Product Portable Liquid Oxygen System Model s PM2200 Series MDD Class 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 99 36 EC and the following documents Document Title Edition BS EN ISO 15614 1 Specification and qualification of welding procedures for metallic materials Welding 2004 procedure test Part 1 BS EN ISO 18777 Transportable Liquid Oxygen Systems for Medical Use Particular Requirements 2005 EN 980 Graphical Symbols for Use in the Labeling of Medical Devices 2003 EN 1041 Information supplied by the Manufacturer with Medical Devices 1998 EN 1251 1 Cryogenic Vessels Part 1 Fundamental Requirements Marking amp Labeling testing 2000 EN 1251 2 Cryogenic vessels transportable vacuum insulated vessels of not more than 1000 liters 2000 volume part 2 design fabrication inspectionand testing EN 1251 3 Cryogenic vessels transportable vacuum insulated vessels of not more than 1000
18. ssel complies with the requirements of Directive 99 36 EC concerning transportable pressure equipment On CE marked Devices ONLY CONSULT ACCOMPANYING DOCUMENTS Symbol for COVERING DEVICE WITH GARMENTS WILL PRODUCE OXYGEN ENRICHED ATMOSPHERE Symbol for SINGLE USE Applies to Cannula only Symbol for Warning low temperature freezing conditions OR Symbol for DO NOT touch Liquid Oxygen or parts that have been in contact with Liquid Oxygen Symbol for Warning High pressure oxidizing gas vigorously accelerates combustion Symbol for Equipment MUST be kept in a well ventilated area at all times ALWAYS keep the Portable in an upright position Manufacturer w Date of Manufacture Symbol for USE NO OI Symbol for NO SMOKING Prescription required y Examine check Mass Humidity Limitation e Atmospheric Pressure Limitation YN Remove from Carry Bag er 4 Attach Content Scale Here Volume FULL Volume HALF FULL Q Volume EMPTY 2 INTENDED USE To be used as a portable supplemental refillable oxygen device which delivers USP United States Pharmacopeia Oxygen at a number of various pulsed settings The device is to be used by patients who may have difficulty extracting oxygen from the atmosphere It is for patients who would normally receive oxygen via nasal cannula It is intended to be used as an ambulatory source of Oxygen ADANGER This p
19. tructions operational verification procedures and standard industry practice and that no modifications substitutions or alterations have been made to the goods shall in its discretion and at its own expense repair or replace the defective component s ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES AND THERE ARE NO WARRANTIES OTHER THAN AS SET FORTH IN THIS CONTRACT Neither the representative of Precision Medical Inc nor any retailers are 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 This writing is a final complete and exclusive statement of the terms of the contract and sale Precision Medical Inc Disclaims any warranty of merchantability fitness for a particular purpose or any other warranty of quality whether express or implied except as set forth above 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 Preci
20. ygen coming from the fill connector when disengaging the Portable from the reservoir ACAUTION DO NOT OVERFILL Filling device longer than above Max fill times can lead to OVERFILLING Overfilling does NOT provide any advantages and can cause problems with the use ofthe device Overfilling can result in a delay of 30 minutes before the Portable can be used Releasing the Vent to Fill Lever will stop the filling process Frost on cap of Portable is a sign of overfill AWARNING If aliquid oxygen leak occurs at the fill connector when you disconnect the Portable reconnect and disconnect the Portable System to help dislodge any ice or other obstruction If the liquid leak persists notify your oxygen supplier DO NOT insert any foreign objects into Fill Connector If you notice a steady stream of liquid oxygen at the fill connector when you disconnect the Portable System stay away from the device and immediately notify your oxygen supplier DO NOT leave the portable liquid oxygen system unattended during the filling operation DO NOT direct flow of oxygen at any person or flammable material NOTE Ifthe Reservoir and Portable System does not disconnect easily they may have become frozen Attempt to disconnect them by depressing the release button on the Reservoir if applicable If this does not work DO NOT USE FORCE Simply allow a few minutes for the frozen parts to warm then disengage the Portable when
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