USER MANUAL - DEHAS Medizintechnik & Projektierung GmbH
Contents
1. 2 For the fill method being used verify the proper saturation pressure of the fill source per section a Liquid oxygen source requirements 3 Attach one 1 end of the transfer line source adapter to the liquid withdrawal valve of the source tank Position the source adapter relief valve straight up 4 Attach a O 30 psig 0 2 07 bar pressure gauge to the Reservoir Oxygen DISS Outlet Connection If the Reservoir contains some liquid oxygen verify that the Reservoir pressure gauge reads in the range of 18 26 psig 1 24 1 79 bar If pressure exceeds 28 psig 1 93 bar service is required DO NOT fill the Reservoir 5 Remove fill connector Protective cap from fill connector on the Reservoir Check the fill connectors on both the Reservoir and the fill adapter to ensure that they are clean and dry Wipe the connectors with a clean lint free cloth or blow dry with gaseous oxygen or nitrogen as needed 6 Using the Vent to fill key open the Vent Valve on the Reservoir by rotating the tool a turn counterclockwise NOTE At this point you may hear a venting noise if the Reservoir unit is pressurized 7 Engage the transfer line to the Fill Connector on the Reservoir by aligning the fill connector on the transfer line directly over the Fill Connector on the Reservoir and apply downward force 8 Maintain a downward force on the transfer line fill adapter while slowly opening the liquid valve on the source tank At this poi2. 5 Verify that the liquid level Indicator is consistent with the delivery schedule and expected patient usage Verify the liquid level Indicator is functioning when activated EASYMATE RESERVOIR 9 NOTE A flashing bottom light for a half second ON and a half second OFF for an eight 8 second duration indicates the battery needs to be replaced 6 Verify that the Fill Connector is not worn leaking or damaged NOTE Ensure that the Protective Cap for the fill connector is not damaged 7 Verify that the slots on the Vent Valve are not bent or broken 8 Verify that the Condensation Collection Container is in place and empty d Fill Procedure A DANGER Explosive hazard Extreme high pressure can rupture a transfer line Make sure the specified pressure relief valve is present in the proper location and functioning properly on the transfer line assembly Fire hazard Liquid oxygen spilled on asphalt or any other combustible surface will increase the possibility of fire if an ignition source is present ALWAYS fill the unit on a noncombustible surface such as concrete or a steel drip pan Fire hazard Liquid oxygen spillage will occur if the Reservoir is tipped over Before transporting secure the Reservoir containing liquid oxygen in an upright position Fire hazard Oxygen can accumulate in a delivery vehicle Exhaust vent gases to outside of vehicle Wear proper protective clothing during the fill process
3. Activation Button Oxygen DISS Outlet Connection Handle Tie Down Point 2 Serial label FILL CONNECTOR CAIRE Portable Reservoir OPERATING INSTRUCTIONS e Read this User manual before operating the Reservoir e Before filling to prevent freezing and possible equipment failure use a clean dry cloth to wipe the fill connectors dry on the Reservoir and Portable EXTREME COLD HAZARD e DO NOT press or move the plastic poppet in the center of the fill connector on the Reservoir This will cause a release of liquid oxygen from the fill connector e DO NOT leave the liquid Oxygen System unattended during the filling operation EASYMATE RESERVOIR 5 liquid level Indicator Activation Button To check the Liquid Oxygen Level Push the Activation Button on the liquid level Indicator The lights will scroll from bottom to top then the lights indicating the level of liquid oxygen will remain on for 5 seconds Each light represents approximately 12 5 of what the Reservoir is designed to contain EXAMPLE This level sensor indicates that Reservoir is approximately 75 Full of liquid Oxygen When ONLY two 2 lights are illuminated the Reservoir has 25 of liquid Oxygen ALMOST EMPTY Contact your liquid Oxygen Supplier to fill the Reservoir e When ONLY the bottom light is flashing indicates that the Reservoir is nearly empty RESERVOIR NEEDS TO BE FILLED e A flashing bottom light for a ha
4. Connection f Checking Saturation Pressure Perform the following procedure as needed to determine the saturation pressure of the liquid oxygen in the Reservoir 1 Attach a O 30 psig O 2 07 bar pressure gauge to the Reservoir Oxygen DISS Outlet Connection Note the pressure indicated on the gauge 2 Momentarily open the Vent Valve on the Reservoir and observe the pressure gauge pointer as it drops 3 Note the pressure value where the gauge drops the lowest and then close the Vent Valve This is the approximate saturation pressure of the Reservoir Saturation pressure readings between 18 and 26 psig 1 24 1 79 bar are in the acceptable pressure range of the unit EASYMATE RESERVOIR 11 LIMITED WARRANTY AND LIMITATION OF LIABILITY DEHAS warrants that the DEHAS EasyMate Reservoir the Product and the following component parts thereof will be free of defects in workmanship and or material for the following period EasyMate Reservoir One 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 re
5. USER MANUAL EASYMATE RESERVOIR PE SERIEN e f T u L e MU SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale by or on the order of a physician Tel 49 451 80904 O Langenfelde 17 Fax 49 451 80904 111 23611 Bad Schwartau www dehas de GERMANY CONTENTS RECEIVING INSPECTION oo 1 INTENDED USE ABBREVIATIONS oo SAFETY INFORMATION WARNINGS AND CAUTIONS oo SPECIFICATIONS To check the liquid Oxygen level _ s s s esse BREATHING FROM THE RESERVOIR 1 102222 BATTERY REPLACEMENT oO cO O O O O N N 0 Ci A N NYO nm m PND E TI w gt JJ JJ D Z lt x J m O m gt D gt O z O TI C O z TI O D lt C2 RECEIVING INSPECTION Remove the DEHAS EasyMate Reservoir from the packaging and inspect for damage If there is any damage DO NOT USE and contact your liquid Oxygen Supplier EASYMATE RESERVOIR 1 INTENDED USE The DEHAS EasyMate Reservoir is intended to provide a stationary storage source of liquid oxygen for Portable liquid oxygen systems and to provide supplemental USP oxygen to patients that may have difficulty extracting oxygen from the air that they breathe Indication The device is to be used by patients who may have difficulty extracting oxygen from the atmosphere Contraindication The device is used for patients who cannot breathe by OPERATOR PROFILE Supplemental oxy
6. elay in use In order to achieve the saturation pressure of the Reservoir the saturation pressure of the LOX fill source must be considered The fill source saturation pressure requirement depends on the type of filling technique used The most common technique Standard Fill uses a fill source with a saturation pressure of 40 50 psig 2 76 3 45 bar The less common technique is the Fast Fill that requires a LOX saturation pressure of 20 22 psig 1 38 1 52 bar In this case the fill source must have a pressure building system so that head pressure in the fill source can be raised in order to transfer the LOX into the reservoir b Required Equipment Liquid Oxygen source Liquid Oxygen transfer line Vent to Fill key P N 505400 Pressure Gauge 0 30 psig 0 2 07 bar P N 505648 c Pre Fill Inspection Perform the following visual inspection of the Reservoir and determine its operational status before filling Correct any problems before filling the Reservoir 1 Ask the patient when applicable if there are any questions or concerns regarding the equipment since the last fill 2 Visually inspect the Reservoir for damage or missing components 3 Verify that the following labels are present and legible 1 Fill Connector label 2 Liquid level Indicator label 3 Outlet Connection label 4 Warning label 5 Serial Number label 4 Verify that no frost or heavy condensation is present on the container below the plastic shroud
7. gen patient that may have ambulatory capabilities requiring oxygen on a continuous basis READ ALL INSTRUCTIONS BEFORE USING This manual instructs a user to operate the EasyMate Reservoir This is provided for your safety and to prevent damage to the Reservoir If you do not understand this manual DO NOT USE the Reservoir and contact your liquid Oxygen Supplier A DANGER Oxygen supplied from the Reservoir is for supplemental use and is not intended to be life sustaining or life supporting ABBREVIATIONS DISS Diameter Indexed Safety System psig Pounds Per Square Inch Gauge lpm liters Per minute USP United States Pharmacopeia MAWP maximum Allowable working Pressure PH Test Pressure SAFETY INFORMATION WARNINGS AND CAUTIONS Indicates an imminently hazardous situation which if not ah DANGER avoided will result in death or serious injury Indicates a potentially hazardous situation which if not avoided could result in death or serious injury AWARNING Indicates a potentially hazardous situation which if not avoided ACAUTION 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 CAUTION CONSULT ACCOMPANYING DOCUMENTS Symbol for NO SMOKING Symbol for Equipment MUST be kept in a well ventilated area at all times EASYIVIATE 2 HESERVOIR Symbol for DO NOT touch Liquid Oxygen or
8. lf second ON and a half second OFF for an eight 8 second duration indicates the battery needs to be replaced EASYMATE 6 RESERVOIR AWARNING If the Portable will not disengage easily the Reservoir and the Portable may have become frozen together DO NOT USE FORCE Simply allow a few minutes for the frozen parts to warm then disengage the Portable when the ice has melted A MINOR LEAK is a trickle or a slight spray of Liquid oxygen coming from the Reservoir The leaking may be stopped by reengaging and disengaging the Portable If the leak persists move the Reservoir to a well ventilated area if possible and call your liquid Oxygen Supplier A MAJOR LEAK is a steady stream of liquid oxygen coming from the Reservoir Ventilate the area by opening a window and or door if possible and stay away from the Reservoir Call your liquid Oxygen Supplier as soon as possible CAUTION Inspect the Reservoir for visual damage before use DO NOT USE if damaged To fill Portable 1 Check the liquid Oxygen level of the Reservoir 2 Remove fill connector protective cap 3 Use a clean dry cloth to wipe the fill connectors on the Portable and the Reservoir 4 Follow the Portable User manual for the filling instructions 5 Carefully position the Portable ensuring that the fill connector of the Portable aligns with the fill connector of the Reservoir 6 Replace fill connector protective cap AWARNING If a liquid ox
9. ll liabilities of DEHAS whether based on contract negligence strict tort or otherwise DEHAS reserves the right to discontinue manufacture of any product or change product materials designs or specifications without notice DEHAS reserves the right to correct clerical or typographical errors without penalty 12 DECLARATION OF CONFORMITY Classification IIb PM2335 CE PM2345 CE Series Classification criteria DEHAS Medizintechnik GmbH Langenfelde 17 23611 Bad Schwartau GERMANY Ce 0432 EasyMate Reservoir Clause 3 2 Rule 11 of Annex IX of MDD We herewith declare that the above mentioned products meet the provisions of the following EC Council Directives and Standards All supporting documents are retained under the premises of the manufacturer and the notified body General Application Directives MDD Medical Device Directive Council Directive 93 42 EEC Of 14 June 1993 Concerning Medical Devices Directive 2007 47 EC Of The European Parliament and of the Council of 5 September 2007 and 2010 35 EC Transportable Pressure Equipment Directive Directives Applied ISO 15223 1 2012 Standards EN 1041 2008 BS EN 1251 1 2000 BS EN 1251 2 2000 BS EN 1251 3 2000 BS EN 1418 1998 BS EN 1626 2009 Notified Body Address Certification Registration No s Devices already manufactured Validity of DOC Notified Body for Pressure Equipment Certification Registration No s Manufac
10. nt a vigorous audible venting noise will confirm that the filling process has begun Adjust the source tank liquid valve as needed to maintain pressure gauge at 20 22 psig 1 38 1 52 bar during the fill EASYMATE 10 HESERVOIR NOTE e It may be necessary to open the source tank liquid valve completely and partially close the Reservoir vent valve to maintain the proper pressure throughout the fill e As the level of liquid oxygen nears the top of the Reservoir inner container the sound and appearance of vapors escaping through the Vent Valve will change The vapor will become denser and as liquid oxygen reaches the Vent Valve a discharge of liquid oxygen will be visible and audible AWARNING Extreme cold hazard Liquid oxygen discharge from the Fill Connector can occur When disconnecting the transfer line never stand directly over the Reservoir Fill Connector If the Reservoir Fill Connector stays open and minor liquid oxygen discharge occurs carefully engage and disengage the transfer line to help dislodge any ice or other obstruction If major liquid oxygen discharge steady stream occurs open the Vent Valve if safely possible to vent pressure and stop the release of liquid oxygen Open windows and doors to ventilate the room and do not walk on areas exposed to liquid oxygen for 60 minutes after frost disappears 9 When you observe the first steady discharge greater than 1 second of liquid oxygen from the Vent Valve clo
11. of an MRI ONLY use Flowmeter 1mFA1883 or dial Flowmeter PM2300RFCV 8CE DO NOT autoclave DO NOT gas sterilize DO NOT clean with aromatic hydrocarbons DO NOT immerse the Reservoir in any kind of liquid Store the Reservoir in a clean area when not in use Avoid dropping the Reservoir or placing it in a position where it could fall or be knocked over and become damaged SPECIFICATIONS Dimensions PM2345 0CE PM2335 0CE Diameter 16 in 40 6 cm 16 in 40 6 cm Height 35 in 88 9 cm 31 6 in 80 3 cm Weight Full 164 5 Ibs 74 6 kg 133 3 Ibs 60 5 kg Empty 51 2 Ibs 23 2 kg 45 2 lbs 20 5 kg Volume of Liquid Oxygen 45 liters 35 liters Working Pressure 18 26 psi 1 24 1 79 bar Maximum Allowable working Pressure MAWP 26 psi 1 79 bar Operating Conditions Temperature OF to 104 F 17 7 C to 40 C Altitude 500 ft 152 m below Sea level to 10 000 ft 3 048 m Storage Conditions Temperature 40 F to 158 F 40 c to 70 C Humidity 95 Noncondensing Oxygen DISS Outlet Connection Restricted to a maximum flow of 10 Ipm 1 Ipm directly from outlet fitting Maximum Usable flow 8 lpm Specifications are subject to change without prior notice EASYMATE 4 RESERVOIR COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact DEHAS Fill Connector Condensation i Collection Container Vent Valve liquid level Indicator Fill Connector
12. parts that have been in contact with Liquid Oxygen Symbol for WARNING HIGH PRESSURE OXIDIZING GAS VIGOROUSLY ACCELERATES COMBUSTION Symbol for USE NO OIL Symbol for PUSH to ACTIVATE Wipe Fill Connector dry ALWAYS keep the Reservoir in an upright position Maximum Flowrate is 8 Liters minute Volume FULL 2 Volume EMPTY Mass lt q Examine check C 0482 Symbol indicates the device complies with the requirements of Directive 93 42 EEC concerning medical devices and all applicable International Standards Symbol indicates the pressure vessel complies with the TT 2266 requirements of Directive 2010 35 EC concerning transportable pressure equipment This equipment 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 DO NOT smoke in an area where oxygen is being used or stored DO NOT disassemble or repair the Reservoir this could create a hazardous condition or cause equipment failure If you have problems questions or are unsure if equipment is operating properly call your liquid Oxygen Supplier DO NOT use if dirt or contaminants are present on or around fill connectors on the Portable or Reservoir DO NOT use oils greases lubricants or any combustible materials on or near the Reservoir wash hands properly prior to usage DO NOT touch liquid oxygen or parts that have been in contact
13. se the Vent Valve and disconnect the transfer line from the Reservoir by lifting the fill adapter straight up If the transfer line will not disengage close the liquid valve on the source tank and allow the transfer line and fill connectors to thaw ACAUTION If the Vent Valve freezes in the open position terminate the fill by disconnecting the transfer line and then allow the vent valve to warm until it closes easily If the vent valve remains open for a period of time the liquid oxygen in the unit will de saturate to a pressure lower than required 10 Close the source tank liquid valve when the frost melts from the transfer line assembly e Post Fill Inspection Perform the following procedure to inspect the Reservoir and determine its operational Status after filling it with liquid oxygen Correct observed problems before placing the unit in service 1 Verify that the Reservoir Fill Connector is closed and not leaking 2 Verify that the Vent Valve is completely closed and not leaking 3 Verify that the pressure gauge attached to the Reservoir Oxygen DISS Outlet Connection reads equal or greater than 20 psig 1 38 bar within five minutes after terminating the fill 4 Verify that there is no frost or heavy condensation on the container below the plastic shroud 5 Verify that all lights are illuminated when the liquid level Indicator button is activated 6 Disconnect the pressure gauge from the Reservoir Oxygen DISS Outlet
14. shipment whichever is longer Should any failure to conform to this warranty appear within the applicable period DEHAS shall upon written notification thereof and substantiation that the goods have been stored installed maintained and operated in accordance with DEHAS s instructions operational verification procedure which is included in the Service manual 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 SEI FORTH IN THIS CONTRACT Neither the representative of DEHAS 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 DEHAS 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 DEHAS 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 a
15. time for the Fill the Portable from from moisture on the Fill Connectors to thaw Reservoir Connectors Bottom light flashes low Battery Call your liquid Oxygen Rapidly Supplier for battery replacement No light s will show Dead battery Call your liquid Oxygen on the Liquid Level Supplier for battery Indicator replacement water leaking from Condensation Container Empty the Condensation Reservoir is full Container MINOR LEAK of Liquid Frost in the Fill Connector Disconnect and reconnect Oxygen Ref page 7 Portable MAJOR LEAK of Liquid Equipment Failure Call your liquid Oxygen Oxygen Ref page 7 Supplier EASYMATE 8 HESERVOIFE ACCESSORIES REPLACEMENT PARTS DESCRIPTION PART Flowmeter 0 8 Ipm 1mFA1883 Dial Flowmeter 0 8 Ipm PM2300RFCV 8CE Condensation Collection Container 505660 Roller Base 505382 PB Protective Cap Assembl 507027 RESERVOIR FILL PROCEDURE For Liquid Oxygen Supplier ONLY e Refer to all applicable governing standards for handling storing transporting and filling of liquid oxygen systems e For further information about recommended testing of the reservoir contact DEHAS e his fill procedure will help the Liquid Oxygen Supplier fill the reservoir in a safe and efficient manner a Liquid oxygen source requirements The Reservoir must only be filled with medical Grade liquid Oxygen The saturation pressure should be a minimum of 23 psig 1 59 bar to ensure proper operation and prevent any d
16. ture Representative Position Date of Issue BS EN 12300 1999 EN ISO 14971 2013 ISO 15001 2011 ISO 7000 2008 BS EN 60601 1 2 2007 BS EN 60601 1 6 2010 BS EN ISO 15614 1 2004 BS EN ISO 18777 2009 Medcert GmbH 0482 Pilatuspool 2 20355 Hamburg GERMANY 4153GB43411109 Date of Expiry 11 2016 SN traceability via Device History records From 08 2013 to Date of Expiry DEKRA Automobil GmbH TT 2266 Handwerkstra e 15 70565 Stuttgart Z O 026 09900 13 Date of Expiry 03 2026 Quality Manager Manager Quality System ISO Representative 20 May 2014 DEHAS Medizintechnik amp Projektierung GmbH Langenfelde 17 23611 Bad Schwartau GERMANY Tel 0049 451 80904 0 001 610 462 8204 Fax 0049 451 80904 111 001 610 262 6080 Tell us how we are doing Visit us at www dehas de 505129EN Rev3 05 20 14
17. vents polishes or any oily substance on Oxygen Equipment Clean exterior surfaces with a cloth dampened with mild detergent and water Wipe dry with a clean cloth prior to use Store Reservoir in a clean area free from grease oil and other sources of contamination 4 Check and empty the Condensation Collection Container daily 5 Clean the Condensation Collection Container with mild detergent and water as wr necessary 6 The safety valves have to be checked or replaced at least every five 5 years RETURNS Returned products require a Returned Goods Authorization RGA Number contact DEHAS All Reservoirs must be depleted of liquid Oxygen prior to shipping and must be packaged in sealed containers to prevent damage DEHAS will not be responsible for goods damaged in transit Refer to DEHAS Return Policy available on the Internet www dehas de DISPOSAL INSTRUCTIONS Dispose of the Reservoir in accordance with the local regulations Li t di Please Recycle Ci TROUBLESHOOTING E If the Reservoir fails to function consult the Troubleshooting Guide below If problem cannot be solved consult your liquid Oxygen Supplier PROBLEM PROBABLE CAUSE REMEDY Portable will not fill 1 Not connecting the Fill 1 make sure the Fill Connectors Connectors completely are fully engaged 2 Contact liquid Oxygen 2 Reservoir empty Supplier to refill Reservoir Unable to disconnect Fill connectors frozen Allow
18. 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 Fill the Reservoir with only medical Grade liquid Oxygen USP applies in the United States Before filling the Reservoir for the first time Reservoir should be purged with oxygen Verify that the fill connector of the Reservoir is compatible with the Reservoir being filled Use only as prescribed by a physician Consult with a transportation company when transporting the Reservoir by a public transportation system EASYMATE RESERVOIR 3 AWARNING Keep equipment in a well ventilated area at all times The Reservoir periodically releases small amounts of oxygen gas that must be ventilated to prevent buildup e DO NOT store liquid oxygen equipment in a closet car trunk or other confined area e DO NOT place blankets draperies or other fabrics over equipment TO AVOID INCREASED RISK OF FIRE e Keep the Reservoir away from electrical appliances Use and store the Reservoir at least five feet from electrical appliances that may cause heat or sparks DO NOT use near any type of flame or flammable explosive substances Use and store Reservoir at least five 5 feet away from equipment such as furnaces water heaters and stoves that may contain open flames ACAUTION The Reservoir contains magnetic ferrous material that may affect the results
19. ygen leak occurs at the fill connector when you disconnect the Portable reconnect and disconnect the Portable to help dislodge any ice or other obstruction If the liquid leak persists notify your liquid Oxygen Supplier If you notice a steady stream of liquid oxygen at the fill connector when you disconnect the Portable stay away from the device and immediately notify your liquid Oxygen Supplier DO NOT direct flow of oxygen at any person or flammable material Use ONLY a Flowmeter connected to the DISS outlet to breathe from the Reservoir Using a Flowmeter other than the DEHAS EasyMate Reservoir Flowmeter will deliver lower than stated values BREATHING FROM THE RESERVOIR Attach a DEHAS EasyMate Reservoir Flowmeter to the DISS outlet connection The DEHAS EasyMate Reservoir Flowmeter is calibrated to function with the restrictor in the outlet fitting of the Reservoir NOTE Maximum Usable Flow 8 Ipm BATTERY REPLACEMENT When the low Battery is indicated by the bottom light flashing rapidly on the liquid Level Indicator refer to section To check the Liquid Oxygen Level for complete instructions For battery replacements call your liquid Oxygen Supplier EASYMATE RESERVOIR CLEANING MAINTENANCE A WARNING e DO NOT allow water to enter any components or Fill Connector DO NOT immerse the Reservoir in any kind of liquid DO NOT use any strong solvent or abrasive cleaners DO NOT use alcohol sol
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