(CGA 870 Connection) Oxygen Conserving Regulator User Manual
Contents
1. high pressure cylinders that provide supplemental oxygen to patients who may have difficulty extracting oxygen from the air they breathe It is for patients who would normally receive the oxygen via a nasal cannula The device delivers 100 oxygen at flow settings It is intended to be used as an oxygen saving device that reduces the drying of the airways READ ALL INSTRUCTIONS BEFORE USING This manual instructs a user to install and operate the Oxygen Conserving Regulator Conserver This is provided for your safety and to prevent damage to the Conserver If you do not understand this manual DO NOT USE the Conserver and contact your Provider ADANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS kPa Kilopascal psi Pounds Per Square Inch l min Liters Per Minute b min Breaths Per Minute EADE UDES SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION BE oa e 7 FASYPULIEJ 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 avoided2. repair the EasyPulse5 Oxygen Conserving Regulator e All repairs must be performed by Precision Medical Inc or Authorized Representative RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be packaged in sealed containers to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Refer to Precision Medical Inc Return Policy available on the Internet www precisionmedical com DISPOSAL INSTRUCTIONS This device and its packaging contain no hazardous materials No special precautions need to be taken when disposing the device and or its packaging Please Recycle SY 11 E TROUBLESHOOTING If the Conserver fails to function consult the Troubleshooting Guide below If problem cannot be solved consult your Provider TROUBLESHOOTING GUIDE Problem Probable Cause Remedy No flow Cylinder valve Open the valve on closed cylinder Conserver in OFF Set to prescribed position setting Cylinder empty Replace cylinder Dial not set at Set dial so indicator proper position points to a setting Conserver not Check position of sensing breath cannula in nose DO NOT breathe through mouth Leaking at Missing or defective Replace with cylinder yoke seal Precision Medical connection yoke seal Defective cylinder Contact your valve Provider PANES
3. 12 REPLACEMENT PARTS Description Part Cannula 504833 Yoke Seal 1221 ACCESSORIES Description Part Carry Bag M6 503920 Carry Bag M4 M6 504184 Carry Bag ML6 ML9 504185 Carry Bag with Conserver properly shoulder strap installed in Carry Bag EADE UDES LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Easy Pulse Oxygen Conserving Regulator the Product will be free of defects in workmanship and or material for the following periods Two 2 years from date of shipment 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 instructions and standard industry practice and that no modifications substitutions or alterations have been made to the goods correct such defect by suitable repair or replacement at its own expense ORAL STATEMENTS DO NOT CONSTITUTE WARRANTIES The representative of Precision Medical Inc or any retailers are not 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 Thus this writing is a final complete and exclusive statement of the terms of that contrac
4. EASYPLLSES5 Oxygen Conserving Regulator 1900 SERIES CGA 870 Connection Z U 198705 shown SAVE THESE INSTRUCTIONS Federal USA law restricts this device to ONLY 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 cece teteee te eeneenees 2 INTENDED USE oii caanis slider iiidainnniss 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS eee ec eee ees 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 PRINCIPLES OF OPERATION ue 5 SPECIFICATIONS nianag SEENEN 6 COMPONENT DESCRIPTION scicscscctctcctacctiecciesctasencdacteatndtecdctevase 7 INS TALLATIO WEE 8 OPERATING INSTRUC ONS oot e teen ete seen 9 MAINTENANCE CLEANING srisniniinnssasinnnranaindseansscanea kassinn 11 CH UE 11 DISPOSAL INSTRUCTION 11 TROUBLESHOOTING sisirin senna nesana e ESES SEANSEN 12 REPLACEMENT PARTS seissen REA dEeeENEEEENEEEEeEEE Neen 13 ACCESSORIES kissirt pse aantas 13 LIMITED WARRANT Y egen adea ranea EEA ia E 14 DECLARATION OF CONFORMITY 0 cece cece cee tee eeneeeneeee 15 FASYPULIEJ RECEIVING INSPECTION Remove the Precision Medical Inc EasyPulse5 Oxygen Conserving Regulator Conserver from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE To regulate
5. O NOT use near any type of flame or flammable explosive substances Use only USP grade medical oxygen The Conserver is equipped with a relief valve If you hear a loud hissing or popping sound coming from the product discontinue use of product close cylinder valve and contact your Provider The Conserver is designed to operate with a single lumen adult cannula with a maximum length of 7 feet 2 1 m The cannula is for single patient use only 4 Oxygen Conserving Regu ACAUTION e Only personnel instructed and trained in its use should operate the Conserver e The Conserver contains magnetic ferrous material that may affect the results of an MRI e DO NOT autoclave e DO NOT gas sterilize with Ethylene Oxide e DO NOT clean with aromatic hydrocarbons Store the Conserver in a clean area when not in use e Avoid dropping the Conserver or placing it in a position where it could fall and become damaged Consistent with the recommendations of the medical community on the use of conserving devices it is recommended that the Oxygen Conserving Regulator be qualified on patients in the situations it will be used e The Conserver may not be able to detect all respiratory efforts of the patient Shallow breathers may not be able to trigger the Conserver e Operating the Conserver outside its range of operating conditions may affect its accuracy and performance PRINCIPLES OF OPERATION The Oxygen Conserver is
6. designed to be used with high pressure oxygen systems It consists of a cylinder connection cylinder contents gauge if equipped high to low pressure regulator orifice plate and a conserving demand module The regulator reduces the high pressure of the cylinder to the working pressure of the orifice plate The orifice plate uses calibrated orifices to deliver a selected flow to the conserving demand module The conserving demand module controls the pulse size and timing to the patient It supplies a pulse of oxygen at the beginning of each breath This reduces the oxygen demand on the system and limits the drying of the airways The flow is determined by setting the flow control knob to the prescribed flow The oxygen is supplied to the patient through the cannula FASYPULSE5 mugen Conserving Regulate 5 SPECIFICATIONS Inlet Pressure Range Pressure Gauge Accuracy 300 3000 psi 2068 20684 kPa 3 2 3 of full scale Dimensions Are approximate and may vary by model Model 198705 Weight Overall Length Width Height Pulse Settings Flow Settings 990z 279g 4 75 in 12 07 cm 2 63 in 6 67 cm 2 50 in 6 35 cm 1 2 3 4 amp 5 l min Equivalents 2 l min Continuous 198705 1 through 6 I min Continuous 198712 Accuracy Continuous Settings within 10 Accuracy Pulse Settings Savings Ratio Trigger Method t SO morcv Breathing Frequency Within 15 of the nom
7. duction quality assurance system has been carried out following the requirements of the UK national legislation to which the undersigned is subjected transposing Annex Il 3 of the Directive 93 42 EEC on medical devices We certify that the production quality system conforms with the relevant provisions of the aforementioned legislation and the result entitles the organization to use the CE 0473 marking on those products listed above Applied Standards BS 341 3 DIN 477 1 EN 837 1 EN1041 EN ISO 14971 EN ISO 15001 ISO 228 1 ISO 15223 1 ISO 10524 1 ISO 10524 3 ISO 18779 SS 367615 a BIE Notified Body B DIE Certification Services Limited Ce 0473 Address Davy Avenue Knowhhill Milton Keynes MK5 8NL UK Certification Registration No s 1126 CE Date of Expiry 03 August 2017 Devices already manufactured S N traceability Device History Records Validity of DOC 04 August 2012 to Date of Expiry Manufacture Representative Quality Manager Position Quality Systems ISO Representative Date of Issue 04 August 2012 Tell us how we are doing Visit us at www precisionmedical com 507628 RevO TDA385 06 14 Printed in USA
8. inal bolus value at each breath rate Up to 5 7 1 Inspiratory effort Negative pressure from patient inhalation Up to 35 b min Cannula Requirement Operating Conditions Temperature Altitude Storage Conditions Temperature Maximum Humidity Oxygen Cylinder Connection Ignition and Fault Tolerance Maximum 7 foot 2 1 m long standard adult single lumen nasal cannula 35 F to 105 F 1 7 C to 40 6 C Sea level to 10 000 ft 0 to 3 048 m 40 F to 140 F 40 C to 60 C 95 Noncondensing CGA 870 Valve Meets ASTM G175 03 Specifications are subject to change without prior notice Manuals available on our Website www precisionmedical com 6 Oxygen Conserving Regulai COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc Dial Indicator T Handle AR UT Cannula Leg Contents Gauge Connection FASYPULSE5 mugen Conserving Regulate 7 INSTALLATION AWARNING Read this User Manual before installing or operating the Oxygen Conserving Regulator Inspect the Conserver and cylinder valve to ensure they are free of oils greases or other contaminants DO NOT direct flow of oxygen at any person or flammable material when cracking open the cylinder DO NOT use without yoke seal DO NOT use plastic yoke seals Use Precision Medical Inc yoke seal made of viton and b
9. may result in property damage CONSULT ACCOMPANYING DOCUMENTS Symbol for USE NO OIL Symbol for NO SMOKING Symbol for COVERING DEVICE WITH GARMENTS WILL PRODUCE OXYGEN ENRICHED ATMOSPHERE 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 AWARNING ALWAYS confirm prescribed dose before administering to patient and monitor on a frequent basis Always follow ANSI and CGA standards for Medical Gas Products and Oxygen Handling G 4 Keep cylinder valve closed at all times when cylinder is not in use NO OXYGEN is delivered when the pointer V is aligned with OFF or between settings This Conserver is not to be used by patients who breathe through their mouths DO NOT use if dirt or contaminants are present on or around cylinder valve product or connecting devices DO NOT use oils greases organic lubricants or any combustible materials on or near this product Wash and dry hands properly prior to usage DO NOT use a humidifier with the Conserver DO NOT allow cylinders to tip or fall Secure gas cylinders so they cannot fall For optimum safety keep cylinder upright whenever possible DO NOT store cylinders near sources of heat or flame DO NOT use while sleeping without consulting your Provider DO NOT smoke in an area where oxygen is being administered D
10. rass The yoke seal supplied with the Conserver is reusable CAUTION Inspect the Oxygen Conserving Regulator for visual damage before use DO NOT USE if damaged DO NOT use tools to tighten T handle this can lead to over tightening and will cause damage to the Conserver Be sure all connections are tight and leak free DO NOT use liquid leak detector to test for leaks 3 4 NOTE For operational instructions on how to operate the cylinder consult your Provider Position the cylinder so the oxygen cylinder valve outlet is pointing away from the user and any other person s Before installing the Conserver crack cylinder valve by opening the valve slightly to remove any foreign particles and then close valve Be sure the Conserver is in the OFF position Align OFF with the indicating pointer V Be sure the CGA 870 connection high pressure inlet has a yoke seal 5 Align Index Pins with Index Pin Alignment Holes in Post Valve 6 Hand tighten T handle until snug 8 Vuen Conserving Regu OPERATING INSTRUCTIONS 1 Attach a standard adult single lumen oxygen nasal cannula no longer than 7 feet 2 1 m to the Conserver s outlet according to the cannula manufacturer s instructions ACAUTION e DO NOT use pediatric low flow nasal cannulas or oxygen masks with the Conserver e DO NOT block the cannula connection or kink cannula tubing when the Conserver is in use
11. t THIS WARRANTY IS EXCLUSIVE AND IS IN LIEU OF ANY WARRANTY OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE OR OTHER WARRANTY OF QUALITY WHETHER EXPRESS OR IMPLIED 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 Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty pace time 14 DECLARATION OF CONFORMITY Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Emergo Europe European Office REP Molenstraat 15 0473 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 EasyPulse 5 Oxygen Conserving Device 198705EN 195405 19DE05 19ES05 19ES05 EN 19GB05 19ES05 19SE05 ES 198705NG 195405NG 19ESO5NG 19ESO5NG EN 19GBO5NG 19SEO5NG 19SEO5NG NO 19WM0501 Classification IIb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD We hereby declare that an examination of the under mentioned pro
12. this may damage the Conserver 2 Place the cannula over your ears and position the prongs in your nose as instructed by your Provider or cannula manufacturer 3 Slowly open cylinder valve counterclockwise until completely open V DN OR 4 Turn dial on the Conserver until indicating pointer is aligned with the prescribed setting NOTE When changing from a Pulse setting to a continuous flow setting the device must be placed in the off position for at least 5 seconds to release back pressure Not following this step will cause the device to rapidly pulse in the continuous flow position 5 Breathe through your nose NOTE When on a pulse setting there is flow or a pulse only at the beginning of each breath If you do not feel the pulse at the beginning of each breath check the setting If there is still no pulse turn dial to an equivalent Continuous setting Because each patient s breathing pattern is different and the environment varies it may be difficult to feel some low setting pulses FASYPULSE5 gen Conserving Regulate 9 6 To remove the Conserver from cylinder e Completely close oxygen cylinder valve e Turn the Conserver dial to any Continuous position e Wait for oxygen to stop flowing from Conserver e Remove the Conserver from cylinder valve e DO NOT try to loosen T handle beyond stop Damage to the Conserver will occur ADANGER NEVER attempt to remove the Conserver from a c
13. ylinder unless the cylinder valve is closed AWARNING e When pointer on contents gauge enters red zone 500 psi 3447 kPa and below it is recommended to change to a full oxygen cylinder e NO OXYGEN is delivered in between settings To avoid injury to patient e ALWAYS confirm prescribed setting before administering to patient and monitor flow on a frequent basis AWARNING e Use only Precision Medical Inc carry bag designed for the EasyPulse5 to prevent an oxygen enriched environment e DO NOT place the unit under clothing while in use When the Conserver is in use a small amount of oxygen is vented Wearing the unit 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 fabrics to return to normal e ALWAYS insert cylinder and Conserver into bag cylinder first with gauge facing mesh Reference accessory photo pg 13 EASYPULSE5S Oxygen Conserving Regulat 10 MAINTENANCE CLEANING 1 Disconnect all connections before cleaning 2 Clean exterior surfaces of the Conserver with a cloth dampened with mild detergent and water 3 Wipe dry with a clean cloth 4 Store the Conserver in a clean area free of grease oil and other sources of contamination CAUTION e DO NOT use cleaning solutions e DO NOT immerse the Conserver in any kind of liquid e DO NOT attempt to
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