(Threaded Connection) Oxygen Conserving Regulator User Manual
Contents
1. USE and contact your Equipment Provider INTENDED USE To regulate 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 the user to install and operate the EasyPulse5 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 Equipment 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 EE SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION BE ee 9 D CE 0473 EE 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 sa2. USER MANUAL EASYPULSES5 Oxygen Conserving Regulator EASYPLULSE5 6 Oxygen Conserving Regulator 1900 Series Threaded Connections 195405 shown SAVE THESE INSTRUCTIONS Federal USA law restricts this device to ACAUTION sale by or on the order of a physician PRECISION MEDICAL 300 Held Drive Northampton PA 18067 USA ISO 13485 Certified Tel 001 610 262 6090 Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING INSPECTION ou1geg guer acini niiiaai anna 2 eg Ge 2 READ ALL INSTRUCTIONS BEFORE USING 0 ee 2 EXPLANATION OF ABBREVIATIONS uu eee cece eee eeeeees 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 PRINCIPLES OF OPERATION Sege eeeEdEREEENAEEEEE EEN 5 SPECIBIGATIONS eegene See eege 6 DIAGRAMS COMPONENT DESCRIPTION ieee 7 INSTALLATION EE 8 OPERATING INSTRUCTIONS 0 sesiis tiaren iias aa 9 MAINTENANCE CLEANING ssisseissnsssisisississssarnnsns sennior 11 RETURNS Seea a a S 11 DISPOSAL INSTRUCTIONS cciscssicccctssssencsseccseessd cectivencasesecacdicecanus 11 TROUBLESHOOTING sirepan aa tie 12 REPLACEMENT PARTS cscccsstsaiviessecudeniiiaeiilvecsieiiec 12 ACCESSORIES reee a E pE east ee Tee ions 13 LIMITED CH EE 14 DECLARATION OF CONFORMITY 0c cece eect 15 EE 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
3. al precautions need to be taken when disposing the device and or its packaging Please Recycle EY 11 EE 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 A No flow Cylinder valve closed Turn on cylinder 2 Regulator in OFF 2 Set to prescribed position setting Cylinder empty Replace cylinder Dial set between Set dial so indicator V settings points to a setting Conserver not sensing 5 a Check position of breath cannula in nose b Do not breathe through mouth B Leaking at Missing or defective Replace Inlet Seal cylinder Inlet Seal connection Defective cylinder Contact your valve Equipment Provider REPLACEMENT PARTS DESCRIPTION PART Cannula 504833 Inlet Seals Viton O rings For models 195405 Serial 100461 or higher 505487 195405NG Serial 178367 or higher For models 19SE05 19SE12 19SEO5NG A 19SE12NG 505214 19DE05 19DE12 19DEO5NG A 19DE12NG 505401 19GB05 19GB12 19GBO5NG amp 19GB12NG 505214 For models 19ES05 19SE12 19ESO5NG A 19SE12NG 505574 dE 12 ACCESSORIES DESCRIPTION PART Carry Bag M6 503920 Carry Bag M4 M6 504184 Cany Bag ML6 M9 504185 Model 195405 Shown Model 195405NG Shown Carry Bag with shoulder strap C
4. ely open 4 Turn dial on the Conserver until indicating pointer V7 is aligned with the prescribed setting 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 e Because each patient s breathing pattern is different and the environment varies it may be difficult to feel some low setting pulses 6 To remove the Conserver from cylinder s 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 ADANGER NEVER attempt to remove the Conserver from a cylinder unless the cylinder valve is closed AWARNING e When cylinder pressure is 500 psi 3447 kPa 34 47 bar and below it is recommended to change to a full oxygen cylinder e NO OXYGEN is delivered in between settings e 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 e When the Conserveris in use a small amount of oxygen is vented Wearing
5. fety alert symbol indicates a potentially hazardous situation which if not avoided 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 standards for Medical Gas Products and High Pressure Oxygen Handling In the United States ANSI CGA and G 4 applies 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 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 the Conserver or connecting devices DO NOT use oils greases organic lubricants or any combustible materials on or near the Conserver Wash and dry hands properly prior to use 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
6. ion 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 and Directive 2007 47 EC on medical devices We certify that the production quality system conforms to 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 EN 1041 EN ISO 14971 EN ISO 15001 ISO 228 1 ISO 10524 1 ISO 10524 3 ISO 15223 1 ISO 18779 SS 367615 a Ae Notified Body AMTAC Certification Services Limited C 0473 Address Davy Avenue Knowhhill Milton Keynes MK5 8NL UK Certification Registration Noe 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 504429 Rev12 6 15 M Printed in USA
7. ircumstances 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 PULSES 14 Oxygen Conserving Regulate DECLARATION OF CONFORMITY Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Emergo Europe European Office Molenstraat 15 0473 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 EasyPulse5 Oxygen Conserving Regulator 198705EN 195405 19DE05 19ES05 19ES05 EN 19GB05 19SE05 19SE05 ES 198705NG 195405NG 19ES05NG 19ES05NG EN 19GB05NG 19SE05NG 19SE05NG NO 19WM0501 EasyPulse 5 6 Oxygen Conserving Device Series 198712EN 195412EN 19DE12 19ES12 19ES12 EN 19GB12 19GB12PC 19SE12 19SE12 ES 198712NG 195412NG 19ES12NG 19ES12NG EN 19GB12NG 19SE12NG 19SE12NG NO Classification Ilb Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD We hereby declare that an examination of the under mentioned product
8. n amp White DIN 477 9 Connection German Standard 19DE05 19DE12 and 19DEO5NG 19DE12NG Labels are Black amp White Cannula Inlet Seal Connection C gt Dial Contents Gauge Gauge Models ONLY Indicator Pointer EE Bullnose Connection British 19GB05 19GB12 Shown and 19GBO5NG 19GB12NG Spanish 19ES05 19SE12 and 19ESO5NG 19SE12NG Inlet Seal Cannula Connection Dial Contents Gauge Gauge Models ONLY j Indicator Leaf j J Pointer White Knob INSTALLATION AWARNING e Read this User Manual before installing or operating the Oxygen Conserving Regulator e Inspect the Conserver and cylinder valve to ensure they are free of oils greases or other contaminants e DO NOT direct flow of oxygen at any person or flammable material when cracking open the cylinder CAUTION e Inspect the Oxygen Conserving Regulator for visual damage before use DO NOT USE if damaged e DO NOT use tools to tighten knob this can lead to over tightening and will cause damage to the Conserver Be sure all connections are tight and leak free e DO NOT use liquid leak detector to test for leaks NOTE For Operational Instructions on how to operate the cylinder consult with your Equipment Provider PULSES 8 Oxygen Conserving Regulator Position the cylinder so the oxygen cylinder valve outlet is pointing away from the user and any other per
9. onserver properly installed in Carry Bag Conserver properly installed in Carry Bag EE 13 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the EasyPulse5 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 contract 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 c
10. rating the Conserver outside its range of operating conditions may affect its accuracy and performance PRINCIPLES OF OPERATION The Oxygen Conserver is 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 PULSES Oxygen Conserving Regulator 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 Weight Overall Length Width Height Pulse Settings Flow Settings Accuracy Continuous Settings No Gauge Models Gauge Models 10 oz 283 g 12 6 oz 357 g 2 5 in 6 4 cm 2 5 in 6 4 cm 1 9 in 4 9 cm 2 8 in 7 0 cm 2 9 in 7 5 cm 3 2 in 8 1 cm 1 2 3 4 amp 5 l min Eq
11. son s Before installing the Conserver crack cylinder valve by opening the valve slightly to remove any foreign particles and then close valve NOTE For NO GAUGE NG Models ONLY The Conserver should only be used on cylinders with a contents gauge Be sure the Conserver is in the OFF position Align OFF with the indicating pointer V Be sure the high pressure inlet connection has a seal DO NOT USE without a seal See Product Diagram NOTE For optimum safety use only a Precision Medical Inc Inlet Seal Viton O ring See Parts List The Inlet Seal supplied with the Conserver is reusable DO NOT USE any other type of seal 5 Attach the Conserver to the oxygen cylinder valve 6 Hand tighten knob clockwise until tight 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 AWARNING 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 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 PULSES Oxygen Conserving Regulator 9 3 Slowly open cylinder valve counterclockwise until complet
12. 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 the Conserver into bag cylinder first with gauge facing mesh Reference Accessory photo pg 13 FASYPULSE5 10 Oxygen Conserving Regulate MAINTENANCE CLEANING 1 Disconnect all connections before cleaning 2 After each use clean exterior 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 from 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 repair the EasyPulse5 Oxygen Conserving Regulator e All repairs must be performed by Precision Medical Inc RETURNS Returned products require a Returned Goods Authorization RGA number contact Precision Medical Inc All returns must be packaged in sealed containers to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Refer to Precision Medical Inc Return Policy available on the Internet www precisionmedical com Manuals available on our Website www precisionmedical com DISPOSAL INSTRUCTIONS This device and its packaging contain no hazardous materials No speci
13. uivalents 2 l min Continuous 195405 1 through 6 I min Continuous 195412 within 10 Accuracy Savings Ratio Trigger Method PULSE ONLY Breathing Frequency Pulse Settings Within 15 of the nominal 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 540 Valve Meets ASTM G175 03 Specifications are subject to change without prior notice Manuals available on our Website www precisionmedical com PULSES 6 Oxygen Conserving Regulator DIAGRAMS COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc MODELS 3 versions shown CGA 540 Connection 195405 195412 Shown and 194504NG 195412NG Inlet Seal Cannula O ring Connection Dial J Contents Gauge Gauge Models Indicator 4 KR Lah ONLY Pointer Green Knob DIN 477 6 Connection Swedish Standard 19SE05 19SE12 Shown and 19SEO5NG 19SE12NG Labels are Gree
14. use while sleeping without consulting your Equipment Provider DO NOT smoke in an area where oxygen is being administered DO NOT use near any type of flame or flammable explosive substances Use only medical grade oxygen In the United States USP applies The Conserver is equipped with a relief valve If you hear a loud hissing or popping sound coming from the Conserver discontinue use close cylinder valve and contact your Equipment 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 PULSES 4 Oxygen Conserving Regulator 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 e 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 e Consistent with the recommendations of the medical community on the use of conserving devices it is recommended that the Conserver 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 Ope
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