USER MANUAL - Pinnacle Medsource
Contents
1. tightening and will cause damage to the Conserver Besure all connections are tight and leak free DO NOT use liquid leak detector to test for leaks NOTE For operational instructions on how to operate the cylinder consult your Provider k Position the cylinder so the oxygen cylinder valve outlet is pointing away from the user and any other person s 2 Before installing the Conserver crack cylinder valve by opening the valve slightly to remove any foreign particles and then close valve 3 Be sure the Conserver is in the OFF position Align OFF with the indicating pointer V 4 Be sure the CGA 870 connection high pressure inlet has a yoke seal Align Index Pins with Index Pin Alignment Holes in Post Valve 6 Hand tighten T handle until snug LEUTE 8 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 DO NOT use pediatric low flow nasal cannulas or oxygen masks with the Conserver 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 OR j 3 Slowly open cylinder valve counterclockwise until com2. being administered DO 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 ACAUTION Only personnel instructed and trained in its use should operate the Conserver The Conserver contains magnetic ferrous material that may affect the results of an MRI DO NOT autoclave DO NOT gas sterilize with Ethylene Oxide DO NOTclean with aromatic hydrocarbons Store the Conserver in a clean area when not in use 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 The Conserver may not be able to detect all respiratory efforts of the patient Shallow breathers may not be able to trigger the Conserver Operating the Conserver outside its range of operating conditions may affect its accuracy and performance PRINCIPLES OF OPERATION The Oxyge
3. 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 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 I
4. 3 EN 1041 Information supplied by the Manufacturer with Medical Devices 1998 EN ISO 15001 Anesthetic and Respiratory Equipment Compatibility with Oxygen 2003 ISO 10993 1 Biological Evaluation of Medical Devices Part 1 2003 ISO 10993 5 Biological Evaluation of Medical Devices Part 5 1999 ISO 10993 10 Biological Evaluation of Medical Devices Part 10 2002 A1 2006 ISO 10524 1 Pressure Regulators for Use with Medical Gases Part 1 Pressure 2006 Regulators and Pressure Regulators with Flow Metering Devices ISO 14971 Medical Devices Application of Risk Management to 2000 A1 2003 Medical Devices ISO 18779 Medical Devices for Conserving Oxygen and Oxygen Mixtures 2005 Particular Requirements ISO 228 1 Pipe threads where tight joints are not made on the threads 2000 Dimensions Tolerances amp Designation SS 367615 Gas Cylinders Valve Outlets amp Couplers 2001 Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate HD60019110 0001 C ISO 13485 Certified 0197 504203 Rev8 E 04 08 50M Printed in USA
5. 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 11 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 Oylinder valve Open the valve on closed cylinder Regulator 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 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 EU LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Easy Pulse Oxygen Conserving Regulator the Product will be free of defects
6. FASYPLLSES Oxygen Conserving Regulator 1900 SERIES CGA 870 Connection 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 Tel 001 610 262 6090 Northampton PA 18067 USA Fax 001 610 262 6080 www precisionmedical com CONTENTS RECEIVING 2 INTENDED USE el e ahd dem gd eti 2 READ ALL INSTRUCTIONS BEFORE USING 2 EXPLANATION OF ABBREVIATIONS see 2 SAFETY INFORMATION WARNINGS AND CAUTIONS 3 PRINCIPLES OF OPERATION essent 5 SPECIFICATIONS o dte eine de ene 6 COMPONENT 7 ntt hee tp eee Retos 8 OPERATING 8 9 MAINTENANCE CLEANING 11 be te i i e enis 11 DISPOSAL INSTRUCTIONS sss 12 TROUBLESHOOTING 0 Rte aides 12 REPLACEMENT PARTS idet ees 18 ACCESSORIES Up EIU 13 LIMITED WARRANTY cette tret ett det bet ves die 14 EU 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 high pressure cylinders that prov
7. ent Operating Conditions Temperature Altitude Storage Conditions Temperature Maximum Humidity Oxygen Cylinder Connection Ignition and Fault Tolerance 2 pm 10 Up to 5 7 1 Inspiratory effort Negative pressure from patient inhalation Up to 35 bpm 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 panes 6 COMPONENT DESCRIPTION ACAUTION Missing or illegible labels must be replaced contact Precision Medical Inc Dial Indicator Pointer T Handle M Cannula Connection Contents Gauge 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 brass 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
8. ide 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 10096 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 DANGER This product is not intended as a life sustaining or life supporting device EXPLANATION OF ABBREVIATIONS kPa Kilopascal psi Pounds Per Square Inch lpm Liters Per Minute bpm Breathes Per Minute FASYPULSEJ SAFETY INFORMATION WARNINGS AND CAUTIONS ADANGER AWARNING ACAUTION CAUTION 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
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 for SINGLE USE 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 3 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
10. n 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 EASYPLI SES gen Conserving Regulate 5 SPECIFICATIONS Inlet Pressure Range Internal Regulated Pressure Pressure Gauge Accuracy 300 3000 psi 2068 20684 kPa 50 psi 345 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 9 9 oz 279 g 4 75 in 12 07 cm 2 63 in 6 67 cm 2 50 in 6 35 cm 1 2 3 4 amp 5 lpm Equivalents 2 lpm Continuous Accuracy Within 15 of the nominal bolus value at each breath rate Continuous Setting Savings Ratio Trigger Method Breathing Frequency Cannula Requirem
11. nc 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 EASYPULSE 5 14 Oxugen Conserving Regulator 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 EasyPulse5 Oxygen Conserving Regulator Model s 1900 Series 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 the following documents Document Title Edition BS 341 3 Transportable Gas Container Valves Part 3 Valve Outlet Connections 2003 DIN 477 1 Gas Cylinder Valves rated for test pressures up to 300 Bar Types 1990 Sizes Connections Screw Threads EN 738 3 Pressure Regulators for Use with Medical Gases Part 3 Pressure 1999 Regulators Integrated with Cylinder EN 837 1 Bourbon Tube Pressure Gauges Dimensions Metrology 1998 Requirements and Testing EN 980 Graphical Symbols for Use in the Labeling of Medical Devices 200
12. nt an oxygen enriched environment 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 ALWAYS insert cylinder and Conserver into bag cylinder first with gauge facing mesh Reference accessory photo pg 13 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 DO NOT use cleaning solutions DO NOT immerse the Conserver in any kind of liquid DO NOT attempt to repair the EasyPulse5 Oxygen Conserving Regulator 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 responsiblefor goods damaged intransit Referto Precision Medical Inc Return Policy available on the Internet www precisionmedical com
13. pletely open 4 Turn dial on the Conserver until indicating pointer V is aligned with the prescribed setting 5 Breathe through your nose and feel a pulse of oxygen as you inhale 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 2 LPM Continuous setting Because each patient s breathing pattern is different and the environment varies it may be difficult to feel some low setting pulses gen Conserving Regulate 9 6 To remove the Conserver from cylinder Completely close oxygen cylinder valve Turn the Conserver dial to 2 LPM Continuous position Wait for oxygen to stop flowing from Conserver Remove the Conserver from cylinder valve DO NOT try to loosen T handle beyond stop Damage to the Conserver will occur DANGER NEVER attempt to remove the Conserver from a cylinder unless the cylinder valve is closed AWARNING When pointer on contents gauge enters red zone 500 psi 3447 kPa and below it is recommended to change to a full oxygen cylinder NO OXYGEN is delivered in between settings To avoid injury to patient ALWAYS confirm prescribed setting before administering to patient and monitor flow on a frequent basis Q AWARNING amp Use only Precision Medical Inc carry bag designed for the EasyPulse5 to preve
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