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1. USER MANUAL OXYGEN SELECT FLOWMETER MODEL 3MFA1001 E Oy T SEHEHSHHE ISO 13485 CERTIFIED Your local distributor N Medical Dynamics TECHNOLOGY OF THE FUTURE TODAY 866 624 3952 www thinkMDI net CE 0197 P Srne O SAVE THESE INSTRUCTIONS Federal U SA 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 P A 18067 U SA Fax 001 610 262 6080 www precisionmedical com RECEIVING INSPECTION Remove the Precision Medical Inc Flowmeter from the packaging and inspect for damage If there is any damage DO NOT USE and contact your Provider INTENDED USE The flowmeter is intended for use by physicians respiratory therapists and other authorized hospital personnel to administer selected doses of medical oxygen to a patient READ ALL INSTRUCTIONS BEFORE USING This manual instructs a Professional to install and operate the Flowmeter This is provided for your safety and to prevent damage to the Flowmeter If you do not understand this manual DO NOT USE the Flowmeter and contact your Provider SAFETY INFORMATION WARNINGS AND CAUTIONS AWARNING ACAUTION CAUTION Indicates a potentially hazardous situation which if not avoided could result in death or serious injury Indicates a potentially hazardous situation which if not av
2. Tube in a vertical upright position Only personnel instructed and trained in its use should operate this Flowmeter Be sure all connections are tight and leak free Only use oxygen safe leak detector to test for leaks DO NOT autoclave DO NOT gas sterilize with EtO Ethylene Oxide DO NOT clean with aromatic hydrocarbons DO NOT immerse Flowmeter in any kind of liquid This will void the warranty Store Flowmeter in a clean area when not in use Only qualified personnel should repair this Flowmeter Continued on inside SPECIFICATIONS Model 3MFA1001 Flow Range 0 15 lpm Gas Oxygen Increments 5 Ipm from 5 to 5 lpm 1 Ipm from 5 to 15 Ipm Accuracy 25 Ipm from 5 to 5 lpm 5 lpm from 6 to 15 Ipm Max Flush Flow Range 60 80 Ipm 50 psi 3 4 bar FOR INTERNATIONAL UNITS SEE PRODUCT LABEL Transport Storage 40 F 40 C to 140 F 60 C Requirements NOTE Storage Transport outside the specified range may cause damage to the flowmeter The effect on accuracy of flow due to variations in ambient tempera ture is standard accuracy 7 3 0 C and 3 0 40 C Flowmeters calibrated at 50 psi 3 4 bar 70 F 21 C standard atmospheric pressure International flowmeters are calibrated per specifications marked on Flow Tube Specifications are subject to change without prior notice OPERATING INSTRUCTIONS AWARNING Read this User Manual before installing or op
3. 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 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 503283 Rev5 09 5 08 5M Printed in USA
4. ce Body Assembly desired flow Knob will not turn Valve seized e Replace Body Assembly No flow at outlet Outlet port in e Align Outlet port with ON arrow OFF position e Turn Knob counterclockwise ANY product returned to Precision Medical Inc for repair must be packaged so as to prevent shipping damage Repairs for damage due to improper packaging will be charged to the customer REPLACEMENT PARTS Model 3MFA1001 Description on uy 50 psi 3 4 bar 1 Disc 1114 2 Housing 1143 3 Flow Tube 1010 4 Tetraseal 1123 5 Float Body 1005 6 Body Assy 503506 L eee 1007 International parts specifications and specific ratings are available upon request 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 Flowmeters Model s 3MFA MDD Class llb 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 93 42 EEC Council Directive Concerning Medical Devices 1993 BS EN 13220 Flow Metering Devices for Connection to Terminal Units of 1999 Medical Gas Pipeline Sys
5. e patient is receiving flow from proper outlet port e FLOW IS ONLY DELIVERED to the selected port indicated by the ON arrow amp e NO FLOW is delivered to the ports indicated by the OFF arrows To avoid injury to patient e ALWAYS confirm prescribed flow before administering to patient and monitor flow on a frequent basis CAUTION DO NOT over tighten Knob when turning off This will cause damage to the Flowmeter e Pressures other than those indicated on the Flow Tube may affect the accuracy of the indicated flow e Gas Temperatures other than 70 F 21 C may affect the accuracy of the indicated flow e Attaching accessories to the outlet which may increase resistance to outlet flow may change indicated flow but will not affect the accuracy of the flow e ONLY use oxygen indexed fittings to connect Flowmeter to oxygen source CLEANING INSTRUCTIONS 1 Disconnect all connections before cleaning 2 Clean exterior surfaces of the Flowmeter with a cloth dampened with a mild detergent and water 3 Wipe dry with a clean cloth TROUBLESHOOTING If the Flowmeter fails to function consult your Provider or Precision Medical Inc Problem Probable Cause Remedy Will not shut off e Leak e Replace Tetraseal and or Housing e Defective Valve e Replace Body Assembly Sticking Float Ball e Debris in Flow Tube Clean Flow Tube Unable to set e Blocked Inlet e Repla
6. erating the Flowmeter CAUTION Inspect the Flowmeter for visual damage before use DO NOT USE if damaged NOTE Precision Medical Inc strongly recommends the use a of kink proof Cannula Turn Knob to the OFF position 2 Connect the Flowmeter to a 50 psi 3 4 bar oxygen gas source For international Flowmeters connect to appropriate oxygen source pressure 3 Verify that the Float Ball is at the very bottom of the Flow Tube NOTE If the Float is not resting at the bottom of the Flow Tube the Flowmeter is leaking consult the Troubleshooting Guide 4 Adjust Flow To increase Turn Knob counterclockwise To decrease Turn Knob clockwise 5 Set flow by aligning center of Float Ball with indicator lines on the Flow Tube 6 Adjusting flow beyond the last calibrated indicator line will result in an undetermined flow 7 To obtain maximum flush flow turn Knob fully Counterclockwise NOTE Flush flow is any flow above the last calibrated line on the Flow Tube with an unrestricted flow as per Specifications 8 Connect up to three 3 medical devices to the outlet ports 9 Push the Locking Button UP and rotate Connector Body to align the ON indicating a arrow with the desired outlet port OFF indicating arrows EF should align with the other two 2 ports not in use AWARNING e ALWAYS rotate and lock connector body into place before using the Flowmeter After activating flowmeter be sur
7. oided 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 CONSULT ACCOMPANYING DOCUMENTS Symbol for USE NO OIL Symbol for NO SMOKING 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 flow before administering to patient and monitor flow on a frequent basis This Flowmeter contains magnetic ferrous material that may affect the results of an MRI ALWAYS rotate and lock connector body into place before using the Flowmeter After activating flowmeter be sure patient is receiving flow from proper outlet port FLOW IS ONLY DELIVERED to the selected port indicated by the ON arrow NO FLOW is delivered to the ports indicated by the OFF arrows To Reduce the Risk of Fire or Explosion ALWAYS follow ANSI and CGA standards for Medical Gas Products and Flowmeters E 7 and Oxygen Handling G 4 DO NOT use oils greases organic lubricants or any combustible materials on or near this Flowmeter DO NOT use near any type of flame or flammable explosive substances vapors or atmosphere DO NOT smoke in an area where oxygen is being administered ACAUTION This Flowmeter must be operated with the Flow
8. tems ISO 14971 Medical Devices Application of risk management to 2007 Medical Devices 2nd Edition 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 ISO 15001 Anaesthetic and Respiratory Equipment Compatibility with Oxygen 2003 Notified Body T V Rheinland Products Safety GmbH C 0197 EC Certificate No HD 60019110 0001 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Medical Gas Flowmeter the Product will be free of defects in workmanship and or material for the following period a Flow Tube and Housing Lifetime of the product b Needle Valve Five 5 years from shipment c All other parts of the Medical One 1 year from shipment Gas Flowmeter not identified in a or b above 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

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