User Manual - Medical Dynamics, Inc.
Contents
1. of risk management 2007 to Medical Devices 2nd Edition EN 980 Graphical Symbols for Use in the Labeling of 2003 Medical Devices EN ISO 15001 Anaesthetic and Respiratory Equipment Compatibility 2003 with Oxygen EN 1041 Information supplied by the Manufacturer with 1998 Medical Devices Notified Body EC Certificate No HD60019110 0001 T V Rheinland Products Safety GmbH C 0197 LIMITED WARRANTY AND LIMITATION OF LIABILITY Precision Medical Inc warrants that the Medical Gas Flowmeter the Product will be ree of defects in workmanship and or material for the following period a Flow Tube 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 are not authorized to make oral warranties about the merch2. ION Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in property damage AN CONSULT ACCOMPANYING DOCUMENTS x Symbol for USE NO OIL S Symbol for NO SMOKING AWARNING e Use this Flowmeter only for its Intended Use as described in this manual e ALWAYS confirm prescribed flow before administering to patient and monitor flow on a frequent basis e This Flowmeter does not contain magnetic ferrous material and should not affect the results of an MRI however any inlet fitting s used need s to be checked for MRI compatibility To Reduce the Risk of Fire or Explosion e Always follow ANSI and CGA standards for Medical Gas Products and Flowmeters and Oxygen Handling 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 DO NOT smoke in an area where oxygen is being administered ACAUTION e This Flowmeter must be operated with the Flow 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 Store the Flowmeter in a clean area free of grease oil and other sources of contamination e DO NOT autoclave e DO NOT gas sterilize with EtO Ethylene Oxide DO NOT clean
3. USER MANUAL Gna FLOWMETER s re MODELS 8MFA1001 shown E 8MFA2001 E 8MFA4001 iS ISO 13485 Certified fis Your local distributor 7 rz N Medical Dynamics ee eee TODAY www thinkMDI net 0197 SAVE THESE INSTRUCTIONS Federal USA law restricts this device to sale ACAUTION 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 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 or air 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 Indicates a potentially hazardous situation AWARNING which if not avoided could result in death or serious injury Indicates a potentially hazardous situation ACAUTION which if not avoided may result in minor or moderate injury CAUT
4. andise 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 inal 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 ncidental 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 o 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 503421 Rev9 4 09 M Printed in USA
5. oof Cannula 1 Turn Knob to the OFF position 2 Connect the Flowmeter to an appropriate gas source The appropriate gas and pressure are specified on the Flow Tube 3 Verify that the Float Ball is at the very bottom of the Flow Tube NOTE Ifthe Float is not resting at the bottom of the Flow Tube the product is leaking consult your Provider or Precision Medical Inc 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 listed above AWARNING To avoid injury to patient e ALWAYS confirm prescribed flow before administering to patient and monitor flow on a frequent basis DO NOT immerse the Flowmeter in any kind of liquid This will cause damage to the Flowmeter and will void the warranty CAUTION e DO NOT over tighten Knob when turning off This will cause damage to the Flowmeter 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 A
6. ttaching 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 appropriate gas specific indexed fittings to connect Flowmeter to gas source Use Oxygen connections for oxygen Flowmeters use air connections for air Flowmeters 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 MAINTENANCE DO NOT attempt to repair the Flowmeter There are no user serviceable parts TROUBLESHOOTING If the Flowmeter fails to function consult your Provider or Precision Medical Inc DECLARATION OF CONFORMITY Manufacturer Authorized European Representative Product Model s MDD Class Classification criteria Precision Medical Inc 300 Held Drive Northampton PA 18067 USA CONTACT Quality Manager Phone 610 262 6090 Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Flowmeters 8MFA lla 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 EN 13220 Flow Metering Devices for Connection to Terminal 1999 Units of Medical Gas Pipeline Systems ISO 14971 Medical Devices Application
7. with aromatic hydrocarbons DO NOT immerse Flowmeter in any kind of liquid This will void the warranty SPECIFICATIONS Model 8MFA4001 8MFA1001 8MFA2001 Gas OXYGEN OXYGEN AIR Scale 0 8 Ipm 0 15 Ipm 0 15 Ipm Increments 0 5 lpm 0 5 Ipm 0 5 Ipm starts at 0 5 lpm from 0 5 to 5 lpm from 0 5 to 5 lpm 1 lpm 1 lpm from 5to 15 lpm from 5 to 15 lpm Accuracy 0 25 lpm 0 25 lpm 0 25 lpm from 0 5 to 5 lpm from 0 5 to 5 Ipm 0 5 Ipm 0 5 Ipm from 6 to 15lpm from 6 to 15 lpm Maximum Flush Flow 44 67 Ipm Range Transport Storage Requirements 40 F to 140 F 40 C to 60 C NOTE Storage Transport outside the specified range may cause damage to the flowmeter The effect on accuracy of flow due to variations in ambient temperature is standard accuracy 7 3 0 C and 3 0 40 C The above flowmeter models are calibrated at 50 psi 3 4 bar 70 F 21 C standard atmospheric pressure International models are calibrated at various pressures specified on the flow tube 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 operating the Flowmeter CAUTION Inspect the Flowmeter for visual damage before use DO NOT USE if damaged NOTE Precision Medical Inc strongly recommends the use of kink pr
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