Flowmeter User Manual
Contents
1. installed restrictor Prior to use check Flowmeter labeling for flow restrictions The 1MFA3001 4MFA1001 amp 6MFA1007 Flowmeters contain a glass Flow Tube which is fragile Special care should be observed to avoid breaking the Flow Tube Continued on Inside SPECIFICATIONS 0 100 cc 10 cc 101 200 cc 14 cc 0 1 I min 1 0 1 l min 0 1 05 l min 0 3 5 I min 25 1 3 5 Vin 0 3 5 15 l min 20 cc 0 200 0 5 I min 25 0 5 l min 0 5 20 l min 0 6 I min 5 0 6 l min 0 6 50 l min 0 8 I min 5 0 8 l min 0 8 25 l min 5 0 5 l min 0 5 25 l min ia ie 1 5 15 l min 6 15 50 l min 2 4 50 I min 02b Min 1 220 Unin 5 26 10 of reading 0 70 I min 5 0 70 l min 0 70 10 of reading Flush Flow is the output of the flowmeter when the flow indicator is beyond the highest calibrated graduation The Flush Flow range is as indicated on the flowmeter labeling Transport Storage Requirements 40 F 40 C to 140 F 60 C The gas and inlet pressures are indicated on the Flow Tube or Flowmeter body 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 32 F 0 C and 3 0 104 F 40 C The above Flowmeter models are calibrated at specified inlet pressure 70 F 21 C standard atmospheric pressure International models are calibrated per specifications mark2. USER MANUAL Calon ake FLOWMETER re MODELS 1MFA 4MFA 6MFA and ng 8MFA Series z7 1MFA3001 Shown SMEATON Shown SAVE THESE INSTRUCTIONS R Federal USA law restricts this device to sale only 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 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 gases 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 CAUTION Indicates a potentially hazardous situation which if AWARNING not avoided could result in death or serious injury Indicates a potentially hazardous situation which if ACAUTION not avoided may result in minor or moderate injury CAUTION Used without the safety alert symbol indicates a potentially hazardous situation which if not avoided may result in prope
3. cause damage to the Flowmeter Pressures other than those indicated on the Flow Tube or Flowmeter body may affect the accuracy of the indicated flow Gas Temperatures other than 70 F 21 C may affect the accuracy of the indicated flow 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 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 DO NOT attempt to repair the 8MFA Flowmeters There are no serviceable parts 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 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 amp Float Ball Unable to set e Blocked Inlet e Replace Body Assembly desired flow Knob will not turn e Replace Body Assembly 8MFA Models DO NOT have serviceable parts RETURNS Returned products require a Returned Goods Authorization RGA number Any product returned to Precision Medical Inc
4. ed on Flow Tube or Flowmeter body Specifications are subject to change without prior notice For the most current manual revision please visit our website www precisionmedical com Tell us how we are doing Visit us at www precisionmedical com 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 proof Cannula Turn Knob to the OFF position 2 Connect the Flowmeter to the appropriate gas source The appropriate gas and pressure are specified on the Flow Tube or Flowmeter body 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 product 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 indicated on flowmeter labeling CAUTION DO NOT over tighten Knob when turning off This will
5. le 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 Inc whether based on contract negligence strict tort or otherwise Precision Medical Inc reserves the right to discontinue manufacture of any product or change produc
6. must be packaged in a sealed container to prevent damage Precision Medical Inc will not be responsible for goods damaged in transit Return Policy available on the Internet www precisionmedical com REPLACEMENT PARTS MODEL Tetraseal Kit Kit Kit Flow Tube 503213 503214 1503215 1012 1152 1010 1021 502459 507573 502117 1011 1031 1891 1897 502053 505271 504407 504823 504407 504434 504824 Assembly 1007 1008 Holder 506176 NA 8MFA Models DO NOT have serviceable parts International parts specifications and specific ratings are available upon request DECLARATION OF CONFORMITY Precision Medical Inc 300 Held Drive Northampton PA 18067 USA Emergo Europe European Office EC Eats Molenstraat 15 0473 2513 BH The Hague The Netherlands Phone 31 0 70 345 8570 Fax 31 0 70 346 7299 Flowmeters 1MFA 4MFA 6MFA amp 8MFA Series Classification lla Classification criteria Clause 3 2 Rule 11 of Annex IX of MDD We hereby declare that an examination of the under mentioned production quality assurance system has been carried out following the requirements of the UK national legislation to which the undersigned is subjected transposing Annex II 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
7. rty damage Operating Instructions ae Symbol for USE NO OIL 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 O gt N OO AWARNING e Use Flowmeters only for their Intended Use as described in this manual e ALWAYS confirm prescribed flow before administering to patient and monitor flow on a frequent basis e Flowmeters may contain magnetic ferrous material that may affect the results of an MRI To Reduce the Risk of Fire or Explosion ALWAYS follow ANSI and CGA standards for Medical Gas Products and Flowmeters and Oxygen Handling DO NOT use or store 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 Flowmeters must be operated with the Flow Tube in a vertical upright position Only personnel instructed and trained in its use should operate this Flowmeter Ensure all connections are tight and leak free Only use oxygen safe leak detector 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 The 1MFA3001 4MFA1001 amp 6MFA1007 Flowmeters may have a factory
8. t materials designs or specifications without notice re 625 LS 2 ASSL x OY S562 C52 S S090 SQ Q eS ot mee oP O 2 962 SESS DT Dav ys LS 000 g 922 s AS S9 x S982 SSS OSS x SSS SS SS Q 3 2 BESS oS gt S9 OS SS SS sh SS oO fe axes 2 Q 5 Q 2 S te SSO lt 2 S au 3 5 G 0 0 S S52 Se SX res es S Oe lt 0 oC LSS a 25 S 2 9 o gt oe me SRT Precision Medical Inc reserves the right to correct clerical or typographical errors without penalty ete eat CSSD SRS ERS a _ _an oes 82 S9 ORY SSS ros 503349 rev5 t4 8 14 M Printed in USA
9. the CE 0473 marking on those products listed above Applied Standards EN 1041 EN 14971 EN ISO 13485 ISO 15001 ISO 15002 ISO 15223 1 Notified Body AMTAC Certification Services Limited C 0473 Address Davy Avenue Knowlhill 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 2 Q lt 922 SS YS lt OQ S 382 a LIMITED WARRAN 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 SoS S90 S ESS SOS So OS 20 5 ZS a 3 2 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 Warranty does not cover breakage abuse 3 os eS SS KZ 0 OSZ eT QS 20 yon SSS e oS SoS LS o 29 SeS S o Should any failure to conform to this warranty appear within the applicab
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