U S E R M A N U A L
OXYGEN
FLOWMETER
MODELS: 1MFA1001(shown)
1MFA3501
1MFA4001
1MFA8001
ISO 13485 Certified
Authorized EU Representative:
EMERGO EUROPE, INC.
Molenstraat 15
2513 BH The Hague
Netherlands
Save these insructions
Federal (USA) law restricts this device to
CAUTION
sale by or on the order of a physician.
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 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
WARNING which, if not avoided, could result in death or
serious injury.
Indicates a potentially hazardous situation
CAUTION which, if not avoided, may result in minor or
moderate injury.
Used without the safety alert symbol indicates
CAUTION 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”
WARNING
• Use this Flowmeter only for its “Intended Use” as described
in this manual.
• ALWAYS confirm prescribed flow before administering to
patient and monitor flow on a frequent basis.
• 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:
• 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.
CAUTION
• 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.
• 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.
SPECIFICATIONS
Model 1MFA3501 1MFA4001 1MFA1001 1MFA8001
Gas OXYGEN OXYGEN OXYGEN OXYGEN
Scale 0-5 lpm 0-8 lpm 0-15 lpm 0-70 lpm
Increments 0.25 lpm 0.5 lpm 0.5 lpm 5 lpm
(starts at 0.5 lpm) (starts at 1 lpm) from 0.5 to 5 lpm (starts at 10 lpm)
1 lpm
from 5 to 15 lpm
Accuracy ± 0.2 lpm ± 0.25 lpm ± 0.25 lpm ± 3 lpm
from 0.5 to 5 lpm
± 0.5 lpm
from 6 to 15 lpm
Maximum
Flush Flow 60 - 80 lpm 70 - 90 lpm
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% @ 32°F (0°C) and -3.0% @ 104°F (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
WARNING
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.
1. Turn Knob to the “OFF” position.
2. Connect the Flowmeter to an oxygen source with the appropriate
pressure as specified on the Flow Tube.
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” listed above.
WARNING
To avoid injury to patient:
• 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
• 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.
• 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 oxygen indexed fittings to connect
Flowmeter to oxygen source. Use Oxygen connections for
oxygen 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.
TROUBLESHOOTING
If the Flowmeter fails to function, consult the Troubleshooting Guide below. If
problem cannot be corrected, consult your Provider or Precision Medical, Inc.
Problem Probable Cause Remedy
Will not shut off •Leak •Replace Tetraseal or Replace
Housing
•Defective Valve •Replace Body Assembly
Sticking Float Ball •Debris in Flow •Clean Flow Tube & Float Ball
Tube
Knob will not turn •Valve seized •Replace Body Assembly
Returned products require a Returned Goods Authorization (RGA) number.
ANY product returned to Precision Medical, Inc. must be packaged in a
sealed container to prevent damage. Precision Medical, Inc. will not be
responsible for goods damaged in transit.
REPLACEMENTS PARTS LIST
Model # Model # Model # Model #
1MFA3501 1MFA4001 1MFA1001 1MFA8001
Description 0-5 lpm 0-8 lpm 0-15 lpm 0-70 lpm
OXYGEN OXYGEN OXYGEN OXYGEN
50psi (3.4 bar) 50psi (3.4 bar) 50psi (3.4 bar) 50psi (3.4 bar)
1 Disc 1009 1114 1009
2 Housing 1143
3 Flow Tube 1012 1152 1010 1021
4 Tetraseal™ 1123
5 Float Ball 1005 1029
6 Body Assy 504407 505271 1670
7 Knob 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): 1MFA 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 EN 13220 Flow Metering Devices for Connection to Terminal Units of Medical Gas 1999
Pipeline Systems
ISO 14971 Medical Devices - Application of risk management to Medical Devices, 2nd Edition 2000+A1:2003
EN 980 Graphical Symbols for Use in the Labeling of Medical Devices 2003
EN ISO 15001 Anaesthetic and Respiratory Equipment - Compatibility with Oxygen 2003
BS EN 1041 Information supplied by the Manufacturer with Medical Devices 1998
Notified Body: TÜV Rheinland Products Safety GmbH
EC Certificate No.: HD60019110 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 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 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.
503282 Rev11 (E) 4/09 Printed in USA