Precision Medical 1MFA3001 User manual

USER MANUAL
OXYGEN
PEDIATRIC
FLOWMETER
MODELS: 1MFA3001 (SHOWN)
4MFA1001
6MFA1001
Authorized EU Representative:
EMERGO EUROPE, INC.
Molenstraat 15
2513 BH The Hague
NETHERLANDS
SAVE THESE INSTRUCTIONS
CAUTION Federal (USA) law restricts this device to
sale by or on the order of a physician.
300 Held Drive Tel: [phone]
Northampton, PA 18067 USA Fax: [phone]
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 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 CAUTION
WARNING Indicates a potentially hazardous situation
which, if not avoided, could result in death or
serious injury.
CAUTION Indicates a potentially hazardous situation
which, if 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 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 contains 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 (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.
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.
• DO NOT autoclave.
• DO NOT gas sterilize with EtO (Ethylene Oxide).
• DO NOT clean with aromatic hydrocarbons.
• DO NOT immerse product in any kind of liquid. This will void
the warranty.
• This Flowmeter may have a factory installed restrictor. Prior to
use, check product labeling for flow restrictions.
•
This Flowmeter contains a glass flowtube which is fragile.
Special care should be observed to avoid braking the flowtube.

SPECIFICATIONS
Model 6MFA1001 4MFA1001 1MFA3001
Flow Range 0-200 cc 0-1 lpm 0-3 lpm
Gas Oxygen Oxygen Oxygen
Increments 20 cc
(starts at 20 cc)
.1 lpm
(starts at .1 lpm)
.125
from .125 to 1 lpm
.25 lpm
from 1 to 3 lpm
Accuracy ± 10 cc
from 0-100 cc
± 14 cc
from 100-200 cc
± .05 lpm ± .15 lpm
Max Flush Flow
Range
500 cc* 6 lpm* 20 - 40 lpm
Transport / Storage
Requirements
-40˚F (-40˚C) to
140˚ (60˚C)
* Restricted Max Flush Flow
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.
Flowmeters calibrated at 50 psi (3.4 bar), 70°F (21°C), standard atmospheric
pressure.
International models 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 a 50 psi oxygen gas source. For international
products, connect to appropriate oxygen source pressure.
NOTE: 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.
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 per specifications.
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.
• ONLY use appropriate gas specific indexed fittings to connect
Flowmeter to gas 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
• Defective Valve
• Replace Tetraseal and/or Housing
• Replace Body Assembly
Sticking Float Ball • Debris in Flow Tube • Clean Flow Tube
Unable to set
desired flow
• Blocked Inlet • Replace Body Assembly
Knob will not turn • Valve seized • Replace Body Assembly
RETURNS
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.

REPLACEMENT PARTS
Description
Model No.
6MFA1001
0-200 cc
OXYGEN
50 PSI
Model No.
4MFA1001
0-1 lpm
OXYGEN
50 PSI
Model No.
1MFA3001
0-3 lpm
OXYGEN
50 PSI
1 Spring 1575 1575 1575
2 Washer 1787 1787 1787
3 Housing 1143 1143 1143
4 Tetraseal™ 1123 1123 1123
5 Flow Tube Kit 503213 503214 503215
6 Float Ball 1576 1576 1576
7 Body Assembly 1891 1897 502053
8 Knob 1007 1007 1007
International parts specifications and specific ratings are available
upon request.
International flowmeters are calibrated per specifications on
flowtube.
DECLARATION OF CONFORMITY
Manufacturer: Precision Medical, Inc.
300 Held Drive, Northampton, PA 18067, USA
CONTACT: Quality Manager
Phone: [phone]
Authorized European Representative: Emergo Europe
Molenstraat 15
2513 BH, The Hague
The Netherlands
Product: Flowmeters
Model(s): 1MFA
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
2000+A:1:2003
Devices, 2nd Edition
EN 980 Graphical Symbols for Use in the Labeling of Medical Devices 2003
BS EN 1041 Information supplied by the Manufacturer with Medical Devices 1998
EN ISO 15001 Anaesthetic and Respiratory Equipment - Compatibility with Oxygen 2003
Notified Body: TÜV Rheinland Products Safety GmbH
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) 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 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.
503284 Rev5 (E) 2/09 Printed in USA