Precision Medical Chrome Flowmeters User Manual

USER MANUAL

FLOWMETER

MODELS:

1MFA, 4MFA, 6MFA and

8MFA Series

1MFA3001 (Shown)

SAVE THESE INSTRUCTIONS

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 Certied www.precisionmedical.com

8MFA1001 (Shown)

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

WARNING

CAUTION

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 avoided, 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.

Operating Instructions

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)

WARNING

• Use Flowmeters only for their “Intended Use” as described in this

manual.

• ALWAYS conrm prescribed ow before administering to patient
and monitor ow on a frequent basis.

• 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 ame or ammable/explosive
substances, vapors or atmosphere.

•

DO NOT smoke in an area where oxygen is being administered.

CAUTION

• 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 & 6MFA1001 Flowmeters may have a
factory installed restrictor. Prior to use, check Flowmeter labeling

for ow restrictions.

•

The 1MFA3001, 4MFA1001 & 6MFA1001 Flowmeters contain a
glass Flow Tube which is fragile. Special care should be observed
to avoid breaking the Flow Tube.

(Continued on Inside)

SPECIFICATIONS

Flow Range Graduations Accuracy

0 – 200 cc 20 cc (0-200)

0 – 1 l/min .1 (0-1) l/min 0-1 ±.05 l/min

0 – 3.5 l/min

0 – 5

l/min .25 (0-5) l/min 0-5 ±.20 l/min

0 – 6 l/min .5 (0-6) l/min 0-6 ±.50 l/min
0 – 8 l/min .5 (0-8) l/min 0-8 ±.25 l/min

0 – 15 l/min

0 – 26 l/min

0 – 70 l/min 5 (0-70) l/min 0-70

.125 (0-1) l/min
.25 (1-3.5)

.5 (0-5) l/min

1 (5-15)

1 (2-26)

l/min

l/min

l/min

Flush Flow is the output of the owmeter when the ow indicator is

beyond the highest calibrated graduation. The Flush Flow range is as

indicated on the owmeter 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 specied range may cause

damage to the owmeter.

The effect on accuracy of ow 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 specied inlet pressure, 70°F

(21°C), standard atmospheric pressure. International models are calibrated

per specications marked on Flow Tube or Flowmeter body.

Specications are subject to change without prior notice.

0-100 cc ±10 cc

101-200 cc ±14 cc

0-3.5 ±.15 l/min

0-5 ±.25 l/min

6-15 ±.50

2-4 ±.50 l/min

5-26 ±10% of reading

l/min

±10% of reading

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

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 the appropriate gas source. The

appropriate gas and pressure are specied 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 ow by aligning center of Float Ball with indicator lines on the Flow

Tube.

6. Adjusting ow beyond the last calibrated indicator line will result in
an undetermined ow.

7. To obtain maximum ush ow, turn Knob fully Counterclockwise.

NOTE: Flush ow is any ow above the last calibrated line on the

Flow Tube with an unrestricted ow, as indicated on owmeter

labeling.

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 or Flowmeter

body may affect the accuracy of the indicated ow.

• Gas Temperatures other than 70° F (21°C) may affect the accuracy of

the indicated ow.

• Attaching accessories to the outlet (which may increase resistance to outlet

ow) may change indicated ow but will not affect the accuracy of the ow.

• ONLY use appropriate gas specic indexed ttings 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

Sticking Float Ball

Unable to set

desired ow

Knob will not turn

8MFA Models DO NOT have serviceable parts.

• Defective Valve

• Debris in Flow Tube

• Blocked Inlet • Replace Body Assembly

• Valve seized • Replace Body Assembly

•

Replace Tetraseal and/or Housing

• Replace Body Assembly

• Clean Flow Tube & Float Ball

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. Return Policy available on the Internet,
www.precisionmedical.com.

REPLACEMENT PARTS *

PART

Spring NA 1575 NA

Washer NA 1787 NA

Disc NA 1009 1114 1009 1114 1009

Housing 1143

Tetraseal™

Flow Tube

Float Ball 1576 1005 1029 1005 1154 1154 1005 1029

Body
Assembly

Knob 1007 1008

Holder 506176 NA

*

International parts specications and specic ratings are available upon request.

2513 BH, The Hague
The Netherlands
Phone: [phone] Fax: [phone]

Classication: IIa
Classication criteria:

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 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

Notied Body:

Address: Davy Avenue Knowlhill Milton Keynes MK5 8NL, UK

Certication Registration No’s:

Devices already manufactured: S/N traceability Device History Records
Validity of DOC: 04 August 2012 to Date of Expiry
Manufacture Representative:
Position: Quality Systems/ISO Representative
Date of Issue: 04 August 2012

6MFA 4MFA 1MFA

1001 3001 3501 4001 1001 8001 5001 1101 1211 2001 9001

Kit #

Kit #

Kit #

503213

503214

1891 1897 502053 505271 504407 504823 504407 504434 504824

8MFA Models DO NOT have serviceable parts.

DECLARATION OF CONFORMITY

Precision Medical, Inc.

Flowmeters 1MFA, 4MFA, 6MFA & 8MFA Series

300 Held Drive
Northampton, PA 18067, USA

Emergo Europe (European Ofce)

Molenstraat 15

1012 1152 1010 1021 502459 507573 502117 1011 1031

503215

Clause 3.2 Rule 11 of Annex IX of MDD

AMTAC Certication Services Limited

1126 CE Date of Expiry: 03 August 2017

Quality Manager

MODEL #

1123

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 identied
in (a) or (b) above

Warranty does not cover breakage / abuse.

Should any failure to conform to this warranty appear within the applicable

period, Precision Medical, Inc. shall, upon written notication 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 modications, 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 nal, 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 prots,

lost sales, or injury to person or property. Correction of non-conformities as

provided above shall constitute fulllment 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 specications without notice.

Precision Medical, Inc. reserves the right to correct clerical or typographical
errors without penalty.

503349 rev5 [t4] 8/14 (?M) Printed in USA