Comweld Medical EZI-FLOW User manual

EZI-FLOWFLOWMETER
Instructions for use
521969-08-317
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Contents Page
1. INTRODUCTION
2. INTENDED USES
3. GENERAL DESCRIPTION
4. PARTS IDENTIFICATION
5. SAFETY PRECAUTIONS
6. EQUIPMENT USE
7. CHECKS AND INSPECTIONS BY THE USER
8. SERVICE RECOMMENDATIONS
9. ACCESSORIES AND REPLACEMENT PARTS
10.SPECIFICATIONS
11.WARRANTY
1. INTRODUCTION
These instructions are intended to provide users
with information on the features, use and care of an
EZI-flow Oxygen and Respiratory therapy flowmeter.
The instructions should be read carefully by every
intended user of an EZI-flow flowmeter in any of its
applications before attempting to use it to ensure
that they are fully conversant with all the information
on the features, use and care of the flowmeter.
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Warning
Read and understand the entire Instructions
for Use before operating this medical device.
Keep them always with the device. Failure to
do so may cause clinical damage to a patient
or damage to the device.

2. INTENDED USES
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The intended purpose of the EZI-flow flowmeter is flow adjustment
and measurement of medical gases for delivery to devices and/or
patients in applications like Oxygen and Respiratory therapy.
It should only be supplied from pressure regulated medical gas
systems. It should be used only in accordance with clinical or
medical advice and by persons instructed and familiar with basic
medical gas handling. Details of the performance of each EZI-flow
model is given in Section 10 Specifications.
3. GENERAL DESCRIPTION
The EZI-flow flowmeter is a pressure compensated flowmeter
suitable for most types of respiratory therapy. Flowmeters are
available for Oxygen (including models intended for low flows,
e.g. paediatric applications) and respiratory air. Flow control is
achieved via an adjustment control knob, and flow measurement
indication is by way of a graduated scale marked on the flow tube.
Use of the EZI-flow flowmeters should always be undertaken with
clinical or medical advice.
The flowmeters are intended to be connected by the user only to
a source of regulated pressure supplying medical gas at 400 kPa,
i.e. medical pressure regulators or medical gas pipeline systems,
fitted with SIS outlets to AS 2896 for the intended gas.
The medical gas source (gas cylinder and pressure regulator, or
pipeline system) should be clearly identified as matching the intended
gas of the flowmeter. Colour coding and sleeve indexing to SIS in AS
2896 is used for the inlet connections to prevent accidental
connection to an incorrect gas. The control knob and outlet
connections are also colour coded for easy gas recognition (Medical
Oxygen is colour coded White, and Medical Air coded Black).
The flowmeter may be connected by the user to downstream therapy
equipment using suitable soft plastic tubing inserted over the plastic
barbed nipple included with the product. Alternatively the barbed
nipple can be removed to access a standard 1/4” BSP connection.
The design features a captive control knob which prevents accidental
disassembly. The flowmeter uses a ball (or bobbin) float which rides
on the gas stream inside the flow tube. The flow tube is marked with a
graduated flow scale and is calibrated for a supply (inlet) pressure of
400 kPa from either a pressure regulator connected to a gas cylinder
or from the wall outlet of a medical gas pipeline system. The flow is
controlled by a needle valve downstream of the calibrated flow tube,
therefore changes in downstream back pressure do not affect the
accuracy of flow measurement, although a change in flow may occur.
A flow limiting orifice protects the patient against excessive
unintended flow. The calibrated flow tube is protected by an outer tube
(shroud) which incorporates a safety blowout against overpressure.

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4. PARTS IDENTIFICATION
4.1 Contents of Package:
Item Description Quantity
1 EZI-flow flowmeter assembly 1
2 Outlet Nut and Nipple assembly 1
3 Instructions for Use 1
4.2 Pictorial Description:
5. SAFETY PRECAUTIONS
- Use the flowmeter only for the purpose for which it is intended
(see above) and in accordance with clinical or medical advice.
Failure to do so may result in clinical damage to the patient.
- Use the flowmeter only for the gas for which it is marked and
colour-coded, always ensuring that the medical gas supply labels
on gas cylinder and pressure regulator or medical pipeline system
match the flowmeter intended gas label (Medical Oxygen is colour
coded White, and Medical Air colour coded Black).
- Use the correct model for the patient and intended maximum
flow, e.g. a low flow model for some paediatric applications.
- Never allow oil or grease near oxygen equipment or in contact
with the flowmeter as an explosion and/or fire may result.
- Never allow any source of ignition or naked flame near the
equipment or patient during oxygen administration and for a
reasonable period afterwards.
- Do not allow the flowmeter outer tube (shroud) to come in
contact with any chemical agents like solvents, aggressive cleaning
media or disinfectants - failure of the outer tube is likely to occur.
Warning

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- Never use excessive force when attempting to close the flow
control valve as seat damage may occur.
- No repair should ever be undertaken by personnel not trained
in the servicing procedures of medical gas equipment.
- Use only manufacturer approved spare parts when servicing the
flowmeter.
- Remove the red coloured plastic protection caps from a new
flowmeter just prior to installation.
- When connected to a pressure regulator fitted to a gas cylinder,
always open the cylinder valve SLOWLY. Rapid opening of the
cylinder valve may damage the equipment.
CAUTION
Equipment connected to high pressure gas cylinders must be
handled with care and in accordance with the recommendations
from the gas supplier.
- If the outer tube appears crazed or cracked, immediately
remove the flowmeter from use and subject it to service.
6. EQUIPMENT USE
6.1 Installation
1. Remove the red coloured plastic protection caps (if fitted) from
the inlet and outlet connections.
Warning
2. Check that the sealing O-ring on the inlet connection is in place
and in good condition (i.e. no cuts, deformation or dirt). Check
for loose fittings.
3. Check that the flowmeter flow control knob is turned off (i.e.
fully clockwise). If the flowmeter is connected to a pressure
regulator fitted to a gas cylinder, ensure that the cylinder valve
is closed.
4. Fit the flowmeter to the gas supply. Only a source of regulated
pressure supplying the correct medical gas at 400 kPa should
be used, e.g. medical pressure regulators or medical gas pipeline
systems, fitted with SIS outlets to AS 2896 for the intended gas.
5. If the flowmeter is connected to a pressure regulator fitted to a
gas cylinder, open the cylinder valve SLOWLY.
The flowmeter must be held at the base whilst tightening the
handwheel connection to the gas supply outlet. The
flowmeter must not be tightened or vertically aligned by
leverage of the outer tube (shroud) component.

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6. Flowmeters connected to pressure regulators fitted to gas
cylinders should be well protected against knocks and impacts,
especially to the outer tube (shroud).
7. Connect any downstream equipment to the flowmeter. The flow
can be adjusted to the desired level using the flow control knob
– rotate anti-clockwise to increase flow, clockwise to decrease
flow.
NOTE: The flow rate in litres per minute is indicated by the position of
the CENTRE of the ball, or the TOP of the bobbin in the flow tube
depending on the model in use.
6.2 Disconnecting the flowmeter
1. Check that the flowmeter flow control knob is turned off (i.e.
fully clockwise).
2. Disconnect any downstream equipment from the flowmeter
outlet.
3. If the flow meter is connected to a pressure regulator fitted to a
cylinder valve:
a. Shut off the cylinder valve supply to the regulator.
b. Open the flowmeter flow control valve until all residual
pressure is bled from the system (ie the ball/bobbin should
fall to the bottom indicating zero flow).
c. Turn off the flow control knob (i.e. fully clockwise).
4. Disconnect the flowmeter via the inlet connector handwheel
connection. Do not loosen the handwheel connection by
leverage of the outer tube (shroud) component.
Warning
Do not check the gas cylinder contents by opening
the cylinder valve until downstream equipment has been
connected to the pressure regulator outlet.
8. Perform the Operational Check and Inspection procedure
(Section 7.1) before using the equipment on each patient. If the
unit fails any part of this checkout procedure, the flowmeter must
be removed from service and repaired before use on a patient.
Units subject to Preventative maintenance programs should be
within test date. (Refer to Section 8.0 Service
Recommendations).
Warning
The specified accuracy from the flowmeter may be
achieved only when:
The flow is set with the flowmeter in a VERTICAL position
The supply (inlet) pressure is 400 kPa

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Care should be taken to ensure that none of the cleaning solution
enters the gas passages of the flowmeter. Do not attempt to clean the
inside of the flowmeter. If internal contamination is apparent, the
flowmeter should be removed from use and inspected by trained
personnel.
6.4 Storage after use
If the flowmeter is not going to be used immediately following
removal from the gas supply, it should be stored in a clean, dry,
7. CHECKS AND INSPECTION BY THE USER
7.1 Operational Check and Inspection
A flowmeter is a critical link in the gas supply to a patient. The
following checks should be performed each time the flowmeter
is connected to the gas supply:-
1. The O-ring on the inlet connection should be in place and in
good condition. (i.e. no cuts, deformation or dirt). A damaged
O-ring may be replaced, when a correct replacement is available,
by removing it with a pointed object (e.g. small precision flat
screw driver), taking care not to damage the inlet nipple, and
inserting the replacement O-ring in place.
2. The flowmeter outer tube should be in good condition and free
from crazing or cracking (irregular scratch marks).
3. The gas specific inlet connector handwheel and the plastic outlet
nut/barbed nipple assembly should be in good, working
condition.
4. The inlet connection fitting is tight and secure.
6.3 Cleaning after use
If the exterior of the flowmeter requires cleaning, use a dry cloth
only. For difficult to remove residues and contaminants, wipe over
with soapy water containing fully dissolved mild soap, then dry. An
isopropyl alcohol wipe may also be used, in which case more
frequent inspection of the flow tube is recommended..
Warning
USE OF CHEMICAL CLEANING MEDIA AND
DISINFECTANTS MAY RESULT IN DAMAGE TO
THE OUTER TUBE (SHROUD).
secure place to prevent accidental knocks and impacts and to prevent
the ingress of dust or contamination to its gas passages.

5. When connected to a gas supply, the flow control knob should be
adjusted through it’s entire range to check for smooth operation.
The ball/bobbin should move smoothly up and down the scale.
Check that the maximum flow is available, that is that the
ball/bobbin reaches the top of the scale. When the flow control
knob is turned off (fully clockwise) the ball/bobbin should fall to
the bottom indicating zero flow.
6. If the flowmeter satisfies the above requirements, it may be used.
7. If the unit fails any part of this checkout procedure, the flowmeter
must be removed from service and repaired before use on a
patient. (Refer to Section 8.0 Service Recommendations).
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7.2 Trouble Shooting
Difficulty Obtaining Flow: Caused by a depleted gas supply,
obstructed supply, obstructed outlet, sticking float or a blocked
inlet filter.
Inaccurate Flow Readings: Caused by poor quality repairs,
leakages, sticking ball or bobbin, incorrect inlet pressure or the
flowmeter is not in a vertical position.
Flow registers when control valve is closed (fully clockwise):
Caused by a damaged needle valve and/or seat, loose valve seat,
worn O-rings, dirt or other contamination.
8. SERVICE RECOMMENDATIONS
An EZI-flow flowmeter is a critical link in the gas supply to a patient.
To ensure that the flowmeter is always in a safe, reliable, useable
condition it is recommended that the unit be placed on a preventive
maintenance program.
The preventative maintenance program should include as a minimum
fixed yearly servicing. Depending on usage, an additional more
frequent service (e.g. six monthly, quarterly or monthly is
recommended.
Frequent Inspection Program
- Operational Check and Inspection (Section 7.1)
Fixed Yearly Servicing
(Note: to be performed by trained service personnel only.
Contact your nearest Comweld Medical service provider for further
information)
- Frequent Inspection (Section 8)
- Inlet O-ring replacement
- Flow Calibration Check
For repairs or service to your EZI-flow flowmeter, contact your
nearest Comweld Medical service provider.
Outer tube crazing or cracking: Caused by contact with chemical
agents, or solvents and most cleaning and disinfecting media -
immediately remove from use and service the flowmeter.

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9. SPARES AND ACCESSORIES
9.1 EZI-flow flowmeter Accessories
Listed below are some of the accessories suitable for use with an
EZI-flow flowmeter. It is recommended that if any other accessories
are intended to be used with an EZI-flow flowmeter, your nearest
authorised distributor should be contacted to check the compatibility
of the accessory.
Description Part No.
Series-O Oxygen Regulator - Type 10 Handwheel
inlet, SIS Outlet 518800
Series-O Oxygen Regulator - Pin Index Yoke inlet,
SIS Outlet 518804
Series-O Air Regulator - Pin Index Yoke inlet,
SIS Outlet 518809
Humidifier - 1/4” BSP female inlet TM11
Therapy Tubing
9.2 User Replacement Parts
Listed below are the items considered to be user replaceable parts. It
is recommended that the user keep stock of such items to ensure
that the EZI-flow flowmeter is always ready for use.
Kit Description Part No. Available for
Inlet Handwheel O-ring (20 pack) 552018 All handwheel models
Outlet wingnut/nipple assy (10 pack) 515830 Oxygen (white)
515849 Air (black)
10. SPECIFICATIONS
@ 400 kPa
Part No. Gas Flow Range Maximum Flow Inlet Connection
515800 Oxygen 0-15L/min. 20 L/min. SIS Handwheel
515820 Air 0-15 L/min. 20 L/min. SIS Handwheel
515824 Oxygen 0-2.5L/min. 6 L/min. SIS Handwheel
515852 Oxygen 0-15 L/min. 20 L/min. 3/8”-26W
(for permanent
connection)

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NOTES:
SIS - Sleeve Indexed System inlet connections from AS 2896 for the
nominated gas.
Outlet Connection: All flowmeters include a plastic barbed nipple to
which soft plastic tubing may be connected. The barbed nipple can
be removed to access a standard 1/4” BSP connection.
Accuracy: All flowmeters have an accuracy of ±5% of FULL SCALE
READING.
Inlet Pressure: All flowmeters are calibrated for an inlet pressure
of 400 kPa.
Inlet filter: All flowmeters are fitted with a 66 micron inlet filter.
11. WARRANTY
products as stated below, CIGWELD shall, upon notification thereof
and substantiation that the product has been stored, installed,
operated, and maintained in accordance with CIGWELD's
specifications, instructions, recommendations and recognized
standard industry practice, and not subject to misuse, repair, neglect,
alteration, or accident, correct such defects by suitable repair or
replacement, at CIGWELD's sole option, of any components or parts
of the product determined by CIGWELD to be defective.
CIGWELD MAKES NO OTHER WARRANTY, EXPRESS OR IMPLIED.
THIS WARRANTY IS EXCLUSIVE AND IN LIEU OF ALL OTHERS,
INCLUDING, BUT NOT LIMITED TO ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR ANY PARTICULAR PURPOSE.
LIMITATION OF LIABILITY: CIGWELD SHALL NOT UNDER ANY
CIRCUMSTANCES BE LIABLE FOR SPECIAL, INDIRECT OR
CONSEQUENTIAL DAMAGES, SUCH AS, BUT NOT LIMITED TO,
LOST PROFITS AND BUSINESS INTERRUPTION.
The remedies of the Purchaser set forth herein are exclusive and the
liability of CIGWELD with respect to any contract, or anything done in
connection therewith such as the performance or breach thereof, or
from the manufacture, sale, delivery, resale, or use of any goods
covered by or furnished by CIGWELD whether arising out of contract,
negligence, strict tort, or under any warranty, or otherwise, shall not,
LIMITED WARRANTY: CIGWELD Pty Ltd, An ESAB Brand, hereafter,
“CIGWELD” warrants to customers of its authorized distributors
hereafter “Purchaser” that its products will be free of defects in
workmanship or material. Should any failure to conform to this
warranty appear within the time period applicable to the CIGWELD