To assist the engineer and technician his manual contains
Infant Flown System
MkIl
Infant Flowm Driver. We suggest that all personnel involved in the service, repair or re-
as
well
as
detailed descriptions of all component parts of the
Manual
111
operating instructions for the
M672,
calibration of this product hlly familiarise themselves with the clinical aspects and usage of the
Infant
Flown System as well as the mechanical and electronic intricacies
as
this
will
assist in
front line service and troubleshooting.
The manual is split into several discreet sections which deal with the major sub-assemblies in
order. This allows work to be undertaken in a logical and methodical manner on one section of
the product without disturbing other parts. However, we recommend that the complete
performance and
any part of the Infant
EM'
(Electro medical Equipment) Ltd. have a policy of continual improvement and update of
all
products. Technical bulletins are sent to
vescation procedure is carried out after any work
Flowm Driver.
all
registered users of the company's products to
keep them informed of any product changes. We welcome suggestions
-
improvement and enhancement
please write to the either the Marketing or Research and
has
been carried out on
from users for product
Development departments with your comments.
mk
.
~
Document No.
M672SM,
.>,
Version
1.10,
Issued
8th
November
1994
Page 1 of
85
Section
Product Description
The
EM'
Flowmeter and Pressure Manometer with integral
used in conjunction with the
make up the
-
The Infant Flowm Driver is assembled
bespoke components. These are a
Flowmeter calibrated for mixed gas between 0 and
associated electronics,
supply.
Mk
II
Infant Flowm Driver is a combined AirIOxygen Mixer, Oxygen Analyser,
EM.
Infant FlowTM
EME
Infant Flowm System.
-
-
--
--___
in
NCPAP
a Beet aluminium enclosure-&om standard and
Sechrist model
an
electronic pressure measuring and
2
alarm
3500
15
systems designed specifically to be
generator. Together these products
Medical Aidoxygen Mixer, a Dwyer
lpm, a galvanic Oxygen Fuel Cell with
limiting
system and a mains power
The Infant Floww Driver is supplied with a pole mount bracket to fit round or square section
from
10
to
35
mrn
poles
M6
tapped holes to accomodate a variety of optional rail mount brackets.
diameter or section. The gas inlet plate is pre-drilled with two pairs of
The Medical Air and Oxygen gas inlets are either British Standard NIST or U.S.A. standard
DISS fittings, other types can be supplied to special order. High pressure Medical Air and
Oxygen hoses must be ordered separately
specifjring the length, colour and end fittings
required.
The patient outlet
IS0 standard
15
mrn
female taper fitting and the pressure monitoring
is
an
inlet is a standard Luer taper fitting. The Oxygen monitor is an integral part of the Infant
Floww Driver and does not require any additional external fittings.
The Oxygen monitor uses a galvanic
fbel cell sensor which is fitted in a pressure controlled
path to avoid variations in delivered gas pressure altering the measured value. The gas which is
used for the Oxygen
to avoid any
risk
analyser is subsequently vented from the rear of the Infant Flowm Driver
of contamination to the patient.
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
2
of
85
Section
3
Product Specification
Gas supply - Nominal 4 Bar (60 PSI) Clean, dry Medical Air and Oxygen.
Range
Power Supply
-
-
-Aidoxygen Mix-er-i2 1-to 1.00% Oxygen, =acy+-3% of selected output
Flowmeter
Pressure relief valve
1. Patient safety
-
Minimum 2 Bar, maximum 6 Bar. Maximum differential pressure 2 Bar.
-
200 to 265 VAC 0.10 A 50 to 60
-
Range 0 to 15 lpm, accuracy
-
2 systems fitted
-
automatic electronic valve system preset to vent to ambient at 1 1 Cn~s H20.
+
Hz
or 90 to 135
-
5%
of selected output
VAC
0.20 A 50 to 60
Hz
--
--
2. System & delivery circuit safety - mechanical internal relief valve preset at 150 Cms H20.
Manometer - Range, 0 to + 12 Cms H20, accuracy * 1 cm Hz0
Oxygen Monitor - Range 0 to 100% Oxygen, accuracy * 2% of span,
Alarm
electronic alarms are set after
System - Four separate
2
alarm
systems are provided all of which are automatic, the
minutes operation without operator intervention although the
operator can manually set or reset them if required.
1.
Supply gases failure, if the differential pressure between the two inlet gases falls outside of
the limit of 2 bar
(30
PSI) or one gas fails completely
an
alarm will sound and the gas at the
higher pressure only will be delivered to the patient.
2. High patient pressure, an audible and visual
This
alarm automatically activates a pressure relieving solenoid which instantly reduces the
pressure in the patient circuit to zero. A second
high
pressure alarm is preset at 11 Crns
high
pressure
alarm
with audible and visual
indication is set 3 Cms H20 above the measured CPAP pressure.
3.
Low
patient pressure, an audible and visual low pressure alarm is set at 2 Cms H20 below
the measured CPAP pressure or at
4.
Failure to deliver correct Oxygen concentration. Audible and visual alarms are provided at
0 Cms H20 if this would otherwise be negative.
5% of the set FI02 with an upper maximum limit of 101% and a lower minimum limit of
20%. There is a low hazard warning at 18% Oxygen or below.
.
.
).
'
Page
3
of
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
85
c-,[
H20.
k
Section
4
Summary of Warnings and Cautions
The
EME
Infant Flowm Driver is a medical device intended for use only by qualified personnel
under the direction of a qualified physician.
Personnel operating this equipment are responsible for reading and thoroughly understanding
-ill
product documentation provided. Statements throughout-the product documentation have
special
Key to Warnings, cautions and notes:
si@cance as follows:
WARNING
CAUTION
attached to it.
NOTE
convenient operation or service of the equipment.
SUMMARY
-
Means there is a possibility of personal injury to the operator or patient.
-
Indicates there is a possibility of damage to the product or other equipment
-
Notes are used to call attention to statements pertaining to more efficient or
OF
ALL
WARNINGS
AND
CAUTIONS CONTAINED
DOCUMENT:
WARNING
Whenever a patient is attached to respiratory care equipment constant attendance
an
is required by qualified personnel. The use of
give
not
occur with the system.
attention.
absolute assurance of
warning
In addition, some problems may. require immediate
for every form of malfbnction that may
alarm
or monitoring system does
THIS
Document
No.
M672SM,
..
'
Version
1.10,
Issued
8th
November
1994
Page 4 of
8
5
WARNING
Mixer must be corrected swiftly as the Oxygen concentration which was selected
will
for the patient
not be delivered during an alarm/bypass situation.
-
WARNING
.
-.
.
--. . . - .
~-
Liquid water or other contaminants
. . -.
in
either gas supply, particularly the
.
-.
-
-
.
.
--
-
--
- - - . -
air
-
supply,
will cause malfunction of this equipment and equipment connected to it.
WARNING
The gas mixer incorporated in this product
-
do not modifjl the inlets to accommodate other source gases such as anaesthesia
is
designed to
mix
Air and
Oxygen only
---
WARNING
Oxygen vigorously accelerates combustion. To avoid explosion hazard do not use
any instrument or other equipment that
may
have been exposed to oil or grease
contamination.
WARNING
The gas failure alarm will not function
Document No.
M672SM,
:,.
;
Version
1.10,
Issued
8th
if
both supply gases are below 2 Bar.
November
1994
Page 5 of
85
WARNING
Ensure that the voltage set on the Infant Fiowm driver
is suitable for the local mains voltage. Equipment
result
if
incorrectly set.
mains
power input module
mfinction and overheating
will
CAUTION
Verifjl that this device has been authorised for use
by
qualified personnel.
CAUTION
The precision gas mixing device incorporated
hnctional or damaged if used without the protective water trap and filters
in
this product may become non-
Do not immerse
Document No.
M672SM,
any
Version
part
1.10,
CAUTION
of
this device or gas or steam sterilise it. Damage will
result.
Issued
8th
November
1994
Page 6 of
85
Section
5
Operating
The Infant FlowTM
demand or expiratory flows via the specially designed
Infant Flow's
subject
--
-
-
-The nomogrm-showinrtk
shown below. Example:-
to a
linear
system
ability
relationship between controlled enriched
provides a
to provide superior CPAP. However, the Infant Flowm generator is
virtually
relad~n~Epb~tw~nTnstantWa~~~G-rnd~flow
8
lpm
will
provide
Instruction
constant airway pressure irrespective of patient
nasal prongs.
gas
in
the order of 5 Cms
flow and CPAP pressure.
This
H20
is the reason for the
-settkgs is
Nasal
CPAP.
Flow
Document No.
Pressure Nomogram
M672SM
Version
1.10,
Issued
for
8th
November
the
EME
1994
Infant
Flow
Fresh
l/min
System
Page 7 of
gas
85
flow
Venfjr that this device has been authorised for use by qualified personnel.
Firmly mount the Infant Floww driver on either the pole and stand or the rail system with
1.
all
of the ancillary equipment such as the Heated Respiratory Humidiiier.
Connect the Medical Air and Oxygen hoses to the Infant FlowTM Driver and then to the
2.
high
pressure source.
NOTE: The gas failure
alarmlbypass will activate when the first gas
is
connected and will reset
upon connection of the second supply gas.
WARNING
Liquid water or other contaminants in either gas supply, particularly the air supply, will
cause malfunction of this equipment and equipment connected to it.
Connect the power cord for the Infant Flowm Driver to a suitable outlet, do not switch on
3.
the driver at this point.
4.
Connect the patient circuit and Infant FlowTM generator as shown in figure
2.
NOTE:
This figure is a general indication of how the devices are interconnected. The actual
configuration may vary dependent on the ancillary equipment used.
Set the required
5.
F102
using the calibrated knob on the AirJOxygen mixer section of the
Infant FlowTM driver.
Set the flowrate to give the prescribed NCPAP pressure using the Nomogram on page
6.
as a reference.
7.
Set the desired delivery temperature on the heated respiratory humidifier
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
and
switch it on.
Page
6
8
of
85
NOTE: We recommend between
8.
There is a choice of head fixation systems. Each Infant Flowm generator is supplied with
a headband
Attach the
Infant FlowTM generator pack or the instruction leaflet enclosed with the bonnet pack or
the laminated card attached to the Infant
9.
Connect the Infant FlowTM Generator to the patient as shown and attach to the headband
using the Velcro strips provided or to the bonnet with the tie ribbons.
10.
Switch on the power to the Infant FlowTM Driver and ensure that the NCPAP pressure is
that which is prescribed. Minor variations between devices occur but the pressure
delivered should always be within
out of specification perform the following checks. The pressure bar graph has been colour
coded for ease of use. The "Normal Range" section of the bar graph indicates the most
commonly used pressures with the Infant
pressures used for the treatment of individual patients must be prescribed by the clinician.
furation
fkation device of choice to the patient as shown on the instruction card in the
as
36"
and 37°C but never higher than 37°C.
standard or,
if
preferred, a bonnet furation is available separately.
Flowm Driver.
*
10%
of those shown on the Nomogram.
Flowm generator. However, the actual
If
they are
a) Ensure that there are no leaks in the patient circuit.
b) Ensure that the Infant
are properly fitted in the patients nostrils.
11.
The electronic alarms will automatically set after a 2 minute stabilisation period. Should
you wish to set them earlier simply hold the
alarm will bleep to indicate that your command has been accepted and the Alarms
indicator will illuminate.
12.
Should you change the
by holding the
operation when changing the prescribed
Oxygen
13.
What to do if
may not be receiving the prescribed
alann window to
ArmfMute button in for three seconds. It is not necessary to carry out this
an
alarm occurs - Always attend alarm conditions immediately as the patient
Flowm generator has the correct size nasal prongs and that they
Armmute button in for three seconds. The
NCPAP
*
treatment pressure it is necessary to reset the alarm level
FI02 as the driver will automatically reset the
5%
of the set value.
FI02 or NCPAP.
Armed
rn
,F
There are two distinct types of alarm fitted in the Infant
Mixer has a mechanical bypass and alarm system fitted which
supply gases is below or above the range of pressure which can be handled satisfactorily.
.,.;
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Flowm Driver. The AirIOxygen
will
sound
if
Page
one of the
9
of
85
The second alarm system consists of
Oxygen monitoring module. This
electronic alarms with the exception of the overpressure alarm are self re-setting.
event of an overpressure being detected the Driver activates a vent to ambient solenoid
valve which removes gas flow
fiom the patient circuit.
an
electronic system built into the pressure and
has
several hctions
as
shown in the table overleaf.
-
In
All
the
Model
Alarm
function
r
Oxygen supply failure
Air supply failure
High
Oxygen Concentration
M672
Infant
FlowTM
Indication
Loud whistle.
Loud whistle.
Audible alarm
indicator illuminated.
&
Driver
High
02
Alarm
Systems
Operator Action
Check and restore Oxygen
supply.
Check and restore
supply.
Check supply gases and
galvanic
Mute button to silence
the audible alarm.
fuel cell. Press the
Air
Low Oxygen Concentration
High Pressure
Low Pressure
I'
-
.
Audible alarm
indicator illuminated.
Audible alarm
pressure indicator
illuminated.
Audible alarm
pressure indicator
illuminated.
&
&
&
Low
High
low
02
Check supply gases and/or
the galvanic
the
ArmlMute button to
silence the audible alarm.
Check the
check for occluded tubes.
Press the
to cancel the alarm or restore
pressure in the circuit.
Check the
check for occluded or
disconnected tubes or nasal
prongs. Press the
button to silence the audible
alarm.
he1 cell. Press
flowrate and
Arm/Mute button
flowrate and
ArmIMute
Page
10
of
1.10,
Issued
8th
.
d
Document
No.
M672SM,
Version
November
1994
85
HEATED
HUMlDIFI
W
AND
HEATED
WIRE
DELIVERY CIRCUIT
I-
I
\
\
--/
I
I
\
/
PLEASE
If
we sug esi using
product! so that the
water can be pressurised.
cnamoer connector end)
a
Gmvitv
NOTE
Wder
Set
is beina used
'INFUSOR'
BAG
of sterile
(6r similar
r-------
7
I
I
I
i
i
:
I'
;
!
i
I
I
I
ELECTRICAL
SINGLE
(SEE PRODUCT
6ft
PRESSURE UNE
USE
LIST
MHAlATlON
(ADD
FROM
ADAPTOR
HEATED
FOR CONflGURATlONS
DELM2RY
-
EXENSION
ON
AND
EXTENDABLE
APPROX 15cm
Ift
BLUE
TUBE
to
55cm)
AND
PART
CIRCUIT
NUMBERS)
I
!,
A
NB
wnen
Document No.
It
is
a
Deot
Oxygen
M672SM.
of
'Heatth
Enri@ed
Version
recommendation that
Gases are being administered.
1.10.
Issued
8th
November
an
Oxygen Anatyser be used
1994
at
Page
ALL
1
1
TIMES
of
85
.
Section
6
Performance Verification Procedure
This performance veri£ication procedure provides a means of determining whether the
EME
Infant FlowTM Driver meets its design speciiications. These tests are intended to be performed
in
the Hospital by qualified personnel. The procedure should be performed at least every four
months or more fiequently
-The check list must be followed exactly and
specifications it should be removed fiom service until calibration
if
desired or
if
the device is suspect.
if
the Idant FlowTM Driver fails to meet any
and/or service is
accomplished.
Service of the
technicians trained
access to the special tools and equipment that are required.
or
an
authorised distributor to insure
EME
MkII
in
the calibration, service and repair of devices of this nature and who have
Infant Flowm Driver should only be undertaken by qualified
If
this is not feasible contact EME
full
reliability and safety of the product.
NOTE: It is recommended that hospital personnel responsible for the Performance Verification
Test maintain records of their activities and identify equipment authorised for use.
WARNING
Oxygen vigorously accelerates combustion. To avoid explosion hazard do not use any
instrument or other equipment that may have been exposed to oil or grease
contamination.
The tests are divided into three parts, the first for the Aidoxygen mixer, the second for the
pressure manometer and the third for the Oxygen Analyser.
Some special equipment is necessary to perform the tests
hlly, this includes an accurate water
manometer, adjustable regulators and an accurate Oxygen analyser. Do not attempt to perform
the tests without suitable equipment.
First
Test
-
AirtOxygen
Mixer
Connect the Infant Flowm Driver to supply gases which are adjustable fiom 0 to 4 Bar or
more. This can be achieved using adjustable regulator sets
Overall Accuracy - sit both supply gas pressures to
Flowmeter.
Compaie Oxygen analyser readings to mixer FIO2 settings of
4
EMJ2
part No. SG100.
Bar.
Select a flow of
.2
1, .40,
15
LPM
.60,
on the
.80 and
Document No.
M672Sh4,
Version
1.10,
Issued
8th
November
1994
Page
12
of
85
1.00. The mixer has a specified accuracy of
f
1%
the setting and the analyser should agree within
Accuracy with varying inlet pressures
Oxygen analyser reading obtained with equal inlet pressures
3
pressures to the mixer to
Bar Oxygen and 4 Bar
f
3%.
If
the Oxygen analyser is accurate to within
4%
at the various settings.
-
Select an FI02 of 60% and observe the reference
(4
Bar each).
Air
and then 4 Bar Oxygen and 3 Bar
Vary
the inlet
Air.
Note the Oxygen analyser reading at each extreme and verifL that the Oxygen reading does not
vary
by more than 1% at each extreme.
-
Alarm module test
(The alarm should be silent) reduce the
Starting with the Oxygen and
Air
should sound and the Oxygen analyser should read 100%. Increase the
slowly, the alarm should cut out at around the
Air
supplies at 4 Bar and an FI02 of .60
inlet supply to 2 Bar or just under. The alarm
Air
supply pressure
3
Bar level. Repeat the procedure varying the
Oxygen pressure. When the alarm sounds the Oxygen analyser reading should drop to 21%.
Air
-
Observe the
inlet filter.
If
this is
dirty
or wet it should be replaced.
Second Test - Pressure Manometer
Tee an accurate water column with the hand pump bulb in line into the pressure input port on
front panel of the electronic module. Check that the manometer is at Zero then inflate the
the
system to 10 Crns H20 and observe that the bar graph display indicates 10 Crns
doesn't, refer the device for
Press the
ArmfMute button for 3 seconds to set the alarms and then increase the pressure to 1
full calibration.
H20. If it
Crns H20, at this point the pressure vent valve should operate and the alarm sound. Increase
the pressure to over-range the bar graph and ensure that
in
pressure
Press the
the system.
ArrnIMute button again to reset the system and inflate to 5 Crns H20. Reset the
all
of the LED'S light up. Release the
alarms and allow the pressure to drop to Zero. Observe that the low pressure alarm activates
immediately. Press the
5 Crns
H20 and observe that the visual alarm cancels.
Set the pressure to
Drop the pressure to
ArmMute button, this should silence the alarm. Restore the pressure to
8
Crns H20 and observe that the high alarm activates after 15 seconds.
3
Crns H20 and observe that the high alarm cancels and that the low
alarm activates after 15 seconds.
h
\
1
7
Third
Set the
FI02 to
.21
and the flowrate to 8 lpm, observe that the Oxygen reading is 21%. If it is
not adjust the lower potentiometer accessible from the
Set the
FI02 to 1.00 and observe that the Oxygen analyser reads 100% after 1 minute. If it is
not adjust the upper potentiometer accessible
100%.
If adjustments are found to be necessary repeat this procedure two or three times as
test
-
Oxygen Analyser
from the left hand side of the driver to read
left hand side of the driver to
there may be some small interaction between the controls.
.>.'
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
13
read
of
85
21%.
Additional Information on
Oxygen
Fuel
Cells
Material Safety Data:
&
Physical
Chemical Data:
Health Hazard Data:
Exposure limits:
Product Name
Potassium Hydroxide
Lead
(Pb)
Primary
OSHA
ACGIH
routes of entry: Ingestion, Eye/Skin Contact.
PEL
TLV
Pure
.05
2
-
Class
R-22TED
(KOH)
mg/cu.m.
mg/cu.m.
15%
(Pb)
(KOH)
Effects of Overexposure:
Ingestion: The electrolyte could be
hdl or fatal
if
swallowed.
Eye: The electrolyte is corrosive, eye contact could result
Dermal:
The electrolyte is corrosive and skin contact will result
Inhalation: Liquid inhalation is unlikely
SignslSyrnptoms of exposure: Contact with skin or eyes
will
cause a burning sensation andlor a
soapy feeling for skin contact.
Oxygen Sensor
Granular
in
permanent loss of vision.
in
chemical bum.
Emergency and First Aid procedures
15
Eye Contact: Flush with water for at least
Skin Contact: Wash
affected area with plenty of water and remove contaminated clothing. If
minutes and get immediate medical attention.
burning persists seek medical attention.
-
Ingestion: Give plenty of cold water
do not induce vomiting, get medical attention.
Handling Information:
Handling precautions: The Oxygen sensors are sealed and under normal circumstances the
contents of the sensors do not present a health hazard. The following information is given as a
guide in the event that a cell leaks.
Protective clothing: Rubber gloves, chemical splash goggles.
Clean-up procedure: Wipe down the area several times with a wet paper towel. Use a fresh
towel each time.
Protective measures
during cell replacement: Before opening the bag containing the cell, check
the cell for leakage. If the cell leaks do not open the bag. If there is liquid around the cell while
in the instrument put
on,gloves and eye protection before removing the cell.
Disposal:
Document 'No.
Should'.be in accordance with all applicable state local or federal regulations.
Page
M672SM,
Version
1.10,
Issued
8th
November 1994
14 of
85
Section
7
Routine Maintenance
Routine maintenance of the Infant Flow* Driver is limited to monthly checking of the Oqgen
analyser calibration and periodic
Mixer and Electronic Pressure Manometer, status of the gas inlet jilters, integrity of the alarm
systems and cleaning of the exterior surfaces.
(4
monthly) checking of the calibration of the Air/Oxygen
-.
-
An
Infant Flowm Driver need of re-calibration, service or repair must not be used until the
necessary procedures are
performed and the equipment has been tested to ascertain that it is
fbnctioning correctly.
full
EME
The
Model M672
is available to qualified technicians to effect calibration, service
contact
EME
or
an
authorised distributor to insure
Mk
II
Infant Flowm Driver Service Manual
and
repair.
full
reliability
and
safety
(Part
No.
M672SM)
If
this is not feasible
as
special tools and
equipment are required.
Routine maintenance as defined
in
this manual may be accomplished by competent individuals
having experience in the maintenance or repair of devices of this nature. Parts designated in
this manual should be replaced only with parts manufactured or sold by
EME
(Electro Medical
Equipment) Ltd.
-
Gas Inlet Filters
There are three gas inlet filters, two on the Air inlet and one on the Oxygen
inlet. These must be replaced periodically. We recommend that this is done annually unless the
Infant
Flowm Driver is being powered by a portable
recommended that the
Air
filters are changed at least every four months.
Air
Compressor. If this is the case it is
-1
The exterior Air filter can be observed through the polycarbonate bowl. If it is discoloured or
wet it should be replaced, re-order part number M11294-5B.
The internal filters are sintered stainless steel. These should be changed annually or more
fiequently
if
there are signs of contamination. It is recommended that the "0" ring seal and
spring are changed. at the same time as the filter. These are available as a kit under part number
S3
522K.
Page
15
of
Document
No.
M672Sh4,
Version
1.10,
Issued
8th
November
1994
85
CAUTION
The precision gas
or damaged
Changing
the
mixing
device incorporated
in
this product may become non-functional
ifused without the protective water trap and filters provided.
Oxygen
Sensor
The Oxygen Sensor must be changed annually or when calibration is no longer possible. The
sensor is located in the mechanical section of the
flowmeter. To gain access to this it is necessary to remove the top cover of the enclosure.
is achieved by removing the four
lifted
cover can be
remaining two
oE Remove the four
M3
x
mm
instrument head screws on the electronic module. The module
M3
x
6mm
M3
Znfant FlowTM Driver immediately behind the
instrument head screws
x
8mm
pan
head screws on the rear cover and the
(2
on each side), the top
This
can
now be slid forward to facilitate easy removal of the Oxygen Sensor. Carefully remove the
electrical connector
clip and unscrew the Oxygen sensor
number is
MR22.
The new Oxygen Sensor must be carehlly screwed into the block, ensure that the
fiom the old cell by using a small blade screwdriver to release the locking
fiom the flowmeter mounting block. Re-order part
"0"
ring
is
fitted before screwing in. Fit the electrical connector into the new Sensor observing the
polarity. Re-assemble the Infant
the Oxygen Sensor to stabilise before performing the
Infant
Flowm Driver for use with patients only after calibration is satisfactory.
FlowTM Driver and switch on the power. Allow two hours for
full two point calibration. Return the
Galvanic Oxygen Fuel Cells tend to
drift for the first few days and it is recommended that the
calibration is checked daily for the first three days after a new Sensor is fitted.
The exterior surfaces of the
Infant
FlowTM Driver can be cleaned with a mild soap or liquid
disinfectant solution. Do not use cleaning agents that contain abrasives.
CAUTION
Do not immerse
any
part
of this device or gas or steam sterilise it. Damage will result.
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
16
of
85
Section
9
Electrical and Electronic description
Four circuit boards comprise the Infant Flowm Driver electronics. These are the power supply
board, the display board, the processor board and the mixer monitor board.
The Power Supply board is mounted on the side of the case adjacent to the mains input
-
--
-module. The board contains the mains transformer, T1; which has two primary windings so
that they may be connected in series or parallel to suit a range of input voltage conditions. The
transformer is protected by a non-resetting thermal
combined
flying leads. Voltage selection is made by
IEC connector, filter, mains switch, dual kse carrier and voltage selector to the PCB
lifting a flap under the fbseholder and sliding the tray
out. The voltage selector may then be withdrawn and refitted
voltage available. Four settings are provided, these are
kse. The mains input is taken &om the
as
required to suit the mains
100V, 120V, 220V and 240V.
A
f
The transformer has four secondary windings which are connected in two pairs to provide the
inputs to the two bridge rectifiers
In series with each of the secondary windings is a
rail and
the
reservoir capacitor for the
hses F5 and F6 are for the f 15 VDC rails. The transformer secondary windings for
+
5 VDC supply are connected in parallel to increase the current available. C3 is the
+
side panel behind the power supply board.
BRl for the
5
VDC regulator,
+
5
VDC rail and
BR2
for the
*
15
hse. Fuses F3 and F4 are for the
REG
3 a LM309K, which is mounted on the
REG
3 is connected to the power supply board with
VDC rails.
+
5
VDC
flying leads.
The transformer secondary windings for the
centre tap to ground. The other two connections are used to supply the AC inputs of
produce raw DC voltages which are referenced to 0
REG1
capacitor
via reservoir capacitor C1 and the negative output supplies
C2.
The regulator pins are bypassed with ceramic capacitors to improve their
*
15 VDC supplies are connected in series with a
BR2
V.
The positive output of
REG2
BR2
supplies
via reservoir
and
transient response and all the power supply rails are fitted with discharge resistors to ensure
that they are safe when the power is turned off or disconnected.
Power is conveyed
fiom the power supply by a cable with a five way power connector at each
end. This connects to the CON2 on the processor board. The display board receives its power
via the forty way connector,
CON1, from the processor board.
rn
'i
The display and processor board are mounted
display board are routed through the 40 way connector
as
a pair on the front panel. The signals to the
CONl.
The pressure bar graph, D4 to
D 16 and the "Alarms Armed" LED'S D18, are driven by IC2, a MM5450N LED driver. The
alarm LED's, D 1 to ~3'and Dl 7 are driven directly fiom port B of the Micro-Controller. The
Page
17
of
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
85
,
.
seven segment Oxygen concentration displays,
ICM7212AMIPL display driver. Also fitted on the display board is the
button,
SW1, and a NORPl2 light dependant resistor, LDRI, for the auto-dimming of the
displays. The luminous intensity for the displays is controlled by a signal derived
LD1
to
LD3,
are driven by
"ARM/MUTEM
fiom
IC1,
push
LDRI.
an
The two display drivers require dierent signals to change the brightness of the displays so two
op-amp circuits are provided on the processor board.
The processor board fits behind the display board and is connected to it by a 40 way
connector,
CONl. The instrument is based around a Motorola MC68705R3P micro-controller,
ICl. This device is one time programmable and, should it become defective, can only be
fiom
EME
replaced with a pre-programmed device obtained
he
micro-controller contains the following elements:
or an authorised distributor.
6800 Micro Computer
24
Bi-Directional
8
Input Only Lines
8
Channel Analogue To Digital Converter
3776 Byte Programmable Read
UO
Lines
Only
Memory
1 12 Byte Random Access Memory
8
Bit Timer
7
Bit Pre-Scaler
Memory Mapped
I/0
The Micro-processor clock signal is generated by XTLl and C2,
capacitor. There is no provision for adjusting the
The pressure sensor
PT1,
is a SensymEME solid state device having a range of 0 to 1 PSI
frequency
a
4
MHz
external crystal .and
of the oscillation.
which is fitted directly to the processor board. It can withstand up to 20 PSI without sustaining
damage. This item is not a standard component as it is specially selected to our specification
for low noise
same specification obtained
The reference section of the
section of IC8 to produce 12 V to energise the pressure sensor. The
signal conditioning for the pressure sensor with potentiometer
stage gain. Stage 1 of
APMO2 so that any offset
the
sensor circuit is applied to the analogue input
signal is
ensures that the inputs to the micro-controller cannot go outside the limits of the
IC4,
and
zero temperature drift at zero. It must only be replaced with a device to the
from
EME
or an authorised distributor.
LMI
0,
IC5,
a
LM324,
can
IC8, produces
is used in conjunction with
be trimmed out. The amplified output
200
mV which is amplified by the op-amp
AMP02,
VR3
being used to adjust the
VR7
IC7, provides the
to swing the output of
from
the pressure
AN0 of the micro-controller. In parallel with this
an
SGS
Thomson L9700 or Texas Instruments TL7726 precision clamp. This
ADC
reference.
Input
AN1 on ICl is used for the signal conditioned mixer monitor potentiometer. This
potentiometer is connected between
depending upon
amplifies the
Document No.
wh&e the mixer shaft is set. Stage 1 of IC6, an LM324 quad op-amp,
signal'and IC6 stage 2, provides an offset to ensure that the output achieves
M672SM,
Version 1.10,
Issued
OV
8th
and
5V
November
and feeds
1994
an
output of a proportion of this
Page
18 of 85
a
level of
O.05V
at
21% 02
and
5V
at
100% 02. VR6
adjusts the offset and
This section of the electronics is used for determining the Oxygen
used to clamp the signal to the micro-controller. Xnput
monitor. IC6 stage
3
whilst stage
gain.
IC4
provides the necessary amplification.
is used to clamp the signal. Input AN4 on IC1 is spare and is connected to ground to
4
provides an offset to
trim
out any zero error from the Oxygen sensor,
AN2
on
VR8
adjusts the offset and
IC1
prevent noise pick-up from getting into the measurement circuitry.
VR5
sets the span.
alann
limits,
IC4
is
is used for the Oxygen
VR4
adjusts the
again
The display brightness levels are generated from the
Board.
A
resistive circuit,
VR2
and
R11,
is used to set the overall brightness level and the fed-
NORP12
signal fed back from the Display
back signal modulates this. The brightness of the 7-segment displays is set by the diierence
between this level and
set a constant current dependant upon the voltage at its wiper. IC5 stage
-
-
--
form a voltage controlled constant current-source.
The audible
MOSFET
alarm
TR1.
15V.
The brightness of the LED'S is adjusted by using trimmer
3
and transistor
-
--
VRl
is fitted on the Processor Board and is driven by the micro-controller via
The audible alarm is powered from the
+5V
rail and is a high efficiency type,
to
TR2
fly
selected for its high output at low voltages.
An
over-pressure relief valve is fitted in the Mat FlowTM Driver to vent any excessive
pressures to atmosphere. This slave over-pressure valve is driven by the micro-controller using
a
solenoid valve as a master. The power source for the solenoid valve is a three terminal
regulator,
MOSFET,
REGI,
TR3,
connected as a constant current source. The solenoid valve is operated by a
connected
in
series with opto-coupler, IC9, to monitor the functioning of the
solenoid valve circuit.
Also fitted on the Processor Board is a two-stage watchdog circuit. The first stage,
Silicon General
inverter is connected so as to allow monitoring of the minus
5V
The
and 15V power rails are monitored by Sense 2 and Sense 3 inputs respectively. The
SG3548N which has four sense inputs, an inverter and a threshold input. The
15V
power rail by Sense 4 input.
IC2, is a
Sense inputs are checked for voltages both over and under the set levels. The tolerance on the
over and under voltages is set by using the threshold input. The resistors, R6 and
R8,
set the
window width to plus and minus 5%. The line input, which is normally used to monitor an ac
input, is used here to gate the watchdog reset pulses from the micro-controller with the power
supply monitor signal to produce the wired-and output at pins
7,
9 and
10.
Whilst
all
is well,
this pulsating signal is applied to IC3 pin 6 to prevent timing out of the watchdog. IC3 is a
Maxim
MAX694CPq Supertex MP694P or an
circuit, of which only the
1.6
second timer is used.
AMD
AD694AN microprocessor supervisory
If
any power rail goes above its permitted
value, the ON output at pin 9 will go low; if any power rail goes below its permitted value, the
UN
output at pin
10
will go low. In either case, the watchdog reset pulses
will
be interrupted
and the micro-controller will reset after 1.6 seconds delay. C7 provides a short delay on
operation of the sense inputs to avoid operation on transients.
is
The mixer monitor
controller shaft position.
Document
No.
M672SM,
mounted on the panel of the mixer unit where it is used to monitor the
'
.:
I
Version
1.10,
Issued
8th
November 1994
Page 19
of
85
Cj
1
Trouble
Shooting
Guide
Problem or Fault
The electronic module
does not function at
-
all.
Electronic Module
continually resetting
All displays dim
Possible cause
No mains power
Power Supply faulty
+
+
-
-
5 VDC faulty
15 VDC faulty
15
VDC faulty
Auto dimming circuit
faulty or not set.
Rectification
Power cord connected?
Mains switch turned on?
Voltage Selector correctly set?
Check primary fuses.
Check plug
Before calibrating the electronic section of the Infant FlowTM Driver the power supply voltages
should be checked. The reference and excitation voltages should be checked next and only then
should the manometer and Oxygen monitor sections be calibrated.
The equip-t required for this is a good
qualityI
for checking the power supply rails, reference and excitation voltages and a 0 to
water
and pressure relief valve.
column
or similar accurate low pressure measuring device for calibrating the manometer
We
do not recommend the use of mechanical pressure gauges for this
purpose as they are inherently inaccurate. A hand pump bulb
Pressure Sphygmomanometers is also required.
supply of
bar pressure Medical
Air
and Oxygen are required.
4
To gain access to the electronics it is necessary to remove the top cover
Howm Driver. This is achieved by removing the top..-two
calib~~-DVM-~~bleofre~01Jrin@-mY
150
Crns
H20
siiar to those used on Blood
To
check and calibrate the Oxygen monitor a
fiom .the Infant
M3
raised countersunk crews on
each side of the cover and then sliding the cover upwards and off The adjustment trimmers are
accessible at the top
left of the electronics module. They
$nay
be adjusted from the side by
using a standard trim tool.
M3
To remove the manometer section completely it is advisable to remove the four
countersunk screws on the
left hand side of the device and the four
M3
x
8mrn
raised
pan head
screws on the back panel. This will enable the complete assembly to be slid forward so that the
connectors can be removed fiom the bottom of the processor board to
allow the assembly to
be come out of the housing.
CAUTION
Disconnect the unit from the mains supply by unplugging the mains cable
from the mains
input module on the rear panel before attempting to remove the electronics module.
Power supply
To check the power rails it is advisable to first disconnect the power connector
checks
CON2
fiom the
processor board. Ensure that the mains supply is connected to the mains input module and that
the voltage selector is set to the correct value. Switch on the power to the unit. The voltage
rails to be checked
Document
No.
M672SM,
are.;
Page
37
of
Version
.
.
1.10,
Issued
8th
November
- . --
1994
-.
~.
...
85
The + 5
The
+I5
The
-1
5
VDC
supply on pin 1 of CON2 with respect to
VDC
supply on pin 3 of CON2 with respect to
VDC supply on pin 5 of CON2 with respect to
0 V
(Digital ground) on pin
0
V
(Analogue ground) on
OV
(Analogue ground) on
2.
pin
pin
4.
4.
Ifthese are
may be reconnected to the processor board and the next set of tests
all
present,
within
5%
of their nominal value and stable the power connector CON2
carried
out.
Display brigbtness set up
First the display brightness must be set. This is done by adjusting
brightness is obtained for the seven segment displays and then adjusting
graph
LED'S are of similar brightness. The light dependant resistor,
VR2
VR1
LDR1,
until the required
occluded to ensure that auto dimming is satisfactory.
Reference voltage checks
The reference voltage may now be checked. Connect the negative input
ground test point,
TP3,
and the positive input to
TP10.
A
reading of
200
of
mV
the
be indicated. The excitation voltage to the pressure transducer is checked on
reference to ground, this should be 12
V
*
0.6
V.
until the bar
may be partially
h
ICS
DVM
10
to the
mV should
pin 6 with
Manometer calibration
With no equipment connected to the pressure input set the manometer to zero with
VR7.
Connect the water column with the hand pump bulb into a "T" piece and into the manometer
pressure input on the front panel. Inflate to
10
Check that the manometer reads
Cms H20, if not, adjust
Release the pressure and check that the zero reading has not changed.
procedure until the readings are correct at both pressures. Pump the system up to
and ensure that the displayed value is
5
Cm
10
Cms H20 and observe that there are no leaks.
VR3
to give the correct reading.
If
it has, repeat the
5
Cms Hz0
H20.
Once calibration is satisfactory pressurise the system to above 12 Cms H20 and ensure that all
segments of the manometer bar graph illuminate, the
alarm sounds and the over-pressure relief solenoid is activated. Press the
high
pressure
LED
is on, that the audible
"MUTE"
button and
ensure that the audible alarm is silenced. Release the pressure in the system and press the
"MUTE"
button, the audible and visual alarms should cancel and the over pressure solenoid
should de-activate.
Document
No.
M672SM,
Version 1.10,
Issued
8th
November 1994
Page
38
of
85
Oxygen analyser calibration
There are two stages to the calibration of the Oxygen analyser, fist- the calibration of the
galvanic
automatic
To calibrate the integral Oxygen analyser the electronic module must be installed in the lower
case with the leads connected to the mixer section of the driver. The Infant
also be connected to a source of Medical
that a reference Oxygen analyser with an accuracy of
venfy the performance.
to
Set the flow to
reference analyser is reading 100% Oxygen. Adjust
display window. Set the mixer control to an
reads 21% Oxygen. Adjust
no hrther adjustments are necessary.
he1 cell itself and secondly the calibration of the mixer monitor which enables
alarm
setting on the set value.
FlowTM driver must
Air
and Oxygen at 4 bar pressure. We recommend
*
1% is fitted
8
lpm and turn the mixer control to indicate an FI02 of 1.0 and ensure that the
VR4
until 100% is displayed in the Oxygen
FI02 of
VR8
until the oxygen display reads 21%. Repeat the process until
.21
and ensure that the reference analyser
in
the outlet of the driver
m
b
-
To calibrate the mixer monitor board ensure that the three way connector from the mixer
control is connected to the processor board. Turn of the electronic module then press and hold
will
the mute button whilst turning the power on again. The Oxygen display
an
setting of the mixer control. Set the mixer to
of
30%.
Set the mixer control to an FI02 of 1.0 and adjust
the process until no
reads 60
elapsed.
Once all of these procedures have been completed the Infant FlowTM Driver may be reassembled.
h
2
digits. The Driver will return to normal operation after a period of 2 minutes has
hrther adjustment is required. Check that at an FI02 of .60 the display
FI02 of .30 and adjust
VR5
until 100% is shown. Repeat
VR6
now show the
to give a display
f-
I
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
39
of
85
Section
10
Mechanical Description
The mechanical components of the Infant FlowTM Driver can be separated into three items:
The enclosure
The
Aidoxygen Mixer
-
~
.
-
.-
..
The Flowmeter/Pressure relief valve assembly
fiom
2mrn
The enclosure is manufactured
epoxy based paint which is very resilient to knocks and substances that may come into contact
with it.
sheet Aluminium and is protected by a powder coat
in
The Manometer section is held
the
left hand side of the enclosure and four
the case by means
M3
washers on the back panel. The Mixer assembly is located by the two
in
the pole mount bracket
place. The rear panel is locked
x
of
four
8rnm
M3
raised countersunk screws on
pan head screws with shakeproof
UNC
in
by the gas inlet mounting plate on
screws that hold
the rear of the Mixer.
The flowrneter mounting block fitted to the left hand side of the mixer routes all output gas
from the mixer to the Oxygen analyser and either the patient circuit or to atmosphere through
the over pressure relief valve system.
the seal is made with
an
"0"
ring between two flat machined faces. This entire assembly may
It
is mounted on the mixer by two
8-32
UNC screws and
be removed for cleaning or repair by removal of these two screws.
The flowmeter is removed by loosening the
M4
grub
screw located on the left side of the
assembly. Once loosened the flowmeter can be pulled forward and the tubing on the rear
detached by pushing the blue ring in towards the flowmeter whilst pulling on the tubing.
removed, it is advisable to replace the
"0"
rings prior to re-assembly.
If
The flowmeter should be cleaned if contaminated and the calibration should be checked
periodically (annually
from the block and disconnect the tubing by pushing the blue ring
if
the supply gases are clean and dry). To clean the flowmeter, remove it
in
towards the flowrneter
whilst pulling on the tubing.. Remove the nut on the top which allows the ball to be removed.
Clean the tube with
damage the acrylic.
warm
.-
soapy water only, do not use spirit based cleaners as this will
Document
No.
M672SM,
Version 1.10,
Issued
8th
November 1994
Page
40 of
85
Flowmeter Calibration Check
To check the flowmeter calibration attach the Infant Flowm driver to the medical
Oxygen supplies and set an
Infant
indicated flow of
Flowm driver to a test flowmeter or flow test device with an appropriate hose. Select an
5
lpm on the Infant Flowm driver flowmeter and vem that the correct flow
is indicated on the test device within
FIO2 of .5 on the mixer control knob. Connect the outlet of the
*
10%. Repeat at
8,
10, 12 and 15 lpm.
air
and
Safety Pressure Relief Valve Setting
--
-back pressure-of &-I=
For the Infant HowTM Nasal
CPAP
I-O-tiesthm
Tr&@Ed-CPAP
generator to function correctly it is necessary to have a
press- iTthe-delivery circuit prior to
the generator. For safety reasons the Infant Flowm driver is equipped with two pressure relief
systems The first is a mechanical safety pressure relief valve designed to protect the equipment
and delivery circuit. This is mounted on the flowmeter mounting block and is not accessible to
the users. It is factory preset at 150 Cms H20 but should be checked periodically.
/
To test the setting and efficacy of the safety pressure relief valve connect the calibrated water
8
column or similar pressure measuring system into the patient circuit. Set a flow of
in
flowmeter and occlude the delivery tube. The pressure
Cms H20
of 150 Cms
*
20 Cms H20.
If
necessary, adjust the safety pressure relief valve to give a reading
Hz0 on the water column.
the patient circuit should reach 150
lpm on the
The second safety relief valve is to protect the patient and consists of an electronic solenoid
valve which operates when the measured pressure in the patient circuit exceeds 11 Cms
H20.
This device is mounted on a bracket on top of the air1Oxygen mixer. Gas fiom the mixer is
passed through a fixed regulator and the solenoid valve and acts on a silicone diaphragm
located under a plate at the rear of the flowrneter mounting block. When an over pressure is
detected the solenoid is activated and the pressure removed
from the diaphragm. This allows
the gas in the patient circuit to vent to ambient through the rear of the block and reduces the
pressure in the patient circuit to virtually zero instantaneously.
It is necessary to check the pressure setting of the electronic safety system periodically. This is
achieved by disconnecting the tube
an
connecting to
should be set for between 160
accurate pressure measuring device such as a mercury column. The regulator
&
tube on the solenoid and check the
from the pressure regulator to the solenoid valve and
180
mrn
Hg (2.5 to 3.0
PSI).
Once tested and set replace the
hnction of the electronic over pressure vent valve.
Oxygen Sensor
The sensor for the Oxygen monitor is a Teledyne R22 electro-chemical galvanic he1 cell. It is
mounted on top of the flowrneter mounting block directly behind the flowmeter. It is supplied
with mixed gas
fiom the mixer through a device which limits the pressure variations which
could otherwise affect it's accuracy. The sensor is expected to have an average life in excess of
one year. The end of life indication for this sensor is when it is no longer possible to calibrate it
accurately, however, it
MR22.
i.s recommended that it is replaced
!,,
annually.
Re-order part number
n
-,I
~
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
4
1
of
85
Document
No. M672SM
Version 1.10,
Issued
8th
November 1994
Page
42
of
85
Document No.
M672SM.
Version 1.10,
Issued
8th
November 1994
Page
43
of
85
n--mpnt
Nn
Mfi77SM
Venion
1.10.
Issued
8th
November
1994
Page
44
of
85
U6
SMC
AIR
flLTER
-
w200
W
r
12
CSK
-
U5
r
52
LON(
PHIUPS
PAN
t
llEMS SHOWN
OF CUSIOMER
AS
ORDER
WPE
z
w
opp m _momq
SIC
DATE
ECN
I
ctro
I
APP
llllI
02/AlR
ASSEMBLY
ITEMS SHOWN
OF
cunom
MOUNTING
FOR
AS
WPL~
ORDER
In>
I
BLOLK
TRICOMF
u
1
ORN
MTE
ORC
EAD
07-07-93
No
67
1
-0
I
CH'O
1
APP
1
PI
PI
6-!
Section
11
.
.
.
.
.
~
-.
~.
,
-
.:~
AirIOxygen
The main body of the Aidoxygen Mixer is a derivative of the Sechrist model
has been designed for both durability and serviceability.
met and the supplies are satisfactorily clean and dry, the mixer
Mixer
If
3500.
This mixer
the criteria for the gas supplies are
will
provide years of reliable use
with relatively little care and service.
--
-
.
..
.
.
This section of the Infant FlowTM Driver service manual is dedicated -entirely to the mixer and
is designed to take the technician through a step by step process to:
Test for proper operation
Troubleshoot malhnctions
Calibrate the mixer
if
necessary
Disassemble and reassemble the mixer
\
,
L
.
'
L
2
.
>
-b
a
Keep the mixer working at its optimum efficiency of design
This section of the
A
Describes all tools
manual
and
is
split into four parts:
test equipment required to calibrate and service the airloxygen
mixer.
B
Details the testing procedures necessary to determine optimum working conditions of
the
air/Oxygen mixer.
troubleshooting guide is given in part
If
service
is
necessary, based on the outcome of the testing, a
B
to determine which component module of the
mixer is involved and what procedures are recommended.
Details the calibration procedures and those necessary for service.
C
and
D Details the dis-assembly
re-assembly procedures.
\
-
Document No. M672SM, Version 1.10, Issued
8th
November 1994
Page 46 of
85
Description of the airloxygen mixer
The airloxygen mixer is made up of three separate but integrated modules:
The proportioning module does the actual gas mixing and proportions the outflow.
The pressure balancing module takes the incoming
differential of
2
Bar
(30
PSI) and reduces this differential to 3 Cms H20 thereby nullifjing
gas
pressures, with a potential
the differences and equalising the incoming pressures.
--
--
--
-
TKe
Alarm
more than
will
be delivered by the mixer until supply gas pressures are restored.
Sidule soudK a cont'iuous~
2
Bar
(30
PSI). When the
alarm
alarm
is activated the gas with the highest pressure
if
the incoming gas pressures differ by
---
Understanding the AirIOxygen Mixer
The Infant Flowm Driver AirIOxygen Mixer is a device to proportion Medical
at operator selected ratios for delivery to patients via the Infant
Floww NCPAP generator.
To accomplish this task properly, several factors must be considered. First, the device must
pennit the operator to select a ratio of the flow of one gas vs. the other gas. This is typically
done by using two variable restrictors, such as needle valves, which are linked together in such
a way that the effective flow areas of the two variable restrictors are inversely proportional.
These variable restrictors are positioned with a calibrated control knob. Movement of the
control knob will increase the effective area for the flow of one gas while decreasing the
effective area for the flow of the other gas. The ratio of the areas will determine the ratio of the
two gas flows. If the two gases are air and oxygen, the percentage of oxygen in the mixed gas
is determined by the formula
Air
and Oxygen
mc
'1
Q0xygen Q~ir
Where Q0xygen
Dimensioning for the effective areas is determined by the desired flow range of the device.
is
the flow of oxygen and QAir is the flow of air in identical units.
A
cross section schematic view of the proportioning valve module of the Infant Flowm Driver
Mixer is shown overleaf. The calibrated control knob is attached to a threaded positioning
shaft. Positioned within two sharp edged orifice seats is a double ended tapered needle valve.
A
spring loaded positioning device acts upon the end of the double ended valve keeping it in
contact with the
Document
No.
thread+ positioning shaft.
M672SM.
Version
1.10,
Issued
8th
November
1994
Page
47
of
85
Rotation of the control knob
adjusting the location of the double ended needle valve relative to the two
will
move the location of the threaded positioning shaft thereby
ofice seats and
defining the effective flow areas for both gases.
This simple system would be all that is necessary to proportion the flow of to gases. However,
if
it is desired to calibrate the control knob and to maintain the ratio of the two gas flows at a
constant value, the pressure differential across both
easily imagine what could happen to the gas flow ratio
orSce areas must be identical. One can
if
the Oxygen pressure increased fiom
4
bar, when the ratio was selected, to 7 bar. Some type of system must be used to regulate the
gas pressure entering the proportioning device preferably making both gas pressures equal.
If
the individual gas pressures entering the proportioning device are equal and the gases flow to a
will
common outlet for mixing, the pressure differential across each of the orifice areas
If
equal.
these conditions are maintained, the ratio of the two gas flows
-
--
-
will
remain constant.
be
Various methods are used by different manufacturers to equalise the two gas supply pressures.
Precision regulators set to equal outlet pressures, dual regulators configured such that one gas
pressure is slaved to the other and devices termed nulling regulators. Nulling regulators were
conceived
use one
gas
regulator
the 1930's for welding and liquid mixing purposes.
pressure to control the other, but either gas may be the controlling gas. A nulling
will
reduce whichever gas pressure is higher to a value equal to the lower gas
In
principle, nulling regulators
in
pressure.
The Infant
Flowm Driver AirIOxygen Mixer uses a nulling regulator to balance the two supply
gas pressures before they enter the proportioning valve. This is shown schematically overleaf.
Two identical needle
valve/seat arrangements are coniigured on opposite sides of a central
diaphragm. They are located so that both valve seats cannot be closed at the same time and
they are designed so that the effective flow area for each gas is inversely proportional to the
other. When one gas source is turned on, that gas pressure will act on the diaphragm pushing it
away
from the needle valvelseat until the valve closes and permits no flow of the gas.
other gas source is turned on, it will find its needle
passing through this open seat will act upon the diaphragm. The diaphragm
valvelseat open and the gas pressure
will
then move to a
If
the
position where the pressure acting upon each side of the diaphragm will move away from the
higher pressure. When the diaphragm moves in this way, the
the higher gas pressure will close down, reducing pressure on the diaphragm.
the opposite needle
valvelseat is opened. Thus, the system will null out differences in the gas
needlelseat which is the source of
At
the same time,
pressures until they are equal. These equal gas pressures are then presented to the
proportioning valve for mixing at the desired ratio.
As
stated previously, a characteristic of a nulling regulator is to create
equal to the lower of the two inlet gas pressures.
zero, the outlet pressure will be zero. It is
In
this case,
desirable to keep pneumatic respiratory care
if
an
outlet gas pressure
one of the inlet pressures is
equipment operating even with the inadvertent loss of one of the supply gases. Therefore a
device is required which will bypass the nulling regulator with the remaining supply gas and
simultaneously activate an
incorporated
in
the Infai.lt FlowTM Driver AirlOxygen Mixer.
alarm to alert attending personnel. Such a bypasslalarm system is
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
48
of
85
Schematic representation
1'
of
the AirIOrygen
Mixer
Document
No.
M672SM,
-
Version
1.10,
-8th
November
1994
. ..
. . .
Page
49-of
85
This device is depicted schematically on the previous page. The supply pressure of
air
and
oxygen are delivered to this module via internally drilled channels. Cross drilling within the
air
module presents the
and oxygen pressures on opposiig ends of two identical moveable
pistons. These pistons are fitted with sealing O-rings and are nominally seated with the force of
a compression spring.
on
The sealing O-rings are of different diameter
generated by the inlet gas pressures are close to the same value.
pressures should drop
in
relation to the other, the resulting forces
back from its seated position and in so doing open a flow channel
the ends of the piston. Therefore the forces
If,
however, one of the gas
will
cause the piston to move
from the higher of the two
inlet pressures to the Proportioning Module outlet. When this occurs, the alarm reed will be
activated and the higher gas pressure will enter the outlet manifold of the proportioning valve
to supply gas pressure to the outlet port, bypassing its normal route.
will
Restoring the lower gas pressure
in
located
the bypass/alarm to prevent the normal gas mixture
The pressure difference in the inlet gas pressures required to activate the
re-seat the moved piston. A one way check valve is
fiom
activating the
alarm
alarm
reed.
is determined
by the dimensioning of the piston seal areas and the seating spring force.
Filters are incorporated in both of the gas inlet connections. One way check valves are also
located in both of the gas inlet connections to prevent the cross flow of one gas supply to the
other source.
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
50
of
85
Tools and Accessories Required for Calibration and DisassemblyIRe-assembly
Special tools and accessories are required to calibrate, disassemble and. reassemble the Infant
Flow Driver
these special tools are available.
Aidoxygen Mixer. No service work on the mixer should
be
undertaken unless
SPECIAL CALIBRATION
Air/Oxygen Mixer Tool Kit
_lL8!Ispanner-~ench-.
3/8" spanner wrench
5/8" spanner wrench
Bypass plate
Brass Plug 10-32
x
Brass 10-32
Roll Pins
Screws (2) 6-32
O-rings
-
1/16" fitting
(8)
008
AND
. .
--
ASSEMBLY TOOLS
Part No. S365
--
>art-NorS36-54
Part No. S3653
Part No. S3652
Part No. S3655
Part No. S3635
Part No. S3
Part No. S3537
Part No. S3559
Part No. S3534
1
10
--
-
--
Figure
Document No.
1.
Special Assembly
.I.
M672SM.
Version 1.10.
Tools
Issued
8th
November 1994
Figure
2.
Calliper & Micrometer
Page
5
1 of
85
GENERAL
CALIBRATION
AND
ASSEMBLY
TOOLS
1/16" Allen Wrench
5/64" Allen Wrench
7/64" Allen Wrench
9/64" Allen Wrench
3/16"
Men Wrench
114" Allen Wrench
3/32" Allen Wrench
7/16" Open End Wrench
112" Open End Wrench
314" Open End Wrench
114" Nut Driver
Internal
Tru-arc
Needle Nose Pliers
Soft
Mallet
Medium Blade Screwdriver
Precision Calliper
Precision Depth Micrometer
LubricantforfOGiigs
--
EQUIPMENT
(see figure 2)
(see figure
---
-Kiytox
240 AC- (Dupont)
REQUIRED
2)
FOR
Oxygen High Pressure Hose with Appropriate Fittings
Air High Pressure Hose with Appropriate
Oxygen Regulator, Adjustable with Pressure Gauge
Air
Regulator, Adjustable
Oxygen Analyser (Calibrated to
with
Pressure Gauge 0-4 Bar (60 PSI)
+
-
Fittings
0-4
1% Accuracy, Readout Accurate to 1% Increments)
Sampling Reservoir (Bottle or Tube)
Oxygen Analyser (Calibrated To
+
-
1% Accuracy, Readout Accurate To
Sampling Reservoir (Bottle Or Tube)
Pressure Gauge
0-4
Bar (60
PSI)
Circlip Pliers
-
TEST SYSTEM
Bar
(60
PSI)
-.
1%
Increments)
ROUTINE
MAINTENANCE
REQUIREMENT
Before attempting to calibrate or repair the AirIOxygen Mixer, a qualified hospital technician
should be familiar with the design and hnction of the device. The following instructions utilise
All
a numbering system which is to be followed in sequence.
parts are numbered and can be
reviewed on the exploded parts diagrams contained herein.
Aidoxygen
Mixer Overhaul
Kit
(Part
No.
S3658)
To ease the task of servicing the airloxygen mixer the overhaul kit includes all of the items
required to
Document No.
carry
out a full service under one part number. The kit includes the following:
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
52
of
85
MIXER
Part Number Description
Items for the Proportioning Module
OVERHAUL
KIT
S3658
S3548
S35
13
1
S3521
1
S3534
I~3520-
1
S3535
S3533
S3521
S3517
1
S3566
1
S3626
1
S3520
1
S3515
I
S3510
[
S3525
Nitrile 0-Ring, BS 006
Nitrile 0-Ring, BS 0 1 1
I
Nitrile 0-Rmg, BS 012 12
I
Nitrile 0-Ring, BS 008
-J_blitrile~&ing~~-01.4
_
I
Paclang Washer, Nylon
I
Adjustment
Items for the Pressure Balancing Module
Nitrile 0-Rmg, BS 012
Nitrile
I
Nitrile 0-Ring, BS 01
I
Nitrile 0-Ring, BS 112 12
]
Nitrile 0-Ring, BS 014 12
]
Spring, SS, LC-014B-4SS
I
Diaphragm Assembly
I
Duck Bill Check Valve 12
-
Shaft 11
0-RUE.
BS 007
--
8
1
5
14
--
-I--.
11
4
2
12
I
I
I
12
11
I
1
S3639
1
S3548
1
S3618
1
~3569
1
S3520
1
S3619
1
S3637
1
33636
(
S3529E
I
S3522K
I
I
I
1
S3578
Items for the AlarmlBypass Module
(
Silicone 0-Ring, BS 008,70 DUR 13
I
Nitrile 0-Ring, BS 006 12
I
Silicone 0-Ring, BS 010,50 DUR 12
I
Nitrile 0-Ring, BS 025 11
I
Nitrile 0-Ring, BS 014 14
I
Spring, 302 SS 12
I
Spring,
I
Check ball, 7/32" Diameter
I
Water Trap filter
]
Air
1
Nitrile
Custom
Items for the Filtration System
and
Oxygen Inlet Filter
.-Items for Flowmeter Block
.
.
0-Iting,
BS 0
13
Kits
11
11
1
1
12
11
I
I
I
I
I
Document No.
M672SM,
-
Version
-
.
1.10,
Issued
.
8th
November 1994
~
Page
53
of
.
-
.
..
85
B.
TEST
PROCEDURE
In order to determine the optimal hnction of the Aidoxygen Mixer and- the potential need for
calibration, service or repair, complete the following test procedures.
1.0
B.
B.
1.1.
Initial Test
Connect the Mixer to clean and
Air
supplies which are independently adjustable fiom 0 to 4 Bar (0 to
System
Set
Up
dry
Medical Breathing Oxygen and Medical Breathing
60
PSI).
--
B .1.2 Conhect
B.
1.3
Direct the flow fiom the flowmeter to a sampling reservoir (i.e. bottle or tube), making
sure that no room
B.
1.4
NOTE:
B.
1.5
B.2.0
B.2.1
Insert the Oxygen analyser probe into the sampling reservoir.
The Oxygen analyser must be calibrated and accurate to
Set a flowrate of 7 lpm
Proportioning Module.
Set the Oxygen and air pressure to
K-fkiGiG%er
tothioutletof the Mixer.
air
is being entrained to dilute the
4
Bar
(60 PSI)
--
mixture.
*
1%.
-
B.2.2
B.2.3
Compare the Oxygen analyser readings to the Mixer settings of
The Mixer has a specified accuracy of
between the Mixer and Oxygen analyser reading, calibration or service may be
necessary (see Troubleshooting Guide).
B.2.4
There is a constant bleed of mixed gas from the bottom of the Proportioning Module.
This bleed is approximately
low flows. These bleed rates are predetermined by the factory and cannot be reset
the field.
Document No.
M672SM,
Version
1.10,
3.5
Issued
*
3%.
lpm and is needed to
8th
November
1994
.21,
.40, .80 and
If
the FI02 varies more than
maintain
accurate FI02's at very
Page
54
of
85
1.0.
*
4%
in
B.3.0
Pressure Balancing Module.
B.3.1
With same test system set up
as
above, select an
FI02
of
.60
and observe the Oxygen
analyser reading.
B.3.2
Vary the inlet pressures to the Mixer to
air
and then to
more than
4
1%
Bar (60
fiom the
PSI) Oxygen and
initial
Oxygen analyser reading, calibration or service may be
2.6 Bar (40
2.6 Bar (40
PSI) Oxygen and
PSI)
air.
If
the
4 Bar (60
FI02
varies by
PSI)
necessary (see Troubleshooting Guide).
B.4.0
pppp-
B.4.1
Alarm Module.
-
--
--
Set air and Oxygen supplies to
4 Bar (60
.
PSI), the alarm should be silent.
-...
?!
B.4.2
Slowly reduce the
(24
and
28
PSI) and the Oxygen analyser should read
supply pressure slowly to
(40 PSI).
air
inlet supply, the
4 Bar (60
alarm
should sound at between
100%.
PSI),
the alarm should reset at or before
Increase the
1.6
and
1.9
Bar
air
inlet
2.7 Bar
B.4.3
B.4.4
B.5.0
B.5.1
B.5.2
B.5.3
Repeat step
Oxygen analyser reading should read
If
the alarm does not function as per the above specifications, calibration or service
4.2
varying the Oxygen inlet supply pressure, when the
21%.
alarm
sounds the
may be necessary (see Troubleshooting Guide).
Air
Inlet Filtration System (most frequent service required).
To test the pressure drop through the waterltrap filter or the internal air inlet filter,
test port has been provided on the rear of the
With a
111 6"
Connect a high pressure gauge
114"
fitting
nut driver, remove the plug from test port and install a Brass 10-32
(Part
No.
S3
10, see Tool Kit).
(0
to 4 Bar or 0 to
Mixer
above the air inlet.
60
PSI) to the
10-32
fitting.
a
x
B.5.4
With the flow set at 7 lpm set the mixer control knob to
indicated at test port.
Document No.
M672SM,
........
Version
1.10,
Issued
8th
November
1994
.21.
Observe the pressure
Page
55
of
.....
.
.
-
85
,
.
B.5.5
If
the difference between the pressure at the test port and the inlet pressure is greater
than 0.65
Bar
(10
PSI)
replace either or both
air
inlet flters (see Routine Maintenance
section).
NOTE:
The Mixer
maintain the delivered FI02 within
fluctuations of the supply pressures. The additional
*
1%
of the selected value with
2%
error is caused by the
will
readability of the set point and scale error.
NOTE:
The outlet pressure of the Mixer
two inlet pressures.
PROBLEM
FI02 not accurate
will
TROUBLE
POSSIBLE
always
SHOOTING GUIDE
CAUSE
be
Oxygen analyser out of
calibration (most common
problem)
Improper purity of supply gases
Wrong gas supplied to inlet
slightly lower than the lower of the
CORRECTION
Re-calibrate Oxygen analyser
Check quality of supply gases
Assure outlets and hoses are
correct
Front or rear seats
worn
Calibration of proportioning
Clean and replace seats
See Calibration Section
valve incorrect
Pressure Balancing Module
malfbnctioning
&lob is herd to turn
?.
.
d
Document No.
M672SM,
Version
Knob has been bumped
bending adjustable
1.10,
Issued
8th
shaft
November
1994
See Calibration for Pressure
Balancing Module
Replace adjustable
shaft and
re-calibrate
Page
56
of
85
PRESSURE
BALANCING
MODULE
PROBLEM
FI02 Change
testing
.
--
>
1%
when
POSSIBLE CAUSE
Air
or Oxygen inlet filter
causing
>
1.3
Bar
(20
PSI)
difference
Regulator needle(s) out of
calibration
3-1s)
on reguiator seat
damaged causing leak
Contamination
from supply
gases
ALARM
MODULE
di
--
CORRECTION
Replace filter
Calibrate
ReplaC~rings and
re-calibrate
Clean and re-calibrate
-
--
PROBLEM
Continuous alarm with
both inlet pressures equal
Alarm not sounding with
loss of one pressure
POSSIBLE CAUSE
Dirty inlet
filter(s)
Bypass check ball leaking
Alarm Module adjustments out
of calibration
Defective Reed
Alann Module adjustments out
of calibration
Alarm
poppets stuck
CORRECTION
Dirty
inlet filter(s)
Need to clean check ball and
seat (see Disassembly of
Alarm
Module)
See Calibration Section
Replace reed
See Calibration Section
Clean, lubricate and
re-calibrate
Document No.
M672SM,
--
.
-
Version 1.10,
.
. .
..
.. .
Issued
.
8th
November 1994
Page
57
of
-
-
----
85
AirJOxygen Mixer Calibration
The AirIOxygen Mixer must be calibrated and tested in conditions similar to the environment
for which the Mixer was designed.
Medical breathing Oxygen and medical breathing
system.
and that the accuracy of the readout is
A
calibrated Oxygen analyser is necessary (be sure the Oxygen analyser is calibrated
in
1%
air
sources
will
increments or better) and a flowmeter is used to
sample the gas mixture being delivered to the Oxygen analyser.
To calibrate the
--
Aidoxygen Mixer, the system must be broken down into the three modules:
--
--
the ~ro~ortioz~ Module, the Pressure BalariC'iE-Module and--the
Disassembly and Re-assemble Section).
NOTE
The order of calibration given must be followed
must be calibrated before the Proportioning Module can be connected and calibrated
and the Pressure Balancing Module and Proportioning Module must be calibrated
together before the
Alarm
Module can be installed
i.e.
the Pressure Balancing Module
and
calibrated.
be required to calibrate the
Alsm
Module (see
C.
C.
1.0
I.
Pressure
I
To calibrate the Pressure Balancing Module, all accessory parts, pole mount, wall
mount, flowmeter and Proportioning
C.
1.2
Using
block, Part No.
sections. The
diaphragm assembly,
Document No.
Balancing
a
3/16"
M672SM,
Module
(See Figure 3)
and
Alarm
Allen wrench, remove the four screws,
air
..
.
Version
S3505, and
block,
Part
Part
1.10,
Issued
divide
No.
S3505, the Oxygen block,
No. S3 5 10.
8th
November
the Pressure Balancing Module into three
1994
Modules must be removed.
Part
No. S3507, from the air
Part
No. S3506, and the
Page
58
of
85
Document No.
M672SM.
'
Figure
.
.
).
'
Version
1.10,
4.
Pressure
Issued
8th
November
Balancing
1994
Module
Page
59
of
85
--
Figure
- - -
-
-
4.
--
Three Sections of the Pressure Balancing Module
--
NOTE: The
C.1.3
Using
assembly
distance should be between
Air
and Oxygen blocks are identical for calibration purposes.
a
precision calliper (see Tool List) measure the thickness of the diaphragm
(
the distance between the 2 diaphragm support plates) (see figure
0.800"
and
0.810".
Regulator Needle Setting Table
Diaphragm Thickness
.810
,809
.808
,807
,805
.804
.803
,802
.80
.800
799
,798
.797
.796
.795
.794
,793
,792
.79
1
.
>
8.'
1
Micrometer Reading
.3975
.3
970
.3965
.3 960
.3945
.3
940
.3935
3930
.3925
.3920
.3915
.3910
.3
905
.3 900
3895
.3890
.3885
.3880
1
5).
The
Document
No.
M672SM.
Version
1.10.
Issued
8th
November
1994
Page
60
of
85
Figure
5.
Holding Calliper
Figure
6.
Micrometer across block
C.
1.4
C.
1.5 Set the depth micrometer (see Tool List) to the setting indicated
Locate the measured diaphragm assembly thickness in the Regulator Needle Setting
Table
and
read across to hd the corresponding depth micrometer setting.
the micrometer across the block cavity (see figure 6).
C.
C.
1.6
1.7
Using either a 111
Using the special Assembly Tool
S3516.
and begin turning clockwise (see figure
The regulator seat.
6"
or a 5/64" Allen wrench loosen the set screw,
AT1
insert into the eccentric adjuster,
6).
Part
No.
S35 12,
and
the regulator needle, Part No.
move up and down.
YOTE:
C.
1.8
Calibration must be done
As the spanner wrench is being turned (always clockwise), the needle and seat will
on
the downstroke of the regulator seat and needle.
amve at top dead centre and start back down. As it starts back down, start sliding
the depth micrometer back and forth across the needle: do not bend the needle.
in
the table and rest
Part
No.
Part
S35
14,
S35
18.
No.
will
4
F
r)
,.I
C.
1.9
Slowly turning the spanner wrench
noise of the depth micrometer contacting the needle as it slides over it.
Document No.
M672SM.
. .
. - -.
Version
- - -
-
-.
1.10.
.
Issued
-.~
8th
November
.
in
veq small increments, listen for the tapping
1994
...
.
.
Page
6
1
of
.
85
C.
1.10
C.
1.11
C. 1.12
At some point in the downstroke of the needle, the depth micrometer
in
come
needle is
contact with the needle.
in
Using either
the proper position.
a
111 6" or a 5/64" Allen wrench, tighten
As
soon
as
the tapping noise ceases, the regulator
up
set screw,
Part
to secure the calibration.
and
Calibrate both blocks in this manner
by replacing the diaphragm assembly
screws,
Part
No. S3
507,
hand tightening
reassemble the Pressure
and
securing the two block halves
only.
Balancing
will
No.
with
no longer
S35 18,
Module
the four
-NOTE:
C.1.13
C.
1.14
NOTE:
C.2.0
Position-the-twwhalves--so-that-they
are-flush-(makesue-that them0 halves of the
module face, where the Proportioning Module mounts, are flush).
Tighten the four screws Part
S3507
in a cross pattern to evenly distribute
No.
pressure.
The Pressure Balancing Module is now calibrated.
At
the end of
must be
performed
Proportioning Module (see figure
all
calibration procedures, a test of the Pressure Balancing Module
to
contirm the calibration.
23534
7)
Document No.
M672SM.
53537
.>.
;
Version
:;C,x/
.A,..
35:
1
Figure
1.
lo1
Issued
0:
i
7.
Proportioning
8th
November
.
Module
1994
.
53531
.5
3549
5
Page
3542
62
of
85
C.2.1
Using a
9/64"
Allen wrench, attach Proportioning Module to Pressure Balancing
Module with four screws Part No.
S3550.
NOTE:
C.2.2
C.2.3
C.2.4
Be sure O-rings are in place between the Proportioning Module and Pressure
Balancing
Install the faceplate, Part No.
a
new overlay, Part No. M671019, to the panel.
Install
the
--
Alarm
--
Using
figure
Module.
M671019, with two screws, Part No. S3559, and
Assembly Tool AT4 (see Tool List) to occlude the
Module from
thePessureeBBalancing_Modulee----
high
pressure inlet ports to
-
a pair of needle nose pliers remove the bypass nipple, Part No. S3547, (see
8).
aflix
2
I~
(
I
i
I
i
i
I
!
i
Document
Figure
8.
Showing needle nose pliers removing nipple
CAUTION
Grasp the nipple at the base next to the Proportioning valve block
or the nipple may be damaged.
No.
M672SM.
Version
1.10.
Issued
8th
November
1994
-
not on the end
Page
63
of
85
,
~
,
.
.
.
C.2.5
C.2.6
Using a
114" nutdriver, install the brass plug,
bypass nipple port.
Install the flowmeter mounting block.
Part
No. S3635, (see Tool List) into
.
-
--
*
r
..
.
-
<.
r
-
%
*.
L
-
C.2.7 Connect the Medical Breathing
C.2.8
NOTE:
--
Connect the proportioning outlet to the calibrated Oxygen analyser.
The Oxygen analyser must be calibrated and the accuracy of the readout scale must
are expressed as true fractional Oxygen concentrations.
C.2.9
Select a flow of
C.2.10 Turn adjustment shaft,
7
Ipm to the Oxygen analyser.
Part
No. S3533, by
30%.
C.2.11 Attach the Mixer control knob,
S3533, and
align
the black indicator on knob with .30 position on the faceplate.
Using a hex wrench, tighten the set screw just enough to attach knob; do not filly
tighten the set screws at this time.
Air
and Oxygen supplies to the respective gas inlets.
hand until
Part
No. S3538, to the adjustment shaft,
the Oxygen analyser reads
Part
--
No.
L
<.
- -
L
7
.A
-
?
b
C.2.12
Turn the knob to .90 position and check the Oxygen analyser reading.
C.2.13 Using special tool AT3, loosen the
C.2.14
adjust the rear seat,
reading of. 90
*
Turn the knob to the .21 position (making sure that the knob hits the stop pin), then
Part
1
%
(see figure 9).
No. S3542, until the Oxygen analyser agrees with knob
up to the .30 position on mixer, the Oxygen analyser should read 30
necessary, rotate the knob until a reading of 30
analyser, and reposition the knob to
the faceplate.
C.2.15
Turn the knob to the .90 position; adjust the rear seat until the
90 k 1%.
jam
nut
Part
No. S3543. Using special tool AT2,
*
1%.
1%
is obtained on the Oxygen
align the knob indicator with the .30 position on
Oxygen
analyser reads
If
>
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
64
of
85
Figure
9.
Adjusting the Rear Seat on the Proportioning Module
C.2.16
C..2.17
Repeat steps
Turn knob to
2.14
1.0
position and make sure that the Oxygen analyser reads at least
(and no higher than
and
2.15
99.5%)
until proper readings are recorded.
and that the knob is hitting the end stop pin.
CAUTION
If resistance is met before stop pin at 1.0 position is reached, do not force the knob.
Re-adjust rear seat slightly
pin position. Recheck the calibration as described above.
C.2.18
Using special tool AT3, tighten the
calibration of the rear seat.
-
just enough to allow free range of movement to stop
jam
nut,
Part
No. S3543, to secure the
3
98%
NOTE:
C.2.19
Document
When tightening the jam nut the
can be compensated for by setting the Mixer knob at
FI02
may drop due to movement of rear seat. This
.90
position and adjusting the
rear seat until the Oxygen analyser reading is slightly above 90% (around
When the
Verifjl that the
No.
M672SM.
jam
nut is tightened the Oxygen analyser should come down to 90%.
full
range of positions can be obtained within a k 3% variation.
Version
1.10.
Issued
8th
November
1994
....~
Page
65
of
91%).
85
C.2.20
When
all
calibrations
are
completed
use
an
Allen
wrench to tighten the knob set
screw(s) Part No. S223.
C.2.21
nipple
Part
No. S3547.
supplies
"OFF",
remove the bypass plate AT4
Turn
the
gas
C.2.22 The calibration of Proportioning Module is now complete.
and
insert the
bypass
C.3.0
Alarm
Module
(see
figures
10)
C.3.1
NOTE:
Document
Slide the
Alarm
Be
sure
No.
M672SM,
Alarm
Figure
Module onto the bypass nipple,
10.
Module to the Pressure
O-rings
are
.
,I
Version
in
place between modules.
1.10,
Issued
Bypass/Alarm
Balancing
8th
Nwember
Module with two screws,
1994
Module
Part
No. S3547,
Part
Page
and
secure the
No.
66
of
S3624.
85
C.3.2
With the Mixer
still
now be performed.
attached to gas supply lines the calibration of
Alarm
Module can
C.3.3 Test procedure for acceptable alarm bleed response:
regulate to
Oxygen down to 2
level.
4
Bar
(60 PSI) leave the
Bar
(30 PSI), the alarm should sound continuously down to this
If
it does sound throughout the 2 to
air
"OFF",
turn
the Oxygen valve "ON" and
the alarm should sound. Turn the
4
Bar
range the alarm bleed is fully
functioning.
CAUTION
The alarm bleed set screw, Part No. S3568, is calibrated at the factory and should
not require calibration.
If
the
C.3.4
alarm
before perfbrming the alarm bleed calibration. The alarm reed may require
adjustment or be damaged or contaminated. To adjust the reed, use a small
instrument screwdriver through the centre hole of the black cover cap,
ISUO10, adjust the screw to obtain the alarm sound over the range.
is not functioning properly, check the alarm reed,
Part
No. S500006,
Part
No.
--
C.3.5
C.3.6
If
the alarm bleed does need calibration, use tru-arc circlip pliers to remove the truarc ring,
the
alarm
Part
No. S3570, that holds the alarm reed cap assembly in place and remove
reed cap assembly complete, Part No. S500006, do not attempt to
disassemble the alarm reed cap assembly.
If
alarm
does not sound at lower range of 2 Bar (30 PSI) the flow to reed needs to
be increased. This is achieved by adjusting the alarm bleed set screw, Part No.
S3568, clockwise.
If
alarm does not sound at the upper range of
4
Bar
(60 PSI), or
hesitates when the cap is occluded, flow to reed must be decreased by adjusting the
alarm
placed in its seat and held by hand to
of
sure that the O-ring,
bleed set screw counter clockwise. After adjustment the reed cap must be
verrfl the
alm
has been tested and verified install the tru-arc ring over the reed cap making
Part
No. S3569, is in place to seal the reed cap assembly.
alarm
function. When the
full
range
Document No.
M672SM,
.
.
.
..
Version 1.10,
..
Issued
. . .-. - . .
8th
November 1994
. . . .
..
-.. -.
Page
67
of
. .
-
-
-
. , . . .
-
--
85
CAUTION
Do not occlude the
r
:,
C.3.7
.
-
-.
NOTE:
To calibrate the bypass
Oxygen and
.-
The Oxygen calibration adjustment is located under the
air
alarm
to
"ON"
outlet ports as permanent damage to the
alarm
Oxygen calibration adjuster,
and regulate to
4
Bar
(60
- - -
PSI).
-
Part
air
-
inlet and the
alarm
No.
--
reed
S3622,
air
calibration
will
turn
the
adjustment is located under the Oxygen inlet.
C.3.8
C.3.9
The
alarm
should be silent.
Using the gas supply regulators set the
reduce the Oxygen supply. The
and
30
PSI).
alarm
air
supply to 4
Bar
(60
PSI)
should sound at between 1.6 and
and slowly
2
Bar
(24
C.3.10
C.3.11
C.3.12
C.3.13
NOTE:
If
no
alarm
sounds, loosen the
(located under the air inlet
Part
jam
No.
nut,
Part
S3622)
No.
S3623,
and turn the Oxygen adjuster
counter clockwise slowly until the
alarm
sounds.
If
the alarm is sounding when the gas supply is turned on, turn the Oxygen adjuster
turn
(under the air inlet) clockwise until alarm stops then
alarm sounds.
the
counter clockwise just until
Reduce the Oxygen pressure to zero to relieve pressure within the hose from the
Mixer to regulator.
After venting, no pressure should build up on the Oxygen regulator gauge.
If
pressure does starts to build up on the Oxygen gauge the duck bill valve,
S3525,
in the Oxygen inlet is leaking and causing a back flow of air into the Oxygen
Part
No.
inlet. Clean or replace the duck bill valve as needed (see disassembly of gas inlet
in
valves
Routine Maintenance Section.
.
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
68
of
85
C.3.14
Open the
before
2.7
Oxygen pressure to 4 Bar (60 PSI), the alarm should stop sounding at or
Bar (40 PSI).
C.3.15
C.3.16
Tighten the jam nut over the Oxygen calibration adjuster
To calibrate the bypass alarm
replacing
located under the Oxygen inlet.
C.4.0
C.4.1
Tests for Mixer function
After
Module test procedure (see Test Procedure Section for Pressuie Balancing Module).
C.4.2 The
C.4.3
To reassemble to the
Section.
to secure the calibration.
air
calibration adjuster, complete steps 3.5 through
air
for Oxygen in the instructions, remembering that the
all
calibration procedures are completed, perform the Pressure Balancing
air
Air/Oxygen Mixer is now calibrated and ready for use.
Want Flown enclosure see the Disassembly and Re-assemble
3.7,
adjuster is
~
DISASSEMBLY
-
General procedures
Before servicing, be sure all exterior connections such as the electrical
power cord, gas lines etc. are disconnected.
D.
D.
1 .O
1.1
Removal of the AirIOxygen Mixer from the Infant FlowTM enclosure.
Remove the four
the Infant
Flowm driver and the four
M3
x
6mrn raised countersunk screws that secure the top cover of
rear cover plate.
D.
1.2
Using 3/16" Allen wrench remove the two screws,
Rail
mount/gas inlet plate on the back of the mixer and slide the plate back and off of
the O-rings.
D.
1.4
Using a 3/16" or 118" Allen key remove the pole mount bracket fi-om the side of the
Infant
lower
Flown driver. The mixer/flowmeter assembly can now be removed from the
housing.
AND
RE-ASSEMBLY
M3 x 8mrn pan head screws that secure the
Part
No. S3630, which hold the
L
-
Document
No.
M672SM,
--
.
.
.
,.
'
Version
-
1.10,
Issued 8th
. . .
.
November
-~
1994
Page
69
of
..
..
85
~. D.2.0
,
.
,
.
D.2.1
Removal
Using a
of
the Flowmeter block from the
9/64"
Allen wrench, remove the two screws,
miser.
Part
No. S3579, from the side
of the flowmeter block. Pull the flowmeter block away fiom the Mixer.
.
.
D.2.2
Save the
O-ring,
Part No. S3578, located between flowmeter block and Mixer for
re-assemble.
,
.
D.3.0
D.3.1
Disassembly into 3 major modules: Proportioning Module, Pressure Balancing
Module
To remove the
the two
and
fixing
Alarm
Alarm
screws,
Module
Module,
Part
Part
No. S3604, use a 7/64" Allen wrench to remove
No. S3624, underneath the module (see figure 13).
Figure
D.3.2
D.3.3
Slide the
lift
the assembly
Remove the overlay fiom the faceplate
Alarm
fiom the faceplate.
L,
Document No.
M672SM.
13.
The Alarm Module being taken
off
Mixer
Module straight back to clear the bypass nipple, Part No.
off
of
the Mixer.
and
remove the two screws,
This
enables the removal of the faceplate from the mixer.
Version
1.10.
Issued
8th
November
1994
Part
Page
70
3547,
No.
of
and
S3559,
85
D.3.4
Figure
Using a
9/64"
Allen wrench, remove the four screws,
Proportioning Module,
fiom the Pressure
figure
20).
Balancing
14.
Proportioning Module removal
Part
No. S3502, and separate the Proportioning Module
Module, making sure not to displace the
Part
No. S3550 from the
"0"
rings (see
4
L
Proportioning Module
D.4.0
D.4.1
D.4.2
D.4.3
D.4.4
D.4.5
Disassembly.
Using either a
S3538,
by
removing the set screw(s), Part No.
Insert special tool
112"
open end wrench to turn
With the fiont seat removed the double tapered needle, Part
Turn the module over to the rear seat, Part No.
Insert special tool
314"
open end wrench.
(see figures
1/16"
or
AT2
into the front seat, Part No.
AT3
into rear seat locking nut,
8)
5/64"
AT2
Allen wrench, release the control knob,
S223,
then pull off the knob.
S3532,
locating holes. Use an
and remove the fiont seat.
No.
S3541,
will fall out.
S3542.
Part
No.
S3543,
and loosen using a
Part
No.
9
Document
No.
M672SM.
Version
1.10.
Issued
8th
November
.
1994
....
Page
7
1
of
85
D.4.6
D.4.7
With the locking nut loosened, insert special tool AT2 into the rear seat unscrew and
remove the rear seat.
The
fkont seat, rear seat and proportioning block can now be serviced.
D5.0
D. 5.1
-
-
D.5.2
D.5.3
D.5.4
NOTE:
Re-assembly
Before reassembling the Proportioning Module inspect
ring
that is cut, flat or worn and apply a light coating of Krytox to the f?ont and rear
of
Proportioning
Module
all
O-rings and replace any
0-
seat O-rings.
-
-
Using special tool AT2,
install
fiont of the proportioning block is identified
making sure not to tear the
O-ring.
Turn the adjustment shaft, Part No.
._
the front seat,
Do not
__
-
Part
install
-
No.
S3532,
by
the presence of two stop pins),
the
knob
into front seat port (the
at this time.
S3533, counter clockwise until resistance is felt.
Place the Proportioning Module front seat down.
The module must be level, which may be accomplished by either placing the module
into a vice or positioning it on two level blocks.
D.5.5
D.5.6
D.5.7
Part
Drop the double tapered needle,
No. S3541, into the rear seat part and make
sure that the needle is standing up straight in the centre of the valve bore.
Part
Install the rear seat,
that the needle stays centred. Using special tool
rear seat down (about
needle. In this position, back
No. S3542, into the rear seat port, working it carehlly so
AT2
(hand tighten only), screw the
6
turns) past the first resistance until contact is made with the
off
1/2
turn.
Calibrate the Proportioning Module (see Calibration Section for Proportioning
Module).
'.
'
Document No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
72
of
85
Pressure
Balancing
Module
(see figure 3)
---
D.6.0
D.6.1
Disassembly of Pressure Balancing Module
For disassembly of the Pressure Balancing Module the Proportioning Module,
Alarm
Module and faceplate must be removed.
D.6.2
Usiig a 3/16" Allen wrench, remove the 4 screws,
Part
No. S3507, from the
air
block, Part No. S3505.
D,6,3--~einedule-cornesapaFt-int03-s~
assembly.
NOTE: Disassembly, re-assembly and calibration of the
air
block and oxygen block are
identical.
D.6.4 Using
a
pair
of tru-arc pliers, remove the
tru-arc
ring
Part
No. S3565.
--
q
--
D.6.5
D.6.6
NOTE:
D.6.7
D.6.8
D.6.9
The cover disc, Part No.
S3564
will
pop up with the spring, Part No. S3515, and the
regulator needle, Part No. S35 14 can be removed.
Using
5/64"
Allen wrench, loosen set screw Part No. S35
18
from side of block.
It is not necessary to completely remove the screw fiom the block.
Using special tool
The
regulator seat,
AT1
remove the eccentric adjuster Part No. S35
Part
No. S3512, can now be removed from either end.
The seat and seat bore can now be serviced.
16.
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
73
of
85
Section
12
~.
.
-
.
.,
.
-
.
-
,
-
,
.
<,
Parts
This is a complete list of all components
Driver. It is intended to enable qualified engineers and technicians to purchase
carry
required to
..
+-parts-list
out service tasks as well as the routine maintenance procedures.
Air DISS Fitting,
Proportioning Valve Block Only
Oxygen Seat
&
Spring)
Document No.
M672SM,
Version 1.10,
Issued
8th November
1994
Page 80 of 85
Part
Number Description
Adjuster
Shaft
Nitrile 0-Ring, BS 008
Packing Washer, Nylon
Truarc Ring
Stop Pin, 1/16"
x
114"
Mixer Control Knob with Stop and Screw
Double Taper Needle
Air
Seat, 0.125
Jam
Nut, Proportioning Valve
Spring Thrust Adaptor
Spring, Proportioning
L-eefPlugmWq
Valve
G.=iat~e:tm
Nipple, 1 0-32
Nitrile 0-Ring, BS 006
118"
Plug,
NPT
Screw, 8-32 x 1" Socket Cap
Screw, 6-32
x
114" Pan Head
Cover Disc
Truarc Ring, 5000-87
Nitrile 0-Ring,
BS
01 8
Lee Plug and Pin, 0.156" Diameter
Nitrile 0-Ring, BS 025
Truarc
Retainer, 118"
Circlip Ring, 5008-1 3
NPT
1
Adaptor, Flowmeter Inlet
Nitrile 0-Ring B S 0 13
Orifice, 0.01
1"
x
0.156 Diameter
BypassIAlarm Sub-Assembly
Pole Mount Clamp
Pole Mount Clamp Knob
AlarmlBypass Block Only
Poppet,
Silicone 0-Ring, BS 010, 50
Spring,
Adjustment Cover Cap,
BypassIAlarm
302
Stainless Steel
DUR
BypasdAlarm
Calibration Adjuster, Bypass/Alarm
Jam
Nut 511 6" x 20, BypassIAlarm
Screw, 6-32 x 1 114" Socket Cap
Bulkhead Fitting, Gas Met
Nittile 0-Ring for S3625, BS 112
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
8
1
of
85
Part
Number Description
Screw, 114 "-20 x 314" Socket Cap
Plug, 10-32
Ball,
Spring,
Check Valve Retainer
Silicone 0-Ring,
Muffler Felt
Mixer Tool Kit
AT3, 518" Spanner Wrench
318" Spanner Wrench
78"
Bypass Plate
Mixer Overhaul Kit
7/32" Diameter,
custom for
Bypass
BypassJAlarm
BS
008, 70
Spanner W~nch-
/Alarm
DUR
-
-
-
-
-
-
Audible
Audible
Warning
Warning
Device Housing
Device Assembly
ST650008 Luer Connector, Plated
Document No.
M672SM,
. .
,.
'
Version
1.10,
Issued
8th
November
1994
Page
82
of
85
Section
13
Summary
The following international standard symbols are used on the EME Infant Floww Driver and
all
in this manual. It is essential that
symbols.
Symbol
Explanation
Class
1,
users of the equipment have a
type
B
Equipment
of
Symbols
fhn
understanding of the
ir
W
Alternating Current
@
a
m
0
Earth
(Ground)
Alarm
Alarm
OK
On, Power connection to mains
cancel
Power disconnection from mains
Document
No.
M672SM.
..
'
Version
1.10.
Issued
8th
November
1994
Page
83
of
85
Section
14
All
changes are logged
all
otherwise indicated
version
may
be fitted to any M672 MkII Infant FlowTM Driver. We recommend that the latest
software changes are compatible with
version available be fitted at
--
I
Serial
No
I
Range
0100
to
01 09
0109
to
0149
Change No.
Original version with level
Effective from 25th August
1
All IC's fitted directly to PCB instead of sockets except for
2
Filters fitted on Oxygen Analyser and Vent to Ambient ports.
Label added to side for Oxygen Analyser calibration.
3
Label added to mixer to indicate gas inlets.
4
5
Service manual updated to include electronic over pressure set up. (Page
6
Service manual updated with additional information on Oxygen Fuel Cells.
(Pages
Product
in
serial number sequence as indicated in the table below. Unless
aU
times.
Change
History
all
hardware and any software
Change
1 .OO
software introduced July
1994
1994
CPU.
12, 13 & 14)
41)
-
-
.-
0150 and up
Change No.
Effective from 8th November
7
Version 1.10 software introduced. To be issued for all M672's
8
New tracking
8
High
pressure Vent to ambient alarm and valve operation changed fiom 15
10
Cms H20 to
100%
11
12
New method of calibration for the Oxygen setting monitor board.
Calibration mode simplified and extended
13
LED
14
IS
Operation & Routine Maintenance Manual updated to Version
16
Service Manual updated to Version
Oxygen for 1 5 minutes
colour in the 7 to
*.
'
High
pressure
11
Cms H20
12
1994
alarm
alarm
Cms
feature
feature removed.
Hz0
range changed fiom green to yellow
1.10
1.10
Document
No.
M672SM,
Version
1.10,
Issued
8th
November
1994
Page
84
of
85
Section
15
WARRANTY
This is the standard warranty for all products manufactured or supplied by
Medical Equipment)
buyer purchasing the said product directly from the company or fiom
distributor or agent as new merchandise.
AU
products supplied by EME are warranted for a period of one year from the date of
installation or eighteen months fiom the date of delivery (whichever comes sooner) to be
from manufacturing defects and to conform to the description thereof contained
Operation and Routine Maintenance Manual, except that such warranty is
days with respect to rubber goods.
EME's sole obligation under this warranty is limited to the replacement or repair of the product
or parts
conform to the description thereof contained in the relevant manual.
consequential damages.
The foregoing warranty shall not apply
or altered by anyone other than an authorised representative of EME without written consent
(ii) subjected to abuse, misuse, negligence or accident
than normal use (iv) the prescribed periodic maintenance and/or services have not been
performed as specified in the relevant manual.
--
theieof which upon examination are found to contain manufacturing defects or not to
Limiied (hereinafter referred to
if
the product or any part thereof has
as
EME) andjsJxtendehonLyde-
EME
(ii)
operated under conditions other
E.M.E.
an
authorised dealer,
limited to thirty
will not be liable for
(i)
(Electro
free
in
the relevant
(30)
been repaired
3
r
'I
There are no warranties which extend beyond this warranty and the description of the products
contained in the relevant Operation and Routine Maintenance Manuals.
warranty
to statutory wwranty and in no way affects the purchaser's statutory rights.
Document No.
as
to merchantability with respect to the products. This warranty is given in addition
M672SM,
Version
1.10,
Issued
8th
November
1994
EME makes no
Page
85
of
85
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