HS AP 3607157 Manual

SI No: N/A, Issue 2, 26 Jun 2017
1Purpose
The purpose of the Assembly Procedure is to define a standard method for assembling and testing all A2A SPACERS.
This will ensure that each device is built in accordance with best practises and easily achieve the minimum
standards required for regulatory compliance.
2Training Requirements
All personnel involved with assembling and/or testing this device must be trained against the latest version of
this Assembly Procedure.
3Materials
As listed in drawing
Required documents
Works Order Route Card Containing Inspection History Card
Kitting list
Inspection and Release Procedure - P3060
Production Line Clearance - P3061
Clear Down Declaration Form - P3061(F)
4Procedure
OP
DEPT
OPERATION
10
10
ASSY
ASSY
Take a diaphragm (36071622) and pull 2 of the ends apart until the cut section fully opens.
Take clamp fingers moulding (36071612)
Assembly Procedure
Document Ref:
AP 3607157
Issue:
01
Issue Date:
19 December 2019
Page 1 of 21
Drawing:
Shown on works order
Description:
A2A SPACER AUSTRALIA
Issued by:
(Production Engineer)
O.Edoo
Signature:
Can be found on signed hard copy
Date
19/Dec/2019
Approved by:
(Production Manager)
A. Ostacchini
Signature:
Can be found on signed hard copy
Date
19/Dec/2019

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 2 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
10
ASSY
Take a diaphragm (36071622) and place it onto this. Make sure the cut-outs line up with the lugs.
Place this pair into press jig 35-2050
Take a valve body and place it on top of this pair

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 3 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Pull the handle fully down to press these parts together.
Take a mouthpiece (36091172) and place the mouthpiece end on the table. Place the valve into it with the angled
edges facing the gaps in the neck.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 4 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Press on this gently with your thumbs. You may hear a click as it falls into place.
20
ASSY
MIDDLE AND BOTTOM ASSEMBLY
Fit together a 3607154 Universal Adaptor to a 3607123P Bottom Section.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 5 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
20
ASSY
Next snap together a 3607111P Middle Section with a Bottom Section. This is done by hand, but it is advisable
to wear gloves to do this.
30
ASSY
FINAL ASSEMBLY
Before assembling the component parts check that there are no dust particles or marks inside the mouldings.
Finally, snap together the Mouthpiece Cap sub assembly with the Middle/Bottom Section sub assembly. Ensure
outside surface is clean.
Examples only

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 6 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
40
ASSY
Pack and label as per assembly drawing 3607216
Pack with a mask if needed. Refer to drawing for current packing and labelling details
50
ASSY
Force Gauge Test
Periodically the whole assembly should be checked for fit i.e. Mouthpiece Cap.
Push on a fully assembled Unit onto the Fixture. Bring the head down to just above the Unit and
clamp. Set the Head so that the probe comes down approximately 3mm from the Mouthpiece
edge.
Bring down the probe ensuring the setting is at zero and the Auto Peak is on.
Take a reading, this must be between 20-70Nm. Again reject any that fail to meet the spec.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 7 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
50
ASSY
Valve tests
Use Piston Pulmonary Waveform Generator.
Insert mouthpiece assembly with two way valve in to pulmonary waveform generator as shown below
Set the operating program as shown below:
F-T 26 waveform
Waveform number 11
Inverse-continue flow type
When you click the fire piston button, this window will appear on the screen.
Set the number of cycles to 2
While the waveform generator is firing, look at the valve to ensure it is opening, as below.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 8 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Once it has finished firing, make sure it returns to a resting state, as below. Also, make sure the valve is flat,
and has not developed any creases or waves. This would show the valve has slipped in its housing.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 9 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
QUALITY AND VISUAL CHECKS
Op 10
Ensure (36071622) valve diaphragm does not pass the cross on the valve body.
It is OK for the diaphragm to be lifted, so long as it is in the direction of the finger section, towards the
mouthpiece if assembled.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 10 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Production Quality and visual checks
Assembly Production Manager, will ensure all quality checks are carried out
during production
Production Operatives will, 100% check each components visually for defects
prior to assembly and packing
Op10
Note: Be aware of stringing around the rim of the mouthpiece cap this must be removed before assembly.
Stringing
Mouthpiece visuals

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 11 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Colour
No (example only images) Yes (example only images)
Parts must be free of blemishes and specks.
Inspection should be carried out with the part at arm’s length.
Single speck only, less than 1mm diameter
(Example
Short shot

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 12 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Water mark
Air bubbles
Damage

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 13 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Op 20
Ensure the colour of components are good and clear to look at and are clear of flow line
No Yes
.
Check adaptor (3607154) has been correctly orientated to locate in bottom section (3607123P)
keyway and adaptor undercut is positioned either side of bottom section aperture.
Check Flex valve diaphragm is being correctly positioned to Valve body prior to assembly

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 14 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Bottoms beware of flow lines, poor mixing and marks. Inspection should be carried out with the part at arm’s
length.
Examples
Black specs

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 15 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Severe Scratches
Op 30
Check Middle and Bottom section artwork against current drawing.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 16 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Op40
Check Assembled A2A spacers have been placed inside an antistatic plastic bag and the open end
has been twisted and push through adaptor opening until flush with base.
Check carton artwork is correct against current drawing.
Check information leaflet (1902956) is present and at current issue level
(See Works Order).
Check carton is labelled correctly (See Works Order/Drawing)

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 17 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Mask faults and defects
Inspection should be carried out with the part at arm’s length.
Air bubbles
Flow lines and water marks

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 18 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Short shot
Sprue
Carton faults and defects
Unglued seam Missing or faint print

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 19 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Torn
Marked or stained
Ensure cartons are correctly Orientated in shipper, and that they and the shipper are correctly
labelled. Details for both can be found on the drawing for each item.

Assembly Procedure
Document Ref:
AP3607157
Issue:
01
Issue Date:
19 December 2019
Page 20 of 21
Drawing:
Shown on Works Order
Description:
A2A SPACER AUSTRALIA
SI No: N/A, Issue 2, 26 Jun 2017
Op50
Before carrying out the bottom and middle component test, you need to pull and push the
assembly in and out 5 times.
Before carrying out the test, you need to fit and remove the cap 5 times.
All units/batches that fail force gauge tests are to be segregated, identified and rejected on
completion of order.