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SI No: N/A, Issue 2, 26 Jun 2017 

1

 

Purpose 

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. 

2

 

Training Requirements 

All personnel involved with assembling and/or testing this device must be trained against the latest version of 
this Assembly Procedure. 

3

 

Materials 

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) 

4

 

Procedure 

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 

Summary of Contents for AP 3607157

Page 1: ...uments 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 4 Procedure 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 ...

Page 2: ...f 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 ...

Page 3: ... 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 ...

Page 4: ...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 ...

Page 5: ...ap 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...

Page 6: ...urrent 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 o...

Page 7: ...monary 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...

Page 8: ...awing 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 ...

Page 9: ...orks 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 ...

Page 10: ...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 ...

Page 11: ...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 ...

Page 12: ...ly 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 ...

Page 13: ... 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 ...

Page 14: ...te 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 ...

Page 15: ...607157 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 ...

Page 16: ... 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 ...

Page 17: ...ue 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 ...

Page 18: ... 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 ...

Page 19: ...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 ...

Page 20: ... 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 ...

Page 21: ...19 December 2019 Page 21 of 21 Drawing Shown on Works Order Description A2A SPACER AUSTRALIA SI No N A Issue 2 26 Jun 2017 5 Revision History Part of Template Prepared by Approved by Date Issue No Reason for change O Edoo A Ostacchini 19 Dec 19 01 Initial creation ...

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