C-PAP Flow Generator

Build Standard Operating Procedure

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Sub - Assemblies & Full Assembly Information
Sub assembly and full assembly information ................................................................................................................... 3
GIN7056_01 – HYPODERMIC BUNG ASSY: .................................................................................................................... 3
GIN7057_01B – ON-OFF VALVE ASSY ........................................................................................................................... 3
GIN7058_01B – FLOW ADJUSTMENT VALVE ASSY ....................................................................................................... 4
GIN7059_01B – OXYGEN ADJUSTMENT ASSY ............................................................................................................... 4
GIN7055_02A – C-PAP FULL ASSEMBLY ........................................................................................................................ 5
Tooling Required: .............................................................................................................................................................. 6
Cleaning:............................................................................................................................................................................ 8
Assembly lubricant & PPE ................................................................................................................................................. 8
Stage 1 - Inlet, Outlet & Bung assembly ........................................................................................................................... 9
Oxygen Inlet – GIN1756_04 .......................................................................................................................................... 9
Patient Outlet – GIN1741 ............................................................................................................................................ 10
Bung – GIN1758_02 .................................................................................................................................................... 11
Stage 2 Hypodermic tube swaging.................................................................................................................................. 12
Hypodermic Bung assembly – GIN7056_01 ................................................................................................................ 12
Stage 2A Hypodermic tube swaging – Reworking undersize tubes ................................................................................ 16
Stage 3 Hypodermic tube fitting into bung & O ring fit .................................................................................................. 17
Stage 4 ON/Off Valve assembly ...................................................................................................................................... 18
On/Off Valve – GIN7057_01B ..................................................................................................................................... 18
Stage 5 - Flow Adjustment Valve – GIN7058_01B .......................................................................................................... 23
Stage 6 - Oxygen Enrichment Valve – ............................................................................................................................. 28
Stage 7 Valve checking procedure – Manual Method .................................................................................................... 33
Stage 7A Valve checking procedure – Automated method HPP specific........................................................................ 34
Stage 8 Final Assembly Build Procedure ......................................................................................................................... 36
Build notes: ................................................................................................................................................................. 36
Main Body assembly ................................................................................................................................................... 36
Installation of Hypodermic bung Assembly ................................................................................................................ 37
Installing Cross Drilling bung ....................................................................................................................................... 38
Install Flow adjustment valve Assembly ..................................................................................................................... 39
Install Oxygen adjustment valve Assembly ................................................................................................................. 40
Installation of ON-OFF valve Assembly ....................................................................................................................... 41
Oxygen Inlet Assembly ................................................................................................................................................ 42
Patient outlet flow insert ............................................................................................................................................ 43
Fit cap .......................................................................................................................................................................... 43
Final Clean ....................................................................................................................................................................... 44
Packaging ........................................................................................................................................................................ 44

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Sub assembly and full assembly information
Pictures below are for reference only. Ensure you always check the relevant drawings for current part numbers

GIN7056_01 – HYPODERMIC BUNG ASSY:

GIN7057_01B – ON-OFF VALVE ASSY

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GIN7058_01B – FLOW ADJUSTMENT VALVE ASSY

GIN7059_01B – OXYGEN ADJUSTMENT ASSY

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GIN7055_02A – C-PAP FULL ASSEMBLY

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Tooling Required:

Assembly No. Part No. Description Qty

BIF3431_01 1.5mm A/F Allen Key Bit 1
BIF3432_01 Snap-on 1/4" to 1/4" hex magnetic 1
GIB2152_01 O Ring Seating Tool 1
GIB2168_01 Bullet 1
GIB2211_01A C-PAP Actuation Handle 1
GIB7325_01 Circlip Fitting Taper Tooling 1
GIB2150_01 Circlip Taper Sleeve 1
GIB2151_01 Circlip Push Tool 1
GIB7326_01 Valve Support Plate 1
FXB1389_01 Cleco Ground Dowel Using BIP2470 2
GIB2158_01 Support Block 1
GIK8783_01 Flow Adjustment Valve Tool Kit
GIN7058_01 Flow Adjustment Valve
Tool List
Assembly No. Part No. Description Qty
BIF3431_01 1.5mm A/F Allen Key Bit 1
BIF3432_01 Snap-on 1/4" to 1/4" hex magnetic 1
GIB2152_01 O Ring Seating Tool 1
GIB2168_01 Bullet 1
GIB2211_01A C-PAP Actuation Handle 1
GIB7325_01 Circlip Fitting Taper Tooling 1
GIB2150_01 Circlip Taper Sleeve 1
GIB2151_01 Circlip Push Tool 1
GIB7326_01 Valve Support Plate 1
FXB1389_01 Cleco Ground Dowel Using BIP2470 2
GIB2158_01 Support Block 1

GIK8784_01 On/Off Valve Tool Kit

GIN7057_01 On/Off Valve
Assembly No. Tool List
Part No. Description Qty
BIF3431_01 1.5mm A/F Allen Key Bit 1
BIF3432_01 Snap-on 1/4" to 1/4" hex magnetic 1
GIB2160_01 O Ring Bullet 1
GIB2167_01 Injector Bullet 1
GIB2189_01 E Clip Fit Tooling 1
GIB2212_01 GIN1736 Socket 1
GIB7324_02 Dowel Fitting Punch Assembly 1
GIB2153_01 1.5MM Dowel Fitting Base 1
GIB2170_01 Pin Fitting Tooling 1
GIK8785_01 Hypodermic Bung Tool Kit
GIN7056_01 Hypodermic Bung Assembly
Tool List
Assembly No. Part No. Description Qty
GIB2162_01 Bullet 1

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 Assembly No. Part No. Description Qty
GIB2206_01 GIN1759 O RING FITTING TOOL 1
GIL1879_01 GIB7334 Needle Assembly Tooling 1
BIF3438_01 Press 1
GIB7334_02 Flared Needle Assembly Tooling 1
GIB2180_02 GIB7334 Push Tool Support 1
GIB2184_01 GIB7334 Push Tool 1
GIB7338_01 Swaging Assembly 1
BIH1953_01 SCREW SCH M6 X 30 6
BIH4664_01 DOWEL DIA.6 X 12 EXTRACTABLE 6
GIB2190_01 GIB7338 DROP HAMMER 1
GIB2191_01 GIB7338 DROP HAMMER GUIDE 1
GIB2192_01 GIB7338 DROP HAMMER WEIGHT 1
GIB2193_01 GIB7338 SWAGING TOOL 1
GIB2194_01 GIB7338 BASE PLATE 1
GIB2195_01 GIB7338 SIDE SUPPORT 1
GIB2198_01 GIB7338 SLIDE HAMMER SUPPORT LOWER 1
GIB2199_01 GIB7338 SLIDE HAMMER SUPPORT UPPER 1
GIB2200_01 GIB7338 DROP HAMMER RAISED LOCK 1
GIB7337_01 Pin Flaring Support 1
GIB2196_01 GIB7337 Pin Support 1
GIB2197_01 GIB7337 Base Plate 1
BIH0202_01 M3x6 SCH 1

GIK8786_01 Full Assembly Tool Kit

GIL1878_02 C-PAP Full Assembly
Tool List
Assembly No. Part No. Description Qty
BIF3433_01 23mm Crows foot 1
GIB2155_01 5/16" Whit crows foot 1
GIB2162_01 Bullet 1
GIB2163_01 O Ring Bullet 1
GIB2173_01 O Ring Bullet 1
GIB7323_01 GIN7043 Support Tool 1
FXB1389_01 Cleco Dowels 2
GIB2164_01 Support Block 1
GIB7329_01 Hypodermic Fitting Tool - Short 1
BIP0241_01 Dowels 2
GIB2169_01 Bung Fitting Tool Short 1
GIB7332_01 Hypodermic Bung Fitting Tool 1
BIP0241_01 Dowels 2
GIB2177_01 Hypodermic bung socket 1
GIB7333_02 GIN1730 Alignment Block 1
BIF0252_03 Dowel 3.0 Dia x 10 1
GIB2179_02 GIN1730 Positioning Tool 1

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Cleaning:

1. All parts should be free of swarf and machine cutting fluid.

2. All parts to be cleaned through an ultrasonic wash line process

Mercedes – Benz HPP Method is outlined below for reference

Equipment: Elma ultrasonic wash line

Stage 1 – Pre-Clean
Duration: 120 seconds
Chemical: Mykal ultrasonic cleaner Aqua 20
Temperature: 53 – 58 Degrees
Ultrasonic Frequency: 45 KHz

Stage 2 – Final Clean

Duration: 120 seconds
Chemical: Mykal ultrasonic cleaner Aqua 20
Temperature: 53 – 58 Degrees
Ultrasonic Frequency: 45 KHz

Stage 3 – Rinse
Duration: 90 seconds
Deionised water
Temperature: 40 – 45 Degrees
Ultrasonic Frequency: 45 Hz

Stage 5
Vacuum dryer process

HPP Specific:

- Elma line program: Program 4

- Dry in Vacuum dryer

Assembly lubricant & PPE

Grease specification
PerFluroLube OT20

Supplier Information

Performance Fluids Ltd

Suite 101, Lomesshaye Business Village
Turner Rd
Nelson
Lancashire
BB9 7DR

Safety Gloves:

Disposable Nitrile Gloves

Safety Glasses

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Stage 1 - Inlet, Outlet & Bung assembly

Oxygen Inlet – GIN1756_04

1. Apply grease to O-ring (BIC0068_01)

2. Using bullet (GIB2173_02) fit O-ring over the threads.

3. Apply a small amount of grease to O-rings and thread

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Patient Outlet – GIN1741

4. Apply grease to O-ring (BIC0064_01)

5. Using bullet (GIB2163_01) fit O-ring

6. Fit silencer (GIN1790_01) over end of outlet

7. Apply a small amount of grease to O-rings and thread as shown below

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Bung – GIN1758_02

8. Apply grease to O-ring (BIC0067_01)

9. Using bullet (GIB2162_01) fit O-ring

10. Finally apply a small amount of grease to O-rings and thread as shown below

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Stage 2 Hypodermic tube swaging

Hypodermic Bung assembly – GIN7056_01

Swaging hypodermic tube (GIN1760_02):

1. GIB7338 is the tooling assembly required for this procedure

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 2. Lift the drop hammer to its highest position. Fit GIB2200 to support the drop hammer.

3. Locate hypodermic tube into swage tooling as shown below:

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 4. Remove GIB2200 and lower drop hammer into the hypodermic tube. Check the alignment of the swaging
tool and the tube on the camera. Check the drop hammer spins in the tube
5. Place the GIN1760_02 into the swaging assembly GIB7338_01 and rest the swaging needle on the installed
hypodermic tube. Do not allow the drop hammer to drop into the tube otherwise the tube will be over
swaged

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 6. Raise the drop weight to the end stop and release, this should result is the end of the tube being swaged as
depicted in the right hand image below. The weight must be dropped from a height of 40mm to ensure the
appropriate swaging. This is currently calibrated on the tooling

7. To remove the tube lift the drop hammer and refit the locking spacer (GIB2200), Remove the tube and the
swaging tool from the location plate and the drop hammer and measure the flange with a micrometre.

The diameter of the swaged tube should now be 1.35mm – 1.25mm.

- If in tolerance please place in the pass box.

- If undersize please put into second drop required box.
- If oversize put in the scrap box.

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Stage 2A Hypodermic tube swaging – Reworking undersize tubes

Note: Undersize components are required to be swaged again using the following process.

Re-fit as per steps 1 – 7.

The weight is now required to be dropped from a height of 20mm

Remove the tube and the swaging tool from the location plate and the drop hammer and re-measure with a
micrometre.

The diameter of the swaged tube should now be 1.35mm – 1.25mm.

- If in tolerance please place in the pass box.

- If out of tolerance after second drop place in scrap box

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Stage 3 Hypodermic tube fitting into bung & O ring fit

1. Using tooling (GIB7334_02) and small hand press carefully fit the hypodermic tube (GIN1760_02) into the
hypodermic bung (GIN1759_03)

2. Apply grease to O-ring (BIC0067_01)

Using bullet (GIB2162_01) fit O-ring

3. Finally Apply a small amount grease to O-ring & Thread as shown below

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Stage 4 ON/Off Valve assembly

On/Off Valve – GIN7057_01B

2. Fit dowel into pin tooling (GIB7324_02) with the dowel chamfer facing up/away from the tooling.

4. Apply a small amount of 648 Loctite to the pin & Insert pin tool with dowel through the large hole aligning
the dowel with hole. Push into position by hand and remove the tooling

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 5. Check the pin is fully in the hole by using the tool to push against the dowel as shown – then allow Loctite to
cure

Caution
Please ensure that any excess Loctite is cleaned off after fitting the dowel
We recommend you use a cotton bud to perform this task

6. Apply grease to O-ring (BIC0071)

7. Using O-ring bullet (GIB2167_01) fit O-ring to the top groove on the valve.

8. Apply grease to the scroll as shown below

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 9. Fit the valve helix into the valve body O-ring end first. The helix will locate onto the dowel and wind through
into the body.

10. Fit E-Clip (BIC0054_01) to shaft using (GIB2189_01) BIC0054 E Clip Fitting Tool

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 11. Apply grease to O-ring (BIC0071_01)
12. Fit O-ring (BIC0071_01) to the bottom groove on the valve.

13. Apply grease to O-ring (BIC0068)

14. Using O-ring bullet (GIB2160_01) fit O-ring to the valve body

15. Apply grease to O-ring and thread as shown

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16. Fit the adjustment knobs as shown below - Caution ensure knob is fully down before fitting grub screw
17. Apply a small amount of 272 Loctite to grub screw.
18. Ensure that grub screw (BIC0059_01) is located onto the flat of the valve.
19. Torque knob (GIN1761_02) onto valve, Torque: 1.0Nm – Required Allen key size 1.5mm
20. Ensure that valve operates smoothly

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Stage 5 - Flow Adjustment Valve – GIN7058_01B

Prepare needle valve by applying the grease as shown below:

1. Apply amount shown:

2. Distribute grease evenly as shown

3. Apply grease to O-ring (BIC0066_01)

Ensuring order and position is correct, fit small washer (GIN1756_01), O-ring (BIC0066_01) then large washer
(GIN1766_01) to needle valve.

*NOTE* Order of fitment MUST be Small washer, then O-ring then large washer to ensure correct function.

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 4. Fit needle valve to Valve Body ensuring that Washers and O-rings are correctly seated using tooling
(GIB2152_01)

*NOTE* When working with snap ring ensure you wear safety glasses.

5. Fit Snap ring into compression/guide tooling (GIB7325_01)

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 6. Fit the partially assembled flow control valve to the valve support plate (GIB7326_01). Place the Taper block
with snap ring fitted and then using the push tool drive the snap ring into the valve body.
** Please note: Once the snap ring is fitted, the valve assembly can no longer be taken apart. It is
recommended that all assembly checks are done prior to fitting the snap ring **

7. Ensure that valve operates correctly and that the needle is able to achieve full travel

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 8. Apply grease to O-ring (BIC0065_01)
9. Using O-ring bullet (GIB2168_01) fit O-ring to the valve body

10. Apply grease to O-ring (BIC0063_01)

11. Finally apply the grease to O-rings and thread as shown

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12. Fit the adjustment knob as shown below - Caution ensure knob is fully down before fitting grub screw
13. Apply a small amount of 272 Loctite to grub screw.
14. Ensure that grub screw (BIC0059_01) is located onto the flat of the valve
15. Torque knob (GIN1761_02) onto valve, Torque: 1.0Nm – Required Allen key size 1.5mm
16. Ensure that valve operates smoothly

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Stage 6 - Oxygen Enrichment Valve –

Ensure part is clean, dry and suitable to use (free from burrs, manufacturing or material defects etc.

Prepare needle valve by applying the grease as shown below:

1. Apply amount shown:

2. Distribute grease evenly as shown

3. Apply grease to O-ring (BIC0066_01)

4. Ensuring order and position is correct, fit small washer (GIN1756_01), O-ring (BIC0066_01) then large washer
(GIN1766_01) to needle valve.

*NOTE* Order of fitment MUST be Small washer, then O-ring then large washer to ensure correct function.

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 5. Fit needle valve to Valve Body ensuring that Washers and O-rings are correctly seated using tooling
[GIB2152_01]

*NOTE* When working with snap ring ensure correct PPE is used.

Fit Snap ring into compression/guide tooling (GIB7325_01)

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 6. Fit the partially assembled flow control valve to the valve support plate (GIB7326_01). Place the Taper block
with the snap ring fitted and then using the push tool drive the snap ring into the valve body.
** Please note: Once the snap ring is fitted, the valve assembly can no longer be taken apart. It is
recommended that all assembly checks are done prior to fitting the snap ring **

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 7. Ensure that valve operates correctly and that the needle is able to achieve full travel

8. Apply grease to O-ring (BIC0065_01)

9. Using O-ring bullet [GIB2168_01] fit O-ring BIP3767_01 to the valve body

10. Fit O-ring (BIP0063_01) to the end of the valve

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 11. Finally apply grease to O-rings and thread as shown

14. Fit the adjustment knobs as shown below - Caution ensure knob is fully down before fitting grub screw
15. Apply a small amount of 272 Loctite to grub screw.
16. Ensure that grub screw (BIC0059_01) is located onto the flat of the valve
17. Torque knob (GIN1761_02) onto valve, Torque: 1.0Nm – Required Allen key size 1.5mm
18. Ensure that valve operates smoothly

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Stage 7 Valve checking procedure – Manual Method

Manual method: Visually check as detailed below:

Oxygen Adjustment Valve Flow Adjustment Valve

GIN7059_01 is
identified by the
turned groove
GIN7058_01
on the collar of
has no
the valve body
groove
machined

A small needle should

The large needle should be visible through the
be visible through the round hole
round hole

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Stage 7A Valve checking procedure – Automated method HPP specific

1. Using visual checking machine check that the Flow and Enrichment valves have been assembled correctly.
2. Select the correct program for the valve you being checked.

3. Select correct program using rotary switch on front of the device.

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 4. Inserting the component into the machine on the right and ensuring that the component is correctly
oriented (flow hole up) the machine will check that the correct needle is in the correct valve.
5. If it is ok the screen will display “OK” and the green light will light up.

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Stage 8 Final Assembly Build Procedure

Build notes:
1. Ensure all valves operate smoothly
2. Visually check all O rings are fitted
3. Visually check grease has been applied to the threads and O rings of each assembly

Main Body assembly

1. Visually check part is clean and free from any damage
2. Fit stickers to the front and rear of the body

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Installation of Hypodermic bung Assembly

1. Check grease has been applied to the O-rings and thread,

2. Install Hypodermic bung assembly into the Main Housing into the port labelled “TO PATIENT”
3. Using (GIB2177_01) Hypodermic bung socket. Torque into position at 2.0Nm.

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Installing Cross Drilling bung

1. Check grease has been applied O-rings and thread,

2 Install Cross drilling bung into the Main Housing into the position as shown below
3 Using (GIB2169_01) Hypodermic bung socket. Torque to 2.0Nm.

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Install Flow adjustment valve Assembly

2. Check grease has been applied O-rings and thread,

3. Check you have the adjustment valve with the small hole as shown
4 Install the valve into the Main Housing into the position labelled “ Flow Adjustment”
5 Caution: Do not wind in using the control knob. Ensure you screw into position using the main body
6 Using a 15mm Crows foot socket torque the valve to 3Nm.

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Install Oxygen adjustment valve Assembly

1. Check Grease has been applied to O ring and thread

2. Check you have the adjustment valve with the large hole as shown
3. Install the valve into the Main Housing into the position labelled “ Oxygen Adjustment”
4. Caution: Do not wind in using the control knob. Ensure you screw into position using the main body
5. Using a 15mm Crows foot socket and torque the valve to 3Nm.

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Installation of ON-OFF valve Assembly

1. Check Grease has been applied to O ring and thread

2. Install the ON/OFF Valve into the Main Housing into the position labelled “ Flow ON/OFF”
3. Caution: Do not wind in using the control knob. Ensure you screw into position using the main body
4. Using socket GIB2212_01 torque the valve to 5.5Nm.

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Oxygen Inlet Assembly

1. Check Grease has been applied to O ring and thread

2. Install the Oxygen Inlet assembly into the Main Housing to the position labelled “ Oxygen Inlet”
3. Manually screw the inlet assembly into positon

4. Torque into positon using a manual torque wrench and 23mm crow’s foot socket
5. Important: Ensure the guide slot is in the vertical position.
6. Final torque must fall between a 4 – 8Nm range
7. This must be checked with (GIB7333_02) GIN1730 Alignment block (As shown below)

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Patient outlet flow insert

1. Check the grease has been applied to O ring and thread

2. Check silencer is free from grease or debris
3. Manually screw the Patient outlet flow insert into positon
4. Install the Patient outlet Flow Insert into the Main Housing into the position labelled “ TO PATIENT”
5. Using a 23mm Crows foot torque to 5.5 Nm.

Fit cap
1. Snap fit cap into the position as shown

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Final Clean
1. Post-test the whole assembly must be wiped down with isopropanol in order to prepare for packaging and
shipping
2. Place unit in plastic bag and seal

Packaging

1. Fit into cardboard box as shown

2. Fit protective card and certification into box

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 3. Fit label to outside of packaging as shown

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