ottobock 4R180 Harmony P4 Vacuum Pump Instruction Manual

Instructions for use 4R180 Harmony P4, 4R181 Harmony P4 HD

4R180 Harmony P4 Vacuum Pump

Product description

INFORMATION
Date of last update: 2022-04-01

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of prob­ lems.
•  Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
• Please keep this document for your records.

1.1 Construction and Function
The 4R180 Harmony P4 and 4R181 Harmony P4 HD mechanical vacuum pumps generate a vacu­ um in the prosthetic socket that improves the connection with the residual limb. The pump is assembled directly on the prosthetic socket.
While walking, the vacuum pump is alternately compressed and released again. This generates the vacuum and simultaneously dampens vertical impact loads. The design also permits slight tor­ sion of the prosthetic socket relative to the foot.
The Harmony system consists of a vacuum pump, a total surface weight-bearing socket, a poly­ urethane liner and a sealing sleeve.
1.2 Combination possibilities
This prosthetic component is compatible with Ottobock’s system of modular connectors. Func­ tionality with components of other manufacturers that have compatible modular connectors has not been tested.

Intended use

2.1 Indications for use
The product is intended exclusively for lower limb exoprosthetic fittings.
2.2 Area of application
Our components perform optimally when paired with appropriate components based upon weight and mobility grades identifiable by our MOBIS classification information and which have appro­ priate modular connectors.
The product is recommended for mobility grade 2 (restricted outdoor walker), mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walker with particularly high demands).

• The maximum approved body weight is specified in the technical data (see page 23).

The product must be used in TT prostheses only.
2.3 Environmental conditions

Storage and transport
Temperature range –20 °C to +60 °C (–4 °F to +140 °F), relative humidity 20 % to 90 %, no mechanical vibrations or impacts
Allowable environmental conditions
Temperature range: –10 °C to +45 °C (14 °F to 113 °F) Moisture: relative humidity: 20% to 90%, non-condensing Chemicals/liquids: fresh water as dripping water, occasional contact with salty air (e.g. near the ocean) Solids: dust
Prohibited environmental conditions
Chemicals/moisture: salt water, perspiration, urine, acids, soapsuds, chlorine water Solids: dust in high concentrations (e.g. construction site), sand, highly hygroscopic particles (e.g. talcum)
2.4 Lifetime
This product was tested by the manufacturer with 3 million load cycles. Depending on the user’s activity level, this corresponds to a maximum lifetime of 5 years.
2.5 Qualification
The product may only be integrated into the prosthesis by O&P professionals who have com­ pelted training as certified Harmony experts

• Fabricating the total surface weight-bearing socket: Fabricating a total surface weightbearing socket is required for the use of the product.

2.6 Absolute Contraindications

• Interim prosthesis
• Effectively non-weight-bearing residual limb end
• Neuromas in the area of the residual limb
• User limitations which prevent the safe use of the product

Safety

3.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICEW arning regarding possible technical damage.
CAUTION!

Risk of injury and risk of product damage

• Comply with the product’s field of application and do not expose it to excessive strain (see page 15).
• Note the combination possibilities/combination exclusions in the instructions for use of the products.
• Do not expose the product to prohibited environmental conditions.
• Check the product for damage if it has been exposed to prohibited environmental conditions.
• Do not use the product if it is damaged or in a questionable condition. Take suitable meas­ ures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist work­ shop).
•  To avoid the risk of injury and product damage, do not use the product beyond the tested life­ time.
• To avoid the risk of injury and product damage, only use the product for a single patient.
• To prevent mechanical damage, use caution when working with the product.
• If you suspect the product is damaged, check it for proper function and readiness for use.
•  Do not use the product if its functionality is restricted. Take suitable measures (e.g. cleaning, repair, replacement, inspection by the manufacturer or a specialist workshop).

Signs of changes in or loss of functionality during use
Among other factors, changes in functionality can be indicated by reduced prosthetic suspension.

Scope of delivery

Spare parts

Designation| Reference number
Elastomer rod (red)| 4Y347
Elastomer rod (yellow)| 4Y348
4 set screws M4x6| 4X902
Lamination disc set (1 lamination disc, 1 lamination dummy)| 4X903
Threaded-ring set for 4R180 (1 threaded ring for 4R180, 4 set screws M4x6)| 4X904
Threaded-ring set for 4R181 (1 threaded ring for 4R181, 4 set screws M4x6)| 4X446

Preparing the product for use

CAUTION
Incorrect alignment or assembly
Risk of injury due to damaged prosthetic components

• Observe the alignment and assembly instructions.

CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connections

• Clean the threads before every installation.
•  Apply the specified torque values.
• Follow the instructions regarding the length of the screws and about how to secure the screws.

INFORMATION
The layup described in this document was approved for the maximum product user body weight.
The prosthetist assumes full responsibility for any change to the layup.

5.1 Fabricating the thermoplastic socket
A prosthetic socket made of thermoplastic synthetic material is fabricated either as a check sock­et or the inner layer of the definitive socket, sealing the definitive socket. The difference between the two prosthetic sockets is the choice of material.

Required materials: 616T283 ThermoLyn clear or 616T252 ThermoLyn rigid for a check socket, 616T183* ThermoLyn PETG clear for a definitive socket, wet sanding paper, degreas­ ing cleaner (such as 634A58 isopropyl alcohol)

1. Vacuum form the prosthetic socket using thermoplastic synthetic material.
2.  Check socket only: Roughen the distal end of the prosthetic socket from the outside with wet sanding paper.
3. Definitive socket only: Roughen the entire prosthetic socket from the outside with wet sand­ ing paper.
4. Degrease the outside of the prosthetic socket.
5. Glue the lamination disc to the prosthetic socket (see page 17).

5.2 Gluing the lamination plate

Required materials: Wet sanding paper, degreasing cleaner (such as 634A58 isopropyl alcohol), 627B4 polyethylene adhesive tape, suitable adhesive (such as 636K49 SuperGlue, sealing resin-talcum mixture, Fabtech +PLUSeries 60-second adhesive), 699G30 synthetic support bandage

1. Roughen the proximal surface of the lamination plate with wet sanding paper.

2. Clean the lamination plate with degreasing cleaner.

3. Screw the lamination plate with the threaded ring onto the vacuum pump.

4. Cover the hole in the centre of the lamination plate with polyethylene adhesive tape (see fig. 2).

5. Install the distal prosthetic components as described in the respective instructions for use.

6. Perform the bench alignment and determine the required structural height and alignment of the prosthetic components relative to the prosthetic socket.

7. INFORMATION: The glued joint between the lamination plate and prosthetic socket must be air tight.
   Glue the lamination plate to the prosthetic socket using suitable adhesive (see fig. 3). In doing so, ensure that air inclusions are avoided.

8. Allow the adhesive to cure fully.

9. Once the adhesive has hardened, unscrew the vacuum pump from the lamination plate.

10.  Either complete the check socket (see page 18) or fabricate the definitive socket (see page 18).

5.3 Completing the check socket

Required materials: 627B4 polyethylene adhesive tape, 699G30 synthetic support bandage

1. Secure the connection between the prosthetic socket and lamination plate with synthetic sup­ port bandage (see fig. 4). In doing so, wrap the support bandage firmly around the prosthetic socket up to the groove in the lamination plate.

2. INFORMATION: In order for the sealing sleeve to seal, it has to overlap an air-tight surface by about 5 cm.
   If required, wrap the support bandage which is permeable to air with polyethylene adhesive tape to create an air-tight surface.

3. Drill a hole (Ø 4 mm) through the middle of the lamination plate into the plaster model (see fig. 5).

4.  Remove the prosthetic socket from the plaster model.

5. Deburr the hole on the inside of the socket.

6. Clean the prosthetic socket, lamination plate and bore hole.

7. Install the vacuum pump (see page 19).
   INFORMATION: Seal the hole in the prosthetic socket with a piece of adhesive tape if the prosthetic socket requires modification after pump installation. This prevents debris from entering the vacuum pump.

8.  Optional: Install the 2R117-0 socket connector as described in the applicable instructions for use. This allows the vacuum level to be determined.

5.4 Fabricating the definitive socket
5.4.1 Laminating the transtibial socket

Required tools and materials:
99B81 PVA bag, 623T3=8 or 623T3=10 Perlon stockinette, 81A1=8 or 81A1=10 nylon tube sock, 616G15 carbon fibre woven hose, Nylglass stockinette 623T9, 617H119 Orthocryl lam­ ination resin 80:20 PRO, string
Requirement: The thermoplastic socket has been fabricated and the lamination plate has been glued on.

1. Apply a thin layer of Vaseline to the inside of the lamination plate (see fig. 6).
2. Insert the lamination dummy into the lamination plate (see fig. 7).
3.  Seal the distal surface of the lamination plate with polyethylene adhesive tape (see fig. 8).
4. Pull a nylon stockinette over the plaster model.
5.  Pull a piece of carbon fibre woven hose (2 times the length of the plaster model) over the plaster model up to the socket brim. Tie off the excess carbon fibre woven hose and fold it over the plaster model.
6. Pull a piece of nylglass stockinette over the plaster model.
7. Pull a piece of carbon fibre woven hose (2 times the length of the plaster model) over the plaster model up to the socket brim. Tie off the excess carbon fibre woven hose and fold it over the plaster model.
8. Pull a piece of Perlon stockinette (2 times the length of the plaster model) over the plaster model up to the socket brim. Tie off the excess Perlon stockinette and fold it over the plaster model.
9. Soak a PVA bag and pull it over the plaster model.
10. Complete the lamination process with Orthocryl.
11. Finish the prosthetic socket (see page 19).

5.4.2 Finishing the prosthetic socket

Required materials: 636W46 Loctite 242

1. Remove the PVA bag.

2. Sand off the laminate distally on the lamination plate and remove the lamination dummy.

3.  Mark the trim line and cut it using an oscillating saw.

4. Drill a hole (Ø 4 mm) through the middle of the lamination plate into the plaster model.

5.  Remove the prosthetic socket from the plaster model.

6. Sand the trim line and round off the edges. Deburr the hole on the inside of the socket.

7. Use compressed air to clean the prosthetic socket, bore hole and lamination plate.

8.  Clean the inside of the lamination plate.

9. Install the vacuum pump (see page 19).
   INFORMATION: Seal the hole in the prosthetic socket with a piece of adhesive tape if the prosthetic socket requires modification after pump installation. This prevents debris from entering the vacuum pump.

10. Optional: Install the 2R117-0 socket connector as described in the applicable instructions for use. This allows the vacuum level to be determined.

5.5 Installing the vacuum pump

Recommended materials: 636W46 Loctite 242, 4R76 or 4R78 double adapter, 704Y40 vice jaws for pyramid

1. Slide the threaded ring onto the vacuum pump (see fig. 9).

2. Mount a 4R76 or 4R78 double adapter on the vacuum pump. Clamp the vacuum pump on the pyramid of the adapter in a vice (see fig. 10).

3.  Set the lamination plate onto the vacuum pump and align it.

4. INFORMATION: The vacuum pump turns by approximately 30° when the threaded ring is tightened.
   Use the pin wrench to tighten the threaded ring (tightening torque: 50 Nm) (see fig. 11).

5.  Fitting: Screw the two (2) set screws into the threaded ring (see fig. 12).

6. Definitive mounting: Apply Loctite to the two set screws and screw them into the threaded ring (see fig. 12). Screw in the set screws until they touch the lamination plate; then tighten them by half a turn.

7. Install the distal prosthetic components as described in the respective instructions for use.

5.6 Adjusting the vacuum pump
Vacuum generation and damping of the vacuum pump can be adjusted using the elastomer rod.
Plantar flexion and dorsiflexion as well as pronation and supination can be adjusted via the pyram­ id receiver.
The rotation of the prosthetic foot can be adjusted by loosening the connection between the vacu­um pump and lamination plate. The vacuum pump can then be realigned.

Adjusting the damping

Required materials: Allen wrench 4 mm

1. Disassemble existing distal prosthetic components.

2. Screw in the adjustment screw in the distal end of the vacuum pump fully to the stop (3174042).

3. Loosen the adjustment screw as described in the adjustment table below.

4. Optional: Fully unscrew the adjustment screw to replace the elastomer rod (3174393).
   Unscrew the set screws of the pyramid receiver sufficiently in order to do so. After inserting a new elastomer rod, complete the adjustment procedure again.

5. Install the distal prosthetic components as described in the respective instructions for use.

Adjustment table (unscrewing the elastomer rod)

Body weight [kg]| Product| Red rod| Yellow rod
50| 4R180, 4R181| 3| –
60 to 70| 3.| –
80 to 90| 2| –
100| 2.| 3
110| 4R181| –| 3
120 to 130| –| 3.
140 to 150| –| 2
The optimal setting depends on the user’s level of activity and preferences. Loosen the adjustment screw of the elastomer rod by a maximum of 4 turns.

Rotation adjustment

Required materials: 636W46 Loctite 242

1. Loosen the 2 set screws in the threaded ring.
2. Loosen the threaded ring using the pin wrench until the vacuum pump can be turned.
3.  Adjust the rotation.
4. Use the pin wrench to tighten the threaded ring (torque: 50 Nm).
5. Apply Loctite to the two (2) set screws and screw them into the threaded ring (see fig. 12).
   Screw in the set screws until they touch the lamination plate; then tighten them by half a turn.

5.7 Checking vacuum generation
First steps

• If a socket connector is installed: Connect a vacuum gauge to the socket connector.
• Without socket connector and vacuum gauge: The sealing sleeve is pulled to the socket brim by the vacuum. Then the socket brim is clearly visible under the sealing sleeve.
• Ask the user to put on the prosthesis. Check the process to exclude errors during donning.
• Get the user to walk in order to build up a vacuum. Get the user to stand and check whether the vacuum is maintained.
• If the vacuum is not maintained: Perform a systematic inspection of the prosthesis.

To perform the check for leaks, the prosthesis is divided into areas.

• Area 1: Sealing sleeve and optional socket connector
• Area 2: Connection to the vacuum pump
• Area 3: Vacuum pump

Check area 1 (with socket connector)
Check socket connector

• Seal the opening to the socket connector on the inside of the prosthetic socket with a small piece of paper and air-tight adhesive tape (e.g.  PVC tape).

• Connect a manual pump to the socket connector and build up a vacuum (approx. 500 hPa or 15 inHg) (see fig. 14).

• Check whether the vacuum is maintained.

• If the vacuum is not maintained: Glue the socket connector again and re-check it.
  Check the sealing sleeve

• Remove the adhesive tape in the prosthetic socket.

• Seal the opening to the vacuum pump on the inside of the prosthetic socket with air-tight adhesive tape (e.g.  PVC tape).

• Get the user to put on the prosthesis and roll the sealing sleeve over the thigh.

• With the manual pump, build up a vacuum on the socket connector (approx. 500 hPa or 15 inHg).

• Check whether the vacuum is maintained.

• If the vacuum is not maintained: Replace the sealing sleeve and check again.

Check area 1 (without socket connector and vacuum gauge)

• Replace the sealing sleeve with a new one.
• Get the user to walk in order to build up a vacuum. Get the user to stand and check whether the vacuum is maintained.
• If the vacuum is not maintained: The problem lies in area 2 or 3.

Check area 3

• Clean the vacuum pump to exclude the possibility of dirty valves (see page 22).
• Remove the vacuum pump from the prosthetic socket and the distal prosthetic components.
• Connect the pump vac test fitting to the proximal suction connection of the vacuum pump (see fig. 15).
• Set the vacuum pump with the hose down onto a suitable surface. Make sure the hose is not kinked.
• Produce a vacuum by pumping and check whether the vacuum is maintained (see fig. 16).
• If the vacuum is not maintained: Send the vacuum pump to the manufacturer.
• If the vacuum is maintained: The problem lies in area 2.

Check area 2

• Seal the opening to the vacuum pump on the inside of the prosthetic socket with air-tight adhesive tape (e.g.  PVC tape).
• Connect a manual pump to the lamination plate and build up a vacuum (approx. 500 hPa or 15 inHg) (see fig. 17).
• Check whether the vacuum is maintained.
• If the vacuum is not maintained:Fill the bore hole between the lamination plate and prosthetic socket, starting at the lamination plate, with sealing resin or Fabtech +PLUSeries 60-second adhesive and allow the adhesive to set.
• Drill a new hole with a smaller diameter and perform the test again.

Use

CAUTION
Use of powder (e.g. baby powder or talcum)
Skin irritation on the residual limb and loss of function of prosthetic components due to clogging with particles or deprivation of lubricant

• Keep the product away from powders.

6.1 Donning the prosthesis

1. Roll the liner over the residual limb. Avoid wrinkles, air pockets and soft tissue displacement as you do so.
2. For liners without a textile coating: Put on a suitable stocking (e.g. 451F21).
3. Slide into the prosthetic socket and unroll the sealing sleeve over the prosthetic socket up to the thigh.

6.2 Doffing the prosthesis

1. Unroll the sealing sleeve from the thigh onto the prosthetic socket.
2. Doff the residual limb and liner out of the prosthetic socket.

Cleaning

7.1 Cleaning the prosthetic socket

• Clean the product with a damp, soft cloth and then let it dry.

7.3 Cleaning the vacuum pump
For qualified personnel: cleaning with compressed air

• With compressed air, carefully blow through the hole in the prosthetic socket to remove dirt in the vacuum pump and one-way valve.

For qualified personnel: flushing with distilled water

1. Remove all distal prosthetic components.
2. Fill the prosthetic socket with approx. 60 ml distilled water.
3. Place a towel on the floor or a table and set the vacuum pump onto it.
4. Run the vacuum pump until the water has been pumped through.
5. Install the distal prosthetic components as described in their instructions for use.

For users: cleaning in the course of use
If the vacuum pump no longer generates a sufficient vacuum and no O&P professional can be reached, the vacuum pump can be rinsed with a small amount of water.

1. Moisten a nylon sheath with distilled water.
2. Position the nylon sheath in the prosthetic socket.
3. Don the prosthesis and use it as normal. The vacuum pump draws the water through the hole in the bottom of the socket.
4. Contact the O&P professional to set an inspection date.

Maintenance

• A visual inspection and functional test of the prosthetic components should be performed after the first 30 days of use.
• Inspect the entire prosthesis for wear during normal consultations.
• Conduct annual safety inspections.
• Perform a visual inspection of the elastomer rod annually. Replace the elastomer rod in case of limited functionality or pronounced signs of wear (see page 19).

Disposal

In some jurisdictions it is not permissible to dispose of the product with unsorted household waste. Improper disposal can be harmful to health and the environment. Observe the information provided by the responsible authorities in your country regarding return, collection and disposal procedures.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

10.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip­tions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorised modification of the product.
10.2 CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE
10.3 Warranty
The manufacturer warrants this device from the date of purchase. The warranty covers defects that can be proven to be a direct result of flaws in the material, production or construction and that are reported to the manufacturer within the warranty period.
Further information on the warranty terms and conditions can be obtained from the competent manufacturer distribution company.

Technical data

Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
[email protected] · www.ottobock.com
© Ottobock · 647G1247=all_INT-10-2204

References

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