ottobock 1C62 Triton Harmony Prosthetic Foot Instruction Manual

ottobock 1C62 Triton Harmony Prosthetic Foot

Single components Single-Component Pack Minimum order quantity

INFORMATION

Last update: 2021-08-17

• 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 problems.
• Report each serious incident in connection with the product, in particular a worsening of the state of health, to the manufacturer and to the relevant authority in your country.
• Please keep this document for your records.

Explanation of symbols

CAUTION: Warning messages regarding possible risks of accident or injury.
NOTICE: Warning messages regarding possible technical damages.
INFORMATION: Additional information on the fitting/application.

Single components

Scope of delivery

The 1C62 Triton Harmony is delivered with the following components:

1. 1C62 Triton Harmony foot module (incl. 4X147 Functional Ring*)
2. 4X147* Functional ring (replacement)
3. 2R117 Socket Connector (2x)
4. 4Y383 Exhaust Flange Kit (incl. 4Y360 Muffler)
5. 2F60 Heel Wedge Kit
6. Tubing/Connector Kit (see Fig. 1, Pos. 8)
7. SL = Spectra-Sock Protective Sock
8. Pre-compression kit
9. 647G675 Instructions for Use

• Additional versions of the 4X147 Functional Ring can be ordered separately (for selections refer to Section 4.4.1).

Accessories (Fig. 1)

(1) Footshell (includes connection cap)
2C6=S Slim Footshell
2C6=(Side)(Size) / (Colour)S
2C6=N Normal Footshell

Single components (Fig. 1; for reordering)

(2) Connection Cap for Footshell (can be ordered individually)
2C20=Slim Connection cap
2C19=Normal Connection cap
(3) SL=Spectra Sock Protective Sock

Single component pack (Fig. 1; for reordering)

(4) 2F60=Triton Heel Wedge Kit
(5) 4Y360 Muffler
(6) 2R117 Socket Connector (2x)
(7) 4Y383 Exhaust Flange Kit

Product description

Combination possibilities

This prosthetic component is compatible with Ottobock‘s system of modular connectors. Functionality with components of other manufacturers that have compatible modular connectors has not been tested.

Indications for use

The 1C62 Triton Harmony is a carbon fiber foot and is a component of the Harmony Elevated Vacuum System, which also includes a Total Weight Bearing Socket, Polyurethane Liner, Air Wick and Sealing Sleeve.
The product is to be used solely for lower limb prosthetic fittings.

Service life

INFORMATION
This component has been tested according to ISO 22675 standard for two million load cycles. Depending on the amputee’s activity this corresponds to a duration of use of two to three years.
We recommend carrying out regular yearly safety checks.

Field 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 appropriate modular connectors.

1C62 = 21 – 24 cm
Recommended for amputees with Mobility Grade 3 and 4 (unrestricted outdoor walkers and unrestricted outdoor walkers with particularly high demands).
Approved for patient weight of up to 100 kg (220 lbs).

1C62 = 25 – 30 cm
Recommended for amputees with Mobility Grade 3 and 4 (unrestricted outdoor walkers and unrestricted outdoor walkers with particularly high demands).
Approved for patient weight of up to 125 kg (275 lbs).

1C62 = 25 – 30 cm
Recommended for amputees with Mobility Grade 3 (unrestricted outdoor walkers).
Approved for patient weight of up to 150 kg (330 lbs).

Please refer to the selection chart below to determine the appropriate stiffness required according to Ottobock recommendations.

Stiffness chart (spring – functional ring)

Patient Weight

| Foot Size
21 cm| 22 cm| 23 cm| 24 cm| 25 cm| 26 cm| 27 cm| 28 cm| 29 cm| 30 cm

kg

|

lbs

| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal| slim| normal
40-47| 88-103| 1-0 Special Order – please contact Customer Service| –| –| –| –| –| –| –| –
48-55| 104-121| 1-1| –| 1-1| –| 1-1| –| 1-1| 1-1| 1-1| 1-1| 1-1| 1-1| –| –| –| –| –| –| –| –
56-65| 122-143| 2-2| –| 2-2| –| 2-2| –| 2-2| 2-2| 2-2| 2-2| 2-2| 2-2| 2-2| 2-2| –| 2-2| –| 2-2| –| 2-2
66-75| 144-165| 2-3| –| 2-3| –| 2-3| –| 2-3| 2-3| 2-3| 2-3| 2-3| 2-3| 2-3| 2-3| –| 2-3| –| 2-3| –| 2-3
76-87| 166-192| 3-4| –| 3-4| –| 3-4| –| 3-4| 3-4| 3-4| 3-4| 3-4| 3-4| 3-4| 3-4| –| 3-4| –| 3-4| –| 3-4
88-100| 193-220| 3-5| –| 3-5| –| 3-5| –| 3-5| 3-5| 3-5| 3-5| 3-5| 3-5| 3-5| 3-5| –| 3-5| –| 3-5| –| 3-5
101-

112

| 221-247| –| –| –| –| –| –| –| –| 4-6| 4-6| 4-6| 4-6| 4-6| 4-6| –| 4-6| –| 4-6| –| 4-6
113-

125

| 248-275| –| –| –| –| –| –| –| –| 4-7| 4-7| 4-7| 4-7| 4-7| 4-7| –| 4-7| –| 4-7| –| 4-7
126-

137

| 276-302| –| –| –| –| –| –| –| –| 5-8| 5-8| 5-8| 5-8| 5-8| 5-8| –| 5-8| –| 5-8| –| 5-8*
138-

150

| 303-330| –| –| –| –| –| –| –| –| 5-9| 5-9| 5-9| 5-9| 5-9| 5-9| –| 5-9| –| 5-9| –| 5-9

• When combining this configuration with the C-Leg, please contact Ottobock Customer Service.
  ** When combining this configuration with the C-Leg or C-Leg compact, please contact Ottobock Customer Service.

Safety instructions

Please inform your patients about these safety issues!

CAUTION
Mechanical damage to the product
Injuries due to changes in or loss of functionality

• Use caution when working with the product.
• If the product is damaged, check it for proper function and readiness for use.
• In case of changes in or loss of functionality, do not continue using the product (see “Signs of changes in or loss of functionality during use” in this section).
• Take any necessary measures (e.g. repair, replacement, inspection by the manufacturer’s customer service, etc.).
• Inform the patient.

CAUTION
Risk of injury as a result of excessive strain.
Excessive impact loading typical with competitive sports beyond running or jumping activities, may weaken the spring elements.

To avoid the risk of accident and possible injury to the patient, the foot must no longer be used after a noticeable loss of function has occurred.
This noticeable function loss may be the result of reduced spring effect or forefoot resistance, in some cases accompanied with abnormal noises.
Measure: Have the prosthetic foot examined and, if necessary, replaced at a specialist workshop.

NOTICE
Function loss due to mechanical damage. If the Functional Ring shows any signs of damage, proper operation of the device cannot be ensured (impossible to create an elevated vacuum).
The Functional Ring is to be protected against mechanical damage. The Functional Ring must be replaced by qualified personnel if it shows any signs of damage (see Sections 4.4 and 4.8).

NOTICE
Health risk as a result of using wrong prosthetic socket. The application of wrong socket techniques can cause health risks for the patient (increased accumulation of fluid in the residual limb, e.g. oedemas). The prosthetic socket has to be fabricated following exclusively the Harmony socket fabrication technique.

NOTICE
Function loss as a result of dirty valves. Proper maintenance and care require periodic flushing 30-60 ml (1-2 fl-oz) of distilled water with about 5 to 10 pumps/steps through the Harmony System in order to clean the valves. If flushing does not solve the issue the plastic valves (4Z106 straight & 4Z108 elbow) can be easily replaced (see figure 7).

INFORMATION

Damage due to incorrect environmental conditions.
Prosthetic components must not be exposed to the following elements:

• Corrosive elements (such as fresh water, salt water, and acids)
• Abrasive substances (e. g. sand)

The foot shell material is not UV- or water-resistant.
Do not grind the surface of this prosthetic foot, as this can lead to premature wear.

Using this medical product under such conditions will render all claims against Otto Bock HealthCare null and void.

Qualification of the prosthetist

The fitting of a patient with a Harmony System may only be carried out by prosthetists who have been authorized by Ottobock after completion of a corresponding training course.

Function

Description of the components (Fig. 2)

• (A) Carbon Fiber Forefoot Spring
• (B) Carbon Fiber Heel Spring
• (C) High Performance Polymer Base Spring
• (D) Carbon Fiber Attachment Spring
• (E) Aluminum Housing
• (F) Optional Heel Wedge
• (G) Functional Ring
• (H) Shaft Assembly
• (I) Intake Valve
• (J) Expulsion Valve

Carbon Fiber Foot with integrated Harmony Vacuum Pump
The main features of the 1C62 Triton Harmony carbon fiber foot are the lightweight construction and the integrated Harmony Vacuum Pump with shock absorbing and rotation functionality. This system permits amputees with MG 3 or 4 the ability to walk effortlessly in everyday life situations including participation in high energy activities.
The integrated Harmony Vacuum Pump is a mechanical pump that can create an elevated vacuum in a prosthetic socket, thereby improving the connection between the amputee and the prosthesis. The vacuum system consists of a polyurethane liner, an air wick, a rigid socket (which is connected to the pump), a sealing sleeve and the 1C62 Triton Harmony with integrated Harmony Pump system.
Once the environment is sealed, the Functional Ring – which is compressed and released during normal walking – draws air from the socket through one-way valves and evacuates it through the pump. After multiple cycles of compression an elevated vacuum of 508-847 mbar (15-25 inHg) is created in the sealed socket environment.
The Functional Ring in the Harmony Pump has a shock absorption and rotational function that help to reduce vertical and torsional forces in the extremities during walking. The result is an improvement for both the function and loading situation of the prosthesis wearer.
The 1C62 Triton Harmony is designed to be used with the footshell and the detachable Foam Connection Cap. The Foam Connection Cap provides effective connection between the foot and cosmetic skin foam cover.
The combination of the carbon fiber foot together with the shock absorbing characteristics of the integrated Harmony system offer the following functional advantages:

• Secure heel strike with noticeable plantar flexion
• Progressive movement of the ankle in the mid-stance phase for the natural rollover of the foot
• Dynamic transition from the stance to swing phase
• Smooth dynamic forefoot response and energy return
• Compensation for uneven terrain
• Improved suspension
• Reduced volume fluctuations
• Reduced forces in the socket
• Improved proprioception
• Axial shock absorption
• Compensation of torsion moments

Technical data

Heel height with slim

footshell (mm)

| 15| 15| 15| 15| 15| 15| 15| –| –| –
Heel height with nor-

mal footshell (mm)

| –| –| –| 10| 10| 10| 10| 10| 10| 10
System height with

slim footshell (mm)

| 163| 164| 166| 167| 175| 177| 177| –| –| –
System height with

normal footshell (mm)

| –| –| –| 173| 175| 177| 181| 183| 189| 191
Weight with slim footshell (g)| 790| 800| 860| 890| 940| 960| 1020| –| –| –
Weight with normal footshell (g)| –| –| –| 900| 950| 980| 1030| 1050| 1110| 1140
Body weight MG3 up to| 100 kg/220 lbs| 150 kg/330 lbs
Body weight MG4 up to| 100 kg/220 lbs| 125 kg/275 lbs
Mobility Grade| 3+4

Handling

Installing the Harmony 2R117 Socket Connector

On a new socket, drill a 6mm (¼“) hole into the socket at a distal, posterior position. For sockets with a 4R136 or 4R138=5 Ottobock One-Way Valve, remove valve from socket and drill into existing hole. Remove burrs from the inside of the socket. Lightly sand the exterior of the socket with medium grit sandpaper to roughen the bonding surface. Wipe with isopropyl alcohol to clean the bonding surface. Also clean the 2R117 Socket Connector with isopropyl alcohol.
Next, apply a thin coating of adhesive (Ottobock recommends 2 Component Urethane Adhesive SL=P091) to the flat surface of the flange as well as the collar. Be careful not to get adhesive in the tapered end.
Insert tapered end of flange into the 6mm (¼“) hole with the tube directed towards the Harmony Pump. Use needle nose pliers to pull the tapered end of flange into the socket until the flat surface of the flange is tight against the outer surface of the socket. Tape the flange in place with vinyl tape. Allow to cure for at least 45 minutes.
Note: For particularly deep or narrow sockets, the tapered flange can be marked with a pen first, then removed and cut. This may require a slightly larger hole (6,5mm or ¼˝). Glue as with normal socket.
Use a round-edge knife to trim the tapered end of the flange inside of the socket. It should be flush with the inside surface of the socket.

Setup

Footshell application/removal

NOTICE
Risk of damage as a result of improper use.
The foot is designed to be used with the footshell. Please avoid frequent removal from and in sertion into the footshell as this can damage the carbon fiber elements.

NOTICE
Risk of damage as a result of improper footshell assembly.
Do not use a screwdriver for assembly and disassembly as this can cause damage to the carbon elements and/or footshell. Ottobock recommends use of 2C100 Footshell Insertion/Removal tool (accessories).

NOTICE
Risk of damage as a result of improper use.
The footshell must not be dusted with talcum powder as this would increase abrasion. Use silicone spray for lubrication if needed. Replace the footshell in case it shows any damage or wear.

Inserting the foot into the footshell:

• Before inserting into the footshell, attach the tube adapter to the prosthetic foot. This facilitates the procedure.
• Use the 2C100 Footshell Insertion/Removal tool provided by Ottobock to insert the carbon foot into the footshell.
• Make sure that the heel of the polymer base spring locks in under the footshell heel tab.

Removing the footsell:

• Insert the 2C100 Footshell Insertion/Removal tool under the heel of the polymer base spring which is located under the heel tabs in the posterior part of the footshell and pry the heel out of the shell. It is then possible to pull the foot out of the footshell.

Bench alignment
The prosthetic foot with cover is clamped in the alignment apparatus.

TT-fitting

Foot size [cm]| Mid-foot anterior to the align ment reference line [mm]| Heel height in alignment apparatus
---|---|---
21 – 25| 25| Effective heel height (shoe heel height – sole thickness of forefoot)

+ 5mm

26 – 28| 30
29 – 30| 35

TF-fitting
Observe the alignment instructions for the chosen prosthetic knee joint.

Connecting the socket connector
Cut the Socket Connector tube to length, slip the back tube collar 4Y310 onto the Socket Con-nector. Attach the proximal intake valve (Fig. 2, Pos. I) on the 1C62 Triton Harmony foot and press tube collar down to secure the Socket Connector.

Static alignment optimization
If necessary, the alignment recommendations (TF modular leg prostheses: 646F219, TT modular leg prostheses: 646F336) may be requested from Ottobock.
Use the L.A.S.A.R. Posture for static alignment optimization of the prosthesis, if available.

Dynamic alignment optimization
Adapt the prosthetic alignment in the frontal plane (ML) and in the sagittal plane (AP) by angle adjustments and/or sliding adjustments, in order to ensure correct heel contact, easy roll-over, and optimal shifting of weight onto the contralateral side. For transstadial amputees please make sure that there is physiological knee flexion during stance phase.
Using the optional heel wedges

CAUTION
Risk of falling due to change of the knee dynamics when using heel wedges.
The use of heel wedges can facilitate stance phase flexion when bearing weight on the prosthesis. Therefore, particular caution is advised during the dynamic alignment optimization – especially when a knee joint without stance phase control is used.

Heel wedge application
Two heel wedges are included to each 1C62 Triton Harmony prosthetic foot:

• „Soft“ Heel Wedge: translucent
•  „Stiff“ Heel Wedge: graphite color

Should the patient feel the heel strike too soft or the knee in hyperextension during the mid-stance phase, the heel can be stiffened by using one of the two heel wedges.

Inserting a heel wedge

INFORMATION
Ottobock recommends to test the foot first without using a heel wedge.

• The heel wedge is designed such that no adhesive is required to affix it to the prosthetic foot.
• Orient the heel wedge (Fig. 3, Pos. F) for insertion so the locking recess (Fig. 3, Pos. L) in the wedge is positioned in the proximal and posterior direction.
• Slide the heel wedge into position from the posterior side of the prosthetic foot between the attachment spring (Fig. 3, Pos. D) and heel spring (Fig. 3, Pos. B).
• The heel wedge is properly installed when the locking recess (Fig. 3, Pos. L) in the heel wedge is fully seated around the mating stop (Fig. 3, Pos. K) on the attachment spring.

Removing a heel wedge

INFORMATION
The heel wedge has a tendency to rotate during removal. Pulling the heel wedge in the direction of rotation helps make the removal easier.

• Push on the medial or lateral side of the heel wedge with your finger to free it from the mating stop (Fig. 3, Pos. K) on the attachment spring (Fig. 3, Pos. D).
• After the heel wedge is partially free grab it by the respective lateral or medial side and pull it free from the prosthetic foot.

Selecting and adjusting the functional ring

The 1C62 Triton Harmony is delivered as a complete foot assembly. The stiffness category of the functional ring is synchronized with the weight category of the foot assembly. If during walking too much compression of the functional ring is observed, an exchange to a stiffer functional ring can be done. If the patient does not reach a sufficient vacuum level, a softer functional ring should be used.

NOTICE
Function loss as a result of improper use. The functional ring may only be selected/adjusted by prosthetists that have been authorized by Ottobock.

Selecting the right functional ring
Use the following selection table to select the right Functional Ring. The Functional Ring version is marked on the intake valve receiver (Fig. 7).

| Body Weight
---|---
kg| 40-47| 48-55| 56-65| 66-75| 76-87| 88-

100

| 101-

112

| 113-

125

| 126-

137

| 138-

150

lbs| 88-

103

| 104-

121

| 122-

143

| 144-

185

| 186-

192

| 193-

220

| 221-

247

| 248-

275

| 276-

302-

| 303-

330

Recommen- ded Func- tional Ring 4X147| 0| 1| 2| 3| 4| 5| 6| 7| 8| 9

Please note that the recommendations do not necessarily represent the optimal selection for the patient. When deviating from the selection data, the Functional Ring with the highest possible stiffness should be selected that nevertheless still creates a sufficient vacuum. Ottobock recommends that a vacuum of approx. 500 mbar (15 inHg) or more should be reached within 50 steps with the prosthesis.
If the patient feels like they are “bottoming out”, a stiffer Functional Ring should be used. If the pump does not reach a sufficient vacuum level, a softer Functional Ring should be used.

Changing the functional ring

1. Remove the foothshell (see Section 4.2.1)

2. Loosen the retaining screw on the distal end of the aluminum housing (Fig. 2, item E) by use of an allen wrench (6 mm). Remove the screw (Fig. 6, Step 1). This can be carried out from below or optionally by inserting an allen key through the hole in the pyramid adapter.

3. Pull the shaft away from the base (Fig. 6, Step 2).

4. Pull off the installed functional ring (Fig. 6, Step 3).

5. Select the desired functional ring (see Section 4.4.1).

6. Preparing the functional ring for initial use.
   Before the first use, it is recommended by Ottobock that separately ordered functional rings are pre-compressed using, for example, the separately available 4X247 Pre-Compression Tool in order to guarantee trouble-free operation. Without pre-compression, new functional rings can be overly stiff. If using the preinstalled functional ring or an already pre-compressed unit please continue with step 7..

   • Open the pre-compression tool.
   • Place the functional ring in the pre-compression tool (Fig. 9)
   • Completely compress the functional ring by tightening the screw completely or clamping in a vise. (Fig. 10)
   • Compression time: Minimum 3 minutes to a maximum of 15 minutes
   • Open the pre-compression tool, remove the functional ring.

7. Slide the functional ring over the shaft (Fig. 6, Step 4).

8. Caution – To prevent unintended loosening of the screwing and thus the risk of falling, clean the threads of the prosthetic foot and the retaining screw so that they are clean and free from grease and other contaminants.

9. Reassemble the prosthetic foot (Fig. 6, Step 5 & 6). Secure the retaining screw with Loctite 243 or 246 and tighten with a 6 mm allen bit in a torque wrench to 15 Nm (133 in-lbs); This will need to be done by inserting the 6 mm allen socket going through the top hole in pyramid.

10. Insert the foot into the footshell (see Section 4.2.1).

Monitoring the elevated vacuum environment

To verify that the Harmony System maintains an elevated vacuum environment, it is necessary to temporarily install the Vacuum Gauge 755Z37 (available separately from Ottobock).

1. To do this, remove the vacuum line from the Harmony P3 Pump‘s intake valve.
2. Next, attach the vacuum line of the Vacuum Gauge (short side) to the pump‘s Intake Valve and connect the loosely hanging Socket Connector to the open barb on the Vacuum Gauge.
3. While the patient is standing and wearing the properly fitting Harmony System, cycle the Harmony P3 Pump to generate a vacuum between 508-847 mbar (15-25 inHg).
4. Stop cycling the pump. If the vacuum is maintained, the system is functioning correctly. If vacuum loss does occur, it will be necessary to check the system (see Section 4.5.1).

Troubleshooting the system if vacuum loss occurs
To determine if the vacuum loss exists in Zone 1, 2 or 3 (Fig. 11) install the gauge as described in section 4.5. Then proceed as follows:

Flow chart:

**Foam cover

**

Both Footshell Connection Caps 2C20 (slim) and 2C19 (normal) serve as a detachable connection between the foam cover and the footshell. They snap into the proximal brim of the footshell.

Please observe the following recommendations:

1. For mounting to the footshell the connection caps of the sizes 21-25 have to be cut along the cutting mark (Fig. 8).

2. Cut the foam cover to length, allowing for distal compression about 0.4 in (10 mm) for transtibial and about 1.6 in (40 mm) for transfemoral covers.

3. With the connection cap attached to the footshell, pull the foam cover over the prosthesis, reassemble the foot and mark the outer contours of the connection cap.

4. Remove the connection cap and clean the foam cover with Isopropyl Alcohol 634A58.

5. Apply 636N9 Ottobock Contact Adhesive or 636W17 Plastic Adhesive to the distal end of the foam cover and to the connection cap.

6. Allow the adhesive to dry (approx. 10 minutes) and cut out a space in the distal foam cover with a grinding and milling machine to allow for precise fit for the upper part of the adapter.
   Sufficient space should be available for the adapter to ensure proper function and eliminate noise during walking.

7. Assemble the foam cover and finish off the outer shape of the foam cover in usual way with carbon foot installed. Any compression of the foam cover by cosmetic stockings or SuperSkin needs to be taken into account.

Cosmetic finish of the prosthesis
The 1C62 Triton Harmony is delivered with two different exhaust valve attachments:

• A short piece of tubing with installed muffler and Double Barb Connector pre-installed at the exhaust valve
• A long piece of tubing with an exhaust flange
  If a cosmetic cover of the prosthesis is desired use a cover with a 34 mm centre hole.

NOTICE
Function loss as a result of improper installed cosmetic cover. If using a 6R8 Foam Cover, it is important that the cover is not compressed along the length of the foam, as this can affect the function of the Harmony pump.

Once the foam cover is in place, determine location of exhaust flange and drill or cut a 6 mm hole. Ottobock recommends placing the exhaust flange medially at the ankle, just above the top of a patient’s shoe. Next, insert tubing (Fig. 12, Pos. 2) and flange (Fig. 12, Pos.3) into the hole of cosmetic cover and connect tubing to Double Barb Connector (Fig. 12, Pos. 1). Make sure that the tubing is not crimped or compressed in any way. The flange can be glued in place if ne-cessary: apply thin layer of glue to flange surface and press into place. Once flange is secure, any extra tubing can be cut to length or simply pressed into the cosmesis until end of tubing is flush with flange.
Note: To achieve the best cosmetic appearance, we recommend that the foam cover is finished with a Soft Touch stockinette.
Note: If salt appears on the outside of the stockinette, it can be washed away with warm water.

Adjustment and final assembly

Due to the high forces in the adapter section, it is indispensable to tighten the adjustment screws of the tube adapter with a torque of 15 Nm (135 lb-in).
Use 710D1 Torque Wrench. Once you have attained the final setting for the prosthesis, use 636K13 Loctite to secure the set screws.

Maintenance instructions

• Foot assembly should be inspected after first 30 days (4 weeks) of use.
• Inspect the entire prosthesis for wear during normal consultations.
• Footshell may require replacement if wear is excessive.

Ottobock recommends replacing the 4X147 Functional Ring after approximately 1 year of use because the stiffness and restoring force can decrease over time. Depending on activity and environmental conditions, this may become necessary at an earlier (or later) point in time. Reduced shock absorption and slower generation of vacuum are typical indicators the patient may notice.

Note: New functional rings may feel stiffer for the patient on the initial days of use.
If vacuum performance decreases without a corresponding decrease in shock absorption performance, one or both of the valves may have become clogged with debris. The best remedy is tore place the valves. Blow any accumulated debris out of the Functional Ring using compressed air while the valves are removed.
When replacing the functional ring at the recommended service interval, wipe all old grease from the shaft and bearings, apply new grease, and replace the two o-rings on the shaft. These o-rings do not affect vacuum performance. They are used to cushion undesirable but necessary movement in the bearing system.

Legal information

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

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 disregard of this document, particularly due to improper use or unauthorized modification of the product.

CE conformity

The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer‘s website.

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