Orthomobility VGK-Go! User manual

Very Good Knee - Go!
Instructions Manual
Distributeur

The knee joint
for transfemoral
amputees and knee
disarticulation

EN
Very Good Knee - Go! GebruiksaanwijzingVersion 2.4.2 3
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
Contents
1. Introduction ......................................................................................................... 5
1.1. Intended Purpose ................................................................................................. 5
1.2. Technology .......................................................................................................... 5
1.3. Recommended User Prole ........................................................................................... 5
1.4. Installation and Adjustments ......................................................................... 6
1.5. Compatibility ........................................................................................... 6
1.6. Lifetime of the Device .............................................................................................. 6
1.7. Identication of the Device ........................................................................................ 7
1.8. Normal use (note stairs) ............................................................................................ 7
1.9. Contact with Water ...................................................................................... 8
1.10. Expectation Management ................................................................................................ 8
1.11. Irregular and Extreme Use ........................................................................................ 8
1.11.1. Extreme Temperature .............................................................................................. 9
1.11.2. Extreme Device Settings ................................................................................ 9
1.12. Body Weight and Additional Load ................................................................................. 9
1.13. Prevention of Overheating ......................................................................................... 9
1.14. Wear and Tear ............................................................................................... 9
1.15. Storage ........................................................................................... 9
2. Alignment ............................................................................................................ 10
2.1. General Alignment ............................................................................................................. 10
2.2. Leg Length ......................................................................................................................... 12
2.3. Socket Flexion .................................................................. 12
2.4. Foot Alignment ......................................................................................................... 12
2.5. Kneeling ............................................................................... 13
3. Controls .......................................................................................................... 14
3.1. Swing release ................................................................................... 15
3.1.1. Setting Swing Release Threshold .......................................................... 15
3.1.2. Conditions for Swing Release ....................................................................... 15
3.2. Stance Flexion Handle ........................................................................................ 16
4. Adjustments .......................................................................................................... 17
4.1. Adjusting the Stairs Mode ............................................................................................. 17
4.2. Ultra High Resistance Mode ........................................................................................... 17
4.3. Adjusting the Cycle Mode ............................................................................................. 17
4.3.1. Bench Testing Cycle Mode ................................................................................... 18
4.3.2. Clinical Set up of Cycle Mode ................................................................... 18
4.4. Swing Phase Adjustments ............................................................................ 19
4.4.1. Maximum Knee Flexion Limitation in Swing ......................................................... 19
4.4.2. Nominal Swing Phase Resistance ..................................................... 19
4.4.3. Terminal Impact Damping ........................................................................................ 20

EN
Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.24
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
5. Finishing Check Points ....................................................................................................... 21
5.1. Essential Movement in Mechanism ........................................................................ 21
5.2. Cosmetic Cover ........................................................................................... 21
5.3. Final Checklist ............................................................................................ 21
6. Care and Maintenance ............................................................................................ 22
7. Product Disposal .............................................................. 23
8. Warranty ................................................................................ 24
9. Liability .................................................................................................................. 25
10. Reporting of a Serious Incident ..................................................................................... 26
11 Declaration of Conformity ............................................................................................... 27
Contents
!
Use the Final Checklist on page 20 to
check the essential installation points

EN
Very Good Knee - Go! GebruiksaanwijzingVersion 2.4.2 5
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
1.1. Intended Purpose
The VGK-Go! is intended to be solely used in lower extremity prosthetic limbs as a
prosthetic knee joint to assist ambulation and activities of daily living. The product
can be used for uni- or bilateral amputation. The VGK-Go! is compatible with
osseointegration, however, permission MUST be obtained from the manufacturer
prior to use with osseointegration. Permission for use with osseointegration is
considered on a case-by-case basis.
The VGK-Go! is best used for medium and long femur length in the residual limb. For
short transfemoral the VGK-S is recommended, and the VGK-X is a good alternative
for people with body weight under 80 kg. Please see our website www.orthomobility.
com
1.2. Technology
The VGK-Go! is a Fluidic Processor Knee (FPK), which uses uidic sensors to respond
to changes in gait in real-time, by adjusting motion resistance within a single step.
1.3. Recommended User Prole
The VGK-Go! is recommended for independent prosthetic users typically of mobility
classes 1-4**. The user’s body weight can be up to 125 kg.
** Users with signicant comorbidity must be carefully monitored in the rehabilitation
period to ascertain the suitability of the device for their needs.
1Introduction

EN
Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.26
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
1.5. Compatibility
The VGK-Go! is compatible with the full complement of prosthetic components,
energy-storing feet, hydraulic ankles, hip components, shock absorbers, etc.
1.6. Lifetime of the Device
In compliance with the EU Medical Device Regulations, Orthomobility has dened a
maximum usage period of 5 Years + 3 months for VGK-Go!. The rate at which the
device is used will vary between patients, but this limit puts a practical, manageable,
and measurable limit on its use. The additional “3 months” have been added to
allow time for shipping and replacement limb tting.
VGK-Go! must not be used after the maximum usage period. The usage period
starts on the date of shipment by the distributor and this date appears on the
product label. If the shipping date is not known, the date of invoice will be used.
Please contact the distributor if the start date is not available.
1.4. Installation and Adjustments
1Introduction
The VGK-Go! must be installed by a Certied Prosthetic/Orthotist (CP or CPO) to
make sure the alignment and control settings are adjusted safely.
The user may adjust the controls under the guidance of their CPO. The CPO must
assess whether the user is able to adjust the knee joint safely. There are special
instructions with regards to use in a wet environment that must be passed to the
user by the CPO.

EN
Very Good Knee - Go! GebruiksaanwijzingVersion 2.4.2 7
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
1.7. Identication of the Device
A VGK-Go! unit may be identied with the serial number that is engraved on the
product, as shown in Fig 1.1.
1Introduction
Fig 1: Location of serial number
1.8. Normal Use (note stairs)
The VGK-Go! has been developed for ambulation and ordinary mobility use: walking,
sitting, kneeling, cycling, and occasional wetting by rain or tap water. The use of
handrails or bannisters is recommended when descending downstairs. Note: to set
up the knee for cycling requires a special procedure to be followed.

EN
Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.28
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
1Introduction
1.10. Expectation Management
Please advise the user that this device is designed to oer functionality that is
compatible with a high level of safety. The high level of safety is likely to elevate their
expectations of their ability, and consequently your patient may nd limits in the
performance of the device. When such an event happens, they are asked to record
the circumstances and report the event back to their CPO.
1.11. Irregular and Extreme Use
Irregular and extreme use may occasionally be required and this should be agreed
with the manufacturer beforehand. Such use may involve water and dirt, mechanical
shock and forceful use. Whereas these may be considered as part of intended use,
it will be required that written permission is sought from the manufacturer so that
such irregular use can be risk assessed, supported, or denied on grounds of risk.
A considered permission/denial/support programme will be discussed on request.
Use of the product in a sauna is excluded. Avoid sand entering the knee.
1.9. Contact with Water
The VGK-Go! is suitable for occasional use in water up to a depth of 1.5 m. However,
the knee joint has no buoyancy in water. There is also a risk of snagging on plants
or objects.
If the knee joint is to be used in wet environments more frequently than once a
month, this requires the manufacturer’s prior agreement such that a care and
maintenance program can be discussed. The manufacturer may limit the use of the
knee joint in wet environments if a care and maintenance program is not followed.
Also note the instructions in Section 6.
1.11.1 Extreme Temperature
The VGK-Go! has been designed for a stable performance over a range of
temperatures. The use in very low temperatures (sub-zero) may cause some
stiffening in the swing and yield action of the joint, which in hands-free slope and
stairs descent could cause an imbalance. In this instance, it is advised to first try
using it close to a handrail. In elevated temperatures (40 degrees plus), the VGK-Go!
maintains its performance fairly well.

EN
Very Good Knee - Go! GebruiksaanwijzingVersion 2.4.2 9
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
1Introduction
1.11.2 Extreme Device Settings
The VGK-Go! permits a high level of resistance in yield. The device has been designed
to contain hydraulic pressures that arise during normal use, including leg-over-leg
stair descent. However, when significant weight is placed on the leg, the device is
not intended to be loaded in flexion in a ‘locked’ mode.
1.12. Body Weight and Additional Load
The VGK-Go! has been designed to allow for a patient body weight of 125 kg and
these persons, at this maximum body weight, to carry not more than 15 kg of
additional load on a daily basis.
1.13. Prevention of Overheating
Do not use VGK-Go! in the sauna because the heat may damage the metal surfaces.
When used intensively, allow heat to escape via the frame by avoiding use of
cosmetic foam covers.
1.14. Wear and Tear
As with any device with mechanical elements, mechanical wear and tear will
eventually occur, and the user and CPO are required to see that regular inspections
and maintenance are carried out. Fair wear and tear includes the possible formation
of corrosion due to regular wet use, especially in salt and chlorinated water, and
urine. Cleaning with fresh water may reduce the impact of salt and chlorinated
water. Fair wear and tear falls outside the standard scope of warranty.
1.15. Storage
The VGK-Go! must be stored in an extended position.

EN
Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.210
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V.
2.1. General Alignment
The alignment of the knee joint must follow the straight hip-knee-ankle line. The
‘Ankle’ refers to where the natural ankle would be, that is between 1/4 and 1/3 of
the foot length. Ideally the knee axis should be 10 mm behind the hip-ankle line (see
Fig 2.1).
2Alignment
Fig 2.1: Alignment of VGK-Go!.