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Related Manuals for Orthomobility VGK-Go!
Summary of Contents for Orthomobility VGK-Go!
- Page 1 Very Good Knee - Go! Instructions Manual Distributeur...
- Page 2 The knee joint for transfemoral amputees and knee disarticulation...
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Page 3: Table Of Contents
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Contents Introduction .......................................... 1.1. Intended Purpose ......................1.2. Technology ................... 1.3. Recommended User Profile ................. 1.4. Installation and Adjustments ................... 1.5. Compatibility ....................1.6. Lifetime of the Device ..................1.7. Identification of the Device .................... - Page 4 VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Contents Finishing Check Points ....................................5.1. Essential Movement in Mechanism ................... 5.2. Cosmetic Cover .................... 5.3. Final Checklist Care and Maintenance .................... Product Disposal .............. Warranty ................Liability ........................Reporting of a Serious Incident ..................
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Page 5: Introduction
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. 1.2. Technology The VGK-Go! is a Fluidic Processor Knee (FPK), which uses fluidic sensors to respond to changes in gait in real-time, by adjusting motion resistance within a single step. -
Page 6: Installation And Adjustments
1.6. Lifetime of the Device In compliance with the EU Medical Device Regulations, Orthomobility has defined 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. -
Page 7: Identification Of The Device
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Introduction 1.7. Identification of the Device A VGK-Go! unit may be identified with the serial number that is engraved on the 1.1. product, as shown in 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. -
Page 8: Contact With Water
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Introduction 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. -
Page 9: Extreme Device Settings
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Introduction 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’... -
Page 10: Alignment
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Alignment 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. - Page 11 VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Alignment 2.2: A vertical hip-knee-ankle line is the preferred alignment. A posteriorly placed hip/greater trochanter is liable to make swing release more difficult. Version 2.4.2 Very Good Knee - Go! Gebruiksaanwijzing...
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Page 12: Leg Length
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Alignment 2.2. Leg Length To help the user easily initiate the swing release, the prosthesis length must be assessed as a LEVEL pelvis, or no more than 10 mm shorter. DO CHECK THE LEG LENGTH. -
Page 13: Kneeling
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Alignment 2.5. Kneeling Extreme or maximum knee flexion will cause the socket to touch the hydraulic unit. This unit can take the forces of kneeling and squatting provided the contact is made 2.3. -
Page 14: Controls
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Controls 3.1: Locations of controls for clinical adjustments 3.2: Positions of the Stance Flexion Handle Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.2... -
Page 15: Swing Release
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Controls 3.1. Swing Release 3.1.1 Setting Swing Release Threshold The VGK-Go! relies on the presence of knee extension and toe-load for swing-phase release. This condition is natural in terminal stance. For most users this switching behaviour is set to be as light as possible. -
Page 16: Stance Flexion Handle
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Controls 3.3: Avoiding unintentional swing release 3.2. Stance Flexion Handle The use of yield resistance (stance resistance) is set using the stance flexion handle, H in 3.1. See Fig 3.2 for possible positions of handle H. -
Page 17: Adjustments
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Adjustments 4.1. Adjusting the Stairs Mode Fig 3.1 3.2. The stairs mode is selected by positioning the stance flexion handle (H) in position W. The rate of knee flexion in stance can be adjusted with the Yield Resistance Valve, Y. -
Page 18: Bench Testing Cycle Mode
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Adjustments 4.3.1 Bench Testing Cycle Mode Bench test the prosthesis to become familiar with the cycling settings. Turn the stance flexion handle to cycling mode and observe that in the factory setting, the knee does not bend easily. -
Page 19: Maximum Knee Flexion Limitation In Swing
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Adjustments 4.4.1 Maximum Knee Flexion Limitation in Swing Reducing the maximum permissible knee flexion creates more forward drive of the knee. This is the MAIN control for swing phase adjustments. The Knee Flexion Limiter (MF in 3.1) is operated with a 1.5 mm Hex key. -
Page 20: Finishing Check Points
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Finishing Check Points 5.1. Essential Movement in Mechanism An essential part of the VGK-Go! mechanism is the slight swivelling motion in the distal knee section. The small gap between the distal knee section and the main frame must remain free of cosmeses, glue, dust particles, wedges, or anything else that could inhibit the movement. - Page 21 The user must inform their CPO of suspected device malfunction. There is a risk of finger trapping between moving parts. Keep hands away from moving parts when bending the knee. Please refer to www.orthomobility.com for more specific maintenance instructions Version 2.4.2 Very Good Knee - Go! Gebruiksaanwijzing...
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Page 22: Product Disposal
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Product Disposal Product disposal is covered on the website: www.orthomobility.com/disposal/ Very Good Knee - Go! Gebruiksaanwijzing Version 2.4.2... -
Page 23: Warranty
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Warranty Orthomobility Ltd. provides a time-based warranty against defects in materials and workmanship in accordance with terms and conditions of sale, and only when bought from approved suppliers. Defects arising from irregular and extreme use, and fair wear and tear are subject to the manufacturer’s discretion. -
Page 24: Liability
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Liability The manufacturer liability for the use of the VGKGo! is limited to faults that occur from a malfunction of the device, caused by faulty materials and/or workmanship and exclude incidental damage due to misuse. The manufacturer cannot take liability for continued use of a known malfunctioning device. -
Page 25: Reporting Of A Serious Incident
VGK-Go! is a low-risk, Class I medical device. In the unlikely event of a serious incident in relation to the device, the incident should be reported to the manufacturer (Orthomobility Ltd.) and the competent authority of the Member State in which the user and/or patient is established. -
Page 26: Declaration Of Conformity
VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Declaration of Conformity The VGK-Go! and its variations made by Orthomobility Ltd, Reg 5143375 conform to the Medical Device Regulation 2017/745. See www.orthomobility.com for the full declaration of conformity. The VGK-Go! and its variations made by Orthomobility Ltd, Reg 5143375 conform to the UK Medical Devices Regulations 2002. - Page 27 VGK-Go! van Orthomobility Ltd., distributeur Loth Fabenim B.V. Version 2.4.2 Very Good Knee - Go! Gebruiksaanwijzing...
- Page 28 Fabrikant Gemachtigde vertegenwoordiger voor EU landen Orthomobility Ltd. CERTLabel UG (haftungsbeschränkt) E1-1.29 Culham Science Centre, Wichertstraße 16/17 ABINGDON, OX14 3DB, UK 10439 BERLIN, DEUTSCHLAND Tel: +44-1865-40-72-48 Tel: +44-203-137-2252 http://orthomobility.com/ http://certlabel.com/ Contact Loth Fabenim B.V. De Liesbosch 14-G 3439 LC Nieuwegein, THE NETHERLANDS...
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