Blatchford BMK2 Lightweight Mechanical Knee User Guide

Blatchford BMK2 Lightweight Mechanical Knee User Guide

BMK2 Knee

1. Description and Intended Purpose

These instructions are for the clinician/practitioner.
The term device is used throughout these instructions for use to refer to BMK2 knee.
Ensure that the user understands all instructions for use, drawing particular attention to the maintenance and safety information.
Users must be given gait training before using this device.

Application
This device is to be used exclusively as part of a lower limb prosthesis.
The device is a compact weight activated knee with an adjustable spring extension bias.
This device is intended for a single user.

Features

• Weight activated adjustable stance control
• Adjustable extension bias control incorporating terminal impact damping
• Maximum flexion angle 130 °

Activity Level
This device is for Activity Level 1 and 2 users only. For maximum user weight see Section 13 Technical Data.

Activity Level 1
Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at fixed cadence. Typical of the limited and unlimited household ambulator.

Activity Level 2
Has the ability or potential for ambulation with the ability to traverse low- level environmental barriers such as curbs, stairs, or uneven surfaces. Typical of the limited community ambulator.

Activity Level 3
Has the ability or potential for ambulation with variable cadence. Typical of the community ambulator who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

Activity Level 4
Has the ability or potential for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress, or energy levels. Typical of the prosthetic demands of the child, active adult, or athlete.

Contraindications
This device is not suitable for users with:

• Extreme muscular weakness, contractures that cannot be correctly accommodated, or proprioceptive dysfunction including poor balance.
• Contralateral joint instabilities or pathology.
• Complicated conditions involving multiple disabilities.
• Users, including bilateral transfemoral amputees, who require a yielding function from the knee to descend stairs or to sit. This can result in damage of the brake mechanism that can adversely affect stability and durability.

Clinical Benefits

• Stabilizing knee activates smoothly on weight bearing to give security when standing and when traversing uneven ground. It then releases cleanly at toe off.
• Resilient action of stabilizing mechanism gives limited stance flexion which reduces shock at heel strike.

2. Safety Information

This warning symbol highlights important safety information which must be followed carefully.

Any changes in the performance or function of the knee e.g. restricted movement, non-smooth motion or unusual noises should be immediately reported to your service provider. During the terminal swing immediately before heel strike, some impact noise may be heard due to the extension assist as the limb reaches full extension.Always use a hand rail when descending stairs and at any other time if available.
Avoid exposure to extreme heat and/or cold.The device is not intended to be used in water or as a shower prosthesis. If the knee comes into contact with water wipe dry immediately.

The device is not suitable for extreme sports, running or cycle racing, ice and snow sports, extreme slopes and steps. Any such activities undertaken are done so completely at the users’ own risk.

Assembly, maintenance and repair of the device must only be carried out by a suitably qualified clinician.

When servicing the device make sure there is no grease in the brake drum.

Ensure only suitably retrofitted vehicles are used when driving. All persons are required to observe their respective driving laws when operating motor vehicles.

The user must not adjust or tamper with the setup of the device. The user should be advised to contact their clinician if their condition changes.

Be aware of finger trap hazard at all times.

Any excessive changes in heel height after finalization of alignment may adversely affect limb function.

3. Construction

Principal Parts

• Body Assembly (aluminum, stainless steel, polyurethane, felt)
• Knee Chassis Assembly (aluminum, stainless steel)
• Stabilizing Mechanism (aluminum, bronze, acetal homopolymer, polyurethane, synthetic rubber)

Note… The friction material in the stabilizing mechanism contains no asbestos.

Component Identification

4. Function

The knee is weight activated and the sensitivity can be customized to suit the stability requirements of the user.

Swing control is adjustable by altering the compression on a coil spring controlling heel rise and extension bias.

5. Maintenance

Maintenance must be carried out by competent personnel.
It is recommended that the following maintenance is carried out annually:

• Check all non-adjuster screws for tightness (see Construction section) (DO NOT tighten the covered nut at the distal end).
• Clean the brake pad and replace the extension stops (see Section 10 Maintenance of Stabilizing Mechanism for procedure).
• In the event of unusual noises suchs as squeaks and creaks and/or reduced stability, carry out maintenance of the stabilizing mechanism, see Section 10 Maintenance of Stabilizing Mechanism. If noises persist contact your Blatchford representative.
• Wear and tear on the extension buffer is acceptable. If excessive noise is present at full extension replace the extension buffer. See Section11 Maintenance of Extension Buffer.
• Check for excessive Medio-Lateral play of the chassis.
• If the trailing edge of the brake band pad is worn down to the plastic of the brake band, replace the complete brake band. (Note: Individual pads cannot be replaced.)
• Ensure orientation of brakeband is correct on reassembly. Always check stability before using.

The user must be handed the User Guide supplied, and be advised to report the following to the practitioner:

• Any changes in body weight or activity level
• Any changes in performance of this device

Changes in performance may include:

• Restricted swing
• Changes in smoothness of swing
• Reduced stability during stance
• Any unusual noise

Cleaning
Use a damp cloth and mild soap to clean outside surfaces, DO NOT use aggressive cleansers. Thoroughly dry before use.

6. Limitations on Use

Intended Life
Service life of the product is covered by the warranty period – a local risk assessment should be carried out based upon activity and usage.

Lifting Loads
User weight and activity is governed by the stated limits.
Load carrying by the user should be based on a local risk assessment.
Note… The device is weight activated and carrying loads may cause the stance support to engage more readily.

Environment
Avoid exposing the device to corrosive elements such as water, acids and other liquids. Also avoid abrasive environments such as those containing sand for example as these may promote premature wear.
Exclusively for use between -15 °C and 50 °C (5 °F and 122 °F).

7. Bench Alignment

8. Alignment Advice and Stability Adjustment

9. Dynamic Alignment

Swing Control Adjustment (Extension Bias)

Note… If operated by hand, the engagement of the terminal impact damping may be felt immediately before full extension; this is normal.

10. Maintenance of Stabilizing Mechanism

Use appropriate health and safety equipment at all times including extraction facilities.

Be aware of finger trap hazard at all times.

Following maintenance it is important to review the user’s stability adjustment.
Refer to the flowchart in the Alignment Advice and Stability Adjustment section.

11. Maintenance of Extension Buffer

Use appropriate health and safety equipment at all times including extraction facilities.
Be aware of finger trap hazard at all times.

12. Troubleshooting

13. Technical Data

Fitting Length

14. Ordering Information

Order Example

BMK2

14.1 Spare Parts
Extension Stop Kit 239453

Stabilizing Mechanism Kit 239553

Liability
The manufacturer recommends using the device only under the specified conditions and for the intended purposes. The device must be maintained according to the instructions for use supplied with the device. The manufacturer is not liable for any adverse outcome caused by any component combinations that were not authorized by them.

CE Conformity
This product meets the requirements of the European Regulation EU 2017/745 for medical devices. This product has been classified as a class I device according to the classification rules outlined in Annex VIII of the regulation. The EU declaration of conformity certificate is available at the following internet address: www.blatchford.co.uk

Compatibility
Combination with Blatchford branded products is approved based on testing in accordance with relevant standards and the MDR including structural test, dimensional compatibility and monitored field performance.
Combination with alternative CE marked products must be carried out in view of a documented local risk assessment carried out by a Practitioner.

Warranty
This device is warranted for 24 months from original date of purchase unless otherwise stated. The Compact Stabilizing Mechanism is warranted for 12 months from original date of purchase unless otherwise stated. Wear and tear on the brake band is excluded from the warranty. The user should be aware that changes or modifications not expressly approved could void the warranty, operating licenses and exemptions. See Blatchford website for the current full warranty statement including wear and tear.

Reporting of Serious Incidents
In the unlikely event of a serious incident occurring in relation to this device it should be reported to the manufacturer and your national competent authority.

Environmental Aspects
Where possible the components should be recycled in accordance with local waste handling regulations.

Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.

Trademark Acknowledgements
Blatchford is a registered trademark of Blatchford Products Limited.

Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK

Blatchford Products Ltd.
Unit D Antura
Kingsland Business Park
Basingstoke
RG24 8PZ
UNITED KINGDOM
Tel: +44 (0) 1256 316600
Fax: +44 (0) 1256 316710
Email: customer.service@blatchford.co.uk
www.blatchford.co.uk

Blatchford Europe GmbH
Am Prime-Parc 4
65479 Raunheim
GERMANY
Tel: +49 (0) 9221 87808 0
Fax: +49 (0) 9221/87808 60
Email: info@blatchford.de
www.blatchford.de
Email: contact@blatchford.fr
www.blatchford.fr

Endolite India Ltd.
A4 Naraina Industrial Area
Phase – 1
New Delhi
INDIA – 110028
Tel: +91 (011) 45689955
Fax: +91 (011) 25891543
Email: endolite@vsnl.com
www.endoliteindia.com

Blatchford Inc.
1031 Byers Road
Miamisburg
Ohio 45342
USA
Tel: +1 (0) 800 548 3534
Fax: +1 (0) 800 929 3636
Email: info@blatchfordus.com
www.blatchfordus.com

Ortopro AS
Hardangervegen 72
Seksjon 17
5224 Nesttun
NORWAY
Tel: +47 (0) 55 91 88 60
Email: post@ortopro.no
www.ortopro.no

Blatchford Europe GmbHAm Prime-Parc 465479 Raunheim Germany

© Blatchford Products Limited 2019. All rights reserved.

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References

• The Most Advanced Lower Limb Prosthetics in the World
• The Most Advanced Lower Limb Prosthetics in the World
• Blatchford Deutschland - Prothetik für die untere Extremität
• Blatchford France | Mobility Made Possible
• The Most Advanced Lower Limb Prosthetics in the World
• endoliteindia.com
• Ortopediske hjelpemidler | Ortopro AS

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