Blatchford BMK2 Knee User Guide

: June 12, 2024
: Blatchford

Table of Contents

Description and Intended Purpose
Safety Information
Construction
Maintenance
Limitations on Use
Technical Data
References
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PK3

Blatchford BMK2 Knee - BMK2 Knee
User Guide
BMK2

Description and Intended Purpose

These instructions are for the user. Please keep these instructions.
The term device is used throughout this document to refer to BMK2 knee.
Make sure that you understand all instructions for use, drawing particular attention to all maintenance and safety information sections.

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 °

Safety Information

This warning symbol highlights important safety information which must be followed carefully.
Any changes in the performance or function of the limb e.g. restricted movement, non-smooth motion or unusual noises should be immediately reported to your service provider.
Always use a hand rail when descending stairs and at any other time if available.
Avoid contamination with liquids and/or powders.
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 practitioner.
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 contact their practitioner 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.

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

Blatchford BMK2 Knee - fig1

Maintenance

Maintenance must be carried out on this device annually. Please contact your practitioner when necessary.
Signs of wear that may affect function should be reported to the service provider.
Any changes in performance of this device must be reported to the to your practitioner.
Changes in performance may include:

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

The practitioner must also be informed of any changes in body weight and/or activity level.
Cleaning
Use a damp cloth and mild soap to clean outside surfaces, DO NOT use aggressive cleansers.
Thoroughly dry before use.

Limitations on Use

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).

Suitable for outdoor use

Technical Data

Operating and	-15 °C to 50 °C
Storage Temperature Range:	5 °F to 122 °F
Component Weight:	580 g (1 lb 5 ozs)
Recommended Activity Level:	2
Maximum User Weight:	125 kg (275 lb)
Proximal Alignment attachment:	Rotating Male Pyramid (Blatchford)
Distal attachment	30 mm dia tube clamp (Blatchford)
Build Height:	127 mm
Proximal pyramid to distal tube end [See Fitting Length below]	( +130 mm)

Fitting Length

Blatchford BMK2 Knee - fig2

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

| Medical Device
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| Single Patient – multiple use

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.

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.co.uk/distributors

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
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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
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