Blatchford MH30 Mercury Prosthetic Knee User Guide

**PK3

Mercury
User Guide
MH30 / MH30 SWING (as shown)
MHPYR / MHPYR SWING
MHDPYRS, MHDPYRM, MHD30S, MHD30M 239452
User Guide**

Description and Intended Purpose

Application
The term device is used throughout these instructions for use to refer to Mercury knee products.
These instructions are for the user.
This device is a knee unit that provides a uniaxial frame for Swing and Stance position activated support for the prosthesis for walking at various cadence on varied terrain (a swing only version is also available). It is intended to improve safety and reduce compensation.
Ensure that you understand all instructions for use, drawing particular attention to all maintenance and safety information.
Features

| Swing & Stance| Swing Only
---|---|---
Tough carbon fibre frame| |
125° knee flexion| |
Long life needle roller bearings| |
Reinforced hydraulic unit| |
Durable urethane kneeler pad| |
Variable cadence| |
Compact design| |
Adjustable stance yield resistance| |
Swing only mode (suitable for cycling)| |
Cylinder flexion lock| |

Safety Information

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

Be aware of finger trap hazard at all times.
Any changes in the performance or function of the limb e.g. instability, double-action, 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.
Any excessive changes in heel height after finalization of alignment may adversely affect limb function.
After continuous use the cylinder can become hot.
Ensure only suitably retrofitted vehicles are used when driving. All persons are required to observe their respective driving laws when operating motor vehicles.
Care should be taken when carrying heavy loads as this may adversely affect the stability of the device.
The user should be advised to contact their practitioner if their condition changes.
Avoid exposure to extreme heat and/or cold.
Assembly, maintenance and repair of the device must only be carried out by a suitably qualified clinician

Construction

Principal Parts

Function

The knee is a uniaxial design comprising a knee pivot connecting a chassis to a carrier. A hydraulic knee control sits within this frame assembly, fitted between the chassis posterior pivot and the carrier distal pivot.
The S&S device has an adjustable yielding hydraulic support activated from knee extension prior to heel strike and released by a hyper-extension moment at any time, usually occurring after mid-stance.
The swing only device has no stance control mechanism and requires a combination of geometric stability and voluntary control during stance phase.
Both devices provide an adjustable hydraulic swing phase control to accommodate variable cadence.

Maintenance

An annual visual inspection is recommended. Check for visual defects that may affect proper function.
Maintenance must be carried out by competent personnel.
The user should be advised:

• Any changes in performance of this device must be reported to the practitioner.
  Changes in performance may include:

• Increase or decrease in knee stiffness.

• Instability.

• Reduced knee support (free movement).

• Any unusual noise.*

• Due to the nature of the hydraulics there may be some slight air noise from the cylinder during the first few steps. This is not detrimental to the function of the unit and should dissipate quickly. If symptoms persist, please consult your practitioner.

Storage and Handling
When storing for prolonged periods place the device vertically with trunnion uppermost.
Alternatively and in addition, air management may be assisted by cycling the knee control several times with the stance resistance switched off.
Use product packaging supplied.
Cleaning
Use a damp cloth and mild soap to clean the outside surfaces.
DO NOT use aggressive cleansers.

Limitations on Use

Intended Life
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.
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 -10 ˚C and 50 ˚C (14 ˚F to 122 ˚F).

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 36 months.
The user should be aware that changes or modifications not expressly approved could void the warranty, operating licenses and exemptions.
See the Blatchford website for the current full warranty statement.
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
This product contains hydraulic oil, mixed metals and plastics. It should be recycled where possible in accordance with local waste recycling 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.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| 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 GmbH
Am Prime-Parc 4
65479 Raunheim Germany

938452PK3/3-0422
© Blatchford Products Limited 2022. All rights reserved.

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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