Blatchford MH30 Mercury Prosthetic Knee User Guide
- June 12, 2024
- Blatchford
Table of Contents
**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
• Carrier Assembly | CF. Composite & St/Steel |
---|---|
• Chassis Assembly | Alu Alloy & St/Steel |
• Hydraulic Control Cylinder | Various inc. Alu Alloy, St/Steel & Hydraulic Oil |
• Distal Dome | Alu Alloy |
• Distal Pyramid | Titanium with St/Steel Bolt |
• Distal Tube Clamp | Alu Alloy |
• Knee Pad | Thermoplastic Elastomer |
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.
**MD** |
Medical Device |
---|---|
Single Patient – multiple use |
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