Blatchford ESKSBMKLP30 ESK+ Manual Knee Lock Instructions

Blatchford ESKSBMKLP30 ESK+ Manual Knee Lock

Product Information

The ESK+ Manual Knee Lock is a knee unit that provides a uniaxial frame for a weight-activated stabilized knee, which supports the prosthesis at various cadences on a variety of terrains. It is designed to improve safety and reduce compensation. The device is equipped with a manually operated knee lock for extra security. It is suitable for use as part of a lower limb prosthesis and is intended for a single user.

Features

• Manually adjusted PSPC (Pneumatic Swing Phase Control)
• Manual knee lock engaged
• Limited stance flexion during weight bearing
• Tough carbon fiber frame
• 115-degree knee flexion
• Adjustable sensitivity of knee stability
• Independent manually adjustable swing controls for flexion and extension
• Locked knee for prolonged weight bearing and additional security

Activity Level

This device is ideally suited for Activity Level 2 users who require more security in certain situations. Some Activity Level 1  and 3 users may also benefit from the device in similar situations, but this decision should be made with proper justification. It is not suitable for use in competitive sports events.

Contraindications

This device is not suitable for:

• Users who have not received gait training

Product Usage Instructions

Please read and understand all instructions for use, including safety information and maintenance instructions, before using the device.

Description and Intended Purpose

• These Instructions for Use are intended for use by the practitioner and user unless otherwise stated.
• The term device is used throughout these instructions for use to refer to Manual Knee ESK+ products.
• Please read and ensure you understand all instructions for use, in particular all safety information and maintenance instructions.

Application

• This device is to be used exclusively as part of a lower limb prosthesis.
• This device is for a single user.
• This device is a knee unit that provides a uniaxial frame for a weight-activated stabilized knee which provides support for the prosthesis at various cadences on on a variety of terrains and is intended to improve safety and reduce compensation.
• It is available with a fixed setting PSPC  (Pneumatic Swing Phase Control) unit.
• The device is equipped with a manually operated knee lock that can be engaged in situations when extra security is needed.

Features

Activity Level
This device is ideally suited to Activity Level 2 users who can benefit from the MKL in situations where more security is required (eight limits apply, see Technical Data). Additionally, some Activity Level 1 and 3 users might also benefit from the MKL in similar situations. But any such decision should be made with sound and thorough justification.

• 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 ambulatory who has the ability to traverse most environmental barriers and may have vocational, therapeutic, or exercise activity that demands prosthetic utilization beyond simple locomotion.

This device is not suitable for use in competitive sports events. These types of users might be better served by a specially designed prosthesis that is optimized for their needs.

Clinical Benefits

• Weight-activated stance control and adjustable swing control provide a smooth, safe gait with a free knee.
• Manually-operated lock allows patient to lock the knee for additional security when needed

Contraindications
This device is not suitable for:

• Users with extreme muscular weakness, contractures that cannot be correctly accommodated, or proprioceptive dysfunction including poor balance.
• Users with contralateral joint instabilities or pathology.
• Users with 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.
• Users with poor hand function may find difficult to operate the manual knee lock.Users must be given gait training before using this device.Make sure that the user has understood all instructions for use, drawing particular attention to all maintenance and safety information sections.

Safety Information

This warning symbol highlights important safety information.

• Beware of finger trap hazard 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 the heel height after finalization of alignment may adversely affect limb function.
• 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.
• The device is not intended for use when immersed in water or as a shower prosthesis. If the limb comes into contact with water wipe dry immediately.

Construction

Principal Parts

• Carrier Assembly Carbon fibre composite & stainless steel
• Chassis Assembly Aluminium alloy, stainless steel, engineering thermoplastic, fibre reinforced (asbestos free) friction material.
• Control Cylinder Aluminium alloy, stainless steel, Titanium, engineering thermoplastic
• Distal Dome Aluminium alloy
• Distal Pyramid Titanium with stainless steel bolt
• Distal Tube Clamp Aluminium alloy
• Patella Engineering thermoplastic

Function

The device is a uniaxial design comprising a knee pivot connecting a chassis to a carrier. A weight activated stabilizing knee mechanism is housed within the chassis. The stabilizing mechanism has a resilient action which provides limited stance flexion under load to absorb shock loads at heel strike. The device incudes a manually operated knee lock mechanism which, when activated by the user, automatically engages at full knee extension and prevents any further knee flexion regardless of applied body weight. When de-activated, the knee returns to weight activated stabilization. A pneumatic control cylinder sits within the carrier assembly, fitted between the chassis posterior pivot and the carrier distal pivot. The cylinder has manually adjustable valves which give independent control of flexion and extension resistance during swing phase.

Maintenance

Visually check the device regularly.
Report any changes in performance of this device to the practitioner/service provider e.g. unusual noises, increased stiffness or restricted/excessive rotation, significant wear or excessive discoloration from long term exposure to UV. Inform the practitioner/service provider of any changes in body weight and/or activity level.

Cleaning

Use a damp cloth and mild soap to clean the outside surfaces. DO NOT use aggressive cleansers. The remaining instructions in this section are for practitioner use only. This maintenance must be carried out only by competent personnel (practitioner or suitable trained technician). To maintain optimum performance, a periodic inspection for unacceptable noise, play and stability is recommended. The period between inspections is determined by factors such as the activity of the user, frequency of usage and the stability setting of the knee. As a guide, if the setting is 6 clicks or above and the user averages 600,000 steps per annum, an annual inspection is recommended. We recommend adjusting the knee to the individuals’ stability requirements to ensure optimal stability and durability. See adjustment guide/flow diagram. The use of a Limb Activity Monitor is recommended to determine step count. At these inspections:

• Check for visual defects that may affect proper function.
• Check condition and satisfactory operation of thigh release cable.
• Dis-assemble, clean and re-assemble knee mechanism.

Advise the user that a regular visual check of the device is recommended and 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.
Storage and Handling
When storing for prolonged periods, the device should be kept dry and within a temperature range of -15 ˚C to 50 ˚C. (5 ˚F to 122 ˚F) Use product packaging supplied.

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 -15 ˚C and 50 ˚C (5 ˚F to 122 ˚F).

Static Alignment

The instructions in this section are for practitioner use only.

Walking Trials

• Fully extend limb to access the adjuster.
• Rotate the SPRING STACK ADJUSTER to achieve the required stability for the individual amputee.
• Note: Audible clicks should be heard upon adjustment, and the adjuster is self locking.
• Tighten the SPRING STACK to reduce stability.
• Release the SPRING STACK to increase stability – See above.
• If required, the adjuster may be reset to the factory setting. This can be achieved by reducing stability by six audible clicks from the maximum stability setting.

Alignment Advice and Stability Adjustment

The instructions in this section are for practitioner use only.

MKL Adjustment

The instructions in this section are for practitioner use only. (These adjustments are carried out at the factory, however, should subsequent adjustment be required, these steps should be followed.) (These adjustments are carried out at the factory, however, should subsequent adjustment be required, these steps should be followed.)

Further Adjustments
The instructions in this section are for practitioner use only.

__

__

Knee does not stabilise

| Increase sensitivity
Shift socket Anteriorly
Replace stabilizing mechanism if trailing edge of brake is damaged
__

Knee does not release

| Decrease sensitivity
Check adjustment of front stop
Shift socket posteriorly
Knee Lock does not engage| Check lock engagement is not impaired/restricted by cos fairing (if fitted)
Play / rock in knee lock| Check adjustment of piston rod
Heel rise too high during swing| See control cylinder IFU
Heel rise too low during swing| See control cylinder IFU
User experiences terminal impact| See control cylinder IFU
Device does not fully extend during swing| See control cylinder IFU

If after following these instructions you still have problems with function please contact the sales team in your area for advice.

Cable Fitting

Using Thigh Release Kit (239640) – available separately. The instructions in this section are for practitioner use only.

1. Lay cable against socket and locate sleeve inside counterbore in front of chassis (make allowance for changes in alignment).
2. Feed inner cable through hole in chassis.
3. Feed cable through cable clamp and secure, clamping onto tinned area at end of cable.
4. When fitting cable to thigh release, ensure release lever operates against the patella to unlock knee as required.
5. Refer to fitting instructions supplied with Thigh Release Kit.

For adjustment of swing control device refer to the PSPC IFU 938057.

Assembly Instructions

The instructions in this section are for practitioner use only.
Removing ESK+ Mechanism Replacement of ESK+ Mechanism
The instructions in this section are for practitioner use only.

Technical Data

• Operating and Storage Temperature Range: -15 ˚C to 50 ˚C (5˚ F to 122 ˚F)
• Component Weight: 1.2 kg (2 lb 11 ozs)
• Activity Level: 1-3
• Maximum User Weight: 125 kg (275 lb)
• Maximum Flexion Angle: 115˚
• Proximal Alignment Attachment: Single Bolt (Blatchford)
• Distal Alignment Attachment: 30 mm Tube Clamp or Male Pyramid (Blatchford)
• Build Height: See Diagrams Below.

Fitting Length

Ordering Information

Order Example

Pneumatic Cylinder

|  |
ESK| SB| MKL| P| 30| ESK| SB| MKL| P| PYR

ESK+

| Single Bolt| Manual Knee Lock| ****

PSPC

| Distal Tube Clamp 30 mm| ****

ESK+

| Single Bolt| Manual Knee Lock| ****

PSPC

| Distal Pyramid

Replacement Parts

• 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, and the brake band for 12 months. 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.
  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.
  BThis product contains hydraulic oil, mixed metals and plastics. Where possible the components should be recycled in accordance with local waste handling regulations.

• Retaining the Packaging Label
  The practitioner is advised to keep the packaging label as a record of the device supplied.

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

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

CONTACT

• Blatchford Inc.
• 1031 Byers Road
• Miamisburg
• Ohio 45342
• USA
• Tel: +1 (0) 800 548 3534
• Fax: +1 (0) 800 929 3636
• Email: [email protected].
• www.blatchfordus.com.
• Blatchford Europe GmbH
• Am Prime-Parc 4
• 65479 Raunheim
• GERMANY
• Tel: +49 (0) 9221 87808 0
• Fax: +49 (0) 9221/87808 60
• Email: [email protected].
• www.blatchford.de.
• Email: [email protected].
• www.blatchford.fr.
• Blatchford Europe GmbH
• Am Prime-Parc 4
• 65479 Raunheim Germany
• 938405PK2/2-0322

© Blatchford Products Limited 2019. 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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