Blatchford PK1 ESK+ Stanceflex Pneumatic Prosthetic Knee Instructions

Blatchford PK1 ESK+ Stanceflex Pneumatic Prosthetic Knee

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 Stanceflex 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.
The device is a uniaxial weight activated stabilized knee with integrated stance flexion element and is intended to improve safety and reduce compensation.
The shin can be fitted with a PSPC (Pneumatic Swing Phase Control) or SmartIP (Smart Intelligent Prosthesis) swing phase control or supplied without a cylinder.
A rubber element at the rear of the knee chassis provides extra stance flexion.

Features

| Manually adjusted PSPC| Microprocessor controlled SmartIP
---|---|---
Stance flexion during weight bearing|

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Tough carbon fibre frame| ✔|

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140 degree knee flexion|

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Adjustable sensitivity of knee stability|

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Independent manually adjustable swing controls for flexion and extension|

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Microprocessor controlled swing control in flexion with manually adjustable terminal impact damping in extension| |

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Activity Level
This device is for Activity Level 2, 3 and 4 users (weight limits apply, see Technical Data). This device might not be suitable for Activity Level 1 users or 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.

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.

Clinical Benefits

• Weight-activated stance control and adjustable swing control provide smooth, safe gait with a free knee.
• Stanceflex improves shock absorption.
• Microprocessor swing control allows optimized gait characteristics across a range of walking speeds. (SmartIP only.)

Contraindications

This device is not suitable for:

• Users with extreme muscular weakness, contractures that cannot be correctly accommodated, or proprioceptive dysfunction including poor lance.
• 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 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.
• Distal Dome Aluminium alloy
• Distal Pyramid Titanium with stainless steel bolt
• Distal Tube Clamp Aluminium alloy
• Patella Engineering thermoplastic
• Stanceflex Rubber Natural rubber
• Stanceflex strap Kevlar
• PSPC Aluminium alloy, stainless steel, titanium, engineering thermoplastic
• SmartIP Control Cylinder Aluminium alloy, stainless steel, Titanium, engineering thermoplastic Electronic components, batteries
  

Function

The knee 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 knee chassis has a pivotally connected top plate which is resiliently supported by a rubber block, this provides a stance flexion action under load and absorbs shock loads at heel strike.

A knee control cylinder sits within this frame assembly, fitted between the chassis posterior pivot and the carrier distal pivot.

The PSPC cylinder has manually adjustable valves which give independent control of flexion and extension resistance during swing phase.

The SmartIP control cylinder uses sensors inside the cylinder to monitor walking speed and automatically adjusts flexion resistance accordingly. Extension control is via fixed adjustment of a terminal impact damper.

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.
If the stability setting is less than 6 clicks and/or the user averages fewer than the average number of steps, the period in between inspections may be longer.
The use of a Limb Activity Monitor is recommended to determine step count.
We recommend adjusting the knee to the individuals’ stability requirements to ensure optimal stability and durability. See adjustment guide/flow diagram.

At these inspections:

• Check for visual defects that may affect proper function.
• Check for M-L play of chassis and excess compression of the Stanceflex rubber. Replace bearings and Stanceflex rubber if necessary.
• Check front stop and replace if necessary.
• Check shin stops and replace if necessary.
• Dis-assemble, clean and reassemble 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.

If this device is used for extreme activity, the maintenance level and interval should be reviewed and if required advice and technical support sought to plan a new maintenance schedule dependent upon the frequency and nature of the activity. This should be determined by a local risk assessment carried out by a suitably qualified individual.

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)

Bench Alignment

The instructions in this section are for practitioner use only.

Walking Trials

Spring Stack Adjuster

Spring Stack Adjuster

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.

Fitting Advice

The instructions in this section are for practitioner use only.

Changing Stanceflex Rubbers

Static

Knee Flexion Following Heel Strike

Static

Knee Flexion Following Heel Strike

Front Stop Adjustment – Adjustable Trunnion

The instructions in this section are for practitioner use only.

Fitted to the PSPC

1. Fully tighten front stop.
   

2. Loosen trunnion clamp screw.
   Turn piston rod to reveal thread and apply Loctite 243.
   Reassemble and screw piston rod fully home. The chassis should now be slightly flexed.
   

3. Apply a light extension load to the knee and gradually unscrew the piston rod (lengthening the cylinder) until the chassis edge is parallel with the top of the shin.
   

4. Note… The stop pads mounted in the chassis and side plate are required to support ML loading. Simultaneous full contact between the stops and the shin is NOT required.
   

Front Stop Adjustment – Non-Adjustable Intelligent Prosthesis
(As fitted to older SmartIP models.)
No adjustment is necessary when using these cylinders. They require the front stop to be fully tightened as shown in Stage 1.

Further Adjustments

The instructions in this section are for practitioner use only.

Shift socket Anteriorly
Replace stabilizing mechanism if trailing edge of brake is damaged
Check Stanceflex rubber and replace if necessary

(See minimum thickness in compression in Knee Flexion Following Heel Strike section)

Knee does not release| Decrease sensitivity
Check correct adjustment of piston rod length
Shift socket posteriorly
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 the function please contact the sales team in your area for advice.

Assembly Instructions

The instructions in this section are for practitioner use only.

Changing Front Stop Buffer

When fitting a new front stop, always re-adjust, and if applicable check length of cylinder if fitted with an adjustable trunnion. (See previous page.)

Changing Shin Stops

1. Remove shin stops and remainder of adhesive. Clean and lightly abrade mating surfaces.
   

2. Apply Loctite 424 on mating surfaces. Press shin stops into place.
   

Removing ESK+ Mechanism

The instructions in this section are for practitioner use only.

Remove all preload and record number of clicks

Brake band material may be wiped clean with paper, do not use solvents.

Replacement of ESK+ Mechanism

1. Offer up side plate to align slot in spindle (2) with dowel (1) but do not fit at this stage.
   

2. Screw spindle to chassis.
   

3. Oscillate during assembly
   

4. 5. 

5. 

6. 

7. Re-apply preload with recorded number of clicks.
   

The instructions in this section are for practitioner use only.

Technical Data

Component Weight:
SmartIP| 1.27 kg (2 lb 12.8 ozs)
PSPC| 1.13 kg (2 lb 8 ozs)
Activity Level:| 2-3 (4)
Maximum User Weight:
Activity Levels 2-3| 125 kg (275 lb)
Activity Level 4| 100 kg (220 lb 7.4 ozs)
Maximum Flexion Angle:| 140˚
Proximal Alignment Attachment:| Single Bolt (Blatchford)
Distal Alignment Attachment:| 30 mm Tube Clamp or Male Pyramid (Blatchford)
Build Height:| See Diagrams Below.

Fitting Length

ESK+ Stance flex with Distal Pyramid

ESK+ Stance flex with 30 mm Distal Tube Clamp

Ordering Information

Order Example

| ESK+ with Stanceflex
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30 mm Distal Tube Clamp| Distal Pyramid
Pneumatic Cylinder| |
ESK| SF| P| 30| ESK| SF| P| PYR
ESK+| Stanceflex| PSPC| Distal Tube Clamp 30 mm| ESK+| Stanceflex| PSPC| Distal Pyramid
SmartIP Knee| |
SMARTIP| SF| 30| SMARTIP| SF| PYR
SmartIP Knee| Stanceflex| Distal Tube Clamp 30 mm| SmartIP Knee| | Stanceflex| Distal Pyramid
No Control Cylinder Fitted| |
ESK| SF| 30| ESK| SF| PYR
ESK+| Stanceflex| Distal Tube Clamp 30 mm| ESK+| | Stanceflex| Distal Pyramid

Replacement Parts

Stanceflex Rubber

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
Single Patient – multiple use

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, 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.

Environmental Aspects

This 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

Customers Support

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

938403PK1/2-0322

© 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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