Blatchford ESK+ Manual Knee Lock User manual

Instructions for Use
Navodila za uporabo
Инструкции за употреба
Upute za uporabu
Návod na použitie
Használati útmutató
Οδηγίες χρήσης
Lietošanas pamācība
Naudojimo instrukcija
Kasutusjuhend
ESK+ Manual Knee Lock
Instructions for Use
ESKSBMKLP30, ESKSBMKLPPYR
EN 2
SL 19
BG 36
HR 53
SK 70
HU 87
EL 104
LV 121
LT 138
ET 155
PK2

2
Contents EN
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ....................................................................................................................3
2 Safety Information....................................................................................................................................................5
3 Construction ...............................................................................................................................................................6
4 Function........................................................................................................................................................................7
5 Maintenance...............................................................................................................................................................7
6 Limitations on Use....................................................................................................................................................8
7 Static Alignment........................................................................................................................................................9
8 Alignment Advice and Stability Adjustment................................................................................................ 10
9 MKL Adjustment..................................................................................................................................................... 11
9.1 Further Adjustments....................................................................................................................................... 12
10 Cable Fitting............................................................................................................................................................. 13
11 Assembly Instructions .......................................................................................................................................... 14
11.1 Removing ESK+ Mechanism ........................................................................................................................ 14
11.2 Replacement of ESK+ Mechanism............................................................................................................. 15
12 Technical Data ......................................................................................................................................................... 16
13 Ordering Information ........................................................................................................................................... 17
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1 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 xed 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
Manually adjusted
PSPC
Manual knee lock
engaged
Limited stance exion during weight
bearing 
Tough carbon bre frame  
115 degree knee exion 
Adjustable sensitivity of knee stability 
Independent manually adjustable swing
controls for exion and extension 
Locked knee for prolonged weight
bearing and additional security 
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Activity Level
This device is ideally suited to Activity Level 2 users who can benet 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 benet from the MKL in similar
situations. But any such decision should be made with sound and thorough justication.
Activity Level 1
Has the ability or potential to use a prosthesis for transfers or ambulation on level surfaces at xed
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.
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 Benets
• 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 aect stability and durability.
• Users with poor hand function may nd dicult 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.
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2 Safety Information
This warning symbol highlights important safety information.
Beware of nger 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 nalization of alignment
may adversely aect limb function.
Ensure only suitably retrotted 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 aect
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 qualied 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.
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3 Construction
Principal Parts
• Carrier Assembly Carbon bre composite & stainless steel
• Chassis Assembly Aluminium alloy, stainless steel, engineering thermoplastic,
bre 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
5
10Nm
Tube Clamp Screw
Pyramid Tube Clamp
Carrier Assembly
Chassis Assembly
Distal Dome
Patella
Control Cylinder
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4 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 exion 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 exion
regardless of applied body weight.
When de-activated, the knee returns to weight activated stabilization.
A pneumatic control cylinder sits within the carrier assembly, tted between the chassis posterior
pivot and the carrier distal pivot.
The cylinder has manually adjustable valves which give independent control of exion and
extension resistance during swing phase.
5 Maintenance
Visually check the device regularly.
Report any changes in performance of this device to the practitioner/service provider e.g.
unusual noises, increased stiness or restricted/excessive rotation, signicant 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/ow diagram.
The use of a Limb Activity Monitor is recommended to determine step count.
At these inspections:
• Check for visual defects that may aect proper function.
• Check condition and satisfactory operation of thigh release cable.
• Dis-assemble, clean and re-assemble knee mechanism.
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6 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).
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 stiness, 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.
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7 Static Alignment
2.5
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.
The instructions in this section are for practitioner use only.
Decrease
Stability
Increase
Stability
Walking Trials
Underside View of Chassis
Build Line
Trochanter
Knee Pivot
Ankle Centre
Spring Stack Adjuster
938405PK2/2-0322

No
10
*Note:
Initial coarse
adjustments may
be carried out in
increments of 2
or more clicks,
followed by ne
adjustment of
a single click as
required
Start
Align as recommended
(Shin Vertical, load line
through knee centre)
With user standing and
limb loaded
Increase
dorsiexion
resistance.
Check level of stability
is sucient for amputee
needs and adjust
accordingly**
**Note,
There may
be a need to
compromise
between
maximum
walking speed
and level of
stability
Adjustment complete
If reducing the sensitivity
fails to have any eect
other than reducing the
stability, check that the
front stop is properly
adjusted
i.e. contacting the chassis
when loaded. Failure to
do so can result in the
brake operating when
hyper- extended
Does the foot have a low
dorsiexion resistance?
Ask user to walk
SLOWLY
Ask user to walk
at NORMAL speed
Does the knee release
smoothly at toe o?
Ask user to walk
FAST
Does the knee release
smoothly at toe o?
unable
to walk
fast
Does the knee release
smoothly at toe o?
Yes No
Yes No
No
No
Yes
Yes
Yes
Increase stability*
8 Alignment Advice and Stability Adjustment
The instructions in this section are for practitioner use only.
underside view of chassis
underside view of chassis
Reduce stability*
With 100% weight on limb,
can the user ex the knee?
Note...Wearer standing
inparallel bars, gently
holding rails.
938405PK2/2-0322

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6 A/F
9 MKL Adjustment
(These adjustments are carried out at the factory, however, should subsequent adjustment be
required, these steps should be followed.)
2.5
2.5
Back o front stop.
2.5
Loosen trunnion
clamp screw.
Turn piston rod
to reveal thread
and apply
Loctite 242 and
reassemble.
6 A/F
Adjust piston rod until the Patella
locks into place over front of
chassis without rocking.
Withdraw trunnion damp
screw and apply LOCTITE 222
to thread, re-assemble and
tighten.
*UNDER NO CIRCUMSTANCES
MUST THE PISTON ROD
WITNESS LINE (RED)
BE VISIBLE BELOW THE
TRUNNION.
Apply a slight
extension load.
Insert a 5mm wide
piece of paper
between fron
stop and buer.
Adjust front stop
until paper can be
removed under
slight resistance.
Any nal adjustment required to
alleviate rocking should be by
adjustment of the front stop.
Check operation of lock again,
immediately prior to tting to wearer.
The instructions in this section are for practitioner use only.
6
5
4
3
12
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9.1 Further Adjustments
Symptom Solution
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 tted)
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.
The instructions in this section are for practitioner use only.
938405PK2/2-0322

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.
1.5
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 tting cable to thigh release, ensure release lever operates against the patella to
unlock knee as required.
5. Refer to tting instructions supplied with Thigh Release Kit.
Using Thigh Release Kit (239640) - available separately.
For adjustment of swing control device refer to the PSPC IFU 938057.
10 Cable Fitting
Cable Clamp
Cable Sleeve
Cable
Release
Lever
Knee Locked Knee Unlocked
Patella and shin components
not shown for clarity.
The instructions in this section are for practitioner use only.
938405PK2/2-0322

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11 Assembly Instructions
3
STP
Oil Treatment
2.5
1
2
1
11.1 Removing ESK+ Mechanism
8
Remove all preload and
record number of clicks
View from below.
3
Brake band material may be wiped clean with paper, do not use
solvents. Clean bore with suitable solvent.
The instructions in this section are for practitioner use only.
7
6
32
1
4 5
938405PK2/2-0322

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3
LOCTITE
222
STP
Oil Treatment
RH
LH
2.5
STP
Oil Treatment
2
1
2
LOCTITE
222
3
11.2 Replacement of ESK+ Mechanism
ORIENTATION IS IMPORTANT!
Assemble at sides and lettering (RH, LH) facing inwards.
Re-apply preload
with recorded
number of clicks.
Underside
view of
chassis.
The instructions in this section are for practitioner use only.
57 6
4
3
2
1
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12 Technical Data
Fitting Length
45 mm
223 mm
45 mm
262 mm
34 mm
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.
ESK+ MKL
with 30 mm Distal Tube Clamp
ESK+ MKL
with Distal Pyramid
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ESK+ with Manual Knee Lock
30 mm Distal Tube Clamp Distal Pyramid
Pneumatic
Cylinder
ESK SB MKL P 30
ESK+ Single
Bolt
Manual
Knee
Lock
PSPC
Distal Tube
Clamp
30 mm
Order Example
13 Ordering Information
Item Part. No.
ESK+ MKL Knee Assembly 239440
Thigh Release Kit 239640
ESK Mechanism Alignment Pin 234914
ESK+ Stabilizing Mechanism Kit 239949
Replacement Parts
ESK SB MKL P PYR
ESK+ Single
Bolt
Manual
Knee
Lock
PSPC Distal
Pyramid
938405PK2/2-0322

Medical Device Single Patient – multiple use
18
Liability
The manufacturer recommends using the device only under the specied 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 classied as a class I device according to the classication rules
outlined in Annex VIII of the regulation. The EU declaration of conformity certicate 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 eld 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 modications 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.
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Vsebina SL
Vsebina................................................................................................................................................................. 19
1 Opis in namen uporabe....................................................................................................................................... 20
2 Varnostne informacije .......................................................................................................................................... 22
3 Konstrukcija.............................................................................................................................................................. 23
4 Delovanje.................................................................................................................................................................. 24
5 Vzdrževanje.............................................................................................................................................................. 24
6 Omejitve uporabe.................................................................................................................................................. 25
7 Statična prilagoditev............................................................................................................................................. 26
8 Pripomoček za poravnavo in nastavitev stabilnosti.................................................................................. 27
9 Prilagoditev MKL .................................................................................................................................................... 28
9.1 Dodatne prilagoditve ..................................................................................................................................... 29
10 Namestitev kabla.................................................................................................................................................... 30
11 Navodila za sestavljanje....................................................................................................................................... 31
11.1 Odstranjevanje mehanizma ESK+.............................................................................................................. 31
11.2 Zamenjava mehanizma ESK+...................................................................................................................... 32
12 Tehnični podatki..................................................................................................................................................... 33
13 Podatki za naročanje............................................................................................................................................. 34
938405PK2/2-0322

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1 Opis in namen uporabe
Ta navodila za uporabo so predvidena za zdravnika in uporabnika, razen če je navedeno drugače.
Izraz pripomoček se v teh navodilih za uporabo uporablja za izdelke Manual Knee ESK+.
Preberite in poskrbite, da boste razumeli vsa navodila za uporabo, predvsem vse varnostne
informacije in navodila za vzdrževanje.
Uporaba
Pripomoček je predviden izključno kot del proteze za spodnje okončine.
Ta pripomoček je predviden samo za enega uporabnika.
Pripomoček je kolenska enota z enoosnim okvirjem za težnostno aktivirano stabilizirano
koleno, ki daje oporo protezi pri hoji z različno kadenco na različnih površinah in je predviden
za izboljšanje varnosti ter zmanjšanje kompenzacije. Na voljo je s ksno nastavitvijo enote PSPC
(nadzor faze pnevmatskega nihanja).
Pripomoček je opremljen z ročno upravljanim kolenskim zapahom, ki ga je mogoče aktivirati
vsituacijah, ko je potrebna dodatna varnost.
Lastnosti
Ročno nastavljena
enota PSPC
Ročni zapah kolena
aktiviran
Omejena eksija med fazo stanja pri
obremenitvi 
Okvir iz trdih karbonskih vlaken  
115-stopinjska eksija kolena 
Nastavljiva občutljivost stabilnosti
kolena 
Samostojno ročno nastavljive krmilne
enote nihanja za krčenje in izteg 
Zaklenjeno koleno za daljšo
obremenitev in dodatno varnost 
938405PK2/2-0322