Blatchford ESK+ 4-Bolt 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+ 4-Bolt
Instructions for Use
ESK4BP30
ESK4BPPYR
SMARTIP4B30
SMARTIP4BPYR
ESK4B30
ESK4BPYR
EN 2
SL 19
BG 36
HR 53
SK 70
HU 87
EL 104
LV 121
LT 138
ET 155
PK2

938404PK2/2-0322
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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 Front Stop Adjustment - Adjustable Trunnion............................................................................................. 11
9.1 Further Adjustments....................................................................................................................................... 12
10 Assembly Instructions .......................................................................................................................................... 13
10.1 Changing Front Stop Buer.......................................................................................................................... 13
10.2 Changing Shin Stops....................................................................................................................................... 13
10.3 Removing ESK+ Mechanism ........................................................................................................................ 14
10.4 Replacement of ESK+ Mechanism............................................................................................................. 15
11 Technical Data ......................................................................................................................................................... 16
12 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 4-Bolt 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 a variety of terrains and is
intended to improve safety and reduce compensation.
The shin can be tted with a PSPC (Pneumatic Swing Phase Control), a SmartIP (Smart Intelligent
Prosthesis) or supplied without a cylinder.
The device has a choice of 4-bolt or T-slot connections proximally and a choice of male pyramid
or 30 mm tube clamp connections distally.
Manually adjusted
PSPC
Microprocessor
controlled SmartIP
Stance exion during weight bearing  
Tough carbon bre frame  
140 degree knee exion  
Adjustable sensitivity of knee stability  
Independent manually adjustable swing
controls for exion and extension 
Microprocessor controlled swing control
in exion with manually adjustable
terminal impact damping in extension

Features

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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 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.
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 Benets
• Weight-activated stance control and adjustable swing control provide smooth, safe gait
with a free knee.
• Microprocessor swing control allows optimized gait characteristics across a range of
walking speeds. (SmartIP only.)
• The stabilizing mechanism has a resilient action which provides limited stanceexion under
load to absorb shock loads at heel strike.
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 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.

Pyramid Tube Clamp
Carrier Assembly
Chassis Assembly
Distal Dome
Patella
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3 Construction
PSPC
SmartIP
Principal Parts
• Carrier Assembly Carbon bre composite & stainless steel
• Chassis Assembly Aluminium alloy, stainless steel, engineering thermoplastic,
bre reinforced (asbestos free) friction material.
• Distal Dome Aluminium alloy
• Distal Pyramid Titanium with stainless steel bolt
• Distal Tube Clamp Aluminium alloy
• Patella Engineering thermoplastic
• PSPC Aluminium alloy, stainless steel, titanium, engineering thermoplastic
• SmartIP Control Cylinder Aluminium alloy, stainless steel, Titanium, engineering thermoplastic
Electronic components, batteries
5
10Nm
Tube Clamp Screw

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4 Function
The knee is a uniaxial design comprising a knee pivot connecting a chassis to a carrier. A weight
activated stabilising knee mechanism is housed within the chassis. The stabilising mechanism
has a resilient action which provides limited stance exion under load to absorb shock loads at
heel strike.
A knee control cylinder sits within this frame assembly, tted between the chassis posterior pivot
and the carrier distal pivot.
The PSPC cylinder has manually adjustable valves which give independent control of exion and
extension resistance during swing phase.
The SmartIP control cylinder uses sensors inside the cylinder to monitor walking speed and
automatically adjusts exion resistance accordingly. Extension control is via xed adjustment of a
terminal impact damper.
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.
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/ow diagram.
At these inspections ;
• Check for visual defects that may aect proper function.
• Check front stop and replace if necessary.
• Check shin stops and replace if necessary.
• Dis-assemble, clean and reassemble.

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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.

Decrease
Stability
Increase
Stability
Walking Trials
Underside View of Chassis
Build Line
Trochanter
Knee Pivot
Ankle Centre
Spring Stack Adjuster
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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.
7 Static Alignment

No
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*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?
8 Alignment Advice and Stability Adjustment
Yes No
No
No
No
Yes
Yes
Yes
Yes
The instructions in this section are for practitioner use only.
underside view of chassis
underside view of chassis
Increase stability*
Reduce stability*
With 100% weight on limb,
can the user ex the knee?
Note...Wearer standing
in parallel bars, gently
holdingrails.

1 2
3 4
938404PK2/2-0322
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For adjustment of swing control devices see appropriate IFU.
9 Front Stop Adjustment - Adjustable Trunnion
Fitted to the PSPC
Fully tighten front stop.
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 exed.
6 A/F -PSPC
Front Stop Adjustment - Non-Adjustable Intelligent Prosthesis
(As tted 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.
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.
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.
The instructions in this section are for practitioner use only.
Withdraw trunnion clamp screw
and apply LOCTITE 222 to thread,
re-assemble and tighten.
*UNDER NO CIRCUMSTANCES MUST
THE PISTON ROD WITNESS LINE BE
VISIBLE BELOW THE TRUNNION.

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

12
12
938404PK2/2-0322
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1
When tting a new front stop, always re-adjust, and if applicable check length of cylinder if tted
with an adjustable trunnion. Adjust if necessary. (See previous page.)
10 Assembly Instructions
10.1 Changing Front Stop Buer
The instructions in this section are for practitioner use only.
10.2 Changing Shin Stops
1
1
Remove shin stops and remainder of
adhesive. Clean and lightly abrade mating
surfaces.
Apply Loctite 424 on mating surfaces. Press
shin stops into place.
Shin Stops
Mating Surfaces
424

7
13
4 5 6
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2
10.3 Removing ESK+ Mechanism
8
Remove all preload and
record number of clicks
View from below.
Clean bore with suitable solvent
8
The instructions in this section are for practitioner use only.
RH
LH
Brake band material may be wiped clean with paper, do not use
solvents.

7
5 6
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4
3
2
1
10.4 Replacement of ESK+ Mechanism
Underside
view of
chassis.
Re-apply preload
with recorded
number of clicks.
The instructions in this section are for practitioner use only.
RH
LH
ORIENTATION IS IMPORTANT!
Assemble at sides and lettering (RH, LH) facing inwards.

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11 Technical Data
Operating and Storage Temperature Range: -15˚C to 50˚C
(5˚F to 122˚F)
Component Weight:
SmartIP
PSPC
1.27kg (2lb 9ozs)
1.13kg (2lb 8ozs)
Activity Level: 2-3 (4)
Maximum User Weight:
Activity Levels 2-3
Activity Level 4
125kg (275lb)
100kg (220lb 7.4ozs)
Maximum Flexion Angle: 140˚
Proximal Alignment Attachment: 4-bolt or T slot
Distal Alignment Attachment: 30 mm Tube Clamp
or Male Pyramid (Blatchford)
Build Height: See Diagrams Below.
Fitting Length
36 mm
223 mm
36 mm
262 mm
34 mm
ESK+ 4-Bolt
with 30 mm Distal Tube Clamp
ESK+ 4-Bolt
with Distal Pyramid

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12 Ordering Information
Order Example
Item Part. No.
4-Bolt ESK+ Knee Assembly 239150
ESK Mechanism Alignment Pin 234914
Front Stop Pad 234903
ESK+ Stabilizing Mechanism Kit 239949
Replacement Parts
ESK+ with 4-Bolt Adapter
30 mm Distal Tube Clamp Distal Pyramid
Pneumatic
Cylinder
SmartIP
Knee
No Control
Cylinder
Fitted
ESK 4B P 30
ESK+ 4-Bolt
Adapter PSPC
Distal Tube Clamp
30 mm
SMARTIP 4B 30
SmartIP
Knee
4-Bolt
Adapter
Distal Tube Clamp
30 mm
ESK 4B 30
ESK+ 4-Bolt
Adapter
Distal Tube Clamp
30 mm
ESK 4B P PYR
ESK+ 4-Bolt
Adapter PSPC Distal Pyramid
SMARTIP 4B PYR
SmartIP
Knee
4-Bolt
Adapter
Distal
Pyramid
ESK 4B PYR
ESK+ 4-Bolt
Adapter
Distal
Pyramid

Medical Device Single Patient – multiple use
938404PK2/2-0322
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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 sprednjega omejevala– nastavljiv tečaj............................................................................... 28
9.1 Dodatne prilagoditve ..................................................................................................................................... 29
10 Navodila za sestavljanje....................................................................................................................................... 30
10.1 Zamenjava blažilnika sprednjega omejevala......................................................................................... 30
10.2 Zamenjava omejeval goleni......................................................................................................................... 30
10.3 Odstranjevanje mehanizma ESK+.............................................................................................................. 31
10.4 Zamenjava mehanizma ESK+...................................................................................................................... 32
11 Tehnični podatki..................................................................................................................................................... 33
12 Podatki za naročanje............................................................................................................................................. 34

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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 4-vijačne izdelke 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.
Golen je lahko opremljena z enoto PSPC (nadzor faze pnevmatskega nihanja), enoto SmartIP
(pametna inteligentna proteza) ali pa je dobavljena brez valja.
Pripomoček ima možnost proksimalne 4-vijačne priključitve ali priključitve s T-režo in možnost
distalne priključitve z moškim piramidnim adapterjem ali 30-milimetrsko cevno objemko.
Ročno nastavljena
enota PSPC
SmartIP, krmiljen z
mikroprocesorjem
Fleksija v fazi stanja pri obremenitvi  
Okvir iz trdih karbonskih vlaken  
140-stopinjska eksija kolena  
Nastavljiva občutljivost stabilnosti
kolena  
Samostojno ročno nastavljive krmilne
enote nihanja za krčenje in izteg 
Z mikroprocesorjem krmiljen nadzor
nihanja pri krčenju z ročno nastavljivim
blaženjem na koncu iztega

Lastnosti