Blatchford BMK2 Knee 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
PK2
BMK2 Knee
Instructions for Use
BMK2
EN 2
SL 20
BG 38
HR 56
SK 74
HU 92
EL 110
LV 128
LT 146
ET 164

2
Contents
938268PK2/1-0422
EN
Contents.................................................................................................................................................................2
1 Description and Intended Purpose ....................................................................................................................3
2 Safety Information....................................................................................................................................................4
3 Construction ...............................................................................................................................................................5
4 Function........................................................................................................................................................................5
5 Maintenance...............................................................................................................................................................6
6 Limitations on Use....................................................................................................................................................7
7 Bench Alignment.......................................................................................................................................................8
8 Alignment Advice and Stability Adjustment...................................................................................................9
9 Dynamic Alignment .............................................................................................................................................. 10
10 Maintenance of Stabilizing Mechanism......................................................................................................... 11
11 Maintenance of Extension Buer..................................................................................................................... 15
12 Troubleshooting..................................................................................................................................................... 16
13 Technical Data ......................................................................................................................................................... 16
14 Ordering Information ........................................................................................................................................... 17
14.1 Spare Parts.......................................................................................................................................................... 17

3
1 Description and Intended Purpose
These instructions are for the clinician/practitioner.
The term device is used throughout these instructions for use to refer to BMK2 knee.
Ensure that the user understands all instructions for use, drawing particular attention to the
maintenance and safety information.
Users must be given gait training before using this device.
Application
This device is to be used exclusively as part of a lower limb prosthesis.
The device is a compact weight activated knee with an adjustable spring extension bias.
This device is intended for a single user.
Features
• Weight activated adjustable stance control
• Adjustable extension bias control incorporating terminal impact damping
• Maximum exion angle 130°
Activity Level
This device is for Activity Level 1 and 2 users only. For maximum user weight see Section 13
Technical Data.
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..
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2 Safety Information
This warning symbol highlights important safety information which must be
followed carefully.
Any changes in the performance or
function of the knee e.g. restricted
movement, non-smooth motion or
unusual noises should be immediately
reported to your service provider.
During the terminal swing immediately
before heel strike, some impact noise
may be heard due to the extension
assist as the limb reaches full extension.
Always use a hand rail when descending
stairs and at any other time if available.
Avoid exposure to extreme heat and/
or cold.
The device is not intended to be used
in water or as a shower prosthesis. If
the knee comes into contact with water
wipe dry immediately.
The device is not suitable for extreme
sports, running or cycle racing, ice and
snow sports, extreme slopes and steps.
Any such activities undertaken are done
so completely at the users’own risk.
Assembly, maintenance and repair of
the device must only be carried out by a
suitably qualied clinician.
When servicing the device make sure
there is no grease in the brake drum.
Ensure only suitably retrotted vehicles
are used when driving. All persons are
required to observe their respective
driving laws when operating motor
vehicles.
The user must not adjust or tamper
with the setup of the device.
The user should be advised to contact
their clinician if their condition
changes.
Be aware of nger trap hazard at all
times.
Any excessive changes in heel height
after nalization of alignment may
adversely aect limb function.
Contraindications
This device is not suitable for users with:
• Extreme muscular weakness, contractures that cannot be correctly accommodated, or
proprioceptive dysfunction including poor balance.
• Contralateral joint instabilities or pathology.
• 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.
Clinical Benets
• Stabilizing knee activates smoothly on weight bearing to give security when standing and
when traversing uneven ground. It then releases cleanly at toe o.
• Resilient action of stabilizing mechanism gives limited stance exion which reduces shock
at heel strike.
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5
Principal Parts
• Body Assembly (aluminum, stainless steel, polyurethane, felt)
• Knee Chassis Assembly (aluminum, stainless steel)
• Stabilizing Mechanism (aluminum, bronze, acetal homopolymer, polyurethane,
synthetic rubber)
Note… The friction material in the stabilizing mechanism contains no asbestos.
Sensitivity
Adjuster
Body
Assembly
Swing Control
Adjuster
Do not adjust or
tighten
Component Identication
The knee is weight activated and the sensitivity can be customized to suit the stability
requirements of the user.
Swing control is adjustable by altering the compression on a coil spring controlling heel rise and
extension bias.
3 Construction
4 Function
Knee Chassis
Assembly
Stabilizing
Mechanism
Extension
Buer
Extension
Buer Plate
5
10Nm
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6
5 Maintenance
Maintenance must be carried out by competent personnel.
It is recommended that the following maintenance is carried out annually:
• Check all non-adjuster screws for tightness (see Construction section) (DO NOT tighten the
covered nut at the distal end).
• Clean the brake pad and replace the extension stops (see Section 10 Maintenance of
Stabilizing Mechanism for procedure).
• In the event of unusual noises suchs as squeaks and creaks and/or reduced stability, carry
out maintenance of the stabilizing mechanism, see Section 10 Maintenance of Stabilizing
Mechanism. If noises persist contact your Blatchford representative.
• Wear and tear on the extension buer is acceptable. If excessive noise is present at full
extension replace the extension buer. See Section11 Maintenance of Extension Buer.
• Check for excessive Medio-Lateral play of the chassis.
• If the trailing edge of the brake band pad is worn down to the plastic of the brake band,
replace the complete brake band. (Note: Individual pads cannot be replaced.)
• Ensure orientation of brakeband is correct on reassembly. Always check stability before
using.
The user must be handed the User Guide supplied, and be advised to report the following to the
practitioner:
• Any changes in body weight or activity level
• Any changes in performance of this device
Changes in performance may include:
• Restricted swing
• Changes in smoothness of swing
• Reduced stability during stance
• Any unusual noise
Cleaning
Use a damp cloth and mild soap to clean outside surfaces, DO NOT use aggressive cleansers.
Thoroughly dry before use.
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6 Limitations on Use
Intended Life
Service life of the product is covered by the warranty period - 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.
Note… The device is weight activated and carrying loads may cause the stance support to engage
more readily.
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 and 122°F).
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8
7 Bench Alignment
Adjust heel
height to suit
the user’s own
footwear
Load line must be fall
between knee pivot center
and up to 5mm anterior to
the knee pivot center.
Users to be aware of
potential nger trap
hazard at all times.
Build Line
Knee Pivot
Center
When aligning the prosthesis for use with the device, position of the load line is critical. The knee
should be aligned so that it is geometrically stable. With exion fully accommodated, the load
line should pass through or up to 5mm anterior of the knee center.
Trochanter
Load Line
For foot alignment, refer to tting
instructions supplied with foot.
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8 Alignment Advice and Stability Adjustment
With amputee standing
and limb loaded
Does the knee release
smoothly at toe o?
Ask amputee to walk
SLOWLY
No
No
Yes
Adjustment
completed
Ask amputee to walk
at NORMAL speed
Does the knee release
smoothly at toe o?
*Full range of adjustment = 5 clicks
Yes
No
Yes
Yes
No
Increase
dorsiex
resistance
Does
the foot
dorsiex
excessively?
Align as recommended:
Shin Vertical, load line
through knee center, or up
to 5mm anterior
With 100% weight on limb,
can the user ex the knee?
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
3
*Increase
Stability
3
*Decrease
Stability
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9 Dynamic Alignment
Swing Control Adjustment (Extension Bias)
Note… If operated by hand, the engagement of the terminal impact damping may
be felt immediately before full extension; this is normal.
Situation Solution
Heel rise too high during
swing or device does not
fully extend during swing.
Increase
spring
assistance
Heel rise too low during
swing or user experiences
terminal impact.
Decrease
spring
assistance
2
Decrease
spring
assistance
Increase
spring
assistance
938268PK2/1-0422

STP
Oil Treatment
11
10 Maintenance of Stabilizing Mechanism
Use appropriate health and safety equipment at all times including extraction
facilities.
Be aware of nger trap hazard at all times.
Alignment Pins
Loosen 2 to 3
turns only
3
Cross Pins
12
3344
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12
Oscillate during
removal
Stabilizing Mechanism Kit
Part No. 239553
5566
7788
Wipe clean the brake band material with
paper, do not use solvents.
Brake Band
938268PK2/1-0422

Loctite
222
13
Re-assembly
Oscillate during
assembly
Note orientation
of mechanism
3
3Nm
9
10 11
12
Clean bore with suitable solvent.
938268PK2/1-0422

STP
Oil Treatment
14
Replace all 4 extension stops
annually. Extension stop kit
Part No 239453
Following maintenance it is important to review the user’s stability adjustment.
Refer to the owchart in the Alignment Advice and Stability Adjustment section.
Extension
Stops
13 14
15 16
Apply a thin smear of lubricant (Part
No. 928105) to the cross pins.
Make sure that no lubricant seeps
into the brake drum. This may cause
the device to become unstable.
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15
11 Maintenance of Extension Buer
Use appropriate health and safety equipment at all times including extraction
facilities.
Be aware of nger trap hazard at all times.
1
Extension
Buer
Extension
Buer Plate Cut
Using a knife, cut and remove the old
extension buer.
Clean the the top surface of the extension
buer plate using a suitable solvent.
2
Loctite
424
Stretch the new extension buer over the the
extension buer plate.
Secure the the extension buer to the
extension buer plate with Loctite 424.
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16
12 Troubleshooting
Symptom Solution
Excessive noise from knee. Clean the brake band and brake drum.
Apply lubricant to the pivot pins.
See Section 10 Maintenance of Stabilizing Mechanism for
procedures.
Knee not stabilising. Check the stability adjustment. See Section 8 Alignment
Advice and Stability Adjustment.
Clean the brake drum.
Check the brake pads for wear and replace the stabilizing
mechanism if the trailing edge of the brake is damaged.
See Section 10 Maintenance of Stabilizing Mechanism for
procedures.
Knee does not release. Check the stability adjustment. See Section 8 Alignment
Advice and Stability Adjustment.
13 Technical Data
Operating and
Storage Temperature Range:
-15°C to 50 °C
5°F to 122 °F
Component Weight: 580g (1 lb 5 ozs)
Recommended Activity Level: 2
Maximum User Weight: 125kg (275 lb)
Proximal Alignment attachment: Rotating Male Pyramid (Blatchford)
Distal attachment 30mm dia tube clamp (Blatchford)
Build Height:
Proximal pyramid to distal tube end
[See Fitting Length on page 17]
127mm
( +130mm)
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17
Fitting Length
127mm
Ø 30mm
60mm
130mm
maximum
130°
34mm
34mm
14 Ordering Information
Order Example
14.1 Spare Parts
Extension Stop Kit 239453
Description Qty Illustration
Extension Stop - BMK2 4
Fitting Instructions 1
BMK2
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Stabilizing Mechanism Kit 239553
Description Qty Illustration
Compact Stabilizing Mechanism 1
Dust Cover LH 1
Dust Cover RH 1
Cross Pin 2
Retainer External ‘E’ Ring 2
Alignment Pin 2
BMK2 Adjustment Warning Tag 1
Fitting Instructions 1
Extension Buer
Description Qty Part Number Illustration
Extension Buer 1 B-0000021
Consumables
Description Qty Part Number Illustration
STP Oil Treatment
Loctite 222 Screwlock
Loctite 424 Adhesive
A/R
A/R
A/R
928105
926001
926104
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19
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 from original date of purchase unless otherwise stated.
The Compact Stabilizing Mechanism is warranted for 12 months from original date of purchase
unless otherwise stated. Wear and tear on the brake band is excluded from the warranty. 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 including wear and tear.
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
Where possible the components should be recycled in accordance with local waste handling
regulations.
Retaining the Packaging Label
You are advised to keep the packaging label as a record of the device supplied.
Medical Device Single Patient – multiple use
Trademark Acknowledgements
Blatchford is a registered trademark of Blatchford Products Limited.
Manufacturer’s Registered Address
Blatchford Products Limited, Lister Road, Basingstoke RG22 4AH, UK
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20 938268PK2/1-0422
Vsebina SL
Vsebina................................................................................................................................................................. 20
1 Opis in namen uporabe....................................................................................................................................... 21
2 Varnostne informacije .......................................................................................................................................... 22
3 Konstrukcija.............................................................................................................................................................. 23
4 Delovanje.................................................................................................................................................................. 23
5 Vzdrževanje.............................................................................................................................................................. 24
6 Omejitve uporabe.................................................................................................................................................. 25
7 Namizna poravnava............................................................................................................................................... 26
8 Pripomoček za poravnavo in nastavitev stabilnosti.................................................................................. 27
9 Dinamična poravnava........................................................................................................................................... 28
10 Vzdrževanje stabilizacijskega mehanizma.................................................................................................... 29
11 Vzdrževanje blažilnika iztega............................................................................................................................. 33
12 Odpravljanje napak ............................................................................................................................................... 34
13 Tehnični podatki..................................................................................................................................................... 34
14 Podatki za naročanje............................................................................................................................................. 35
14.1 Nadomestni deli ............................................................................................................................................... 35