Blatchford S400 User manual

S400
Instructions for Use
ENS400
EN Instructions for Use 3

1 Description andpurpose
Product Code
•ENS400 Polycentric mechanical knee unit with lock (Aluminum)
These instructions are for use by the practitioner.
•The ENS400 knee is to be used exclusively as part of a lowerlimb prosthesis. Intended
User:
•Recommended for amputees with Mobility Grades 2/3
•Weight limit for a user is up to 125kg/275lbs
Contra-indications
•Residual muscular weakness, contractures or proprioceptive dysfunction including poor
balance
•Contra lateral joint instabilities or pathology
•Complicated conditions involving multiple disabilities
•Non level K2/K3 users
Ensure that the user has understood any Instructions for use,
drawing particular attention to the safety information.

2 Construction
Principle Parts:
•Frame
•Knee head
•Knee control
AluminumAlloy, Brass, Stainless Steel, Steel
AluminumAlloy, Stainless Steel
Various materials principallyAluminumAlloy, Stainless Steel,
Polyurethane Bumper
(a) (b) (c)
Fig. 1 (a) Posterior View (b) Anterior View (c) Lateral View of Knee Unit

Spare parts of ENS400 (spare parts available with the spare parts number shown)

The caution symbol highlights safety information which must be followed carefully
3 Function
•Adjustable extension assist spring
•Upper pyramids facilitating alignment adjustment for all socket designs
•Adjustable the head level of knee
•A low profile carbon body for variety of residual limb lengths
•The Flex/Ext resistance of knee adjustable
4 Safety Information
Be aware of finger trap hazard at all times
Any changes in performance of the knee e.g. instability or double action in the
knee, should be immediately reported to the Clinician/Practitioner
Always use a hand rail when descending stairs and at any other time if
available
Any excessive changes in heel height may adversely affect the stability of the
knee
The user should be advised to contact their Clinician/Practitioner if their
condition changes

5 Maintenance
Maintenance must be carried out by qualified personnel.
A visual inspection annually is recommended.
Check for visual defects that may affect proper function.
A loaner system is available should servicing be required.
The wearer should be advised:
Any changes in performance of this device must be reported to the
Clinician/Practitioner.
Changes in performance may include:
•Increase in knee stiffness
•Knee instability
•Any unusual noises
Cleaning:
Use a damp cloth and mild soap to clean the outside surface. DO NOT use
aggressive cleansing agents.
If the limb comes into contact with salt or chlorinated water, it should be rinsed
with fresh water and dried.

6 Limitation on use
Intended Life:
•Service life of the product is covered by the warranty period.
•This product is recommended for use with other Blatchford Products.
•A local risk assessment should be carried out based upon activity and usage
Lifting Loads:
Amputee weight and activity is governed by the stated limits.
Load carrying by the amputee should be based on a local risk assessment.
Environment:
Avoid abrasive environments such as those containing sand for example as these
may promote premature wear.
Operating and Storage Temperature Range:
Exclusively for use between temperatures of -10˚C and 50˚C [14˚F and 122˚F]

7 Alignment and Set-up
Users be aware of potential finger trap hazard

1. Assemble the prosthesis.
2. Recommended static/bench alignment is with the foot externally rotated 5
degrees, the socket flexed 5 degrees and abducted 5 degrees. However this will
solely be dependent upon the alignment of the residuum.
3. Make sure that foot is perpendicular to the pylon on the ground level.
4. Make sure that knee unit is also perpendicular to the ground. ( h line is
parallel with ground)
5. Make sure the gravity gline pass through the center of the knee bottom.
6. Set the static alignment taking into account the heel height of the footwear.

8 Knee Adjustment
8.1 Extension assist adjustment of the base spring unit
Use 6mm wrench driver and turn the screw of
base spring unit clockwise to compress the
inner spring to increase extension assistance.
Turn the screw anti-clockwise to decrease the
extension assistance.
After fitting the kneejoint onto the pylon, please make sure to use Loctite 242 to
secure the pinch bolt.
8.2 Adjusting the Flex/Ext resistance of knee
Use a 3mm wrench driver and turn both two
screws on the back of linkage clockwise to
increase resistance of movement. Contrarily,
turn both two screws on the back of linkage anti-
clockwise to decrease resistance of movement.
Please turn both screws equally so that the force on inner bearer is distributed
evenly.
Use 5mm wrench driver turn the screw located
in linkage clockwise to make knee head tilting
back (high front/low rear). Contrarily, turn the
screw anti-clockwise to make knee head tilting
forward (low front/high rear).
8.3 Adjusting the head level of knee

In general, making head tilting backwards is the most common adjustment. On the
other hand, too much knee head leaning forward will lower the function of rubber
bumper between head and back linkage.
8.4 The upper male adaptor adjustment
Loose the bolt of head male pyramid by a 8mm
wrench driver. Adjust the position of male pyramid
according to the alignment of prosthesis.
When all adjustments are done tighten the 8mm
bolt with 30Nm torque setting. Use Loctite 242 to
glue the bolt.
8.5 Lamination instructions for Lotus adapter (for use with existing socket)
1) Attach lotus plate to socket. Use alignment fixture for pre-aligned position. Center
hole must be protected. Only a small amount of epoxy glue is necessary. Do not get
wire cage in glue. When epoxy is dried and alignment is secured move the socket
to the laminating fixture.
2) Apply one layer of a composite material (NSP, Fiberglass or Carbon) under the
cage on a well sanded socket
3) Apply a layer of nylon over the cage and ring. Tie a strong fiber around the nylon
just below the ring. Do not invert back over.
4) Apply a second layer of composite over the Nylon. Tie a strong fiber around the ring
groove. Invert the composite then the nylon over.
5) Fill distal hole with clay or silicone putty. Lubricate the distal plate with a light coat of
petroleum jelly.
6) Finish with a PVA bag and lamination.

9 Maintenance of knee unit
9.1 Change the front head axial cover:
Use a small screw driver to pick out the “C”
spring so that the front axial cover can be taken
off for replacement.
9.2 Change rubber bumpers
Use a small screw driver to pick out the rubber
bumper of knee level adjusting screw which is
located on upper linkage bar and replace it with
a new one.
Use a small screw driver to pick out the rubber
bumper of two-level adjusting screw which is also
located on linkage bar but beneath the rubber
bumper of “knee level adjusting screw” and
replace it with a new one.
Use a 2.5mm wrench driver and turn the screw
as shown in the picture to disable the lock
function. Therefore, patient can walk this knee as
a normal four bar knee temperately.
9.3 Disabling Lock Mechanism

9.4 Change the spring of knee base
Use this special tool to take out whole base set of
knee.
Carefully remove the spring from base.
Replace new spring or other components of
this base.
Clean all components of base if necessary.
Assemble the whole base unit back to knee by
following reversed steps.

10 Technical Specification
Operating and Storage Temperature Range: -10˚C to50˚C 14˚F to122˚F
Weight: 678g
RecommendedActivity: K2/K3
Maximum User Weight: K2: 125kg (275lbs)
K3: 100kg (220lbs)
ProximalAlignment attachment: Rotatable Socket Attachment
Plate Rotatable Lotus Adaptor
Distal Alignment attachment: Tube Clamp
Tube clamp torque setting: 12Nm
Build Height: Knee to Distal end 130(+20)mm
Materials: Aluminum Alloy, Stainless Steel, Steel, Rubber
Key Dimensions:
Max.145
130mm
20mm

11 Warranty
Warranted for 2 years from the date of invoice by Blatchford Products Ltd.
The user should be aware that changes or modifications not expressly approved will void
the warranty.
12 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 damage caused by
the component combinations that were not authorized by the manufacturer.
CE Conformity
This product meets the requirements of 93/42/EEC guidelines for medical products. This
product has been classified as a class I product according to the classification criteria
outlined in appendix IX of the guidelines. Please keep this manual in safe place for
future use.

UK
Blatchford Products Ltd.
Unit D Antura
Kingsland Business Park
Basingstoke
RG24 8PZ
UNITED KINGDOM
Tel: [phone]
Tel: [phone]
Email: customer.service@
blatchford.co.uk
www.blatchford.co.uk
US & Canada
Blatchford Inc.
1031 Byers Road
Miamisburg
Ohio 45342
USA
Tel: [phone]
Fax: [phone]
Email: [email protected]
www.blatchfordus.com
Germany
Blatchford Europe GmbH
Fritz-Hornschuch-Str. 9 (3.OG)
D-95326 Kulmbach
GERMANY
Tel: [phone]
Fax: [phone]
Email: [email protected]
www.blatchford.de
France
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Parc d’Activités de l’Aéroport
125 Impasse
Jean-Baptiste Say
34470 PEROLS
FRANCE
Tel: [phone]
Fax: [phone]
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www.blatchford.fr
India
Endolite India Ltd.
A4 Naraina Industrial Area
Phase - 1
New Delhi
INDIA – 110028
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Norway
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www.ortopro.no
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