Instructions for how to order a Custom ToeOFF/BlueRocker

Transcription

Instructions for how to order a Custom ToeOFF/BlueRocker
Instructions for how to order a Custom ToeOFF/BlueRocker
and Custom AFO Standard/Rigid. Carefully read this instruction
sheet before use!
ToeOFF/BlueRocker-Custom follows our standard ToeOFF-Family warranty rules as long as no shape and/or property
from the right hand column of the form has been ordered. If shape and/or property in the right hand column has been
chosen the product becomes “special made” and will be named “Custom AFO Standard or Rigid, and the responsibility
for the product falls on the prescriber. For Custom AFO Standard or Rigid we guarantee that the product has been
produced according to GMP (Good Manufacturing Practice) with a warranty time of 6 months.The warranty does not
include function or effects on durability created through the composition of properties.
Intended Use:ToeOFF is intended to support a foot when the ability to actively dorsiflex is reduced or completely
lost. BlueRocker is intended to support a foot when the ability to actively dorsiflex is reduced or completely lost and
when extra stability is needed to support the ankle joint. BlueRocker is primarily developed to meet the extra need for
stability with patients that need dorsiflexion assist on both left and right limbs.
Indications: Stroke, Multiple sclerosis, Post-polio syndrome, Muscular dystrophy, Spinal cord injuries,Traumatic brain
injuries, Guillian-Barre syndrome, Charcot-Marie-Tooth, Myelomeningocele or Cerebral palsy. ToeOFF and BlueRocker
are preferred when footdrop is combined with ankle instability.These two orthoses can also be used for partial foot
amputations, most proximal level is Chopart.
Special precautions should always be taken for patients with reduced feeling
in the lower extremities. Daily monitoring of skin condition is advised.
We strongly recommend fitting the patient with a standard ToeOFF/BlueRocker when
possible to get a baseline for the type of product strength you are looking for, from that
point you can choose more/less control in the M-L or A-P planes.
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The ordering form on the following pages is divided into different sections.
The basic information on the first page must always be filled out.
The additional information should be filled out for products that do not follow
the standard product.
If any shapes/properties in the right hand column are chosen the product responsibility shifts to the practitioner.
The same demands for fitting and adjustments should be followed as for a regular ToeOFF or BlueRocker. Read the instructions in the ToeOFF-Family Clinical Manual.
Patent no.: ToeOFF, ToeOFF Short, ToeOFF Fantasy, ToeOFF NFR, BlueRocker, BlueRocker NFR, KiddieGAIT, KiddieGAIT NFR
AU736950, BE1005297, BE1114626, DK1005297, DK1114626, FI1005297, FI1114626, FR1005297, FR1114626, IE1005297,
IE1114626, IT1005297, IT1114626, CA2279225, CNZL97181689.1, NL1005297, NL1114626, NO313656, PL194247, CH1005297,
CH1114626, ES1005297, ES1114626, GB1005297, GB1114626, SE1005297, SE1114626, DE69709184.8-08 DE69732541.5-08,
US5897515, ATE210417, ATE289187 ©
This form is only valid for use within the USA.
Contra indications:ToeOFF and BlueRocker should not be used by patients with leg ulcers or in cases where moderate to severe edema is present, or where moderate to severe foot deformities are evident.ToeOFF and BlueRocker
should not be used when severe spasticity is present.The definition for spasticity is described in the ToeOFF Family
Clinical Manual.
Instructions for how to send in a Scan,
Cast or Measurements
How to Scan a foot
Put the foot in neutral on a ”block” with the arch of the foot visible. If the patient is wearing
corrective insoles (varus/valagus) to correct a malformation, it can be beneficial to scan with the insoles
in position. Scan the foot in neutral or with desired heel height. It is important that the patient does
NOT move during the scanning, as this can affect the final result. If possible include the knee in the scan. Surfaces that will need relief should be clearly marked with landmarks (center point included).
Align the scanned foot both anterior and medially. Position the foot so it is visible from the front.
Please be sure to export your file as a .cxpxp extension. - Please contact Allard USA for
information about other acceptable file formats.
Measurement
When ordering a product from measurements, both circumferential and M-L measurements should be
taken with the patient sitting and the leg in 90o. Please send two photos of the patient. First, with the
patient standing mark the anterior of the patient’s leg with a plumb line (this is to show any tibial angluation) and take a photo. Then place a piece of tape that measures exactly 4” on the posterior aspect of
the calf (it should be placed vertically and is used for scaling). Take a digital photo from approximately 2m
(6 ft.) distance and try to be at the same height as the leg (you will probably need to kneel down).
Order form
From the information given in the order form an orthosis will be manufactured where foot length,
width, heel height, stiffness and stability is comparable to a standard ToeOFF/BlueRocker, unless otherwise noted on the form.
Reference data
Make sure that the patients foot length and length of lower leg (knee center to floor) is filled out on the
order form. If the patient has an odd shaped leg, please send a few photos (anterior, lateral and medial
view) together with the order form.
Page 2 / 5
This form is only valid for use within the USA.
Negative Cast-must be formed from fiberglass/synthetic cast or STS-sock and MUST have
a posterior opening (so the natural shape of the tibial crest is captured).
Do the casting on an unloaded foot. If the patient is wearing corrective insoles (varus/valgus) to
correct a malformation, it can be beneficial to cast with the insoles on the patient. Cast the foot in
neutral or with desired heel height. If any surfaces need relief, mark these clearly with a colored pen.
Draw a plumb line on the anterior and lateral aspects of the cast. These lines will represent the patients
varus/valgus angle, as well as the dorsi/plantarflexion angle of the leg. Also draw a plumb line
on the lateral side of the cast. Send the well dried cast together with the order form.
Negative casts MUST have a POSTERIOR opening.
Basic information for ordering a Custom ToeOFF/BlueRocker and Custom AFO
Standard/Rigid.This page should always be filled out and sent in with the order.
Date: Purchase no:
Company:
Orthotist:
Phone:
E-mail:
Address:
This order is made from:
Scan Cast (negative)
Measurement Modified Standard ToeOFF/BlueRocker
Scan/cast is with insoles: YES
NO (When patient is using corrective insoles (varus/valgus). Make sure you
remove the inserts before sending cast for fabrication. Only possible for order by Scan or positive Cast).
Objective for ordering a custom as
opposed to a standard ToeOFF or BlueRocker:
Patient ID (same ID as for cast or file):
Diagnosis:
Patient has been fit with or is currently using a ToeOFF______ or BlueRocker_______.
size
size
Plantar/dorsiflexion: Neutral can be achieved in active/passive ankle joint motion
(10o dorsiflexion) : YES NO
Partial foot amputation: YES
Activity level: NO Short distances indoor with or without assistance
Short distances indoor and outdoor
Manage daily activities without problems
Walk longer distances without problems
High activity, sports on a daily basis
From the information above a ToeOFF/ BlueRocker will be manufactured where the foot
length, foot width, heel height, A-P stiffness and M-L stability is equal to a standard product.
ToeOFF:
Left Right Bilateral
BlueRocker:
Left Right
Bilateral
Fantasy:
Ivory
Black
Dark Blue Purple
Accessories: Page 3 / 5
None T-Strap
SoftKIT Black SoftSHELL Beige SoftKIT Beige SoftKIT Brown Empty Form
ComfortKIT
FOS
This form is only valid for use within the USA.
Height:
Weight: Foot length: Lower leg height :
(pounds)(knee center to floor)
Step by Step Guide for Custom ToeOFF® and BlueRocker™
Fitting & Product Selection (All grey boxes needs to be filled out)
STEP 1 Evaluate Patient with Standard ToeOFF® or BlueRocker™
This will establish a baseline for which the Custom product can be made, at which point you can then change the dynamic properties.
Choose ToeOFF or BlueRocker:
Based on Patient’s height, weight, shoe size, and
proximal deficits.
Note:
If patient is +20lbs. over average weight consider
going up 1 size or 2 sizes.
If patient is +40lbs. over average weight consider
stepping up to a BlueRocker.
Pt. evaluated with
(Type and Size)
1. 2. 3. Fitting
Choose proper shoe.
Measure Heel Height of Shoe
(Critical Step).
Accommodate TeoOFF/BlueRocker with
heel/toe lift if necessaary to match heel rise of ToeOFF/BlueRocker.
Shoe Selection
Patient’s foot length
PATIENT
STABILITY
WITHOUT
ORTHOSIS
HIGH
LOW
PRODUCT
STABILITY
LOW
HIGH
YpsilonTM
ToeOFF®
- Shank & counter
- Toe-to-heel
- Rocker sole
- Facilitate 3rd rocker
BlueRockerTM
STEP 2 Capture the Patient model with Cast, Scan or Measurements.
Cast:
1. Posterior/Medial opening.
2. Anterior & Lateral plumb lines.
Scan:
File extension type:
(*.cxpxp).
Measurements:
1. Fill out pages 3, 4 & 5 Completely
2. Picture required.
Method Used
Measure Heel Height of Shoe: Critical to get proper alignment of ToeOFF
or BlueRocker. Either measure with a ruler or with calipers.
3/8”
1/4”
1/2”
5/8”
3/4”
*By choosing anything higher than 1” the product will not be covered
under the same warranty as a standard product. It will be covered under
GMP (Good Manufacturing Practices) for 6 months.
*Other
1”
1/2”
Change the M-L Stiffness: Compare to Baseline ToeOFF/BlueRocker.
1x Stiffer
None
2x Stiffer
1x LessStiff
2x LessStiff
Opening
Change the A-P Stiffness: Compare to Baseline ToeOFF/BlueRocker.
Scan
Plumb Line
Tibial Relief
None
1x Stiffer
2x Stiffer
1x LessStiff
2x LessStiff
Tibial Relief
Relief of Tibial Crest: Must be marked on cast or scan.
None
3mm (1/8”)
5mm (1/4”)
Other
Relief of OTHER Bony Prominences: Must be marked on cast or scan.
None
Page 4 / 5
3mm (1/8”)
5mm (1/4”)
Location
I realize that if I choose a heel height greater than 1” or if the patient’s foot is outside the
tested parameters that the product that I am ordering will be considered a Custom AFO
and it will not qualify for the same warranty as a standard product. Allard will guarantee
that the product has been produced according to GMP (Good Manufacturing Practices)
with a warranty of 6 months.
X____________________________
Signature
This form is only valid for use within the USA.
STEP 3 Fill out Custom Forms Completely
Only use this page if you are ordering a product from measurements.The information on page
3 and 4 must also be completed and sent with the order.
Patient ID:
Left Right
Circumf.
M-L
40cm (16”) from floor
mm
mm
35cm (14”) from floor
mm
mm
30cm (12”) from floor
mm
mm
25cm (10”) from floor
mm
mm
20cm (8”) from floor
mm
mm
mm
mm
mm
mm
15cm (6”) from floor
10cm (4”) from floor
Foot length =
Place a piece of tape that measures exactly 10cm (4”) on the posterior aspect of the calf
(it should be placed vertically and is used for
scaling). Take a digital photo from approximately
2m (6 ft.) distance and try to be at the same
height as the leg (you will probably need to
kneel down).
10 cm (4”)
2 m (6 ft.)
Page 5 / 5
mm
Empty Form
This form is only valid for use within the USA.
Side: