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. • • • • • 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:
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