Ankle. Wrist. Instruction Manual

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Earl Maxwell
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Your Authorized Representative: Ankle Wrist (MDSS)

30175 Hannover, Germany Tele: 49-511-62 62 86 30 Elbow

USA 1.651.415.9000; 1.800.328.2536 360390 Rev.

Dynamic ROM Wrist Extension/Flexion Orthosis Elbow

1 Your Authorized Representative: Ankle Wrist (MDSS) Medical Device Safety Service GmbH Schiffgraben Hannover, Germany Tele: Elbow Supination Empi 205 Hwy 22 East Clear Lake, SD USA ; Rev. A 2010 Empi 1/ Instruction Manual Advance Dynamic ROM Wrist Extension/Flexion Orthosis Elbow Orthosis Supination Orthosis Ankle Orthosis Knee Orthosis Below Knee Amputee Orthosis

Table of Contents Introduction... 1 Indications for use... 1 Warning... 1 Contraindications... 1 Precautions... 1 Product Description... 2-3 Instructions for Use.

2 Table of Contents Introduction... 1 Indications for use... 1 Warning... 1 Contraindications... 1 Precautions... 1 Product Description Instructions for Use... 4 General fitting instructions for flexion and extension devices... 4 Unpack and review components... 4 Prepare device for fitting... 4 Operating the lock lever and lock lever safety... 4 Fit the device... 5 Strut length adjustment... 5 Cuff and strap adjustment Inspect the fit... 6 Initiating treatment... 6 Post-wear criteria... 7 Fitting tips Removal guidelines... 8 Advance Dynamic ROM Wrist... 8 Fitting instructions... 8 Palmar support positioning options... 9 Cuff adjustment and strap adjustment... 9 Advance Dynamic ROM Supination...10 Fitting instructions...10 Custom adjustment...10 Advance Dynamic ROM Ankle...11 Fitting instructions...11 Custom adjustment...12 Special considerations for inversion...12 Advance Dynamic ROM Below Knee Amputee (BKA) Extension...13 Patient selection criteria...13 Care Instructions...13 Maintenance...13 Cleaning...13 Declaration of Conformity...14 Limited Warranty and Disclaimer Notes:

3 4. Claim Procedure (cont.) sole reasonable discretion that the product contains defective workmanship or materials, Empi will refund to purchaser the purchase price for the defective product or return the repaired product or a replacement product to purchaser, freight and insurance pre-paid, as soon as reasonably possible following receipt of the product by Empi. If the product does not contain defective workmanship or materials, Empi will return the product to the purchaser, freight and insurance billed to the purchaser. 5. Disclaimers THE WARRANTY SET FORTH ABOVE IS IN LIEU OF ALL WARRANTIES EXPRESS, IMPLIED OR STATUTORY, INCLUDING, WITHOUT LIMITATION, WARRANTIES FOR MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT AND WARRANTIES ARISING FROM THE COURSE OF DEALING OR USAGE OF TRADE. IF NOTWITHSTANDING THE ABOVE LANGUAGE, AN IMPLIED WARRANTY IS HELD TO EXIST, SUCH IMPLIED WARRANTY SHALL ONLY EXTEND FOR THE LIFETIME OF THE INITIAL PURCHASER OF THE PRODUCT. No employee, representative or agent of Empi has any authority to bind Empi to any affirmation, representation or warranty regarding the product except as expressly stated in this warranty. Introduction The goal of dynamic splinting is to apply a low-load prolonged stress to connective tissue. Indications for use Dynamic orthoses may be used to increase joint range of motion and alleviate stiffness from contractures that result from surgical procedures, prolonged immobilization and joint trauma. Contraindications Patients should not use this device if they have: Severe osteoporosis Thrombophlebitis Severe spasticity Any neurological or vascular changes while wearing device or when range of motion is otherwise contraindicated (e.g., due to severe abnormal joint alignment or pathological boney block that inhibits joint movement). Warning Collagen fiber rupture can occur if stressed beyond 2% of resting length. To prevent skin breakdown while wearing the BKA, ensure a proper fit, provide adequate padding, and consider application of custom molded socket. Glossary of Symbols Keep away from sunlight Keep dry Precautions Use with caution on patients with: - Mild to moderate spasticity - Clonus - Healing skin wounds Device should only be worn while resting or sleeping. It is not designed to provide stability or support. It is not recommended to wear this device when operating machinery, motorized vehicles, during exercise or any other physical activity. Handle device with care. When device is being fitted or adjusted, struts may move unexpectedly. Strut movement may cause pinching. Dropping or misuse may cause component damage. 16 1

4 Product Description 1. Tension spring: Patented eccentric spiral torsion spring mechanism provides continuous levels of tension with little or no end-range drop-off. 2. Angle reference scale: Provides general reference for measuring angle of deflection of orthosis movement. Use a goniometer for precise measurements. 3. Tension control lever: Adjusts level of tension or force of the tension spring. 4. Tension control indicator: Displays tension control setting from 0-10, (low-high). 5. Lock lever: Locks device into place at one of several angles. 6. Lock lever safety: Prevents disengagement of lock lever. 7. Adjustable struts: Allows lengthening and shortening. 8. Cuff: Conforms to patient s limb for custom fit and comfort. 9. Foam Pads: Provide even pressure distribution and comfort over treated area. 10. Adjustment straps: Securely fastens device to patient. 11. Palmar Support (Wrist device): Detachable and allows for free-floating lateral movement, or locks into slight ulnar, radial, or neutral positions. 12. Stabilizing Bars (Flexion devices, elbow and knee devices only): Curved, non-adjustable bars help maintain splint position and maximize flexion range. Limited Warranty and Disclaimer 1. Limited Warranty Empi warrants to the initial purchase ( The Purchaser ) and to no other person that the Advance ROM orthosis ( The Product ) shall be free from defects in material and workmanship for one year from the date of purchase. Empi will, at Empi s option, refund the purchase price for, repair or replacement of any defective product during the warranty period. 2. Exclusions from the Warranty Accessories including, but not limited to, detachable foam pads, are excluded from the warranty and are sold AS IS. This warranty is voided immediately as to any product which has been repaired, altered or modified by any person other than authorized employees or agents of Empi or which have been subjected to misuse, abuse, neglect, damage in transit, accident or negligence. 3. Limitations on Liabilities Empi s sole liability in the event of a breach of the Warranty shall be limited to refunding the purchase price, repair or replacement of the defective product. EMPI SHALL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY DEFECT, FAILURE, MALFUNCTION OF THE PRODUCT OR FROM ANY OTHER MATTER RELATING TO THE PRODUCT, INCLUDING, BUT NOT LIMITED TO, LOSS OF PROFITS, LOSS OF REVENUE, INABILITY TO USE THE PRODUCT OR MEDICAL EXPENSES. IN NO EVENT SHALL EMPI S LIABILITY UNDER ANY CAUSE OF ACTION WHATSOEVER RELATING TO THE PRODUCT EXCEED THE PURCHASE PRICE OF THE PRODUCT. 4. Claim Procedure In order to recover under this warranty, purchasers must send Empi or Empi s authorized agent written detailed notice of the defect prior to the expiration of the warranty period and within 30 days of discovery of the defect. Upon Empi or the agents written request and authorization, purchaser shall return the product to Empi or authorized agent for inspection using the original shipping carton or a durable substitute. Notice and return shipment shall be sent to your local-authorized Empi agent. Empi shall not be responsible for damage due to improper shipping or packaging. If Empi determines in its 2 15

markings on your Advance Dynamic ROM Orthoses are your assurance of its conformity to the highest applicable

5 We, Empi Inc., located at 205 Hwy 22 East Clear Lake SD USA Wrist flexion declare under its sole responsibility, that the markings on your Advance Dynamic ROM Orthoses are your assurance of its conformity to the highest applicable standards of medical equipment safety. The following mark may appear on you device Council Directive 93/42/EEC Concerning Medical Devices (Medical Device Directive). Elbow extension orthosis &

Instructions for use To properly fit and use the device, follow the recommended steps below before beginning use.

Device comes fully assembled. Unpack and review component diagram to identify key areas. 2. Prepare device for fitting a.

Pre-shape cuffs to 90 from the strut. e. Lock device at approximately 45 (or patient s comfortable range of motion), secure the lock lever safety in place. 3.

To engage the lock lever, depress the lock lever while placing a slight amount of force on the strut, until the lever rotates and locks into the desired angle.

Advance Dynamic ROM Below Knee Amputee (BKA) Extension Patient selection criteria For optimal results with this device, a minimum stump of 4 inches (» 9 cm) is

Patients demonstrating swelling and inflammation may require additional padding Care Instructions Maintenance: Under normal use and conditions no special care

6 Instructions for use To properly fit and use the device, follow the recommended steps below before beginning use. General fitting instructions for flexion or extension devices (specific wrist, supination, ankle and BKA directions are provided after removal instructions) 1. Device comes fully assembled. Unpack and review component diagram to identify key areas. 2. Prepare device for fitting a. Check device labels to verify correct extremity and force direction. b. Unfasten adjustment straps on cuff. c. Verify the Tension Control Setting is at zero. d. For Flexion devices, release the 2 middle hooks-and-straps from the buckles. Pre-shape cuffs to 90 from the strut. e. Lock device at approximately 45 (or patient s comfortable range of motion), secure the lock lever safety in place. 3. Operating the lock lever and lock lever safety The locking feature locks the device into 5 increments to assist application/ removal of device. To engage the lock lever, depress the lock lever while placing a slight amount of force on the strut, until the lever rotates and locks into the desired angle. To apply the safety, rotate lever until safety engages the lock. Advance Dynamic ROM Below Knee Amputee (BKA) Extension Patient selection criteria For optimal results with this device, a minimum stump of 4 inches (» 9 cm) is recommended. Patients demonstrating swelling and inflammation may require additional padding Care Instructions Maintenance: Under normal use and conditions no special care is required to maintain proper function and performance of this device. If for some reason your device does not operate as expected, please contact Empi. If the device is used for an extended time, the foam pads and/or adjustable straps may need to be replaced. Replacement kits are available by contacting your authorized Empi distributor. Cleaning: To clean the struts, use a mild detergent or all-purpose cleaner and wipe dry. 4 13

Advance Dynamic ROM Ankle (cont.) Custom adjustment 1.

Calf cuff: If additional cuff conformity is required, remove the device, remove the foam pad and adjust.

Adjust the strut so the ball of the foot rests on the midpoint of the foot cradle.

Ankle foam pad: Position the ankle foam pad to minimize any neurovascular pressure on the dorsum of the foot.

cradle and/or increase the tension on the lateral tension spring to help encourage movement out of inversion. 4.

Position strut and tension spring cover on lateral side of body part. b. Align and center the spring with the joint axis.

Strut length adjustment a. To achieve optimal fit, changing the distal or proximal strut length may be

7 Advance Dynamic ROM Ankle (cont.) Custom adjustment 1. Strut length: Position proximal strut so cuff does not restrict knee motion. Check strut length and adjust as needed. 2. Calf cuff: If additional cuff conformity is required, remove the device, remove the foam pad and adjust. Replace the foam pad and re-apply. Secure the strap. 3. Foot cradle: Can be adjusted to accommodate various lengths. Adjust the strut so the ball of the foot rests on the midpoint of the foot cradle. Do not impede ankle dorsiflexion with foam pads or heel cradle. 4. Ankle foam pad: Position the ankle foam pad to minimize any neurovascular pressure on the dorsum of the foot. Special considerations for inversion The dual tension springs and adjustable foot strut length offer a variety of options to assist in foot positioning. Since inversion often accompanies an ankle plantarflexion contracture, shorten the lateral strut on the foot plate cradle and/or increase the tension on the lateral tension spring to help encourage movement out of inversion. 4. Fit the device a. Slide specific body part through proximal cuff and distal cuff. Position strut and tension spring cover on lateral side of body part. b. Align and center the spring with the joint axis. Align struts parallel to the long bones. On Flexion devices, stabilizing bars should not touch patient skin. 5. Strut length adjustment a. To achieve optimal fit, changing the distal or proximal strut length may be required. b. Do not restrict motion with distal strut. c. Do not impinge on tissues with proximal strut. Caution: Extending strut beyond last adjustment may cause leaf pin to fall out. If this occurs, reinsert leaf pin. 6. Cuff and strap adjustment a. Cuff adjustment: Bend cuffs so they maintain proper strut alignment and conform comfortably to the patient s limb. Foam pads may be repositioned on the cuffs or trimmed/sized to maximize patient comfort. 12 5

6. Cuff and strap adjustment (cont.) b. Strap adjustment: Secure proximal and distal straps, then middle straps. Straps should be snug enough to allow a finger between strap and skin.

Recommendation: Locate buckles on the medical sides of the cuff and position them so the straps are pulled across the open ends of the cuff. 7.

Proper fitting of Advance Dynamic ROM Orthosis is essential for maximum therapeutic effectiveness and patient comfort. 8.

Set tension level at zero and instruct patient to wear the device for 2-4 hours. Patient should be alert but non-active, so tolerance to the device can be monitored. (See Table 1 and 2). b. Increase treatment time.

8 6. Cuff and strap adjustment (cont.) b. Strap adjustment: Secure proximal and distal straps, then middle straps. Straps should be snug enough to allow a finger between strap and skin. On the Flexion devices the middle straps do not have to be as snug because their purpose is to ensure proper alignment and positioning of joint axis. Recommendation: Locate buckles on the medical sides of the cuff and position them so the straps are pulled across the open ends of the cuff. 7. Inspect the fit Check alignment and adjusts straps as needed. Check for any neurological or vascular changes, such as numbness or tingling. Proper fitting of Advance Dynamic ROM Orthosis is essential for maximum therapeutic effectiveness and patient comfort. 8. Select splint function For dynamic splinting disengage both the lock lever and lock lever safety. 9. Initiating treatment a. Determine initial tolerance. Set tension level at zero and instruct patient to wear the device for 2-4 hours. Patient should be alert but non-active, so tolerance to the device can be monitored. (See Table 1 and 2). b. Increase treatment time. Maximum treatment time should be established by a physician or therapist. Gradually increase treatment time based on the patient s connective tissue remodeling stage and follow post-wear criteria. Treatment time and tension recommendations are listed in Table 1 and 2. c. Increase treatment tension. Increase tension levels when no gain in range of motion is made and post-wear soreness lasts less than 60 minutes. Caution: Overtightening or overloosening the tension spring can damage the mechanism and/or cause injury. A solid red block appearing in the tension indicator window indicates overtightening or overloosening. Advance Dynamic ROM Ankle Fitting instructions 1. Initial product preparation is the same as other ROM devices. 2. Loosen adjustment straps on the calf, ankle, heel, and foot plate. 3. Slide foot into device and align tension springs with medial and lateral malleoli. 4. Align proximal struts with the long bones of the calf medially and laterally. 5. Position ball of foot on midpoint of foot cradle and loosely secure heel cradle strap to proper position. 6. To achieve proper fit: a. Remove foam pad from calf cuff. b. Loosen hook and loop on calf. c. Gradually overlap calf cuff for a snug/comfortable fit. 7. Re-secure straps by tightening double pull ankle adjustments strap and tightening calf strap so the strap pulls across open end of calf cuff. 6 11

Advance Dynamic ROM Supination Fitting instructions 1. Initial product preparation is the same as other ROM devices. 2.

$Guidelines for use: Post tissue trauma/orthopedic Range of motion limitations caused by inflammatory process due to trauma, fracture, surgery, etc.$ Connective Tissue Required Force Time-Usage per Day Remodeling Stage 1 (hours) Acute Inflammatory: 0-5 days Low* Minimum 1-3 Fibroplastic Stage: 1-3 weeks Low* 1-3 Consolidation: 3-9 weeks Low

Connective Tissue Required Force Time-Usage per Day Remodeling Stage 1 (hours) Acute Inflammatory: 0-5 days Low* Minimum 1-3 Fibroplastic Stage: 1-3 weeks Low* 1-3 Consolidation: 3-9 weeks Low

9 Advance Dynamic ROM Supination Fitting instructions 1. Initial product preparation is the same as other ROM devices. 2. Align the device so the center of the tension spring lines up with the longitudinal axis of the forearm. Post-wear criteria The patient should not experience additional soreness/stiffness for more than one hour following removal of device. Check for neurological or vascular changes. Table 1. Guidelines for use: Post tissue trauma/orthopedic Range of motion limitations caused by inflammatory process due to trauma, fracture, surgery, etc. Connective Tissue Required Force Time-Usage per Day Remodeling Stage 1 (hours) Acute Inflammatory: 0-5 days Low* Minimum 1-3 Fibroplastic Stage: 1-3 weeks Low* 1-3 Consolidation: 3-9 weeks Low Moderate* 3+ Maturation: 9 weeks Moderate 6-8 Custom adjustment 1. Adjust the distal strut so the hand cradle is positioned just behind the knuckles of the hand. 2. Position the proximal strut so the cuff does not impinge on the medial axial tissue. 3. If strut adjustment is required, change proximal or distal strut length by depressing the leaf pin and lengthening or shortening as needed. 1 Currier, D., Nelson, R. and Cummings, G., Dynamics of Human Biological Tissues. F.A. Davis Company. Ch 1-2, *Warning: Collagen fiber rupture can occur if stressed beyond 2% of resting length. Table 2. Guidelines for use: Immobilization/Neurologic Range of motion limitations caused by contracture formation due to stroke, closed head injury, or other nervous system injury. Hypotonicity or mild to moderate hypertonicity (spasticity) usually present. Connective Tissue Required Force Time-Usage per Day Remodeling Stage 1 (hours) Disorganization: 0-6 weeks Low 1-3 Consolidation Stage: 7+ weeks Moderate Currier, D., Nelson, R. and Cummings, G., Dynamics of Human Biological Tissues. F.A. Davis Company. Ch 1-2, Fitting tips To ensure proper strut alignment, bend malleable cuff to form 90 angle to strut, then apply and shape to the patient. Position limb at end range and use minimum tension level to maintain end range position (i.e., sit with leg outstretched versus using dynamic spring tension to position leg). 10 7

Total end range treatment (TERT) time 2 can be divided into several sessions versus one longer session to accommodate patient needs without impacting results.

ulnar radial range of motion. 2. Lock-out option: Insert and tighten the allen head screw in one of the corresponding holes at the base of the Palmar support.

Always lock device into position. b. Unfasten adjustment straps. c. Slowly remove limb from device. Advance Dynamic ROM Wrist Fitting instructions 1.

Position the buckles on the radial side of the wrist so the straps pull across the open ends of the cuffs. 2. Slide the hand and arm through proximal cuffs.

10 Fitting tips (cont.) When muscle guarding is present, use lock and lock safety to hold joint until muscle relaxes, then release lock and lock safety for dynamic treatment. Total end range treatment (TERT) time 2 can be divided into several sessions versus one longer session to accommodate patient needs without impacting results. 2 Flowers, K. and LaStayo, P., Effects of Total End Range Time on Improving Passive Range of Motion. Journal of Hand Therapy 7: , Palmar support positioning options 1. Free floating: Removing the allen head screw located at the base of the Palmar support will provide unrestricted movement throughout the patient s available ulnar radial range of motion. 2. Lock-out option: Insert and tighten the allen head screw in one of the corresponding holes at the base of the Palmar support. This positions the Palmar support in neutral or in slight (» 4 ) radial or ulnar positions depending on hole selected. 10. Removal guidelines a. Always lock device into position. b. Unfasten adjustment straps. c. Slowly remove limb from device. Advance Dynamic ROM Wrist Fitting instructions 1. Initial product preparation is the same as other ROM devices. Cuff adjustment and strap adjustment (Wrist device) If necessary, reposition straps. Position the buckles on the radial side of the wrist so the straps pull across the open ends of the cuffs. 2. Slide the hand and arm through proximal cuffs. Positioning of the hand: a. Extension device: Palm should rest on top of hand platform. b. Flexion device: Hand platform should rest on back (dorsum) of hand. An optional custom moldable finger platform is available. Contact your authorized Empi distributor to order. 3. Position the struts and tension spring on the ulnar side of the forearm. Align device so the center of the tension spring lines up with the wrist-joint axis. Align the struts parallel to the long bones of the forearm on the ulnar side. 8 9

Thank you for purchasing the AB COASTER. Our customer service staff is ready to help and to answer any questions.

Thank you for purchasing the AB COASTER. Our customer service staff is ready to help and to answer any questions. Our phone number is: 908-879-2713 The Ab Coaster Company, 173 Route 206, P.O. Box 9 Chester,