Stretch Beyond Your Expectations.

Transcription

1 CLINICIAN INSTRUCTIONS Dynasplint Proximal Interphalangeal Joint Extension System Corporate Headquarters: toll-free fax Canada: toll-free fax Europe: phone fax INDICATION: Dynasplint Proximal Interphalangeal Joint Extension Systems are used for the treatment of joint stiffness and limited range of motion due to: Arterial and venous microsurgical repair Arthrotomies Burns Dislocations Fractures Hemophilia Rheumatoid arthritis Tendon and ligamentous repairs DYNASPLINT and Dynasplint Systems are registered trademarks of Dynasplint Systems, Inc. Stretch Beyond Your Expectations.

2 FITTING INSTRUCTIONS STANDARD FITTING INSTRUCTIONS: STEP 1: With tension screws backed out 8mm, slip finger into unit so that the cams are in line with the finger s PIP joint. See Figure 1. FIGURE 1. Counterforce Strap FIGURE 1-A Using goniometer mm. This scale reading shows a 4.5mm tensionsetting adjustment. Struts Extension Wires Loading Screw (Figure 1-A shows force measurement) Metacarpal Platform Pad Finger Cradle O-ring Cam Pad Plate STEP 2: If needed, adjust the length of the metacarpal platform pad so that it rests on the volar surface of the metacarpal head. See Figures 1 and 2. FIGURE 2. PIP Unit Metacarpal Platform Length Adjustment Hook-shaped ends of strut wires can be applied to three separate locations to change platform length. Platform screw allows for length adjustment and secures platform assembly in place. Hook-shaped ends of strut wires must be located typically in the same adjustment location to provide for equal strut length. 1

3 STEP 3: Adjust the finger cradle to achieve a comfortable width for both the cradle and the cams. If the finger is swollen at the PIP joint, widening the finger cradle will open the space between the cams and the patient s PIP joint. See Figure 3. FIGURE 3. Finger Cradle Width Adjustment Finger cradle can be moved forward and backward by pushing it equally along the strut tubes. Clockwise to reduce width Clockwise to increase tension Counterclockwise to increase width Counterclockwise to reduce tension STEP 4: Adjust the finger cradle lengthwise by finger pressure according to Figures 4A and 4B. Try to place cradle as close as possible to, but not beyond or distal to the DIP joint. Do not pull off strut tubes. (See Troubleshooting if this occurs). Once finger cradle is in desired position, place backup o-rings against cradle. FIGURE 4A. Shorten Proximal Length Adjusment FIGURE 4B. Lengthen Distal Length Adjustment STEP 5: Adjust the counterforce strap to maintain placement of the cams in line with the patient s PIP joint axis of rotation. See Figure 1. Give the patient the Patient Instruction Booklet to take home with the Dynasplint Proximal Interphalangeal Extension System. 2

4 Protocol Patients should wear the unit at the highest tolerable tension setting for the longest time possible. Optimally, the patient will wear the Dynasplint System for six to eight continuous hours, usually overnight. The tension should be set to produce as much as, but not more than, 30 minutes of post-wear stiffness beyond normal discomfort. Success in restoring range of motion depends on patient tolerance, compliance, length of time since onset, and cause and severity of stiffness/contracture, e.g., fracture, dislocation, ligament repair, etc. STANDARD PROTOCOL: Protocols vary according to individual health practitioner s discretion. Less Aggressive 1. Set tension screws to 6mm for ROM deficits greater than or equal to 30º or 5mm for ROM deficit of less than 30 º. See Figures 1 & Have patient wear the PIP System for minutes out of every waking hour for the first day; minutes every 2 hours for the second day; 1-2 hours on, 1 hour off the third day; then begin overnight wear. These advances are made provided no more than minutes of post-wear discomfort is experienced. 3. Once maximum wearing time is achieved, begin advancing tension by 0.5mm (approximately 1 / 2 turn of the screw) each night, again provided no more than minutes of post-wear discomfort is experienced. 4. Tension advances may not be necessary each night, especially in the later stages of treatment. This is determined by the patient s post-wear discomfort not exceeding 30 minutes. 5. Desired sensation: approximately minutes of post-wear discomfort in the morning from nighttime wear. 6. If nighttime wear is not achieved, wear the Dynasplint System 1-2 hours out of every 3 hours during the day and advance tension setting according to steps 3, 4, and 5. More Aggressive 1. Set tension screws to 6mm for ROM deficits greater than or equal to 30º or 5mm for ROM deficits of less than 30 º. See Figures 1 and Have patient wear the PIP System minutes out of every hour for the first day; then begin overnight wear. These advances are made provided no more than minutes of post-wear discomfort is experienced. 3. Follow steps 3 through 6 of the Less Aggressive protocol. 3

5 SPECIFICATIONS - STANDARD Range of Motion: 65 flexion to 25 hyperextension Screwhead Measurement Torque STANDARD PIP EXTENSION SCALE SETTING (Measured at 30º flexion) Values expressed in kilogram/centimeter torque. The above force calculations represent averages on 3 randomly selected Dynasplint Systems measured at 30º flexed positioning. For precise scientific applications, it is advised to measure the specific PIP System being used. CONTRAINDICATIONS: Although Dynasplint Systems can provide unusually conservative stretching force, these devices are contraindicated where range of motion therapy is inappropriate. PRECAUTIONS: Severe osteoporosis, thrombophlebitis and severe spasticity. NOTE: This device is restricted to use on the order of a licensed health care practitioner. 4

6 TROUBLESHOOTING Instruct patient to remove the Dynasplint System immediately if pain or numbness occurs. PROBLEM: SOLUTION: Finger cradle is pulled off end of strut tubes. Reapply cradle with rubber O rings in proper place as follows: Remove both tension-adjusting screws. Turn cradle-width-adjusting screw counter clockwise until the cradle separates into 2 pieces. Slide one of the cradle halves onto the short tube; insert rubber O ring into slot; visually align O ring centrally over end of tube; then with gentle back and forth rotation of cradle half, push cradle half onto tube with O ring in place. Repeat Step 3 for the other half. Carefully align both cradle halves and reconnect with width-adjustment screw. Reinsert both tension-adjusting screws. PROBLEM: SOLUTION: Pain. Decrease the tension by 1 / 2 turn increments (0.5mm) until unit is tolerated. Unless absolutely necessary, do not decrease wearing time. Some patients may have to resort to daytime/evening use and/or multiple sessions, i.e., two four-hour daytime/evening sessions. PROBLEM: SOLUTION: Numbness. Check strap for over-tightness and decrease wearing tension by 1 / 2 turn increments. Repeat adaption wearing schedule. 5

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8 1996 Dynasplint Systems, Inc. Dynasplint Systems, Inc. products are covered by one or more of the following U.S.A. patents: 5,558,624; 5,645,521; 6,413,231; 6,506,172; 6,740,051; 6,908,475; 6,942,629; 6,942,631; 4,485,808; 4,508,111; 4,538,600; 4,944,290; 4,947,835; and 5,070,868. Other patents issued and/or pending in the U.S.A. and internationally. The product described in the enclosed literature is intended for the specific purpose as per the instructions attached. Any use of this product outside of its intended purpose on any body part or in a manner outside the protocol established by Dynasplint Systems, Inc., is a use of the product for which it, its divisions and employees cannot be held responsible. All implied warranties of fitness for use for any other purpose (or purposes) are expressly disclaimed.