ottobock 28P30 Palmar Splint Instructions

28P30 Palmar Splint
Instruction Manual

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Foreword

INFORMATION
Date of last update: 2022-03-10

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of prob­ lems.
• Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
• Please keep this document for your records.

These instructions for use provide important information on the fitting and application of the 28P30 Manu Neurexa plus wrist orthosis and the 28P31 wrist positioning splint.

Product description

Product overview

28P30 Manu Neurexa plus (see fig. 1)

Item| Designation| Reference number
1| Torx wrench|
2| Self-adhesive hook-and-loop patches|
3| Hand support bar|
4| Orthosis|
5| Padded strap for hand support bar| 29P30
6| Forearm straps
7| Forearm pad
Item| Designation| Reference number
---|---|---
1| Hand support pad| 29P31
2| Y-hook-and-loop closure
3| Finger closure strap
4| Thumb-metacarpus closure strap
5| Hand support|

Intended use

Indications for use
The orthosis is intended exclusively for orthotic fittings of the wrist joint and exclusively for con­ tact with intact skin.
The orthosis must be used in accordance with the indications.

Indications
Pareses of the forearm and hand musculature Paralysed forearm and hand musculature with slight spasticity, for instance after:

• Stroke
• Brachial plexus injuries
• Cervical intervertebral disc prolapse
  Indications must be determined by the physician.

Contraindications
Absolute Contraindications

• Moderate and severe spasticity of the forearm and hand musculature

Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries, inflamma­ tion, prominent scars that are swollen, reddening, and hyperthermia of the fitted limb; pronounced varicose veins, especially with return flow impairment, lymphatic flow disorders, including unclear soft tissue swelling distal to the support; sensory and circulatory disorders in the area of the arm and hand.

Lifetime
28P30
The product is designed for a maximum lifetime of 2 years.
28P31
The product is designed for a maximum lifetime of 1 year.
3.5 Effects
The orthosis stabilizes the wrist joint; the position of the wrist joint is continuously variable, and the movement of the hand is limited in the palmar or dorsal direction. The hand can be held with either palmar or dorsal support. The orthosis facilitates therapeutic treatment, hand function, and physical activity. The 28P30 Manu Neurexa plus can be combined with the 28P31 hand position­ ing splint and also the 5065N Omo Neurexa plus shoulder support.

Safety

Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.

General safety instructions
CAUTION
Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs

• The product may be used by one person only.
• Clean the product regularly.

CAUTION
Incorrect or excessively tight application
Skin irritation due to overheating, local pressure points due to tight application to the body

• Ensure that the product is applied properly and fits correctly.
• When in doubt, do not continue to use the product if skin irritation occurs.

CAUTION
Contact with heat, embers, or fire
Risk of injury (such as burns) and risk of product damage.

• Keep the product away from open flames, embers, and other sources of heat.

NOTICE
Contact with oils, salves, lotions, or other products that contain oils or acids
Insufficient stabilization due to loss of material functionality

• Do not expose the product to oils, salves, lotions or other products that contain oils or acids.

NOTICE
Improper use and changes
Change in or loss of functionality as well as damage to the product

• Use this product with care and only for its intended purpose.
• Do not make any improper changes to the product.

NOTICE
Use of a worn or damaged product
Limited effectiveness

• Before each use, check the product for functional reliability and for possible wear or dam­ age.
• Do not continue using a product that is no longer functional, or that is worn or damaged.

Handling
INFORMATION

• The daily duration of use and period of application is generally determined by the physi­cian.
• The initial fitting and application of the product must be carried out by qualified personnel.
• Instruct the patient in the handling and care of the product.
• Instruct the patient to see a physician immediately if any exceptional changes are noted (e.g. worsening of the complaint).

Size Selection
The product is supplied in a universal size and can be used on both sides. The orthosis length and forearm supports can be adapted.

Adaptation
Adapting the orthosis length
The length of the orthosis is changed by sliding the forearm supports on the arm bar. The arm bar can be adapted to the requirements of the patient.

1. Loosen the screws for the bar (see fig. 1, item 4) with the wrench (see fig. 1, item 1).
2. Place the patient’s elbow in a 90° flexion position.
3. Apply the orthosis laterally on the forearm.
4. Position the supports of the orthosis between the wrist joint (see fig. 2 ) and approx. 2 cm from the olecranon (see fig. 3 ). INFORMATION: The distal support has to be applied to the ulnar head. In the case of patient-specific pressure sensitivity at this point, the support can be applied directly before it. Ensure that the edge of the distal forearm support does not press on the back of the hand.
5. Mark the length adjustment on the bar.
6. Take off the orthosis and tighten the screws with the wrench (torque value: 1 Nm) (see fig. 4).

Adapting the orthosis angle
The angle adjustment range is 30° max. in palmar flexion or dorsiflexion, with one position respectively corresponding to 10°. The positions are marked by holes in the orthosis joint.

1. Loosen the screw on the orthosis joint with the wrench (see fig. 7 ).
2. Place the patient’s elbow in a 90° flexion position.
3. Apply the orthosis laterally on the forearm and align it.
4. Set the orthosis joint to the desired angle.
5. Mark the angle position.
6. Remove the orthosis and tighten the screw with the wrench (torque value: 3.6 Nm).

Adapting the hand support bar

1. INFORMATION: Align the hand support bar with the curve facing up.
   Insert the hand support bar (see fig. 1, item 3) into the orthosis (see fig. 8 ).

2. Place the patient’s elbow in a 90° flexion position.

3. Apply the orthosis laterally on the forearm.

4. Slide the hand support bar and position it under the palm according to the individual condi­ ions.

5. Take off the orthosis and tighten the screw with the wrench (torque value: 1 Nm).

Adapting the forearm supports

1. Place the patient’s elbow in a 90° flexion position.
2. Apply the orthosis laterally on the forearm.
3. Mark the required lengths of the supports (see fig. 5).
4. Trim the supports with scissors (see fig. 6).
5. Sand the cut edges smoothly.
6. Check the fit of the orthosis again and rework it as needed.

Adapting the forearm pad
Prerequisite: Take off the orthosis.

1. Apply the self-adhesive hook-and-loop patches to the inside of the supports (see fig. 9).
2. Position the pads inside the supports according to their shape and fasten them with a hook-and-loop.
3. Individually trim the pads with scissors, leaving a 5 mm overhang along the edges of the sup­ ports (see fig. 10).

Adapting the forearm straps
The forearm straps are attached to the integrated slots in the supports. With correct assembly, the pull loop of the strap has to be on top.

1. Pull the strap through the lower slot in the support and fasten it with the hook-and-loop clos­ ure.
2. Pull the strap through the upper slot in the support and fasten it at the hook-and-loop closure, individually adapting the strap circumference to the arm.

Adapting the pad of the padded strap for the hand support bar
Prerequisite: Take off the orthosis.

1. Open the padded strap (see fig. 1, item 5).
2. Cut the interior plastic tube to length with scissors (see fig. 11 ), taking the patient’s hand width into account as the measurement.
3. Optional: Trim the shorter padded hook-and-loop closure with scissors (see fig. 12 ).
4. Slide the padded strap over the hand support bar and fasten the hook-and-loop closure (see fig. 13, see fig. 14 ).

Adapting the padded strap for the hand support bar
Prerequisite: The orthosis is attached to the forearm straps.

1. Lay the hand onto the padded hand support bar (see fig. 15).

2. Pull the strap over the hand between the thumb and fingers, and fasten it with the hook-and-loop closure under the padded strap (see fig. 16 ).
   INFORMATION: Close the strap at the bottom or top, depending on the patient.

3. Optional: Shorten the hook-and-loop with scissors.

Adapting the 28P31 hand positioning splint

1. Position the patient’s hand on the hand support (see fig. 18, item 5).
2. Mark the thumb side and the finger sizes on the hand support (see fig. 19).
3. Trim the hand support to the correct size along the slots using scissors (see fig. 20 ).
4. Sand the cut edges smooth.
5. Starting on the bottom, thread the thumb-metacarpus closure strap (see fig. 21 ), positioning the strap guide loop on the thumb side. Slide the strap opening over the safety  closure for hand support.
6. Attach the self-adhesive hook-and-loop patch to the bar in the area of the center of the thumb and use it to secure the strap (see fig. 22).
7. Shorten the closure strap so that there is sufficient material for attaching the Y-hook-and-loop closure. Attach the Y hook-and-loop closure. Optional: Sew the Y-hook-and- loop closure to the strap.
8. Starting on the bottom, thread the finger closure strap into the bar (see fig. 23, see fig. 24, see fig. 25 ).
9. Connect the hand support to the hand support bar (see fig. 26 ).
10. Fasten the safety closure (see fig. 27 ).
11. Position the patient’s hand on the hand support.
12. Fasten the split closure strap on the thumb (see fig. 28 ).
13. Fasten the split closure strap on the metacarpus.
14. Fasten the finger closure strap (see fig. 29 ).

Applying the hand support pad

1. Attach the self-adhesive hook-and-loop patches evenly distributed to the top of the hand sup­ port.
2. Put the pad onto the hand support.
3. Use scissors to cut the pad to size.

Application
Application of the 28P30 Manu Neurexa plus

• Prerequisite: All hook-and-loop closures are open.
• Prerequisite: Place the orthosis on a table in front of the patient, open to the top.

1. Insert the forearm into the orthosis until the hand is lying fully on the hand support.
2. Fasten the straps.
3. Make sure that the straps fit closely without constriction.

Application of the 28P30 Manu Neurexa plus with 28P31 hand positioning splint

• Prerequisite: All hook-and-loop closures are open.
• Prerequisite: Place the orthosis on a table in front of the patient, open to the top.

1. Insert the forearm into the orthosis until the hand is lying fully on the hand positioning splint.
2. Fasten the straps.
3. Make sure that the straps fit closely without constriction.

Application of the 28P30 Manu Neurexa plus with 5065N Omo Neurexa plus

• Prerequisite: The covers of the snap fasteners on the 28P30 Manu Neurexa plus have been removed.
• Prerequisite: The 28P30 Manu Neurexa plus has been put on.
• Prerequisite: The 5065N Omo Neurexa plus has been put on.
• Prerequisite: The suitable connecting straps have been attached to the snap fasteners of the shoulder cuff.
• Prerequisite: The forearm cuff of the 5065N Omo Neurexa plus has been removed.

1. Open the hook-and-loop closures of the connecting straps.
2. Attach the strap guide loops to the snap fasteners on the wrist orthosis (see fig. 39, see fig. 40), connecting the snap fasteners of the same color to each other (black-black/red-red).
3. Guide the connecting straps through the strap guide loops from the inside to the outside and adjust the length with the hook-and-loop closure (see fig. 41, see fig. 42 ).  The strain on the shoulder joint should be relieved and the shoulder should be rotated slightly outwards.
4. Check the relief function on the shoulder. Adjust the length of the straps if necessary.

Retrofitting
Changing the hand support of the 28P31 hand positioning splint to the hand support bar of the 28P30 Manu Neurexa plus

1. Open all straps (see fig. 30, see fig. 31 ).
2. Open the safety closure (see fig. 32).
3. Remove the hand support from the hand support bar (see fig. 33, see fig. 34 ).
4. Attach the hand support pad to the hand support bar with the fixation strap (see fig. 35, see fig. 36 ) and fasten the strap (see fig. 37).

Removal

1. Open all straps.
2. Remove the orthosis from the forearm.

Cleaning

NOTICE
Use of improper cleaning agents
Damage to the product due to the use of improper cleaning agents

• Only clean the product with the approved cleaning agents.

Textile pads

1. Remove all textile pads from the orthosis.
2. Fasten all hook-and-loop closures.
3. Recommendation: Use a laundry bag or net.
4. Wash the textile pads in warm water at 30 °C with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
5. Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove, or radiator).
6. Reattach the textile pads to the orthosis.

Orthosis frame

1. Wipe with a damp cloth as needed.
2. Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).

Disposal

Dispose of the product in accordance with national regulations.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip­ tions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorized modification of the product.

CE conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt · Germany
T +49 5527 848-0 · F +49 5527 848-3360
[email protected] · www.ottobock.com

References

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