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Donjoy MAXTRAX 2.0 - English - Device Usage and Safety; Intended User Profile; Intended Use and Indications; Performance Characteristics

Donjoy MAXTRAX 2.0
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4B
2
4A
BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING
INSTRUCTIONS COMPLETELY AND CAREFULLY. CORRECT
APPLICATION IS VITAL TO THE PROPER FUNCTIONING OF THE
DEVICE.
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ENGLISH
4. つま先ら始めて脚のべてのブーツを固定し
4A)。
記:は取交換が可能足首関節の2 ストップ
のそぞれーズにせて更することができま
足首交差交差希望場合は、3反対側の前
D 。ス 2スト 3上に交差反対側支柱のDリン
通して固定します
4B
5. 腱( )は 、ぴ
り外すこともできます。
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エアライナーの
6. エアナーを膨には、ナーが快適なクン性サポ提供
になて放動作を数回繰過度に膨張
い(
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7. ーカナー空気には、収縮ボ圧力が快適に
なるまでを抜きますライきつすぎると感じる時を抜いてださ
い。注意製品の装着中にナーがすぎ場合は、収縮ボ
ナーの空気を直ちに担当の医療専門家に相談ださ
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8. ーカーを取り外すにすべてのスをゆるめライナークロージ
ャを外します。
9. ーを再装着すには2 4ます
10. かか部分がーを希望す場合は、用の使
インソーり取ることできます
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注記再装着の際に適切にるには、スを外す前に
てく
注記圧が高いほ歩行時のサポトは横にな場合は低め
の圧力が快適で圧力は、締めた緩めた調整
清浄手順ナーは、中性洗剤をて冷水中手洗い自然乾燥さ
記:すぎが不十分だと洗剤残留物に皮膚の炎症や製品材料が劣化る原因
るこります。
保管手順本製品を使用では常温で保管ださい。
証:DJO, LLCは、材料や工程の不具合に購入日か 6 、ユ
は一部を修理あいは交換本保証が現地規
制と矛盾範囲につては当該現地規制の規定が適用
特許出願中。
要処方。
1人の患者にのみ使用しい。
天然ゴス不使用。
材料成分
コンポーネン 材料
フレーム 射出成形ポプロピ
イナ
、コ
ン、ABSPVC、シ 、ス TPU
外底 EVA/ラバー(ラテックを含有しない)
中敷 EVA/ラバー(ラテックを含有しない)
フッ/ ープ ナイロ
INTENDED USER PROFILE: The intended user should be a licensed medical
professional, the patient or the patient’s caregiver. The user should be able to read,
understand and be physically capable of performing the directions, warnings and
cautions in the information for use.
INTENDED USE/INDICATIONS: The DonJoy Maxtrax 2.0 Air Walker is designed to
provide comfort, support and immobilization to the lower leg, ankle and foot. It may
be suitable for the treatment of soft tissue injuries of the lower leg such as acute
ankle sprains, stress fractures of the lower leg, stable fractures of the foot and/or
ankle including metatarsal fractures, Achilles tendon repairs and post-operatively
following bunion (Halux Valgus) surgery (modified Lapidus Fusion).
PERFORMANCE CHARACTERISTICS:
Customizable fit designed to provide comfort to the limb or body segment.
Soft-good/ semi-rigid designed to restrict motion through elastic or semi-rigid
construction.
Providing immobilization or controlled movement to the limb or body segment.
CONTRAINDICATIONS: This device is contraindicated for unstable fractures of
the lower leg, ankle and foot. Do not use if you are allergic to any of the materials
contained within this product.
NOTE: Due to the molded outer sole, the orthopedic walker may be slightly higher
than a normal street shoe, therefore an athletic shoe or a street shoe with a ½”
heel, may be worn if necessary for patient comfort. A ProCare ShoeLift
TM
also may
be used on the shoe worn on the non-affected foot.
For Air liner, inflate and deflate the bladder once before use to ensure the integrity
of the air chamber.
WARNINGS AND CAUTIONS:
This device is to be used under the supervision of a healthcare professional. The
determination of when to apply the brace and the frequency and duration of use
should be strictly at the discretion of the treating physician. Always consult with
your physician before making changes to the brace.
Application of this device is recommended only when the fracture is
demonstrably stable and there are acceptable limits of angular and rotational
deformity.
Do not use this device on patient’s incapable of communicating physical
discomfort.
Check your skin frequently for “hot spots” and skin irritation.
Do not use this device if you cannot feel sensations whether due to post-op
anaesthesia, nerve, skin or other conditions.
Use caution when walking on slippery or wet surfaces to avoid injury.
Do not use over open wounds.
Do not over tighten straps. This may result in reduction of blood flow or
sensation.
Do not over-inflate aircells. Improper aircell inflation may cause significant skin
irritation, especially in people with diabetic neuropathy. Reduce aircell pressure
with any visual skin changes or reported discomfort.
Do not modify the device or use the device other than intended.
If you develop an allergic reaction and/or experience itchy, red skin after coming
into contact with any part of this device, please stop using it and contact your
healthcare professional immediately.
Do not use this device if it is damaged and/or the packaging has been opened.
If pain, swelling, changes in sensation or other unusual reactions occur while
using this product, consult your medical professional immediately.
NOTE: Contact manufacturer and competent authority in case of a serious incident
arising due to usage of this device.
APPLICATION INFORMATION:
For first time application, loosen all straps and remove liner from boot.
1. Removable foam ankle pads are provided for patient comfort (
Figure 1
).
2. Place foot in liner and secure with contact closure. Make sure the heel fits
snugly into the posterior portion of the liner. Secure the forefoot flap on the liner
first followed by the lower leg portion. Make sure liner fits snug top to bottom
(
Figure 2)
.
知らせ 大限久性と快適性を得られるよう最先端技術によりあらゆる努力が払われていま
すが本製品の使用に怪我が防止れるう保証はあません。
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