English - DJO ISOFORMTM SIO Bedienungsanleitung

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ENGLISH

BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS
COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE PROPER
FUNCTIONING OF THE DEVICE.
INTENDED USER PROFILE: The intended user should be a suitably trained
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: Designed to support the lower back and
may be suitable for people with sacroiliac pain, dysfunction, lower back pain,
sprains/strains.
PERFORMANCE CHARACTERISTICS: Soft-good/semi-rigid good designed
to restrict motion through elastic or semi-rigid construction.
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CONTRAINDICATIONS: Pulmonary, cardiovascular or skeletal conditions
which have risk to be made worse as a result of compression and/or
pressure, unstable, displaced fractures. Do not use if you are allergic to any of
the materials contained within this product.
WARNINGS AND CAUTIONS: If you experience any pain, swelling, sensation
changes, excessive discoloration, irritation to the skin or any unusual
reaction while using this product, consult your medical professional. If any
distortion of the support panels, fraying or deterioration of lace cables is
noticed, discontinue use. Brace is intended to be worn over clothing. Brace
should be appropriately sized to the patient to ensure proper support and
function. If the brace does not fit properly, it may be adjusted by a healthcare
professional. Care should be taken with patients, especially the elderly, not
to apply the brace too tightly, which MAY cause excessive pressure. Patients
should be instructed on appropriate tensioning during ongoing use. Patient
should see a healthcare professional for a replacement if a product quality
issue occurs within the warranty timeframe. Brace should not be exposed
to moisturizers, chemicals, or solvents, as they may affect durability. This
product must be prescribed and fitted by a suitably trained professional.
The frequency and duration of use should be determined by your healthcare
professional. Do not modify the device without a healthcare professional
present. Do not use device other than instructed in this IFU. Keep out of
reach of children under three years of age to avoid accidental ingestion
of the small parts. Do not use over open wounds. Do not use the device
if it is damaged and/or the packaging has been opened. NOTE: Contact
manufacturer and competent authority in case of a serious incident arising
due to usage of this device.
APPLICATION INFORMATION:
SIZING:
1. Begin by taking a measurement of the circumference of the patient
approximately 1" (2.5cm) above the widest part of the hips. For patients
whose circumferential measurement is between sizes, select the larger
brace.
2. Match the patient's size to the Sizing Chart below.
FITTING:
3. To adjust waist belt circumference, align the tip of the hook and
loop attachment on the rear panel section. Repeat for opposite side.
(Figure A)
NOTE: The pull tab may be oriented on either the right or left-hand side
of the patient, however the loop exterior with the donning mitt should be
secured on the opposite side of the pull tab.
APPLICATION INSTRUCTIONS:
4. Loosen the brace by detaching the pull tab from the loop exterior and
pulling the brace in opposite directions. (Figure B)
SIZE CIRCUMFERENTIAL MEASUREMENT
S/M Less than 48" (122 cm)
L/XL 49" - 60" (125 cm - 152 cm)
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ブレースを外す
8. ループ外延部からプルタブを外して、 ブレースを緩めます。 ループの外延部から
着用ミッ トを外し、 ブレースを取り外します。
プルタブ長の調整 (オプシ ョン)
9. プルタブを短縮するには、 プルタブポケッ トからレーススプールを取り外し、 スプ
ールにレースを巻き付けます。 プルタブを長くするには、 スプールから巻かれて
いるレースをほどきます。 ( 図 E)
10. レーススプールをプルタブポケッ トに挿入し戻します。
清浄手順 ：
中性洗剤を使用して、 水 (86° F/30° C) で手洗いします。 空気乾燥させます。
注記 ： すすぎが不十分だと、 残った洗剤による皮膚の炎症や製品素材が劣
化する原因になることがあります。
アイロンをかけないでください。
乾燥機を使用しないでください。
漂白しないでください。
材料 ： ナイロン、 ポリエステル、 ポリウレタン、 ポリエチレン、 綿、 アクリル、 ポリ
プロピレン、 シリコン、 合成ゴム、 EVA.
保証 ： DJO, LLCは、 材料や工程の不具合に対しては、 購入日から6ヶ月間に限りユニッ
トおよびアクセサリのすべてまたは一部を修理あるいは交換します。 本保証が現地
規制と矛盾する範囲については、 当該現地規制の規定が適用されます。
単一患者用です。
LATEX
天然ゴムラテックス不使用。
注記:機能や強度、耐久性、快適性を最適化でき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
製品の使用により負傷が予防されるという保証はまったくありません。
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