
A B D
E
C
ENGLISH
BEFORE USING THE DEVICE, PLEASE READ THE FOLLOWING INSTRUCTIONS
COMPLETELY AND CAREFULLY. CORRECT APPLICATION IS VITAL TO THE
PROPER FUNCTIONING OF THE DEVICE.
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。
231
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.
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.
SIZE CIRCUMFERENTIAL MEASUREMENT
S/M Less than 48” (122 cm)
L/XL 49” - 60” (125 cm - 152 cm)
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)
5. Wrap the belt approximately 1” (2.5cm) above the widest part of the hips,
centering the rear section at the midline of the lower back so that the belt is just
above the crease of the buttocks. Secure hook portion of donning mitt to the
loop exterior. (Figure C)
NOTE: When reapplying the brace, it is easiest to guide the belt by inserting a hand
ブレースを外す
8.
プルタブ長の調整 (オプション )
9.
(
E)
10.
清浄手順:
注 記:
材 料:
保 証:DJO, LLC6
単一患者用です。
LATEX
天然ゴムラテックス不使用。