Össur MIAMI JTO THORACIC EXTENSION, Инструкция по эксплуатации

Страница: 6 / 57

6
ENGLISH
Medical Device
Magnetic Resonance (MR) safe
INTENDED USE
The device is intended to restrict movement in the low cervical and high
thoracic spine
X-ray and CT lucent.
The device must be fitted and adjusted by a healthcare professional.
Indications for use
For conditions requiring gross immobilization of the low cervical and/or
high-thoracic spine:
• Low C-Spine and high T-Spine precaution for trauma patients.
• Immobilization for pre and post low C-spine and high T-spine
surgery.
• Other conditions requiring gross immobilization of the low-cervical
and/or high-thoracic.
No known contraindications.
Warnings and Cautions:
Regular cleaning of the device and the skin beneath along with inspection
of the skin for any signs of irritation is required to reduce the risk of skin
ulceration. Bedridden patients are at an increased risk for skin ulceration.
The Chin Strut may be removed (with a healthcare professional's
approval) for sleep or when the patient is supine.
Patients under C-Spine precautions require supine application of the
device.
GENERAL SAFETY INSTRUCTIONS
The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should immediately contact a healthcare professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.
FITTING INSTRUCTIONS
Size Selection
The device is designed exclusively for use with the Miami J Collar, Miami
Jr collar (Size P3), and Miami J Select (Setting 1-5). Fits adult patients
with a waist circumference greater than 24 inches / 61 cm.
Device Application
The device should be worn over light clothing.
Ensure that correct spinal protocol is followed.
1. Remove sternal pad from collar (Fig. 1) and Chin Strut from the Front
Panel of the device (Fig. 2) .