Comfy Med CM-102M - User Manual

Instruction Manual
Please read this Instruct
ion Manual carefully before u
Back Brace CM-102M
Non-Sterile Medical Device
Intended Use
This Back Brace is manufactured for medium duty
use and should not be worn any longer
than 4 hours in one session or 12 hours per day.
For support in the event of:
1. Pain in the lower spine (lumbar region, lumbar spine)
2.
Wear and tear in the small vertebral joints (lumbar facet syndrome)
3. Muscle tension
4. Athletic and physical strain
5. Dystonia in the lumbar spine
Only use after consulting your physician in the event of:
1. Higher-grade instability of the lumbar spine
2. External injuries
3.
Neurological deficiencies (emanating nerve pain or paralysis of lower extremity)
4. Circulatory disorders
If back pain persists please consult a physician.
Safety Information
Risk of injury!
• Should problems arise remove the Back Brace immediately and consult a physician.
• Do not apply the Back Brace so tight that it limits your blood supply.
• Before each use, please check the Back Brace for
tears and damages.
• This Back Brace may only be used in a flawless condition.
• Do not wear the Back Brace while sleeping or during longer rest periods.
Risk of skin irritations!
• In individual cases – very rarely -
skin reactions and irritations may r
• Do not wear this item longer than 8h da
ily as well as no longer than 3
• Wash body parts covered by the brace regularly in order to avoid skin irritations.
• In order to avoid allergic skin reactions, the skin must be free of gels,
ointments, oils or similar substances.
Should problems arise, please consult a physician immediately.
Comfy
d
ion Manual carefully before u
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use and should not be worn any longer
Wear and tear in the small vertebral joints (lumbar facet syndrome)
Neurological deficiencies (emanating nerve pain or paralysis of lower extremity)
• Should problems arise remove the Back Brace immediately and consult a physician.
• Do not apply the Back Brace so tight that it limits your blood supply.
tears and damages.
• Do not wear the Back Brace while sleeping or during longer rest periods.
skin reactions and irritations may r
esult.
ily as well as no longer than 3
h in one session
• Wash body parts covered by the brace regularly in order to avoid skin irritations.
• In order to avoid allergic skin reactions, the skin must be free of gels,
greases,

Summary

Intended Use of Back Brace

Usage Guidelines and Limitations

Specifies medium duty use, with a maximum of 4 hours per session or 12 hours per day.

Conditions for Support

Lists specific lower spine issues like pain, facet syndrome, muscle tension, and athletic strain.

Physician Consultation Criteria

Outlines conditions requiring medical advice before use, such as instability or neurological issues.

Safety Information and Precautions

Risk of Injury Warnings

Details on immediate action for problems, avoiding over-tightening, and checking for damage.

Risk of Skin Irritations

Addresses potential skin reactions and provides preventive measures like regular washing and clean skin.

Applying the Back Brace

Back Brace Component Explanation

Identifies and describes the main belt, spines, handles, and removable lumbar pad.

Step by Step Application Instructions

Brace Application Procedure

A visual and textual guide for correctly fitting and tightening the brace for maximum comfort and support.

Removable Lumbar Pad Usage

Instructions on how to position and use the lumbar pad for adjustable pressure and support.

Technical Specifications and Care

Sizing Chart and Materials

Provides belt size options, belly size measurements, and lists construction materials.

Cleaning and Care Instructions

Details on washing the brace, including temperature, bleach, drying, and ironing prohibitions.

Product Warranty Information

Outlines the 12-month warranty coverage, exclusions, and contact information for support.

Overview

1. Function Description
2. Important Technical Specifications
3. Usage Features
4. Maintenance Features

The ComfyMed Back Brace CM-102M is a non-sterile medical device designed for medium-duty use to provide support for various lower back conditions. It is intended to be worn for no longer than 4 hours in one session or 12 hours per day.

Function Description:

The back brace is designed to provide support for:

• Pain in the lower spine (lumbar region, lumbar spine).
• Wear and tear in the small vertebral joints (lumbar facet syndrome).
• Muscle tension.
• Athletic and physical strain.
• Dystonia in the lumbar spine.

It should only be used after consulting a physician in cases of higher-grade instability of the lumbar spine, external injuries, neurological deficiencies (such as emanating nerve pain or paralysis of the lower extremity), or circulatory disorders. If back pain persists, a physician should be consulted.

The brace works by utilizing an elastic main belt (A), vertical polypropylene spines (B), and an outer compression band (D) with steel handles (C). The elastic main belt (A) can be tightened for a snug fit. The outer compression band (D) provides additional stabilization to the lumbar region, with its tightness directly influencing the support provided by the vertical spines (B). An optional Removable Lumbar (Compression) Pad (E) can be positioned anywhere inside the brace or removed entirely, allowing users to customize the level of pressure and support to the lumbar region.

Important Technical Specifications:

• Model: CM-102M
• Type: Non-Sterile Medical Device
• Materials of Construction: Neoprene Rubber, Highly Elastic Nylon Fabric, Polypropylene, Steel Alloy. It is 100% Latex and Chemical Free.
• Available Sizes:
  • REG (Regular): Suits belly sizes 26-37 inches (65-95 cm), corresponding to S-L.
  • LGE (Large): Suits belly sizes 38-50 inches (96-125 cm), corresponding to XL-4XL.
  • Note: Waist size should be measured at or above navel level, with the measuring tape not pulled tight. Do not measure at the trouser belt line.

Usage Features:

• Application Process:
  1. Loosen the outer compression band and reattach it to the main belt.
  2. Position the back brace centrally on your back.
  3. Fold the left side of the belt (without Velcro) over your stomach first.
  4. Fold the right side (with Velcro) to overlap, ensuring a comfortable and slightly tight fit. Adjust as necessary for maximum comfort.
  5. Use the steel handles (C) to tighten the outer compression band (D) to achieve the desired level of back support.
  6. The steel handles allow for easy adjustment of the compression band's tightness and support level at any time, and also aid in removing the strong Velcro.
• Removable Lumbar Pad (E): This pad provides additional pressure to the lumbar region if desired. It attaches and detaches easily via Velcro and can be positioned anywhere inside the brace. Users are encouraged to try the brace with and without the pad to determine what provides the best results in support and comfort.
• Safety Information:
  • Remove the brace immediately and consult a physician if problems arise.
  • Do not apply the brace so tightly that it restricts blood supply.
  • Check the brace for tears and damages before each use; it must only be used in flawless condition.
  • Do not wear the brace while sleeping or during longer rest periods.
  • In rare cases, skin reactions and irritations may occur.
  • Do not wear the brace longer than 8 hours daily, or longer than 3 hours in one session.
  • Regularly wash body parts covered by the brace to prevent skin irritations.
  • Ensure the skin is free of gels, greases, ointments, oils, or similar substances to avoid allergic skin reactions.
  • Should problems arise, consult a physician immediately.

Maintenance Features:

• Cleaning and Care:
  • Before first use, wash the back brace thoroughly.
  • It is advisable to wash the brace after every 2 or 3 uses.
  • For machine washing, place the back brace inside a cotton bag.
  • Wash separately.
  • Washing Instructions Symbols:
    • Hand wash
    • Machine wash, gentle or delicate, at 30°C
    • Do not bleach
    • Do not tumble dry
    • Do not iron
    • Do not dryclean
• Warranty: The product comes with a 12-month warranty from the date of purchase, covering material and production errors. The warranty does not cover improper use or inappropriate handling. Proof of purchase is required, and shipping costs are excluded. For assistance, contact Enquiries@ComfyMed.com.au.

Comfy Med CM-102M Specifications

General

Brand	Comfy Med
Model	CM-102M
Category	Personal Care Products
Language	English