Trulife T34 T-Series Braces Hyperextension Orthosis with Pubic Pad User Guide

T34, T37, T39, T39S T-Series Braces
Installation and User Guide
31558-001 REV H 2022-05-23

T34 T-Series Braces Hyperextension Orthosis with Pubic Pad

Product| Description| Hip Circumference (cm)| Pelvic Band
Length (cm)| Product
Height (cm)
---|---|---|---|---
T34-02| HYPEREXTENSION SPINAL BRACE SMALL| 76-83| N/A| 43-17
T34-03| HYPEREXTENSION SPINAL BRACE MEDIUM| 83-94| N/A| 45-50
T34-04| HYPEREXTENSION SPINAL BRACE LARGE| 94-104| N/A| 48-54
T34-05| HYPEREXTENSION SPINAL BRACE X-LARGE| 104-114| N/A| 53-59
T37-02| HYPEREXTENSION SPINAL BRACE W/PELVIC BAND SM-MD| 76-94| 43-48| 43-50
T37-04| HYPEREXTENSION SPINAL BRACE W/PELVIC BAND LG-XL| 94-114| 53-59| 48-59
T39-02| ARTICULATING HYPEREXTENSION BRACE SM-MD REGULAR| 76-94| 43-48| 43-50
T39-04| ARTICULATING HYPEREXTENSION BRACE LG-XL REGULAR| 94-114| 53-59| 48-60
T39S-02| ARTICULATING HYPEREXTENSION BRACE SM-MD SHORT| 76-94| 43-48| 39-43
T39S-04| ARTICULATING HYPEREXTENSION BRACE LG-XL SHORT| 94-114| 53-59| 43-50
Accessories| Description
---|---
T343739-KIT-LG-XL| STRAP KIT LG/XL SPINAL HYPEREXTENSION T34/T34S/T37/T39/T39S
T343739-KIT-SM-MD| STRAP KIT SM/MD SPINAL HYPEREXTENSION T34/T34S/T37/T39/T39S
T343739-QUICK-RELEASE-KIT| QUICK RELEASE KIT FOR SPINAL HYPEREXTENSION T34/T34S/T37/T39/T39S
T34PADKIT| PAD KIT SPINAL HYPERXTENSION T34 /T34S
T37T39PADKIT| PAD KIT SPINAL HYPERXTENSION T37/T39/T39S

INDICATIONS

Vertebral compression fractures, Osteoporosis, vertebral arthritis and post- surgical support.

IMPORTANT NOTE

• These instructions are only general guidelines and may be altered by the Fitting Specialist according to each individual’s needs or the specifications of the prescribing physician.
• Any attempt at moving a patient in an acute and/or post-operative condition should be facilitated with help from support staff and all necessary precautions should be taken.
• Treatment protocol may vary from institution to institution and the adherence of these requirements is the responsibility of the Fitting Specialist.

APPLICATION, INSTALLATION AND USE

Recommended application, installation and use procedures must be followed for maximum safety and service life.

• The metal components are powder-coated and it is recommended that the shaping be done by hand. If bending irons are necessary, it is recommended that only rounded bending irons are used. Care should be taken not to bend at the slot/screw locations.

• On quick release side of strap, adjust length to patient and cut off excess. Once strap tension is established there should not be any need for adjustments.

Attention

• Follow the physician’s and the fitting specialist’s instructions for length of brace wear.
• Follow physician’s and the fitting specialist’s instructions for activities that are acceptable while wearing the orthosis.
• Physician’s orders should supersede all protocol.

INSTALLATION AND USE

1. Always wear a tight fitting undershirt as a buffer under the orthosis.
2. Ensure the Tension buckle (FIGURE 1) is in the open position and the quick release buckle is unattached from the quick release post.
3. While lying down, gently log-roll onto the back pad and strap without any bending or twisting of your spine. Insert your thumb into rope of quick release buckle (FIGURE 2) and pull buckle up and over quick release post. You may need assistance for this procedure. 4. Close Tension buckle on opposite side.

Maintenance instructions

• Bars can be cleaned with soap and warm water or rubbing alcohol.
• Pads can be removed and washed with warm water and mild soap then air dried.

STORAGE AND USE

There are no identified restrictions on the temperature of storage and use.
DISPOSAL
There are no hazardous materials in the device. Comply with local and national laws and regulations.

LEGAL INFORMATION

The use of this class 1 medical device is subject to the respective national laws of the country of use and may vary accordingly. The user of this device should report any serious incident to Trulife and the competent authority of the country of use.

Trulife
3225 Woburn St. Suite 160 Bellingham, WA 98226 USA Phone (+1) 360 697 5656
Email supportop@trulife.com|
MDSS GmbH
Schiff graben 41
30175 Hannover Germany
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LIMITED WARRANTY

Trulife warrants that the PRODUCT will be free from defects in material and workmanship from the date of installation for the warranty period stated on the PRODUCT warranty card.
This warranty will not apply if the PRODUCT has been damaged by misuse, abuse, neglect, improper care, failure to follow instructions, abnormal wear and tear, or in the event that the PRODUCT has been modified/repaired by persons unauthorized by Trulife.
If a defect in material or workmanship is found during the warranty period, Trulife will, at Trulove’s option, either repair or replace the product. If it is not possible to repair or replace the product, Trulife will be limited to refunding the purchase price.
Trulife will not be liable under any legal theory for any direct, indirect, special, incidental or consequential damages arising from the use of or inability to use this product.
The application guidelines for this Trulife product are for the use of and by a certified, qualified practitioner only. Patients are not to attempt to apply or adjust the item unless expressly instructed to do so by the practitioner responsible for the prescription and/or initial fitting of the device. All patient questions should be referred to the practitioner and not to the manufacturer. The manufacturer warrants only that the enclosed product has been inspected for quality and can be effective for certain indications, but final decisions and ongoing monitoring must be made by the medical professional(s) prescribing and/or fitting the device to determine its effectiveness for an individual patient. Patient compliance is an integral part of the entire protocol and must be adhered to in order to avoid potential problems and to maximize the effectiveness of the prescribed product.
As a condition of the sale of any Trulife product, this product is restricted to a “Single Patient Use Only” by the originally fitted patient in order to protect the care provider and the patient against potentially adverse consequences of infectious disease transmission, material instability in adapting to the configuration of the original user and/or decrease in effectivity. Any express or implied warranties are voided if the product is reused or fitted to another patient. Additionally, a license of right to use under any relevant patents pertaining to the product is terminated with the cessation of use by the original patient. As with all Trulife products, this product must be prescribed and applied by a qualified practitioner to determine it meets the needs of the particular patient and accomplishes the desired results.

Trulife www.trulife.com

References

• Prosthetics Orthotics Pressure Care Specialists | Global | Trulife
• Prosthetics Orthotics Pressure Care Specialists | Global | Trulife

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