BabyBrace VMH-01 User manual

VMH BRACING, LLC
U.S.A.and International Patent Pending
Figure 4
Figure 9Figure 8Figure 7
Figure 6
Figure 5
Figure 10
LUMBOSACRAL GESTATIONAL/
POST-NATAL ORTHOSIS
S
M
L
XL
28.5 – 43.1 inches 30.4 - 47.1 inches 33.3 -52.4 inches 36.5 - 57.6 inches
Table 1
Model Number : VMH-01
© 2015
PRODUCT SUPPORT
For product support, please call 813.515.5066
INTENDED FOR USE ON A SINGLE PATIENT
Figure 11 Figure 12
Figure 13
Instruction Manual for
BabyBrace®
PATENT PENDING

WARNING- Do not use the panels during late stages of pregnancy. Any
use of the anterior and/or posterior panel should be performed under the
advisement of a trained medical professional. Use of the anterior panel should
be post-natal and directed by a physician and/or trained medical
professional. It is recommended that the anterior panel only be used after
complete healing of a C-section wound.
COMPONENTS
Figure 3 1. Large Rigid Padded Back Panel - Padded Side
2. Large Rigid Padded Back Panel - Velcro Side
3. Small Rigid Front Panel - Padded Side
4. Small Rigid Front Panel - Velcro Side
FITTING
ASSEMBLY
•The velcro side of the panels (Figures 3.2 & 3.4) should be attached to
the brace (Figure 1.1).
•The large back panel (Figure 3.1) can be directly attached to the
inner midline (Figure 1.2) of the front view of the brace. It is
recommended that use of panels be under the supervision of a medical
professional.
•The small front panel (Figure 3.3) can be attached to the brace in 2
positions, but should only be used under the direction of a medical
professional.
•It can be attached directly to the inner side (Figure 1) of the main
support straps and also be attached to the inner surface of the
adjustable arms (Figure 2.1) after the main straps are fastened. In this
position the front panel will be in-between the adjustable arms and the
main straps.
USE AND CARE
MATERIAL CONTENTS
Main brace: 25% cotton, 40% polyester, 35% spandex
Front and back panels : thermoforming plastic, 80%polyester padding, 20%
spandex
WARRANTY
VMH Bracing, LLC will repair or replace all or part of the unit
and its accessories for material or workmanship defects for a period of
three years from the date of the sale.
PRODUCT SUPPORT
For product support, please call +1 813-515-5066
INTENDED FOR USE ON A SINGLE PATIENT
1
2
3
34
Front View
Back View
Please, do not use this brace until you have read the entire instruction manual on the
appropriate use of the brace. The correct application of the device is essential to its
proper functioning and safety . It is also important that you should have a thorough
understanding of the brace prior to using it.
This brace should NOT be a substitute for sound medical advice from a spinal specialist
and/or OB/GYN. Please consult with your physician to ensure you do not have one of
the potentially dangerous causes of back pain.
INDICATIONS
Gestational lower back pain. Post-natal lower back pain.
CONTRAINDICATIONS
Do NOT use before ruling out potentially dangerous causes of back pain. In cases of
preeclampsia, eclampsia, ectopic pregnancies, abnormal fetal genetic testing, or
any high risk pregnancy, do NOT use the brace. Do NOT use if the patient presents
circulation problems. In cases of displaced fractures, do NOT use the brace. In cases
of cardiovascular, pulmonary, or skeletal conditions that are sensitive to compression
or pressure, do NOT use the brace. It is up to the physician to exclude any medical
conditions that would be a contraindication to the brace use.
WARNINGS AND PRECAUTIONS
This brace is intended for two distinct purposes: gestational support and post-natal
support.
The front and back attachable panels are part of the post-natal kit. Do NOT
over-tighten the brace to the extent where it becomes uncomfortable and/or
restrictive. Do NOT use the front and back attachable panels during late stages of
pregnancy. It is up to the prescriber’s discretion whether they recommend use of front
and back attachable panels during early stages of pregnancy. This brace should be
used in conjunction with a healthy back exercise program. This brace serves as
a protective crutch to reduce the forces of stressful activities throughout maternity. The
reduction of stress on the lower back can prevent muscle imbalances that cause back
pain during maternity. In case of pain, irritation to the skin, swelling, prolonged
discoloration, or any unusual reaction, immediately remove the brace and consult your
physician (spine specialist or OB/GYN). Care should be taken to avoid the excess
pressure points from the panel edges when sitting or bending. Do not expose to heat
over 130°F (55°C).
GESTATIONAL KIT
COMPONENTS
Figure 1 (Front View) 1. Main Support
2.
Inner Midline
3.
Main
straps
Figure 2 (Back View) 1. Adjustable Arms (on each side)
SIZING
Start by taking a circumferential measurement of the patient at the waist, starting from
the hips to the umbilicus (Figure 10). Match the patient’s size to the Brace Size Selection
table (Table 1). A fitter should be present to obtain the appropriate size and fitting.
•If the brace is being used during the 1st or 2nd trimesters, we recommend that you
step up to the next size from the Brace Size Selection table to allow for growth.
•If the brace is being used during the 3rd trimester, we recommend you follow the
Brace Size Selection table.
APPLICATION
•Step 1- Main straps are held in both hands (Figure 4) and they will GENTLY be pulled
snug with the left main strap being placed under the belly (Figure 5). The right main strap
will then overlap the left main strap being attached via the velcro. This should be placed
in a position of comfort (Figure 6).
•Step 2- The adjustable arms will allow you to apply varying degrees of tension.
DO NOT OVERTENSION THE ADJUSTABLE ARMS OF THE SUPPORT, the support should be
snug but never TIGHT and/or restrictive.
•The adjustable arms can also be overlapped and attached to one another allowing
for the arms to be placed in different positions on the belly (Figures 7,8 & 9).
1
GESTATIONAL KIT
POST-NATAL KIT
12
Figure 1
Figure 2
Figure 3
Warning: Do not use front panel over un-healed C-section
wound.
PATENT PENDING
T
•
BABYBRACE® fitting and adjustments to be performed by a licensed medical professional only.
•Brace panel fitting and adjustments to be performed by a licensed medical
professional ONLY.
•Panels are pre-molded but may need to be contoured to appropriately
fit patients with different body habitus.
If there is any discomfort while using the panels, assistance from a
trained medical professional will be required to make adjustments to the
brace panels.
The anterior/front panel should never be placed directly on a C-section
wound unless directed to do so by prescribing physician.
•
For any questions, please contact your physician for further instruction.
•
•
POST-NATAL KIT
•
•
•
•
Table of contents
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