instructions of use .pdf - VACOped

Instructions for use
Introduction
VACO ® ped is a revolutionary fracture management system
for the treatment of injuries of the lower leg and foot. A
self-adapting vacuum cushion (bean bag) provides castlike
stabilization. The use of adapters allows for different
settings of fixation or range-of-motion. VACO ® ped can be
used as a pre- or post-operative splint, a cast replacement
and/or a functional orthosis. Serial casting can be prevented,
e.g. for the treatment of Achilles tendon ruptures.
VACO ® ped offers exchangeable liners to enable advanced
hygiene and comfort. Even aqua therapy while wearing
the boot may now be an option during rehabilitation.
These instructions provide general information regarding
the handling of the VACO ® ped device. Additional
information, including video instructions, can be found
at www.vacoped.com.
Product characteristics
• For ankle joint immobilization in 0°
(Standard VACO ® ped version) and 0°, 15° or 30°
plantar flexion (VACO ® achill Version)
• Functional orthosis offering defined range-of-motion
settings
• Rapid, pressure-free and reversible application
utilizing the vacuum technology
• Easy access for wound control and/or physiotherapy
• Radiolucent
• Can be worn on the left or right foot, 3 sizes
Trouble Shooting
Painful pressure areas
Repeat the application process. During the process, while
the vacuum cushion is soft, adjust the content of the
vacuum cushion away from the pressure point.
Vacuum cushion is too hard
Pull colored valve ring forward and move from side to side
to allow air to enter.
The sole cannot be attached
Carefully bend the sole so the walking surface is bent
outward and then attach to the boot. Inspect that all the
connectors are secure.
Range of motion setting
The dorsal adapter 10° - 0° - 10° may be used to allow for
a range of motion settings between 10° plantar flexion
and 10° dorsal extension. Therefore, the 0°/15°/30°
adapter has to be exchanged for the 10° - 0° - 10° adapter,
according to the guidelines under the section Adapter.
Do not use a front band with the adapter 10° - 0° - 10°.
Cleaning
Rigid shell and straps
Can be washed in a dishwasher-style washing machine at
up to 95° C (200° F). Please assure that vacuum cushion,
terrycloth liner and sole have been removed before.
Shell system should be closed and secured with straps.
Terry cloth liner
These are made from cotton and are machine washable at
60° C/140° F (please close Velcro tabs first). For hygienic
reasons, each patient is given two new Terry cloth covers.
Terry cloth liners are intended for single-patient use.
Vacuum cushion
The cushion can be cleaned with soap and water.
Check for damage
Check for damage: Prior to the application, inspect the
device for tears, holes, cracks and other damages. If such
damages are detected, the affected piece or the entire
system needs to be replaced.
Storage
In a dry, dust-free place at 5° - 25°C (41° F – 77° F)
Postoperative treatment
Weeks
after
surgery
1
2
3
4
5
6
7
8
Sizes
EU S 35-39
M 39-42
L 42-46
Further information
If you have any questions, please contact your retailer or
OPED directly. You may also consider visiting our webpage:
www.vacoped.com
OPED Inc.
47 Loring Drive
Framingham, MA 01702
USA
Fon +1/508 /879 0762
Fax +1/508/879 0769
contact@opedinc.com
Joint position/
Range of
motion
Weight-bearing
OPED AG
Sumpfstraße 5
6312 Steinhausen
Schweiz
Fon +41 (0)41/ 748 53 35
Fax +41 (0)41/ 748 53 40
contact@oped.ch
Next
appointment
UK S 2 1/2 - 6 US S Men 5-7, Women 7-9
M 6 1/2 - 8 M Men 7-9, Women 9-11
L 8 1/2 - 11 L Men 10-13, Women 11+
Instructions for use
WM-TEVP-01-2-EN, © by artraction design 03/05

Application procedure I
Valve functions
Attaching and changing the sole
(1) (2)
Bean bag becomes soft:
Pull valve rim, then bend
valve gently sideways
guiding line
2.)
1.)
Open valve on vacuum cushion (see also valve functions)
and remove the front shell. Place foot in inner boot and
close Velcro tabs. Then insert foot with inner boot in shell.
Application procedure II
Bean bag fixed in place:
Push down the valve rim
and use the pump
Removal: Pull down both levers at the same time to
unlock (1) and the push the sole toward the back to
remove (2).
Insert front (ventral) adapter
• Insert adapter on one side (top and bottom at
the same time, see diagram)
• Pull rubber and insert in the same way
on the other side
• For freedom of movement at ROM 10° - 0° - 10°,
remove front adapter and do not replace
Insert spreader (1)
In cases of a severely swollen ankle, the spreader creates
more space in the rear (dorsal) shell.
• Attach spreader (as illustrated) to the guiding line
on the dorsal shell
• Press the center of the spreader inwards with both
hands and assure that the spreader clicks into place
Close valve cap
2.)
Replacement: Do not depress side levers when replacing
sole. Align the raised plastic barbs on the foot sole to the
open slots of the boot. Push the sole forward and an
audible click will be heard. Inspect that all the connectors
are secured.
1.)
Use of Achilles pad (VACO ® achill only)
Remove spreader (2)
• Press the locking spring inwards on one side with the
thumb, keeping the index and middle fingers on the
outer edge of the spreader
• Repeat this procedure on the other side
• Remove spreader
Note: In the US, the ankle spreader is sold separately.
Put on front shell and close straps. The recommended
sequence is as shown in the diagram. For optimum adjustment,
patients who are allowed weight bearing should take
a few steps and then re-adjust the tension of the straps.
Application procedure III
Attach the vacuum pump to the valve stem and
evacuate the air. The vacuum cushion will feel hard to the
touch. Remove pump and close valve cap. Check and if
necessary re-adjust the tension of the straps.
Exchange of terry cloth liner
Opening
for valve
The vacuum cushion is placed inside a terry cloth liner
similar to a pillow inside a case. To get it out, open the
zipper in the back and pull out the vacuum cushion. When
getting the vacuum cushion back into a liner, please
assure that all the wings are inserted properly. Evacuating
the vacuum cushion will make insertion easier. Close the
zipper all the way.
Adapter
The rear adapter is used to change the position of the
boot to 0°, 15° or 30°. When the adapter is placed in the
boot the number 0° is at the top and the 30° at the
bottom. The adapter screw has two openings for the key.
Turn the key, positioning the arrow to the open position
and remove the adapter. Adjust the boot by moving the
back (calf) portion. Once in the correct position, insert the
key, turn until the arrow on the adapter points to the
lock position. When the rear adapter is set in a neutral or
0° position, the 0° band on the front shell should be used.
It is recommended to insert the Achilles Pad while using
the VACO ® achill in the 30° plantar flexion position. Place
the Achilles Pad on the inside of the posterior rigid shell.
Slide the top portion of Achilles Pad under the boot strap,
then snap the hooks in place.
Important safety instructions
If any pain, numbness in the toes or blueness of the
feet cannot be corrected by repeating the adjustment
procedure, see a doctor immediately. Medical
treatment is required in these circumstances.
Always check that the sole is firmly in place and
never walk without a sole – DANGER OF SLIPPING! Do
not walk without front shell being properly attached
and secured by girth straps.
• It is not recommended that patients drive an
automobile while wearing the VACO ® ped
• Ensure that all girth straps are securely tightened
• Inspect the device prior to application for tears,
holes or other damage, particularly after washing.
If you suspect that a device is damaged, contact
your OPED representative