Modular P36 PLUS Anleitung Seite 2

A D A P T I N G F O R T H E D O C T O R / T E C H N I C I A N
S C O P E O F D E L I V E R Y
R EF. P3 5K PLUS · R EF. P35 A PLUS
Hyperextension brace Modular plus includes:
1 Apply the hyperextension brace frontally, with the patient lying down (fi g. A).
A 1 x Frame made from light aluminium alloy
with safety lock closure
2 Loosen the screws on the lateral bars (fi g. B) on the front (fi g. C).
REF. P35K PLUS · REF. P35A PLUS · 3 Proceed to make the adjustments on the vertical axis (fi g. D):
REF. P36 PLUS · REF. P45 PLUS
- lengthen or shorten the hyperextension brace until the pelvic band rests on the
B 1 x Fluctuating sternal plate pubis and the plate on the sternum; if necessary, remove the screws and place
1 x Back plate (lumbar plate) (without fi g. )
them in a more suitable position to adapt the hyperextension brace to the patient
- tighten the screws and make sure the patient can sit without
REF. P38K PLUS
discomfort; if necessary, make further vertical adjustments
C 1x Delta-pectoralis pads fastened on crescent shaped bar
- make sure the lateral bars are the same length after adjustment
REF. P36 PLUS
4 Now make the horizontal adjustments (fi g. E):
D 1 x Fixed pubic pad
- adapt the hyperextension brace to the width of the patient's chest
REF. P35K PLUS · REF. P35A PLUS
- tighten the screws, checking the symmetry with respect to the sagittal plane
REF. P38K PLUS · REF. P45 PLUS
E 1 x Floating pelvic band with spring (can be blocked) 5 Adjust the brace accurately to adapt it to the morphology of the patient:
- shape the pelvic band (fi g. L and M)
REF. P45 PLUS
- shape the armpit sections (fi g. N and O), so that they adhere well to the pectoral area
F Toothed wheel under the arm to adjust the pressure
- shape the lateral bars at the level of the pelvis (fi g. P), following the reference fold
against the sternum
(to shape them more accurately we recommend using bending tools)
REF. P35A PLUS (acqua)
F
Padded parts and belt in water-repellent material,
suitable for use in water
C H A R A C T E R I S T I C S A N D M A T E R I A L S
REF. P38K PLUS
• Frame made from light aluminium alloy
• Frame construction 1 Apply the hyperextension brace frontally, with the patient lying down (fi g. A).
• Back pad can be positioned either horizontally or vertically 2 Loosen the screws on the lateral bars (fi g. B) on the front (fi g. C).
• Adjusted via screws
3 Proceed to make the adjustments on the vertical axis (fi g. D):
• Lever closure made of plastic with safety lock
- lengthen or shorten the hyperextension brace until the pelvic band rests on the
• Newly designed strap with special hook closure system for adjusting the length
pubis and the plate on the sternum; if necessary, remove the screws and replace them
• Underarm protective lining in non-toxic, non-allergic material
in a more suitable position to adapt the hyperextension brace to the patient
• Adjustable Velcro ® straps
- tighten the screws and make sure the patient can sit without
• REF. P35K PLUS · REF. P35A PLUS · REF. P45 PLUS:
discomfort; if necessary, make further vertical adjustments
Movable sternal plate
- make sure the lateral bars are the same length after adjustment
• REF. P38K PLUS:
4 Now make the horizontal adjustments (fi g. E):
Delta-pectoralis pads mounted to a half-moon plate as replacement for the sternal pad
- adapt the upper part of the hyperextension brace to the width of the patient's chest
• REF. P35K PLUS · REF. P35A PLUS · REF. P45 PLUS REF. P38K PLUS:
- tighten the screws, checking the symmetry with respect to the sagittal plane
Spring oscillation of the pelvic strap (with the option of securing at 0° and 18°)
• REF. P36 PLUS: Fixed pubic pad 5 Adjust the delta-pectoralis pads so as to obtain a proper support:
• REF. P35A PLUS: - tighten the screws all the way to lock them in this position (fi g. F)
Padded parts and belt in water-repellent material, suitable for use in water - shape the connecting strip between the pads to fi t the patient's morphology (fi g. G)
• REF. P45 PLUS:
6 Adjust the brace accurately to fi t the morphology of the patient:
Toothed wheel under the arm to adjust the pressure against the sternum:
- shape the pelvic band (fi g. L and M)
each tooth equals 5° setting variation
- shape the armpit sections (fi g. N and O), so that they adhere well to the pectoral area
• REF. P35K PLUS · REF. P36 PLUS · REF. P45 PLUS REF. P38K PLUS:
- shape the lateral bars at the level of the pelvis (fi g. P), following the reference fold
Padded parts made of soft foam with non-toxic, synthetic leather cover
(to shape them more accurately we recommend using bending tools)
I N D I C A T I O N S
• Traumatic fractures (T10-L1/L2)
• Osteoporotic or metastatic-related compression fractures of the thoracic spine
and the dorsolumbar transition (T10-L1/L2)
• Osteomalacia with fractures
• Dorsolumbar osteoarthritis
• Substitute for plaster corset
A D A P T I N G F O R T H E D O C T O R / T E C H N I C I A N
REF. P36 PLUS
1 Apply the hyperextension brace frontally, with the patient lying down (fi g. A).
2 Loosen the screws on the lateral bars (fi g. B) on the front (fi g. C)
and on the pubic pad (fi g. K).
3 Proceed to make the adjustments on the vertical axis (fi g. D):
- lengthen or shorten the hyperextension brace until the pubic pad rests on the pubis
1 A B
and the plate on the sternum; if necessary, remove the screws and place them
in a more suitable position to adapt the hyperextension brace to the patient
- tighten the screws and make sure the patient can sit without discomfort;
if necessary, make further vertical adjustments
- make sure the lateral bars are the same length after adjustment
E
4 Now make the horizontal adjustments (fi g. E):
- adapt the upper part of the hyperextension brace to the width of the patient's chest;
tighten the screws, checking the symmetry with respect to the sagittal plane
- adjust the lower part to the patient's waist width, tighten the screws checking
C D
the symmetry with respect to the sagittal plane
5 Adjust the brace accurately to fi t the morphology of the patient:
- shape the bars of the pubic pad
- shape the armpit sections (fi g. N and O), so that they adhere well to the pectoral area
REF. P45 PLUS
F
G
1 Apply the hyperextension brace frontally, with the patient lying down (fi g. A).
2 Loosen the screws on the lateral bars (fi g. B) on the front (fi g. C).
3 Proceed to make the adjustments on the vertical axis (fi g. D):
- lengthen or shorten the hyperextension brace until the pelvic band rests on the
K
pubis and the plate on the sternum; if necessary, remove the screws and place
them in a more suitable position to adapt the hyperextension brace to the patient
- tighten the screws and make sure the patient can sit without
discomfort; if necessary, make further vertical adjustments
H I
- make sure the lateral bars are the same length after adjustment
4 Adjust the inclination of the underarm section:
- Remove the screw and metal cap from the hinge between the vertical upright
and the underarm section (fi g. H)
- Raise the underarm section, turn to the desired inclination and fi t it back
on the toothed wheel (fi g. I).
- Fit the metal cover and screw back in place, and tighten the screw
- Repeat the same operation on the other underarm section, taking care to set
the same inclination on both sides.
L M 5 Now make the horizontal adjustments (fi g. E):
- adapt the hyperextension brace to the width of the patient's chest; tighten the screws,
checking the symmetry with respect to the sagittal plane
6 Adjust the brace accurately to adapt it to the morphology of the patient:
- shape the pelvic band (fi g. L and M)
P
- shape the armpit sections (fi g. N and O), so that they adhere well to the pectoral area
- shape the lateral bars at the level of the pelvis (fi g. P), following the reference fold
(to shape them more accurately we recommend using bending tools)
N O
PU TT I N G ON T H E APPL I A NC E
FO R T HE PAT I EN T
PO SI T I ON I N G OF T H E LU M B AR PAD
(FO R AL L M OD E L S )
1 Open the closure lever and unhook the belt from the knob screw (A).
7 In accordance with the physician's instructions, position the lumbar plate along
2 Position the hyperextension brace on the chest, pass the belt behind the back
the spinal column in vertical or horizontal position where prescribed (fi g. R): and fasten it to the knob screw (A).
- remove the knob screw and place it at the desired height (in one of the special
3 Position the hyperextension brace so that the sternal plate is centered on the
brass bushings) and tighten it
chest (B) and the pelvic band is not uncomfortable when sitting (C).
- move the lever to the desired height using the two screws that fasten
4 Fasten the hyperextension brace using the closure lever (D).
it to the metal structure (fi g. S)
- in case of vertical positioning of the lumbar pad, remove the strap
from the horizontal buckles and thread it through the vertical ones
8 Adjust the belt length:
- having the closure lever open slide the belt into the buckles and
fasten it with the corresponding Velcro ® fastener
- fi t the hook in the knob screw
- if necessary, make further adjustment to the straps to obtain the desired
pressure in the lumbar area: the optimum pressure is obtained when
the hyperextension brace remains in place even with the closure lever open (fi g. T)
9 Fasten the hyperextension brace using the closure lever (fi g. T).
10 Make sure the lumbar pad is centered securely on the spinal column
and secure it using the strap and the corresponding buckles (fi g. U).
DE CL ARAT IO N O F C O NFO RM IT Y
As the manufacturer, ORTHOSERVICE AG declares with sole responsibility that this product
is a Class I medical product and has been manufactured in accordance with the basic
requirements of the directives 93/42/EEC and 2007/47/EEC. These operating instructions
were created in accordance with the specifi cation of the above-mentioned directives. They
aim to ensure the safe and correct use of the medical product.
R S T U
M AIN T E N AN CE
Hand wash at max. 30° C with neutral soap (a sponge is recommended); do not dry in the
vicinity of heat sources (or, better, dry with a cloth) Check screws for tight fi t regularly.
Contact an orthopaedic technician for the replacement of used parts.
I N ST R UCTI O N S FOR B LOCK I N G T HE P ELV I C B AN D
Do not dispose of the product or any of its components into the environment.
(for the physician or orthopedic expert)
PRE CAU T IO N S
If necessary, it is possible to block the moving mechanism of the pelvic band
It is advised that the pressure exerted by the product does not act on parts of the body
(pre-set on delivery) by adjusting the lateral spring mechanisms.
suffering from wounds, swelling or lumps. The product should not be tightened too fi rmly so
Follow the following procedure:
as to avoid the development of pressure points or compression of the nerves or blood vessels
I. Loosen the central screw (A). Remove the plastic cover (B). underneath. It is advisable to wear the product over a garment, avoiding direct contact with
II. Move the pelvic band with one hand, while moving the block plate (D) and mounting it the skin. If in doubt about how to apply, contact an orthopaedic technician. The device should
on the outer pin (C) with the other hand. (The pelvic band can be blocked in 2 positions) not be worn in the vicinity of open fl ames or strong electromagnetic fi elds. Do not release the
III. Reattach the plastic cover by mounting it on the fi xation pin (E) fi rst, and tension of the belt abruptly, in order to prevent sudden collapse of the trunk.
on the central screw thread afterwards. Tighten the screw.
WA RNIN G S
IV. Proceed in the same way on the opposite side.
The product may only be used in the event of medical indication or when prescribed by a
Make sure that the the mechanisms are blocked in the same manner, physician and must be applied by an orthopaedic technician, the competent authority fi gure
with the block plate (D) in the same position. for the application as well as for information on the safe use, according to individual needs.
To ensure the effectiveness, tolerability, and correct operation, it is necessary that the device
is put on with the utmost care. Any changes to the structure or adjustment of the device
must be prescribed by a physician and performed by an orthopaedic technician. Under no
circumstances should the adjustment made by the physician/orthopaedic technician be
altered. Use of the product is recommended for a single patient. With hypersensitive patients,
direct contact with skin may cause redness or irritation. In the case of onset of pain, swelling,
lumps or any unusual reaction, immediately contact your physician.
T RAD EM ARKS O F M AT E RIAL S
Velcro ® is a registered trademark of Velcro Industries B. V.
modular plus
REF. P35K PLUS · REF. P36 PLUS
REF. P38K PLUS · REF. P45 PLUS
3-Punkt-Hyperextensionsorthese
REF. P35A PLUS
3-Punkt-Hyperextensionsorthese
acqua
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Anweisung sorgfältig
Headquarter: ORTHOSERVICE AG
Via Milano 7 · CH-6830 Chiasso (TI) · Switzerland
info@orthoservice.com · www.orthoservice.com
Niederlassung Deutschland: Orthoservice Deutschland GmbH
Flugstraße 7 · D-76532 Baden-Baden · Deutschland
info@orthoservice.de · www.orthoservice.de
Sede italiana: RO+TEN s.r.l.
Sede legale: Via Fratelli Ruffi ni, 10 · I-20123 Milano (MI) · Italia
Sede operativa e amministrativa:
Via Comasina, 111 · I-20843 Verano Brianza (MB) · Italia
info@roplusten.com · www.roplusten.com
Società soggetta a Direzione e Coordinamento (art. 2497bis CC):
Orthoservice AG (CH) · 6830 Chiasso (TI) · Switzerland
9D CFG00054INT01.0614