PathRight Medical RestoreX Gebrauchsanweisung Seite 14

Troubleshooting (Cont.):
8) What if my curvature is further back on the penis than the point of bending?
This is acceptable. See pictures on pages 18-20 for recommendations on
counterbending. In a clinical trial evaluating RestoreX, curvatures that were closer to the
body responded just as well as those that were directly over the point of bending. Bending
is important because it allows more force to be applied to the direction of curvature than
other areas of the penis. If the distance from the penis tip to the curvature of your penis
is greater than 4 in (10.16 cm), only use the first or second stop (30° or 60°). Limiting the
angle of opposite force will increase the tension applied to the disease location.
Care:
Do not use a lubricant on RestoreX as it may permanently damage the device.
•
Cleaning – To clean the device, wipe off any visible soil or contaminants from surfaces
•
using a soft towel or facial tissue. Next, clean all surfaces of RestoreX using a cloth
moistened with soap and water. DO NOT wash or immerse RestoreX in water, as this may
damage the interior components. Allow RestoreX to air-dry thoroughly in a ventilated
location before storing.
Dispose of the device according to your local regulations.
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www.RestoreX.com
RestoreX | Instructions for Use |
Symbol Symbol Title
Manufacturer
Date of
Manufacture
REF
Catalogue number
REF
REF
REF
LOT
LOT
Batch code
LOT
LOT
REF
LOT
Consult instructions for
use or consult electronic
instructions for use
Unique device identifier
UDI
Patient information
website
Authorized
representative in the
EC REP
European Community/
European Union
Medical Device
www.RestoreX.com
RestoreX | Instructions for Use |
Description Source
Indicates the medical ISO 15223-1 Ref. 5.1.1
device manufacturer.
Indicates the date when ISO 15223-1 Ref. 5.1.3
the medical device was
manufactured.
Indicates the ISO 15223-1 Ref. 5.1.6
manufacturer's catalogue
or model number.
Indicates the ISO 15223-1 Ref. 5.1.5
manufacturer's batch code.
Indicates the need for ISO 15223-1 Ref. 5.4.3
the user to consult the
instructions for use
Indicates a carrier that ISO 15223-1 Ref. 5.4.3
contains unique device
identifier information
Indicates a website where ISO 15223-1 Ref. 5.7.4
a patient can obtain
additional information on
the medical product
Indicates the authorized ISO 15223-1 Ref. 5.1.2
representative in the
European Community/
European Union
Indicates the item is a ISO 15223-1 Ref 5.7.7
medical device
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