VDW SILVER - Page 24

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1. Initial Notes
NOTE
• The current user manual is only valid
for VDW.SILVER
®
devices upgraded with
Software version R 1.0. With this Software
Upgrade, the VDW.SILVER
®
endo motor can
be used both in rotary as well as in recip-
rocating mode. If you have upgraded your
VDW.SILVER
®
with Software version R 1.0,
please replace your current VDW.SILVER
®
user manual with these instructions.
• For detailed instructions on how to up-
grade your VDW.SILVER
®
with Software
version R 1.0, please refer to the separate
Upgrade Instructions in your RECIPROC
®
Upgrade Kit.
• For detailed instructions on how to use
RECIPROC
®
instruments, please refer to the
RECIPROC
®
DIRECTIONS FOR USE enclosed
in your RECIPROC
®
Upgrade Kit or consult
www.reciproc.com.
• If you have already used your
VDW.SILVER
®
device, the initial steps for
preparing and installing the device might
not be relevant for you. As you have added
a new fuction to your endo motor, we rec-
ommend, however, to read these directions
for use completely and thoroughly.
2. Indications for Use
FOR DENTAL USE ONLY!
The VDW.SILVER
®
upgraded with software R 1.0
is a medical device according to the Medical
Device Directive 93/42/EEC, revised by the
Directive 2007/47/EC. It is designed for use by den-
tists for use with dental root canal instruments in
continuous rotation and in reciprocating movement.
This device has to be used only in hospital
environments, clinics or dental offices by qualified
dental personnel.
3. Contraindications
Do not use the device for implants or any other
dental procedure outside endodontics.
4. Warnings
In this chapter a description of serious adverse
reactions and potential safety hazards for the
product or the user/patient is included. Please
read the following warnings before use.
WARNINGS
• The device may be used only in suitable
locations and only by specialized physicians
licensed to practice dentistry.
• Should any liquid exit from the device
that may be attributed to battery leaks,
discontinue use of the device immediately
and ship it to an authorized service center
for battery replacement.
• Do not expose the device to direct or
indirect sources of heat. Operate and store
the device in a safe environment.
• Do not alter or modify the device; VDW
GmbH declines any responsibility in case of
alteration or modification of the device.
• The VDW.SILVER
®
upgraded with soft-
ware 1.0 requires special precautions as re-
gards electromagnetic compatibility (EMC)
and must be installed and commissioned
in strict conformity with the EMC information
provided in this user manual. Specifically,
do not use the device close to fluorescent
lamps, radio transmitters and remote
controls.
• In order to avoid possible risks due to
electromagnetic interference, do not use
any electrical medical device or electrical
device of any other kind in proximity to the
VDW.SILVER
®
upgraded with software R 1.0.
The electromagnetic radiation emitted by
the device is below the recommended limits
set forth in pertinent regulations in force (EN
60601-1-2:2007).
• Do not use the device in the presence
of free oxygen or anesthetic substances or
flammable products. Operate and store the
device in a safe environment.
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