Vista Apex phasor Benutzerhandbuch Seite 9

SYMBOL IDENTIFICATION
Description for additional symbols.
Serial Number
Manufacturer
Manufacturing Date
Class II Medical
Electrical Equipment
Type BF Patient Applied Part
Keep Dry
Part Number
This symbol is a mandatory
marking for devices entering
the European market to indicate
conformity with the essential
health and safety requirements
set out in European Directives
Do not reuse
Warning / Caution
BATTERY DISPOSAL
Batteries contain toxic material and should not be disposed of in landfills
or incinerators. Dispose of depleted batteries as directed by your local solid
waste handling regulations. To dispose of the battery in North America, we
recommend www.call2recycle.com to locate a recycling facility near you.
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SAFETY NOTES, WARNINGS
AND PRECAUTIONS
Read all instructions before operating this unit. The Phasor™ heated
Consult instructions for use
composite delivery system emits high intensity light waves and must only be
Temperature Limitation used as indicated in this manual.
The Phasor™ composite gun is a medical device which is subject to IEC 60601-1
(EN 60601-1) and EMC directives IEC 60601-1-2 (EN 60601-1-2) Edition 4.0,
Humidity Limitation
as well as the 93/42/EEC Medical Device Directive. The composite gun complies
with the relevant EU regulations.
Pressure Limitation
The device has been shipped from the manufacturer in a safe and technically
sound condition. In order to maintain this condition and to ensure risk-free
Batch Code /
Lot Number operation, the notes and regulations in these Instructions for Use have to be
observed. To prevent damage to equipment and risk for patients, users and
European Representative
third parties, the following safety instructions have to be observed.
Do not use if seal or packaging
is compromised
CAUTION: U.S. federal law restricts
this device to sale by or on the
order of a dental professional.
This symbol refers to the special
disposal of electrical and electronic
devices in EU countries. Please do
not discard this device in household
garbage. Check the proper means
of disposal in your country at your
community recycling, waste center
or at your dealer. Take care to
dispose of properly.
Autoclavable up to the
temperature specified
WARNING:
• The user should test the product before use to ensure proper
functionality. Test each flow setting with the tooth models provided.
• As with any heavily used medical device, the user needs to ensure
a functional backup is readily available.
• DO NOT keep or position near flammable materials, or materials
that could combust.
• DO NOT look directly into the IR light output when the device is on.
• DO NOT insert fingers, instruments, or other objects into the
handpiece when the battery pack is removed.
• DO NOT autoclave the handpiece, battery, charging cord or stand.
• ONLY heat composite starting at room temperature.
• DO NOT heat composite if it is already at an elevated temperature
from use in the Phasor™ or other warming devices.
• ONLY USE replacement batteries provided by the manufacturer.
• ONLY DISPENSE composite after warming. Not intended to dispense
composite at room temperature or below.
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