15
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.
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, as well as the 93/42/EEC Medical Device Directive. The composite
gun complies with the relevant EU regulations.
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
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
third parties, the following safety instructions have to be observed.
Summary of Contents for phasor 408800
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