Dentsply Sirona SmartLite Pro EndoActivator Gebrauchsanweisung Seite 7

2.1.6 Transport
• Intact devices can be transported by land freight or air freight in the original packaging . The
applicable requirements must be met (see table below) .
• Defective devices can also be transported by air freight or land freight in the original
packaging . If the battery is defective, the device must not be transported by air freight
under any circumstances .
• Leaking liquid can be an indicator of a defective battery .
Standards and regulations that apply to the transport of SmartLite Pro® system
• For international shipping of lithium-ion batteries, refer to the International Air Transport
Association (IATA) guidelines, located at http://www .iata . o rg/lithiumbatteries .
• For shipping of lithium-ion batteries within the United States, refer to the U .S . Department
of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) site at
http://www .phmsa . d ot . g ov/hazmat/ guidance .
Air Freight
Intact device or • UN 3481 Lithium batteries in equipment
defective device • IATA Packing instruction 967 Part II
with intact battery • Special regulations issued by airlines
and national regulations must be
complied with
Device with Not possible
defective battery
2.2 Precautions
This product is intended to be used only as specifically outlined in these Instructions for Use .
Any use of this product inconsistent with these Instructions for Use is at the discretion and sole
responsibility of the dental practitioner .
• Do not use a handpiece and attachment which has not been properly processed . Protect the
handpiece and attachment from gross contamination by applying the single-use, FDA-cleared
SmartLite Pro EndoActivator™ Barrier Sleeve . Barrier sleeves are non-sterile and intended for
single-use only . Discard after use . Do not reuse sleeves in other patients in order to prevent
cross-contamination .
• Do not attempt to negotiate or force tip into strongly curved canals to their full working
length . Tip fracture may occur . Do not bend the tip excessively to avoid motor stalling or
obstructing tip oscillation .
• Do not remove the tip from the root canal while still oscillating to avoid splashing of liquid .
• Do not apply the barrier sleeve too tightly over the attachment head to avoid motor stalling or
obstructing tip oscillation . Briefly check proper tip operation outside the patient`s mouth before
intraoral use .
• Use only Dentsply Sirona supplied power supply, power cord, charging base and battery . Use
of any accessories other than specified in this Instructions for Use may result in damage to the
handpiece and its components as well as unpredictable performance .
• Do not use adjacent to or stacked on other equipment . If adjacent or stacked use is necessary,
closely watch system and its components to verify normal operation in this configuration .
• Do not autoclave the handpiece, attachment or activator tips . Sterilizing will cause component
damage and may cause bodily injury .
• Barrier sleeves and activator tips are designed for single use only . The barrier sleeves are ready for
use . Do not attempt to reprocess for reuse .
• Stabilize attachment head when attaching or removing activator tip to limit lateral force applied to
handpiece connection . Excessive force may damage the connection between attachment
and handpiece .
Land Freight
• UN 3481 Lithium batteries in equipment
• ADR Special provisions 188 f) and g)
• International, multilateral agreements M
228 and M 259
• ADR SV 661 (international, road)
• Regulations issued by GRS
(German Joint Battery Takeback System
Foundation) for the transport of waste
lithium batteries (FRG, road)
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