Technical Specifications - Dentsply Maillefer ProPex Manual De Usuario

H Maintenance of your Propex.
The device doesn't contain user serviceable parts. The service and repair should be provi-
ded by trained service personnel only.
The equipment may be cleaned with a cloth impregnated with soap and water. Use of che-
mical agents may cause damage to the equipment.
The accessories (lip clip, connection hook) must be sterilized between treatments (by auto-
clave at 134 °C).
The measuring cable can't be autoclaved.
I Guarantee
Propex is guaranteed for 24 months from the date of purchase. The accessories (cables,
battery etc.) are guaranteed for 6 months.
The guarantee is valid for normal usage conditions. Any modification or accidental damage
will render the guarantee void.
J

Technical Specifications

Propex complies to IEC60601-1 safety standard and the requirement of CE Marking of
Conformity.
Propex electronic apex locator belongs to following category of medical devices:
– Internally powered equipment (3.6 V NiMH rechargeable battery)
– Type LF (Low Frequency) applied parts
– Not suitable for use in the presence of flammable anaesthetic mixtures with air or
with oxygen or nitrous oxide
– Continuous operation
– Ingress of liquids – not protected
– Environmental conditions during transportation: temperature: –20ºC to +60ºC
(0 to 140ºF); relative humidity: 10% to 90%, non-condensing
Technical specifications
Type of screen: liquid crystal
Supply: NiMH 3.6 V battery
External charger: 120 V/50 Hz or 220V /50 Hz input– 6V DC output
Warning: The charger should comply with the requirements of
IEC 60950 standard
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K Standard symbols
On the device label appear standard symbols as follows:
Class II equipment
Attention, consult accompanying documents
Direct current
Disinfection, cleaning and sterilization procedure for dental
instruments and their supports
Foreword
For hygiene and sanitary safety purposes, all medical devices commercialised by Dentsply
Maillefer owe to be disinfected, cleaned or yet sterilized before using them into the mouth.
Some devices are considered as one usage instruments , anyhow they must follow the
same procedure.
Area of application
Cutting instruments, manual or mechanical such as:
Root canal files and broaches, manual or mechanical;
Diamond burs, made of tungsten carbide, stainless steel or carbon steel;
Reamers, drills;
Condensation and filling instruments.
Supports, kits and systems of instrumental organization.
Hand instruments.
Exclusion
Paper points
Standard and Regulation References
ISO 9001, EN 46001, Quality System
European Medical device directive for CE marking, 93/42 EEC of 14th June 1993
ISO 1942-3 Dental vocabulary
ISO/DIS 17664, Sterilization of medical devices.
Type BF applied part
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