8 Technical data
8 Technical data
8.1 Technical specifications
General information
Manufacturer
PaloDEx Group Oy
Nahkelantie 160, FI–04300 Tuusula, FINLAND
Quality system
In accordance with ISO13485 standard
Environmental management system
In accordance with ISO14001 standard
Conformity to standards:
IEC 60601-1
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC60601-2-65
CAN/CSA –C22.2 No. 601-1-M90
CE models marked according to the Medical Device Directive
93/42/ EEC
Device data
Product Name
FOCUS
™
Intraoral X-ray
Type
FOCUS
Protection against electric shock
Class I
Degree of protection
Type B
Protection against the ingress of liquids
IP20
Mode of operation
Continuous operation with intermittent loading (momentary
operation of x-rays)
Source of power
Mains connection, plug or fixed
Software version
3.0 or higher
FOCUS
™
27
