Midmark Preva - Compliance with Applicable Standards; Certified Components; Authorized Representatives

Preva Installation/Service Manual, 00-02-1577, Revision E01
12
Compliance with Applicable Standards
Radiation
Protection
The certified components of the Preva Dental X-ray System comply with
Radiation Performance Standards 21 CFR, Subchapter J, at the time of
manufacture.
The certified components of the Preva Dental X-ray System comply with IEC
60601-1-3 Radiation protection/X-ray equipment.
UL 2601-1 File
Number:
E181750
Classified by Underwriters Laboratories Inc. with respect to electrical shock,
fire and mechanical hazards only in accordance with UL 2601-1, and
CAN/CSA C22.2 NO, 601.1-M90, and to the following particular standards,
IEC60601-2-7, IEC60601-2-28.
EMI/EMC
IEC60601-1-2
Certified Components
System
Component
Reference
Number
Tubehead
30-A1027
Control Unit. Preva
30-A0010
Control Unit. Preva Mobile
30-A0013
Modular BLD, 20 cm Lg., 60 mm Cone, White
30-A2196
Modular BLD, 20 cm Lg., 30x40 mm Cone, White
30-A2198
Modular BLD, 20 cm Lg., 20x30 mm Cone, White
30-A2199
Modular BLD, 20 cm Lg., 35x45 mm Cone, Gray
30-A2221
Modular BLD, 20 cm Lg., 35x45 mm Cone, White
30-A2222
Modular BLD, 30 cm Lg., 35x45 mm Cone, Gray
30-A2223
Modular BLD, 30 cm Lg., 35x45 mm Cone, White
30-A2224
Modular BLD, 20 cm Lg., 60 mm Cone, Gray
30-A2228
Modular BLD, Base, Gray
30-A2205
Modular BLD, Spacer, Gray
30-A2206
Modular BLD, Spacer, White
30-A2208
Authorized Representatives
North America
Midmark Corporation
1001 Asbury Drive
Buffalo Grove, Illinois 60089 U.S.A.
(847) 415-9800
Fax: 847-415-9801
www.midmark.com
Europe
CE Partner 4U
Esdoornlaan 13
3951DB Maarn
The Netherlands
www.cepartner4u.eu