3
1.1. Indications for Use
The device is an X-Ray generator that provides the radiation necessary for the formation of a
radiographic image from which a radiographic diagnosis may be made.
1.3. Product Specification´s
Class 1,
B type equipment
- Electric Discharge Protection:
type
- CE-MDD: Class IIb
- FDA: Class II, Code EHD and regulation number 872.1800
- Water Proof Protection: IPX0 (Standard Equipment)
1.4. Obligation of the installer
- Make sure the voltage is accorded with the manufacturer requirements and range
- Make sure the switch can cut off the power supply when x-ray working to ensure safety
- Install and test the x-ray according to the Installation Manual (technicians only)provided by
manufacturer
- Provide Operation Manual to the final users
-
Follow all the instructions inside this Manual. XZeal Technologies, Inc. is not responsible for
any injury caused by improper installation or use
OPERATION
1.2. Main equipment parts
X Ray Tube head, Timer, Arms and base - fixation support according the model (Structure)
1. Introduction
Applicable Standards
The XZeal Z70 Mobile, comply with the following standards:
- DHHS Performance Standard FDA 21 CFR Subchapter J
- IEC EN 60601-1:2006 + AC:2010
- IEC EN 60601-2:2007 + AC:2010
- IEC EN 60601-3:2008 + AC:2010
- IEC EN 60601-28: 2010
- IEC EN 60601-2-65:2012
Dental X-Ray Unit
Z70
70kVp - 7mA
1.5. Obligation of the user - User's notice
- Use the equipment according to this User´s Manual
- Maintain the equipment according to the maintenance timetable suggested by the
manufacturer. If the equipment is not properly maintained by the Users , the Manufacturer
and the dealer will not respond for any accident caused by incorrect operation
- If some accident happens during the equipment operation and result in death, hurt or healthy
damage, please inform immediately the responsible governmental department, manufacturer
and dealer
- The user must inform the part number and serial number described on the Labels, in case it is
necessary information about the product
Operation Manual