
Catalogue
iRay Technology Co. Ltd. 7
Contents
CONTENTS....................................................................................................................... 7
1. SAFETY INFORMATION............................................................................................ 9
1.1 Safety precautions........................................................................... 10
1.2 Notes for Using................................................................................ 14
2. GENERAL DESCRIPTION........................................................................................... 16
2.1 Scope............................................................................................... 17
2.2 Characteristic................................................................................... 17
2.3 Intended use .................................................................................... 18
2.4 Standard Product Components ....................................................... 18
2.5 Components Description.................................................................. 19
2.6 Product Specification....................................................................... 20
3. INSTALLATION............................................................................................................ 24
3.1 Detector Installation......................................................................... 25
3.2 Software Installation......................................................................... 27
3.3 Detector Configuration..................................................................... 27
4. OPERATION................................................................................................................. 38
4.1 Main Operation ................................................................................. 39
4.2 Block diagram ................................................................................... 39
4.3 Work Flow......................................................................................... 40
4.4 Description of workflow..................................................................... 40
5. REGULATORY INFORMATION .................................................................................. 42
5.1 Registrant Information....................................................................... 43
5.2 Manufacturer Information.................................................................. 43
5.3 Medical equipment safety standards ................................................ 43
5.4 References harmonized standards under Directive 93/42/EEC....... 44
5.5 The compliance for each EMISSIONS and IMMUNITY standard or
test specified by IEC60601-1-2 standard................................................ 45
5.6 Lithium-ion Capacitor Reference Standards..................................... 47
5.7 Product Label.................................................................................... 48
5.8 Radio Frequency Compliance Information ....................................... 48
5.9 INFORMATION TO USER................................................................ 49
6. SOFTWARE OPERATION INFORMATION ................................................................ 51
6.1 Default Settings................................................................................ 52