LORAD AFFINITY Series, Service Manual

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1-8 P/N 9-500-0255
Service Manual
Chapter 1: General Information
Compliance Data
4.0 Compliance Data
The Mammography System conforms to all applicable FDA regulations. Labels addressing
the certifiable components are fixed to the unit at several points (refer to Figure 1-4). The
main identification label containing the equipment model number and serial number is near
the input power receptacle on the Gantry.
The serial number is used to track units for warranty and service purposes, and will be
requested should it become necessary to contact L
ORAD
regarding the machine.
Note… The L
ORAD
Bucky devices (18 x 24 cm and 24 x 30 cm) are certified
components that do not have to be reported on form FDA 2579 (Ref BRH:
Doc MA3499).
4.1 Compliance Statement
The manufacturer states that this device conforms to:
• Medical Device Directive 93/42/EEC Annex II.
• ISO 9001:1994, EN 46001 1993, ISO 13485
• IEC 601-1: Safety Requirements For Medical Electrical Systems
• IEC 601-1-2: Electromagnetic Compatibility
• IEC 601-1-3: General Requirements for Radiation Protection
• IEC 601-1-4: Safety of Programmable Electrical Medical Systems
• IEC 601-2-7: Safety Of High Voltage Generators
• IEC 601-2-28: Safety of X-ray Source Assemblies
• IEC 601-2-32: Safety of Associated Equipment
• IEC 601-2-45:2001: Safety of Mammographic Equipment
• FDA, 21 CFR [Parts 820, 900 and 1020]
• UL 2601-1: General Requirements for Safety
• CSA 22.2. No. 601.1: General Requirements for Safety
4.1.1 Remote Indication of the Ready State
If it is desired to indicate the “Ready State” at a location other than at the operator
panel, such as at the room door, a signal is available on the Host Microprocessor
Board (PN 1-003-0493), connector AJ31 between pins 5 (+5 V, active high) and 9
(ground). This signal is a low level logic signal that drives the relay to provide remote
activation of an indicator lamp (LED).
Caution: Do not use external power supply to drive the output.