User's Manual

45
Standards
Electrical safety
IEC 60601-1:2005+A1:2012 (EN
60601-1:2006+A1:2013)
EMC and regulatory
compliance
IEC 60601-1-2:2014
(EN 60601-1-2:2015)
Ophthalmic instruments -
Fundamental requirements
and test methods - Part 1:
General requirements
applicable to all ophthalmic
instruments
ISO 15004-1:2006
General radio compliance
Federal Communications
Commission (FCC)
National Communications
Commission (NCC)
Equipment connected to the analog or digital interfaces must be
certified according to
the representative appropriate national
standards (such as EN 60601-1 and IEC 60601-1). Furthermore, all
configurations shall comply with the system standard IEC 60601-1.
Anyone who connects additional equipment to the signal input part or
signal output-part configures a medical system and is therefore
responsible for the system complying with the requirements of the
system standard IEC 60601-1. If in doubt, consult the technical service
department of your local representative.
NCC
取得審驗證明之低功率射頻電機，非經核准，公司、商號或使用者均不得擅自變更頻率、加
大功率或變更原設計之特性及功能。
低功率射頻器材之使用不得影響飛航安全及干擾合法通信；經發現有干擾現象時，應立即停
用，並改善至無干擾時方得繼續使用。
前述合法通信，指依電信管理法規定作業之無線電通信。低功率射頻器材須忍受合法通信或
工業、科學及醫療用電波輻射性電機設備之干擾。
應避免影響附近雷達系統之操作。
高增益指向性天線只得應用於固定式點對點系統。