Electrical Safety, Emc And Associated Standards; Screening Protocols - Maico easyScreen Operation Manual

6.6 Electrical Safety, EMC and Associated Standards

• ANSI/AAMI ES/IEC/EN 60601-1: Medical Electrical Equipment, Part 1
General Requirements for Safety
• CAN/CSA-C22.2 No. 60601-1: Medical Electrical Equipment, Part 1
General Requirements for Basic Safety and Essential Performance
• UL/IEC/EN 60950-1: Information Technology Equipment - Safety - Part 1:
General Requirements
•
IEC/EN 60601-1-1 General requirements for safety; Collateral standard:
Safety requirements for medical electrical systems
• IEC/EN 60601-1-2: Medical Electrical Equipment - Part 1-2: General
Requirements for Basic Safety and Essential Performance - Collateral
Standard: Electromagnetic Compatibility - Requirements and tests
• DIN/EN/ISO 14971 - Application of risk management to medical devices
• Essential Requirements of the current European Union Medical Device
Directive 93/42/EEC
• RoHS (Restriction of the use of certain Hazardous Substance

6.7 Screening Protocols

easyScreen is delivered with default screening protocols already present on the
instrument as seen in section 6.1. MAICO recommends use of these protocols.
If your NHS program requires different screening parameters additional protocols can
be installed into the HearSIM™ application, reviewed and transferred to your
easyScreen. Follow these instructions.
1. In HearSIM™, go to the Device menu and the Protocols tab.
2. Select the Add protocol control.
3. Review the list of available protocols residing in the default browser path.
4. Select the desired protocol and select Open. The protocol will be added to
the Protocols list.
5. Follow the instructions in the HearSIM™ manual sections 6.5 and 6.6 to
transfer the desired protocols to your easyScreen.
8508935 Rev. 4
Operation Manual easyScreen
86 04/04/2019