6.1 ALARM CONDITION

6.1.1 * General - Rational יש שאלות

ü If ALARM CONDITIONS are grouped into PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS or other ALARM CONDITION groups by the MANUFACTURER, this shall be disclosed in the instructions for use.

ü Compliance is checked by inspection of the instructions for use.

6.1.2 * ALARM CONDITION priority - Rational

ü ALARM CONDITIONS shall be assigned to one or more of the following priorities: HIGH PRIORITY, MEDIUM PRIORITY, or LOW PRIORITY. Unless a particular ALARM CONDITION priority is specified in a relevant particular standard, the assignment of priorities is part of the RISK MANAGEMENT PROCESS and shall be based on Table 1. The priority of each ALARM CONDITION shall be disclosed in the instructions for use. Priorities may be identified in groups.

ü Compliance is checked by inspection of the instructions for use and RISK MANAGEMENT FILE.

Table 1 – ALARM CONDITION priorities