ANSI AAMI DF80 pdf free download

ANSI AAMI DF80 pdf free download.Medical electrical equipment- Part 2-4: Particular requirements for the safety of cardiac defibrillators (including automated external defibrillators).
For brevity, Part 1 is referred to in this Particular Standard either as the “General Standard” or as the “General Requirement(s).”
The numbering of sections, clauses and subclauses of this Particular Standard corresponds with that of the General Standard. The changes to the text of the General Standard are specified by the use of the following words:
“Replacement” means that the clause or subclause of the General Standard is replaced completely by the text of this Particular Standard.
“Addition” means that the text of this Particular Standard is additional to the requirements of the General Standard.
“Amendment” means that the clause or subclause of the General Standard is amended as indicated by the text of this Particular Standard.
Subclauses or figures which are additional to those of the General Standard are numbered starting from 101, additional annexes are lettered AA, BB, etc., and additional items aa), bb), etc.
The term “this Standard” is used to make reference to the General Standard and this Particular Standard taken together.
Where there is no corresponding section, clause or subclause in this Particular Standard, the section, clause, or subclause of the General Standard, although possibly not relevant, applies without modification.
Where it is intended that any part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard.
The requirements of this Particular Standard take priority over those of the General Standard.
1.5 Collateral Standards
Addition:
The following Collateral Standards apply:
IEC 60601-1-1:2000, Medical electrical equipment—Part 1-1: General requirements for safety—Collateral standard: Safety requirements for medical electrical systems
IEC 60601-1-2:2001, Medical electrical equipment—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests
IEC 60601-1-4:1996, Medical electrical equipment—Part 1: General requirements for safety—4. Collateral Standard: Programmable electrical medical systems
Additional item:
aa) Supplementary instructions for use
The instructions for use shall additionally contain the following:
*1) a warning not to touch the PATIENT during defibrillation;
*2) a description of the correct type and method of handling the DEFIBRILLATOR ELECTRODES in use as well as a prominent warning that DEFIBRILLATOR ELECTRODES shall be kept well clear of other electrodes or metal parts in contact with the PATIENT. The OPERATOR shall be advised that other MEDICAL ELECTRICAL EQUIPMENT which has no DEFIBRILLATION-PROOF applied parts shall be disconnected from the PATIENT during defibrillation;
3) advice for the OPERATOR to avoid contact between parts of the PATIENT’S body such as exposed skin of head or limbs, conductive fluids such as gel, blood, or saline, and metal objects such as a bed frame or a stretcher which may provide unwanted pathways for the defibrillating current;
*4) any environmental limitations regarding storing the EQUIPMENT (e.g., in a car or an ambulance under severe climatic conditions) immediately prior to use;
5) where means are provided for monitoring via SEPARATE MONITORING ELECTRODES, instructions for the placement of these electrodes;
*6) a recommendation calling the OPERATOR’S attention to the need for periodic maintenance of the EQUIPMENT irrespective of usage, especially:
— cleaning of any reusable DEFIBRILLATOR ELECTRODES and the insulating parts of the handles;
— sterilization procedures for any reusable DEFIBRILLATOR ELECTRODES or handles, including recommended sterilization methods and maximum sterilization cycles, if applicable;
— cleaning of any reusable monitoring electrodes;ANSI AAMI DF80 pdf download.