User Manual |
Safety information
26
European representative.
Serial number.
Does not contain natural rubber LATEX.
Do not reuse.
Non-sterile.
Do not use if the packaging is damaged.
Keep away from sunlight.
Adhesive pads operation temperature limits.
Consult instructions for use.
LOT
Lot code.
REF
Catalog number.
Date after which the product cannot be used.
Standards
DualMax was designed following performance and safety national and
international standards. Among them are:
• NBR IEC 60601-1 - Medical electrical equipment - Part 1: General requirements
for basic safety and essential performance.
• NBR IEC 60601-1-2 - Medical electrical equipment - Part 1-2: General
requirement for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and test.
• NBR IEC 60601-1-4 - Medical electrical equipment - Part 1-4: General
requirements for the safety - Collateral Standard: Programmable electrical
medical systems.
• NBR IEC 60601-1-6 - Medical Electrical Equipment - Part 1-6: General
requirements for basic safety - Collateral Standard: Usability.
• NBR IEC 60601-2-4 - Medical electrical equipment - Part 2-4: Particular
requirements for the basic safety and essential performance of cardiac
defibrillators.
• NBR IEC 60601-2-27 - Medical electrical equipment - Part 2-27:
Particular requirements for the basic safety and essential performance of
electrocardiographic monitoring equipment.
• NBR IEC 80601-2-30 - Medical electrical equipment - Part 2-30: Particular
requirements for the basic safety and essential performance of automated non-