User manual |
Safety Information
14
Adverse effects
Superficial burns may occur to the patient’s skin on the area in contact with the
electrodes. To minimize this effect, apply the pads soon after removing their
protective envelope and press them firmly to the patient’s skin.
The skin should be dry, or electrical current leakage may happen, enlarging burn
area and reducing treatment efficiency.
Standards
Eazy PRO 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 60601-1-6 - Medical Electrical Equipment - Part 1-6: General
requirements for basic safety - Collateral Standard: Usability
• NBR IEC 60601-1-8 - Medical electrical equipment - Part 1-8: General
requirements for basic safety and essential performance - Collateral standards:
General requirements, testes and guidance for alarm systems in medical
electrical equipment and medical electrical systems
• NBR IEC 60601-2-4 - Medical electrical equipment Part 2-4: Particular
requirements for the basic safety and essential performance of cardiac
defibrillators.
Or equivalent IECs.
The current versions of technical standards can be verified on the
Product Conformity Certificate, available at www.instramed.com.br.
Device care
Do not place the equipment where it may fall on the patient. Do not lift the
equipment by its cables or connections.
Place cables connected to the patient in order to restrict the possibility of
strangulation.
Always keep the equipment and its accessories clean and well maintained.
If you suspect a fall or external damage, do not use the equipment.
