Elite II Vaporizer

What's in the Box

• 1× Grenco Medical Elite II Vaporiser
• 1× USB-C Charging Cable
• 1× Cleaning Brush
• 1× Packing Tool
• 1× Hemp Case
• 1× User Manual

Important Information

The Grenco Medical Elite II Vaporizer is included on the Australian Register of Therapeutic Goods (ARTG) for use with specific prescribed medicines. It is designed for use with dried, prepared material where permitted within the relevant regulatory framework.

This battery-operated device is portable and intended for use in accordance with prescribing guidance.

Note: Always follow the instructions provided by your healthcare professional and refer to official guidance for further information.

Compliance with International Safety Standards 

The Grenco Medical Elite II complies with the following international standards:

IEC 60601-1:2006/AMD1:2013/AMD2:2021 Medical electrical equipment, Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2015/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electro-magnetic compatibility - Requirements and tests.

IEC 60601-1-11:2015/AMD1:2020 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.

IEC 60601-1-6:2010/AMD1:2013/AMD2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62304:2006/AMD 1:2015 Medical device software - Software life cycle processes

IEC 62366-1:2015/AMD 1:2020 Medical devices – Part 1: Application of usability engineering to medical devices

ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity. GRENCO MEDICAL ELITE II: Instructions For Use V2.3 17

ISO 10993-10:2021 Biological evaluation of medical devices Part 10: Tests for skin sensitization.

ISO 10993-18:2020 Biological evaluation of medical devices Part 18: Chemical characterization of medical device materials within a risk management process

ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for irritation.

ISO 18562-1:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process.

ISO 18562-2:2024 Biocompatibility of breathing gas pathways – Part 2 Tests for emissions of particulate matter.

ISO 18562-3:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 3: Tests for emissions of volatile organic substances

ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 4: Tests for leachables in condensate

UN 38.3 United Nations Manual of Tests and Criteria (Lithium Battery Transportation Testing)