Compliance & Safety

This page documents the regulatory compliance of the Inara sensor (model INA-V3) and provides safety information for use, care, and disposal.

Product

Inara sensor, model INA-V3 Supplied by Inara Technology Pty Ltd (ABN 12 680 067 752) 509 Lyons Road West, Five Dock NSW 2046, Australia support@inara.technology

Australian regulatory compliance

The Inara sensor (INA-V3) is registered with the Australian Communications and Media Authority (ACMA) as a compliant device and bears the Regulatory Compliance Mark (RCM).

ACMA Supplier Code: E21990

The device has been assessed against the following Australian Standards:

• AS/NZS 4268:2017 — Radio equipment and systems, short range devices
• AS/NZS CISPR 32:2015 — Electromagnetic compatibility of multimedia equipment, emission requirements
• AS/NZS CISPR 35:2015 — Electromagnetic compatibility of multimedia equipment, immunity requirements
• AS/NZS 62368.1:2018 — Audio/video, information and communication technology equipment, safety requirements
• AS/NZS 4417.2:2012 — Marking of electrical and electronic products (RCM)

A copy of the Declaration of Conformity is available on request at support@inara.technology.

FCC compliance (Bluetooth module)

The Inara sensor uses a pre-certified Bluetooth Low Energy module.

FCC ID: SH6MDBT42V (Raytac MDBT42V, nRF52832-based)

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

HIPAA compliance

Inara supports HIPAA-compliant workflows for professional and clinical accounts that handle protected health information (PHI).

Our HIPAA program is designed around administrative, technical, and physical safeguards for PHI, including:

• Role-based access controls for professional and clinical account data
• Encrypted transport for data sent between Inara apps, services, and storage
• Restricted access to raw clinical data and operational audit controls
• Separation between marketing data and clinical account data
• Business associate support for covered entities and clinical customers

Inara acts as a business associate when a covered entity uses Inara to create, receive, maintain, or transmit PHI on that entity's behalf. Clinics and professional organizations should use clinical account workflows for patient data and contact Inara for business associate agreement requirements.

Safety information

Battery and charging

• Use only the supplied charging dock with a USB-C power source rated 5V DC, 1A or less.
• Do not puncture, crush, incinerate, or expose the battery to temperatures above 60°C.
• Stop using the device immediately if you notice swelling, leaking, or unusual heat, and contact support.
• Charge in a dry, well-ventilated area away from flammable materials.

Skin contact

• The Inara sensor is intended for short-term placement against intact, healthy skin during training. It is not a medical device and is not intended to diagnose, treat, cure, or prevent any disease.
• Discontinue use and consult a medical professional if you experience skin irritation, redness, or discomfort.
• Do not use over broken skin, open wounds, recent surgical sites, or areas with infection.
• Do not use on the chest if you have an implanted pacemaker, defibrillator, or other active implanted medical device.
• Not intended for use on pregnant women without prior consultation with a healthcare professional.

General

• Keep dry. The sensor is splash-resistant but not waterproof. Do not submerge.
• Operating temperature: 5°C to 40°C.
• Storage temperature: −10°C to 50°C.
• Do not disassemble the sensor or charging dock. There are no user-serviceable parts inside.

Disposal

Do not dispose of the Inara sensor or its charging dock in general household waste. The device contains a rechargeable lithium-polymer battery and electronic components that must be recycled appropriately.

In Australia:

• Drop off end-of-life devices at any council e-waste collection point.
• For battery-only disposal, use a B-Cycle drop-off location.

You may also return the device to Inara at the address above for recycling at no cost.

Product specifications

Compliance enquiries

For Declarations of Conformity, technical documentation, or regulatory questions, contact:

Inara Technology Pty Ltd Attn: Compliance 509 Lyons Road West, Five Dock NSW 2046, Australia support@inara.technology