Need NZ certification for Bluetooth device purchase overseas?

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DS248

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#279716 3-Nov-2020 12:00

Looking at getting a personal ECG device from overseas as the model I am looking at is currently not available in NZ.

The device (https://store.alivecor.com/products/kardiamobile6l) connects to a mobile phone by 'Low Energy' Bluetooth (I assume Bluetooth 4?).

Given that Bluetooth operates (a) at a set frequency band [2.4 GHz ISM spectrum band] and (b) only over a short distance range, I assumed a compliant Bluetooth device would not need separate NZ EMC certification. I did discuss with a person at https://www.rsm.govt.nz/ but could not get a straight answer - just kept referring to their website. Surely every single Bluetooth device or dongle does not require its own separate RSM certification? Must be multiple tens of thousands of different Bluetooth devices?

Can anyone here please clarify whether separate RSM certification is required for an item like the KardiaMobile?

Looking at bringing this in for personal use, not in bulk for selling.

bmoff

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#2597004 3-Nov-2020 12:50

I have one of these, it's just a standard Bluetooth device. Doesn't require any special certification. Bought mine from Amazon.

sbiddle

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#2597018 3-Nov-2020 13:27

No it doesn't require certification but anything using an ISM band does need to be compliant with the rules for that ISM band.

DS248

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#2597022 3-Nov-2020 13:33

Thanks for the clarification

01EG

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#2597162 3-Nov-2020 16:36

bmoff:

I have one of these, it's just a standard Bluetooth device. Doesn't require any special certification. Bought mine from Amazon.

How it different from a smartwatch(Samsung/Apple)?

bmoff

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#2597233 3-Nov-2020 19:29

I don't know, I've had no experience with smart watches. The Kardia was recommended by my cardiologist.

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#2597241 3-Nov-2020 19:49

Ditto, was recommended for a relative by a cardiologist

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freitasm

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#2597245 3-Nov-2020 19:57

I have a Withings Move ECG (review here), available in New Zealand retail.

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DS248

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#2597246 3-Nov-2020 19:58

Or, more correctly the non 6L version was. The 6L (6 leads) provides more info though the extra not essential (ecg machine typically used in hospital has 12 leads). I gather the new sports watches with ecg output are more like the standard KardiaMobile (1 lead).

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#2597250 3-Nov-2020 20:02

Back to the original topic, Bluetooth-certified devices do not need any specific NZ certification as they are already within the regulations for the standard.

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