Shimmer 3 - Informed Consent Statement

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Realtime Technologies Ltd Shimmer User Manual

Informed Consent Statement

Shimmer is an open flexible platform intended for qualified personal conducting research in wearable sensor

applications. Consequently, although great care was taken in the design of this device, there is some inherent

risk both with the design and manufacturing that you assume when the device is in close proximity to your

body or the body of your test subjects. Depending on local regulations, Shimmer may not fully comply with

commercial product testing standards. Shimmer as sold lacks medical certifications (e.g. ANSI/AAMI/IEC).

Shimmer devices should never be used for diagnostic purposes without full consideration of operator and

subject risk. The following list describes some of the subject risks:

 There is a risk of electrical shock due to manufacturing defects or improper use (see usage guidelines

and warnings).

 There is also a risk of sustaining a burn due to a catastrophic failure of the device which could result

from overheating of components.

 There is a risk of radio interference with the operation of other electronic devices and we make no

claims to the consequences of this.

 There is a risk of some minor skin irritation from electrode pads over prolonged periods of time which

may cause discomfort.

 The device is not designed with proper safeguards for defibrillation. As such, electrodes must be

removed before defibrillation is attempted.

Data privacy limitations: It should be understood from the outset and you should communicate to test subjects

that the physiological data that is streamed, stored, and analyzed through use of the device is not anonymized

or privacy-protected in any way and you should take appropriate precautions in the protection and handling of

such data in your research activities. Shimmer itself may buffer raw physiological data unencrypted on the

integrated flash memory device. RF data streaming from the Shimmer may not be encrypted and could be

intercepted by others. RF data downstream from an aggregation device, such as a cell phone may not be

encrypted and is likewise susceptible to access.

Physiological data generated through use of Shimmer may indicate conditions that your test subject was

previously unaware of prior to participation in research using the device.

There may be a risk of exposure to minute amounts of chemicals from the manufacturing process or the

components themselves (such as latex, lead etc.).

There may be an increased risk of physical injury by the physical presence of the device on a test subject’s

body and you fully assume this responsibility.

Realtime Technologies Ltd is not liable for damage or loss of data when using the Shimmer platform.

Some Shimmer peripherals rely on 3rd party driver support. Whilst Realtime/Shimmer Research have tested

features using a typical system, in some cases the end user will need to contact the peripheral vendor for

resolution of installation, compatibility or operational issues.

By your use of Shimmer you acknowledge these and other risks inherent in the use of an experimental device

and you assume full responsibility for testing this device with human subjects.

This device cannot be marketed or put into service within the EU until it has been made to comply with the

Medical Devices Directive 93/42/EEC. In the United States, Shimmer is an investigational device, limited by US

law to investigational uses.

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