Table of Contents Overview About GENEActiv ............... 3 Technical Specification ..............4 Getting Started System Requirements ..............5 What’s Included ................5 Charging Charging ..................6 LED Signals ................7 Device Setup & Configuration Installing Software ..............8 For Windows ..................8 For Mac ....................
The captured data can be further downloaded through the charging cradle and the software. GENEActiv also incorporates a digital ambient light sensor to record luminous intensity (lux) of white light. Digital Temperature Sensor measures near-body temperature which is influenced by both the wearer and environment.
b) Technical Specification Physical Parameters Size 43mm x 40mm x 13mm Weight 16g (without strap) Main Housing Material PC/ABS (medical device grade) Light Guide Material PC (medical device grade) Data Contact Material Gold-plated Strap PU resin Battery Type Rechargeable lithium ion polymer Environmental Protection Water-resistant to 10m (IP67 –...
Spring bar tool with pins • 4-up charger/download cradle with USB cable To successfully use the GENEActiv, you must have access to the 4-up charger/download cradle to connect to the PC via the USB cable. Additional body straps and accessories are available upon request.
LED Signals When not recording, the battery charge level can be checked by pressing the button on the device. See diagram below for LED indicators. A green flash indicates that the device is OK to go into storage if it is no longer in use. A red flash or no flash at all means that the device should be charged (this function is not available if a device has been configured to record).
The Microsoft Store is the recommended source as the software will be kept up to date automatically with the new releases. If the store is not available on your PC, however, please email info@activinsights.com It is important that once the GENEActiv software has been downloaded, users also need to download the ‘GENEActiv Drivers’ (.zip) from...
No GENEActiv devices connected GENEActiv devices Once the device is connected, you will see the device number(s) displayed in the panel underneath GENEActiv devices section. Under the device(s) serial numbers you will see the the length of data recorded and frequency, together with the battery charge level.
This tab allows you to convert one or more .bin files into Raw data csv files and Epoch csv files that can be read by the GENEActiv viewer and Excel. You can use this tab to convert .bin files into AWD files which can be analysed using Actiware software.
At least one device must be selected. It can be useful to configure multiple devices together when a trial subject will wear several GENEActiv devices on different body locations. This process will overwrite any data onboard the device. It is important that any previous data collected has been successfully extracted.
Start Mode There are four different start modes: ‘On Button Press’ means that recording will start after the ‘device is removed from the charger cradle and the button (hidden under the serial number) on the device is pressed. In this mode the green light will give a longer flash when the button is pressed to indicate recording has started.
d) SETTINGS If you are configuring multiple devices with the same settings, you can set default Erase and Configure values. Click the Settings icon at the top right corner of the page and click Set current as defaults. You can change this at any point by clicking Clear defaults.
Data Collection & Extraction a) Extracting data Open the GENEActiv software and connect the charging cradle to a USB port. Insert a GENEActiv device into the cradle and select the device you wish to extract data from. Click ’Extract’ from the bottom right menu.
b) Reading Data Converting Data On the Extracted Data Files section, you have the option to select one file or a folder containing one or more .bin files to load. Once you have selected the file, on the right-hand side of the screen, at the bottom of the page, you will see two tabs.
1 bit reserved (set to zero) The GENEActiv device stores raw data to allow all processing to be completed off-line. Calibration data is created in production and recorded to be applied in post-processing. Accelerometer x, y & z axis: calibrated measurement = (output*100 - offset) / gain (g)
AWD files The upgraded GENEActiv software also now supports AWD file outputs from raw data for seamless integration into existing sleep analysis packages ( Actiware software from Philips / Respironics). The conversion algorithms and their implementation have been verified and validated by Activinsights to ensure the approximation is fit for purpose.
Sensor Axes & Body Positions The device should be fitted to the wrist in the most intuitive manner – with the serial number in the correct orientation to be read by the wearer and with the ‘crown’ to the right – like a watch. On the right hand, with the arm relaxed to the side, the device will appear to the observer:...
Cleaning the Device To clean the GENEActiv, wipe with a cloth or scrub with a soft bristle brush using warm soapy water or a mild detergent solution and allow to air dry. Alcohol wipes and mild sterilising solutions are also appropriate.
Regulatory Compliance European Compliance GENEActiv is a Class I Medical Device based on Rules 1 & 12 from Annex IX, conforming to the Essential Safety & Health requirements and provisions of EC Council Directives 93/42/EEC, Annex VII. The application of the classification rules is governed by the intended purpose of the device.
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Regulatory Standards GENEActiv 1.2. 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.
• Do not disassemble the device or charger. The battery in the device is not replaceable. If the device or charger is damaged, dispose of it responsibly or return to Activinsights. • If the device becomes warm to the touch whilst in use, remove and return to Activinsights. • Do not wear while charging or connected to USB.
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Activinsights Ltd, Unit 11, Harvard Industrial Estate, Kimbolton, Cambridgeshire, PE28 0NJ, United Kingdom...
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