Condor AT0503 User Manual

Condor Instruments Ltda. 17/05/2017

ACTTRUST – USER MANUAL

Model: AT0503

ActStudio Version:

1.0.6.0

Index

Introduction ....................................................................................................... 5

Indications of Use............................................................................................ 5

Contraindications ............................................................................................ 5

Adverse Effects ............................................................................................... 5

Maintenance ................................................................................................... 5

Warnings and General Precautions ................................................................. 5

Training and Qualification ................................................................................ 5

ActDock ............................................................................................................ 6

Description ...................................................................................................... 6

Cleaning and Maintenance .............................................................................. 7

Using the ActDock........................................................................................... 7

ActTrust ............................................................................................................ 8

Description ...................................................................................................... 8

Cleaning and Maintenance .............................................................................. 8

ActStudio Software............................................................................................ 9

Installation ....................................................................................................... 9

Windows .................................................................................................... 9

OS X .......................................................................................................... 9

Control Menu ................................................................................................ 10

Quick Operations Buttons ........................................................................ 13

Support Menu ............................................................................................... 14

Data Menu .................................................................................................... 15

Log List .................................................................................................... 15

Data Import/Export ................................................................................... 19

Sleep Diary .............................................................................................. 22

Light/Dark Phase ..................................................................................... 24

Configuring ActTrust for an Operation ........................................................... 26

Putting ActTrust Into Power Down Mode ....................................................... 29

Extracting ActTrust Data ............................................................................... 31

Solving data problems.............................................................................. 34

Data Analysis ................................................................................................ 36

Sleep Scoring .......................................................................................... 36

Statistics .................................................................................................. 44

Daily Statistics.......................................................................................... 46

Chronobiology .......................................................................................... 48

Actogram ................................................................................................. 51

Periodogram ............................................................................................ 54

Cosinor .................................................................................................... 58

Tab System .............................................................................................. 62

Report ................................................................ ...................................... 63

Report Settings ........................................................................................ 64

Making a Report ............................................................................................ 66

Rebooting ActTrust ....................................................................................... 68

Generating a Report of the ActTrust ............................................................. 69

Important Tips ............................................................................................... 70

Calculate Analysis .................................................................................... 70

Generate Statistics ................................................................................... 70

Quick Tips ................................................................................................ 70

Export Graphs .......................................................................................... 71

Export Data Tables .................................................................................. 71

Zoom on Graphs ...................................................................................... 72

Scroll Bar Hidden on OS X ....................................................................... 72

General Settings ...................................................................................... 73

Database Menu........................................................................................ 73

Copying the Database.............................................................................. 74

Language Selection ................................................................ ................. 74

Selected Log Information ......................................................................... 75

ActStudio Exit Message ........................................................................... 75

Version Log .............................................................................................. 75

ESET Endpoint Antivirus issues ............................................................... 76

Troubleshooting .............................................................................................. 78

Specifications .................................................................................................. 80

Applicable Standards ...................................................................................... 81

Manufacturer’s declaration - Electromagnetic Immunity and Emission ............ 82

Symbols .......................................................................................................... 85

Introduction

Before using the device, read the user manual as a whole.

Indications of Use

The ActTrust is an ultra-compact, lightweight, wrist-worn activity, temperature and ambient light monitor that can be used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and assess activity in any instance where quantifiable analysis of physical motion is desirable. The device is intended to

monitor limb or body movements during daily living and sleep.

Contraindications

There are no contraindications to the use of the device.

Adverse Effects

Patients should inform your doctor and discontinue use immediately if they experience itching or irritation in the contact area of the device with the skin.

Maintenance

Sterilization is not required for nay part of the product.

PRECAUTIONS

Inspections and repairs should only be performed by an authorized agent. Under no circumstances should you attempt to open or personally carry out repairs or maintenance of the device.

This product must be inspected by a Condor authorized service center five years from the date of manufacture, before that, the device is intended to provide a safe and reliable operation provided that it is operated and maintained in compliance with the instructions provided by Condor. The details concerning the Condor warranty applicable are provided with the device from its original purchase. Of course, like all electrical devices, be careful and request inspection at a Condor authorized service center if any malfunctions are detects.

Warnings and General Precautions

Warnings

A warning to the possibility of personal injury.

• Before using the device, read the entire manual.

• The device and its accessories must be used only for the purpose for which they are intended.

• Only use accessories and parts that are original and approved by Condor.

Additional equipment connected to medical electrical equipment must comply with the respective IEC or ISO standards (p. Ex., IEC 60950 relating to data processing equipment). In addition, all configurations must meet the requirements for medical electrical systems (see IEC 60601-1-1 or clause 16 of the 3rd Ed. Of IEC 60601-1, respectively). Anyone who connects additional equipment to medical electrical equipment configures a medical system and is therefore responsible for the system to comply with the requirements for medical electrical systems. It called attention to the fact that local laws take precedence over the above requirements. If in doubt, contact your local representative or service department.

Training and Qualification

Any operator must have read the manual and have the computer skills necessary to configure the device

The analysis should only be made by people who are qualified to make them

ActDock

Description

The ActDock (common name: USB Adapter) is composed of four parts, the Lid, The Base, The Back Cover and the PCB. This accessory is intended to adapt the USB pins in the ActTrust to a normal USB connector.

Pull gently to open

Hole for light

sensor and

button testing

Click

Golden

contacts

USB

Conector

Lid

Base

Back

Cover

PCB

Cleaning and Maintenance

 Only clean using a damp cloth and mild soap.

Notes:

 Avoid contact with gasoline, benzine, thinner or acetone and, in case of

contact with any of these substances, clean the device using a damp cloth and mild soap as soon as possible.

 Do not use abrasive cleaning components or highly alkaline (e.g.,

saponaceous or ammonia-based cleaners).

 Do not use Isopropanol or Butyl Cellulose in any surface of the dock.

Using the ActDock

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1

2

3

1. Guarantee that the golden pins in both the dock and in the ActTrust are aligned as shown.

2. Rotate de ActTrust in order to dovetail it in dock.

3. Close the dock and pressure it until the click locks.

ActTrust

Description

The ActTrust is an Activity Recording Device (Actimeter) that measures Activity, Wrist temperature and light exposure. It is intended to be worn in one of the limbs to assess sleep parameters needed to evaluate sleep quality and sleep disorders. It requires one of the ActDock accessories to extract the data.

Cleaning and Maintenance

 Wash only with warm water and mild soap.  Always wash the device when it got into contact with salt water.  Whenever the ActTrust is going to be stored, put the same into power

down mode.

 Do not leave the ActTrust with the battery fully discharged for long

periods. This may reduce the lifetime of the internal battery.

 If the ActTrust is stored for long periods, perform a full charge of the

battery every 6 months.

Temperature

sensor

Light Sensor

Event Button

Notes:

 Avoid contact with gasoline, benzene, thinner or acetone and, in case of

contact with any of these substances, wash the device with mild soap and water as soon as possible.

 Do not use abrasive cleaning components or highly alkaline (e.g.,

saponaceous or ammonia-based cleaners).

 Do not use Isopropanol or Butyl Cellulose in the protective surface of the

ActTrust.

 Do not swim or dive with ActTrust.

ActStudio Software

The ActStudio software is used to extract, export and analyze data from the ActTrust. It is composed basically by 3 menus that are described in the next sections. Note that this manual was written based on the ActStudio version found on the cover of this manual and some features described here may not be available in previous versions.

Installation

This software does not require any installation. It can be run from a pen drive or any other external device or from the computer itself.

Windows

To run the software just unzip the software files on the desired folder and then run the EXE file.

OS X

To run the software on OS X just open the DMG file and then run the ActStudio APP file.

Control Menu

INFORMATION

DEVICE

Name of the connected device.

ID

Unique identifier of the connected device.

BATTERY

Charge status of the battery of the connected device and its power.

CHARGING

CHARGED

HARDWARE

VERSION

Hardware version of the connected device.

FIRMWARE

VERSION

Firmware version of the connected device.

POWER MODE

Active or Power Down.

MEMORY

Percentage of the memory used.

POWER MODE

Label

Identifies whether the device is set to power down (storage mode) when disconnected from the dock.

POWER DOWN: Device will enter in power down mode

when you disconnect it from the dock.

ACTIVE: Device will enter in standard operation mode

when you disconnect it from the dock.

Power Down

Button

Sets the connected device to enter power down mode when disconnected from the dock.

Active Button

Sets the connected device to not enter power down mode when disconnected from the dock.

SENSORS

ACCELEROMETER

Instantaneous sampled value from the internal accelerometer.

TEMPERATURE

Instantaneous sampled value from the temperature sensors (°C).

LIGHT

Instantaneous sampled value from the light sensor.

TIME

System

Date and Time of the computer.

Device

Date and Time of the connected device.

Sync Time Button

Synchronizes the time of the device connected to the computer's time.

CONFIGURATIONS

DESIRED

Desired settings of the connected device.

CURRENT

Current settings of the connected device.

Mode

Activity sampling mode: TRIAXIAL: Vector composition of the three axes.

UNIAXIAL: Each axis is calculated independently (not

available)

PIM: Proportional Integral Mode TAT: Time Above Threshold ZCM: Zero Crossing Mode

Interval

Sampling interval (in seconds between 1 and 86400).

APPLY Button

Apply the desired settings at the connected device.

LOG

Memory Usage

Memory usage of the connected device.

ERASE Button

Clears the data stored in the memory of the connected device.

READ Button

Read the data stored in the memory of the connected device.

Quick Operations Buttons

There are 2 buttons in the Control Menu that do not add any new functionality to the ActStudio software, but rather makes operations with the ActStudio software quicker. They are basically scripts that automate a series of operations implemented by other controls.

1. APPLY / SYNC / ERASE: performs the same operation as if the user had pressed the buttons APPLY (in the CONFIGURATIONS section), Sync Time (in the TIME section) and ERASE (in the LOG section) sequentially.

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2. READ / SAVE / POWER DOWN: performs the same operation as if the user had pressed the buttons READ (in the LOG section), SAVE (in the LOG section) and ENABLE (in the POWER DOWN section) sequentially.

Support Menu

SUPPORT

MAKE

REPORT

Button that generates a report with relevant information about the connected device.

SAVE

REPORT

Button that saves the report generated with the MAKE REPORT button.

RESET

Button that resets the connected device.

Data Menu

Log List

In the Log List page, you can manage all logs stored in the database. In the Log List page you can select a log to perform analyzes, edit its trial information (e.g. subject name, gender, date of birth), disable a log (it will still be available in the disabled logs), enable a log that is disabled and permanent delete disabled logs from the database.

ACTION MENU

The menu that provides the options to perform actions from the selected log in the table below.

SHOW

DISABLED

LOGS

By selecting this option only the disabled logs will be shown in the table below.

DELETE ALL

It will permanently delete all disabled logs from the database. Note 1: you can only delete all logs when the "Show Disabled Logs" option is selected.

Note 2: this process may take a few seconds to complete

(depends on the database size) because it will delete the disabled logs and will rebuild the database file. It will probably decrease the database size.

ENABLE

Enable a disabled log.

DISABLE

Disable an enabled log. It will still available by selecting the "Show Disabled Logs" option.

EDIT INFO.

Edit the trial information: subject name, gender, date of birth and description.

SELECT

Loads the selected log to perform analyzes. When you select a log the ActStudio will automatically redirect to the "Import/Export Data" page.

FILTER

This field is used to filter the logs in the log list visualization. When you write some word in this field it will automatically filter the log list. It filters the logs by Device ID, Subject Name, Gender and Log Type.

LOG LIST VISUALIZATION

The ActStudio provides two ways of data visualization in the Log List page.

TABLE VIEW

It will show all logs from the database in a table view, and the user can sort the log list based on the column by clicking on the column header.

TREE VIEW

It will show all logs from the database in a tree view. This option groups the logs with the same subject name and the user can expand or collapse each item to facilitate the visualization.

FIELDS

ID

Log ID from the database. It is used for internal control and can be used to identify what log are you using when you have multiple logs from the same subject.

DEVICE

ActTrust device ID. It represents the ID of the device used to register the data. If a log is included into the database from a log file this field will be empty.

SUBJECT

NAME

The subject name of the data sample.

GENDER

Gender of the subject.

DATE OF

BIRTH

Date of birth of the subject.

LOG TYPE

Original: It represents an original data log from the device

or from the log file. Note: the “original” data must never be “edited”. When you are editing an “original” log and save it, it will be saved as a new “edited” log.

Edited: An “edited” log is generated when you are editing an “original” log and clicks on the save button to save it into the database.

Note: when you are editing an "edited" log and tries to save

it, you can choose if wants to create a new log from it or if wants to override the current log.

CREATED AT

Shows the date and time when the log was inserted into the database.

UPDATED AT

If the log has already been updated, it will show the date and time of your update.

QUICK ACTIONS MENU

By right clicking on the log list table, you will see one of the quick actions menus shown below. The quick action menus provide the same options from the main action menu and a few extra options.

This menu is shown only for the "Enabled" logs. In addition to the main options, here you can "Disable All" enabled logs.

This menu is shown only for the "Disabled" logs. In addition to the main options, here you can "Enable All" disabled logs and "Delete" only a selected log.

DELETING ALL DISABLED LOGS

By clicking on the "Delete All" button the following message will be shown to you confirm the process:

By clicking on the Yes option all the disabled logs will be permanently deleted from the database. The following message will be shown while the logs are being deleted:

As the message explains, this process may take a few seconds to complete (it depends on the database size), and you need to wait until it finishes.

Note: this option should be used when you have some disabled logs that you want to permanently delete. If you want to permanently delete only one or two logs use the single delete option provided by the quick actions menu.

EDITING DATABASE LOG

When you select a log from the database through the Log List page the log information will be shown in the right upper corner of the ActStudio, and it means that you are editing an existing log. You can edit the log data by changing the period selection, log selection, time zone, sleep diary and sticky notes. When you finish the edition, you can click on the "Save to Database" button.

Here we have two options:

1. If you are editing an "Original" log it will insert a new log with the "Log Type" "Edited", then the selected log (and log information) will be changed to this new log. It means that now you are editing this new log (the "Edited" log).

2. If you are editing an "Edited" log you will see the following message:

Here you can choose one of the following options:

 Save as a new log: it will insert the current data log as a new

log into the database and will change the selected log to this new one.

 Override the current log: it will override the current log data.

Be careful to not override important information.

 Cancel: it will only cancel the operation and will not save the log

into the database.

Data Import/Export

PERIOD SELECTION

Field used to select the period of the data to be filtered.

INITIAL

Initial date and time of the sample.

FINAL

Final date and time of the sample.

RESET

Redefine to the original period (initial and final).

APPLY

Apply the period selected.

LOG SELECTION

Field used to select types of log to be filtered.

EVENTS

Event logs (e.g. button press)

DATA

Data logs (activity, temperature and light).

MIXED

Just data logs (DATA) will be exported, but will be informed if there was some event during the Data log period.

CHANGE TIMEZONE

Field used to change the time zone of the entire period.

HOURS

The field used to select the time zone.

APPLY

Add or subtract hours of the column DATE/TIME in the entire period.

RESET

Reset the DATE/TIME column to the original time zone.

EXPORT/IMPORT

DATA DELIMITER

Character used to delimit data when exported. TAB

SEMICOLON(;)

DECIMAL MARK

Character used as decimal mark when exported. COMMA(,)

Point(.)

DATA SELECTION

Field used to select which data types will be exported.

DATE/TIME

Date and time of the log.

MS

Milliseconds value of the log.

EVENT

Value of the event. Mixed Mode: Indicates whether there was an event during this log period.

TEMPERATURE

Value of the temperature (in ° C).

EXT.

TEMPERATURE

Value of the external temperature (in ° C).

PIM

Activity value calculated in Proportional Integral Mode

PIMn

Value of the PIM normalized per second.

TAT

Activity value calculated in Time Above Threshold mode.

TATn

Value of the TAT normalized per second.

ZCM

Activity value calculated in Zero Crossing Mode

ZCMn

Value of the ZCM normalized per second.

LUX

Value of the light intensity in lux (Only hadware 2.x)

AMB LIGHT

Value of the light intensity in µw/m² (Only hadware 3.x)

RED LIGHT

Value of red light intensity in µw/cm² (Only hadware 3.x)

GREEN LIGHT

Value of green light intensity in µw/cm² (Only hadware

3.x)

BLUE LIGHT

Value of blue light intensity in µw/cm² (Only hadware 3.x)

IR LIGHT

Value of IR light intensity in µw/cm² (Only hadware 3.x)

DATE FORMAT

Date and Time field formatting when exported. NORMAL: Date and time delimited by a space.

DELIMITED: Date and time delimited by the delimiter character (DATA DELIMITER) chosen. CUSTOM: Date and time in the format HHMM.

INCLUDE

HEADER

Selects whether to include a header in the exported data. Note: if the user does not include the header in the log file, the ActStudio will no longer open this file.

SAVE BUTTON

Saves the extracted data with the desired settings.

OPEN BUTTON

Open data from old logs (the data must have the header).

INSERTING LOG IN THE DATABASE

Every time you open a new log file you will see the following message:

If you select the "Yes" option, the log that you opened will be inserted into the database and will be available every time you open the ActStudio. Otherwise, if you select the "No" option the log will not be inserted into the database.

Sleep Diary

In the Sleep Diary menu, the user can insert data from a manual sleep diary provided by the patient. This data can be used as a parameter to the sleep scoring algorithm.

DATA INSERTION

Field used to insert the data from a sleep diary.

Bed Time

Field to insert the date and time that the patient went to bed.

Get Up Time

Field to insert the date and time that the patient got up.

Delete All

Deletes all registers from the sleep diary table.

Delete

Delete a selected row in the sleep diary table.

Cancel

If has any row selected this button cancel the edit operation.

Add

Adds the inserted data to the table to be used as parameter at the sleep scoring algorithm.

Edit

The edit button is shown when a row is selected by double clicking. Clicking at the edit button will edit the selected row.

IMPORT/EXPORT DATA

Field used to import or export data to text file.

IMPORT

Button to import the sleep diary data from a text file. Must be a text file exported by the sleep diary menu.

EXPORT

Button to export the sleep diary data to a text file.

TABLE

The table is used to show the inserted data. The data in the table are the same that will be used as parameter to the sleep scoring algorithm. The user can edit or delete any row of this table, by selecting the row using the double click.

Light/Dark Phase

Form used to define parameters to be used in the Sleep Scoring and Statistics menus. These parameters are basically used to define when the day

starts and when it ends, and to define the main sleep periods.

LIGHT/DARK PHASE

Start Time

Light Phase

The start time of the light phase of the day.

Dark Phase

The start time of the dark phase of the day.

End Time

Light Phase

The end time of the light phase of the day (read only).

Dark Phase

The end time of the dark phase of the day (read only).

SUNRISE AND SUNSET

Calculate the apparent sunrise and sunset times based on the latitude, longitude, date and UTC offset. The sunrise is used as the start time for the light phase and the sunset is used for the start time of the dark phase.

Country

The user can select a country, a state and a city to automatically load the latitude and longitude. The database has all cities from Brazil and United States and the main cities of other countries.

State

The user can select a state. The states will be automatically loaded when the user selects a country. The states from the United States are defined as "state-county", because the same state can have more than one city with the same name. Not all countries have registered states.

City

The user can select a city. The cities will be automatically loaded when the user selects a state. By selecting a city the latitude and longitude will be automatically loaded, but you can always manually change it. If the city that you need is not in the database you can also insert the latitude and longitude manually.

Date

The user can define a date to calculate the sunrise and sunset. By default it gets the current date.

UTC offset

The user can set the desired UTC offset. It gets the current UTC offset by default.

Latitude

The latitude must be defined by the user.

Longitude

The longitude must be defined by the user.

Calculate

By clicking on the Calculate button the sunrise and sunset times will be calculated and automatically set in the light and dark phases start time. If you want to save the latitude and longitude as default, just save the ActStudio settings.

SLEEP PERIOD

Day

Used to select the main sleep periods in the day (based on the light and dark phases).

Night

Used to select the main sleep periods in the night (based on the light and dark phases).

Min. Sleep

Period

Used to select only sleep periods longer than this time.

Select only

one main

period

This option is used in the buttons "Main Sleep Periods" from the Sleep Scoring and Statistics pages. By checking this option the "Main Sleep Periods" function will select only one main sleep period for each day.

Select multiple

main periods

This option is used in the buttons "Main Sleep Periods" from the Sleep Scoring and Statistics pages. By checking this option the "Main Sleep Periods" function will select multiple main sleep periods for each day.

Configuring ActTrust for an Operation

1. The user must delete all data on the device used before starting a new sampling to maintain data consistency. In order to do so, click the ERASE button in the LOG field. A window asking if you really want to delete the data from the device will appear. Click YES.

2. Choose the sampling mode and the sampling interval in the

CONFIGURATIONS field. Click the APPLY button. Note: the device memory must be erased before applying new

configurations. An alert message will be shown to the user choose to save the data or not. Another alert message will be shown to the user confirm the operation to delete the data in the device.

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Condor AT0503 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual