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Copyright © 2013, Condor Instruments Ltda. 

82

 

                                              Av. Brigadeiro Luis Antonio, 551, cj 124 - Cep:01318-000

 

 

Manufacturer’s declaration - Electromagnetic 
Immunity and Emission 

The medical electrical equipment needs special precautions regarding electromagnetic compatibility (EMC) and needs to be 

installed and put into service according to EMC information contained herein.

 

Manufacturer’s declaration – Electromagnetic Emission  

The product is suitable for use in a specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an 

electromagnetic environment as described below.

 

Emission Test

 

Compliance

 

Electromagnetic Environment Guidance

 

RF-Emission

 

(Radio frequency) CISPR11 

 

Group 1

 

The product use RF energy only for its internal function. Therefore, its RF emissions are very 
low and not likely to cause any interference in nearby electronic equipment.

 

RF-Emission

 

(Radio frequency) CISPR11

 

Class B

 

The product is suitable for use in all establishments, including domestic establishments and 
those directly connected to the public low-voltage power supply network that supplies buildings 
used for domestic purpose.

 

Harmonic emissions  
IEC 61000-3-2

 

Do not Apply

 

Voltage fluctuations / flicker 
emissions  
IEC 61000-3-3

 

Complies

 

 

Manufacturer’s declaration – Electromagnetic Immunity I  

The product is suitable for use in a specific electromagnetic environment. The customer and/or the user of the product should assure that it is used in an 

electromagnetic environment as described below.  

Immunity Test

 

IEC 60601-1-2 Level

 

Compliance Level

 

Electromagnetic Environment Guidance

 

Electrostatic discharge (ESD) 
IEC 61000-4-2

 

± 6 kV contact

 

± 8 kV air

 

± 6 kV contact

 

± 8 kV air

 

Floor should be wood, concrete or ceramic tile. If floors are covered 
with synthetic material, the relative humidity should be at least 30 %

 

Electrical  fast  transient/bursts 
IEC 61000-4-4

 

± 2 kV for power 
supply lines  
± 1 kV for 
input/output lines

 

Do not Apply

 

The device is recharged via computer, is not subject directly to the 
power source

 

Surge  
IEC61000-4-5 

± 1 kV differential  

mode  

± 2 kV common mode

 

Do not Apply

 

The device is recharged via computer, is not subject directly to the 
power source

 

Voltage dips, short interruptions 
and voltage variations on power  
supply input lines  
IEC61000-4-11

 

<5% U

T

  

(>95% dip in U

T

) for 

0.5 cycle  
40% U

T

  

(60% dip in U

T

) for  

5 cycles  
70% U

T

  

(30% dip in U

T

) for  

25 cycles  
<5% U

T

  

(>95% dip in U

T

) for 5 

sec

 

Do not Apply

 

The  device  is  recharged  via  computer,  is  not  subject  directly  to  the 
power source

 

Power frequency(50/60  
Hz) magnetic field  
IEC 61000-4-8

 

3 A/m 

 

3 A/m 

 

Power frequency  magnetic fields should be at  levels characteristic of a 
typical location in a typical commercial or hospital environment.

 

NOTE 1: 

U

T

 is the mains (AC) voltage before apply test levels 

 

 
 
 

Summary of Contents for AT0503

Page 1: ...Condor Instruments Ltda 17 05 2017 ACTTRUST USER MANUAL Model AT0503 ActStudio Version 1 0 6 0...

Page 2: ...ctDock 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 Ope...

Page 3: ...ing 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...

Page 4: ...Copyright 2013 Condor Instruments Ltda 4 Av Brigadeiro Luis Antonio 551 cj 124 Cep 01318 000 Applicable Standards 81 Manufacturer s declaration Electromagnetic Immunity and Emission 82 Symbols 85...

Page 5: ...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 devic...

Page 6: ...e 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...

Page 7: ...oid 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 clean...

Page 8: ...e 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...

Page 9: ...io 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 wr...

Page 10: ...124 Cep 01318 000 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...

Page 11: ...wn 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 I...

Page 12: ...rigadeiro Luis Antonio 551 cj 124 Cep 01318 000 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 dat...

Page 13: ...onality 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...

Page 14: ...d 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 in...

Page 15: ...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 perfo...

Page 16: ...ist 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...

Page 17: ...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 th...

Page 18: ...n 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 opti...

Page 19: ...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 t...

Page 20: ...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 calcul...

Page 21: ...xported 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 da...

Page 22: ...ime 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 Del...

Page 23: ...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 Th...

Page 24: ...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 th...

Page 25: ...late 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 ActStu...

Page 26: ...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 Cli...

Page 27: ...ge check the BATTERY field When the battery is fully charged it will be indicated as CHARGED 5 With all the desired settings done the device can be removed from the dock and it will be already in oper...

Page 28: ...Cep 01318 000 A message asking if you want to delete all the device data And if you do not delete the device data you will receive the following message In this case the configuration is not applied...

Page 29: ...In POWER MODE field click in the Power Down button Make sure the field show s POWER DOWN 2 It is recommended to wait until the ActTrust s battery is fully charged before putting it in storage mode To...

Page 30: ...dock it will automatically come into the datalogger mode If you want to check the device actually is in storage mode press the event button a few seconds after it is removed from the dock The buzzer s...

Page 31: ...ll freeze while reading When the log is completely loaded 100 the ActStudio will automatically check if the data has some problem If the data has some gap that happens when the device is connected to...

Page 32: ...evice the following message will be shown You can choose if wants to save the log into the database by clicking on the Yes option or if you don t need to save it in the database click on the No option...

Page 33: ...TA SELECTION field 6 Select the types of log to be included in the exported file in the LOG SELECTION field 7 Change the time zone if needed in the CHANGE TIMEZONE field 8 The exported data can be see...

Page 34: ...SAVE POWER DOWN Button with the additional effect of enabling the power down mode of the device Solving data problems When reading the data from the device or from a log file the software will check...

Page 35: ...ActStudio find a gap in the data the following message will be shown The user can choose to fill the gap with null values 0 or not Note when the data are loaded to process analysis we recommend fill...

Page 36: ...t All the states defined in the sleep scoring graph can be manually edited using the action menu described below Plot Setup There is a configuration menu called Plot Setup on the top of the graphs On...

Page 37: ...in the graph Editable 1 These 3 editable areas can be used to manually insert some visual information to the graphs For example you can insert the time that the user practiced some physical activity...

Page 38: ...where the user has clicked Awake empty Sleeping blue Resting green and OffWrist purple Note changing the state will affect the statistics 3 Menu used to insert an Event mark or a Sleep Diary mark The...

Page 39: ...using the Name field When you finish your edition just click on the Apply button to apply the changes to that editable region Sticky Notes You can include a sticky note for any day in the plot area To...

Page 40: ...graph it will receive a little point on the left upper corner 1 and it will also show a tooltip with the note content when you stop with the mouse cursor on it 2 Note to delete a sticky note you must...

Page 41: ...orithm proposed in the work entitled Automatic sleep wake identification from wrist activity 1 using the data selected by the user Custom this option will use the Condor Instruments algorithm based on...

Page 42: ...entification from wrist activity 1 RESTING Algorithm This option is not in use at the moment Source The data source to be used to define the resting state This option is used in the Cole Kripke algori...

Page 43: ...aved Save This button will save the current settings as the default settings When the ActStudio starts these settings will be loaded automatically Ok Just used to close the window References 1 Cole R...

Page 44: ...e calculation of the Bed Time parameter in the Summary Statistics Its default value is equal to the start time of the Sleep Scoring Get Up Time The start time of the day to be considered in the calcul...

Page 45: ...eiro Luis Antonio 551 cj 124 Cep 01318 000 Select All Rows Select all rows checkboxes in the Statistics Table and updates the Summary Statistics Deselect All Rows Deselect all rows checkboxes in the S...

Page 46: ...the selected rows DAILY STATISTICS Day of the Week Shows the day of the week based on the date Date Shows the date that represents each day according to the parameter bed time from the statistics tab...

Page 47: ...sodes The percentage of the secondary sleep episodes of each day Secondary Sleep Episodes Total Time Total Sleep Time Awakenings in Main Sleep Episodes The total number of awakenings in the main sleep...

Page 48: ...urs of greatest activity The O_M10 onset M10 is the start date and time of the M10 period The L5 is calculated by the average value of followed 5 hours of lower activity The O_L5 onset L5 is the start...

Page 49: ...ay separately Zero OffWrist ZO In the calculation considers the points that are marked as OffWrist as zero Without OffWrist WO Do not use the points that are marked as OffWrist in the calculation Max...

Page 50: ...DATA SELECTION Field used to select the period and the data that will be used in the calculation Date Select the initial date Time Select the initial time Days Select how many days will be used in the...

Page 51: ...actogram will also print the sleep scoring states if the sleep scoring was calculated the sleep diary if the user has entered some values and the light dark phases PERIOD AND DATA SELECTION Fields us...

Page 52: ...this field will be shown the selected parameters date time days and data CURVES Sleep Scoring States Show or Hide the Sleep Scoring States in the graph Sleep Diary Show or Hide the Sleep Diary in the...

Page 53: ...on the parameters defined in the Light Dark Phase page When using the temperature or light to generate the actogram the raw data will be normalized even when using the Original Data option The tempera...

Page 54: ...Square Periodogram Its Utility for Analysis of Circadian Rhythms of Sokolove and Bushell 1978 The periodogram is calculated based on the following formula The function was modified to compute the valu...

Page 55: ...605 the third result will be Q610 and so on Scale Change the graph scale to enhance visualization Period Unit p Used to define the measurement unit of the periodogram results Seconds Minutes or Hours...

Page 56: ...he chronobiology functions RESULTS This field is used to show the peak values calculated by the periodogram and to show each result value Q from the periodogram curve This table can be saved as TXT or...

Page 57: ...ime period but it can also happen when the min frequency max frequency or step do not match with the selected time period Another alert message that can be shown in the Periodogram analysis is related...

Page 58: ...tion that can be found at the following link http www mathworks com matlabcentral fileexchange 20329 cosinoranalysis content html cosinor html The Matlab function follows the cosinor analysis of a tim...

Page 59: ...used in the calculation e g PIM TAT ZCM Cycle Length This parameter is defined automatically but can be edited by user based on prior knowledge of time Alpha Used for confidence interval calculations...

Page 60: ...own in the graph Acrophase Select if the Acrophase curve will or will not be shown in the graph Amplitude Select if the Amplitude curve will or will not be shown in the graph ZERO AMPLITUDE TEST Ampli...

Page 61: ...lowing message can be shown when the user tries to calculate the Cosinor analysis This message represents that the confidence limits for Amplitude and Acrophase do not have calculable bounds Usually t...

Page 62: ...s page By clicking on the plus sign a new tab will be created at the end of the current tabs By clicking on the minus sign the last tab will be removed All tabs are independent and all analyzes will b...

Page 63: ...ender Field used to select the gender of the subject Body Part This field is used to select the Body Part where the actimeter was used to collect the data If the none option was selected this field wi...

Page 64: ...s insert a logo and footer HEADER AND FOOTER Field used to put a logo at the header and a message at the footer e g address Logo Used to select a logo by clicking the Load Image button supported forma...

Page 65: ...own in the report Sleep Diary Table Select if the Sleep Diary Table will or will not be shown in the report Sleep Scoring Select if the Sleep Scoring will or will not be shown in the report Sticky Not...

Page 66: ...1 cj 124 Cep 01318 000 Making a Report 1 Extract or load the data to be analyzed 2 Go to the Sleep Scoring page and verify the data 3 If necessary all the areas off wrist sleep rest can be edited and...

Page 67: ...551 cj 124 Cep 01318 000 5 On the report menu insert all relevant data about the subject 6 On the Report Settings page select the options that will be shown in the report 7 Click on the print report...

Page 68: ...opyright 2013 Condor Instruments Ltda 68 Av Brigadeiro Luis Antonio 551 cj 124 Cep 01318 000 Rebooting ActTrust 1 In the Control Menu Navigate to the Support Menu 2 Press the RESET button and wait 1 2...

Page 69: ...01318 000 Generating a Report of the ActTrust 1 Navigate to the Support Menu 2 Press the MAKE REPORT button and wait for the report to be generated and displayed in the text box 3 Press the SAVE REPOR...

Page 70: ...lculate Analysis button in the Main Menu If you do not modify the parameters in the analysis functions it will calculate the analysis with the default parameters Generate Statistics The statistics are...

Page 71: ...01318 000 Export Graphs Every graph can be saved as image PNG JPEG or BMP by right clicking the mouse on it and selecting the Save as Image option Export Data Tables Every data table can be saved as...

Page 72: ...new versions of OS X the option to hidden until activated by use is the default option To change this option please follow the step by step shown below It will make the scroll bars always display whe...

Page 73: ...l Settings it will also reset the Sleep Scoring Algorithm Settings and the Footer content from the Report Settings page Database Menu You can easily import and export database files by using the datab...

Page 74: ...xport it you can save it to a pen drive or any other device as well as the ActStudio folder The exported file is a copy of the local database not the database itself so the local database will not be...

Page 75: ...g is this original log or edited log ActStudio Exit Message If you try to close the ActStudio when you are editing a database log that was not saved yet you will see the following message If you selec...

Page 76: ...munication with external devices e g ActTrust It blocks the communication between the ActStudio and the ActTrust and the data cannot be extracted from the device This feature is configurable and you c...

Page 77: ...Copyright 2013 Condor Instruments Ltda 77 Av Brigadeiro Luis Antonio 551 cj 124 Cep 01318 000...

Page 78: ...not hearing any beep This can be caused mainly by two reasons The first is due to a low battery charge of the ActTrust The second is the possibility that the device is in power down mode In both cases...

Page 79: ...If contacting by email please attach the report generated by ActStudio The numbers that appear in ActStudio seems strange This may be due to a problem initializing the device when the battery charge...

Page 80: ...mpling Period 3 Months Using 60s epoch Battery Life 3 Months Using 60s epoch Battery type Rechargeable Li ion Water Resistance IP67 Sampling Interval Settable from 1s to 86400s Sensors Accelerometer W...

Page 81: ...each spectrum individual and the total light intensity Operation interval 0 01 8388 61 W cm2 Precision 10 a 10 W cm2 typical Standard Description IEC60601 1 2006 Medical electrical equipment Part 1 G...

Page 82: ...tion Electromagnetic Immunity I The product is suitable for use in a specific electromagnetic environment The customer and or the user of the product should assure that it is used in an electromagneti...

Page 83: ...oadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered if the measured field...

Page 84: ...ation This device should be disposed in accordance with the rules and regulations of the country in which the disposal takes place For more information about the disposal of products please contact th...

Page 85: ...tention warning Read the operation instructions Recyclable material Weee Waste Eletrical and Eletronic Equipment Dispose at appropriate site Temperature Limits Applied part type BF Fabrication batch Y...

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