Condor ACTLUMUS User manual

Condor Instruments Ltda.
17/01/2023
ACTLUMUS - USER MANUAL
Modelo: AL0101
ActLumus Controller
2.1.0 version

Copyright © 2022, Condor Instruments Ltda. 2
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Index
Introduction.........................................................................................................3
Indications for use........................................................................................... 3
Contraindications............................................................................................. 3
Adverse effects................................................................................................ 3
Maintenance.................................................................................................... 3
General Warnings and Precautions................................................................. 3
Training and qualification................................................................................. 4
ActDock Lumus (ADL0101)................................................................................5
Description and Functionality .......................................................................... 5
Maintenance and Cleaning.............................................................................. 6
Using ActDock Lumus..................................................................................... 7
ActLumus (AL0101)............................................................................................ 8
Description and Functionality .......................................................................... 8
Maintenance and Cleaning.............................................................................. 8
Software ActLumus Controller............................................................................ 9
Installation....................................................................................................... 9
Windows...................................................................................................... 9
Control Menu................................................................................................. 10
Real Time Data Tab...................................................................................... 13
Support Tab................................................................................................... 14
Specifications...................................................................................................15
Applicable Standards ....................................................................................... 16
Manufacturer's guide and statement —Immunity and electromagnetic
emissions ......................................................................................................... 17
Symbology........................................................................................................ 21

Copyright © 2022, Condor Instruments Ltda. 3
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Introduction
Before using the device, read the manual in its entirety.
Indications for use
ActLumus is an ultra-compact and lightweight monitor of activity, temperature and ambient pulse light that can be
used to analyze circadian rhythms, automatically collect and store data for sleep parameters, and valiate activity
in any instance where quantifiable analysisof physical motion is desired. The device is intended to monitor limb
or body movements during daily life and sleep.
Contraindications
There are no contraindications to the use of the device.
Adverse effects
Patients should tell their doctor and discontinue use immediately in case they experience itching or irritation in
the skin contact area of the device.
Maintenance
Sterilization is not required for any part of the product.
PRECAUTIONS
Inspections and repairsshould only be carried out by an authorised agent. Under no circumstances should you
attempt to open, or personally repair or maintain the device.
This product must be inspected by an authorized Condor service centre five years after the date of manufacture.
Prior to this, the device is intended to provide safe and reliable operationprovided that its use and maintenance
complies with the instructions provided by Condor. Details regarding the applicable Condor warranty are provided
with the device fromyour original purchase. Obviously, like all electrical devices, you should be careful and request
inspection of the device at a Condor authorized service center if you detect anomalies in it.
General Warnings and Precautions
Notices
Thevision for the possibility of bodily injury.
•Before using the device, read the manual in its entirety.
•The device and accessories should only be used for the purpose for which they are intended.
•Use only original and Condor approved accessories and parts.
Additional equipment connected to electrical medical equipment must comply with the respective IEC or ISO
standards (e.g. IEC 60950 for data processing equipment). In addition, all configurations must meet the
requirements for electrical medical systems (see IEC 60601-1-1 or clause 16 of the 3rd ed. of IEC 60601-1,
respectively). Anyone who connects additional equipment to electrical medical equipment configures a medical
system and is therefore responsible for the system meeting the requirements for electrical medical systems.
Attention is drawn to the fact that local legislation has precedence over the above-mentioned requirements. If in
doubt, consult your local representative or technical assistance department.
WARNING: The use of this adjacent equipment or other equipment should be avoided, as itmay result in improper
operation, If this use is necessary, it is advisable that this and the other equipment be observed to verify that they
are operating normally
WARNING: The use of accessories, transducers and cables other than those specified or supplied by the
MANUFACTURER of this equipment could result in high electromagnetic emissions or reduced electromagnetic
immunity from this equipment and result in improper operation
WARNING: Portable RF communication equipment (including peripherals such as antenna cables and external
antennas) should not be used within 30 cm of any part of the (EQUIPMENT IN OR IN SYSTEM), including cables
specified by the MANUFACTURER, otherwise performance degradation of this equipment may occur

Copyright © 2022, Condor Instruments Ltda. 4
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Notifications
•Condor Instruments and ActLumus are trademarks and therefore subject to applicable copyright laws and
regulations.
•This product is manufactured by:
Condor Instruments Ltda - EPP
Rua Professor Tulio Ascarelli, 290, Vila Madalena
São Paulo - SP CEP.: 05449-020
Note
The EMISSION characteristics of this equipment make it suitable for use in industrial areas and hospitals (ABNT
NBR IECICISPR 11 class A), if used in a residential environment (for which ABNT N8R IEC/CISPR 11 class B is
normally required), this equipment may not offer adequate protection for radio frequency communication services,
The user may need to take mitigation measures, such as relocating or reorienting the equipment,
Training and qualification
Any operator must have read the manual and have the necessary computer skills to configure the devices
Analyses should only be carried out by persons qualified to do so

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
ActDock Lumus (ADL0101)
Description and Functionality
‘
Pull to open
Hole for light
sensor and
button test
Click
Gold Plated
Contacts
USB
Cable
Lid
Base
Rear
Cover
PCB
USB
Cable

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
The ActDock Lumus (common name: USB/Bluetooth adapter) consists of five
parts, the Lid, The Base, the Rear Cover, the PCB and the USB cable. This
accessory is intended to adapt the USB pins in ActLumus to a normal USB
connector as well as enable the Bluetooth connection of the ActLumus to the
computer.
Maintenance and Cleaning
•Clean with damp cloth and mild soap.
Notes:
•Avoid contact with gasoline, benzene, thinner or acetone and, in case of
contact with one of these substances, clean with damp cloth and neutral
soap as soon as possible.
•Do not use abrasive or highly alkaline products (e.g., saponaceous or
ammonia-based cleaning products).
•Do not use Isopropanol or Butyl cellulose on any of the dock surfaces.

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Using ActDock Lumus
1. Ensure that the gold pins of both the dock and the device are aligned as
shown in the figure.
2. Rotate actlumus to fit it into the dock.
3. Close the dock and press until the click locks.
4
1
2
3

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
ActLumus (AL0101)
Description and Functionality
ActLumus is a Device whose function is to use activity data, skin temperature
and exposure to light. It is intended to be used in one of the limbs to hurt the
sleep parameters needed to assess sleep quality and sleep disorders. Requer
one of the ActDock Lumus accessories to extract the data.
Maintenance and Cleaning
•Wash only with warm water and mild soap.
•Always wash the device when it has contact with salt water.
•Whenever ActLumus is to be saved, put it to Off mode.
•Do not leave ActLumus for long periods with the battery fully discharged.
This can lead to a reduction in the service life of it.
•If the device is stored for long periods of time make a full charge on it
every 6 months.
Notes:
•Avoid contact with gasoline, benzene, thinner or acetone and, in case of
contact with one of these substances, clean with damp cloth and neutral
soap as soon as possible.
•Do not use abrasive or highly alkaline products (e.g., saponaceous or
ammonia-based cleaning products).
•Do not use Isopropanol or Butyl cellulose on any of the surfaces of
ActLumus.
Light sensor
Event button
LED
Temperature
sensor
Off-Wrist
sensor

Copyright © 2022, Condor Instruments Ltda. 9
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
•Do not go swimming or dive with ActLumus.
Software ActLumus Controller
ActLumus Controller software is used to extract, export, and analyze ActLumus
data. It has 3 main menus as explained below. Please note that this manual
was written based on the version of ActLumus Controller found on the cover of
this manual and some features described here may not be available in earlier
versions
Installation
This software does not require any installation. It can run from thumb drives or
any other form of external drive or from the computer itself.
Windows
To run the program just unpack it in the preference folder and run the EXE file.

Copyright © 2022, Condor Instruments Ltda. 10
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Control Menu
CONNECTION
DOCK
Represents dock connection state
DEVICE
Represents device connection
AUTO CONNECT
Enables the software to connect to some device
automatically. If the user enters a number on the
editable line bellow, the software will connect
only to the device that has the ID entered.
DEVICE LIST
List just below the editable line that lists the
available devices to connect to. By double-
clicking on a list item, the software will attempt
to connect to the chosen device.
DISCONNECT
Button to disconnect from a connected device.
DEVICE INFO
Connected device information:
MODEL: Model

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
ID: Device ID
FIRMWARE: Firmware Version
HARDWARE: Hardware Version
MECH REV: Mechanical Review
HARD ID: Device Hardware ID
DEVICE STATUS
Connected device status:
STATUS: Battery Status
ERROR: Device Error
BATTERY STATUS
Connected device battery status:
LAST FULLY CHARGED: date of the last full
charge
DAYS PASSED: days since the last full charge
CONTROLS
READ
Button to read the data stored on the connected
device.
MEMORY USAGE
Percentage of the memory used from the
connected device.
ERASE
Erases internal memory from the connected
device.
SYNC
Synchronizes the device time with the system
time.
TRIAL INFORMATION
ID: patient’s identification
DATE OF BIRTH: patient’s date of birth
GENDER: patient’s gender
DEVICE PLACEMENT: Where the device is
placed on the patient.
Clear Fields
Clear the Trial information fields.
Select Patient
Select a patient from the database to fill the Trial
Information fields.
LOAD
Loads the information from the connected device
to fill the Trial Information fields.
APPLY
Apply the current Trial Information fields to the
device.
POWER DOWN
The connected device will enter low-power mode
when it is disconnected and removed from the
dock
ACTIVATE
Activates the connected device.

Copyright © 2022, Condor Instruments Ltda. 12
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020

Copyright © 2022, Condor Instruments Ltda. 13
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Real Time Data Tab
REAL TIME SENSORS
Real-time data from those collected by the sensors of the connected device.
MELANOPIC LUX
Melanopic Lux Measurement
PHOTOPIC LUX
Phototopic Lux Measurement
ACCELEROMETER
Accelerometer measurement
TEMPERATURE
Temperature sensor measurement
BATTERY
VOLTAGE
Measurement of the voltage of the device's internal
battery
CAPACITIVE
SENSOR
Measurement of capacitive sensor

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Support Tab
SUPPORT
RESET
Reinitializes connected device.
READ SYSTEM
LOG
Boots reading the system logs of the connected device.
SAVE
Saves the system log to a text file.
BOOT ERROR
Reports if there were any errors at the time of device startup
on any of the system components.
SYSTEM LOG
Text box below the READ SYSTEM LOG button. Contains
system logs read from device memory
BATTERY
Graph with battery voltage stored in logs.

Copyright © 2022, Condor Instruments Ltda. 15
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Specifications
General Specifications
Weight Without Bracelet
12g
Weight With Bracelet
31g
Dimensions
33,5 mm x 26,5 mm x 13mm
Environmental conditions
•Operating conditions: 0°C to 50°C (32 °F
to 122 °F)
•Storage Temperature : -20 °C to 50 °C (-4
°F to 122 °F)
•Operating Pressure, Storage and
Transportation: 480 to 780mmHg
•Operating Humidity, Storage and
Transportation: 10 to 90%
Memory
8MB
Sampling Time
1 month (60s sampling interval)
Battery Time
1 month (60s sampling interval)
Battery type
Rechargeable Li-ion
Tightness
IP67
Sampling Interval
60s
Sensors
Accelerometer
Skin temperature
Spectral Light + Photon + Melanopic
Off-Wrist
Communication
Bluetooth
Activity logging modes
PIM, TAT e ZCM
Electromagnetic compatibility
The product meets all applicable
electromagnetic compatibility (EMC)
requirements in accordance with IEC60601-1-2
for home, commercial, and light industry
environments. For more details see
"Manufacturer's Guide and Statement —
Immunity and Electromagnetic Emissions."
Power voltage
3,7V c.c.
Accelerometer
Axes
3
Resolution
12 bits
Sampling Rate
25Hz

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Notes:
•The manufacturer reserves the right to change these specifications without prior notice
Applicable Standards
Temperature Sensors
Precision
+/-0.5°C (20°C to 40°C)/ 1°C For other values
Operating Range
0°C –70°C
Light Sensor
Spectrum
Phototopic, Melanopic and Spectral
Observations
It takes the intensity of each of the 10 channels
and makes a combination to get melanopic,
photopic and total light.
Operating interval
1 –100.000 Lux
Precision
10% to 1,000 Lux (typical)
Pattern
Description
IEC60601-1:2006
Electrical medical equipment - Part 1:
General requirements for basic safety and
essential performance.
IEC60601-1-2:2014
Electrical medical equipment - Part 1-2:
Collateral Standard: Electromagnetic
compatibility - Requirements and tests.
IEC60601-1-11:2010
Electrical medical equipment –Part 1-11:
Collateral standard: Requirements for
electrical medical equipment and electrical
medical health systems used at home.

Copyright © 2022, Condor Instruments Ltda. 17
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Manufacturer's guide and statement —
Immunity and electromagnetic emissions
Medical electrical equipment requires special precautions regarding the
Electromagnetic Compatibility (CEM) and also needs to be installed and put into operation according to the
information regarding the EMC contained in this document.
Guide and Manufacturer's Declaration - Electromagnetic Emissions
The device is intended for use in the electromagnetic environment specified below. It is advisable that the purchaser or user of the device ensures
that it is used in such an environment.
Emissions test
Adhesion
Electromagnetic environment - guide
RF emissions
(Radio frequency) CISPR11
Group 1
The device only uses radio frequency energy for its inner workings. For this reason, RF
emissions are very low and are unlikely to cause interference to electronic equipment in
their vicinity.
RF emissions
(Radio frequency) CISPR11
Class B
The device is suitable for use in all locations, including homes and locations connected
directly to the low-voltage public network that provides power to
Harmonic emissions
IEC 61000-3-2
Does not apply
Domestic purposes.
Fluctuations in voltage/
Emissions with jitter
IEC 61000-3-3
Accordingly
Guide and Manufacturer's Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. It is advisable that the purchaser or user of the device ensures
that it is used in such an environment.
Immunity test
Test level IEC
60601-1-2
Compliance level
Electromagnetic environment - guide
Electrostatic Discharge (DES)
IEC
61000-4-2
± 8 kV Per contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV Via or
± 8 kV Per contact
± 2 kV, ± 4 kV, ± 8
kV, ± 15 kV Via or
The floors should be made of wood, concrete or ceramic. If the
floors are covered by synthetic material, the relative humidity
should be at least 30%.
Fast/salvac electrical
transients
IEC 61000-4-4
± 2 kV for power
supply lines
± 1 kV for
input/output lines
Does not apply
The device is charged via computer and is not directly subject to
the power supply network
Outbreaks
IEC 61000-4-5
± 1 kV line(s) the
line(s)
± 2 kV line(s) solo
Does not apply
The device is charged via computer and is not directly subject to
the power supply network
Voltage outages, short
interruptions and voltage
variations in the input lines of
the power supply
IEC 61000-4-11
<5% Ut (>95% drop
in Ut) during 0.5
cycle
40% Ut (60% drop in
Ut) for 5 cycles
70% Ut (30% drop in
Ut) for 25 cycles
<5% Ut (>95% drop
in Ut) during
5
Does not apply
The device is charged via computer and is not directly subject to
the power supply network
Magnetic field generated by
the frequency of the electrical
network (50/60 Hz)
IEC 61000-4-8
30 A/m
30 A/m
Magnetic fields in the frequency of the power supply network
should have levels characteristic of a typical location in a typical
hospital or commercial environment.
NOTE 1: Ut is the voltage of alternating current before applying the t level

Copyright © 2022, Condor Instruments Ltda. 18
Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Guide and Manufacturer's Declaration - Electromagnetic Immunity
The device is intended for use in the electromagnetic environment specified below. It is advisable that the purchaser or user of the device ensures
that it is used in such an environment.
Immunity test
Test level IEC
60601-1-2
Compliance level
Electromagnetic environment - guide
Mobile or portable RF communication equipment should not be
used at smaller distances from any part of the device, including
cables, than the recommended separation distance calculated by
the equation applicable to the transmitter frequency.
Recommended separation distance
RF driven
IEC 61000-4-6
3 Vrms
150 kHz a 80 MHz
3 Vrms
d = 1.17 √P
Irradiated RF
IEC 61000-4-3
10 V/m
80 MHz a 2,7 GHz
10 V/m
d = 0,35 √P 80 MHz a 800 MHz
d = 0,70 √P 800 MHz a 2.5 GHz
Where Pis the maximum declared level of transmitter output
power in Watts (W) according to the transmitter manufacturer and
d is the recommended separation distance in meters (m).
The field intensity from fixed RF transmitters, determined by an
electromagnetic survey of field a, is less than the compliance level
for each frequency range
Interference may occur in the vicinity of equipment marked with
the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the highest frequency range is applicable.
NOTE 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by the absorption and reflection of structures, objects and
people.
a - The field intensity of fixed transmitters, such as base stations for radio phones (cellular /wireless), terrestrial mobile radios, amateur radio, broadcasting
broadcasts (AM and FM) and television, cannot, in theory, be accurately predicted. To evaluate the electromagnetic environment caused by fixed RF transmitters,
an electromagnetic inspection of the site should be carried out. If the field strength value at the location where the device is being used exceeds the applicable RF
compliance level mentioned above, the device should be checked for proper operation. If unusual performance is observed, additional measures may be required,
such as changing the position or installation location of the device.
b - In the frequency range between 150 kHz and 80 MHz, the field intensity should be less than 10 V/m.

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Guide and Manufacturer's Statement - RF Immunity
Recommended separation distances between portable and mobile RF
communications equipment and the device
The device is intended for use in an electromagnetic environment in which RF irradiation disturbances are controlled. The purchaser or user of the
device can help prevent electromagnetic interference by keeping the minimum distance between mobile or portable RF communications equipment
(transmitters) and the device, as recommended below, according to the maximum output power of the communications equipment.
Separation distance according to transmitter frequency (m)
Maximum rated
transmitter output power
(W)
150 kHz a 80 MHz
d = 1,17 √P
80 MHz a 800 MHz
d = 0,35 √P
800 MHz a 2.5 GHz
d = 0,7 √P
0,01
0,12
0,04
0,07
0,1
0,37
0,11
0,22
1
1,17
0,35
0,7
10
3,70
1,11
2,21
100
11,70
3,50
7,0
For transmitters whose maximum output power is not indicated above, the recommended separation distance d in meters (m) can be determined
using the equation applicable to the transmitter frequency, where P is the maximum output power of the transmitter in Watts (W) according to the
transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance is applicable for the highest frequency range.
NOTE 2: These guidelines may not apply to all situations. Electromagnetic propagation is affected by the absorption and reflection of structures,
objects and people.
Test frequency
[MHz]
Band [MHz]
Service
Modulation
Maximum
power [W]
Distance
[m]
Immunity
test level
(V/m)
385
380-390
TETRA 400
18Hz pulse modulation
1,8
0,3
27
450
430-470
GMRS 460,FRS 460
FM ± 5 kHz deviation
2
0,3
28
1kHz sine
710
704-787
LTE Band 13, 17
Pulse modulation 217 Hz
0,2
0,3
9
745
7480
810
800-960
GSM 800/900, TETRA 800, iDEN
820, CDMA 850, Banda LTE 5
Pulse modulation 18 Hz
2
0,3
28
870
930
1720
1700 -1990
GSM 1800; CDMA 1900; GSM 1900;
DECT; Banda LTE 1, 3, 4, 25; UMTS
Pulse modulation 217 Hz
2
0,3
28
1845
1970
2450
2400-2570
Bluetooth, WLAN 802.11 b/g/n, RFID
2450, Banda LTE 7
Pulse modulation 217 Hz
2
0,3
28
5240
5100 - 5800
WLAN 802.11 a/n
Pulse modulation 217 Hz
0,2
0,3
9
5500
5785

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Professor Tulio Street Ascarelli, 290 - Vila Madalena, São Paulo, SP - Cep:05449-020
Essential Performance
Within normal operation the ActLumus equipment must show the accelerometer, light sensor and temperature sensors
every 1 (one) minute and should store the collected data within its non-volatile flash memory.
Failuresrelatedto Electromagnetic Disturbances
In case the device suffers a failure related to electromagnetic disturbances it is expected that the device will presentloss
of data associated with reset events.
Environmental information
This device must be disposed of in accordance with the laws and regulations of the country in which the disposal takes
place. For more information on product disposal, please contact your Condor representative or specialist distributor in
your area, or visit our website at www.condorinst.com.
Maintenance Related to Electromagnetic Perturbations
The Device does not require any maintenance related to electromagnetic disturbances during its expected service life.
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