Corscience CS10803 User manual

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Combination Sensor
Manual
CS10803

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Manufacturer: Corscience GmbH & Co. KG
Hartmannstraße 65
91052 Erlangen
Germany
www.corscience.de
Product Name: Combination Sensor
Contact Address EU:
BEE Medic LLC.
Zeppelinstrasse 7
78224 Singen
Germany
eMail: info@ beemedic.de
Website: www.beemedic.de
Contact Address non-EU and EMEA:
BEE Medic LLC.
Husenstrasse 57
9533 Kirchberg / SG
Switzerland
eMail: [email protected]
Website: www.beemedic.ch
Contact Address USA:
BEE Systems, Inc.
6400 Canoga Ave.
Suite 211
Woodland Hills, CA 91367
USA
eMail: in[email protected]
0482
CS 60505D-en – July 2019

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Contents
OVERVIEW........................................................................................................ 5
1 INDICATIONS FOR USE............................................................................ 6
2 SAFETY NOTICES..................................................................................... 6
2.1 Usage..................................................................................................................................................6
2.2 Intended Purpose..............................................................................................................................7
2.2.1 INTENDED USE......................................................................................................................7
2.2.2 USER POPULATION...............................................................................................................7
2.2.3 CONTRAINDICATIONS.........................................................................................................7
2.2.4 TARGET PATIENT POPULATION – MEDICAL CONDITIONS ........................................7
2.2.5 ENVIRONMENT......................................................................................................................8
2.2.6 DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION...........................................8
2.3 Basic Regulations..............................................................................................................................8
2.4 Personnel and Qualification.............................................................................................................8
2.5 Personal Safety Information............................................................................................................8
2.6 Device-related Safety Information ..................................................................................................9
3 FUNCTION................................................................................................ 11
3.1 Description.......................................................................................................................................11
3.2 Electromagnetic Compliance.........................................................................................................13
4 SET-UP..................................................................................................... 14
4.1 Unpacking the Combination Sensor..............................................................................................14
4.2 Enabling the Combination Sensor.................................................................................................14
4.3 Connecting the Combination Sensor to the digitizing unit..........................................................15
5 OPERATION............................................................................................. 16
5.1 Interpretation of the measured data .............................................................................................17
5.1.1 Definition HRV.......................................................................................................................18
5.1.2 Definition Stress Index............................................................................................................18
6 CLEANING, MAINTENANCE, STORAGE AND DISPOSAL ................... 19
6.1 Cleaning and Maintenance.............................................................................................................19
6.2 Storage.............................................................................................................................................19
6.3 Disposal............................................................................................................................................19
7 TECHNICAL DATA................................................................................... 20

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8 PLUG DIAGRAM...................................................................................... 20
9 NOTICES ON EMC ACCORDING TO EN 60601-1-2............................... 21
10 WARRANTY.......................................................................................... 23
11 COPYRIGHT NOTICE........................................................................... 23
12 DECLARATION OF CONFORMITY...................................................... 24

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Overview
It can be useful in terms of therapy to measure not only the EEG but also other physiological
parameters and to provide feedback based on them. A device that does exactly this is the
Combination Sensor. It’s highly functional housing contains three different sensors with
measuring amplifiers, which allow for the precise and low-noise measurement of three
physiological parameters. The Combination Sensor has the following properties:
3-in-1 Sensor:
The unique sensor arrangement measures the Galvanic Skin Response (GSR), the skin
temperature and the heart rate of the patient.
High Precision and Speed:
The Combination Sensor contains highly precise amplifiers with an excellent signal-to-noise
ratio. These are right next to the sensors themselves, which allows for an even better signal
even when using a long cable to connect to the EEG NeuroAmp®.
Professional Design:
Your clients will appreciate the highly functional design. The Combination Sensor can easily be
attached to a single finger. All materials are biocompatible and fulfill the strict regulations for
medical devices.
Thanks to the internal amplifiers, the roughly two-meter-long cable can even be extended by
extension cables with minimal effect on the measurements.
General Properties
- Easy to use.
- Functional design to allow
for quick and reliable
measurements.
- Direct interface to the EEG
NeuroAmp®.
- Complies with all applicable
regulations for medical
devices.
Technical Data
- Number of sensors: 3
- GSR sensor range: 0.2-
100µMho
- Temperature sensor range:
20-40°C, Time constant:
60s
- Heart rate: Optical
measurement using 940nm
and 660nm at the fingertip
.
Rate: 62 measurements/s
Power Supply
No batteries required – Power
supplied by EEG NeuroAmp®

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1 Indications for Use
The Combination Sensor is a biofeedback sensor to measure GSR, skin temperature and heart
rate. GSR and skin temperature are not measured in absolute values. The purpose is to
measure trends. The Combination Sensor may only be used by trained professionals who can
ensure safe handling. The Combination Sensor can only be used in conjunction with the EEG
NeuroAmp®.
The device is not intended for diagnostic purposes or for patient monitoring.
Notice
US Federal Law restricts this device to sale by, or on order of, a physician or any
other practitioner licensed by the law of the state in which he or she practices to
use or order the use of this device.
2 Safety Notices
2.1 Usage
Please take your time to read these instructions carefully and become familiar with the functions
of the Combination Sensor. These instructions are part of the product and must be stored in
such a way that they are available anytime. Please only use the device for purposes outlined in
Chapter 2.2, Indications for Use.
The Combination Sensor may only be used by trained personnel.
The following table explains the warning symbols used in these instructions:
WARNING
Points out potentially
dangerous situations that
may lead to severe injury or
death.
CAUTION
Points out potentially
dangerous situations that
may lead to injury.
CAUTION
Points out situations that
could lead to damage to the
device.
NOTICE
Points out a situation that
does not lead to death,
injury or damage of
property.

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The meaning of the symbols on the label of the Combination Sensor:
Conformity symbol
Please dispose of the
product properly, do not
put into regular trash.
Manufacturer
Year of production
QR Code
Serial number
Medical device
2.2 Intended Purpose
2.2.1 INTENDED USE
The Combination Sensor is a biofeedback sensor to measure GSR, skin temperature and heart
rate. GSR and skin temperature are not measured in absolute values. The purpose is to
measure trends. The Combination Sensor may only be used by trained professionals who can
ensure safe handling. The Combination Sensor can only be used in conjunction with the EEG
NeuroAmp®.
The device is not intended for diagnostic purposes or for patient monitoring.
2.2.2 USER POPULATION
The Combination Sensor may only be used by trained professionals who can ensure safe
handling.
2.2.3 CONTRAINDICATIONS
There are no known contraindications for the Combination Sensor.
The Combination Sensor may only be used on intact skin. The skin may not be injured and may
not be compromised in its physiological function. In rare cases, allergic reactions to the material
of the Combination Sensor were observed. The strap of the Combination Sensor may not be
applied too tightly. Blood flow to the finger must be sufficient at all times.
For disinfection, please follow the method outlined in chapter 6.1.
2.2.4 TARGET PATIENT POPULATION – MEDICAL CONDITIONS
The device can be used on adult and pediatric patients. The finger must be long enough to fit
adequately into the Combination Sensor. The device is used on patients undergoing
neurofeedback therapy in order to serve the therapist as an indicator for the relaxation state of
the patient by monitoring trends.
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2.2.5 ENVIRONMENT
The Combination Sensor may be used in professional healthcare facilities, such as physician
offices. It is not intended for use in home healthcare environments or in special environments,
such as heavy industry or HF surgical environments.
2.2.6 DEVICE DESCRIPTION AND PRINCIPLES OF OPERATION
For device description and principles of operation, please see chapter 3.
2.3 Basic Regulations
Make sure that you follow the national and local re ulations with re ard to the use of this
device as well as biofeedback.
2.4 Personnel and Qualification
•The therapist is responsible for the safety of the entire biofeedback system, consisting of the
Combination Sensor and other hardware, sensors and software, tactile feedback systems,
animations, etc. The therapist is also responsible for ensuring that the computer on which
the data recording software runs is powerful enough to process the data volume provided by
the Combination Sensor quickly enough that all software that build upon this data can be run
without additional delay.
•The therapist is responsible for the correct and safe biofeedback treatment. The therapist is
responsible for possible side effects, which appear during or after biofeedback treatment.
•The Combination Sensor may only be used by trained personnel.
•The patient may not be left unsupervised at any point during the treatment.
•
2.5 Personal Safety Information
ADVERSE EFFECTS
No adverse effects are known for the device itself. However, in case biofeedback therapy is
performed by inexperienced or careless practitioners, it may cause unwanted effects, such as
those associated with inappropriate activation, including tiredness, drowsiness, restlessness,
and sleep dysregulation. Another unwanted effect that can occur is headaches. Such
adverse effects should subside promptly unless inappropriate training is continued. The signals
of the Combination Sensor do not control the feedback animations of the patient software, they
are only displayed on the therapist screen.
The therapist is responsible for applying appropriate therapy methods. The Combination Sensor
may therefore be used only by a professional who can ensure sound handling practices.
The manufacturer of the Combination Sensor does not assume liability for any adverse effects
whatsoever caused by biofeedback therapy.
Notice
Any serious incident that has occurred in relation to the device should be
reported to the manufacturer and the competent authority of the Member State
in which the user is established.

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WARNING
Entanglement or Strangulation by the cable of the Combination Sensor
•The patient and the cable should always be arranged in a way that it is not
possible for the patient to become entangled or strangled by the cable.
2.6 Device-related Safety Information
WARNING
•The Combination Sensor may not be used with a patient undergoing a
treatment that involves strong electromagnetic fields or electrical signals such
as defibrillation, HF-surgery or MRI. The Combination Sensor is not defibrillator-
proof.
•The Combination Sensor may not be used for monitoring or diagnosing
patients.
• Th e Combination Sensor must be applied to healthy skin only. The skin must
be undamaged and not impaired in its physiological function.
•The band must always be loose enough to allow sufficient blood flow through
the finger. Otherwise, false data could be measured.
•Please note that nail varnish on the fingernail can lead to false heart rate
values.
•The strap on the Combination Sensor must consist of biocompatible materials.
Use the included medically approved Kinesiotape.
•For hygienic reasons, use a new strap for each new patient.
WARNING
Damage or electrical shock due to use of inappropriate accessories
Accessories that are not intended for use with the Combination Sensor may
damage the product, impair performance, breach the regulations or even cause
electrical shocks. Inappropriate use may have dangerous consequences or at
least damage the device and render the warranty invalid.
•Only use the Combination Sensor with devices that are intended for use with it,
such as the EEG NeuroAmp®.
•Do not plug the cable of the Combination Sensor into devices which are not
intended for use with the Combination Sensor, even if the connectors fit.
WARNING
Incorrect measurements due to strong electromagnetic fields
Mobile phones, x-ray machines, high frequency therapy devices or other devices,
which radiate electromagnetic radiation, can influence and falsify the signals.
•Make sure that the recommended distances to radio wave emitters are met (see
chapter 9 “Notes on EMC”).
•The function of Combination Sensor could be degraded by exposure to
electromagnetic disturbances exceeding the limits defined in chapter 9. This
would be noticed by distorted signals. In this case take care to eliminate the
electromagnetic disturbances before continuing operation.

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WARNING
Portable RF communications equipment (including peripherals such as antenna
cables and external antennas) should be used no closer than 30 cm (12 inches)
to any part of the Combination Sensor, including cables specified by the
manufacturer. Otherwise, degradation of the performance of this equipment could
result.
CAUTION
Damage due to electrostatic discharge
Take anti-ESD measures such as anti-static mats or a humidifier to condition hot,
dry air.
•The unit is not susceptible to electromagnetic disturbances below IEC 60601-1-2 immunity
test levels, as long as the connection cable including extension cables is not longer than
three meters.
CAUTION
Damage due to water or moisture
The Combination Sensor may not be submerged in water or other liquids.
•Do not pour liquids over the Combination Sensor and avoid situations where the
Combination Sensor comes into contact with liquids.
•The Combination Sensor should not be used or stored in dusty, moist or dirty environments.
•Please check the sensors on the Combination Sensor for contamination regularly. The
sensors must be kept clean, because particles on the sensor surface may influence the
measurements. Use a cotton swab or tissues moisturized with Isopropanol or rubbing
alcohol to carefully clean the sensors.
CAUTION
Injury to children or damage to the device
•Store the unit out of reach of children to prevent them from injuring themselves
or others and to avoid damage to the product.
CAUTION
Damage by inappropriate handling or repair attempts
Inappropriate handling may damage the device and render the warranty invalid.
Repair only by qualified personnel
•Do not attempt to open the product and repair it yourself. The manufacturer
accepts no liability for any damages thus incurred
•The Combination Sensor should be stored in its original packaging in a dry place, at which
the temperature lies between -10°C and +60°C. Storage locations at which condensation of
water out of the air may occur are to be avoided.

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3 Function
3.1 Description
Figure 1: Usage of the Combination Sensor in a Biofeedback session
The Combination Sensor consists of an arrangement of three sensors to measure Galvanic Skin
Response, skin temperature and heart rate (see Figure 2). It contains amplifiers and signal
processing electronics, which allow for an excellent signal quality as well as the use of a long,
easy to handle connection cable. The signals of the Combination Sensor do not control the
feedback animations of Cygnet, they are only displayed on the therapist screen.
Figure shows a detail image of the Combination Sensor, which can be attached to a finger with
the strap opened. To do this, one finger (preferably the index finger on the left or right hand) is
placed on the Combination Sensor so that the fingertip lays in the indent in the front of the
sensor, and the strap fastened around it (see Fehler! Verweisquelle konnte nicht gefunden
werden.). Please make sure that the Combination Sensor is attached firmly, but that the strap is
still loose enough to allow sufficient blood flow to the finger.
The Combination Sensor can be connected directly to the EEG NeuroAmp®. Please make sure
that the Combination Sensor is connected only to the rightmost socket on the EEG NeuroAmp®
(see Figure 4 ). The EEG NeuroAmp® supplies power to the amplifiers and signal processing
electronics.
During measurements, the patient should avoid moving the finger. The hand should be laid on
the thigh or a table.
Combination
Sensor
Bio-Signals
EEG NeuroAmp
®
Therapist computer
Client screen
Client feedback

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Figure 2: Detail image of the Combination Sensor with the localization of the three individual
sensors. For the sake of clarity, most of the finger strap is cropped.
Fi ure 3: Combination Sensor is attached by the finger strap to the left index finger.
Sensors for GSR
Li ht
source for blood flow
and reflectivity measurements
Optical sensor
Temperature sensor
(not visible)

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Fi ure 4: Connection of the Combination Sensor cable to the rightmost socket on the EEG
NeuroAmp®. The Combination Sensor only functions when connected to this specific socket.
3.2 Electromagnetic Compliance
The Combination Sensor was tested according to the IEC 60601-1-2 and complies with:
•IEC / CISPR 11, Class B (RF emission)
•IEC 61 000-4-2 (Electrostatic Discharge - ESD)
•IEC 61 000-4-3 (RF susceptibility)
•IEC 61 000-4-6 (RF asymmetric)
The Combination Sensor should not be connected to a cable with a total length of over 3
meters. This maximum length also applies to the serial interface cable in connection with an
extension cable.

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4 Set-Up
4.1 Unpacking the Combination Sensor
WARNING
Death due to suffocation if packing material is swallowed
•Store packing material out of reach of children
Unpack your Combination Sensor.
Please verify that the device is not damaged. If the device is damaged, please return it for a
replacement.
4.2 Enabling the Combination Sensor
Before use, please check if the Combination Sensor is enabled in the software. If you want to
switch between disabled and enabled, the data acquisition must be stopped. It cannot be done
during a running session.
Figure 5: Enabling the Combination Sensor

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4.3 Connecting the Combination Sensor to the digitizing unit
The Combination Sensor has a Mini-Din8 plu , which plu s directly into the EEG NeuroAmp®.
Please make sure to only plug the Combination Sensor into the rightmost socket on
the EEG NeuroAmp® (see Fi ure 4). Interfaces to other di italization units mi ht be added in
the future.
WARNING
Electrical shock or damage due to use of inappropriate accessories
•Accessories that are not intended for use with the Combination Sensor
may damage the product, impair performance, breach the regulations or
even cause electrical shocks. Inappropriate use may have dangerous
consequences or at least damage the device and render the warranty
invalid.
•Use only in conjunction with equipment that is indended for use with the
Combination Sensor such as the EEG NeuroAmp®.
•Do not plug the cable of the ComiSensor into equipment unless it is
meant to work with it, even if its plugs fit.
Before connecting the Combination Sensor to the EEG NeuroAmp®, please verify that all eight
pins on the plug (Mini-Din8) are intact. If a pin is offset, bent, or missing, please return the
device for a replacement.
Carefully plug the Combination Sensor into the rightmost socket on the EEG NeuroAmp®. If the
device is plugged into any other socket, it is no longer functional, meaning that measurement
signals can no longer be transmitted to the digitalization unit.
CAUTION
Incorrect measurements if other peripheral devices are connected to the
EEG NeuroAmp®.
•When the Combination Sensor is connected to the EEG NeuroAmp®, only the
following additional bio/neurofeedback devices and sensors may be connected:
one EEG pIRx3 sensor on the middle input sockets and/or one tactile
Neurofeedback device on any of the free input sockets. If any other devices are
connected to the EEG NeuroAmp® while the Combination Sensor is connected,
this may lead to malfunction in the Combination Sensor.

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5 Operation
The Combination Sensor is controlled entirely by the Biofeedback/Neurofeedback software on
the computer and powered by the EEG NeuroAmp®. No user interaction with the device is
necessary.
In order to attach the Combination Sensor to the finger, cut off a 10cm-long piece of the tape
that comes with the sensor. Remove the white foil on the back. Insert the band through the latch
of the sensor and wrap the band around finger and sensor. The sensor should be attached to a
finger firmly, but still loosely enough to allow sufficient blood flow through the finger. If the strap
is too loose or too tight, this will affect measurement results. It does not matter which hand or
finger is used for measurement. The thumbs are not useful for measurements.
The finger and hand on which the sensor is measuring should be moved as little as possible
during the session to avoid interfering with the measurement. To support this, the hand could be
placed on a table or on the thigh during the measurement (s. Fi ure 6)
The Combination Sensor does not require a settling time or calibration. Measurements can
begin immediately after the sensor has been attached to the finger.
Fi ure 6: Durin measurements, the fin er and sensor should be held as still as possible
Check proper function of the Combination Sensor before starting a session with your patient by
starting the clinician software on your computer. The graph display of the clinician screen must
show data acquisition.

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5.1 Interpretation of the measured data
Fi ure 7: Display of the sensor data
Fi ure 7 shows the recorded sensor data. The HRV (Heart Rate Variability - first diagram) and
the Stress Index (last diagram) are calculated according to established methods described in
the literature.
All displays can be zoomed in or out by clickin on “+” or “-“. The position of the curves can be
adjusted by clickin on the arrows. Furthermore, every display, except the EEG Trend display,
can either be set in manual or automatic mode to ali n the raph.

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5.1.1 Definition HRV
HRV is defined as the deviation of the current heart rate from a completely rhythmic sequence.
The numerical value displayed as HRV corresponds to the Min / Max interval of the heart rate in
a defined time slot.
In general, a higher value indicates that the heart is able to change the time between two
heartbeats depending on physical or psychological stress and therefore react flexibly to varying
challenges.
5.1.2 Definition Stress Index
The stress index calculated in the last diagram is used in space medicine and originates from
Prof. Baevsky. In a broader sense, this is the mathematical description of a histogram. The only
measure on which the calculation is based is the R-R interval. This indicates the time interval
between two consecutive heartbeats.
In order to achieve statistical relevance, value windows of approximately 120s are required. This
is why no stress index is displayed at the start of the measurement. As soon as a value
appears, the 120s computation window is continuously shifted and results can be produced
continuously.
The small window below the blue control panel shows the determined heartbeats in the form of
a sawtooth characteristic. This diagram is a good indication whether the sensor is detecting
correct data for the heartrate measurement. If a (relatively) continuous signal is not seen here,
then it should be checked if the sensor is attached correctly to the finger.

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6 Cleaning, Maintenance, Storage and Disposal
Great care was taken to develop and produce this device, and it should be handled with just as
much care. If you follow these instructions carefully, you avoid the premature expiry of the
warranty and enjoy the safe use of your product for years.
6.1 Cleaning and Maintenance
For disinfecting your Combination Sensor we recommend the disinfectant wipes Incidin Wipes
Premium. These are moistened with the disinfectant Incidin Foam. Other wipes that are
compatible with Incidin Foam can be used alternatively.
To clean the Combination Sensor, rub across the area that has been in contact with the finger of
the patient with the soaked disinfectant tissue, twice clockwise and twice anticlockwise.
Particular care must be taken to press the wipe into the pits of the Combination Sensor and
wipe these parts thoroughly. Discard the cloth after this procedure and spray Incidin Foam again
onto the above mentioned critical parts and leave it there for at least 5 minutes. The surfaces
must remain moist within this 5-minute time period.
The finger strap is exchanged for each new patient and discarded after the session.
Please check the sensors regularly for dust and dirt and clean the sensors carefully, if needed,
with a cotton ball or soft cloth with alcohol or isopropanol. Otherwise the accuracy of
measurement will be adversely affected.
No maintenance is required for the Combination Sensor. If the unit is damaged, please return it
for a replacement.
6.2 Storage
The Combination Sensor should be stored in its original packaging in a dry place, at which the
temperature lies between -10°C and +60°C. Storage locations at which condensation of
moisture out of the air may occur are to be avoided.
6.3 Disposal
Dispose of the unit as an electronic device in accordance with any applicable local, state and
federal laws and regulations.

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7 Technical Data
Sensors Number of sensors 4
Skin resistance 0.2 – 100µMho, Umax 2.5V, Imax 2.5µA
Heart rate Optical measurement using 940nm and 660nm
Temperature range 20°- 40°C or 68°-104°F
Measurement rate 62 samples/s
Time constant (Temp) 60 s
Interface Power Supply 5V / 5mA
Plug Mini-Din8, male
Signals 3 x 0…5V
Mechanical Interface Sensor housing with cable
Environment Storage and Transport Temperature: -10°C…+60°C, no condensation,
air pressure: 500 ... 1060 hPa
Operation Temperature: -10°C…+50°C, no condensation,
air pressure: 700 ... 1060 hPa
8 Plug Diagram
Fi ure 8: Connection diagram of the Combination Sensor