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.