Medical Computer Systems MCScap Clinic, MCScap Sleep, MCScap Electrode Set, MCScap Professional User Manual

MCScap
EEG electrode caps
USER MANUAL
© 1993-2018 Medical Computer Systems Ltd.
MCScap. User manual
PRODUCT OFFICIAL INFORMATION Product name: MCScap
Description:
MCScap is system of the EEG-recording cap with removable passive Ag/AgCl electrodes and accessories.
MCScap is intended for use with encephalographs and amplifiers of medical signals, e.g. FirstAmp, NVX and other
similar devices.
MCScap can be used in clinical practice, neurology and functional diagnostics, and also to scientific researches.
GMDN code: 63131, Electroencephalographic electrode cap, reusable
Product code by 93/42/EEC: MD 0100 General non-active, non-implantable medical devices
Classification: class I as per Appendix IX of Directive 93/42/EEC, rule 1.
Declared for compliance with: European Directives 93/42/EEC (MDD), 2011/65/EU (RoHS 2), 2002/96/EC (WEEE)
Manufacturer: Medical Computer Systems Ltd.
ADDRESS: Passage 4922, bldg.4-2, Zelenograd, Moscow, 124460, Russia. PHONE/FAX: +7 495 913 31 94 / +7 495 913 31 95. E-mail: mks@mks.ru Internet: www.mks.ru Internet-shop: www.mcscap.com
Authorized representative in EU: GVB-geliMED GmbH.
ADDRESS: Ginsterweg 4a 23795 Bad Segeberg, Germany. PHONE/FAX: 0 45 51 - 95 67 30 / 0 45 51 - 95 67 33. E-mail: export@gvb-gelimed.de Internet: www.gvb-gelimed.de
Customer service: For questions about this product please contact at:
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 2 from 16
MCScap. User manual
WARNING
Do not use the EEG cap with removable passive Ag/AgCl electrodes and accessories (hereafter - product) for other
purposes than it is intended.
Use IEC 60601-1 standard to combine the product with other devices such as encephalograph. The operator bears
the responsibility for use of any devices together with a product. Use of a product with other devices should not lead to failure and-or increase of a risk level of the operator and the patient. Using electrodes of the same type.
Do not operate the product within powerful radio interference producing sources such as arc welders, radio thermal
treatment equipment, x-ray machines or any other equipment that produces electrical sparks. 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 product, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.
Do not use in magnetic resonance imaging. Always observe the safety requirements of this manual for operation and maintenance. If any problems don’t open the
product, do not unauthorized repairs, any doubts please contact your local supplier.
Take care of the product’s components. Avoid the cables’ breaks, kinks, tension, excessive stretching of the EEG cap
and other mechanical efforts. Take care of arranging cables/wires to avoid the risk of entanglement or strangulation.
Electrode sensors are fragile and require careful and caring treatment. Always put electrodes on a soft surface, such
as a napkin or a towel.
Reapply of a product present a potential risk of cross-infection especially when are used on abraded skin, unless they
are restricted to a single patient or disinfection between patients.
Use the special EEG electroconductive gel/paste for the EEG acquisition.
Don’t break the conditions of transportation, storage and operating of the product. Do not expose the product to direct sunlight.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 3 from 16
MCScap. User manual
Warranty
The manufacturer hereby guarantees that the product will be free from any defects in materials and workmanship (except for consumables) for the period of one year from the date of delivery. This warranty does not apply to any damages caused by wrong use, modification, and non­fulfillment of operation requirements. If this product requires repair under our warranty, a customer shall notify the supplier or manufacturer about the defects and send the product thoroughly packed in a shipping container to the supplier or manufacturer for the purpose of inspection and service.
Please, look thoroughly through this manual before its use. The manual contains detailed information and guidelines required for proper and safe operation of this product. Failure to follow these requirements may result in wrong results, damage or injury. The manufacturer disclaims its responsibility for any injuries or losses caused by product misuse. The manufacturer reserves its right to make changes and amendments in this manual without notice, which improve the performance of this product. If any misprints occur in this document, they will be corrected in further publications.
Symbols on labels
Refer to instruction manual
Mild process. Maximum washing temperature 30° C
Do not tumble dry
Do not dry clean
Drip dry in the shade
Waste Electrical and Electronic Equipment. Separate collection with electrical and electronic equipments for recycling.
This device conforms to Directive 93/42/EEC.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Caution.
Hand wash only
Do not wring
Do not iron
Catalog number
Date of manufacturing.
Serial number.
Page 4 from 16
MCScap. User manual
Common description
EEG-caps are made of elastic material that provides the most comfortable fit of the electrodes without additional
adjustment. Numerous holes are intended for ventilation and electrode alignment to head according to modified combinatorial electrode nomenclature
1
.
Many sizes of cap cover the head sizes from 24 cm to 66 cm head circumference. EEG-cap fixed to the head using chin
belt or chest belt. Reusable EEG electrodes have a channel for gel and the recording surface is silver/silver chloride (Ag/AgCl). Sintered
technology of sensors guaranties minimal polarization and long-term stability. Electrode contact with the skin is provided through EEG gel.
EEG electrodes fixed to the EEG-cap using special fixing ring or the electrode hole on the cap. EEG electrodes are connected to an electroencephalograph through single or united connectors.
Point EEG electrodes MCScap-E sensor for
installation in a fixing ring
Сup EEG electrodes MCScap-NT sensor for installation on
the textile base of the EEG-cap (similarly for other electrodes
MCScap-С, MCScap-T, MCScap-NTC, MCScap-NTH)
Electrode sensor
1
Oostenveld, R. & Praamstra, P. The five percent electrode system for high-resolution EEG and ERP measurements. Clinical Neurophysiology
2001; 112: 713-719
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 5 from 16
MCScap. User manual
INSTRUCTIONS FOR USE
STEP 1. Measure the circumference of the patient's head.
Head size measure around the fullest part of the head just above the ears using a flexible tape measure. Taking the measurement at the forehead. Circumference of the head should be measured at a point approximately one inch above the eyebrows or at whatever point gives the largest possible measurement. After the measuring choose the proper cap size.
STEP 2. Put the cap on the patient. Beginning from the front of head, where the subject may hold the edge of cap, pulling the cap
over of the head. Next, adjust the electrode position Cz halfway between Nasion and Inion. The frontopolar and occipital electrode positions should now be placed correctly. Otherwise choose another cap size. When measured correctly, the frontopolar electrodes (e.g. Fp1/Fp2) should lie directly above the eye brows.
Make sure, that Cz is right-left-centered as well, and that lateral electrode positions are symmetrical.
Affix the cap with the chin belt. Pay attention to the correct location of its. The wide part of a belt should fit a chin and shouldn’t slump on the neck. The belt tension should provide reliable fixing of cap.
Don’t pull in tight chin belt. The subject should feel comfortable even during long-term research.
Attach the cap on the head is possible with use the chest belt. This type of attachment is effective in cases where during the test pressure of the chin strap hinders the patient's actions, for example, if the patient should talk.
The chest belt is attached directly to the patient's chest. Chest belt is arranged in V-shape or X­shape, which contributes to a secure fit of the cap. Tension is regulated by the length of the straps.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 6 from 16
MCScap. User manual
STEP 3. Insert the electrodes in the cap accordance with the research scheme.
Point EEG electrodes insert into fixing ring until it stops. Cup EEG electrodes insert into electrode hole. Pay attention that electrode cables are not confused and not bended. To avoid confusion of wires, use coupler for wires. Insert a coupler tip through the hole at
the other end, strongly tighten and then fix a tip with velcro.
STEP 4. Connect the electrodes to the skin through EEG gel. Fill the syringe with gel. Gel should not be too fluid nor too viscous. Set supplied the nozzle-
dispenser. The nozzle-dispenser should sit tightly on the syringe and should not hang or subside. Use only supplied the nozzle-dispenser with blunt needle. Spiky needle can damage patient skin.
Slide the hair directly under the EEG electrodes with use the nozzle-dispenser needle. It will help to reduce the impedance and increase the quality of researches.
STEP 5. Fast connection. In cases where it is necessary to promptly fast disconnect or connect the electrodes
mounted on the patient, for example, when registering somnogrammy, can be used passive adapter. It can also be used when it is necessary to increase the distance from the patient to the amplifier.
Minimizing impedances
Recommended to use electroencephalograph in mode of impedance measurement. Insert a syringe needle of the nozzle-dispenser into a hole of electrode and squeeze out a few gel. Then take out a needle from hole and remove remaining gel. If it has not given results repeat procedure. If after that the impedance remains too high, check the electrode.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 7 from 16
MCScap. User manual
Maintenance
Electrodes and cap after use should be immediately cleared of gel while it has not dried up!
Recommended a thorough cleaning after each recording. For cleaning a product make sure it is not connected to an electroencephalograph any more. Dont wet the connectors!
The connectors must be max far from the any liquids!
For the cap with preinstalled electrodes: Dont take electrodes from the cap with preinstalled electrodes for cleaning after recording. Carefully clean the cap with electrodes together.
For the cap with removable electrodes and TouchProof connectors: Carefully take the electrodes from the cap:
- for a point EEG electrode with rotational motions remove it from the fixing ring;
- for a thin (cup) EEG electrodes pull site of cap portion near the hole of the electrode with another hand and remove the electrode from the hole. Do not pull the electrode!
Under most circumstances cleaning of caps and electrodes is carried out in a detergent. Be attentive: dish-detergents often leave a film. A childrens shampoo will be a good choice. Improper maintenance can lead to product damage. Do
not use abrasive materials, strong disinfectant solutions, for example, on acetone basis to product clearing.
For disinfection use 70% ethanol solution. Never soak a product in the solution but wipe it with soft gauze moistened with ethanol. Before disinfection carefully wash out a product from the gel rests. Also, gas sterilization with ethylene oxide is acceptable.
Warning
- do not soak electrodes in saline solution or chloride because salt is generally aggressive to the electrodes surface and corrosion of connections will result;
- do not use autoclave or other hot sterilization methods because the wire insulation can be damaged.
Afterwards rinse the cap with warm water and the electrodes with distilled water. Finally dry them thoroughly with a soft cotton cloth. The rest can be dried in the air.
The electrodes and caps should be stored in a dark and dry place. When assembling a product follow the research scheme. In case of damage contact your supplier.
See video How to clean MCScap products? at our website www.mcscap.com/video/
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 8 from 16
g
g
MCScap. User manual
Malfunctions and their correction
Malfunction Possible cause Corrective actions
Torn cap. Excessive stretching and other
mechanical efforts of the EEG cap. Electrode positions on the head are no correctly.
Electrode connectors can not be connected to the
Larger or smaller of the cap. Use another cap size.
Erroneous placement of electrodes. Insert the electrodes in the cap accordance with
Electrode connectors do not comply with
the cap. cap Electrode connectors can not be connected to the electroencephalo
raph.
Electrode connectors do not comply with
the electroencephalograph.
No signal. Electrodes are not connected to the
electroencephalo
raph. No contact between an electrodes and patient’s skin. Electrodes are faulty. Replace the electrode. Wet cap. Dry cap.
One or several EEG leads have high level of noise.
Poor contact between an electrode and patient’s skin System are located near to the power line sources that generate disturbances
Replace the EEG cap.
the research scheme. Replace the electrode or the cap.
Replace the electrode.
Connect the electrodes to the electroencephalograph. Minimizing impedances.
Minimizing impedances.
Bring system as far apart as possible from electric wiring, outlets, transformers or other electric power equipment.
If you fail to remedy a trouble, contact the local supplier or manufacturer.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 9 from 16
MCScap. User manual
Technical data
Parameter Value
Image
SET CLINIC SLEEP PROFESSIONAL ELECTRODE SET
routine EEG,
scientific research
Recommended application area
routine EEG
routine EEG,
sleep EEG,
high resolution EEG,
TMS-EEG
scientific research,
high resolution EEG,
MR-compatible EEG
available by order
MCScap-E
MCScap-NTC
Electrode type MCScap-С MCScap-T
MCScap-NT available
by order
MCScap-T, MCScap-
NT, MCScap-NTH
available by order
Material of electrode sensor Ag/AgCl Ag/AgCl sintered Ag/AgCl sintered Ag/AgCl sintered
Number of electrodes (channels)
20 (19)
20 (19)
from 11 up to 129
available by order
from 11 up to 129 available by order
20 (19)
25 (24)
from 11 up to 129 available by order
Electrode polarization ≤ 50 mV ≤ 50 mV ≤ 50 mV ≤ 50 mV
Resistance of electrodes insulation
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
≥ 1000 MΩ ≥ 1000 MΩ ≥ 1000 MΩ ≥ 1000 MΩ
Page 10 from 16
MCScap. User manual
Parameter Value
SET CLINIC SLEEP PROFESSIONAL ELECTRODE SET
Dielectric strength of electrodes insulation
Diameter of a conductive surface
Square of a conductive surface
The impedance of the electrode
1500 V 1500 V 1500 V 1500 V
6(+1/-1) mm 3(+1/-1) mm 6(+1/-1) mm
2
26(+1/-1) mm
7(+1/-1) mm2 ≥ 30 mm2
depending on the type
of electrode
depending on the type
of electrode
≤ 5 kΩ ≤ 5 kΩ ≤ 5 kΩ ≤ 5 kΩ
Spare electrode no no 1 1
Fp1, Fp2, F3, F4, C3,
Channels in Standard caps
C4, P3, P4, O1, O2,
F7, F8, Т3, T4, T5,
T6, Cz, Fz, Pz, GND
Ear electrodes no
Fp1, Fp2, F3, F4, C3,
C4, P3, P4, O1, O2,
F7, F8, Т3, T4, T5, T6,
Cz, Fz, Pz, GND
no,
сan be included by
order
Fp1, Fp2, F3, F4, C3,
C4, P3, P4, O1, O2,
F7, F8, Т3, T4, T5, T6,
Cz, Fz, Pz, GND
no
can be included by
order
According to system
10-20, 10-10, 10-5
yes
no
Marking of the electrodes yes yes yes
(labels for marking are
Included)
Additional wire protection no no yes no
Exit of electrode cable from the cap
back of the head top of the head back of the head no
TouchProof 1.5 mm
Connector type D-sub DB25 Male D-sub DB25 Male D-sub DB25 Male
(DIN 42 802-ST)
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 11 from 16
MCScap. User manual
Parameter Value
SET CLINIC SLEEP PROFESSIONAL ELECTRODE SET
Length of the electrode cable
Standard set
Available sizes
1.2 m 1.5 m 1.5 m 1.2 m
EEG cap CLINIC,
EEG starter kit (gel,
syringe, needle,
brush), User manual
XL (60-66 cм),
XL/L (57-63 cм),
L (54-60 cм),
L/M (51-57 cм),
M (48-54 cм),
M/S (45-51 cм),
S (42-48 cм),
S/XS (39-45 cм)
EEG cap SLEEP,
additional fixator
(elastic bandage),
EEG starter kit (gel,
syringe, needle, brush),
User manual
XL (60-66 cм),
XL/L (57-63 cм),
L (54-60 cм),
L/M (51-57 cм),
M (48-54 cм),
M/S (45-51 cм),
S (42-48 cм),
S/XS (39-45 cм)
XS (36-42 cм), Inf I (32-36 cм), Inf II (28-32cм), Inf III (24-28cм)
EEG cap
PROFESSIONAL,
1 spare electrode with
TP connector,
EEG starter kit (gel,
syringe, needle, brush),
bag, User manual
XL (60-66 cм),
XL/L (57-63 cм),
L (54-60 cм),
L/M (51-57 cм),
M (48-54 cм),
M/S (45-51 cм),
S (42-48 cм),
S/XS (39-45 cм)
2 textile caps MCScap 10-20 with fixing rings,
26 EEG electrodes
MCScap-E, ear
electrode fixators, 2
sets of labels for marking electrodes, EEG starter kit (gel,
syringe, needle, brush),
bag, User manual
XL (60-66 cм),
XL/L (57-63 cм),
L (54-60 cм),
L/M (51-57 cм),
M (48-54 c
м),
M/S (45-51 cм),
S (42-48 cм),
S/XS (39-45 cм)
Size by color
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
by color of the textile
cap
by color of the seam by color of the seam by color of the seam
Page 12 from 16
MCScap. User manual
Parameter Value
SET CLINIC SLEEP PROFESSIONAL ELECTRODE SET
Weight less 1 kg less 1 kg less 1 kg less 2 kg
Mean time to failure (MTTF)
150 cycle 300 cycle 300 cycle 300 cycle
Warranty 12 months 12 months 12 months 12 months
Mechanical resistance according IEC 60601-1:2005 (ed3.1)
Operating conditions +10 ... +45°C, relative humidity of 40 to 80%
Storage conditions +5 ... +45°C, relative humidity up to 80%
Transportation conditions -50 ... +50°C, relative humidity up to 97% without condensation
Note:
1. The default settings are highlighted in bold font.
2. Cycle refers a use, disassembly, washing and disinfection of the helmet, cleaning and disinfection of the electrodes.
Compliance Restriction of Hazardous Substances
The object is in conformity with Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS2).
Utilization
This device is subject to disposal upon expiration of its service life, providing that its performance is fully used up. This device must be disposed according to regulations of local legislation. If the EU countries, electronic equipment is subject to
the European Directive 2012/19/EU (WEEE). Do not dispose this device with normal household waste.
Electrode nomenclature according to: Oostenveld, R. & Praamstra, P. The five percent electrode system for high­resolution EEG and ERP measurements. Clinical Neurophysiology 2001; 112: 713-719.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 13 from 16
MCScap. User manual
10-20 system
Electrode positions and labels:
- yellow circles indicate positions of the 10-20
system (T3, T4, T5 and T6 corresponds to T7, T8, P7 and P8 of the 10-20 system)
- black circles indicate positions of the “ground”
GND (AFz of the original 10-20 system) EEG
electrode.
NOTE: A1 and A2 electrodes are placed on the
left and right ear lobes.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 14 from 16
MCScap. User manual
10-10 system
Electrode positions and labels:
- yellow circles indicate positions of the original 10-20 system,
- white circles indicate additional positions introduced in the 10-10 extension,
- black circles indicate positions of the “ground”
GND (AFz of the original 10-20 system) EEG
electrode.
NOTE: A1 and A2 electrodes are placed on the
left and right ear lobes.
Medical Computer Systems Ltd.© tel. +7 495 9133194 Passage 4922, 4-2, Zelenograd, fax. +7 495 9133195 Moscow, 124460, Russian Federation www.mks.ru
Page 15 from 16
MCScap size table
Correct size is important for quality EEG acquisition and patient comfort. Check the head circumference of patient before EEG examination.
Loading...