lifelines Trackit Mk2 EEG Amplifier User Manual
- June 13, 2024
- lifelines
Table of Contents
- Trackit Mk2 EEG Amplifier
- Version History
- Disclaimers & Warranties
- Illustrations
- Overview and Technical Description
- Installation and Maintenance
- Connections and usage
- The setup and recording software
- Appendix 1: Specifications
- Appendix 2: Photic Stimulation
- Appendix 3: Additional Events Information
- Appendix 4: PC Setup
- Appendix 5: Wireless
- Appendix 6: Troubleshooting Guide
- Appendix 7: Manufacturer’s Declaration
- Documents / Resources
T4 EEG Am plifier
User Manual
32 channel version: T432
68 channel version: T468 Part no. 51285- 006
Issue 1.9
Trackit Mk2 EEG Amplifier
Created
Digitally signed by Michael
Hulin
Date: 2018.03.02 10:27:46 Z| Checked
Digitally signed by David Hulin
DN: cn=David Hulin, o=Lifelines Ltd,
ou=Development,
email= david.hulin@llines.com, c=GB
Date: 2018.03.02 11:01:33 Z| Approved
Digitally signed by Michael Hulin
Date: 2018.03.02 11:55:04 Z
---|---|---
Version History
V1 (23 June 2016)
- Initial release
V1.1 (09 Aug 2016)
- Amended part numbers in section 1.4.
V1.2 (28 Sep 2016)
- Various amendments for IEC 60601-1.
V1.3 (13 Dec 2016)
- Amendments to Nonin and Aux Input specifications in section 1.6.
- Changed ‘Contraindication’ to ‘Warning’ in section 1.2. There are no contraindications for this device.
V 1.4 (08 February 2017)
- Added to section 1.2 “CONTRAINDICATIONS: There are no known contraindications to the use of this equipment”.
- Added to section 1.2 and 2.3 “WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth”.
- Removed drawing numbers in section 1.4.
- Amended section 2.4: Internal Li-lon backup battery operation.
- Added to Section 4.1: “Note: If a Setup that uses greater than 32 channels plus the Nonin is attempted…”.
- Added to section 3.3 details of battery replacement frequency.
V1.5 (10 March 2017)
- Amended instructions concerning oximeter and Aux. input sensors.
V1.6 (13 March 2017)
- Further amendments to instructions concerning oximeter and Aux. input sensors.
V1.7 (22 March 2017)
- Added to Aux DC Input instructions — “for hospital and clinic use. Not for home use” in section 1.6 and 3.3.
V1.8 (18 August 2017)
- Photic operation added in Appendix 2.
- Wireless operation added in Appendix 5.
V1.9 (08 November 2017)
- Added disinfection information in section 2.8.
- Change of N.B. to 0086 (BSI).
Disclaimers & Warranties
The information in this section is subject to change without notice.
Except as stated below, Lifelines Ltd makes no warranty of any kind with
regard to this material, including, but not limited to, the implied warranties
of merchantability and fitness for a particular purpose. Lifelines shall not
be liable for errors contained herein or for incidental or consequential
damages in connection with the furnishing, performance or use of this
material.
Lifelines shall warrant its products against all defects in material and
workmanship for one year from the date of delivery.
Misuse, accident, modification, unsuitable physical or operating environment,
improper mainte- nance or damage caused by a product for which Lifelines is
not responsible will void the warranty.
Lifelines do not warrant uninterrupted or error-free operation of its
products.
Lifelines or its authorised agents will repair or replace any products that
prove to be defective dur- ing the warranty period, provided that these
products are used as prescribed in the operating in- structions in the user’s
and service manuals.
No other party is authorised to make any warranty to assume liability for
Lifelines products. Life- lines will not recognise any other warranty, either
implied or in writing. In addition, services per- formed by someone other than
Lifelines or its authorised agents or any technical modification or changes of
products without Lifelines prior, written consent may be cause for voiding
this warranty.
Defective products or parts must be returned to Lifelines or its authorised
agents, along with an explanation of the failure. Shipping costs must be
prepaid.
Lifelines Ltd. manufactures hardware and software to be used on or with
standard PC-compatible computers and operating software. Lifelines, however,
assumes no responsibility for the use or reli- ability of its software or
hardware with equipment that is not furnished by third-party manufactur- ers
accepted by Lifelines at the date of purchase.
All warranties for third-party products used within the T4 system are the
responsibility of the rele- vant manufacturer. Please refer to the relevant
documentation on each product for further details.
This document contains proprietary information that is protected by copyright.
All rights are re- served. No part of this document may be photocopied,
reproduced in any other form or translated into another language without the
prior written consent of Lifelines.
Trademarks
Microsoft, Windows and Windows NT are registered trademarks of the
Microsoft Corporation. All other trademarks and product names are the property
of their relevant owners.
Responsibility of manufacturer
The manufacturer and distributor consider themselves responsible for the
equipment’s safety, relia- bility and performance only if:
- any peripheral equipment to be used with the T4 system is supplied by third-party providers recommended by the manufacturer;
- assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorised by the manufacturer;
- the electrical installation of the relevant room complies with the appropriate requirements;
- the equipment is used by a health-care professional and in accordance with the instructions for use.
Note: the manufacturer has a policy of continual product improvement;
hence the equipment pecifications are subject to change without notice.
Check with Lifelines or your distributor if a software update is available.
Note: Medical electrical equipment needs special precautions regarding
EMC and needs to be in- stalled and put into service according to the EMC
information provided in the Appendix.
Software and Virus Protection
Lifelines takes all reasonable steps to ensure that its software is virus-
free. In line with modern computing practice, it is advisable that continual
protection against viruses, trojans, malware, ad- ware etc. is provided on the
PC used for installation and the surrounding systems. Please note the
following recommendations which should be supported by your internal
|1T/Computing department procedures and practices:
- Virus protection software should be installed on every computer at risk of infection. This software should have a resident (online) shield and provide email scanning if appropriate.
- Virus scanning should be set to manual mode or automatic if desired but at a time when the system is not being used.
- All programs offering auto-update features, including Windows, should be set to manual or automatic if desired but at a time when the system is not being used.
- Adopt formal departmental or organisational procedures to ensure the integrity and safe operation of the medical equipment and supporting systems.
Illustrations
Figure 1 Connect ingt he T4 Am plifier – Clinical Use | 16 |
---|---|
Figure 2 Connect ingt he T4 Am plifier – Home Use | 17 |
Figure 3 Connect ingt he T4 Am plifier ( front face) | 18 |
Figure 4 Connect ingt he T4 Am plifier ( back face) | 18 |
Figure 5 New Patient dialog | 21 |
Figure 6 New Patient database | 22 |
Figure 7 Signal List | 22 |
Figure 8 Signal Editing Tool | 23 |
Figure 9 EEG setup | 23 |
Figure 10 Setup Recording dialog | 24 |
Figure 11 Channel setup | 24 |
Figure 12 Recording Channel editing | 25 |
Figure 13 Trackit software toolbar | 25 |
Figure 14 Trackit Control Panel | 26 |
Figure 15 Ongoingt race display | 27 |
Figure 16 Adjust display parameters | 27 |
Figure 17 Impedance check | 28 |
Figure 18 Online Event Viewer | 28 |
Figure 19 Montage Editor | 29 |
Figure 20 Photic Stimulation | 34 |
Figure 21 Photic Stimulation control window | 34 |
Figure 22 Photict rigger signal definition | 35 |
Figure 23 User Events | 37 |
Figure 24 Events Tem plate set up | 37 |
Figure 25 Free-text Event | 37 |
Figure 26 Event List | 38 |
Figure 27 Options Tab 1 | 39 |
Figure 28 Options Tab 2 | 39 |
Figure 29 Options Tab 3 | 40 |
Overview and Technical Description
1.1 General description
Indications for use
The T4 EEG Amplifier is intended to be used as a front-end amplifier to
acquire, store and transmit electrophysiological signals (wireless or cabled).
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
General description
The Trackit T4 EEG Amplifier is a multi-channel electroencephalograph
designed for use in routine EEG and lab monitoring applications and due to its
small size, can be used in ambulatory applications. In this situation, the EEG
electrodes are fitted to the patient by a trained clinician prior to the
patient being sent home. No subsequent intervention is required by the
patient. Upon completion of the recording, the data which is stored on a
memory card is reviewed by a clinician using review and analysis software on a
PC.
It is a compact USB amplifier which provides 32 channels (or 68 channels with
internal expansion option) with built-in calibration and electrode impedance
measurement. Also provided is a Nonin pulse oximeter interface, a Patient
Event input and an Aux DC input. Optional wireless communication is available
(Bluetooth and WLAN WIFI).
There are two variants of the Trackit T4 EEG Amplifier:
- Trackit T4-32 providing 24 referential + 8 poly channels.
- Trackit T4-68 providing 64 referential + 4 poly channels (using internal expansion board).
Plug-on Patient Connection Units (PCUs) provide 32 channel touchproof inputs
(model T4-PCU 24+8) or 68 channels (model T4-PCU 64+4).
The Amplifier is intended to be connected to a USB port on a PC which is
powered from a medically approved power supply. In addition it can be battery
powered in ambulatory applications.
This equipment is intended only as an adjunct device in patient assessment; it
must be used in conjunction with other methods of patient diagnosis. The
equipment does not sustain or support life.
Intended User
The intended user of the equipment is a healthcare professional who has the
training and knowledge to undertake EEG examinations and is familiar with EEG
equipment and practice.
1.2 Cautions and Warnings
WARNING: Do not use the T4 EEG Amplifier in an MRI environment, in an oxygen
rich environment or during defibrillation.
WARNING: This equipment is intended to be used by a healthcare
professional and in accordance with these instructions for use which must be
read in their entirety before the device is used.
WARNING: This equipment in intended only as an adjunct device in patient
assessment; it must be used in conjunction with other methods of patient
diagnosis. This equipment is not be used for the determination of brain death.
WARNING: Only use the PC and the medical-grade power supply as supplied
or authorised by Lifelines.
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
WARNING: Lifelines does not supply EEG electrodes. The unit accepts
standard 1.5 mm touchproof electrodes using DIN 42802-style connectors. To
ensure patient safety, the electrodes used must be approved to the Medical
Device Directive 93/42/EEC in Europe or FDA cleared for use in USA.
CAUTION: The conductive part of electrodes and their connectors,
including the Neutral electrode, should not contact other conductive parts
including earth.
WARNING: Do not plug the USB connector into any device other than the PC
supplied or authorised by Lifelines. Do not connect any other equipment to the
PC.
CAUTION: Do not touch simultaneously any accessible USB or other contacts
on the PC and the patient.
WARNING: Strangulation hazard due to long cables. As with all medical
equipment, carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
CAUTION: Ensure that carrying bag and straps are worn over clothing to
prevent any possibility of skin irritation.
CAUTION: When in close proximity to the Amplifier, do not use mobile
phones, transmitters, power transformers, motors, or other equipment that
generates magnetic fields. Refer to the Appendix for more information. Medical
electrical equipment needs special precautions regarding EMC and needs to be
installed and put into service according to the EMC information provided in
the Appendix.
WARNING: The function or safety of the equipment could be impaired if it
has been subjected to unfavourable conditions in storage or in transit. If at
any time function or safety is thought to be impaired, the instrument should
be taken out of operation and secured against unintended use.
WARNING: Do not open or modify the equipment without the authorization of
the manufacturer.
CAUTION: Federal (USA) law restricts this device to sale by or on the
order of a physician.
CONTRAINDICATIONS: There are no known contraindications to the use of
this equipment.
1.3 Explanation of symbols
**** | Type BF applied part |
---|---|
Input / output connection | |
Follow operating instructions | |
Input connection | |
Special recycling required, do not dispose of in landfill. When this |
equipment has reached the end of its useful life, it must be disposed of in an
environmentally- friendly way. Waste electrical and electronic equipment
(WEEE) requires special procedures for recycling or disposal. This includes
batteries, printed circuit boards, electronic components, wiring and other
elements of electronic devices. Follow all of your respective local laws and
regulations for the proper disposal of such equipment. Contact your local
distributor for information concerning this.
| Consult warnings in User Manual
| Pushbut ton
| Manufact urer
| Memory card read/ write
| On/ Off and pat ient event swit ch
| Bluetooth
| WLAN WiFi
| Nonin Xpod Pulse Oximeter
| Internal battery hazard – refer t o sect ion 1.7
Storage and transport symbols
| Temperature limits
---|---
| Relative humidit y limits
| International protection code
| Fragile
| Atmospheric pressure limits
| Keep dry
Prot ected against ingress of solid object 12.5 mm diameter.
Prot ected against access to hazardous parts with finger.
Prot ected against ingress of water dripping (15° tilt ed) .
1.4 The Amplifier and its parts
The T4 EEG Amplifier is a multi-channel electroencephalograph designed for
use in routine EEG and lab monitoring applications.
It is acompact USB amplifier which provides 32 channels (or 68 channels with
internal expansion option) with built-in calibration and electrode impedance
measurement. A Nonin XPOD interface is provided, a Patient Event input and an
Aux DC input. Optional wireless communication is available (Bluetooth and WLAN
WiFi).
The Amplifier is intended to be connected to a specific PC and a medical grade
power supply. Refer section 3.1 for details.
Caution:
Only use the PC supplied or authorised by Lifelines
Only use the medical-grade mains power supply with it as supplied or
authorised by Lifelines
The T4 EEG Amplifier comprises the following components:
T4-32 Amplifier | part number 1505 |
---|---|
T4-68 Amplifier | part number 1501 |
T4-PCU 24+ 8 | part number 1552 |
T4-PCU 64+ 4 | part number 1553 |
USB Power Bank battery | part number 1560 |
Battery cable | part number 1561 |
T4 bag and straps | part number 1562 |
Patient event switch | part number 1353 |
Xpod Pulse Oximeter Nonin | part number 1327 |
Trackit tool | part number 1115 |
Amplifier USB cable | part number 1277 |
Lenovo ThinkPad laptop computer | part number 1389 |
Medical grade power supply | part number 1390 |
Mains cable, UK | part number 1066 |
Trackit software CD, standard | part number 1009 |
Part numbers may be preceded by ‘L14’ on labelling or packaging.
1.5 Specifications and safety
Refer to Appendix 1 for specifications.
The Amplifier has been certified and complies with the following standards:
IEC 60601-1 and| European standard for medical electrical equipment, general
re-
---|---
IEC 60601-2-26| quirements and particular requirements for EEG systems.
ANSI/AAMI ES 60601-1| AAMI Deviations from |EC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90| Canadian standard for medical electrical equipment,
general re- quirements.
IEC 60601-1-2| European standard for medical electrical equipment, EMC
require- ments, calling:
CISPR11| Conducted Emissions, Group 1, Class B
CISPR11| Radiated Emissions, Group 1, Class B
IEC61000-4-2| Electrostatic Discharges
IEC61000-4-3| Immunity – Radiated RF Field
IEC61000-4-4| Immunity – Transients Bursts
IEC61000-4-5| Immunity — Surges
IEC61000-4-6| Immunity — Conducted
IEC61000-4-8| Immunity — Power frequency fields
IEC61000-4-11| Immunity — Voltage dips, interruptions
IEC61000-3-2| Harmonic Emissions
IEC61000-3-3| Voltage Fluctuations/flicker
*Note: Compliance is provided by the PC.
Classification of system
Classification | Clinical use | Home use |
---|---|---|
Degree of protection against electrical shock | Internally powered; or it can |
be connected to a PC which is powered by a medical grade Class I power supply.
Type BF applied parts.| Internally powered. Type BF applied parts.
If a PC is supplied, it has no electrical connection to the Amplifier & has no
applied parts.
Degree of protection against harmful ingress of water| Ordinary (no
protection) or IP22 (Amplifier in bag)| IP22 (Amplifier in bag)
Mode of operation| Continuous operation| Continuous operation
Suitability for use in an oxygen rich environment| Not suitable| Not suitable
1.6 Description of the components
The T4 Amplifier
The T4 USB amplifier provides 32 channels (or 68 channels with internal
expansion option) with built-in calibration and electrode impedance
measurement. A Nonin XPOD interface is provided, a Patient Event input, an Aux
DC input and an Electrocap connector. The Amplifier has built in type- BF
patient isolation and has a USB interface to the PC. Optional wireless
communication is available (Bluetooth and WLAN WiFi).
The Patient Connection Unit (PCU) connects the standard 1.5mm touchproof EEG
recording elec- trodes attached to the patient to the T4 unit. It is available
either as a T4-PCU 24+8 (32 channel) unit or a T4 PCU 64+4 (68 channel). The
PCU is plugged into the front of the unit and retained with two screws
operated by the supplied special tool.
Applied parts, type BF
EEG Electrodes
The amplifier connects to standard 1.5mm touchproof EEG recording electrodes
arranged in a standard 10-20 pattern (T4 PCU 24+8) or the grid layout (T4 PCU
64+ 4), attached to the pa- tient’s head.
WARNING: Lifelines does not supply EEG electrodes. The Amplifier accepts
standard 1.5 mm touchproof electrodes using DIN 42802-style connectors. To
ensure patient safety, the elec- trodes used must be approved to the Medical
Device Directive 93/42/EEC in Europe or to the relevant local standards
outside Europe.
CAUTION: The conductive part of electrodes and their connectors,
including the Neutral elec- trode, should not contact other conductive parts
including earth.
Oximeter Sensor
The amplifier is approved for use with a Nonin 8000AA sensor which attaches to
the patient’s finger.
Patient Event pushbutton
The Patient Event Pushbutton is used by the patient to record the instance of
a significant event.
Aux DC Input
The amplifier is approved for use with a SleepSense body position sensor, type
1575, for hospital and clinic use. Not for home use.
CAUTION: Only use approved sensors as specified by Lifelines.
USB Cable
The Amplifier plugs directly into a USB port on the PC.
WARNING: The Amplifier must only be used with the USB cable provided with
the unit.
USB Power Bank battery pack for ambulatory applications The Amplifier plugs
directly into the USB port on the Power Bank.
WARNING: The Amplifier must only be used with the USB Power Bank supplied
or authorised by Lifelines.
Micro-SD Memory Card
The micro-SD card is used to store the EEG data recorded by T4. Storage cards
of varying capacity are available in the micro-SD format.
Bags and Straps for ambulatory applications
The Bag houses the Amplifier and battery.
Medical grade AC/ DC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage
current must be con- trolled. The laptop PC mains power supply must be a
special medical-grade type with appropriate safety standards, supplied or
authorised by Lifelines.
WARNING: The laptop must only be connected to the medical-grade laptop power
supply supplied or authorised by Lifelines. Do not use a standard laptop power
supply.
Only use the laptop supplied or authorised by Lifelines.
The Setup and Recording Software
The T4/Trackit setup software runs under Microsoft Windows 2000 (with SP2),
Windows XP, Win- dows Vista, Windows 7, 8 or 10 on the host PC and is used to
setup and review the T4 Amplifier and to record on to the PC.
Functions of the software:
- Download the recording template. This includes which electrodes are used and the recording montage. See section 4.2, step 2.
- Perform a calibration check of the Amplifier. See section 4.2, step 8.
- Perform an EEG recording. See section 4.2, step 8.
- View on-going EEG traces. See section 4.2, step 9.
1.7 Replaceable parts
Lifelines Ltd. will make available on request circuit diagrams, component part
lists, descriptions, calibration instructions, or other information that will
assist service personnel to repair those parts that are designated by
Lifelines Ltd. as repairable by service personnel.
Internal battery replacement — service personnel only
The T4 amplifier contains a replaceable lithium ion rechargeable coin cell,
type LIR2450.
WARNING: Battery replacement by inadequately trained personnel could
result in a haz- ard. It must be replaced only with the correct type and it
must be installed correctly with +ve uppermost.
- Remove PCU and the four screws from underside of instrument, two from the front and two from the rear mouldings. Remove bottom of case.
- Un-clip the wrap-around screen to expose the battery beneath.
- Grasp battery between thumb and forefinger and pull it from the socket.
- Push replacement battery into the socket ensuring +ve is uppermost.
- Re-clip the wrap-around screen and reassemble the case.
Battery safety instructions
Do not attempt to open, puncture, disassemble or modify the battery in any
way.
Do not subject the battery to sudden shock or heat.
Do not dispose of battery in fire.
Installation and Maintenance
WARNING: The following section must be read and understood before the
equipment is switched ON.
Note: Medical electrical equipment needs special precautions regarding
EMC and needs to be in- stalled and put into service according to the EMC
information provided in the Appendix.
The function or safety of the equipment could be impaired if it has been
subjected to unfavourable conditions in storage or in transit. If at any time
function or safety is thought to be impaired, the instrument should be taken
out of operation and secured against unintended use.
The manufacturer should be contacted (details on page 3) for assistance, if
needed, in setting up, using or maintaining the equipment; or to report
unexpected operation or events.
The assembly of the system and any modifications during its service life
require evaluation to the requirements of IEC 60601-1.
2.1 Checks for completeness and integrity
- Remove the equipment from the packaging case(s).
- Use the parts list to check that all ordered items have been received.
- Check for signs of damage that may have occurred during transit or storage. If any damage is found, do not use the instrument; contact your distributor.
2.2 Environmental parameters for operation
The operational and storage/transportation environmental conditions are as
follows:
Operational:
Temperature: +5°C to +40°C
Relative humidity: 15% to 93% non-condensing
Atmospheric pressure: 700 hPa to 1060 hPa
WARNING: Do not obstruct any cooling slots. Position the equipment so
that air flows freely.
Storage and transport:
Temperature: -25°C to + 70°C
Relative humidity: Up to 93% non-condensing at + 70°C
Atmospheric pressure: 500 hPa to 1060 hPa
2.3 Power supply connections
Power requirements
Standard USB port.
Power consumption
Maximum power from USB port: 2.5W.
Medical grade AC mains power supply module for Laptop PC
Where EEG studies are conducted within the patient environment the leakage
current must be con- trolled. The mains power supply must be a special
medical-grade type with appropriate safety standards, as supplied or
authorised by Lifelines.
Mains power input: 100—240 Vac, 47-63 Hz, 1.4 A@115 Vac, 0.7 A @ 230 Vac.
Output: 20 Vdc, 5.25 A.
WARNING: The laptop must only be connected to the medical-grade laptop
power supply supplied or authorised by Lifelines. Do not use a standard laptop
power supply.
Only use the laptop supplied or authorised by Lifelines.
WARNING: To avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
WARNING: The Amplifier must only be used with the USB cable provided with
the unit.
2.4 Battery Operation Time
USB Powerbank Li-Polymer battery pack
When fully charged the battery pack will typically power the unit for 36 hours
depending on the number of channels, sample rate and wireless usage.
The typical service life is 2 years.
Internal Li-lon backup battery
The internal backup battery will enable the unit to continue operating for a
short period of time (15 mins approx.) to allow the main battery pack to be
replaced. It is recharged automatically, when- ever the main battery pack is
connected, with acquire off. The state of charge is displayed, as de- scribed
in section 3.4, whenever the unit is internally powered from the backup
battery. To charge manually, operate the pushbutton several times to activate
the backlight and if the reading drops below approximately 70%, charge the
battery for about 10 minutes by connecting the main battery pack or connecting
to a USB port.
The typical service life is 500 charge-discharge cycles.
2.5 Use in the home environment
Where the equipment is intended to be used in the home, the unit and its
battery should be oper- ated in its bag where it is protected against ingress
of solid objects and water to a degree of IP22. The laptop PC is optional in
the home environment and may be used for video recordings. There is no
connection between the PC and the T4 Amplifier unit, as all communication is
accomplished wirelessly.
Keep the equipment away from sources of heat.
Do not use mobile phones.
Do not allow pets or children to interfere with the sensor cables.
When the equipment is operated with or without its Bluetooth or WiFi on, other
devices in the vicin- ity should be moved away or turned off to reduce the
likelihood of interference to the equipment or by the equipment.
The T4 may have internal radios fitted. These are approved industry-standard
Bluetooth and Wi-Fi types which present minimal risk of reciprocal
interference with other equipment.
2.6 Use with other equipment
Defibrillators and HF surgical equipment
The equipment is not defibrillator proof and should not be used in situations
where a defibrillator is likely to be used.
The equipment should not be used with, or in the presence of, high frequency
surgical equipment.
Other patient-connected equipment
When used simultaneously with other patient-connected equipment, for
example a cardiac pace- maker or other electrical stimulator, it is unlikely
that a safety hazard will arise. However always consult the documentation
supplied with the other patient-connected equipment to ensure that all
hazards, warnings and cautions are considered before the equipment is used
together.
Leakage current
This system is designed to comply with IEC 60601-1, the international standard
for medical elec- tronic equipment, which specifies the permissible levels of
leakage current. A potential hazard ex- ists in the summation of leakage
currents caused by connecting several pieces of equipment to- gether. Because
this system can be used in conjunction with standard electronic devices, the
total leakage current should be tested whenever the system is modified.
There should be no electrical connections between the system equipment, which
is powered via a medical grade power supply, and any other equipment powered
from another mains supply.
2.7 Interference
The T4 will continue to operate in the presence of radio frequency magnetic
fields (RF) and the ef- fects of electrostatic discharges (ESD) and other
interference, in accordance with the requirements of EN60601-1-2. However, the
T4 amplifier records signals of very low amplitude, and these sig- nals
themselves are not immune to the effects of RF, ESD and low-frequency magnetic
field inter- ference. Such interference may cause signal artefacts.
The T4 may have internal radios fitted. These are approved industry-standard
Bluetooth and Wi-Fi types which present minimal risk of reciprocal
interference with other equipment.
However, when the equipment is operated with or without its Bluetooth or WiFi
on, other devices in the vicinity should be moved away or turned off to reduce
the likelihood of interference to the equipment or by the equipment
Caution: When in close proximity to the amplifier, do not use mobile
phones, transmitters, power transformers, motors, or other equipment that
generates magnetic fields. Refer to the Appendix for more information.
Note: Medical electrical equipment needs special precautions regarding
EMC and needs to be in- stalled and put into service according to the EMC
information provided in the Appendix.
2.8 Maintenance and cleaning
The T4 Amplifier and its accessories require no routine testing,
calibration or maintenance proce- dures apart from occasional cleaning and
checking for wear and damage to all parts including the accessories.
No servicing or maintenance of the equipment should take place while in use
with a patient, except for replacement of the external battery.
Cleaning
Prior to each re-use of the system, all the outer surfaces of the T4
Amplifier, bag and power pack may be cleaned, as required, with a cloth
moistened with a mild detergent solution.
Disinfection of the equipment can be carried out by the use of QAC-based
disinfectants. Wipes are recommended in order to prevent the ingress of any
liquid into the equipment. Suitable products include Mikrozid Sensitive Wipes
(Schulke & Mayr GmbH), Microbac forte (Paul Hartmann AG), Dis- tel Wipes
(Tristel Ltd.).
For cleaning instructions for the laptop refer to the manufacturer’s
documentation.
Caution: Do not allow any liquid to enter the case of any instrument or
connector. Do not use ace- tone on any of the instruments.
2.9 Disposal of equipment
The expected service life of the equipment, parts and accessories is three
years, except for the USB Powerbank battery pack which is two years. When the
device and its parts and accessories has reached the end of its operating
life, it should be disposed of in accordance with local waste regula- tion
authority that is typically within the local government office.
Caution: Do not dispose of batteries by incineration.
Connections and usage
3.1 Overview Figure 1 Connecting the T4 Amplifier —
Clinical Use
Where the entire T4 system including the PC is used within the patient
environment, the mains leakage currents and safety and regulatory requirements
are met by the use of the special medi- cal-grade laptop power
supply.Figure 2 Connecting the T4 Amplifier – Home Use
The laptop PC is optional for home use where it may be used for video
recordings. There is no con- nection between the PC and the T4 Amplifier unit,
as all communication is accomplished wirelessly.
3.2 Laptop installation and operation
WARNING: The laptop must only be connected to the medical-grade laptop
power supply supplied or authorised by Lifelines. Do not use a standard laptop
power supply.
Only use the laptop supplied or authorised by Lifelines.
- Connect the power cord to the medical-grade power supply.
- Connect the power supply output to the power input connector on the laptop.
- Connect the power cord to mains power outlet.
- Note that the mains power cord serves as a power disconnect device. It should be installed near the equipment and be easily accessible.
- For laptop installation and operation refer to the manufacturer’s instructions supplied with it.
3.3 Connecting the T4 System
Clinical Use
The T4 Amplifier is optionally housed inside its bag with battery or used
standalone. It is plugged into the PC USB port using the cable supplied, part
number 1277 as shown below, or a wireless connection can be used instead. The
USB Cable is plugged into the rear housing of the T4 Amplifier using the RJ45
plug and into any USB port on the laptop PC.
Warning: Do not plug the cable into any other equipment other than the
laptop PC provided with the system. 7 Note: In transportable, i.e. body-
worn situations within the clinic, the Amplifier must be housed in- side its
bag after being disconnected from the PC, for protection against spillage of
liquids.
Home Use
The T4 Amplifier is battery powered and is housed inside its bag where it
is protected against in- gress of solid objects and water to a degree of |P22.
The laptop PC is optional and may be used for video recordings. There is no
connection between the PC and the T4 Amplifier unit, as all communi- cation is
accomplished wirelessly.
Note that for Home Use applications, the patient should be given a Patient
Instruction Sheet, which details essential usage and safety instructions
concerning the equipment and battery replacement. Refer to the Patient
Instruction Sheet for details.
Estimating the precise recording time of the battery is difficult as it
depends on the number of channels, whether Bluetooth or Wi-Fi are enabled,
oximeter use, etc. For recordings over 24 hours in length it is recommended
that the patient is given instructions to replace the battery every 24 hours.
Connecting the T4 Amplifier
The top face of the T4 houses the display and the patient event pushbutton.
For display details re- fer to section 3.3 below. Pressing the pushbutton
records a patient event and illuminates the back- light of the display.
Above the pushbutton is a circular aperture which houses a light level
sensor.Figure 3 Connecting the T4 Amplifier (front
face)
The front face of the Amplifier’s PCU is laid out in a standard 10-20 format
(T4 PCU 24+8) or a grid layout (T4 PCU 64+4). It accommodates standard
touchproof electrode leads fitted with DIN 42802 connectors.
WARNING: The Amplifier accepts standard 1.5 mm touchproof electrodes
using DIN 42802-style connectors. To ensure patient safety, the electrodes
used must be approved to the Medical Device Directive 93/42/EEC in Europe or
to the relevant local standards outside Europe.
CAUTION: The conductive part of electrodes and their connectors,
including the Neutral electrode, should not contact other conductive parts
including earth.
WARNING: Carefully route patient cabling to reduce the possibility of
patient entanglement or strangulation.
The top edge of the Amplifier provides for several other connections, as shown
below.Figure 4 Connecting the T4 Amplifier (back face)
-
Nonin Xpod: the circular connector allows for the connection of a Nonin Xpod pulse oxime- ter for measuring SpOs. This is plugged into the circular connector and the appropriate sen- sor plugged into the Xpod device. Note that Lifelines does not supply sensors and these will need to be sourced separately.
Note: the Nonin Xpod should not be used if more than 32 channels are on.
Refer to the manufacturer’s instructions supplied with the sensor when fitting it to the pa- tient.
The appropriate recording setup will need to be used as described in section 4.1. -
Aux1: a3.5mm mono jack connector allows for the connection of the Sleepsense body po- sition sensor, type 1575, for hospital and clinic use. Not for home use.
-
Patient Event: this 3.5mm jack connector allows for the connection of a standard Patient Event Thumb Switch.
CAUTION: All these connections are type BF isolated. The conductive part of connectors and transducers should not contact other conductive parts including earth. Always ensure that the transducer fitted is suitable for a connection of this type. -
Micro-SD memory card slot.
-
Host connection RJ45 socket.
WARNING: Cables must be routed carefully to avoid risk to the patient of
entanglement and strangulation.
3.4 Starting the system
To start the system proceed as follows:
- Plug the PC into the mains supply.
- Switch on the PC and wait for Windows to load.
- Ensure T4 Amplifier is connected via the USB lead.
- Launch Trackit application and continue as detailed in section 4.
- These procedures also apply following a mains interruption.
Indicators
The following indicators are shown on the display on the top face of the
T4:Where the symbols indicate the fields to the right to have the
following meanings:
| Current time, hh:mm
---|---
| Elapsed recording time, hh:mm (‘–:–‘ if not recording)
| Battery capacity, % or ‘USB’ if external power applied
| Micro-SD card storage capacity in Mbytes, xxxxM (remaining capacity if
recording)
B| If the internal Bluetooth option is fitted, this indicates that it is
on. Pressing the pushbutton 4 times within 4 seconds toggles the setting to
off, indicated with a b. If the Bluetooth option is not fitted, nothing is
displayed.
W| If the internal WiFi option is fitted, this indicates that it is on.
Pressing the pushbutton 5 times within 4 seconds toggles the setting to off,
indicated with a w. If the WiFi option is not fitted, nothing is displayed.
| Whenever a wireless connection is made the w symbol is displayed.
L/R| Recording in progress
R Recording in progress
L Recording and Low memory card capacity remaining (< 8 minutes) during
recording (accompanied by auditory beep every 30 seconds)
- When the battery is low, there is an auditory beep at 1Hz rate. There is no additional information displayed.
3.5 Shutdown of the system
At the completion of a study proceed as follows to shut down the system:
- Stop the recording by pressing the ‘PC Record Off’ button
- Exit the Trackit program.
- Shut down Windows.
- Switch off the PC and disconnect the mains supply.
After the recording is finished, the Micro-SD memory card is removed for
reading in a PC.
3.6 Battery replacement and charging
For ambulatory, body-worn applications the T4 is powered from a USB Power
Bank. The T4 plugs directly into the USB port on the Power Bank. Ensure that
this uses the 1A socket on the Power Bank. After connection, press the green
‘ON’ pushbutton on the side of the battery.1. Open zip at bottom of bag to access battery
Unplug cable from battery
Withdraw discharged battery from bag
Do not connect cable to any other equipment2 Insert charged battery into bag
Plug cable into battery
Turn battery on using button on side
Close zip
WARNING: The Amplifier must only be used with the USB Power Bank supplied
or au- thorised by Lifelines.
- Do not short circuit this device. To avoid short circuit, keep the device away from any metal objects (e.g., hair clips and keys).
- This device may get hot during use, and this is normal. Hold carefully.
- This unit is not user repairable.
- Do not heat this device or throw it into a fire.
- Do not drop or place the unit under a heavy object.
- Keep this device away from high temperature, wet, or dusty environments.
- During charging keep the device out in the open to allow excess heat to dissipate.
- Charge M5 for 4 hours / M10 for 8 hours before initial use.
- Keep the USB output port and micro-USB input port clean and free of obstruction.
- For additional instructions, consult the documentation supplied with the battery.
To replace the battery in the Bag, unzip the bottom of the Bag to gain access
to the battery con- nection. Unplug the USB connection to the battery and
replace with a fully charged unit.
When not connected to the T4 unit, the battery is charged by using the micro-
USB socket and con- necting to a standard USB port, using the supplied cable.
Battery Charging
Connect the micro-USB charging cable supplied to the Battery and use a USB
connection for charg- ing. The battery capacity display will illuminate to
show how much of the battery is charged. Once all the LEDs are lit, the
battery is fully charged and is ready for use.
For additional instructions, consult the documentation supplied with the
battery.
Do not charge the battery when used in the Home Environment.
WARNING: Do not charge the battery whilst it is connected to the T4 unit.
WARNING: Do not charge the battery when the equipment is in use.
The setup and recording software
The setup software is available on CD. A readme file describes installation.
Check with your distrib- utor or Lifelines if a newer version of software is
available.
The Trackit software is designed to work with both the Trackit recorder and
the T4 Amplifier and with the optional Photic Stimulator.
The software is supported on Microsoft Windows 2000 (with SP2), Windows XP,
Windows Vista and Windows 7 and Windows 8.
The USB drivers will be found on the CD. After connecting the Amplifier to the
PC for the first time, at the Windows prompt, browse to the folder CD
Drive:\USB Drivers. From there Windows will find the correct drivers for the
version of Windows being used.
The software has the following functions:
- Define signal types: create labels to attach to inputs
- Attach the desired signal type (label) to the recording input
- Create a recording montage and download it to the amplifier
- Perform a calibration of the inputs
- Start and stop a recording session
4.1 Setting up a recording protocol
Summary
Step 1 Define the patient ID
Step 2 Define the signals — if required ‘
Step 3 Define the inputs — if required °
Step 4 Define the recording channels — if required *
Step 5 Activate the recording control
Step 6 Connect the 74 for setup
Step 7 Check T4 status
Step 8 Start a recording
Step 9 View the ongoing EEG traces
Notes:
- Defining signals is usually done once only or very occasionally. The T4 Amplifier arrives with a default set of signals that should suffice for most applications, hence it may only neces- sary to add signal types for polygraphic recordings (airflow, respiration etc).
- Defining inputs, recording channels and montage is usually only done once per setup type. This entire setup can then be saved and recalled for future use.
Step 1 Define the patient ID
-
Select the New patient icon on the toolbar.
New Patient icon -
Enter the patent name and Recording ID into the New Patient di- alog.
This information is saved with the recording setup for download to the recorder in a future recording.
It is possible to configure the system to use a patient database instead of
the simple dialog shown above.Step 2 Define the signals
—if required
Defining signals is usually done once only or very occasionally. The T4
Amplifier arrives with a de- fault set of signals that should suffice for most
applications, hence it may only necessary to add signal types for polygraphic
recordings (airflow, respiration etc). lf for any reason the signals have not
been created, it is necessary to define all the signals (labels) that are to
be used for montage creation in Step 3. The signal editor allows the creation
of up to 64 distinct signals ranging from the standard 10/20 EEG signals such
as FP1 O2, to Respiration, Pulse and other polygraphy inputs.
Step 3 explains how to calibrate an AUX input.
To define a signal:
1 Click the View all signals tab in the Signal editor dialog box.2
Double click on the signal you want to edit. This brings up the Signal editor
tab), allowing you to create a relevant signal or label to be entered into the
signal list.3 Type in the Signal name (e.g. Fo1).
Note that for EEG signals this must be case-sensitive.
4 Select a signal type (in this case EEG).
5 Click on the Change button. The signal is now entered into the list under
the View all signals tab.
6 If the signal is not an EEG signal, it may be necessary to insert a display
sensitivity value by un- checking the Master control check box.
Signals that have been defined with their own independent sensitivities appear
in red in the trace display. Further editing and changes to these sensitivity
values in the trace display will be saved back into the signal library.
Step 3 Define the inputs
Note that if a pre-saved setup is available then this can be opened directly
from the Open menu item, and this section skipped. Other- wise, if a new setup
is being created, proceed as follows:
-
Select the Spanner icon on the toolbar. This opens the tabbed Setup Recording dialog.
Spanner icon -
Under the Amplifier Channels tab select the signals (labels) to be attached to the physical inputs.
For example, EEG input 1 may require the label Fo1 and so on according to the standard 10/20 nomenclature.
Double click the channel name and select the relevant signal label from the Setup Hardware EEG channel dialog.
The order of the signal labels in
the pull down list is the same as the order of the signals in the sig- nal
list defined using the signal-editing tool.
Amplifier setup: amplifier setup activates the recording inputs in preparation
for a recording. For most applications you need perform amplifier setup only
once — when the system is first installed — since the amplifier setup is saved
with the recording montage for future recall and usage. See Step 4 below.
If you want to use the recording channel order defined in amplifier setup,
click on Auto Record Setup in the Setup Recording dialog box. You can then
skip Step 4 (Define the recording channels). Poly and AUX inputs: these inputs
can be set to either referential (EEG mode), bipolar AC or bi- polar DC. They
are ideal for polygraphic signals such as respiration, airflow, EKG, body
position (DC mode) etc.
To calibrate an AUX input to reflect a required unit of scale for a given
voltage input use the signal editor — see Step 2). Select the appropriate
units, e.g. %, or mm Hg, and enter the Physical Signal Amplitude required to
generate the Amplifier Input Voltage.
Also in the Aux input section is the SaO2 channel for the Nonin Xpod unit.
Select this channel if us- ing the Xpod. Note: If a Setup that uses greater
than 32 channels plus the Nonin is attempted to be downloaded to the recorder,
an error is displayed and the download prevented.
Step 4 Define the recording channels
Step 4 can usually be skipped, since the Auto Record Setup button will copy
what you have defined under the inputs in Step 3 into the list of recording
channels. ,
However, you can define and save recording montages for spe- cific recording
needs, and recall them for future usage.
Creating a montage follows the same principle as the signal creation and input
definition tool: click on the channel number to define the active and
reference label of choice.
An example of a recording montage is shown below.
4.2 Configuring the amplifier
When you have finished setting up the recording protocol, connect the T4 to
the host computer.
Steps 5 to 9 describe configuration and set-up of an EEG recording.
Step 5 Activate the recording control
The Trackit application software will normally connect automatically to the
T4 Amplifier as soon as it is plugged in. Otherwise, from the Trackit toolbar
select the Trackit Control Panel (‘handshake’) icon which will allow for
manual connection. Key
1 New Patient
4 Ongoings On
7 Calibration On
10 Page Up
13 Notch Filter On/Off
16 Videometry (optional)
19 Vertical sensitivity
22 Stop playback
25 Stop paging
28 Playback time
31 Hi-filter selection| 2 Setup Recording
5 Ongoings Off
8 Calibration Off
11 Get Trackit Events
14 PC Record On
17 Photic Stimulation
20 Chart speed
23 Start playback
26 Page forward
29 Montage selection| 3 Trackit Control Panel
6 Impedance Check On
9 Page Down
12 Email Events List
15 PC Record Off
18 Hyperventilation
21 Open files for playback
24 Page back
27 Paging speed
30 Lo-filter selection
---|---|---
Clicking on the ‘handshake’ icon brings up the Control Panel dialog box.
Step 6 Connect T4
Check that the T4 is connected properly. The software will normally connect
automatically, how- ever to do this manually, in the Control Panel select the
USB option for the T4 and click on Con- nect.After a couple of seconds Status shows ‘T4 Online’.
Most of the parameters in the Status section do not apply to the T4 and the
panel is disabled. How- ever the few that do apply are detailed in the next
step.
Step 7 Check T4 status
Use the Control Panel to check that the T4 is correctly online. For the 14,
the Status part of the Control Panel gives you the following information:
Acquire — on or off: Shows whether the 14 is acquiring or not.
Patient event: Shows that the external patient event marker is activated.
CF card: Shows whether a CF card is present.
Acquire ready: Shows that a valid recording setup has been loaded into the T4.
Note that further status information is available on the 2″ tab. These
parameters do not apply to the 14.
Step 8 Start a recording
Click on the Send Setup button. Wait for the setup to upload to the Trackit
recorder. This should take a few seconds.
Click on the Start Record icon on the main screen in the toolbar to start
recording. Ongoing traces will be displayed on the PC. These can be turned on
or off by clicking on this icon:
To perform an Impedance Check click on this icon: The channel LED will
illuminate to indi- cate when the electrode impedance is greater than the set
level. The set level can be set with the two push-buttons on the amplifier
front panel.
To perform a Calibration check, click on this icon: The waveforms will show a
square wave of amplitude 8 mV pk-pk and frequency 1 Hz.
Step 9 View the ongoing EEG traces
To view the ongoing traces at any time, whether recording or not, click on the
following icon:
When you do this, one of the following things occur:
- Ifthe T4 is connected to the PC, and has been sent a valid recording setup, the traces appear wiping from left to right across the display.
- Ifthe T4 has not been sent a setup from the PC, the system asks for the recording setup held in the T4 before displaying the traces.
Sensitivity, Chart speed, Notch
Filter and Hi/ Lo filters: as is often the case when viewing a live trace
display, the sensitivity, chart speed and filters need be adjusted for optimal
viewing. Use the drop down lists on the toolbar.
To adjust the display parameters for an individual channel, click on the
channel label. This displays a dialog box for that channel, with a check- box
for master control, trace On or Off, and Numeric. Click on Numeric if you want
the numeric value displayed under the label. This can be useful when for
displaying units such as mmHg or degrees C.
When a channel is under individual channel control the label is depicted in
red. When display of that channel is turned off, the label is greyed Out.
Impedance check: to carry out an impedance check, click on the impedance check
icon on the Trackit toolbar.
If recording has started , the impedance check is displayed on the trace
display with an impedance check event.
The impedance check works via pass/fail threshold selection. Impedance values
above the selected threshold (fail) are displayed on a red background. Values
below (pass) are displayed on a green back- groundNotch filter: to
set a notch filter, use Other Options from the View Menu. Notch filters are
either 50Hz or 60Hz depending on where the system is to be used (USA 60Hz;
Europe 50Hz).
To activate the notch filter, click on the Notch Filter icon in the Trackit
toolbar.
Trackit events: to view all recorded events in the recording online, click on
the Get Trackit Events icon in the Trackit toolbar.
Events are displayed in the online event viewer with a description and
time. Key:
-
Opens the list of event types
Additional icons at Playback time: -
Opens an event file for an older re- cording
-
Navigate forwards or backwards
-
Selects the best trace resolution
-
Selects the max. number of traces
-
Enter a ‘Go to’ time here
The event list allows the user not only to see when events took place, but to
also view the data be- hind those events.
To display a page of EEG around an event of interest, double click on the
event in the list. To navi- gate forwards or backwards, press the forward or
backward arrow buttons. Or you can go to a par- ticular time in the recording
by entering the time (as hrs, min, sec) in the recording time fields.
4.3 Montage Editor
This is available via the Setup | Montage menu on the main screen, and
displays the Montage Edi- tor as shown below.
The Montage Editor allows the setting-up of 16 user montages and the As-
recorded montage. Note that the As-recorded montage can only have its channel
on/off and channel master/special control edited (and if special, the channel
sensitivity and filters). All the other 16 user montages are fully definable
and can have the following parameters set for each channel:
-
Active channel name. This is either chosen from the drop-down list representing the current Sig- nal Library signals, or typed in directly.
-
Ref. channel name. This is either chosen from the drop-down list representing the current Signal Library signals, plus Ref and Gnd, or typed in directly.
-
Channel On or Off. If off, the channel label is greyed-out and no trace is displayed.
-
Master or Special Control. If Special, then the Sensitivity, Low Filter and High Filter can be set.
Additional controls are provided to allow: -
Update. Copies the current settings into the currently selected channel.
-
Add. This adds a channel to the end of the Montage list.
-
Insert. This insert a channel above the currently selected channel.
-
Remove. This removes the currently selected channel.
-
Montage name.
If anything is changed, an option is presented to save all changes to disk or
not. If not saved, changes are only temporary.
Note that some of the montage parameters can be changed outside the Montage
Editor, by clicking on a channel label to bring up the Channel Information
window. These changes are only temporary (although you can save them later by
subsequently going into the Montage Editor). 4.4 Reading an EEG
recording
Click the ‘Open all playback files’ button on the left hand side of the
Trackit software toolbar to playback a recording and browse to the folder and
file required. This will open the EDF file and any associated files.
If currently recording to the PC, it is possible to open this file for
simultaneous playback. This will open the current EDF file and all video files
and the current Events list. Playback occurs in the nor- mal way. The 2″
playback window can be set to tile horizontally or vertically.
As an alternative to the Trackit software which offers basic playback
features, any EDF-compatible viewer can be used to read the standard EDF files
recorded by the Trackit.
All Trackit recordings have a user-definable 8-character file name with ‘.edf’
extension. They are stored in EDF format, readable in all EDF-compatible EEG
browsers. In an EDF-compatible browser, the patient’s name and recording ID
are displayed in the test properties.
Lifelines currently recommends:
- Lifelines iEEG
- Nihon Kohden 1100 and 1200 EEG
- Neurotronics Polysmith Sleep software
- Nicolet One EEG
- Natus Coherance EEG (formerly Deltamed/Itmed)
- Persyst Insight EEG
Appendix 1: Specifications
Note: Lifelines reserves the right to change product specifications at
any time without notice. This is in-line with the company’s policy of
continual product development.
T4 Amplifier Specifications
EEG inputs
Number of EEG channels| 32 referential (monopolar) inputs, expandable to 64
with expansion option
---|---
ADC Resolution| 24 bits
Sampling| 250 — 16000 Hz
Input impedance| >20 Mohms
Common mode rejection ratio| > 100dB @ 50 and 60 Hz
Equivalent input noise| <1.5 **** Vpp, <0.2uV rms
Gain| 12 ± 0.5%
Max Input Vaits| 750mVpp (including DC)
Quantisation| 0.17uV/bit @ Gain = 12 and Bits = 22
Bandwidth (-3dB)| DC to 4193Hz
Max common mode input voltage| 0.4Vpp
Input bias current| < +0.3 nA
Front-end Calibration| 8mVpp +5% at 0.98Hz
Impedance Check current| 24nA +20% at 7.8Hz
Polygraphy inputs
Number of polygraphy inputs | 8 poly (bipolar) inputs |
---|---|
ADC Resolution | 24 bits |
Sampling | 250 – 16000 Hz |
Input impedance | >20 Mohms |
Common mode rejection ratio | > 100dB @ 50 and 60 Hz |
Equivalent input noise | <1.5 **** Vpp, <0.2uV rms |
Gain | 12 +0.5% (AC), 4 +0.5% (DC) |
Max Input Vaits | 750mVpp AC setting (including DC), 2.25Vpp DC setting |
Bandwidth (-3dB) | DC to 4193Hz |
Quantisation | 0.17uV/bit @ Gain = 12 and Bits = 22 |
Max common mode input voltage | 0.4Vpp |
Input bias current | < +0.3 nA |
Front-end Calibration | 8mVpp +5% at 0.98Hz |
Impedance Check current | 24nA +20% at 7.8Hz |
Aux. high-level DC Inputs
Number of Aux channels | 1 |
---|---|
ADC Resolution | 24 bit s |
Sampling | 250 – 16000 Hz |
Input impedance | 100 Kohm s |
Gain | 4 ± 0.5% |
Max Input Vdiff | 2.25Vpp |
Bandwidth (-3dB) | DC t o 4193Hz |
Connections, ports and con-trols
Patient Connection Unit| Plug-on unit with touchproof 1.5mm sockets. Variants:
24 referential channels + 8 bipolar (model T4-PCU 24+ 8)
64 referential channels + 4 bipolar (model T4-PCU 64+ 4)
---|---
Aux DC Inputs| 1 Jack socket 3.5mm
Patient Event Input| 1 Jack socket 3.5mm
Front-panel push-button| On/Off and Patient Event
Host PC Connector| 1 RJ45 socket providing USB port (isolated from patient) or
power input from external battery
Nonin Xpod (SaQ2)| 1 Binder 710 series 3-pin socket
LED indicators| LED for disk access
Micro-SD card port| 1 Micro-SD socket
Internal Battery| 1 type LIR2450 Lithium-ion rechargeable Coin cell
Internal beeper|
LCD display| Displays time/date, recording time, battery life and disk space
Bluetooth Wireless
Type | Bluetooth 4.0 |
---|---|
Output power | 11dBm max. |
Output frequency | 2.402 – 2.480 GHz, ISM band |
Data rate | 1.3 Mbps max. |
Protocols | Standard Bluetooth – SPP, GATT, DUN, PAN |
Modulation | GFSK, DQPSK. Frequency Hopping Spread-Spectrum (FHSS) |
Error correction | Forward Error Correction (FEC), Automatic repeat request |
(ARQ).
Security| Authorization and authentication of devices, proprietary Inter- face
Protocol
Type Approvals| Europe (ETSI R&TTE); US (FCC/CFR 47 part 15 unlicensed modular
transmitter approval); Canada (IC RSS); Japan (MIC – formerly TELEC)
R&TTE Directive 1999/5/EC| Effective use of frequency spectrum:
Medical Electrical Equipment| EN 300 328
EMC: EN 301 489-1, EN 301 489-17,
EN 61000-6-2
Health and safety: EN 62479,
EN 60950-1, IEC 60950-1
IEC 60601-1-2
Bluetooth Qualification| V4.0
Wireless LAN
Type | 2.4 GHz IEEE Std. 802.11 b/g Wireless LAN Module |
---|---|
Output power | 12dBm max. |
Output frequency | 2.412 to 2.462 GHz, ISM band |
Data rate | 230kKbps max. |
Protocols | TCP, UDP, DHCP, DNS, ICMP, ARP, HTTP Client, and FTP Client |
Modulation | 802.116 Compatibility: DSSS (CCK-11, CCK-5.5, DQPSK-2, DBPSK-1) – |
802.11g: OFDM
Error correction| Forward Error Correction (FEC)
Security| WEP-128, WPA-PSK (TKIP), WPA2-PSK (AES)
FCC| Part 15.247 FCC T9J-RN171
IC| RSS-210 low-power communication device
CE| ID# 0681
REG| U9M21103-4249-C
Radio| EN 300328 V1.7.1 (10/2006)
EMC| EN 301489-1 V1.8.1 (04/2008)
EN 301489-17 V2.1.1 (05/2009)
Safety| EN 60950-1:2006+A11:2010, EN 50371 2002-03
Physical characteristics
Weight | 2/0g |
---|---|
Size | 17cm x 9cm x 3cm |
Safety and EMC standards
The system has been certified and complies with the following standards:
IEC 60601-1 and| European standard for medical electrical equipment, general
re-
---|---
IEC 60601-2-26| quirements and particular requirements for EEG systems.
ANSI/AAMI ES 60601-1| AAMI Deviations from |EC 60601-1 (USA).
CAN/CSA 22.2 No 601.1 M90| Canadian standard for medical electrical equipment,
general re- quirements.
IEC 60601-1-2| European standard for medical electrical equipment, EMC
require- ments, calling:
1EC55011| Conducted Emissions, Group 1, Class B
IEC55011| Radiated Emissions, Group 1, Class B
IEC61000-4-2| Electrostatic Discharges
IEC61000-4-3| Immunity – Radiated RF Field
IEC61000-4-4| Immunity – Transients Bursts
IEC61000-4-5| Immunity — Surges
IEC61000-4-6| Immunity — Conducted
IEC61000-4-8| Immunity — Power frequency fields
IEC61000-4-11| Immunity — Voltage dips, interruptions
IEC61000-3-2| Harmonic Emissions
IEC61000-3-3| Voltage Fluctuations/flicker
*Note: Com pliance is provided by t he PC
T4 Am plifier
Degree of protection against electrical shock (when con- nected to host
system)| Type BF
---|---
Type of protection against electrical shock (when con- nected to host system)|
Opt ically isolat ed USB am plifier
Mains isolat ion t ransform er for PC
Degree of protection against harmful ingress of water| Ordinary ( no prot ect
ion)
Mode of operation| Cont inuous
Degree of safety of application in the presence of a flammable anaesthetic
mixture with air or with oxygen or nitrous oxide| Not suit able
Appendix 2: Photic Stimulation
An optional Lifelines Photic Stimulator is available which can be used with
the T4 to asses patient photosensitivity in EEG studies. For a detailed
description of operation, connection and specifica- tions please refer to the
separate documentation “Lifelines Photic User Manual”.Click on the Photic Stimulation icon in the top toolbar to bring
up the Photic Stimulation control panel, shown below.This window allows single, manual, sweep and
complex sequences of Photic stimulation to be pro- duced. Photic start/stop
events are recorded as shown above. By using the Trigger output from the
Photic Stimulator and connecting to an Aux input on the T4, the actual Photic
flash ‘ticks’ are pro- duced in the recording.
Note: to setup a suitable Photic trigger signal definition open the
Signal library as described in sec- tion 4.1, and define a signal with a name
“Photic’, set it to type DC, units mV and Physical Signal Amplitude of +-
1000mV/V. Set the sensitivity to non-master and 10mV/mm.
Appendix 3: Additional Events Information
For the T4 EEG system, events types are as shown below.
- 56 Automatic events (hardware events, photic start/stop, video start/stop etc.)
- 40 user-configurable events
- Free-text events entered during acquisition
Event List Key| Event No.| Contents| Type| Size|
Total size| Mapping
---|---|---|---|---|---|---
0| 0| No event| Fixed| 16 x 16| 256| Auto
1| Stop recording| Fixed| Auto
2| Start recording| Fixed| Auto
3| Door Open| Fixed| Auto
4| Door Closed| Fixed| Auto
5| Host On| Fixed| Auto
6| Host Off| Fixed| Auto
7| Low Battery| Fixed| Auto
8| OK Battery| Fixed| Auto
9| Imp.Check- Mode| Fixed| Auto
10| Calibrate Mode| Fixed| Auto
11| Normal Mode| Fixed| Auto
12| Electrodes on| Fixed| Auto
13| Electrodes off| Fixed| Auto
14| Patient Event| Fixed| Auto
15| External Event| Fixed| Auto
1| 16| Awake”| User-config| 16 x 16| 256| Fl
17| Asleep”| User-con fig| F2
18| Eyes open”| User-config| F3
19| Eyes closed”| User-config| F4
20| Lights on”| User-con fig| F5
21| Lights off”| User-config| F6
22| Drowsy”| User-con fig| F7
23| I| User-con fig| F8
24| Photic start| Fixed| Auto
25| Photic stop| Fixed| Auto
26| HV start| Fixed| Auto
27| HV >>| Fixed| Auto
28| HV stop| Fixed| Auto
29| Post HV start| Fixed| Auto
30| Post HV >>| Fixed| Auto
31| Post HV stop| Fixed| Auto
2| 32| Video start| Fixed| 32 x 32| 1024| Auto
33| Video stop| Auto
34| Video move- ment| Auto
35| Trackit connect| Auto
36| Trackit discon- nect| Auto
37 – 63| Reserved| Auto
3| 64 —95| ?| User-config| 32 x 32| 1024| Shift F1-8 Ctrl+Shift Fl-8
4| 96 —159| ?| User-config (free-text)| 64 x 64| 4096| F12
| | | | | |
The user-configurable events are edited and setup before acquisition. These
are automatically saved and restored by the program. For ease of entry during
acquisition, 24 of these events are mapped to the keyboard F1- F8 keys, Shift
F1 — F8 and Control + Shift Fi — F8 keys.
Clicking on the Events icon on the main program window allows these
configurable events to be edited as shown below. If the system is recording,
selecting an event marks it in the recording. If not recording, selecting an
event allows it to be edited.The Events icon also brings up an option to
print an events template for overlaying on the key- board. Facilities are
provided to scale the printout to fit different size keyboards. Free Text Events
During a recording, pressing the F12 keyboard key allow a free-text event
to be created. The event is recorded at the time F12 is pressed and a window
is displayed allowing the entry of descriptive text which can be entered at
the user’s leisure. During this time all the other types of events can be
activated.During playback, all the events are
displayed for the file by clicking on the Events icon. Double- clicking on an
event in the list jumps to that point in the recording. All the events are
also dis- played in their correct position in relation to the EEG along the
bottom of the main window.
The events may be sorted alphabetically by clicking on the ‘Event’ heading in
the list. This is con- venient for grouping all event types together, e.g.
Photic. Clicking on the ‘Time’ heading sorts the events back into
chronological time.
Appendix 4: PC Setup
Options| Tab 1
The Options panel Tab 1 contains general settings which are self-explanatory
as shown below. Figure 27 Options Tab 1
Options| Tab 2
The second tab in Options is shown below.![lifelines Trackit Mk2 EEG Amplifier
-
Options Tab 1](https://manuals.plus/wp-content/uploads/2023/10/lifelines- Trackit-Mk2-EEG-Amplifier-Options-Tab-1.jpg)Most of these options are not applicable to the 14, except for:
- Use File Length instead of EDF Length. This a playback feature and if ticked, the file length is used instead of the edf length parameter embedded in the edf header. Due to the fact that the T4’s memory card can be removed at any time, there can be a partial 1s data block at the end of the file and so the actual size may not be an exact multiple of 1s.
Screen Size
This Slider Bar allows the screen size to be set so that the Chart Speed
for the traces exactly matches the cm/s selected. To use, adjust the slider so
that it is 30 mm from the left-hand end.
Options| Tab 3 Most of these options are not applicable to the
14, except for:
- XPOD channel name SPO2 (otherwise SAQ2). This option allows the XPOD channel name to be either SPO2 or SAO2. This is because some playback software requires a specific label to enable recognition.
- Screen Width Calibration. This allows the program to be calibrated to the screen width.
- Default folder for EEG and Video files. This allows the program to always record EEG and/or video files to the same default folder. Use Browse to find and/or create the default folder for recordings.
- Automatically create patient folder here. If checked, the program will automati- cally create a patient folder in the default recording folder set above without any user intervention. If not set, the user choses where to save the recording using the standard save file dialogue window.
- Connect at program launch. If checked, the program will automatically connect to the T4 at launch.
Appendix 5: Wireless
Introduction
T4 has optional built-in Bluetooth and WiFi capabilities.
Using the internal Bluetooth module in the T4, wireless connections can be
established with it from a Bluetooth-enabled PC. Using the internal WiFi
module in the T4 wireless connections can be es- tablished with it via a
Wireless Access Point (WAP). This allows the T4 to be monitored remotely over
a secure wireless link up to a range of about 100m or greater (dependent on
hardware and environmental factors).
System overview
The Bluetooth module is Bluetooth Qualified v4.0. The WiFi module is IEEE
802.11 b/g certified. For full specifications, refer below.
Bluetooth is a device to computer wireless connection and will connect to any
suitably certified Bluetooth host, like a PC or laptop. The connection process
uses authentication and password pro- tection.
The WiFi (wireless LAN Module) is a device to network wireless connection and
will connect to a designated network via a Wireless Access Point (WAP). The
connection process uses authentication and password protection.
Connection and use
Both the Bluetooth and WiFi connections require secure passwords to be
entered.
During the Bluetooth pairing process, the correct password must be entered to
establish the con- nection. As shown below, a secure password authorization
and authentication process takes place during the pairing
procedure.Once
established, the T4 acts as the server and provides the SPP service to the PC
acting as a cli- ent.
During the setup of the WiFi module, the WAP SSID is entered together with its
password, as shown below.If an attempt is made to connect to an unsecure network
without a password, this is prevented and an error displayed as shown below.
For maximum security it is recommended that only WPA2 ac- cess is
allowed.When
the Trackit application has established the Bluetooth connection, a connection
quality moni- tor labelled “Comms.Q’” is displayed in the status bar at the
bottom left of the main screen, as shown below.This number given as a percentage is an
approximate indication of the amount of data received as a ratio to that
expected, calculated every second. It is most likely to drop below 100% when
either device is at the limit of the transmission range or when either antenna
is adversely obscured or un- der the influence of interference. It will be
noticed that the wireless transmission will use its availa- ble bandwidth to
try to “catch-up” after a drop in signal quality and the indication can read
more than 100% momentarily. A reading, therefore, of less than 100% does not
necessarily mean a per- manent bad connection since data flow can increase
shortly afterwards. A sustained low value over several seconds will cause the
Trackit application to close the connection. If the Autoconnect fea- ture has
been enabled in Options, the application will automatically attempt to
reconnect to the T4 every 10 seconds.
Wireless Communication (general information)
A wireless link can be subject to interference and disruption to
communication.
Bluetooth is a wireless technology designed for short-range wireless
connections between devices in a wireless personal area network (WPAN).
Bluetooth is compliant with the IEEE 802.15 standard and operates in the 2.4
GHz band. Wi-Fi is a wireless technology designed to connect devices and an
infrastructure in a wireless local area network (WLAN). Wi-Fi is compliant
with various IEEE 802.11 standards such as 802.11a, 802.11b, 802.119, and
802.11n. 802.11b and 802.119 operate in the 2.4 GHz band, 802.11a operates in
the 5 GHz band, and 802.11n can operate in both bands Both Wi-Fi and Bluetooth
are based on spread spectrum signal structuring. With this radio trans-
mission technique, a narrowband signal is expanded across a given portion of
the radio frequency spectrum to result in a broader or wideband signal. Such a
wideband signal provides a very strong immunity to interference compared to a
narrowband signal.
Bluetooth uses Frequency Hopping Spread Spectrum (FHSS), whilst WiFi uses
Direct Sequence Spread Spectrum (DSSS). Given that both technologies operate
in the same frequency band, this use of differing techniques can result in
interference issues. FHSS devices and DSSS devices per- ceive each other as
noise.
Both Bluetooth and WiFi technologies, however, use sophisticated error
detection and error correc- tion techniques to deliver correct data.
Additionally, if a transmission cannot be decoded due to in- terference, the
transmission is resent. This interference will, of course, increase as the
number of coexistent devices in proximity to each other increases. Due to the
robust error detection mecha- nisms, however, as the interference level
increases, data continues to be delivered correctly, but the data rate
decreases as the number of dropped packets increases.
In terms of security, both system use authentication with encryption and pin
codes/pass words. In addition, the T4 itself uses a proprietary Interface
Protocol thus preventing a non-authorised user from taking control of the
device.
When transmitting wirelessly, data packages are time-stamped when acquired by
the amplifier, be- fore being transmitted, and when received by the
application they are recorded according to this timestamp. In this way, there
is no risk associated with delayed communications or missing data packets over
a wireless link since, if the recording software detects missing packages, an
event is inserted into the recording to notify the operator. In the extreme
case whereby the interference causes the wireless link to be dropped all
together, the application automatically reconnects when the interference is
removed.
Quality of Service and Associated Risks
- The risk of corrupt data due to interference is very small due to error detection, error cor- rection and resend data packet mechanisms. In addition to this error detection and correc- tion, the application provides time-stamped data packages, which enables the detection of corrupt, delayed or missing data.
- The risk of missing data due to interference is also very small, but at the extreme, the data rate decreases aS more and more data packets have to be dropped and resent. Ultimately, in the presence of extreme interference, the data rate will decrease to zero and the wire- less link will be dropped. This situation is also adequately handled with the provision of time-coded data packets, which enables the detection of corrupt, delayed or missing data. In the extreme case whereby the interference causes the wireless link to be dropped all to- gether, the application automatically reconnects when the interference is removed. This sit- uation is very similar to being out-of-range and the same mechanisms apply and, again, the application will automatically reconnect when the device comes back into range. In the presence of extreme and persistent interference, the cabled USB connection is, of course, available.
- The risk of unauthorised users is very small due to the authentication requirements of the wireless link and the fact that the T4 Interface Protocol is proprietary.
- The medical system uses mature, industry-standard hardware and protocols: Bluetooth and WiFi. This ensures that the system utilises all the benefits associated with these mature standards, concerning the authentication, data integrity and interference performance as discussed in this document.
- The radio modules are tested according to their own EMC emissions and immunity stand- ards: EN 300 328, EN 301 489-1, EN 301 489-17 and IEC 60601-1-2 (Bluetooth).
- The radio modules are pre-certified and Type Approved.
Considering the medical system function, its indication for use and very low
risk associated with a low level of concern, the analysis, evaluation and
preventative measures undertaken reveal the low risk associated with wireless
communication. In the presence of extreme interference, the rate of delivery
of data packets will decrease until ultimately, the wireless link is dropped.
Wireless communication problems are identified, prevented and mitigated, as
described. The application identifies these wireless problems and
automatically reinstates the wireless link if dropped in the presence of
extreme interference. Alternatively, the cabled USB connection is available.
Pre-compliant Wireless Modules
The use of pre-compliant, certified and Type-approved optionally-fitted
internal Bluetooth and WiFi wireless modules which comply with applicable
national radio regulations ensures best perfor- mance, interoperability,
coexistence and quality of service is achieved.
Specifications (taken from Appendix 1).
Bluetooth Module
Specifications:
- Type: Bluetooth 4.0.
- Output power: 11dBm max.
- Output frequency: 2.402 – 2.480 GHz, ISM band.
- Data rate: 1.3 Mbps max.
- Protocols: Standard Bluetooth – SPP, GATT, DUN, PAN.
- Modulation: GFSK, DQPSK. Frequency Hopping Spread-Spectrum (FHSS).
- Error Correction: Forward Error Correction (FEC), Automatic repeat request (ARQ).
- Security: authorization and authentication of devices, proprietary Interface Protocol.
Conformance:
- Type Approval: Europe (R&TTE), US (FCC/CFR 47 part 15), Canada (IC RSS).
- R&TTE Directive 1999/5/EC
- Effective use of frequency spectrum: EN 300 328
- EMC: EN 301 489-1, EN 301 489-17,EN 61000-6-2
- Health and safety: EN 62479, EN 60950-1, IEC 60950-1
- Medical Electrical Equipment IEC 60601-1-2
- Bluetooth Qualification v4.0.
WiFi Module
Specifications:
- Type: 2.4 GHz IEEE Std. 802.11 b/g Wireless LAN Module
- Output power: 12dBm max.
- Output frequency: 2.412 to 2.462 GHz, ISM band.
- Data rate: 230kbps max.
- Protocols: TCP, UDP, DHCP, DNS, ICMP, ARP, HTTP Client, and FTP Client.
- Modulation: 802.11b Compatibility: DSSS (CCK-11, CCK-5.5, DQPSK-2, DBPSK-1) – 802.11g: OFDM.
- Error Correction: Forward Error Correction (FEC).
- Security: WEP-128, WPA-PSK (TKIP), WPA2-PSK (AES), proprietary Interface Protocol.
Conformance:
- Type Approval: Europe (R&TTE), US (FCC/CFR 47 part 15), Canada (IC RSS).
- R&TTE Directive 1999/5/EC
- Effective use of frequency spectrum: EN 300 328
- EMC: EN 301 489-1, EN 301 489-17
- Health and safety: EN 60950-1, EN50371
Interference
The T4 Amplifier will continue to operate in the presence of radio frequency
magnetic fields (RF) and the effects of electrostatic discharges (ESD) and
other interference, in accordance with the requirements of |EC60601-1-2.
However, the amplifier records signals of very low amplitude, and these
signals themselves are not immune to the effects of RF, ESD and low-frequency
magnetic field interference. Such interference may cause signal artefacts.
Caution: when in close proximity to the amplifier, do not use mobile
phones, transmitters, power transformers, motors, or other equipment that
generates magnetic fields. Refer to the Appendix for more information.
Caution: when using the amplifier in close proximity to other devices
using Bluetooth or WiFi communication, orientate or position these devices for
least interference. If possible separate the devices or turn off their
wireless communication.
Note: Medical electrical equipment needs special precautions regarding
EMC and needs to be installed and put into service according to the EMC
information provided in the Manufacturers Declaration in the Appendix.
Appendix 6: Troubleshooting Guide
COM port problems with Bluetooth communication to Trackit T4
The COM port is available but is being used by another application.
This could well be the case if an application such Microsoft Active Synch
is installed and polling the COM port for a Windows CE device. Make sure
Connection Mode for Active Synch is set to Only When Device is Connected, and
not to Continuous.
Make sure other applications such as virus protection software and personal
firewalls (ZoneAlarm) are not accessing the COM port while a connection to
Trackit is being made.
Problems starting the recording
The setup has not been sent correctly
Under Trackit Status, in the Control Panel, check that Acquire Ready shows
Yes. If it is not ready, acquisition cannot begin. This could be caused by
incomplete transmission of the Trackit T4 setup. Try to adjust the
transmission delay for serial communication in the Trackit software as
described above.
An incorrect setup has been sent
If an incompatible setup has been sent to the Trackit T4 the message; “unable
to comply” will indi- cate that. If an incorrect setup has been sent, the
Trackit Control Panel will show ‘Acquire Ready: No’.
The card is not formatted correctly
If the card is not formatted with a correct 16-bit FAT, a recording cannot
commence. Format the flash card using the inbuilt Trackit format utility under
Get Card Info. See ‘Get Card Info’, in 5.5 Advanced Settings.
Caution: do not attempt to do a low-level format, or do a standard format
using a SCSI or USB card reader.
The card is corrupted
Disk corruption can be caused when a flash card is removed from Trackit or
the Card reader while data is being written or accessed.
Trackit T4: always stop a recording, or if hot swapping wait for the write LED
to go out, before re- moving the card.
Card reader: make sure the device is stopped, in Card Services, before
removing the Card. This is especially important in Win2000 systems using a USB
card reader, where the activity LED stays on for several seconds after
deleting an old file. If the card is removed when this LED is on, the card
will be corrupted and a reformat will be necessary. Always stop and eject the
card using the icon in the Windows system tray before physically ejecting it.
The card is not inserted correctly
If the flash card is not pushed in far enough, the card will not engage the
pins on the card reader.
‘No CF card present’, in the Status section of the Trackit Control Panel, will
evidence this.
File review problems
The card is not formatted in FAT16
When a recording is made on a card formatted in FAT32 it will appear to be
severely truncated and most probably unreadable. If you Know a recording has a
duration of >24 hours but it only shows up as several minutes in review, the
most likely cause is that the card is not formatted in FAT16.
Notes:
- This problem does not occur if the format has been performed using the inbuilt Trackit format utility.
- Trackit software detects corrupted or incorrectly formatted cards prior to recording.
Appendix 7: Manufacturer’s Declaration
EMC Compatibility
This section contains specific information regarding the device’s
compliance with EN 60601-1-2.
Note: Medical electrical equipment needs special precautions regarding
EMC and needs to be in- stalled and put into service according to the EMC
information provided here.
WARNING: The use of accessories, transducers and cables other than those
specified, with the exception of transducers and cables sold by the
manufacturer of the equipment as replacement parts for internal components,
may result in increased emissions or decreased immunity of the equipment.
Accessory name | Type | Length | Manufacturer |
---|---|---|---|
USB Interface Ca- ble | USB | 2.8 m | USB shielded cable |
Input electrodes | EEG disc elec- trodes | 1 m | Unshielded EEG disc electrodes |
Nonin XPOD | Shielded | 2 m | Nonin |
Aux. Connector cable | Shielded | 1 m | Shielded cable |
Patient Event Switch | CM-5 | 2 m | Zygo |
WARNING: The equipment or system should not be used adjacent to or
stacked with other equip- ment and that if adjacent or stacked use is
necessary, the equipment or system should be ob- served to verify normal
operation in the configuration in which it will be used.
Guidance and Manufacturer’s Declaration
Electromagnetic Emissions
EN 60601-1-2
The T4 is intended for use in the electromagnetic environment specified
below. The customer or user of the T4 should assure that it is used in such an
environment.
Emissions Test| Compliance| Electromagnetic Environment
Guidance
---|---|---
RF em issions CISPR11/EN55011| Group 1| The T4 uses RF energy only for its
internal function. Therefore, its RF emissions are very low and are not likely
to cause any interference in nearby electronic equipment.
RF emissions CISPR11/EN55011| Class B| The T4 is suitable for use in all
establishments, including domestic establishments and those directly connected
to the public low voltage power supply network that supplies buildings used
for domestic purposes.
Note: Only the recommended or supplied PC must be used in the system to ensure
compliance.
Harmonic emissions EN 61000-3-2| Class A
Voltage fluctuations/Flicker emissions EN 61000-3-3| Complies
Electromagnetic Immunity
EN 60601-1-2
The T4 is intended for use in the electromagnetic environment specified below.
The customer or user of the T4 should assure that it is used in such an
environment.
Immunity Test| EN 60601-1-2 Test Level| Compliance Level|
Electromagnetic Environment Guid- ance
---|---|---|---
Electrostatic dis- charges (ESD) EN 61000-4-2| +/- 6 kV:Contact +/- 8 kV:Air|
+/- 6 kV:Contact +/- 8 kV:Air| Floors should be wood. concrete or ceramic
tile. If floors are covered with synthetic ma-terial. the relative humidity
should be at least 30%
Electrical fast Transi- ents/burst
EN 61000-4-4| Compliance is provided by the recommended PC equipment.|
Compliance is provided by the recommended PC equipment.| Mains power should be
that of a typical cornmercial and/or hospital environment
Surge
EN 61000-4-5| Compliance is provided by the recommended PC equipment.|
Compliance is provided by the recommended PC equipment.| Mains power should be
that of a typical commercial and/or hospital environment
Voltage dips,short in- terruptions and volt- age variations on
power supply input lines
EN 61000-4-11| Compliance is provided by the recommended PC equipment.|
Compliance is provided by the recommended PC equipment.| Mains power should be
that of a typical cornmercial and/or hospital environment. If the user of the
T4 requires continued operation during power mains interruptions. it is recom
mended that the T4 be powered from an uninterruptible power supply or a
battery
Power frequency
(50/60 Hz) magnetic field
EN 61000-4-8| 3 A/m| 3 A m| Power frequency magnetic fields should be at
levels characteristic of a typical location in a typical commercial and/or
hospital en-vironment
Immunity Test| EN 60601 Test Level| Compliance Level|
Electromagnetic Environment Guidance
---|---|---|---
| | | Portable and mobile RF communications equipment should be used no
closer to any part of the T4, including cables than the recommended separation
distance calculated from the equation applicable to the frequency of the
transmitter.
Recom mended separation distance
RF Common mode/ Conducted Susceptibility EN 61000-4-6| 3 Vrms
150 kHz to 80 MHz| 3 Vrms| d = 13.5/V) \’P = 1.2 ,;I:’
Note: using unshielded input leads
Radiated RF Elect romag – net ic Fields
EN 61000-4-3| 3 V/m
80 MHz to 2.5 GHz| 3 V/m| d = [3.5/E] ,:P : 80 MHz to 800 MHz = 1.17 ,d:,
d = [7/E] \’1″: 800 MHz to 2.5 GHz = 2.33 ,d:,
Note: using unshielded input leads”
| | | Where P is the maximum output power rating of the transmitter in watts
(W) according to the manufacturer and d is the recommended separation distance
in meters (m).
Field strengths from fixed RF transmitters, as determined by an
electromagnetic site survey’, should be less than the compliance level in each
frequency range b.
Interference may occur in the vicinity of equipment marked with the following
symbol:
NOTE 1. At 80 MHz and 800 MHz, the higher frequenc range applies.
NOTE 2. These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
a. Fieid strength from fixed transmitters, such as base stations for radio
(cellular/cordless) telephones and land mobile radios, amateur radio, AM and
FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the
measured field strength in the location in which the T4 is used exceeds the
applicable RF compliance level above, the T4 should be observed to verify
normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the T4.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less
than 3 V/ m.
c. The immunity levels for conducted RF are for unscreened input electrode
leads 1 m in length and worse-case coupling, including any resonances across
the frequency band. The interference is less when the coupling plane of the
interference source is not in the same plane as the electrode leads.
d. The immunity levels for radiated RF are for unscreened input electrode
leads 1 m in length and worse-case coupling, including any resonances across
the frequency band. The interference is less when the polarisation plane of
the interference source is not in the same plane as the electrode leads.
Recommended separation distance between portable and mobile RF
communications equipment and the T4 EEG System
EN 60601-1-2
The 14 is intended for use in the electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the user of the T4
can help prevent electromagnetic interference by maintaining a minimum
distance between portable and mobile RF communications equipment
(transmitters) and the T4 as recommended below, according to the maximum
output power of the communications equipment.
Rated maximum out-
put power of trans-
mitter| Separation distance according to frequency of transmitter
m
---|---
W| 150 kHz to 80 MHz
d= 1.17√P| 80 MHz to 800 MHz
d= 1.17 √IP| 800 MHz to 2.5 GHz
d= 2.33√P
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 1.2| 12| 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.
NOTE 1. At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
NOTE 2. These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.
Lifelines Ltd, 7 Clarendon Court,
Over Wallop, near Stockbridge,
Hampshire S020 8HU, UK
Telephone +44 (0)1264 782226
www.LLines.com
sales@LLines.com
****0086
Documents / Resources
|
lifelines Trackit Mk2 EEG
Amplifier
[pdf] User Manual
Trackit Mk2 EEG Amplifier, Trackit Mk2, EEG Amplifier, Amplifier
---|---
References
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