TruScan EEG Service Guide Type CL a PT rev 2 April 2016

Table of Contents TruScan EEG Service Guide

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Terminology ...4 General Information ...6 Warranty Conditions...9 List of used legislation and CSN standards ...10 Installation, training, switching the device on and off ...11 Operating conditions and environment ...12 Configuration and assembly ...13 Electroencephalograph TruScan Type CL ...18 Electroencephalograph TruScan type CL - General Assembly ...19 Electroencephalograph TruScan type CL - General Assembly with movable arm (FlexiTrolley) ...26 Electroencephalograph TruScan type CL - General Assembly with LTM ...27 Electroencephalograph TruScan type CL - General Assembly with LTM on the mobile arm ...29 Elektroencefalograf TruScan Type PT ...30 System Connection ...32 Computer connection ...33 Block diagram of Electroencephalograph TruScan type CL - General Assembly...37 Block diagram of Electroencephalograph TruScan type CL for LTM...40 Block diagram of Electroencephalograph TruScan type PT ...41 Technical specification ...42 Operational safety ...43 Interference ...45 Maintenance and Calibration ...47 Consumables ...49 Storage and transport conditions ...54 Disposal of the device and packing materials ...55 Contact ...56

Instructions for use This service manual is intended for the TruScan Electroencephalograph device types CL 24, CL 32, CL 64, CL 128, CL 256 and PT 24, PT 32, PT 64 and PT 128. Service Manual is used for operating and service personnel in understanding the technical information about the device, which is marketed with the trade name TruScan. Knowledge of this manual is essential for achieving safety and proper operation. This guide provides information about basic technical characteristics of the device, installation and commissioning, possible assembly instructions for use, conditions of safe operation and more. Operation of this device requires at least a basic knowledge of EEG examination. Electroencephalograph TruScan® is the full name of the medical device EEG, which devides into type CL and PT, with different numbers of recording channels and portability. For electroencephalograph TruScan device description see chapter General information.

Warning:

Instructions for electroencephalograph TruScan use, must be available at all times to operate the device.

Without the prior written permission of DEYMED Diagnostics Ltd. no part of this document in any form or by any means can be copied or reproduced. © 2016 DEYMED Diagnostic Ltd. All rights reserved.

Terminology Name

Definition

Service personnel

Service staff are technicians who repair medical devices within the organization (hospital, clinic or other establishment), ensures their register, resolve any technical problems and order regular technical safety checks. Their education should be in a technical field, ideally with a focus on medical technology. Knowledge of basic technical standards is required for service personnel.

Operator

A person who provides all the necessary settings on the machine and uses it for the intended purpose. Most often a doctor or nurse.

Optical Cable Optical cable comprising optical fibers that transmit signals in the form of light. Fiber optic cable is an insulator, does not lead electric current, contributes significantly to increased resistance to interference and to increase patient safety. Passive Cooling

Passive cooling means, that the heat from the processor is removed from the cooler spontaneously, without the use of fans. Due to the absence of fan, noise is reduced to a minimum.

Recording Channel

Circuit in the amplifier, which scans only one signal. For example, 24 Channel amplifier can capture up to 24 signals simultaneously.

Traveler

Portable base version of the PT, which includes EEG keyboard, USB adapter, connecting elements for the amplifier.

Consumables Consumables used for EEG examination, it is either a disposable material (EEG gel, pre-gelled surface electrodes) as well as reusable electrodes, caps and other listed in chapter "Consumables". Electrodes, EEG caps and the like are included in the consumables due to the limited lifetime, due to aggressive effects of the gel. EEG

Abbreviation for "electroencephalograph".

TMS

The acronym "Transcranial Magnetic Stimulation".

NMR

Abbreviation for "Nuclear Magnetic Resonance", or magnetic resonance imaging.

Power Supply A source of electrical energy, which is not part of the medical device or medical system. Supplier

Manufacturer's authorized representative, or directly manufacturer.

Amplifier

Main part of the EEG system, where electrodes or caps can be connected. Often called the "headbox".

USB Adapter Adapter that is positioned between the EEG Headbox and Control PC. Main Switch

The main switch is located on the cover of the power transformer, used to disconnect the whole unit from the mains.

Intended use

General Information

Electroencephalograph TruScan type CL and PT are used to record and display EEG, on the basis of which it is possible to determine the patient's diagnosis by physician.

Description Electroencephalograph TruScan offers the latest features in EEG systems, intuitive software and small compact amplifier (Headbox unit), which is powered by batteries. The versatility of this unit allows use in both portable type (PT) and the type with hospital cart (CL). When used on a hospital cart, you can easily withdraw amplifier unit and use it in a portable version, along with a laptop. The entire system is software-controlled and in addition to standard EEG including photostimulation, it can be used to investigate the VEP, P300 and video EEG monitoring. Via the network interface it can be connected to a local or hospital computer network. Electroencephalograph TruScan is a versatile system and can be combined with other certified systems such as Electromyograph TruTrace, magnetic stimulator DuoMAG and Polysomnograf SomniPro 19. The device is considered functional if it is able to fulfill its purpose.

Warning:

Electroencephalograph TruScan is permitted to connect only with medical devices mentioned above, for connection to another medical device, permission is required from the manufacturer.

Types Type CL (Clinical) - AC power 110-120V ~ 50/60 Hz or 220-240 V ~ 50/60 Hz. Model: CL 24,CL 32, CL 64,CL 128, CL 256 Type PT (Portable) - a portable version, powered by a laptop (5V DC from the USB connector). Model: PT 24, PT 32, PT 64 a PT 128 The individual types are more specified in chapter System Overview and Components.

Nameplates Nameplate pattern (type CL).

The nameplate is normally located on the back side of the support leg of the hospital cart, type PT is located at the bottom of Traveler.

Indications and contraindications Indication • Epilepsy • Dementia

Contraindication • For the device itself is no known, only possibly with the electrode accessories • When photostimulating it should be borne in mind, that it is able to evoke an epileptic seizure

Explanation of symbols in the manual and on the unit The following symbols are used on labels electroencephalograph TruScan, knowledge of these symbols is needed for operator. Classification of Device: Type BF (IEC 60601.1)

Amplifier Input

Read carefully the operating instructions.

Warning! This symbol indicates that not following these instructions might be harmful to you and other users or might damage your TruScan EEG or other equipment. Caution "dangerous voltage" inside the device is high, potentially dangerous voltages!

The manufacturer declares conformity with relevant legal requirements, which assessed the notified person no. 1014 (EZU Praha) Year of manufacture

Manufacturer

Serial Number This symbol indicates that the TruScan EEG is electric and electronic waste and therefore cannot be disposed of in normal domestic waste bins, and must be treated as “waste".

Operating air temperature

Classification of electroencephalograph TruScan IIa, active, non-sterile (According to Annex No.9 Government Regulation No. 54/2015 Coll. , as amended, implementing rule # 10 in Class IIa). Electroencephalograph is powered from the mains (type PT is powered from a laptop via a USB connector ) and is made in protection class I. Electroencephalograph degree of protection is IP 20 (device is protected against contact with hazardous parts with a finger, without protection against ingress of liquids). The device is designed for continuous operation in an environment free of flammable anesthetics.

Declaration of Conformity The manufacturer issued for this product Declaration of Conformity according to law no. 54/2015 Coll.. The declaration of conformity is included with a new device, or is available on request from the manufacturer.

Warranty Conditions The manufacturer guarantees the device for 24 months. The warranty period begins on the date of installation of the device. During this period, the manufacturer guarantees in the event of failure, its free removal, replacement, or repair. The warranty does not cover defects, that are caused by improper handling, failure to comply with the conditions set out in this manual, accident, modification, unsuitable operating conditions, improper maintenance. The manufacturer and supplier is not liable for consequential damages caused by the inability to use the device for the duration of its failure. Some components may have separate warranty period as stated in the user documentation for the product. Accessories has its own guarantee. This product and its components will perform reliably only if they are operated, maintained and stored in accordance with the instructions contained in this manual. Defective product must not be used. Replaceable parts (generally electrode accessories), where is visibly obvious that are worn, missing or damaged they must be replaced with undamaged. EEG device operator is solely responsible for any failures resulting from improper use or maintenance, or repair by anyone other than a qualified representative of the Supplier and also because of failure caused by any parts that have been damaged or altered by anyone other than a qualified representative of the Supplier.

List of used legislation and CSN standards Electromyography TruTrace is in compliance with these laws and standards:

Act no. 268/2014 Coll.

The law on medical devices.

Government Regulation Government Regulation on technical no. 54/2015 Coll. requirements for medical devices. Directive 93/42 / EEC

The Medical Devices Directive.

Government regulation on the restriction of use Government Regulation of certain hazardous substances in electrical and no. 481/2012 Coll. electronic equipment. Medical electrical equipment. Part 1: General requirements for safety. Medical electrical equipment - Part 1-1: General requirements for safety - Collateral Standard: CSN EN 60601-1-1 ed.2:2001 Requirements for health security. electrical systems. Medical electrical equipment - Part 1: General CSN EN 60601-1-4:1998 requirements for safety - 4th family standard: Programmable medical electrical systems. Medical electrical equipment - Part 2-40: Particular requirements for safety, CSN EN 60601-2-40:1999 electromyography and evoked potentials evaluation. Medical electrical equipment - Part 1-2: General requirements for basic safety and CSN EN 60601-1-2 ed.2:2008 essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. Medical electrical equipment - Part 1-6: Particular CSN EN 60601-1-6 ed.3:2010 requirements for basic safety and essential performance - Collateral standard: Usability. Medical devices - Application of risk management CSN EN ISO 14971:2012 to medical devices. Biological evaluation of medical devices - Part 1: CSN EN 10993-1:2010 Evaluation and Testing within a risk management process. Medical devices - Symbols for labels, labeling and CSN EN ISO 15223-1:2012 information provided with medical devices - Part 1: General requirements. CSN EN 60601-1:1994

Installation, training, switching the device on and off Installation Electroencephalograph TruScan can be installed only by people authorized by the Supplier. These during installation also verifies, that the location where the device is to be installed is suitable for this purpose, given the level of interference in these areas and with regard to claims that are specified in the description area in the instruction manual.

Warning:

• Operators must be thoroughly familiar with these instructions for use and should know the ground rules for EEG examination • Patient can not operate the system

Training Before putting the device into operation, all people using the unit must be trained by supplier. The Protocol of training is created and signed by both the person who conducted the training and users. Scope of training must be chosen with regard to the configuration of the installed devices in the workplace.

Switching the device on After installation and training, operator can use the device independently. Before switching on the device, plug the power cord into the outlet. Pressing the power switch to "I ON" will turn on the entire device, including the control PC, monitor and printer. Then, turn on your computer and printer (if you want to use it) by pressing the start button on their cover. The picture below shows the location of the main switch and buttons for turning on (the printer can be placed elsewhere than button shown in the figure, because of multiple types used). Continue by running the software.

Switching off the device For safe shutdown and storing test results properly, turn off the TruScan software first. Then exit the Windows operating system through the Start menu, the entire system automatically shuts down within a few seconds. This is indicated by the green light turning off, on the front of the Control PC (see figure). You can turn off the printer independently, if you do not, during the interval set by the printer manufacturer it will transition to an energy saving mode. Then you can turn off the main switch position to "0 OFF". You don't have to unplug the device from the outlet.

Operating conditions and environment The environment in which the EEG is used, must be selected with regard to operation safety and the possibility of being influenced by other devices (magnetic resonance, magnetic stimulator, etc ..). The room where the Electroencephalograph TruScan is used, must not be exposed to sudden changes in temperature or vibrations. This could result in generation of artifacts - thermoelectric or microphone potentials, whose shape follows the thermal or mechanical action. In rooms where the EEG examination is performed is prohibited to use sources producing extremely high levels of electromagnetic waves, such as mobile or portable phones, transformer solder and fans. If, there is still interference despite these measures, increase the distance between the source of radio frequency interference and the unit, or relocate where this disturbance does not occur. When in doubt, whether the interference is sufficiently suppressed, contact your supplier. The patient should be placed as close to the EEG amplifier unit as possible. The presence of correctly shod and dressed operator near the patient under standard conditions is not harmful. Generally, you should not use synthetic carpets or armchairs with artificial upholstery. Movement of people close to the patient, especially if they are dressed in synthetic garments, may couse artefacts when using a long time base, in the form of of high amplitude waves and slow frequencies. All power cables from the power supply network and the devices they power are recommended to be placed far away from the measured person. For lighting fixtures is recommended to choose a long fluorescent tubes. Flashing fluorescent tube may cause pulse artifacts. Recommended lighting fixtures are classical bulbs, compact fluorescent or LED lighting. The amplifier unit should be placed as close to the measured person as possible. All large metal objects, including furniture in the patient proximity should be grounded. In to a useful signal can penetrate following interference signal due to close alternating magnetic field and a strong static magnetic field (see chapter Interference).

Warning:

For safety reasons this device must be connected to the mains with protective grounding, impedance of the power supply shall meet the conditions set out in CSN standard 33 2000-4-41 ed.2 in Article 411.4.4. Selected place of use, of course, must also satisfy the basic operating conditions: Ambient temperature Ambient Humidity

15-30°C 20-60% (non-condensing)

Configuration and assembly Individual assembly configurations of Electroencephalograph TruScan, may vary depending on the specific order. Part of a data network to which is TruScan electroencephalograph connected, may be a review station. It consists of a standard computer and the TruScan Explorer software. Computer with review station is not a medical device and can be plugged into a standard power supply network. TruScan Explorer software is regarded as a medical instrument.

Types: Type CL (Clinical) - type identification CL 24, CL 32, CL 64, CL 128 and CL 256 (figures after CL notes the number of recording channels). One amplifier unit includes 24 or 32 channels. To build a version with more than 32 channels, it is necessary to involve multiple amplifier units. One USB adapter can connect up to two amplifiers, for the version with 256 channels, it is necessary to use eight amplifiers and four USB adapters. When connecting multiple amplilfiers to up to 256 channels, the total value of leakage current is in accordance with the CSN 60601-2-26 ed.2.:2003. Connection of multiple amplifiers is explained in chapter "System connection"

Example of possible CL configurations: Electroencephalograph TruScan type CL - General Assembly without photostimulation lamp on the hospital cart

Electroencephalograph TruScan type CL - General Assembly on the hospital cart

The simplest type of assembly of Electroencephalogram TruScan CL on the hospital cart.

Basic set on the hospital cart, the amplifier and photo-stimulation lamp is attached to a moveable arm.

Electroencephalograph TruScan type CL - General Assembly on the hospital cart for LTM

Electroencephalograph TruScan type CL - General Assembly for a table with FlexiTrolly and movable arm

This assembly provides a large number of tests, including a long time monitoring in the dark.

Basic configuration placed on a table with movable arm on the FlexiTrolly, is ideal for small office, where there is no need to move the computer with monitor.

Electroencephalograph TruScan type CL - General Assembly on the hospital cart with double movable arm on FlexiTrolly

Basic set on the hospital cart with double movable arm, offers comfort in the possibility of working at the cart, while the movable arm can be positioned as close as possible to the patient.

Upgrade Individual configurations can be supplemented by other parts, such as other FlexiTrolly with cameras for LTM, photo-stimulation lamp, printer, infrared lamp etc .. Adding parts to the device (photo-stimulation lamp, movable arm, etc.) is called "upgrade ". This upgrade is always carried out only by the supplier. The upgrade is not always as easy as adding another physical part, it is often necessary to modify an existing device or to install other software.

FlexiTrolley with cameras for LTM

Demonstration of FlexiTrolly with cameras for the long term monitoring, which can be combined with for example basic set on hospital cart. In the case of an upgrade, in which the complete camera system for long-term monitoring is used it is also necessary to upgrade a PC (to be supplemented by a special network card). More information about the line-up with long-term monitorking, please refere to Chapter "Electroencephalograph TruScan type CL - basic set with LTM.

Photo-stimulation lampa

Photo-stimulation lamp can also be retrofitted on the moveble arm of the hospital cart.

Type PT (Portable) - portable version, which is powered from a laptop (5V DC from USB port) PT 24, PT32, PT64 and PT128 (digits after PT indicates the number of recording channels) to achieve variations PT 64 is required to use two amplifiers and one USB adapter, variant PT128 is necessary to use two USB adapters and four amplifiers. When connecting multiple amplilfiers to up to 256 channels, the total value of leakage current is in accordance with the CSN 60601-2-26 ed.2.:2003. Connection of multiple amplifiers is explained in chapter "System connection"

Elektroencefalograf TruScan typ PT se skládá vždy ze Snímací jednotky, USB adaptéru a kabelů k propojení jednotlivých komponent. Dle jednotlivé kofigurace se může elektroencefalograf TruScan typ PT skládat i z traveleru (nahrazuje USB adaptér, kabely a klávesnici) a fotostimulační lampy. Electroencephalograph TruScan type PT always consists of an amplifier unit, a USB adapter and cables to connect the individual components. According to various configurations electroencephalograph TruScan type PT may also consist of Traveler (replaces USB adapter, cables and keyboards) and photo-stimulation lamp.

Example of possible configurations of the type PT: TruScan electroencephalograph type PT - General Assembly

TruScan electroencephalograph type PT - Traveler

Upgrade

Upgrade for type PT is also possible, but partly limited due to use of the notebook. Most often it is connecting photo-stimulation lamps, other amplifier units or Traveler.

Warning:

• Do not connect any device to the electroencephalogram TruScan, if this is not explicitly stated in the instructions for use. If in doubt, contact your supplier.

Connecting to a computer network • physical layer If necessary, to connect TruScan EEG version PT (portable EEG) to local or hospital computer network, it's needed for metallic connection to the computer network to use insulating separator, that ensures fulfillment of the prescribed standard insulation properties. For wireless or optical transmission is this requirement waived. • logical layer Communication in between the Recording and Reviewing station respectively Server runs over standard TCP-IP and is not encrypted, so the use of public computer networks (e.g. the Internet) is technically possible, but not recommended due to the absence of transmission of encoded communication channel. For this reason, it is not possible to ensure the protection of personal data.

Connecting external devices to PC

The electroencephalograph TruScan is allowed to connect a USB flash drive or external hard drives with an internal power supply, external hard drives with external power supply should not be used because of possible interference during the recording of the EEG signal (if using an external drive with power supply, it is not allowed to connect a power supply of this drive directly to the power network, but only through a safety transformer (for PT version is the ability to connect an external drive with power supply excluded).

Warning:

• For the interconnection of components always use the original cables. During any manipulation with the fiber optic cables is forbidden to bend to radius smaller than 20 cm, other cables to the bending radius of 10 cm to avoid damage to the cables at too sharp angle bend.

Electroencephalograph TruScan Type CL Advantage of type CL is compactness, while maintaining the availability of all controls. It also minimizes the amount of externally routed cables. Among separable parts of electroencephalograph TruScan type CL include only the amplifier unit, type PT have more separable parts. This type is often used in neurological clinics where there is enough space for investigation bed. The total weight of complet system in basic assembly is about 50kg.

Warning:

• Workdesk and especially retractable keyboard holder is not designed for excessive mechanical load, eg. sitting on it.

Electroencephalograph TruScan type CL - General Assembly Electroencephalograph TruScan type CL in basic package excels in its practicality, it offers everything that is needed for recording of a standard EEG and evoked potentials. Hospital cart is equipped with four wheels, two of which are equipped with brakes for solid stopping of the entire system.

EEG amplifier unit

TruScan EEG unit amplifies the input signal of active electrodes towards the reference electrode, converts it into a digital format and transmits it through the optical cable into the USB adapter. Thurum this cable runs also communicate back from USB adapter to the amplifier unit. The amplifier unit is for security reasons and in order to ensure the least possible interference from the network, completely isolated from the PC, the amplifier is powered by a Li-Ion batteries, but they can be charged when not acquiring EEG signal. All device parameters are totally independent of battery condition. When critically low voltage, the device automatically shuts down and can not be used without changing or charging the batteries. Battery status, respectively needs to charge the battery is indicated in the TruScan Acquisition software. After using the system it's not necessary to take out the battery, or to shut down the system, it automatically turns off after leaving the control program or disconnecting fiber optic line. Under exceptionally adverse circumstances, with open optical connector the amplifier may self-activate, when optical receiver is impacted by extremely inappropriately modulated light (eg. By placing open input into close proximity with the monitor). Daily shine of any amount will not turn on the amplifier. This selfactivation does not affect the life of the device, but it can discharge the battery. At a distance greater than 30 cm from conventional pulsed optical sources such as eg. fluorescent lighting or light from the television, the amplifier will not self-activate. An important aspect of the amplifier unit is measuring the size of the transition impedance between the active electrode and the skin in real time. In measuring the size of the transition impedance of the reference electrode unit is measured and shows the size of the sum of the impedance between the reference electrode and the ground electrode. Since the size of the impedance within the patient is negligible against the size of the transition impedance of skin to electrode, impedance measurement relates to nearly perfectly conducting internal tissues of the patient. DC component of the active electrodes is measured also with respect to the reference electrode, the DC polarization voltage of reference electrode - ground electrode is the voltage difference of the reference and the ground electrode. The amplifier unit measures all signals againts reference electrode, used montage