Xltek Protektor32 User and Service Manual Rev J

XLTEK Protektor32

User & Service Manual

Table of Contents INTRODUCTION... 8 USING THIS MANUAL ... 8 ABOUT THE PROTEKTOR32 ... 9 Protektor32 Features ... 9

PURPOSE OF THE PROTEKTOR32 ... 10 Indications for Use ... 10 Protocols ... 10

UPGRADE FROM 16 CHANNEL TO 32 ACTIVE AMPLIFIER CHANNELS ... 11 PROTEKTOR32 SAFETY AND STANDARDS CONFORMITY... 12 Essential Performance ... 12 Standards Compliance and Normative References Information ... 12 Declaration of Compliance for IEC 60601-1-2 ... 14 Table 3 - Electromagnetic Emissions ...14 Table 4 - Immunity Test Levels - Enclosure Port ...14 Table 5 – Immunity Test Levels – Input A.C. Power Port ...15 Table 7 – Patient Coupling Port ...16 Table 8 – Immunity Test Levels - Signal Input / Output Parts Port ...16 Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment ...17 Declaration of Compliance for FCC ... 17

WARNINGS AND CAUTIONS... 18 Critical Warnings and Cautions ... 18 General Warnings ... 18 General Cautions ... 22 Audio/Visual Stimulation Warnings ... 22 Electrostatic Discharge (ESD) handling procedures and warnings ... 23

DESCRIPTION OF SYMBOLS ... 24

SPECIFICATIONS: PROTEKTOR32 ... 26 General Specifications ... 26 System Architecture ... 27 Waveform Acquisition ... 27 Amplifiers ... 27 Stimulators ... 28 Electric Stimulator Energy Limits... 30

PROTEKTOR32 LABELING... 31 Isolation Box Label (Top) ... 31 Isolation Box Warning Label (Bottom) ... 31 Acquisition Box Label (Top)... 32 Acquisition Breakout Box Label (Front) ... 32 Stimulator Box Label (Top) ... 33 Stimulator Box Label (Front) ... 33 Stim Pod Labels ... 34 Acquisition Pod Labels ... 34

PROTEKTOR32 SYSTEM CONFIGURATION... 35 CONNECTING THE PROTEKTOR32 ... 36 USING THE TCMEP MODULE ON PROTEKTOR32 ... 38 Contra-Indications and Exclusions ... 38 Protocol for Elicitation of TcMEPs ... 38 TcMEP Warnings and Cautions ... 39 Stimulation Limitations of the TcMEP Modality ... 40 Energy Limitation Per Pulse ...40 Energy Limitation Per Time Period ...40 Pulse Train Safety Limits Energy Calculation ...40

OUTPUT WAVEFORMS ... 43

XLTEK Protektor32

User & Service Manual

ELECTRIC STIMULATOR LOAD... 44 Standard Stimulator ... 44 Tcmep Stimulator ... 44 Surgical Probe ... 44

CAUTERY DETECTOR ... 45 Connecting the Cautery Detector ... 45 Operating Instructions ... 46 Electrosurgery Setup ... 46 Guidelines for the use of Protektor32 with Electro-Surgical Units (ESU) ... 46 Cautery Detector Warnings and Cautions ... 47

SETTING UP TESTS WITH PROTEKTOR32 SOFTWARE (EPWORKS) ... 48 CREATING A PROTEKTOR32 TEST WITH THE WIZARD ... 67 RECORDING (ACQUISITION) ... 76 About Recording (Acquisition) ... 76 Example of a Single Acquisition Screen ...76 Example of a Multiple Acquisition Screen ...77 Check Impedance... 77 Seeing Results: The Waveform Window ... 78 Display Mode ... 80 Using Markers... 82 Place a Marker on a Waveform ...83 Change the Location of a Marker ...84 Delete a Marker ...84 Measuring Waveforms With Cursors...85 Waveform Window Properties ... 85 Waveform Window Properties: General Tab ...85 Waveform Window Properties: Layout Tab ...86 Waveform Window Properties: Misc Tab ...86 Waveform Window Context Menus ... 87 Waveform Context (right-click) Menu ...87 Trace Context (right-click) Menu ... 89

Waveform Window Context (right-click) Menu ... 90 Trace Properties ... 92 Trace Properties Window ...92 Trace Properties: Trace Tab ...92 Trace Properties: Channel Tab ...93 Trace Properties: Group Tab ...94 Waveform Properties ... 96 Waveform Properties: Waveform Tab ...96 Waveform Properties: Trace Tab ...97 Waveform Properties: Channel Tab ...98 Waveform Properties: Group Tab ...98 Waveform Properties: Notes Tab ...100 Controlling the Stimulators - The Stimulators Window ... 101 Controlling the Acquisition - The Groups Window ... 102 Raw Sweeps Window ... 102 Rejection Threshold Bars ...102 Waveform Properties Label ...103 Raw Sweeps Window Context Menu ...103 Avoiding Parasitic Noise ... 103 Using the Periodic Parasitic Signal Avoidance Utility ... 103 Automatic Stimulation Rate Adjustment ... 104 Manage Stimulator Settings... 104 Workflow ... 105 Periodic Noise Remaining in the Averaged SSEP for Known Frequencies ...105 New Noise Frequencies in the Averaged SSEP ...106 Off-Line Processing: Defining Optimal Stimulation Rates...107 Reviewing Studies ... 108 Log Book ... 109 Tracking Notes - The Log Book ...109 Log Book Context Menu ...109 Timebar ... 110 Using the Timebar ...110 Main Features of the Timebar ...110 Timebar Navigation Buttons ...111 Timebar (right-click) Context Menus ...112 Timebar Ticks ...113 Timebar Links to Windows in the Study ...114 Trending ... 116 Viewing Calculations - The Trending Window ...116 Trending Display Configurations ...117

XLTEK Protektor32

User & Service Manual

Trending Window Context Menu ...119 History ... 121 History Window ...121 History Display Configurations ...124 History Window Context Menu ...125 EEG Live Window ...127 EEG Review Window ...128 Spectral Window: CSA and DSA ...129

MENUS AND TOOLBARS ... 138 File Menu ... 138 Edit Menu ... 139 View Menu ... 139 Controls Menu ... 141 Cursors Menu ... 141 Tools Menu ... 142 Window Menu ... 143 Help Menu ... 144 EPWorks Help ...144 About EPWorks ...144 Toolbars... 145 Toolbar Buttons ...145 Customizing EPWorks ... 147 Customize: Options Tab ...147 Customize: Notes Tab ...149 Customize: Traces Tab ...150 Customize: Sets Tab ...151 Customize: Waveforms Tab ...153 Customize: Trending Tab ...155 Customize: History Tab ...156 Customize: Stimulators Tab ...158 Customize: Colors Tab ...160 Customize: Reporting Tab...162 Customize: Timebar Tab ...162

REPORTING ... 165 Creating Generic Reports ... 165 Creating Customized Reports ... 165

What is a Reporting Template? ... 165 Creating Test-Specific Templates ... 165 Creating Study Templates ... 166

REMOTE MONITORING ... 167 Before You Begin: ... 167 LocalPortal ... 167 RemotePortal ... 167 Multiple Connections... 167 Additional Information and Terms ... 167

VIDEO MICROSCOPE ... 169 RECOMMENDED USER PERFORMED MAINTENANCE ... 170 Routine System Maintenance ... 170 General User Performed Maintenance ... 170 Maintenance Warnings ... 170

TROUBLESHOOTING... 171 Minimizing 60 Hz Noise ... 171 General Troubleshooting Checklist ... 172

GETTING HELP... 173 Step 1: Document the Incident ... 173 Step 2: Contact Technical Support ... 173

ACCESSORIES ... 174 A TOTAL SERVICE SOLUTION ... 175

XLTEK Protektor32

User & Service Manual

Introduction Thank you for purchasing the Xltek Protektor32. Natus is one of the world's top manufacturers of neurodiagnostic equipment and software and is committed to providing you with technologically advanced products that are practical and easy to use. We encourage all feedback and any suggestions you have regarding any aspect of the Xltek Protektor32 system, the manual, our line of accessories and our support services. The Xltek Protektor32 headbox connects to:  

The Xltek Desktop for low-cost applications; The Xltek Laptop for portable applications. WARNING: We strongly recommend that you read the Warnings and Cautions section before operating Protektor32.

Using This Manual This manual describes the theory, features, set up, operation, and maintenance of the Protektor32 hardware. It also provides information on troubleshooting, specifications and getting help. When going through the procedures, we recommend you read the entire section first, before beginning a sequence. Also, please follow instructions carefully. Various symbols and typographical conventions are used throughout the manual. The following table illustrates them and describes their meanings and functions.

Symbol/

Description/Function

Convention A warning or caution that provides important information that should not be missed. Read all warnings carefully before starting the system for the first time. In some cases, a personal safety hazard may be indicated. A note that provides extra information. Bold

Bold text denotes key words and phrases.

BOLD CAPS

Bold capital letters indicate extra emphasis.

About the Protektor32 The Protektor32 Intraoperative Monitoring System (IOM) contains a complete data acquisition system that has built-in amplifiers, A/D Converters, Digital Signal Processors, CPUs, and storage devices.

Protektor32 Features              

16 or 32 Active Amplifier Channels Two (2) independent electrical stimulators, each with eight switchable output ports, and a lowcurrent probe port One (1) auditory stimulator One (1) visual stimulator Two (2) bi-directional external triggers Full bandwidth acquisition (60 kHz sampling) OR (Operating Room) ready Simultaneous multi-channel EP, EMG, and EEG Ultra-low-noise amplifiers Connects to laptop or desktop Small and light enough to be carried into the OR Switch matrix Stim pods Breakout box

The Protektor32 can be interfaced to other equipment through 2 external trigger input/outputs, and a cautery detection port. The system provides a flexible and efficient toolset that allows users to quickly setup and perform advanced IOM studies including simultaneous access to all modalities. Protektor32 modalities include:        

Electroencephalography (EEG) Free Run and Triggered Electromyography (EMG) Somatosensory Evoked Potentials (SSEPs) Brainstem Auditory Evoked Potentials (BAEPs or BAERs) Visual Evoked Potentials (VEP) Transcranial Motor Evoked Potentials (TcMEPs) EP Grid-Display Direct Nerve Stimulation

XLTEK Protektor32

User & Service Manual

Purpose of the Protektor32 Indications for Use The Protektor32 system, composed of both hardware and software, is intended to be used for intraoperative neurological Monitoring. The instrument uses EEG, EP, EMG and Transcranial Stimulation techniques (TcMEP) to provide the healthcare professionals with information to help assess a patient’s neurological status during surgery. The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software’s outputs is as follows:  

The EEG, EP, and EMG waveforms are intended to help the user assess a patient’s neurological status during surgery. Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier Transform (FFT) displays (CSA, DSA) are intended to help the user analyze the EEG and EP waveforms.

This device is intended to be used by qualified medical practitioners, trained in Electroencephalography, Evoked Potentials and Electromyography, who will exercise professional judgment when using the information.

Protocols As stated by the America Academy of Neurology (2008) “[...] the quality, extent and type of monitoring [...] is exquisitely reliant on the rigors of the monitoring procedure and protocols, and the clinical expertise of the monitoring physician.” All things considered, Intraoperative neurophysiological monitoring depends on the collection of data that will be judiciously interpreted by the trained professional to identify neurological changes due to operative manipulations. The Protektor32 offers flexibility to accommodate user needs for intraoperative monitoring. It provides an easily accessible interface to quickly set up protocols when performing the following intraoperative monitoring procedures:  



Central Sulcus Mapping: A method for intraoperative determination of the central sulcus using SSEP and/or Motor Evoked Potentials. Pedicle Screw Stimulation: A method or technique for monitoring pedicle screw placement and performed by applying stimulation of the “pedicle screw” and recording the evoked EMG activity from the muscles innervated by the spinal nerve roots at risk. Direct Nerve Stimulation: A method used to evaluate damaged nerves. It is based on the possibility to record and analyze a type of evoked potential (EP) called Nerve action potential (NAP) which is a the total electrical potential that develops and travels within a nerve after its constituent nerve fibers have been stimulated- either physiologically or physically- to a level above their threshold.

The above reflects TcMEP protocols only as they relate to the intended use of the Protektor32.

Upgrade from 16 Channel to 32 Active Amplifier Channels If your Protektor32 is configured for 16 active amplifier channels, it is easily upgraded from 16 active amplifier channels to 32 channels. To perform the upgrade, contact your Natus Representative.

XLTEK Protektor32

User & Service Manual

Protektor32 Safety and Standards Conformity Essential Performance The potential sources of unacceptable risk identified to characterize the ESSENTIAL PERFORMANCE of EMG DIAGNOSTIC EQUIPMENT are: 

  

Minimum noise on a waveform or artifacts or distortion in an image and any error of a displayed numerical value which cannot be attributed to a physiological effect and which may alter the diagnosis Free from the display of incorrect safety-related indications Free from the production of unintended or excessive stimulation output Free from the production of unintended or excessive patient applied parts surface temperature

Standards Compliance and Normative References Information Intraoperative Neuromonitoring device, Model Protektor32, transportable / mobile (when mounted on cart), rated: 24Vdc, 2A. For use with external power supply (Jerome Industries; model WSL524MC; rated 100~240Vac, 50/60Hz, 140VA; Xltek P/N 005307) 1. 2. 3. 4.

Type of protection against electric shock: Class I Degree of protection against electric shock: Type BF Degree of protection against ingress of water: IPX0 Degree of safety of application in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide: Equipment not suitable for use in the presence of a flammable anaesthetic mixture with air or with oxygen or nitrous oxide. 5. Mode of operation: Continuous 6. Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa The Protektor32 and its accessories have been designed to comply with the following national and international standards. Table 1 – Safety Standard of Compliance and Normative References IEC 60601-1:2012 (Ed. 3.1)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance Includes national deviations as shown below.

ANSI / AAMI ES 60601-1:2005 + A1:2012

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

CSA C22.2 No. 60601-1:2014-03

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

EN 60601-1:2006 +A1:2013

Medical electrical equipment – Part 1: General requirements for basic safety and essential performance

IEC 60601-2-40:1998 (Ed. 1.0)

Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

IEC 60601-1-6:2010 (Ed. 3.0) + A1: 2013

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 62366: 2007 (Ed. 1.0) + A1: 2014

Medical devices – Application of usability engineering to medical devices

Table 2 – EMC Standard of Compliance and Normative References IEC 60601-1-2:2014 (Ed 4.0)

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance– collateral standard: electromagnetic compatibility – requirements and tests

IEC 60601-2-40:2016 (Ed. 2.0) – Clauses 201.17 and 202

Medical electrical equipment - Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment

IEC 61000-4-2:2008 (Ed. 2.0)

Electromagnetic Compatibility (EMC) Part 4-2: Testing and Measurement Techniques - Electrostatic Discharge Immunity Test

IEC 61000-4-3:2010 (Ed. 3.2)

Electromagnetic Compatibility (EMC) Part 4-3: Testing and Measurement Techniques - Radiated, Radio-frequency, Electromagnetic Field Immunity Test

IEC 61000-4-4:2012 (Ed. 3.0)

Electromagnetic Compatibility (EMC) Part 4-4: Testing and Measurement Techniques - Electrical Fast Transient/Burst Immunity Test

IEC 61000-4-5:2005 (Ed 2.0)

Electromagnetic Compatibility (EMC) Part 4-5: Testing and Measurement Techniques - Surge Immunity Test

IEC 61000-4-6:2013 (Ed. 4.0)

Electromagnetic Compatibility (EMC) Part 4-6: Testing and Measurement Techniques - Immunity to Conducted Disturbances, Induced by Radio-frequency Fields

IEC 61000-4-8:2009 (Ed. 2.0)

Electromagnetic Compatibility (EMC) Part 4-8: Testing and Measurement Techniques - Power Frequency Magnetic Field Immunity Test

IEC 61000-4-11:2017 (Ed. 2.1)

Electromagnetic Compatibility (EMC) Part 4-11: Testing and Measurement Techniques - Voltage Dips, Short Interruptions and Voltage Variations Immunity Tests

IEC 61000-3-2:2018 (Ed. 5.0)

Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for Harmonic Current Emissions

IEC 61000-3-3:2013 (Ed. 3.0)

Electromagnetic Compatibility (EMC) Part 3-3: Limits - Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems

CISPR 11:2010 (Ed. 5.0) + A1

Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance Characteristics - Limits and Methods of Measurement

XLTEK Protektor32

User & Service Manual

Declaration of Compliance for IEC 60601-1-2 Table 3 - Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Protektor32 is intended for use in the electromagnetic environment specified below. The customer or the user of the Protektor32 should assure that it is used in such an environment. Emissions test

Compliance

Electromagnetic environment - guidance

RF emissions CISPR 11

Group 1

The Protektor32 uses RF energy only for its internal function. Therefore, its RF emissions are very low and not likely to cause any interference in nearby electronic equipment

RF emissions CISPR 11

Class A

Harmonic emissions IEC 61000-3-2

Class A

The Protektor32 is suitable for use in all establishments other than domestic and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.

Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

Warning: This equipment/system is intended for use by healthcare professionals only. This equipment/system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Protektor32 or shielding the location.

Table 4 - Immunity Test Levels - Enclosure Port Phenomenon

Electrostatic Discharge

Basic EMC Standard or Test Method

Immunity Test Levels – Professional Healthcare Facility Environment

IEC 61000-4-2

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air

Radiated RF EM Fields

IEC 61000-4-3

3 V/m 80 MHz – 2,7 GHz 80 % AM at 1 kHz

Proximity Fields from RF Wireless Communications Equipment

IEC 61000-4-3

See “Enclosure Port Immunity to RF Wireless Communications Equipment” Table below

Rated Power Frequency Magnetic Fields

IEC 61000-4-8

30 A/m 50 Hz or 60 Hz

Table 5 – Immunity Test Levels – Input A.C. Power Port Phenomenon

Immunity Test Levels – Professional Healthcare Facility Environment

Basic EMC Standard

Electrical Fast Transients / Bursts

IEC 61000-4-4

± 2 kV

Surges

IEC 61000-4-5

± 0,5 kV, ± 1 kV

IEC 61000-4-5

± 0,5 kV, ± 1 kV, ± 2 kV

IEC 61000-4-6

3V

100 kHz repetition frequency

Line-to-line (Differential Mode) Surges Line-to-ground (Common Mode) Conducted Disturbances Induced by RF Fields

0,15 MHz – 80 MHz 6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Voltage Dips

IEC 61000-4-11

100% dip; 0,5 cycle At 0°, 45°, 90°, 135°, 180°, 225°, 270° and 315° 100% dip; 1 cycle and 30% dip; 25 cycles (50Hz) Single phase: at 0°

Voltage Interruptions

IEC 61000-4-11

100% dip; 250 cycles (50Hz) /300 cycles (60 Hz)

XLTEK Protektor32

User & Service Manual

Table 7 – Patient Coupling Port Phenomenon

Electrostatic Discharge

Basic EMC Standard or Test Method

Immunity Test Levels – Professional Healthcare Facility Environment

IEC 61000-4-2

± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air 3V 0,15 MHz – 80 MHz

Conducted Disturbances Induced by RF Fields

IEC 61000-4-6

6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Table 8 – Immunity Test Levels - Signal Input / Output Parts Port Phenomenon

Basic EMC Standard

Electrostatic Discharge

IEC 61000-4-2

Electrical Fast Transients/Bursts

IEC 61000-4-4

Immunity Test Levels – Professional Healthcare Facility Environment ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air ± 1 kV 100 kHz repetition frequency 3V 0,15 MHz – 80 MHz

Conducted Disturbances Induced by RF Fields

IEC 61000-4-6

6 V in ISM bands between 0,15 MHz and 80 MHz 80 % AM at 1 kHz

Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Test frequency (MHz) 385

Band (MHz)

Service

Modulation

Maximum

Distance

IMMUNITY

Power

(m)

TEST LEVEL

(W) 380 –390

TETRA 400

Pulse

(V/m)

1,8

0,3

27

2

0,3

28

0,2

0,3

9

2

0,3

28

modulation 18 Hz 450

430 – 470

GMRS 460, FRS 460

FM ± 5 kHz deviation 1 kHz sine

710

704 – 787

LTE Band 13, 17

745

217 Hz

780 810

Pulse modulation

800 – 960

GSM 800/900, TETRA 800, iDEN 820, CDMA 850,LTE Band 5

Pulse modulation

1,700 – 1,990

GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS

Pulse modulation 217 Hz

2

0,3

28

2,450

2,400 – 2,570

Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7

Pulse modulation 217 Hz

2

0,3

28

5,240

5,100 – 5,800

WLAN 802.11 a/n

Pulse modulation

0,2

0,3

9

870

18 Hz

930

1,720 1,845 1,970

5,500

217 Hz

5,785

Declaration of Compliance for FCC Note:

This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense.

Warning:

Changes or modifications not expressly approved by the manufacturer could void the user's authority to operate the equipment.

XLTEK Protektor32

User & Service Manual

Warnings and Cautions Critical Warnings and Cautions The Protektor32 is intended for use ONLY by qualified individuals who have received training on this device. This user/service manual should be read and understood fully before commencing use of the product. Use of the Protektor32 high-current stimulator for transcranial stimulation can cause biterelated injury. It is imperative that effective preventative measures be implemented BEFORE using the device for this purpose.

General Warnings It is the responsibility of the institution where the Protektor32 unit is installed to ensure that the requirements of IEC60601.1.1-M92 - Collateral Standard: Safety Requirements for Medical Electrical Systems are fulfilled in the particular installation. Non-medical electrical equipment (printers and computers) complying with the appropriate IEC or ISO safety standards may be directly connected to the Protektor32 serial and network ports for data-transfer functions only if both the Protektor32 and the equipment are outside of the patient environment and no patient-applied parts are connected to the patient. For further details on how to comply with this standard regarding non- Xltek supplied printers or VGA monitors, please consult the standard or contact Xltek Technical Support at 1-800303-0306 or [email protected]. WARNING: To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Connecting electrical equipment to a MULTIPLE SOCKET OUTLET (MSO) effectively leads to creating a MEDICAL ELECTRICAL (ME) SYSTEM and the result can be a reduced level of safety. For the requirements that are applicable to an ME SYSTEM, please refer to IEC 60601-1 Ed. 3.1. Connection of a patient to high-frequency surgical equipment (electrocautery) and to an electromyograph or evoked response equipment simultaneously may result in burns at the site of the electrical stimulator or biopotential input part electrodes and possible damage to the electrical stimulator or biological amplifiers. Operation in close proximity (for example 1 m) to shortwave or microwave therapy equipment may produce instability in the electrical stimulator output. The device is NOT intended to operate in the vicinity of strong sources of potential electromagnetic interference such as MRI or CT.

Electrostatic Discharge (ESD) Precaution: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions. Disconnect the cables before moving, cabling, or performing any set up procedures. Connectors marked with the ESD protection symbol should not be touched. All wires to/from the patient must NOT contact any of the conductive parts of the device including earth.

Preventive maintenance is required every six months. This should include chassis and patient leakage current measurements at a minimum.

The device is not protected against defibrillation. All wires to/from the device should be removed before using a defibrillation. Do NOT use this device in the presence of implanted electronic devices unless a specialist medical opinion has been obtained. Do NOT place the stimulation electrodes such that the stimulation current will be trans-thoracic (crossing the area of the chest and thorax.)

The Protektor32 headbox carries ordinary classification for the level of protection against ingress of liquids (IPX0). It is not drip or splash proof.

The Protektor32 headbox requires a properly grounded electrical outlet. The internal isolation transformer must not be bypassed under any circumstances. Stimulating electrodes must be large enough so that the current density is always less than 2 mA r.m.s./cm2. Current densities exceeding 2 mA r.m.s./cm2 may require special attention of the operator. For example, if the stimulus is stimulating at 100 mA at 10 Hz, with a duration of 1 ms, then the stimulus electrode must be at least 0.5 cm2. For a detailed description and calculations of the stimulation parameters needed to achieve less than 2 mA rms / cm2 refer to section Using the TcMEP Module on Protektor32. When an electrode with a small surface area is used (such as a needle electrode), the current density rises. Current density in TcMEP mode is dependent on the stimulation strength (voltage) and number of pulses. If the stimulation parameters are different from those detailed in the table and the voltage is greater than these thresholds, it may cause skin burns. Patient movement may occur during stimulation, leading to inadvertent neural injury. Take adequate steps to avoid stimulation when patient movement could cause injury.

XLTEK Protektor32

User & Service Manual

The Protektor32 shall be used ONLY with legally-marketed electrodes in the country where in use. For instance, in the United-States use ONLY FDA-approved, legally-marketed electrodes. In Canada use ONLY Health Canada-approved legally-marketed electrodes.

Hazardous voltages are exposed when the lid of the Protektor32 headbox is removed.

This system is NOT AP or APG rated. DANGER: Explosion hazard. Do not use in the presence of flammable anesthetics.

Do not turn on the system until all cable connections have been made and their integrity checked. The proper use of this device for its intended purpose can only be assured once all instructions have been read and understood. If there are any questions regarding the operation of this device, please contact your Xltek representative at once. The sale, distribution or use of this device is restricted to, by or on order of a licensed medical practitioner. The Protektor32 headbox is a Type BF device. According to the IEC 60601-1 standard, a BF device is an applied part isolated from other parts of the equipment to such a degree that no current greater than a set level flows if an unintended voltage is connected to the patient. This set level of current is the maximum patient leakage current allowable in a single fault condition. All of the patient connections of the Protektor32 headbox are electrically isolated. However, these connections are not intended for direct cardiac contact. Electrical Shock Hazard. Do not connect electrode inputs to earth ground. The patient headbox contains warning symbols to remind you that the connections are intended for isolated patient connections only.

Remove all unused power cables from the vicinity of the Protektor32 system.

Connect all patient electrodes to fully electrically isolated physiological devices only. Connection to any other device or external outlet may result in personal injury.

The Protektor32 headbox accepts only touch-proof style electrode inputs. Do not attempt to use any other style of patient electrode input. No equipment other than devices connected to the Protektor32 may be powered by an isolation transformer. The current rating of the transformer must be sufficient to operate all of the devices powered by it. Refer to the current ratings of each individual device. Possible interference with signals may occur in certain situations (for example, poor grounding in circuitry and close proximity to other instrumentation such as an MRI).