natus XLTEK Protektor32 User manual

XLTEK Protektor32
Instructions for Use

XLTEK Protektor32 Instructions for Use
1
Publisher’s Notice
009090, REV I
Xltek Protektor32 Instructions for Use
Natus Medical Incorporated
DBA Excel-Tech Ltd. (XLTEK)
2568 Bristol Circle
Oakville, Ontario, L6H 5S1 Canada
Tel: [phone] or Fax:
905 - 8 29- 5304
Tol
l Free (US & Canada): 800-303-0306
Technical Support Email: [email protected]
Website: natus.com
EUROPEAN AUTHORIZED REPRESENTATIVE:
Natus Manufacturing Limited
IDA Business Park, Gort
Co. Galway, Ireland
Copyright © 2020 by Natus Medical Incorporated.
Issued in September 2020
All rights reserved. This manual contains proprietary information, which is protected by copyright and
may not be copied in whole or in part except with the prior written permission of Natus Medical
Incorporated. The copyright and the foregoing restrictions on the copyright use extend to all media in
which this information is preserved.
This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus
Medical Incorporated or its distributors. Natus Medical Incorporated makes no representations or
warranties of any kind whatsoever with respect to this document. Natus Medical Incorporated disclaims
all liabilities for loss or damage arising out of the possession, sale, or use of this document.

XLTEK Protektor32 Instructions for Use
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TABLE OF CONTENTS
PROTEKTOR32 – INTRAOPERATIVE NEUROPHYSIOLOGICAL MONITORING .................. 6
Indications for Use ............................................................................................................................................. 6
Protocols ........................................................................................................................................................... 6
SAFETY INFORMATION........................................................................................................................ 7
Critical Warnings and Cautions........................................................................................................................... 7
General Warnings .............................................................................................................................................. 7
General Cautions ..............................................................................................................................................11
Audio/Visual Stimulation Warnings...................................................................................................................11
Protektor32 with the Electro-Surgical Units (ESU) – Guidelines ..........................................................................12
Output Waveforms ...........................................................................................................................................12
Electrostatic Discharge (ESD) handling procedures and warnings.......................................................................13
PROTEKTOR32 SAFETY AND STANDARDS CONFORMITY ....................................................14
Essential Performance.......................................................................................................................................14
Standards Compliance and Normative References Information .........................................................................14
Declaration of Compliance for IEC 60601-1-2 .....................................................................................................17
Table 4 - Immunity Test Levels - Enclosure Port......................................................................................................17
Table 5 – Immunity Test Levels – Input A.C. Power Port.........................................................................................17
Table 7 – Patient Coupling Port ...............................................................................................................................18
Table 8 – Immunity Test Levels - Signal Input / Output Parts Port..........................................................................18
Table 9 - Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment .........19
Declaration of Compliance for FCC ....................................................................................................................20
REGULATORY SYMBOLS....................................................................................................................21
PROTEKTOR32 SYSTEM CONFIGURATION.................................................................................23
Protektor Headbox............................................................................................................................................24
Protektor32 Headbox Features ...............................................................................................................................24
USING THE TCMEP STIMULATOR WITH PROTEKTOR32 ......................................................28
Safety Information............................................................................................................................................28
Contra-Indications and Exclusions...........................................................................................................................28
Protocol for Elicitation of TcMEPs......................................................................................................................28
TcMEP Warnings and Cautions ..........................................................................................................................29
Stimulation limitations of the TcMEP modality..................................................................................................30
Pulse Train Safety Limits ..........................................................................................................................................30
Current Density........................................................................................................................................................31

Instructions for Use XLTEK Protektor32
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RECOMMENDED USER PERFORMED MAINTENANCE..............................................................33
Routine System Maintenance............................................................................................................................33
General User Performed Maintenance ..............................................................................................................33
Maintenance Warnings .....................................................................................................................................33
Environmental Conditions.................................................................................................................................34
Waste Management..........................................................................................................................................34
PROTEKTOR32 SOFTWARE / EPWORKS ....................................................................................35
Setting Up Tests ................................................................................................................................................35
Create a Basic Test...................................................................................................................................................35
DATA ACQUISITION ............................................................................................................................50
Types of Recordings ..........................................................................................................................................50
Live Data Recording Window Overview .............................................................................................................50
Acquisition Toolbar...........................................................................................................................................51
Stimulators Window ................................................................................................................................................51
Groups Window....................................................................................................................................................... 51
Waveform Window .................................................................................................................................................52
Waveform Display Mode – Menu Options ..............................................................................................................53
Using Markers..........................................................................................................................................................55
Measuring Waveforms with Cursors .......................................................................................................................56
Impedance Check..............................................................................................................................................57
EEG / SPECTRAL WINDOWS.............................................................................................................59
EEG Live Window ..............................................................................................................................................59
EEG Review Window .........................................................................................................................................59
Reviewing EEG Data.................................................................................................................................................59
EEG Review Window Overview ...............................................................................................................................60
Spectral Window: CSA and DSA EEG........................................................................................................................61
Quadrant-DSA Window ...........................................................................................................................................63
Spectral Review Windows .................................................................................................................................64
REVIEWING A STUDY .........................................................................................................................65
Timebar ............................................................................................................................................................66
Timebar Overview ...................................................................................................................................................66
Log Book...........................................................................................................................................................68
Trending Window Overview..............................................................................................................................69
History Window Overview ................................................................................................................................70
History Window – All Traces....................................................................................................................................70
REPORTS ................................................................................................................................................72

XLTEK Protektor32 Instructions for Use
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Creating Generic Reports ..................................................................................................................................72
REMOTE MONITORING......................................................................................................................73
Before You Begin ..............................................................................................................................................73
XLTEK Portals ....................................................................................................................................................73
LocalPortal ...............................................................................................................................................................73
RemotePortal...........................................................................................................................................................73
Multiple Connections ..............................................................................................................................................74
Additional Information and Terms ..........................................................................................................................74
TOOLBAR BUTTONS ...........................................................................................................................76
ACCESSORIES ........................................................................................................................................77

Instructions for Use XLTEK Protektor32
6
Protektor32 – Intraoperative Neurophysiological
Monitoring
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.

XLTEK Protektor32 Instructions for Use
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Safety Information
The Protektor32 System is intended for use ONLY by qualified individuals who have received training
on this device. Read carefully this manual and make sure you fully understand all warnings and
cautions, and the procedures to follow before operating the Protektor32 system.
For TcMEP specific warnings and cautions, refer to the section “Using the TcMEP Module on
Protektor 32”in this manual.
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 bite-
related 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 1-800-303-0306 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.

Instructions for Use XLTEK Protektor32
8
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.

XLTEK Protektor32 Instructions for Use
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Patient movement may occur during stimulation, leading to inadvertent neural injury. Take
adequate steps to avoid stimulation when patient movement could cause injury.
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.

Instructions for Use XLTEK Protektor32
10
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).
The accessories of this device may include several kinds of disposable, sterile electrode
needles. These needles are labeled as STERILE and the method of sterilization is
documented on the packaging. These electrodes should not be used if the sterile
packaging has been tampered with.
The computer (desktop PC or laptop) connected to the Protektor32 headbox has a cooling
fan. Keep this area unobstructed to prevent overheating.
When the Protektor32 comes to the end of its operating life, it should be disposed of in
accordance with local waste disposal regulations.
Do not place more than 10lbs in the accessory bin on the Protektor32 Cart.
Multiple Portable Socket Outlets (MPSO) shall not be placed on the floor.
Additional MPSO or extension cord shall not be connected to the system.
Do NOT connect items which are not specified as part of the system.
Do NOT touch any Protektor32 accessible metal parts and the patient simultaneously.
Do NOT connect non-medical equipment, which has been supplied as a part of the system,
directly to the wall outlet when the system is supplied via MPSO with a separating
transformer.
Do NOT connect electrical equipment which, has not been supplied as a part of the
system, to the MPSO.
Connection of a patient to high-frequency surgical equipment (electrosurgical unit) 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. To minimize the potential for
such issues, read and follow the section of this manual labelled: “Guidelines for the use of
Protektor32 with Electro-Surgical Units.”
Corruption/loss of data over network due to unplugging the network cable or data
interruption during data transfer/hardware failure/ corrupt software.

XLTEK Protektor32 Instructions for Use
11
Do not install any other software than the EPWorks Software. Natus assumes no
responsibility when the equipment is not used as described in this manual.
Never touch the patient while connecting or disconnecting any connectors.
Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the
Protektor32 System, including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
General Cautions
It is recommended that the stimulator probe be disinfected between patients with 70%
isopropyl alcohol. This is not a method of sterilization if the stimulator is used invasively.
Turn off all system power and disconnect the power cord from the system and the wall
before attempting to clean the unit. The Protektor32 headbox can be wiped clean with a
soft, damp cloth using non-conductive distilled water, electrically non-conductive inert
surfactants or an Xltek-approved cold sterilizing agent. It is important to dry off the units
quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do not
use any abrasive cleaner on the system.
Inspect all cables and connections (especially the power cord) often for signs of fraying or
other damage. Do not operate the Protektor32 headbox if you suspect damage to any of the
cables or the power cord.
Do not leave any cables attached to the Protektor32 headbox when transporting the unit.
This may cause connections to become loose or malfunction during operation of the unit.
Do not turn on the power to the Protektor32 headbox immediately after bringing it in from a
cold environment to one at room temperature. Allow the unit to assume the ambient
environmental temperature (i.e. one hour warm up).
The isolated switch mode power supply is intended for connection only to a 110V, 120V,
220V or 240V external (wall) outlet.
Audio/Visual Stimulation Warnings
Only the Telephonics Model TDH-39P headphones and ear inserts (TIPS) provided have
been approved for use with your Protektor32. Patient isolation in accordance with
IEC60601-1 is dependent on the approved parts.

Instructions for Use XLTEK Protektor32
12
Only equipment approved to IEC950, IEC 60601-1 or a similar safety standard may be
connected to the VGA port on the Protektor32. The final system must be configured to meet
the requirements for safety of medical systems prescribed by IEC60601-1-1.
Exposure to excessive sound can cause temporary and even permanent hearing loss.
Long-term exposure to excessive light can cause temporary and even permanent changes
in visual acuity.
Patient electrical isolation is ensured when all peripherals (headphones, printer, goggles,
monitor) attached to the Protektor32 are Xltek-approved. The final system configuration
must meet the requirements of IEC60601-1 for safety of medical systems.
If you choose to attach a VGA display other than the model supplied by Xltek, it MUST
either meet IEC60601-1 or the leakage current requirements for your jurisdiction.
Protektor32 with the Electro-Surgical Units (ESU) – Guidelines
Follow the safety guidelines below to ensure proper use of Protektor 32 with the Electro-Surgical Unit.
Failing to follow these guidelines may result in skin burns to the patient, and /or damage to the Protektor
32 unit.
1. When ESU is active, keep the ESU pencil away from the Acquisition box and stimulation
electrodes.
2. Use as large as possible patient ground electrode connected to the Protektor32 ground input.
3. Do not place Protektor32 ground electrode(s) in close proximity to the ground return electrode for
the ESU. Do not connect the ESU ground electrode to the Protektor32 ground.
4. Ensure that the dispersive pad for the ESU has a good electrical contact with the patient.
Although certain ESUs have a mechanism for checking the quality of contact, always visually
inspect the dispersive pad to ensure that it is properly applied.
Do not activate the electrosurgical unit for extended periods of time, unless the ESU
electrode is in direct contact with the patient.
Output Waveforms
The output waves from the Protektor32 are required to electrically stimulate the patient and evoke a
response. These waves have no D.C. component and are limited to ±400V and 100 mA on the standard
electrical stimulators, ±500V and 1500mA on the TCeMEP stimulator, and ±10V and 40mA on the
surgical probe stimulators. Since there is no D.C. component to the output, there are no specific
precautions which need to be taken with regard to a D.C. component.
If the load impedance exceeds the voltage limit for a given current, the stimulation output is attenuated in
proportion to the resistance. Typical loads would be in the range of 500 Ohms to 10 kOhms. The

XLTEK Protektor32 Instructions for Use
13
stimulation pulse duration ranges from 0.05 ms to 1.0 ms. Pulses are repetitive up to a maximum
frequency of 500 Hz.
Electrostatic Discharge (ESD) handling procedures and warnings
Before performing any setup or placement procedures, it is recommended that all clinical staff read and/or
are trained on the precautions outlined in this section.
WARNING: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions.
Disconnect the cables before moving, cabling, or performing any set up procedures.
Some semiconductor (solid state) devices can be easily damaged by static electricity.
Such components are commonly called Electrostatically Sensitive Devices (ESD). Do not
touch the accessible conductive parts for the Connectors marked with the ESD symbol.
Follow these techniques to help reduce the incidence of component damage caused by
static electricity:
•Immediately before handling any product components assemblies, drain the electrostatic charge from
your body by touching a known earth ground.
•Minimize body motions when handling unpackaged replacement ESDs. Motions such as brushing
clothes together or lifting your foot from a carpeted floor can generate enough static electricity to
damage the product components.
•Avoid carpets in cool, dry areas. If provided, leave the product components in their anti-static
packaging until ready to be installed.
•Take care when connecting or disconnecting cables. When disconnecting a cable, always pull on the
cable connector or strain-relief loop, not on the cable itself.
WARNING: A damaged cable can cause a short in the electrical circuit. Prevent damage to
the connectors by aligning connector pins before you connect the cable.
WARNING: Misaligned connector pins can cause damage to system components at power-
on.

Instructions for Use XLTEK Protektor32
14
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. Type of protection against electric shock: Class I
2. Degree of protection against electric shock: Type BF
3. Degree of protection against ingress of water: IPX0
4. 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

XLTEK Protektor32 Instructions for Use
15
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

Instructions for Use XLTEK Protektor32
16
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 Instructions for Use
17
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 The Protektor32
is suitable for use in all establishments other than
domestic and those directly connected to the public low-voltage
power supply network that supplies buildings used for domestic
purposes.
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.
Harmonic
emissions IEC
61000-3-2
Class A
Voltage
fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Table 4 - Immunity Test Levels - Enclosure Port
Phenomenon Basic EMC
Standard or Test
Method
Immunity Test Levels – Professional
Healthcare Facility Environment
Electrostatic Discharge 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 Basic EMC
Standard
Immunity Test Levels – Professional
Healthcare Facility Environment

Instructions for Use XLTEK Protektor32
18
Electrical Fast Transients /
Bursts
IEC 61000-4-4 ± 2 kV
100 kHz repetition frequency
Surges
Line-to-line (Differential Mode)
IEC 61000-4-5 ± 0,5 kV, ± 1 kV
Surges
Line-to-ground (Common Mode)
IEC 61000-4-5 ± 0,5 kV, ± 1 kV, ± 2 kV
Conducted Disturbances
Induced by RF Fields
IEC 61000-4-6 3 V
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)
Table 7 – Patient Coupling Port
Phenomenon Basic EMC Standard
or Test Method
Immunity Test Levels – Professional
Healthcare Facility Environment
Electrostatic Discharge IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Conducted Disturbances
Induced by RF Fields IEC 61000-4-6
3 V
0,15 MHz – 80 MHz
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
Immunity Test Levels – Professional
Healthcare Facility Environment
Electrostatic Discharge IEC 61000-4-2 ± 8 kV contact
± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
Electrical Fast Transients/Bursts IEC 61000-4-4 ± 1 kV