XLTEK Trex and Trex HD User & Service Manual Rev K

User & Service Manual

Xltek® Trex / Trex HD Amplifier

Table of Contents 1.

INTRODUCTION... 6 1.1.

INTENDED USE... 6

1.2.

USING THE MANUAL ... 7

1.3.

M ANUAL CONVENTIONS ... 7

2.

SAFETY AND STANDARDS CONFORMITY ... 8 2.1.

2.2.

3.

SAFETY AND STANDARDS CONFORMITY FOR XLTEK TREX HD ... 8 2.1.1.

STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES ... 8

2.1.2.

DECLARATION OF COMPLIANCE FOR IEC 60601-1-2 ... 10

2.1.3.

ELECTROMAGNETIC IMMUNITY (EMI) INFORMATION – FCC... 14

SAFETY AND STANDARDS CONFORMITY FOR XLTEK TREX ... 14 2.2.1.

STANDARDS OF COMPLIANCE AND NORMATIVE REFERENCES ... 14

2.2.2.

DECLARATION OF COMPLIANCE FOR IEC 60601-1-2 ... 16

WARNINGS AND CAUTIONS ... 20 3.1.

GENERAL WARNINGS... 20

3.2.

ELECTRICAL W ARNINGS AND CAUTIONS ... 22

3.3.

WIRELESS OPTION WARNINGS AND CAUTIONS* ... 23

3.4.

PATIENT ENVIRONMENT WARNINGS AND CAUTIONS ... 23

3.5.

PULSE OXIMETER WARNINGS... 24

3.6.

PULSE OXIMETER SENSOR WARNINGS ... 26

3.7.

TRANSPORTATION W ARNINGS ... 27

3.8.

CONDUCTED IMMUNITY WARNINGS ... 27

4.

PROCEDURES AND WARNINGS ... 28 4.1.

ELECTROSTATIC DISCHARGE (ESD) HANDLING PROCEDURES AND WARNINGS... 28

4.2.

CONDUCTED IMMUNITY PROCEDURES AND WARNINGS ... 28

5.

DESCRIPTION OF SYMBOLS ... 30

6.

SPECIFICATIONS ... 32 6.1.

XLTEK TREX HD ... 32

6.2.

XLTEK TREX ... 33

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Xltek® Trex / Trex HD Amplifier

User & Service Manual

1. Introduction ®

The Xltek Trex amplifier, with its leading-edge mechanical design, provides you with maximum reliability and performance for clinical electroencephalographic (EEG) and polysomnographic (PSG) recordings. It ® is designed to be used with Natus SleepWorks™ or NeuroWorks software to assist with diagnosis. The Trex HD is equipped with a Bluetooth module which communicates wirelessly with a Trex Video Interface that communicates with a video camcorder. The content in this manual applies equally to both Trex and Trex HD devices unless explicitly stated. The Trex offers these features: 

Connects to XLTEK computer



24 referential AC inputs



4 differential AC inputs



4 non-isolated DC inputs for connection to XLTEK patient-worn transducers



Internal memory for up to 96hr of EEG recording



Battery powered by two AA alkaline batteries (see Section 12 - Guaranteeing Sufficient Battery Power)



Bluetooth module for wireless synchronization with HD video (Trex HD only)



Isolated serial port



Patient-event switch interface WARNING: We strongly recommend that you read the Warnings and Cautions section of this manual before operating this amplifier.

1.1. Intended Use The Trex HD is intended to be used as an electroencephalograph: to acquire, digitized, store and archive electroencephalographic signals. The Trex HD is intended to be used by either trained medical professionals or someone instructed by a trained medical professional. It is designed for use in clinical environments such as hospital rooms, epilepsy monitoring units, intensive care units, and operating rooms. It can be used with patients of all ages, but is not designed for fetal use. The sale, distribution, or use of this device is restricted to, by, or on order of a physician. The Trex HD is supplied with a standard label displaying markings for EEG studies; for convenience when performing Sleep studies, the user may apply the “Trex HD Sleep” label with markings designed for Sleep studies (provided). See “Section 8 - Unpacking” for pictures of the labels. NOTE: The functionality of the Trex HD is not affected by the label and all instructions, warnings and cautions described in this manual still apply.

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User & Service Manual

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WARNING: The Trex HD should NOT be used as an apnea monitor.

1.2. Using the Manual This manual provides basic information and instructions that will enable you to set up and operate the Trex HD amplifier. When going through the procedures, we recommend that you read the whole section first, before starting the sequence. In order to achieve the optimal use, Trex HD must be installed and operated according to the instructions provided in this user manual. Please follow all instructions carefully. NOTE: In addition to reading this manual, we encourage you to explore the online Help of the software to enable you to take advantage of everything that XLTEK has designed the Trex HD amplifier to do. More detailed instructions relating to the operation and customization of the system are provided in the online Help.

1.3. Manual Conventions Various symbols and typographical conventions are used throughout the manual. The following table illustrates them and describes their meanings and functions. Symbol/ Convention

Description/Function

This symbol denotes a warning or important information that should not be missed. Read all warnings and cautions carefully before starting the system for the first time. This symbol indicates a note that contains important supplemental information.

Bold

Names of control keys, function keys, options, and labels are shown in bold. Bold text is also used to emphasize important names or ideas.

Italic

Italic text is used for captions.

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Xltek® Trex / Trex HD Amplifier

User & Service Manual

2. Safety and Standards Conformity 2.1. Safety and Standards Conformity for XLTEK Trex HD The following section applies to Trex HD only. For Safety and Standards Conformity for Trex, see Section 2.2.

2.1.1. Standards of Compliance and Normative References Electroencephalograph system, model Trex HD; rated two AA 1.5V batteries, 0.065A, 0.170W. 1. 2. 3. 4. 5.

Type of protection against electric shock: Internally Powered Equipment Degree of protection against electric shock: Type BF Degree of protection against ingress of water: IPX0 Mode of operation: Continuous Environmental Conditions: Normal: 5-40°C, 15-93% rH, 700-1060hPa

Trex HD Video Interface. 1. 2. 3. 4. 5.

Type of protection against electric shock: Class II Degree of protection against electric shock: No applied parts Degree of protection against ingress of water: IPX0 Mode of operation: Continuous Environmental Conditions: Normal: 5-40°C, 15-93% rH, 700-1060hPa

The Trex HD and its accessories have been designed to comply with the following national and international standards. Table 1 - Safety Standard of Compliance and Normative CAN/CSA-C22.2 No. 60601-1: 08(R2013) + C2:2011

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

ANSI/AAMI ES60601-1:2005/(R)2012 + C1:2009/(R)2012 and A2:2010/(R)2012 IEC 60601-1:2005 + C1:2006 and C2:2007, Third Edition CENELEC EN 60601-1:2006 + A1:2013 CAN/CSA C22.2 No 601.1-M90 UL 60601-1:2003

Medical Electrical Equipment Part 1: General Requirements for Safety

IEC 60601-1:1988 + A1:1991 + A2:1995 IEC 60601-2-26:2012, Edition 3 CENELEC EN 60601-2-26 L2003, Edition 2

Medical Electrical Equipment - Part 2-26: Particular Requirements for the Safety of Electroencephalographs

CAN/CSA C22.2 No. 60601-2-26-04 IEC 60601-2-26: 2002 CAN/CSA C22.2 No. 60601-1-4-02 IEC 60601-1-4: 1996 + A1: 1999

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Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems

User & Service Manual

Xltek® Trex / Trex HD Amplifier

EN ISO 80601-2-61:2011, Edition 1

Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

IEC 60601-1-6:2010, Edition 3.0

Medical Electrical Equipment - Part 1-6: General requirements for safety - Collateral Standard: Usability

CAN/CSA C22.2 No. 60601-1-6-05 IEC 60601-1-6: 2004 IEC 62366:2007, Edition 1.0

Medical devices – Application of usability engineering to medical devices

IEC 60601-1-11:2010, Edition 1.0

Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

CAN/CSA C22.2 No. 60601-1-1-02

Medical Electrical Equipment - Part 1-1: General Requirements for Safety - Collateral Standard: Safety Requirements for Medical Electrical Systems

IEC 60601-1-1: 2000

Table 2 - EMC Standard of Compliance and Normative References IEC 60601-1-2:2007, Edition 3.0 IEC 60601-1-2:2001 +A1:2004 / EN 60601-1-2:2001 +A1:2006

Medical Electrical Equipment Part 1-2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests

IEC 61000-4-2:2008 / EN 61000-42:2009

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

IEC 61000-4-3:2006 +A1:2007 +A2:2010 / EN 61000-4-3:2006 +A1:2008 +A2:2010

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 61000-4-4:2004 +A1:2010 / EN 61000-4-4:2004 +A1:2010 IEC 61000-4-5:2014, ed 3.0 IEC 61000-4-5:2005 / EN 61000-45:2006

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

IEC 61000-4-6:2008 / EN 61000-46:2009

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

IEC 61000-4-8:2009 / EN 61000-48:2010

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

IEC 61000-4-11:2004 / EN 61000-411:2004

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

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Xltek® Trex / Trex HD Amplifier IEC 61000-3-2:2014, ed 4.0 IEC 61000-3-2:2005 +A1:2008 +A2:2009 / EN 61000-3-2:2006 +A1:2009 +A2:2009 IEC 61000-3-3:2013, ed 3.0 IEC 61000-3-3:2008 / EN 61000-33:2008 CISPR 11:2009 +A1:2010 / EN 55011:2009 +A1:2010

User & Service Manual Electromagnetic Compatibility (EMC) Part 3-2: Limits - Limits for Harmonic Current Emissions

Electromagnetic Compatibility (EMC) Part 3-3: Limits - Limitation of Voltage Changes, Voltage Fluctuations and Flicker in Public Low-voltage Supply Systems Industrial, Scientific and Medical (ISM) Radio-Frequency Equipment - Electromagnetic Disturbance Characteristics Limits and Methods of Measurement

2.1.2. Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the Trex HD should assure that it is used in such an environment. Emissions Test RF emissions

Compliance Group 1

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

Class B

The Trex HD is suitable for use in all establishments, including domestic establishments and those directly connected to public low voltage power supply network that supplies buildings used for domestic purposes.

CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2

Class A

Voltage fluctuations/ flicker emissions

Complies

IEC 61000-3-3

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Electromagnetic Environment – Guidance

User & Service Manual

Xltek® Trex / Trex HD Amplifier

Table 2 - Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex HD should assure that it is used in such an environment. Immunity Test

IEC 60601 Test Level

Compliance Level

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electrostatic fast transient/burst

±2 kV for power supply lines

±2 kV for power supply lines

IEC 61000-4-4

±1 kV for input/output lines

N/A – lines <3m

Surge

±1 kV Line to Line

±1 kV Line to Line

IEC 61000-4-5

±2 kV Line to Earth

±2 kV Line to Earth

Voltage dips, short interruptions and voltage variations on power supply input lines

<5% UT (>95% dip in UT) for 0.5 cycle

<5% UT (>95% dip of UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (>60% dip of UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (>30% dip of UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

<5% UT (>95% dip of UT) for 5 sec

3 A/m

3 A/m

Electrostatic Discharge (ESD) IEC 61000-4-2

IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

Electromagnetic Environment Guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the Trex HD requires continued operation during power mains interruption, it is recommended that the Trex HD to be powered from a suitable uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFESUPPORTING Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex HD is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex HD should assure that it is used in such an environment. Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Test Level IEC60601-1-2

3 Vrms

Compliance Level

3 Vrms

150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Trex HD, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance:

3 V/m

d=1.2 ×√P

150kHz to 80MHz

d=1.2 ×√P

80MHz to 800MHz

d=2.3 ×√P

800MHz to 2.5GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic Site surveya, should be less than the compliance level in each frequency rangeb. Interference may occur in the vicinity of equipment marked with the following symbol:

.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

a

Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Trex HD is used exceeds the applicable RF compliance level above, the Trex HD should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Trex HD. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Table 4 - Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Trex HD The Trex HD is intended for use in the electromagnetic in which radiated RF disturbances are controlled. The customer or user of the Trex HD can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Trex HD as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W)

Separation distance according to the frequency of transmitter (m) from 150kHz to 80MHz

from 80MHz to 800MHz

from 800MHz to 2.5GHz

d= 1.2 x √P

d= 1.2 x √P

d= 2.3 x √P

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For the transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in Watts (W) according to the transmitter manufacturer. Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people

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2.1.3. Electromagnetic Immunity (EMI) Information – FCC NOTE: This equipment has been tested and found to comply with the limits for Class B digital devices, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. 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. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of more of the following measures: 

Reorient or relocate the receiving antenna



Increase the separation between the equipment and receiver



Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.



Consult the dealer or an experienced radio/TV technician for help.

WARNING: Changes or modifications not expressly approved by XLTEK may void the user’s authority to operate the equipment.

2.2. Safety and Standards Conformity for XLTEK Trex The following section applies to Trex only. For Safety and Standards Conformity for Trex HD, see Section 2.1.

2.2.1. Standards of Compliance and Normative References Electroencephalograph system, model Trex; rated two AA 1.5V batteries, 0.065A, 0.170W. 1. 2. 3. 4. 5.

Type of protection against electric shock: Internally Powered Equipment Degree of protection against electric shock: Type BF Degree of protection against ingress of water: IPX0 Mode of operation: Continuous Environmental Conditions: Normal: 10-40°C, 30-75% rH, 700-1060hPa

The Trex and its accessories have been designed to comply with the following national and international standards. Table 1 – Safety Standard of Compliance and Normative References CAN/CSA C22.2 No 601.1-M90

Medical Electrical Equipment Part 1: General Requirements for Safety

CAN/CSA C22.2 601.1S1:1994

Supplement No 1-94 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety

CAN/CSA C22.2 601.1B-90:1998

Amendment 2 to CAN/CSA C22.2 601.1-M90 Medical Electrical Equipment Part 1: General Requirements for Safety

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UL 60601-1:2003

Medical Electrical Equipment Part 1: General Requirements for Safety

IEC 601-1:1988 + A1:1991 + A2:1995

Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance

IEC 60601-2-26:1994

Medical electrical equipment Part 2-26: Particular Requirements for the Safety of Electroencephalographs

IEC 60601-1-4:2000 (1.1 Ed.)

Medical Electrical Equipment - Part 1-4: General Requirements for Safety Collateral Standard: Programmable Electrical Medical Systems

Table 2 – EMC Standard of Compliance and Normative References IEC 60601-1-2:2001 / EN 60601-1-2:2001 (2nd Ed)

Medical Electrical Equipment Part 1-2:General Requirements for Safety Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

IEC 61000-4-2:1995 / EN 61000-4-2:2001

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

IEC 61000-4-3:1995 / EN 61000-4-3:2001

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

IEC 61000-4-4:1995 / EN 61000-4-4:2001

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

IEC 61000-4-5:1995 / EN 61000-4-5:2001

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

IEC 61000-4-6:1996 / EN 61000-4-6:2003

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

IEC 61000-4-8 / EN 61000-4-8

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

IEC 61000-4-11:1994 / EN 61000-4-11:2000

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

IEC 61000-3-2:1995 / EN 61000-3-2:2001

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

IEC 61000-3-3:1994 / EN 61000-3-3:1998

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

EN50082-1:1997

Electromagnetic compatibility. Generic immunity standard. Part 1: Residential, commercial and light industry

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EN50082-2:1995

Electromagnetic compatibility. Generic immunity standard. Part 2: Industry

CISPR 11:2003 / EN 55011:2003 Class B, Group 1

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

ANSI C63.4:2004

American National Standard for Methods of Measurement of Radio-noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9KHz to 40 GHz

CISPR 16-1-1:2004

Specification for Radio Disturbance and Immunity Measuring Apparatus and Methods. Part 1-1: Measuring Apparatus

2.2.2. Declaration of Compliance for IEC 60601-1-2 Table 1 - Electromagnetic Emissions Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Trex is intended for use in the electromagnetic environment specified below. The customer of the Trex should assure that it is used in such an environment. Emissions Test RF emissions

Compliance Group 1

The Trex 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

Class A

The Trex 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.

CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2

N/A

Voltage fluctuations/ flicker emissions

N/A

IEC 61000-3-3

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Xltek® Trex / Trex HD Amplifier

Table 2 - Electromagnetic Immunity Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex should assure that it is used in such an environment. Immunity Test

Electrostatic Discharge (ESD)

IEC 60601 Test Level ±6 kV contact

Compliance Level

Electromagnetic Environment Guidance

Complies

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment.

±8 kV air

IEC 61000-4-2

Electrostatic fast transient/burst

±2 kV for power supply lines

N/A

IEC 61000-4-4

±1 kV for input/output lines

N/A

Surge

±1 kV differential mode

N/A

Mains power quality should be that of a typical commercial or hospital environment.

N/A

Mains power quality should be that of a typical commercial or hospital environment. If the user of the Trex requires continued operation during power mains interruption, it is recommended that the Trex to be powered from a suitable uninterruptible power supply or a battery.

N/A

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment.

IEC 61000-4-5

±2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

<5% UT (>95% dip in UT) for 0.5 cycle 40% UT (60% dip in UT) for 5 cycles 70% UT (30% dip in UT) for 25 cycles <5% UT (>95% dip in UT) for 5 sec

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

3 A/m

NOTE: UT is the AC supply voltage prior to application of the test level.

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Table 3 - Electromagnetic Immunity – for EQUIPMENT and SYSTEMS that are not LIFESUPPORTING Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex should assure that it is used in such an environment. Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

Test Level IEC60601-1-2

3 Vrms 150 kHz to 80 MHz 3 V/m 80 MHz to 2.5 GHz

Compliance Level

Complies

Electromagnetic Environment - Guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Trex, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance: d=1.2 ×√P

150kHz to 80MHz

d=1.2 ×√P

80MHz to 800MHz

d=2.3 ×√P

800MHz to 2.5GHz

Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic Sitec, should be less than the compliance level in each frequencyd. Interference may occur in the vicinity of equipment marked with the following symbol:

.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies. Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

c

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Trex is used exceeds the applicable RF compliance level above, the Trex should be observed to verify normal operation. If abnormal operation is observed, additional measures may be necessary, such as re-orienting or relocating the Trex. d Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Xltek® Trex / Trex HD Amplifier

Table 4 - Recommended Separation Distances Recommended separation distances between portable and mobile RF communications equipment and the Trex The Trex is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Trex can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Trex as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter (W)

Separation distance according to the frequency of transmitter (m) from 150kHz to 80MHz

from 80MHz to 800MHz

from 800MHz to 2.5GHz

0.01

0.12

0.12

0.23

0.1

0.38

0.38

0.73

1

1.2

1.2

2.3

10

3.8

3.8

7.3

100

12

12

23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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Xltek® Trex / Trex HD Amplifier

User & Service Manual

3. Warnings and Cautions 3.1. General Warnings NOTE: It is recommended that all data be stored using redundant storage capabilities. This can help to minimize data loss in the event of a failure of the primary drive. Proper use of this device depends on the careful reading of all instructions and labels that come with or on the system. Inaccurate measurements may be caused by incorrect application or use. The amplifier is classified as an IP0 – ordinary degree of protection against ingress of water according to IEC 529. The amplifier is classified as a class II device according to IEC601-1. The computer used with a Trex HD amplifier must either be approved by XLTEK and supplied as part of an IEC 601 approved system, or it must be approved to IEC 950 or similar and kept outside of the patient environment, (that is, at least 1.5 meters from the patient laterally and not within a height of 2.5 meters from the floor in the area occupied by the patient). Only use the Trex/Trex HD in conjunction with approved devices and accessories. Use of cables other than those specified or sold by the manufacturer on the equipment, may result in increased emissions or decreased immunity of the equipment and may cause the system to be non-compliant with the requirements of IEC 60601-1-2:2007 To ensure the validity of signals, do not operate the device near any sources of electromagnetic interference. 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. For detailed handling procedures, see Section 3.6. Turn off all system power and disconnect the power cord from the system and the wall before attempting to clean the unit. The Trex HD unit 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 unit quickly. Avoid letting liquid seep into any of the internal electronics of the system. Do not use any abrasive cleaner on the system. When the Trex amplifier is in the IPX2-certified pouch, it is offered protection from dripping water from above the device for up to 10 minutes in duration.

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User & Service Manual

Xltek® Trex / Trex HD Amplifier

XLTEK systems are not AP or APG rated. DO NOT USE an XLTEK system in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. Device accessories may include several kinds of disposable, sterile needle electrodes. 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 two AA batteries used to operate the Trex HD should be removed if the Trex HD is not likely to be used for some time.

Dispose of used, non-rechargeable batteries in accordance with local regulations.

The Trex HD needs special precautions regarding Electromagnetic Compatibility (EMC) and must be installed and operated according to EMC guidelines (see Section 2.1.2). Using the Trex HD with cables and accessories not approved by XLTEK may negatively affect EMC performance, including electromagnetic immunity (see Section 2.1.3). External equipment may interfere with the performance of the Trex HD, even if that other equipment complies with CISPR Emission requirements (see Section 2.1.3). The Trex HD should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the amplifier should be observed to verify normal operation in the configuration in which it will be used. See Section 2.1.2 for minimum recommended separation distances. Do not connect items which are not specified as part of the Trex HD system to the system. Never use equipment that has parts missing or equipment that might contain loose parts inside of it (that is, inside an enclosed portion of the equipment). If you suspect a piece of equipment has missing or loose parts, contact XLTEK. Routinely inspect system cables and components for regular wear and tear. WARNING: Third-party software installed on the acquisition computer may interfere with the operation of the XLTEK software. Please consult Technical Support before installing thirdparty software on the computer. WARNING: No modification of this equipment is allowed.

The Trex HD is IPX2 marked when inside the carrying case.

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Xltek® Trex / Trex HD Amplifier

User & Service Manual

3.2. Electrical Warnings and Cautions XLTEK systems are intended for connection to a properly grounded electrical outlet only.

Conductive parts of electrodes and their connectors are not to contact other conductive parts including earth.

Do not place MULTIPLE PORTABLE SOCKET-OUTLETS (MPSOs) on the floor.

Do not connect additional MPSOs or extension cords to the Trex HD system.

Do not use the MPSO with the Trex HD system for supplying power to any equipment that is not part of the system. To avoid the possible hazards caused by the summation of leakage currents when all the parts of the system are interconnected, no equipment other than devices connected to the Trex HD may be powered by the isolation transformer. The current rating of the isolation transformer must be sufficient to operate all of the devices powered by it. Refer to the current ratings of the isolation transformer and current rating for each individual device connected. Do NOT connect non-medical equipment which has been supplied as 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. ELECTRICAL SHOCK HAZARD: Do NOT turn on the system power until all cables have been connected, verified and visually inspected for any damage. Failure to inspect the cables may result in electrocution. Verification of electrical safety should be performed routinely. ELECTRICAL SHOCK HAZARD: Do NOT service the system. Refer servicing to qualified personnel only. Do NOT use repaired components without proper testing.

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User & Service Manual

Xltek® Trex / Trex HD Amplifier

3.3. Wireless Option Warnings and Cautions* *Trex HD only, not applicable to Trex The wireless feature of the Trex HD presents a synchronization of the EEG signal with the video recording. This feature is not a substitute for other means of patient monitoring and supervision. Like other wireless devices, this feature is limited in operating range. The range will also be reduced substantially if there is any physical interference between the Digital Camcorder unit and the Trex HD. In either of these situations, the wireless data will not be received by the acquisition computer. The Trex HD contains FCC ID: R47F2M03GL which complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The Trex HD contains F2M03GLA which has passed the Bluetooth Qualification/Certification process as specified within the Bluetooth Specifications and as required within the PRD 2.0. QDID: B012541. Mobile RF communications equipment may affect the Trex HD and interfere with wireless operation. See Section 2.1.3 for guidelines.

3.4. Patient Environment Warnings and Cautions NOTE: The patient environment is defined as the area within 1.5 meters of the patient laterally and within 2.5 meters of the floor in the area occupied by the patient.

The Trex HD amplifier is NOT intended for use with High Frequency Surgical Equipment. Connect all patient electrodes to fully electrically isolated physiological devices only. Connecting patient electrodes to any other device or external outlet may result in personal injury. The amplifier accepts only touchproof style electrode inputs. Do NOT attempt to use any other style of patient electrode input. The patient event switch attached to the Trex HD is NOT intended for critical patient-safetyrelated incidents.

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