natus Trex HD User & Service Manual
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natus Trex HD User & Service Manual

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User & Service Manual

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  • Page 1 Trex HD Monitoring Amplifier ™ User & Service Manual...
  • Page 2 This copy of the User Manual shall be used only in accordance with the conditions of sale of Natus Neurology Incorporated or its distributors. Natus Neurology Incorporated makes no representations or warranties of any kind whatsoever with respect to this document.

  • Page 3: Table Of Contents

    Performing an ambulatory monitoring study in NeuroWorks..........37 9.1.4. Powering Down the System ....................39 9.2. Adding the Trex HD Monitoring unit to a belt or a lanyard ..........40 9.2.1. Belt Setup .......................... 40 9.2.2. Lanyard Setup ........................41 9.3.
  • Page 4 Natus External Battery Pack ..................50 12.1. External Battery Pack Warnings and Cautions ..............50 12.2. Using the External Battery Pack with the Trex HD Monitoring System ......51 How to Disable Channels and Set Frequency ............52 Maintenance, Cleaning, & Disposal................53 14.1.

  • Page 5: Introduction

    This Trex HD Monitoring amplifier can only be used with the NeuroWorks/SleepWorks 8.1.1, and 9.3 and later. The Trex HD Monitoring 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.

  • Page 6: Intended Use

    Trex HD Monitoring 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 Monitoring must be installed and operated according to the instructions provided in this user manual. Please follow all instructions carefully.

  • Page 7: Safety And Standards Conformity

    The essential performance of the Trex HD Monitoring amplifier system is defined in the particular standards IEC 60601-2-26 and ISO 80601-2-61. It is EEG equipment that incorporates a pulse oximeter without an alarm. The Trex HD Monitoring and its accessories have been designed to comply with the following national and international standards.
  • Page 8 Trex™ HD Monitoring Amplifier User & Service Manual Table 1 - Safety Standard of Compliance and Normative CAN/CSA-C22.2 No. 60601-1: 08(R2013) + Medical electrical equipment – Part 1: General C2:2011 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...
  • Page 9 User & Service Manual Trex™ HD Monitoring Amplifier Table 2 - EMC Standard of Compliance and Normative References IEC 60601-1-2:2007, Edition 3.0 Medical Electrical Equipment Part 1-2:General Requirements for Safety - Collateral Standard: IEC 60601-1-2:2001 +A1:2004 / EN 60601- Electromagnetic Compatibility - Requirements and 1-2:2001 +A1:2006 Tests IEC 61000-4-2:2008 / EN 61000-4-2:2009...

  • Page 10: Declaration Of Compliance For Iec 60601-1-2

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The Trex HDTrex HD Monitoring is intended for use in the electromagnetic environment specified below. The customer or the Trex HD Monitoring should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment –...
  • Page 11 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex HD Monitoring is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex HD Monitoring should assure that it is used in such an environment. Immunity Test...
  • Page 12 Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The Trex HD Monitoring is intended for use in the electromagnetic environment specified below. The customer or the user of the Trex HD Monitoring should assure that it is used in such an environment. Immunity test...
  • Page 13 Recommended separation distances between portable and mobile RF communications equipment and the Trex HD Monitoring The Trex HD Monitoring is intended for use in the electromagnetic in which radiated RF disturbances are controlled. The customer or user of the Trex HD Monitoring can help prevent electromagnetic...

  • Page 14: Electromagnetic Immunity (Emi) Information - Fcc

    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 or TV technician for help. • WARNING: Changes or modifications not expressly approved by Natus may void the user’s authority to operate the equipment.

  • Page 15: Warnings And Cautions

    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 Monitoring unit can be wiped clean with a soft, damp cloth using non-conductive distilled water, electrically non-conductive inert surfactants or a Natus -approved cold sterilizing agent.
  • Page 16 Section 2.1.2 recommended separation distances. Do not connect items which are not specified as part of the Trex HD Monitoring 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).

  • Page 17: Electrical Warnings And Cautions

    User & Service Manual Trex™ HD Monitoring Amplifier Do not install the Trex HD Monitoring system or use an electrical outlet within 10 feet of a swimming pool. Do not use with an electrical outlet in the bathroom. 3.2. Electrical Warnings and Cautions Natus systems are intended for connection to a properly grounded electrical outlet only.

  • Page 18: Electrostatic Discharge (Esd) Precautions

    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 acquisition computer and the Trex HD Monitoring. In either of these situations, the wireless data will not be received by the acquisition computer.
  • Page 19 Do NOT touch any Trex HD Monitoring system accessible metal parts and the patient simultaneously. Do not use the Trex HD Monitoring system in the vicinity of MRI or CT systems. Do not allow loose electrodes to contact metal parts.

  • Page 20: Pulse Oximeter Warnings

    Trex™ HD Monitoring Amplifier User & Service Manual 3.6. Pulse Oximeter Warnings The Nonin XPOD pulse oximeter is to be operated by qualified personnel only. This ® manual, the instructions for use for any pulse oximeter sensor or cable extender, the accessory directions for use, all precautionary information, and specifications should be read prior to use.

  • Page 21: Pulse Oximeter Sensor Warnings

    Oximeter readings may be affected by the use of an electrosurgical unit (ESU). Inspection of monitors, cables, and probes should be completed prior to each use to ensure compatibility and maintain patient safety. The Trex HD Monitoring amplifier system does NOT include SpO or Pulse Rate alarms. 3.7. Pulse Oximeter Sensor Warnings Before using, carefully read the sensor directions for use.

  • Page 22: Transportation Warnings

    Make sure that any platform, table, cart, or other surface used during the operation, transport, or temporary or permanent storage of the system and its components is adequate, sturdy, and safe. Natus is not responsible for any injury or damage that may result from inadequate, poorly constructed, or unapproved transports, carts, or operating surfaces.

  • Page 23: Conducted Immunity Warnings

    User & Service Manual Trex™ HD Monitoring Amplifier 3.9. Conducted Immunity Warnings In environments where parasitic electrical noise interferes with the electrical biologic signal, there is no risk of misinterpretation of EEG waveforms or ancillary data. Any abnormal pattern or out of range value is confirmed by trained medical professionals performing the test.

  • Page 24: Procedures And Warnings

    Trex™ HD Monitoring Amplifier User & Service Manual 4. Procedures and Warnings 4.1. Electrostatic Discharge (ESD) Handling Procedures and Warnings Before performing any setup or placement procedures, read the precautions outlined in this section. It is recommended that all staff receive both explanation and training in ESD procedures. WARNING: Be sure to take the appropriate Electrostatic Discharge (ESD) precautions.

  • Page 25: Conducted Immunity Procedures And Warnings

    User & Service Manual Trex™ HD Monitoring Amplifier 4.2. Conducted Immunity Procedures and Warnings Conducted immunity is defined as the ability of an electronic product to tolerate the influence of electrical energy from other electronic products or electromagnetic phenomena. The electrical energy from other electronic devices located in nearby equipment are usually propagated through the connecting cables.

  • Page 26: Description Of Symbols

    Trex™ HD Monitoring Amplifier User & Service Manual 5. Description of Symbols Standard Symbol Standard Title Symbol Title Explanation Reference ISO 15223-1 Medical devices – Manufacturer Indicates the medical Symbols to be used device manufacturer. Symbol 5.1.1 with medical device labels, labelling, and information to be supplied...
  • Page 27 User & Service Manual Trex™ HD Monitoring Amplifier Standard Symbol Standard Title Symbol Title Explanation Reference 2012/19/EU Waste Electrical and Disposal at the end Indicates that Electronic of operating life electrical and Equipment (WEEE) instructions electronic equipment waste should not be discarded together with unseparated waste but must be...
  • Page 28 Trex™ HD Monitoring Amplifier User & Service Manual Standard Symbol Standard Title Symbol Title Explanation Reference Quantity Number of parts in a package. IEC 60417 Graphical symbols Class II equipment Identifies equipment for use on equipment meeting the safety Symbol 5172 requirements specified for Class II equipment according...
  • Page 29 User & Service Manual Trex™ HD Monitoring Amplifier Standard Symbol Standard Title Symbol Title Explanation Reference ISO 15223-1 Medical devices – Keep dry Indicates that the Symbols to be used medical device Symbol 5.3.4 with medical device needs to be labels, labelling, and protected from information to be...

  • Page 30: Specifications

    Trex™ HD Monitoring Amplifier User & Service Manual 6. Specifications Specification Value(s) Patient Electrical Connections 24 Referential Inputs (+ ground, + reference) 10 mV pk-to-pk Resolution 16 bit A/D 4 Differential Inputs 10 mV pk-to-pk Resolution 16 bit A/D Common Mode Rejection Ratio -113 dB @ 60 Hz DC Removal ±...
  • Page 31 User & Service Manual Trex™ HD Monitoring Amplifier Specification Value(s) Operating Parameters Operating Environmental Limits Temperature: 5°C to 40°C Humidity: 15% to 93% Atmospheric Pressure: 700 hPa to1060 hPa Transport and Storage Temperature Range - 40°C to 70°C Transport and Storage Humidity Range 10% to 100%, including condensation Transport and Storage Atmospheric 500 hPa to 1060 hPa...

  • Page 32: Product Images

    Trex™ HD Monitoring Amplifier User & Service Manual 7. Product Images 7.1. Front View Trex HD Monitoring Amplifier Power LED Status LED Oximeter / Photic Connection Reference Input (forward) Common Input (rear) 24 Referential Inputs (two rows) Patient Event Button Connection...

  • Page 33: Rear View

    User & Service Manual Trex™ HD Monitoring Amplifier 7.2. Rear View NOTE: Dispose of used, non-rechargeable batteries in accordance with local regulations and manufacturer’s instructions.

  • Page 34: Unpacking

    Sleep studies, the user may apply the “Trex HD Sleep” label with markings designed for Sleep studies (provided). NOTE: The functionality of the Trex HD Monitoring is not affected by the label and all instructions, warnings and cautions described in this manual still apply.

  • Page 35: Accessories And Replacement Parts

    Trex HD Cable for LED Photic Stimulator 019822 Trex HD External Battery Pack Kit 105005 Trex HD Oximeter Package (Nonin) NOTE: The Trex HD Monitoring amplifier should only be used with cables, transducers, electrodes, sensor, and switches that are supplied or approved by Natus.

  • Page 36: Setting Up

    Trex HD Monitoring units are patient-worn. • NOTE: There is a risk of injury if the Trex HD Monitoring unit is not properly fitted to the patient. NOTE: Please ensure that the patient has been provided with the proper contact information for assistance.

  • Page 37: Performing An Ambulatory Monitoring Study In Neuroworks

    A backfill option is available to upload the study data recorded up to that point for review. • • To prepare the Trex HD, insert two new AA batteries (while the Trex HD is disconnected from the tablet). Next, connect the Trex HD Monitoring headbox to the tablet via USB. 9.1.3.1.
  • Page 38 Add appropriate Streaming Profile to the Acquisition Profile Next steps: • Ensure the amber light on the Trex HD is flashing to indicate it is recording to internal memory. Connect a fully charged battery pack to the Trex HD (optional). •...

  • Page 39: Powering Down The System

    Trex™ HD Monitoring Amplifier 9.1.3.3. Backfill and reviewing an ongoing ambulatory monitoring study To review the data recorded to the Trex HD Monitoring internal memory during an ongoing ambulatory study without stopping the recording: In ambulatory monitoring mode, connect the Trex HD Monitoring to the computer and click the Begin Backfill icon in NeuroWorks.

  • Page 40: Adding The Trex Hd Monitoring Unit To A Belt Or A Lanyard

    1. Attach the pouch to the belt, by threading it through the back of the pouch. 2. After attaching the electrodes to the patient, place the Trex HD Monitoring into the pouch with the electrode wires exiting at the top or on the sides, as required.

  • Page 41: Lanyard Setup

    3. Close the zippers as much as possible so that the Trex HD Monitoring is secured in the pouch. 4. Once the Trex HD Monitoring is enclosed in the pouch, place the lanyard over the patient’s shoulder, or hang it on the bedside post.

  • Page 42: Setting Up Trex Hd Monitoring Amplifier For A Non-Video Study

    3. If a Photic Stimulator is needed, insert the Photic Stimulator into the Photic Stimulator connection on the base unit. 4. When you are ready to run a study, connect the patient leads and transducers to the Trex HD Monitoring.

  • Page 43: Testing The Trex Hd Monitoring Amplifier

    9.4.1. Calibration and Verification There is no need to calibrate the software or the Trex HD Monitoring amplifier. All calibration is done at the factory before the system is shipped. To verify that the Trex HD Monitoring amplifier is correctly calibrated, perform the following procedure: 1.

  • Page 44: Impedance Check

    Trex™ HD Monitoring Amplifier User & Service Manual Channel Test Signal Control The Channel Test Signal control turns on the channel test signal according to the last settings saved and displays a Test Signal toolbar. The Test Signal toolbar is located above the trace display. The toolbar has controls for shape, amplitude and frequency.

  • Page 45: Nonin Xpod Pulse Oximeter

    NOTE: Refer to the Instructions for Use for any pulse oximeter, sensor, or cable extender prior to use. The following topic lists the specifications for the Nonin Xpod board that is built into the Trex HD Monitoring Amplifier. The board connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via the NeuroWorks software.

  • Page 46: Available Oximetry Sensors

    Trex™ HD Monitoring Amplifier User & Service Manual 10.3.2. Available Oximetry Sensors Model Number Description 8000AA-1 Adult Articulated Internal Spring Finger Clip, 1 m (3 ft) cable 8000AA-3 Adult Articulated Internal Spring Finger Clip, 3 m (9.8 ft) cable 8000AP-1 Pediatric External Spring Finger Clip, 1 m (3 ft) cable 8000AP-3 Pediatric External Spring Finger Clip, 3 m (9.8 ft) cable...

  • Page 47: Measurements

    User & Service Manual Trex™ HD Monitoring Amplifier 10.4. Measurements This pulse oximeter module is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin. Pulse rate and SpO values are updated every 1/3 second and consist of a 4-beat average. Measurement Wavelengths and Output Power •...

  • Page 48: Guaranteeing Sufficient Battery Power

    11.1. Battery Power with AA Batteries (only) The Trex HD Monitoring is powered by two AA alkaline batteries for ambulatory recordings. An optional external battery pack is available to extend recording time without the need to replace batteries. For more information, see Battery Power with AA Batteries and External Battery Pack.

  • Page 49: Battery Power With Aa Batteries And External Battery Pack

    An external pack must be connected after ambulatory recording is initiated. With a Pulse Oximeter sensor connected to it, the Trex HD Monitoring can run for 48 hours with a set of new AA batteries and a power pack recording to internal memory.

  • Page 50: Natus External Battery Pack

    Doing so may result in serious bodily injury or death due to electrical shock. Do not install the Trex HD Monitoring system or use an electrical outlet within 10 feet of a swimming pool.

  • Page 51: Using The External Battery Pack With The Trex Hd Monitoring System

    12.2. Using the External Battery Pack with the Trex HD Monitoring System The Trex HD Monitoring external battery pack is connected to the Trex HD Monitoring via the mini-USB input. When the external battery pack is providing power to the Trex HD Monitoring, the green external power LED light remains on.

  • Page 52: How To Disable Channels And Set Frequency

    13. How to Disable Channels and Set Frequency Disabling unused channels will help maximize battery life. In NeuroWorks or SleepWorks, choose Edit > Settings > Acquisition. Select Trex HD Ambulatory in the first drop- down box. In the Channel Status section, select Set manually.

  • Page 53: Maintenance, Cleaning, & Disposal

    • Electrodes and accessories The Trex HD Monitoring amplifier and its components should not be immersed in water or any other fluid. To clean, use a damp cloth to wipe all surfaces. The Trex HD Monitoring amplifier is designed to be extremely portable. As such, the Trex HD Monitoring is subject to increased daily wear and tear.

  • Page 54: Disposal

    User & Service Manual 14.2. Disposal At the end of the expected service life, when disposing of the Trex HD Monitoring amplifier and its components, it is recommended that federal, state, and local laws be followed for proper disposal of printed circuit boards, plastics, and metal parts.

  • Page 55: Troubleshooting

    Ask the patient to relax. Inspect your cables. Make sure there is a tight connection between the Trex HD Monitoring and the computer. Make sure the patient electrodes are connected to the correct channel in the amplifier. Make sure the patient electrodes fit properly into the amplifier (not loosely).

  • Page 56: Getting Help

    User & Service Manual 16. Getting Help Natus is committed to providing you with support so you can operate the Trex HD Monitoring amplifier with ease and confidence. If you need help, follow these steps to find a solution: Step 1: Document the Incident Carefully document the incident.

  • Page 57: Index

    Procedures ..............24 Impedance Check ............. 43 Warnings ..............24 Intended use ..............6 Warnings and Cautions..........22 Connect Trex HD Monitoring to Computer ....... 41 LED color functionality ............. 41 Disable Channels ............... 51 Disposal ............... 52, 53 Maintenance ..............52 Recommendations ............
  • Page 58 User & Service Manual Trex HD Monitoring Patient Electrical Connections ......... 29 Non-Video Study Setup ............. 41 Physical Capabilities ..........29 Trex HD Monitoring Amplifier ........29 Operating Parameters ..........30 Safety ............... 29 Operator Placement ............35 Trex HDTrex HD Monitoring Amplifier Optional Accessories ............
  • Page 59 User & Service Manual Trex™ HD Monitoring Amplifier Conducted ..............24 Conducted Immunity ........... 22 Unpacking ................. 33 Electrical............... 16 Using the Manual ..............6 Electrostatic ..............23 ESD ................23 External Power Pack ............ 49 General ................ 14 Verification ............... 42 Patient Environment ............
  • Page 60 A Total Service Solution Standing behind every XLTEK product is Natus Medical Incorporated, an internationally respected innovator of medical products and services. Our Neurology systems are backed up by an in-house support team staffed with technical and clinical experts, 24/7 support, remote support via WebEx or VPN, the largest clinical and technical field support network in Neuro/Sleep and customized service contracts that include preventative maintenance visits and computer upgrades.

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