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User & Service Manual

XLTEK Trex HD Amplifier

59

Do NOT use petroleum-based or acetone solutions, or other harsh solvents, to clean the
amplifier.

15.2. Disposal

At the end of the expected service life, when disposing of the Trex HD 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. For disposal of non-Natus accessories, please follow the instructions provided
with these items.

15.3. Expected Service Life

The expected service life of the Trex HD system is seven (7) years. Refer to the

Instructions for Use

for

any accessories or sensors for their expected service life.

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Summary of Contents for Xltek Trex HD

Page 1: ...Xltek Trex HD User Service Manual ...

Page 2: ...ll 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...

Page 3: ...ON FCC 14 3 WARNINGS AND CAUTIONS 15 3 1 GENERAL WARNINGS 15 3 2 ELECTRICAL WARNINGS AND CAUTIONS 17 3 3 WIRELESS OPTION WARNINGS AND CAUTIONS 18 3 4 PATIENT ENVIRONMENT WARNINGS AND CAUTIONS 18 3 5 PULSE OXIMETER WARNINGS 19 3 6 PULSE OXIMETER SENSOR WARNINGS 21 3 7 TRANSPORTATION WARNINGS 22 3 8 CONDUCTED IMMUNITY WARNINGS 22 4 PROCEDURES AND WARNINGS 23 4 1 ELECTROSTATIC DISCHARGE ESD HANDLING ...

Page 4: ...TORY VIDEO STUDY 36 9 4 1 SETTING UP CAMCORDER AND TREX HD VIDEO INTERFACE TVI 37 9 5 TESTING THE TREX HD AMPLIFIER 40 9 5 1 CALIBRATION AND VERIFICATION 41 9 5 2 CHANNEL TEST 41 9 5 3 IMPEDANCE CHECK 42 10 TRANSPORT SYSTEM SPECIFICATIONS AND MAINTENANCE 43 10 1 XLTEK TROLLEY SPECIFICATIONS 43 10 2 ERGOJUST CART SPECIFICATIONS 44 10 3 MAINTENANCE 44 10 4 WARNINGS AND CAUTIONS 44 10 5 ELECTRICAL IN...

Page 5: ...NS 52 13 4 USING THE EXTERNAL POWER PACK KIT 53 13 5 EXTERNAL POWER PACK AND CHARGING DETAILS 54 13 5 1 EXTERNAL POWER PACK LED INDICATORS 54 13 6 CHARGING THE EXTERNAL POWER PACK 55 13 7 DISCONNECTING THE EXTERNAL POWER PACK 55 13 8 STORING THE EXTERNAL POWER PACK 55 13 9 TROUBLESHOOTING THE EXTERNAL POWER PACK 56 14 HOW TO DISABLE CHANNELS AND SET FREQUENCY 57 15 MAINTENANCE CLEANING DISPOSAL 58...

Page 6: ...erface 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 digitize 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 ...

Page 7: ... probe or sensor used 1 3 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 ...

Page 8: ...HD Amplifier 7 Symbol Convention Description Function 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 ...

Page 9: ...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 60601 1 08 R2013 C2 2011 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 Medical electrical equipment Part 1 General r...

Page 10: ...ic safety and essential performance collateral standard electromagnetic compatibility requirements and tests 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 ed 3 0 with A1 2007 A2 2010 Electromagnetic Compatibility EMC Part 4 3 Testing and Measurement Techniques Radiated Radio frequency Elec...

Page 11: ...he 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 Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 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 i...

Page 12: ...e that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV differential mode 2 kV common mode Complies Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 100 drop 0 5 periods 0 45 90 135 180 225 270 315 100 dip 1 period 30 dip 25 30 periods 40 dip ...

Page 13: ...rvey1 should be less than the compliance level in each frequency range2 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 Table 4 Test specif...

Page 14: ... 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5 240 5 100 5 800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5 500 5 785 NOTE If necessary to achieve the IMMUNITY TEST LEVEL the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m The 1 m test distance is permitted by IEC 61000 4 3 a For some services only the uplink frequ...

Page 15: ...munications 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 th...

Page 16: ... 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...

Page 17: ...cked 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 l...

Page 18: ...e 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 wit...

Page 19: ...e party responsible for compliance could void the user s authority to operate the equipment 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 ...

Page 20: ...such a way as to make it difficult to operate the disconnection device Potential allergic reactions could occur Consult clinician on any allergies before use Do not use the Trex HD system when outside its carrying case as the device is not IPX certified when used outside of the case No parts of the ME equipment shall be serviced or maintained while in use with a patient 3 5 Pulse Oximeter Warnings...

Page 21: ...y substance containing dyes that change usual arterial pigmentation may cause erroneous readings Loss of pulse signal can occur when the patient has hypotension severe vasoconstriction severe anemia or hypothermia Loss of pulse signal can occur when there is arterial occlusion proximal to the sensor Loss of pulse signal can occur when the patient is in cardiac arrest or is in shock Do not immerse ...

Page 22: ... material Do not use pulse oximetry sensors during MRI scanning as this could potentially cause burns The pulse oximeter may affect the MRI image and the MRI unit may affect the accuracy of the oximetry measurements Placement of a sensor on an extremity with a blood pressure cuff arterial catheter or intravascular line may cause inaccurate measurements Loss of pulse signal can occur when the senso...

Page 23: ...PPING HAZARD During transport the user should guide the cart using both hands ensuring the wheel base is aligned so that a single caster leads in the direction of motion Failure to lead the cart with one wheel could result in a tipping hazard when ascending or descending steps or thresholds 3 8 Conducted Immunity Warnings In environments where parasitic electrical noise interferes with the electri...

Page 24: ...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 car...

Page 25: ... on the EEG waveforms which are coupled together with off the scale values for auxiliary sensors Follow these techniques to help identify the sources and to increase the immunity towards parasitical noise Verify the power supply and all portable multiple socket outlets are off the floor and in a dry location If parasitic noise is present on the EEG waveforms try to identify possible culprits by di...

Page 26: ...cription ATTENTION Consult Accompanying Documents Consult Accompanying Documents Consult Operating Instructions Protective Earth Ground Type BF Equipment Dangerous Voltage Alternating Current Direct Current Power On Power Off EU only Do Not Dispose as Unsorted Municipal Waste CE Mark ...

Page 27: ...ess Bluetooth Identification USB Connection Nonin Pulse Oximeter Sensor SpO2 Connector Not for Continuous Monitoring no alarm for SpO2 Non Waterproof Device Manufacturer Information Made in Canada The ETL mark is a safety symbol that shows the product was independently tested and certified to applicable U S and Canadian product safety standards TUV Safety Tested and Production Monitored ...

Page 28: ...nnel Crosstalk 56 dB Electrode Connections including common input Touchproof 4 Non Isolated DC Inputs 5 Volts Resolution 16 bit A D Impedance kOhm 2 5 5 10 25 Channel Test Signal Software selectable Sampling Frequency 200 Hz 256 Hz 512 Hz Physical Capabilities Oximeter Photic Stim Connection Yes either or Patient Event Button Yes Interface Cable USB 2 0 USB Cable Standard Length 1 8 m 5 9 ft Main ...

Page 29: ...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 Pressure Range 500 hPa to 1060 hPa Wireless Transceiver BT121 Protocol Bluetooth 4 2 BR EDR Operating frequency 2 402 2 480 GHz Transmission power 12dBm FCCID QOQBT121 ...

Page 30: ... Front View Trex HD Amplifier 1 Power LED 2 Status LED 3 Oximeter Photic Connection 4 Reference Input forward 5 Common Input rear 6 24 Referential Inputs two rows 7 Patient Event Switch Connection 8 DC Inputs rear row 9 Differential Inputs forward row 10 USB Connection bottom ...

Page 31: ...Xltek Trex HD Amplifier User Service Manual 30 7 2 Trex HD Rear View NOTE Dispose of used non rechargeable batteries in accordance with local regulations ...

Page 32: ...D User Service Manual Trex HD Warning Document Patient Instructions Booklet Diary English Trex HD Sleep Label NOTE 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 NOTE The functionality of the Trex HD is not affected by the lab...

Page 33: ...arkets Trex HD package HD Camcorder kit camcorder carrying case tripod clamp Trex HD Video Interface kit Trex HD Video Interface LANC cable 7 0 in 0 18 m Acquisition laptop Software license Other optional accessories Trex HD XLTEK trolley with optional video Power pack for up to 72 hours of continuous recording Sleep accessory kit EEG accessory kit Patient event switch 2 4 m 7 9 ft SD flash card f...

Page 34: ...TE There is a risk of injury if the Trex HD unit is not properly fitted to the patient NOTE Prior to sending the Trex HD system home with a patient please ensure that the patient has been provided with the proper contact information At no point should the system be leaned against or rested upon Refer to the Transport System Specifications and Maintenance section for placement details and cautions ...

Page 35: ... patient can be accomplished by using either the belt or the lanyard setup NOTE The pouch and belt or lanyard system must be worn over top of the patient s clothes or hospital garment 9 2 1 Belt Setup To use the belt setup 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 into the pouch with the electrode ...

Page 36: ...s as required 3 Close the zippers as much as possible so that the Trex HD is secured in the pouch 4 Once the Trex HD is enclosed in the pouch place the lanyard around the patient s neck or shoulder or hang it on the bedside post 5 Insert the patient event button into the holder on the side of the pouch and the gather the electrodes into a ponytail Note If a power pack is being used enclose it in t...

Page 37: ...cers to the Trex HD 9 4 Setting up Trex HD Amplifier for an Ambulatory Video Study 1 Connect the Trex HD and camcorder to the acquisition computer using the supplied or Natus approved cables Use the supplied USB to mini USB cable to connect the camcorder to the computer see Figure 2 2 Using the software prepare the camcorder for wireless connection with the Trex HD amplifier For detailed instructi...

Page 38: ...n station after the study has ended Video cannot be monitored or reviewed on a computer prior to its upload NOTE For detailed instructions on starting stopping and uploading an ambulatory video study using the Trex HD see the Trex HD Technical Guide P N 009318 9 4 1 Setting up Camcorder and Trex HD Video Interface TVI This video functionality is available only with the Trex HD The Trex HD contains...

Page 39: ...nearby Trex HD amplifier 9 4 1 2 Camcorder Mounting Configurations The Trex HD camcorder with TVI can be mounted on a tripod or a clamp Camcorder Mounting Options 1 1 1 1 1 Camcorder with Infrared Light IR Attachment The infrared light illuminator provided with the camcorder can be attached to the camcorder during operation to extend recording range during dark or night conditions Optional Infrare...

Page 40: ...Configuration Clamp Configuration Camcorder Mounting A IR Illuminator B Camcorder C Trex HD Video Interface D Camera Ball Pivot E Mounting Clamp Stud F Mounting Clamp G Mounting Clamp Wedge H Tripod NOTE Refer to manufacturer instructions for operation and installation of components A B D E F G and H ...

Page 41: ...amcorder 9 4 1 4 LANC Cable Connections 1 Connect this end to the Trex HD Video Interface Use the port with the camcorder symbol 2 Connect this end to the camcorder Use the port labeled LANC 9 5 Testing the Trex HD Amplifier The Trex HD amplifier is fully assembled tested and calibrated before being shipped to you The following sections describe some tests you can perform to verify the performance...

Page 42: ...otch filter to OFF 9 Verify that no sine wave is greater than 50 microvolts peak to peak 50 microvolts represents gain match to 1 NOTE For more information on setting up a montage consult online Help 9 5 2 Channel Test While in Acquisition mode a channel test may be performed to check whether a signal is being properly processed from the amplifier to the display A channel test applies a test signa...

Page 43: ...ance Check Lock onto a channel Click Lock Channel Then make adjustments to the electrode connection until satisfactory levels are achieved Proceed to a full impedance check Click Release Lock End the impedance check Click End Save the impedance check as part of the study Click End and Start Recording An impedance check displays bar graphs that show the impedance of each electrode connection A gree...

Page 44: ... System setup and installation should be performed by Natus qualified personnel only 10 1 XLTEK Trolley Specifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs including equipment A1 Video Camera 1 3 A2 IR Illuminator 2 2 B Monitor Mount 10 10 C Work Surface 0 10 D Storage Bin 0 10 E Keyboard Tray 3 5 F Natus Photic Stimulator Mount 5 5 G Tray for Acquisition DT 20...

Page 45: ...m 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 Natus is not responsible for any injury or damage that may result from improper cable storage during transport WARNING Do not tilt the trolley cart more than 10 incline as this will compromise the ...

Page 46: ...ey any express or implied license to use the device with replacement parts which would alone or in any combination with this device fall within the scope of one or more of the patents relating to this device 11 2 Indications for Use The Xpod is intended to provide medical device manufacturers with a small low power oximeter that can be easily attached to a host device externally The Xpod measures ...

Page 47: ... 5 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 8000J 1 Adult Flex 1 m 3 ft cable 8000J 3 Adult Flex 3 m 9 8 ft cable 8001J...

Page 48: ...le 11 6 Measurements This pulse oximeter module is designed to determine the percentage of arterial oxygen saturation of functional hemoglobin Pulse rate and SpO2 values are updated every 1 3 second and consist of a 4 beat average Measurement Wavelengths and Output Power3 Red 660 nanometers 0 8 mW max avg Infrared 910 nanometers 1 2 mW max avg using Nonin PureLight sensor Factors that may degrade ...

Page 49: ...entrations cardiogreen or other intravascular dyes carboxyhemoglobin methemoglobin dysfunctional hemoglobin artificial nails or fingernail polish a sensor not at heart level 11 7 Displayed Ranges Displayed ranges for the Nonin Xpod 0 to 100 for SpO2 18 to 321 BPM for pulse rate ...

Page 50: ...AA batteries must be inserted This will ensure that your ambulatory amplifier has enough onboard memory and battery power to record for the duration of the study It is recommended that batteries be replaced every 24 hours with a set of new AA batteries NOTES It is strongly recommend that you use major brand name AA alkaline batteries such as Duracell Coppertop Duracell Procell or equivalent Do not...

Page 51: ...b Sampling frequency must be set to 200 Hz c Two new AA batteries must be inserted in the Trex HD and d A power pack must be connected after ambulatory recording is initiated NOTES With the settings described in this section with brand new AA batteries and a fully charged power pack it is recommended that patients be advised to replace the internal batteries according to a fixed schedule Standard ...

Page 52: ...s for charging details 13 2 External Power Pack Specifications Specification Value s Size cm 7 0 x 12 1 x 2 5 h x w x d Weight 300g LED Indicators 1 Charging Indicator 4 Status Indicators Connector 5 pin Trex HD Charging Cable 5 pin to mini USB 15 cm 6 in Capacity Nominal 6 6AH 40WH Self power Consumption Idle mode 100 uA Discharging mode 8 mA Charging mode 8 mA Charging Voltage 12 V Charging Time...

Page 53: ... recharge annually if not used sooner Battery should not be left in a discharged state Recharge battery immediately after use Do not open or allow water to enter battery case Sealed unit do not disassemble No field serviceable parts inside case Do not attempt to open the case or expose to moisture Doing so may result in serious bodily injury or death due to electrical shock Do not install the Trex...

Page 54: ...ftware or by disconnecting the Trex HD from the acquisition computer 4 Connect a fully charged power pack to the Trex HD using the Trex HD cable provided 5 Place the power pack securely in the Trex HD pouch with the headbox Keep the power pack connected for the duration of the study It is recommended that the power pack be charged to full capacity prior to each use To charge it disconnect the Trex...

Page 55: ...1 External Power Pack LED Indicators The percentage of remaining capacity of the power pack can be seen on the end of the unit while connected to the Trex HD The number of LEDs illuminated indicates power pack capacity If the power pack is being charged the state of the charge will be indicated by the same four 4 LEDs Battery Status Indicator Status 75 100 Four lights 50 75 Three lights 25 50 Two ...

Page 56: ...rging will begin 5 LED situated under the charging icon illuminate while charging and indicate the state of the charge See External Power Pack LED Indicators for additional charging details 6 Charging is complete when the amber LED changes to green 13 7 Disconnecting the External Power Pack To disconnect the power pack 1 Rotate the plastic sleeve of the power supply cable to unlock it 2 Remove the...

Page 57: ...Remove the power supply plug and reconnect to the power pack connector Defective power pack Replace the power pack Power pack is too hot cold Allow power pack to return to room temperature Power Pack becomes hot Defective power pack Disconnect power pack from power supply immediately Replace power pack and remove from further service Error message amber light flashing Over discharge of power pack ...

Page 58: ...t drop down box 3 In the Channel Status section select Set manually 4 In the pane below select the following channels All DC channels DC1 DC2 DC3 and DC4 Differential Channels DIF2 DIF3 and DIF4 Pulse Rate PR and Oxygen Saturation OSAT 5 Click the button 6 In the Sampling Frequency section select 200 DIF1 should not be turned off because it is needed in order to perform the impedance check ...

Page 59: ... a damp cloth to wipe all surfaces The Trex HD amplifier is designed to be extremely portable As such the Trex HD is subject to increased daily wear and tear Taking basic care of the system and avoiding extreme physical abuse helps prolong the lifespan of the Trex HD 15 1 Recommendations Disconnect all cables from the Trex HD before wiping Wipe using a soft damp cloth using non conductive distille...

Page 60: ...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 For disposal of non Natus accessories please follow the instructions provided with these items 15 3 Expected Service Life The expected service life of the Trex HD system is seven 7 years Refer to the Instructions for Use for any accessories or se...

Page 61: ...circuit such as printers mechanical beds vacuum cleaners or other potential sources of interference Install a medical grade ground to make sure that your clinic has a properly grounded electrical system Change the acquisition cable You should always have a backup acquisition cable Check the gain and timebase settings to ensure that they are appropriate for the current test You may also want to che...

Page 62: ...ften restarting the computer will solve a problem 3 Close all applications 4 Click the Start button on the Windows taskbar 5 Choose Shut Down from the Start menu 6 Select Restart the computer and click Yes Step 4 Shut Down the Computer Sometimes you need to shut down the computer completely in order to solve a problem 1 Click the Start button on the Windows taskbar 2 Choose Shut Down from the Star...

Page 63: ...dult 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 8000J 1 Adult Flex 1 m 3 ft cable 8000J 3 Adult Flex 3 m 9 8 ft cable 8001J Neonatal Flex 1 m 3 ft cable 8008J Infant Flex 1 m 3 ft cable 8000Q2 Ear Clip 1 m 3 ft cable 8000R Reflectance 1 m 3 ft cable 8000SS Sen...

Page 64: ...le 6000CP Sensor Disposable Pediatric 45 cm 17 5 in cable 6000CI Sensor Disposable Infant 90 cm 35 5 in cable 6000CN Sensor Disposable Neonate 90 cm 35 5 in cable 6500SA Sensor Durafoam Disposable Standard 1 m 3 ft cable 6500MA Sensor Durafoam Disposable Small 1 m 3 ft cable EEG and Sleep accessories which can be used with the Trex HD amplifier are available for you to browse the Natus Neurology C...

Page 65: ...onnection 35 Conducted Immunity Procedures 23 Warnings 23 Warnings and Cautions 21 Connect Trex HD to Computer 35 D Disable Channels 55 Disconnecting External Power Pack 53 Power Pack 53 Disposal 56 57 E Electrical Warnings and Cautions 16 Electrical Input 43 Electromagnetic Emissions 9 Electromagnetic Immunity 10 Electromagnetic Immunity for EQUIPMENT and SYSTEMS that are not LIFE SUPPORTING 11 E...

Page 66: ...Oximetry Sensors 45 Indications for Use 44 Measurements 46 Sensor Warnings and Cautions 20 Warnings and Cautions 18 R Recommended Separation Distances 12 S Safety Standard of Compliance and Normative 7 Safety Standards 7 Set Frequency 55 Setting Up 32 Setting Up for Ambulatory Study 35 Setting Up for Camcorder Video Interface 36 Setting Up for Non Video Study 34 Specifications External Power Pack ...

Page 67: ... Electrical Connections 26 Physical Capabilities 26 Safety 26 Wireless Transceiver 27 Testing 39 Unpacking 30 Tripod and Clamp Mounting Overview 38 Trolley 42 Trolley Cart Maintenance 43 Troubleshooting 58 External Power Pack 54 Power Pack 54 Troubleshooting Checklist 58 U Unpacking 30 Use External Power Pack 51 Power Pack 51 Using the Manual 6 V Verification 40 Video Interface Mounting 39 Video I...

Page 68: ...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 Natus Medical Incorporated DBA Excel Tech Ltd XLTEK 2568 Bristol Circle Oakville Ontario L6H 5S1 Canada T 1 905 829 5300 F 1 905 829 5304 w...

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