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User & Service Manual

Natus Quantum Amplifier

Symbol

Description

CE Mark

Class II Equipment (non-grounded enclosure)

ESD Sensitive

Static Sensitive

Base to Breakout Cable

Breakout to Breakout Cable Connector (not available on Quantum 64)

Cortical Stimulator Adapter Connector

Breakout Box Status LED

DC Inputs 13 to 16 Breakout Cable Connector

Patient Event Button Connector

Nonin Pulse Oximeter Sensor SpO2 Connector

LAN Connection

USB Connection

Manufacturer Information

Содержание Quantum

Страница 1: ......

Страница 2: ...porated 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 Med...

Страница 3: ...OF COMPLIANCE FOR FCC 16 3 CONTRAINDICATIONS AND WARNINGS 17 3 1 CONTRAINDICATIONS 17 3 2 WARNINGS AND CAUTIONS 17 3 2 1 GENERAL WARNINGS 17 3 2 2 ELECTROSTATIC DISCHARGE ESD PRECAUTIONS 19 3 2 3 ELE...

Страница 4: ...UNIT 41 7 2 POTENTIAL EQUALIZATION CONDUCTOR 41 7 3 CONNECTING THE BREAKOUT BOXES TO THE NATUS BASE UNIT 41 7 3 1 CONNECTING TO THE SECONDARY BREAKOUT BOX 42 7 3 2 REMOVING THE CONNECTIONS 42 7 4 CON...

Страница 5: ...10 2 1 SETTING UP NEUROWORKS FOR MULTIPLE SUBJECT CONNECTIONS 66 11 TRANSPORT SYSTEM SPECIFICATIONS AND MAINTENANCE 68 11 1 XLTEK TROLLEY SPECIFICATIONS 68 11 2 NEUROWAND CART NO PC SPECIFICATIONS 69...

Страница 6: ...SIGNAL QUALITY 78 16 ACCESSORIES REPLACEMENT PARTS LIST 79 17 GETTING HELP 82 18 APPENDIX A 83 18 1 DIGITAL TRIGGER INPUT PORT WIRING DIAGRAM 83 19 APPENDIX B 85 19 1 BULK CONNECTOR PIN BOX INPUT 85...

Страница 7: ...ential channels per breakout 2 breakouts cascade able up to 256 channels Up to 8 configurable differential channels per 128 channel breakout 2 inputs per channel Breakouts storing data in internal mem...

Страница 8: ...the patient during long term monitoring Isolation transformers are intended to provide power for all system components while ensuring the safety of operators and patients Carts are intended to suppor...

Страница 9: ...N42802 touch proof connectors Low voltage EEG EMG EOG or ECG signals are amplified low pass filtered and converted from analog to digital 2 The Natus Base Unit connected to the computer through a stan...

Страница 10: ...nventions Various symbols and typographical conventions are used throughout the manual The following table illustrates them and describes their meanings and functions Symbol Convention Description Fun...

Страница 11: ...omply 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 C...

Страница 12: ...lity EMC Part 4 5 Testing and Measurement Techniques Surge Immunity Test IEC 61000 4 6 ed 2 0 with A1 2004 A2 2006 Electromagnetic Compatibility EMC Part 4 6 Testing and Measurement Techniques Immunit...

Страница 13: ...t Compliance Electromagnetic Environment Guidance RF emissions CISPR 11 Group 1 The Quantum uses RF energy only for its internal function Therefore its RF emissions are very low and not likely to caus...

Страница 14: ...uld be 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...

Страница 15: ...e recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site1 should be less than the compliance level in each frequency2 Interfere...

Страница 16: ...0 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation b 217 Hz 2 0 3 28 1 845 1 970 2 450 2 400 2 570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5...

Страница 17: ...ted in a commercial environment This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instruction manual may cause harmful interfere...

Страница 18: ...d with this device Operation of this equipment with input signals in excess of a range of 10mV may cause incorrect results 3 2 Warnings and Cautions 3 2 1 General Warnings NOTE It is recommended that...

Страница 19: ...incorrect application or use When replacing the fuse for the Quantum amplifier system it must be replaced by a fuse with the same type and rating as the original fuse Replacement fuses should be purc...

Страница 20: ...atic 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...

Страница 21: ...onformity section for minimum recommended separation distances Do not connect items which are not specified as part of the Quantum amplifier system to the system 3 2 3 Electrical Warnings and Cautions...

Страница 22: ...al grade receptacle 3 2 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...

Страница 23: ...RESS INJURY HAZARD Sustained use of this product without ergonomic consideration may result in repetitive stress injury User is not to position ME equipment in such a way as to make it difficult to op...

Страница 24: ...ys and Carts validated by Natus for use with the Quantum amplifier system may be used 3 2 6 Pulse Oximeter Sensor Warnings Refer to the pulse oximeter sensor user manual for associated precautions war...

Страница 25: ...tatic 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 co...

Страница 26: ...is present on the EEG waveforms try to identify possible culprits by disconnecting nearby equipment from the common power source Lay out the interconnection cables as far as possible from the cables b...

Страница 27: ...n ATTENTION Consult Accompanying Documents Consult Accompanying Documents Consult Operating Instructions Pushing Prohibited Protective Earth Ground Type BF Equipment Dangerous Voltage Alternating Curr...

Страница 28: ...tic Sensitive Base to Breakout Cable Breakout to Breakout Cable Connector not available on Quantum 64 Cortical Stimulator Adapter Connector Breakout Box Status LED DC Inputs 13 to 16 Breakout Cable Co...

Страница 29: ...28 Symbol Description Non Waterproof Device Equipotential stud Fragile IPX0 No protection against ingress of water according to IEC 60529 IPX1 Protection from dripping water from above the device for...

Страница 30: ...TL Pulse Oximetry Channels SpO2 Pulse Rate Input Impedance Common Mode DC Input Impedance 1 Gohm Differential Mode 44 Mohm 280pF 20 Input Noise3 2 uV pk to pk 0 1Hz to 100 Hz Common Mode Rejection rat...

Страница 31: ...hPa Transport and Storage Temperature Range 25 C to 60 C Transport and Storage Humidity Range 10 95 Transport and Storage Atmospheric Pressure Range 500 hPa to 1060 hPa Dimensions Size length x width...

Страница 32: ...ge Maximum Charge Voltage 4 2V 50mV Maximum Continuous Charge Current 1080 mA Maximum Continuous Discharge Current 2000mA Operating Conditions Charging Temperature 0 C to 45 C Discharging Temperature...

Страница 33: ...Natus Quantum Amplifier User Service Manual 32 6 Product Images and Description 6 1 Quantum Amplifier System with 128 to 256 channels...

Страница 34: ...User Service Manual Natus Quantum Amplifier 33 6 2 Quantum 64 Amplifier System...

Страница 35: ...power supply 7 Fuse Compartment Labeled with Fuse T1 6A 250V 80VA 100 230VAC 8 Labeled with 9 Can be used to connect DC signals from external devices Labeled with DC1 DC12 10 Photic Stimulator Connec...

Страница 36: ...th 4 Nonin Oximeter Connection Labeled with 5 Patient Event Button Connection Labeled with 6 Breakout Main to Breakout B Cable Connection Labeled with 7 Breakout Box Status LED Labeled with 8 Reserved...

Страница 37: ...tum Amplifier User Service Manual 36 6 4 1 Quantum Breakout MAIN Bottom View 1 Battery compartment 6 5 Quantum Pin Box Options 6 5 1 Standard Numerical Pin Boxes 1 Standard Numeric Channel Inputs 1 25...

Страница 38: ...Box 1 Standard 10 10 10 20 Channel Inputs See Connecting the 10 10 10 20 Pin box to the Quantum Breakout for additional information NOTE The 10 10 10 20 pinbox is unavailable with the Quantum 64 break...

Страница 39: ...cted too Connector Pin layout is available in Appendix B The last 16 inputs of each 64 channel pin box are also available as individual touch proof inputs These may be used for connecting additional e...

Страница 40: ...with 3 DC Inputs 13 to 16 Breakout Cable Connection Labeled with 4 Nonin Oximeter Connection Labeled with 5 Patient Event Button Connection Labeled with 6 This functionality is unavailable Labeled wi...

Страница 41: ...onnector for all 64 channel and are designed for convenient connection of head caps with up to 64 electrodes Other electrodes such as Subdermal grids may be connected too Connector Pin layout is avail...

Страница 42: ...on the acquisition computer 3 Connect the power cable base to breakout cable patient event button and any additional accessories DC input cables Stimulator adapter cable etc as required 7 2 Potential...

Страница 43: ...Breakout box 1 are connected you can connect an additional breakout box which provides additional channels for use with the Quantum Amplifier To Connect to the Secondary Breakout box 1 Connect the bl...

Страница 44: ...the image below by sliding the lock towards the back of the breakout box 3 Seat and lock additional pin boxes into the breakouts as required NOTE Prior to removing the Standard or Bulk Connector pin...

Страница 45: ...er pin box module into place 2 Once the larger pin box module has been connected seat 4 in the image below and lock 5 in the image below the smaller input module into position 3 Create or select a Qua...

Страница 46: ...User Service Manual Natus Quantum Amplifier 45 5 Activate the 10 10 module for the Quantum by selecting the checkbox next to 10 10 MODULE under the Pinboard Usage section...

Страница 47: ...ly NOTE When the Base Unit is connected to an acquisition computer via USB the maximum sample rate is 2048Hz When the Base Unit is connected to an acquisition computer via gigabit Ethernet sample rate...

Страница 48: ...lified personnel only NOTE When the natus base unit is connected to an acquisition computer via USB the maximum sample rates are 4096Hz When the Base Unit is connected to an acquisition computer via g...

Страница 49: ...seconds The following user interface appears 2 Press the Settings button on the touchscreen to access the IP Configuration NOTE The amplifier supports both DHCP and static TCP IP address configuration...

Страница 50: ...the DNS server will enable manual entry of the IP address and DNS server for the base unit 4 Press Save to finalize changes to the IP configuration 5 Press Close to return to the main screen 6 From t...

Страница 51: ...ss is set as intended and that the connection information related to the breakout and pin boxes show that all components are recognized by the system NOTE If DHCP was not used the DHCP STATIC item wil...

Страница 52: ...is connected but the software has not established a connection with the headbox If it is TRANSPARENT then no network cable is plugged in NOTE If a USB connection is used the above connection will be...

Страница 53: ...from the base this icon shows briefly when the breakout is reconnected but switches to the stored icon while the study backfills and uploads the data to the NeuroWorks SleepWorks software Indicates th...

Страница 54: ...t System Specifications and Maintenance section for placement details and cautions for the different cart transportation options Refer to the corresponding Instructions for Use for all system componen...

Страница 55: ...udy consult the NeuroWorks manual directly NOTE In order to record a study the base unit must be connected to a PC and the base unit must be connected to the Quantum breakout boxes via the patient cab...

Страница 56: ...essed allows the impedance test screen to display With the Cycle feature set to ON in the NeuroWorks SleepWorks User interface the system will automatically measure and display impedances for each 64...

Страница 57: ...sition computer is powered down The following message is displayed in the NeuroWorks SleepWorks acquisition application NOTE While in Ambulatory Mode the data is stored to the internal memory at a max...

Страница 58: ...nd available memory in the NeuroWorks status bar or in the Heads Up window If the main sampling rate is set to 256Hz ambulatory data will also be stored in 256Hz A new fully charged extrernal battery...

Страница 59: ...ackfill to resume If the NeuroWorks recording is stopped while the breakout is in ambulatory mode or while backfill is ongoing the remaining ambulatory data must be downloaded using the Ambulatory Man...

Страница 60: ...ional information 3 Connect the Secondary Breakout box to the Main Breakout box See Connecting Secondary Breakout Boxes for information 4 Connect the stimulator control cable 016728 to the connectors...

Страница 61: ...ry Breakout Boxes Please refer to the diagram below for reference Natus Base Unit connected to the Nicolet Cortical Stimulator when two breakout boxes are used 9 7 Powering Down the System Utilize the...

Страница 62: ...uantum pouch es nor the breakout box es should be covered by blankets or any other material Failure to follow these instructions could raise the temperature of the Quantum Breakout s above normal oper...

Страница 63: ...together to enclose the breakout box es completely 5 The top of the pouch can be secured by snapping the top to the main part of the pouch 6 If more than one breakout box is being used connect multip...

Страница 64: ...the data to the computer The computer software will display and store this data see Figure 1 Figure 1 Physical Connection of the Quantum System When the Base unit is physically disconnected from the B...

Страница 65: ...g Not Discharging Critical Capacity Not Writing Reserved Yellow Flash DSM Active Critical Level Charging Discharging Critical Capacity Writing or Error Breakout upgrade or Error None None Not Ready No...

Страница 66: ...be recorded Note The last 8 inputs on the pinboard cannot be used Breakout Common Reference Mode Clinical Independent Reference Mode Animal Research max active inputs max subjects max active inputs Q...

Страница 67: ...he Independent reference box checked This is found in the Acquisition Tab of the Edit Settings Dialog When selected this ensures that each subject has an independent reference dictated in the software...

Страница 68: ...characters underscores and dashes Do not use other characters including but not limited to NOTE If an attribute or setting on the current named profile is changed an asterisk is placed to the left of...

Страница 69: ...System setup and installation should be performed by Natus qualified personnel only 11 1 XLTEK Trolley Specifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs includin...

Страница 70: ...ecifications Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs including equipment A1 Video Camera 4 4 A2 IR Illuminator 2 2 B Amplifier Mount 5 5 C Storage Bin 0 10 D Isolatio...

Страница 71: ...e ErgoJust cart please refer to the Natus ErgoJust Installation Functionality Guide p n 019667 Mounting Location Default Equipment Equipment Weight lbs Maximum Load lbs including equipment A Natus Pho...

Страница 72: ...he 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...

Страница 73: ...mer Details EU Electrical input 200 240V AC 2 24A 50 Hz Isolation Transformer Powervar ABC500 22MED North America Electrical input 120V AC 3 0A 60 Hz Isolation Transformer Powervar ABC300 11MED Japan...

Страница 74: ...18 to 321 beats per minute BPM 13 2 Pulse Oximeter Instruction for use The indication of a signal inadequacy and or probe faults for the SP02 sensor is alarmed through the Neuroworks 9 0 software and...

Страница 75: ...1 m 3 ft cable 8000SL 3 Sensor Reusable Soft Large 1 m 3 ft cable 8000Q2 Sensor Reusable Ear Clip 8000R Sensor Reusable Reflectance 6000C Sensor Disposable Cloth Series 6500 Sensor Disposable Durafoa...

Страница 76: ...Ethernet cables Electrodes and accessories The Quantum amplifier and its components should not be immersed in water or any other fluid To clean use a damp cloth to wipe all surfaces including the LCD...

Страница 77: ...14 3 Disposal At the end of the useful service life when disposing of the Quantum amplifier and its components it is recommended that federal state and local laws be followed for proper disposal of p...

Страница 78: ...des fit properly into the headbox not loosely Make sure that there are no apparent breaks in the patient electrode cables Are any of the electrodes touching If so they are causing a short circuit and...

Страница 79: ...ntrol bar appears above the waveform display 3 Point to the first menu on the Channel Test control bar and click Sine or Square The Sine wave setting is good for general use A low frequency Square wav...

Страница 80: ...to Base Cable 16ft 5m 013415 Natus Quantum Breakout to Breakout Cable 32in 81cm 014162 Natus Quantum Pin Box 1 64 014163 Natus Quantum Pin Box 64 128 014164 Natus Quantum Pin Box 129 192 014165 Natus...

Страница 81: ...sformer JA 015170 Replacement Fuse Natus Base Unit 982A0558 Nicolet Cortical Stimulator 016728 Natus Base Unit to Nicolet Cortical Stim Cable 013833 Natus Quantum Stim Input Cable 8ft 2 4m 013769 Natu...

Страница 82: ...uantum Amplifier 81 EEG accessories which can be used with the Quantum amplifier are available for you to browse in the Natus Neurology Accessories Catalog online at www natus com or call Natus Sales...

Страница 83: ...skbar 2 Navigate to the Excel Tech Documentation folder Step 3 Restart the Computer Often restarting the computer will solve a problem 1 Close all applications 2 Click the Start button on the Windows...

Страница 84: ...d the events in the study The trigger input is available with Natus Quantum and natus Brain Monitor The trigger inputs are not available when using EMU40EX breakout with Natus Base Trigger signals app...

Страница 85: ...and annotation with value 2 Trigger on TRIG 3 input generates a square wave and annotation with value 4 Trigger on TRIG 4 input generates a square wave and annotation with value 8 Trigger on TRIG 5 i...

Страница 86: ...Conductor Pin Channel Solid Band Solid Band 1 1 Black Red N C N C 2 Red Black 3 TP5 2 3 Black White 66 GND 4 White Black 7 C1 3 5 Black Green 9 C2 6 Green Black 28 C3 4 7 Black Blue 27 C4 8 Blue Blac...

Страница 87: ...ite Orange 54 C40 44 Orange White 40 REF 23 45 Blue Yellow 23 C41 46 Yellow Blue 52 C42 24 47 Blue Brown 18 C43 48 Brown Blue 49 C44 25 49 Blue Orange 17 C45 50 Orange Blue 46 C46 26 51 Brown Yellow 4...

Страница 88: ...21 Pulse Oximeter 23 Transportation 23 Trolley 74 Cleaning 78 Quantum Amplifier Belt 78 Quantum Amplifier Harness 78 Quantum Amplifier Pouch 78 Recommendations 78 Connection 10 10 Pinbox 43 10 20 Pinb...

Страница 89: ...oduct Images 32 Sample Rates 31 Specifications 29 Standard Pin Box 36 System Images 32 Usage and Features 47 Quantum Breakout Boxes 35 39 Quantum Standard Pin Box 36 R Removing Cable Connection 42 S S...

Страница 90: ...User Service Manual Natus Quantum Amplifier 89 Electrical 20 Electrostatic 24 ESD 24 General 17 Patient Environment 21 Pulse Oximeter 23 Transportation 23 Trolley 74 X XLTEK Trolley 71...

Страница 91: ...affed 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 inc...

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