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Nicolet Systems

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April 27, 2015

Labels and symbols

The following labels and symbols may be affixed to the 

Nicolet EEGwireless32/64

 

system:

When applied on device: 

Attention: Consult Accompanying Docu-

mentation. (ISO 7000-0434A)

When used in documentation: 

Caution, Warning or Precaution fol-

lows.

Consult Operating Instructions. Failure to follow operating instructions 

could place the patient or operator at risk. Image on blue background. 

(ISO 7010 M002)

Consult Operating Instructions. (ISO 7000-1641)

European Authorized Representative.

Manufacturer.
Natus Neurology Incorporated

 

3150 Pleasant View Road 

Middleton, WI USA 53562

608-829-8500 

1 800-356-0007 

Fax: 608-829-8589 

www.natus.com 

Disposal at end of operating life instructions.

CE Mark and Notified Body. 

(Compliant to Medical Device Directive 93/42/EEC)

Type BF equipment.

RX Only

CAUTION:

 USA Federal law restricts this device to sale or on the 

order of a licensed medical practitioner.

Содержание Nicolet EEGwireless32

Страница 1: ...rated or one of its subsidiaries All rights reserved Natus is a registered trademark of Natus Medical Incorporated All product names appearing on this document are trademarks or registered trademarks...

Страница 2: ......

Страница 3: ...iration body position snore heart rate oxygen saturation and other physiologic signals All ages of patients are served including infants either within a medical facility or outside a medical facility...

Страница 4: ...orporated or its distributors Natus Neurology Incorporated makes no representations or warranties of any kind whatsoever with respect to this document Natus Neurology Incorporated disclaims all liabil...

Страница 5: ...ons of Directive 1999 5 EC The following signed and translated declaration of conformity We Natus Neurology Incorporated at 3150 Pleasant View Road Middleton WI USA declare under our own responsibilit...

Страница 6: ...c Absorption Rate valueis 0 0154 W kg This hardware uses the FreeRTOS operating system Go to www freertos org for more information THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES OPERATION IS SUBJE...

Страница 7: ...and avoid potential problems during system operation Do NOT use cables with unattended and unsupervised children Do NOT wrap cables around your neck Keep batteries away from children Conductive parts...

Страница 8: ...patient during an MRI study Other patient connected equipment When used simultaneously with other patient connected equipment for example a cardiac pacemaker or other electrical stimulator it is unli...

Страница 9: ...attention to the Safety information before applying power to and using your Nicolet Brand system Fixed installation guide Please see the Fixed Installation guide Section 3 269 620300 and Section 5 26...

Страница 10: ...s batteries printed circuit boards electronic components wiring and other elements of electronic devices Follow all of your respective local laws and regulations for the proper disposal of batteries a...

Страница 11: ...ant to Medical Device Directive 93 42 EEC Technical support Domestic International Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdesk natus com...

Страница 12: ...ould place the patient or operator at risk Image on blue background ISO 7010 M002 Consult Operating Instructions ISO 7000 1641 European Authorized Representative Manufacturer Natus Neurology Incorpora...

Страница 13: ...CC wireless compliance d Safety summary e Use with other equipment f Defibrillators and High Frequency surgical equipment f MRI equipment f Other patient connected equipment f Read the Safety Referenc...

Страница 14: ...r 1 8 Headbox interchangeability 1 8 Electrode labels 1 9 Headbox dry erase label information 1 9 Inspecting the system 1 10 Cleaning instructions 1 10 Cleaning the Nicolet EEGwireless32 64 amplifier...

Страница 15: ...ed network communication and a supply or battery 3 7 Cabling the wired network communication to a laptop with power supply or battery 3 8 Cabling the computer with video options 3 9 Cabling the amplif...

Страница 16: ...a protocol 5 6 Change View the sampling rate 5 6 Check the impedance 5 7 Impedance threshold check 5 8 Start recording EEG 5 9 Disconnecting from the system 5 9 Optional steps 5 10 Enabling automatic...

Страница 17: ...attery indications 7 8 Nicolet EEGwireless32 64 Amplifier Onboard Memory Onboard memory 8 3 Data download rate 8 5 Example modes of operation 8 6 Mode 1 Wireless with external battery pack 8 6 Mode 2...

Страница 18: ...Question 2 What happens if I try and review an exam that is incomplete 12 6 Question 3 How do I know if an exam has been completely downloaded by looking in NicVue 12 6 Question 4 Why does a single ex...

Страница 19: ...April 27 2015 1 1 1 Introduction This guide describes how to operate the Nicolet EEGwireless32 64 amplifier in conjunction with the Nicolet EEG system and software...

Страница 20: ...Nicolet Systems 1 2 April 27 2015 Blank page...

Страница 21: ...bulatory and ICU monitoring provides low signal amplification alternating current AC recording of physiological signals and is designed specifically to amplify EEG and intracranial EEG signals provide...

Страница 22: ...d within 10 minutes of removal If an external battery or AC power is connected to the Nicolet EEGwireless32 64 amplifier the internal battery will be charged Communication EEG data can be transmitted...

Страница 23: ...rt L Disconnect headbox latch V Power on off button C Electrostatic sensitive M Electrode leads cover W LED Wireless transmission on D Network port N SpO2 X Start recording button E LED Ethernet conne...

Страница 24: ...eries arrive at 40 Contact Natus Neurology Incorporated customer service if you believe your amplifier s internal batteries need to be replaced If the amplifier is going to be stored for extended peri...

Страница 25: ...c cover 1 Grasp the plastic cover on both sides with one hand 2 Grasp the Nicolet EEGwireless32 64 amplifier with the other hand 3 Carefully slide the plastic cover off the Nicolet EEGwireless32 64 am...

Страница 26: ...dbox pull the headbox towards yourself 3 Carefully lift off the Nicolet EEGwireless32 64 amplifier from the headbox Figure 1 Headbox interchangeability You cannot use a 64 channel headbox with a 32 ch...

Страница 27: ...el Figure 2 64 channel electrode label NOTE The two grounds are linked together in the Nicolet EEGwireless32 64 amplifier You do not need to provide two grounds but they are available for redundancy T...

Страница 28: ...tment and follow all appropriate policies Routine equipment cleaning recommendations are provided below Cleaning the Nicolet EEGwireless32 64 amplifier The Nicolet EEGwireless32 64 amplifier and acces...

Страница 29: ...ound the connectors and panel edges Remove stubborn dirt with a clean soft cloth slightly dampened with a mild detergent soap or low level disinfectant detergent solution Allow the items to air dry be...

Страница 30: ...tients be disinfected before the next patient uses it Cleaning the garment Wash contaminated garments with laundry detergent and hot water or with a phenolic household detergent The garment should be...

Страница 31: ...corporated service representative only You have the sole responsibility for any malfunctions resulting from improper maintenance or repair by anyone other than an authorized Natus Neurology Incorporat...

Страница 32: ...Nicolet Systems 1 14 April 27 2015 Blank page...

Страница 33: ...April 27 2015 2 1 2 Using the garment This chapter describes how to use the Nicolet EEGwireless32 64 amplifier garment as well as how to clean the garment...

Страница 34: ...Nicolet Systems 2 2 April 27 2015 Blank page...

Страница 35: ...3 Garment Cable and insert the Nicolet EEGwireless32 64 amplifier into the garment NOTE See the next chapter for additional cabling information 1 Snap the battery pouch to the four snaps on the garme...

Страница 36: ...and 4 3 Connect the primary battery to the Nicolet EEGwireless32 64 amplifier Figure 3 4 Connect the second battery cable to the Nicolet EEGwireless32 64 amplifier if using an optional second battery...

Страница 37: ...April 27 2015 2 5 Garment 8 Fold the side flap over the front and snap Figure 4 9 Fold the bottom flap up Figure 5 10 Fold the top flap down and snap to the bottom flap Figure 6 4 5 6 4 8 10 9...

Страница 38: ...der strap assembly over the patient s shoulder and clip the other end of the shoulder strap to the top fastening loop R2 3 Repeat steps 1 L1 and 2 L2 for the left shoulder strap 4 Feed the electrode l...

Страница 39: ...epeat steps 1 L1 and 2 L2 for the left shoulder strap 4 Feed the electrode leads through the electrode sleeve 4 5 Adjust the straps as necessary for a snug fit Attach the optional second battery NOTE...

Страница 40: ...Nicolet Systems 2 8 April 27 2015 Blank page...

Страница 41: ...Cabling the system This chapter contains the cabling diagrams for the various configurations available for use with the Nicolet EEGwireless32 64 amplifier NOTE Connector styles in this chapter may va...

Страница 42: ...Nicolet Systems 3 2 April 27 2015 Blank page...

Страница 43: ...nded to guard against the power connector being inserted in the wrong orientation which can result in damage to the amplifier and or power connector Refer to the figure below which shows the proper or...

Страница 44: ...ns power shown in battery charging mode fixed install Legend Description A Amplifier B Access point connected to hospital network C Antenna D Photic strobe option E Event button option F SpO2 option G...

Страница 45: ...wer shown with two battery packs WiFi roaming mode N i c o l e t w i r e l e s s E E G 3 2 A A B C D E F G Legend Description A Amplifier B Access point connected to hospital network C Antenna D Event...

Страница 46: ...J K L M Legend Description Legend Description A Amplifier I Network switch B Photic strobe option J Computer C Event button option K Monitor D SpO2 option L Medical grade power supply PSU EEG64 E Iso...

Страница 47: ...uired to only use 115VAC input power on the Panel PC Power Pack Legend Description Legend Description A Amplifier H Network switch B Photic strobe option I PanelPC C Event button option J Medical grad...

Страница 48: ...input power on the Laptop Power Pack Legend Description Legend Description A Amplifier I Laptop Power Supply B Photic strobe option J Laptop C Event button option K Medical grade power supply PSU EEG...

Страница 49: ...olation transformer J Camera power supply B Access point Wireless Amplifier option only K IR Illuminator option C Antenna L Camera option D Computer E Ethernet to hospital network wallplate 1 From wir...

Страница 50: ...ing the amplifier for use with the configuration utility N i c o l e t w i r e l e s s E E G 3 2 A A C B D Micro USB cable Legend Description Legend Description A Amplifier C Medical grade power suppl...

Страница 51: ...eless32 64 Amplifier Operation This chapter describes how to operate the Nicolet EEGwireless32 64 amplifier Please see Chapter 5 for instructions on operating the Nicolet EEGwireless32 64 amplifier co...

Страница 52: ...Nicolet Systems 4 2 April 27 2015 Blank page...

Страница 53: ...Make sure the Nicolet EEGwireless32 64 amplifier is always visible to the operator e g worn outside a thicker robe or hanging from a bed rail or head board either in the garment or the amplifier by it...

Страница 54: ...he Power button A in Figure 1 for 3 5 seconds When power is turned on the Power LED B illuminates Figure 1 Error codes Refer to the Error Codes chapter at the end of this manual for a description on h...

Страница 55: ...the Impedance test to illuminate the LEDs again 1 Hold down the Impedance Check button A in Figure 1 for 12 seconds to initiate the impedance check 2 Press the Impedance Check button repeatedly until...

Страница 56: ...impedances For electrodes with out of range impedances 1 Check the electrode connections to the amplifier Electrodes with out of range impedances may appear noisier than those with in range impedances...

Страница 57: ...s You can acquire multiple studies from a single patient when connected to a Nicolet brand system all data will appear with appropriate start and stop times and dates marked NOTE To acquire data from...

Страница 58: ...ta from the amplifier 1 Press the Start Study Record button A in Figure 1 for 3 5 seconds to start a study The Study Started LED B illuminates when the study starts Stop a study from the amplifier 1 P...

Страница 59: ...eared after an exam was completed the Amplifier Contains Data menu appears when attempting to start a recording This prompt shows the size of the exam located on the amplifier the patient ID under whi...

Страница 60: ...our patient exam list and cancel the recording This is done by 1 Select Cancel on this menu 2 Select Cancel on the Amplifier Selection screen 3 Close the recorder program using the X in the top right...

Страница 61: ...n will download the EEG data from the amplifier and will not contain the annotations or events entered by the technician at the beginning of the exam These annotations can be preserved by retrieving t...

Страница 62: ...Nicolet Systems 4 12 April 27 2015 Blank page...

Страница 63: ...acquire EEG This Chapter describes how to operate the Nicolet EEGwireless32 64 amplifier controls from the Nicolet brand system Please see the previous chapter for instructions on controlling the Nico...

Страница 64: ...Nicolet Systems 5 2 April 27 2015 Blank page...

Страница 65: ...fier This procedure describes using the Nicolet brand system to setup and acquire EEG For more information please see the Nicolet Software Reference guide 269 604601 CD part number 482 639403 Wireless...

Страница 66: ...aximum total storage on the amplifier s onboard storage as well as the total remaining storage are displayed An estimate of the total storage time remaining given the current sampling rate is also dis...

Страница 67: ...e same identifier as your amplifier If the dialog in Figure 2 does not appear and you see an Amplifier Disconnected select the proper Protocol from the Protocol menu to view the wireless panel dialog...

Страница 68: ...of channels with which your amplifier is configured 3 The amplifier is ready to start acquiring data NOTE If you change to a different protocol e g 64 wireless to a 32 wireless when Powerloss Recover...

Страница 69: ...Software Reference Guide Miscellaneous Quick Steps chapter Acquisition tab for additional information NOTE If you disconnect the Headbox from the Amplifier during an Impedance test and then reconnect...

Страница 70: ...art 7 The Recorder window appears with a watermark that says Not Recording and with the EEG scrolling across the screen but not yet being saved to the hard drive Select Record to start the recording u...

Страница 71: ...t enabled select Record start recording NOTE Select Record again to stop recording EEG NOTE If the patient goes out of range while performing an impedance check the impedance values will not be record...

Страница 72: ...ou change to a different montage 1 Select Settings and then Misc at the bottom of the Editor window or Select Protocol Settings and then Misc at the bottom of the Editor window 2 Checkmark Automatic I...

Страница 73: ...ired montage or Select the desired Montage shortcut button or Right click on the trace labels select Montage and then select the desired montage NOTE If the Laplacian button becomes disabled 1 Open th...

Страница 74: ...e labels select All Traces Sensitivity and then select the desired sensitivity or Right click on the trace labels select Adjust Selected and then select the desired sensitivity Select the Timebase 1 F...

Страница 75: ...esired filter settings or Right click on the trace labels select Adjust Selected select HighCut LowCut and then select the desired filter settings Selecting additional Filters In NicoletOne there is a...

Страница 76: ...Right click on the trace labels select Adjust Selected and then select Notch Display the Reader window optional 1 Select Review to display the Reader window to the left of the Record window if you wa...

Страница 77: ...col Settings and then select Misc at the bottom of the Editor window Splitting the recording at a specified file duration a Click on the Maximum File Duration radio button b Select the file duration a...

Страница 78: ...amplifier stores data locally The amplifier has onboard memory and stores all data acquired EEG and Patient Event to its onboard memory When the amplifier communication is restored to the network or...

Страница 79: ...r to a network running the Nicolet acquisition station a The Ethernet cable connecting the amplifier to the Nicolet acquisition station is disconnected causing the Nicolet software to display an alert...

Страница 80: ...cquisition station is disconnected causing the Nicolet software to display an alert that a disconnect has occurred b The disconnect lasts longer than 10 minutes c The amplifier is reconnected to the n...

Страница 81: ...gure 1 You can select specific sampling frequencies between 128 Hz to 12000 Hz Figure 1 NOTE If you select a sampling rate over 4096 Hz while in the wireless mode you will be prompted to turn the wire...

Страница 82: ...Nicolet Systems 5 20 April 27 2015...

Страница 83: ...April 27 2015 6 1 6 Wireless Operation...

Страница 84: ...Nicolet Systems 6 2 April 27 2015 Blank page...

Страница 85: ...le If the Acquisition station on which NicoletOne is running has a power outage NicoletOne will attempt to restart acquisition when power is restored to the workstation If the amplifier that you are u...

Страница 86: ...Nicolet Systems 6 4 April 27 2015 Blank page...

Страница 87: ...April 27 2015 7 1 7 Using the EEGwireless32 64 Batteries This chapter contains information about the batteries that may be used with the EEGwireless32 64 amplifier...

Страница 88: ...Nicolet Systems 7 2 April 27 2015 Blank page...

Страница 89: ...d Customer Service if you believe your internal batteries need to be replaced The external battery charge indicators The five LEDs on the battery charger indicate the current charge in percent as show...

Страница 90: ...nal batteries Below is information regarding the run and life time of the batteries Note that the values here are only estimates The actual run time and life of the batteries depend on how the amplifi...

Страница 91: ...ngle battery pack your battery life will approximately double with 2 battery packs connected You cannot sample above 4096 Hz in the Wireless mode SamplingRate Hz 32 Channel 64 Channel Wired Hours Wire...

Страница 92: ...or if no external power is connected running on internal batteries Replace the External batteries or the Recorder to a wall outlet Figure 1 External battery and charger Replacing a worn out external b...

Страница 93: ...h a medical grade power supply Figure 3 Legend Description A Battery Nicolet BAT1 B Charger Nicolet CHG1 C Medical power supply PSU EEG64 D Wallplate Hospital mains A B C D Legend Description A Amplif...

Страница 94: ...r and the internal batteries are charged If the Power LED is green and blinks yellow every 5 seconds then the amplifier has external power and the internal batteries are charging If the Power LED is y...

Страница 95: ...April 27 2015 8 1 8 Nicolet EEGwireless32 64 Amplifier Onboard Memory This chapter contains information about the Nicolet EEGwireless32 64 onboard memory...

Страница 96: ...Nicolet Systems 8 2 April 27 2015 Blank page...

Страница 97: ...Tests and Patient Event When the amplifier communication is restored to the network or Acquisition station the data stored locally on the amplifier is transmitted along with the current live data The...

Страница 98: ...Data Storage for 1 Hour Gbytes Estimated Storage Time with 32GB SD Card Estimated Data Storage for 1 Hour Gbytes Estimated Storage Time with 32GB SD Card 12000Hz 4 0 7 Hours 6 6 4 Hours 10000Hz 3 3 8...

Страница 99: ...ated by Nicolet in the Amp Contains Data window is not the same as the e file size on disk The downloaded e file will be approximately 70 of what is indicated in the Amp Contains Data window Data down...

Страница 100: ...procedure which does not have wireless access You can use this mode Mode 3 Wired network with external battery pack Wired modes allow use of higher sampling rates Example You are wired and want the p...

Страница 101: ...ty This chapter describes the configuration utility which is a piece of software independent of the Nicolet brand system The purpose of the configuration utility is to allow you to troubleshoot the am...

Страница 102: ...Nicolet Systems 9 2 April 27 2015 Blank page...

Страница 103: ...Click Windows Start Config Utility 2 When the utility launches you will be prompted for a password See the password that was supplied with the amplifier When using the Configuration Utility you have...

Страница 104: ...t the settings and then update the firmware This section displays the current IP address of the amplifier and the port on which it is operating NOTE Do not set the port to anything other than 26010 or...

Страница 105: ...l the access point SSID s you must select Apply and reboot the amplifier for the changes to take effect The amplifier attempts to connect to the access points in the order they appear in the dialogue...

Страница 106: ...rom the amplifier without connecting to the Nicolet brand system If the amplifier is connected to the Nicolet brand system and a study is started from the software the sampling rate selected becomes t...

Страница 107: ...April 27 2015 10 1 10 Electromagnetic Compatibility EMC...

Страница 108: ...Nicolet Systems 10 2 April 27 2015 Blank page...

Страница 109: ...or stacked use is necessary the user should verify normal operation in that configuration EMI by nature can be a possible source of disturbance to electronic equipment This device should be used in a...

Страница 110: ...ecial precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this User manual Portable and mobile RF communications equipment can affect...

Страница 111: ...ho is electrostatically charged Further an explanation should be given of methods to prevent build up of electrostatic charge and how and why to discharge one s body to earth or to the frame of the EQ...

Страница 112: ...customer or the user of the Nicolet EEGwireless32 64 amplifier can help prevent electromagnetic interferences by maintaining a minimum distance between portable and mobile RF communications equipment...

Страница 113: ...mpliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Nicolet EEGwireless32 64 amplifier uses RF energy only for its internal function Therefore its RF emissions are very low...

Страница 114: ...Test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The Nicolet EEGwireless32 64 amplifier uses RF energy only for its internal function Therefore its RF emissions are v...

Страница 115: ...61000 4 5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interru...

Страница 116: ...the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 d 1 17 80 MHz to 800 MHz d 2 23 800 MHz to 2 5 G...

Страница 117: ...RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the Nicolet EEGwireless32 64 amplifier is used exceeds the applicable RF co...

Страница 118: ...Nicolet Systems 10 12 April 27 2015 Blank page...

Страница 119: ...April 27 2015 11 1 11 Error Codes This chapter contains error codes that may appear while operating the Nicolet EEGwireless32 64 Amplifier...

Страница 120: ...Nicolet Systems 11 2 April 27 2015 Blank page...

Страница 121: ...ifier 2 Turn power on again to Nicolet EEGwireless32 64 amplifier 3 If the error has been corrected the LEDs will stop flashing If the error can not be corrected please contact Natus Neurology Incorpo...

Страница 122: ...ating on internal batteries only Temperatures are within set limits Yellow LED with short flash off every 5 seconds d Amplifier has external power the internal batteries are low and NOT charging Tempe...

Страница 123: ...remains contact Natus Neurology Incorporated Customer Service 5 Error trying to allocate memory for the UDP connection An amplifier power cycle will normally fix this problem If the error remains cont...

Страница 124: ...us Neurology Incorporated Customer Support 15 A JTAG reset has occurred Try cycling the power If the error remains contact Natus Neurology Incorporated Customer Support 16 A reset external to the CPU...

Страница 125: ...Incompatible firmware versions When combined AVR Firmware version 1 0 77 Gas Gauge Image version 0 1 6 and FPGA Firmware version 1 0 8 and higher are compatible When combined AVR Firmware version 1 0...

Страница 126: ...Nicolet Systems 11 8 April 27 2015 Blank page...

Страница 127: ...April 27 2015 12 1 12 Frequently Asked Questions FAQ This chapter contains frequently asked questions concerning the Nicolet EEGwireless32 64 Amplifier...

Страница 128: ...Nicolet Systems 12 2 April 27 2015 Blank page...

Страница 129: ...r is associated with a different computer Solution You can either delete the current data off the amplifier using the computer with which you started the initial recording or use the amplifier configu...

Страница 130: ...using a 32 channel amplifier you must have a 32 channel or w10 20HB protocol selected This is indicated in the Amplifier Details Solution You must select Cancel from the amplifier selection screen Wh...

Страница 131: ...er has been selected Solution Follow the instructions in the dialogue box by changing the appropriate channels to or from bipolar in the protocol Note If this happens frequently change the default bip...

Страница 132: ...the data that has been currently downloaded Downloading an exam from the Amplifier requires that the exam not be open for review on any other PC s Question 3 How do I know if an exam has been complet...

Страница 133: ...nd I am still recording During LTM studies your memory card may fill up completely while you are still conducting the study When this happens NOTE The recording LED will start to blink and amplifier w...

Страница 134: ...Nicolet Systems 12 8 April 27 2015 Blank page...

Страница 135: ...ery with a medical grade power supply 7 7 the external batteries 7 6 Charging the battery from the amplifier with a medical grade power supply 7 7 Checking the batteries charges 7 4 Cleaning instructi...

Страница 136: ...SpO2 operation 4 11 IT requirements g L LED Ethernet connectivity 1 5 Power connectivity 1 5 Wireless transmission on 1 5 LEDs Impedance check 1 5 Impedance range 1 5 Live Data Delay 5 4 M Maintenanc...

Страница 137: ...the EEGwireless32 64 amplifier 5 3 Signal strength 5 4 Specification sheet h SpO2 1 5 SpO2 operation 4 11 Stand Alone Mode feature starting a recording from the amplifier 4 7 Start a study from the a...

Страница 138: ...Nicolet Systems 4 April 27 2015 Blank page...

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