FCC ID: PX9-AC9260NGW Intel Wireless-AC 9260

 

M900P 8-inch Rugged Windows Tablet Intel Apollo Lake Pentium N4200 Windows 10 IoT Enterprise User Guide Document Version 1.0 Document Part No. 915211101049 Please read these instructions carefully before using this product, and save this manual for future use. 2 8-inch Rugged Windows Tablet M900P User Guide Contents CONTENTS ................................................................................................................................................................................2 CHAPTER 1: READ ME FIRST ......................................................................................................................................................4 1.1 ADVISORY CONVENTIONS ................................................................................................................................................................ 5 1.2 SAFETY INFORMATION .................................................................................................................................................................... 6 1.3 HANDLING AND MAINTENANCE ........................................................................................................................................................ 9 1.4 DECLARATION OF CONFORMITY (DOC) ............................................................................................................................................ 10 CHAPTER 2: GETTING STARTED ............................................................................................................................................... 11 2.1 INTRODUCTION ........................................................................................................................................................................... 12 2.2UNPACKING ................................................................................................................................................................................ 12 2.3DESCRIPTION OF PARTS ................................................................................................................................................................. 13 2.4HOTKEYFOR SPECIFIC FUNCTIONS .................................................................................................................................................... 13 2.5FIRST-TIME OPERATION ................................................................................................................................................................ 15 2.5.1 Installing Battery ............................................................................................................................................................ 15 2.5.2 Charging Your Tablet ...................................................................................................................................................... 16 2.5.3Starting the Tablet ........................................................................................................................................................... 16 CHAPTER 3: SETTING UP WINDOWS ....................................................................................................................................... 17 3.1 OPERATING SYSTEM INTRODUCTION ............................................................................................................................................... 18 3.2SETTING UP WINDOWS 10 IOT ENTERPRISE ...................................................................................................................................... 18 CHAPTER 4: OPERATING THE DEVICE ...................................................................................................................................... 21 4.1 HOTTABINTRODUCTION ................................................................................................................................................................ 22 4.2SETTINGS .................................................................................................................................................................................... 23 4.2.1PC Information................................................................................................................................................................. 23 4.2.2Battery Information ......................................................................................................................................................... 23 4.2.3 Using thePhysical Function Keys (Hotkeys) .................................................................................................................... 24 4.3SHORTCUTS................................................................................................................................................................................. 25 4.4CHANGING TOUCHSCREEN MODES .................................................................................................................................................. 25 4.4.1 Switch via Built-in HotTab Utility .................................................................................................................................... 26 4.4.2 Switch via Programmable Function Buttons .................................................................................................................. 26 4.5USING WIRELESS COMMUNICATIONS ............................................................................................................................................... 27 4.5.1 Using theWireless LAN (Wi-Fi) ........................................................................................................................................ 27 4.5.3 Using the GPS ................................................................................................................................................................. 28 4.5.4 Using the Bluetooth ........................................................................................................................................................ 28 4.6TURNINGON/OFFLED INDICATORS ................................................................................................................................................. 29 4.7TURNINGON/ OFF THE LIGHT SENSOR ............................................................................................................................................. 29 4.8USING BARCODE READER .............................................................................................................................................................. 29 4.8.1 Device Configuring and Setting ...................................................................................................................................... 30 4.8.2 Setting the 1D/2D Barcode Scanner Symbologies .......................................................................................................... 35 4.8.3 Adding a Prefix or Suffix ................................................................................................................................................. 37 CHAPTER 5: FREQUENTLY USED SETTINGS .............................................................................................................................. 39 5.1 SCREEN RESOLUTION SCALING AND SETTING ..................................................................................................................................... 40 5.1.1 Changing Display Scaling (Recommended) .................................................................................................................... 40 5.1.2 Changing Screen Resolution ........................................................................................................................................... 41 5.2 REPLACING BATTERY .................................................................................................................................................................... 42 5.3 USING RECOVERY WIZARD TO RESTORE COMPUTER ........................................................................................................................... 44 5.4 D-SUB PIN DEFINITION ................................................................................................................................................................. 47 5.5COM PORT DEFINITION ................................................................................................................................................................ 47 5.6 PAIRING WITH A WIRELESS BLUETOOTH BARCODE SCANNER ................................................................................................................ 50 5.6.1 Setup Computer for Bluetooth Pairing ........................................................................................................................... 50 5.6.2 Set up the Barcode Scanner for Bluetooth Pairing ......................................................................................................... 54 5.6.3 Perform Bluetooth Pairing .............................................................................................................................................. 54 5.7BASIC TROUBLESHOOTING ............................................................................................................................................................. 56 CHAPTER 6: ACCESSORIES ....................................................................................................................................................... 58 6.1 ACCESSORIES INTRODUCTION ......................................................................................................................................................... 59 6.2 INSTALLING GATEWAY VG-100 ..................................................................................................................................................... 60 APPENDIX ............................................................................................................................................................................... 61 APPENDIX A: SPECIFICATIONS .............................................................................................................................................................. 62 Contents 3 4 8-inch Rugged Windows Tablet M900P User Guide Chapter 1: Read Me First This chapter provides safety information, handling and maintenance precautions and other important information about using the M900P rugged tablet. 1.1 Advisory Conventions Four types of advisories are used throughout the user manual to provide helpful information or to alert you to the potential for hardware damage or personal injury. These are Notes, Important, Cautions, and Warnings. The following is an example of each type of advisory. Chapter 1: Read Me First 5 Note:

A note is used to emphasize helpful information Important:

An important note indicates information that is important for you to know. Caution/ Attention A Caution alert indicates potential damage to hardware and explains how to avoid the potential problem. Unealertedattentionindique un dommage possible lquipement et explique comment viter le problmepotentiel. Warning!Avertissement!

An Electrical Shock Warning indicates the potential harm from electrical hazards and how to avoid the potential problem. Un Avertissement de Choc lectriqueindique le potentiel de chocssur des emplacements lectriques et comment vitercesproblmes. 6 8-inch Rugged Windows Tablet M900P User Guide 1.2 Safety Information Precaution on Battery Pack Prcaution avec le bloc-pile Do Not Disassemble, Modify, or Insert Sharp Objects Into the Battery Pack. Electrolyte leakage, generation of heat, ignition or rupture may result.

[FR] Ne pas dmonter, modifier, ou insrer des objets pointus l'intrieur du bloc-pile. Une fuite d'lectrolyte, la gnration de chaleur, l'amorage ou la rupture peuvent tre occasionns. Do Not Short the Positive (+) and Negative (-) Terminals of the Battery. Generation of heat, ignition or rupture may result. When carrying or storing the device, do not place the battery pack together with articles that may contact electricity.

[FR] Ne pas court-circuiter les bornes Positive

(+) et Ngative (-) de la pile, la gnration de chaleur, l'amorage ou la rupture peuvent tre occasionns. Lors du transport et du rangement de l'appareil, ne pas placer le bloc-

pile en mme temps que des articles pouvant crer un contact lectrique. Do Not Apply Shocks to the Battery by Dropping It or Applying Strong Pressure to It. Electrolyte leakage, generation of heat, ignition or rupture of battery may occurs.

[FR] Ne pas faire subir de choc la pile en la laissant tomber ou en appliquant une forte pression dessus. Une fuite d'lectrolyte, la gnration de chaleur, l'amorage ou la rupture peuvent tre occasionns. Do Not Charge the Battery Other Than Methods Those Specified In This Manual. If the battery is not charged using one of the specified methods, electrolyte leakage, generation of heat, ignition or rupture may result.

[FR] Ne pas charger la pile par d'autres mthodes que celles spcifies dans ce manuel. Si la pile n'est pas charge en utilisant l'une des mthodes spcifies, une fuite d'lectrolyte, la gnration de chaleur, l'amorage ou la rupture peuvent tre occasionns. The elements of the INSTRUCTIONAL SAFEGUARD shall be as follows:

- Element 1a: not available

- Element 2: CUATION or equivalent word or text

- Element 3: Risk of explsion if the battery is replaced by an incorrect type or equivalent text

- Element 4: optional

[FR]Les lments de la sauvegarde pdagogique sont les suivants:

- Elment 1a: non disponible

- Elment 2: CUATION ou mot ou texte quivalent

- Elment 3: Risque dexplication si la batterie est remplace par un type incorrect ou un texte quivalent

- Elment 4: facultatif When the Battery Pack Has Deteriorated, Replace It with a New Battery. Continued use of a damaged battery pack may result in heat generation, ignition or battery rupture.

[FR] Lorsque la pile est dtriore, la remplacer par une nouvelle pile. L'utilisation continue d'une pile endommage peut occasionner une gnration de chaleur, l'amorage ou la rupture de la pile. Do Not Expose the Battery Pack to Excessive Heat, or Extreme Heat (Near Fire, in Direct Sunlight for example)Generation of heat, ignition or rupture may result

[FR] Ne pas exposer le bloc-pile une Chaleur Excessive, ou une Chaleur Extrme (Prs d'un feu, sous la lumire du soleil par exemple)Une production de chaleur, l'amorage ou la rupture peuvent tre occasionns Do Not Use the Battery Pack With Any Other Products. The battery pack is rechargeable and is only designed for this specific product. If it is used with a product other than the specified product, electrolyte leakage, generation of heat, ignition or rupture may result.

[FR] Ne pas utiliser avec un autre produit La batterie est rechargeable et a t conue pour un produit spcifique. Si elle est utilise sur un produit diffrent de celui pour lequel elle a t conue, des pertes dlectrolytes et une production de chaleur sont possibles, elle risque galement de prendre feu ou de casser. Chapter 1: Read Me First 7 Do Not Use This Product With Battery Other Than the One Specified.

[FR] Ne pas utiliser ce produit avec une batterie autre que celle spcifie Discontinue using device immediately if you notice the battery is swelling, or looks puffy or misshapen. Do not attempt to charge or use the device. Do not handle a damaged or leaking battery. Do not let leaking battery fluid come into contact with your eyes, skin or clothing.

[FR] Si vous remarquez une pile gonfle, largie ou anormale, cesser lutilisation de lappareil immdiatement. Nessayez pas de recharger lappareil ou de lutiliser. Ne pas manipuler une pile qui fuit ou qui est endommage. Ne laissez pas de liquide qui fuit entrer en contact avec vos yeux, votre peau ou vos vtements. 8 8-inch Rugged Windows Tablet M900P User Guide General Product Safety Scurit gnrale des produits Do not block any ventilation openings. Do not place the product against a wall or on a plate or in an enclosed space as doing so might impede the flow of cooling air.

[FR] Ne pas bloquer les ouvertures de ventilation. Ne pas placer le produit contre un mur ou dans un espace clos de faon entraver la circulation de l'air de refroidissement. Do not place the product near any heat sources such as radiators, warm air intakes, stoves or other heat-generating devices

(including amplifiers or other heat producing equipment).

[FR] Ne pas placer le produit prs d'une source de chaleur comme des radiateurs, les arrives d'air chaud, poles ou autres produits gnrant de la chaleur (y compris les amplificateurs ou autre quipement produisant de la chaleur.) Protect the power cord from being crushed or pinched, particularly in the area of the plugs, any receptacles used, and the point of exit from the apparatus. Do not break off the ground pin of the power cord.

[FR] Empcher le cordon d'alimentation d'tre cras ou pinc, en particulier dans les zones de prises, des containers utiliss, et du point de sortie de l'appareil. Ne pas casser la broche de terre du cordon d'alimentation. Do not disregard the safety that a polarized or grounded connection can provide. A polarized connection consists of two plugs, one of which is larger than the other. A grounded connection has two blades and a third one that is grounded. If the main plug provided cannot be inserted intoyour outlet, consult an electrician to replace your obsolete outlet.

[FR] Ne pas ignorer la scurit qu'une prise polarise ou une prise de terre peut prvoir. Une prise polarise se compose de deux fiches, dont l'une est plus large que l'autre. Une prise de terre possde deux lames et une troisime qui est la terre. Si la fiche principale fournie ne peut tre insre dans votre prise, consultez un lectricien pour remplacer votre prise obsolte. Use only accessories specified by the manufacturer.

[FR] Utiliser uniquement les accessoires spcifis par le fabricant. This product should not be used near water such as bathtubs, sinks, swimming pools, wet basement, etc.

[FR] Ce produit ne dois pas tre utilis prs de l'eau comme les baignoires, les viers, les piscines, les sous-sols humides, etc. Use only with its transport carriage, stand, tripod, console or table specified by the manufacturer or sold with the product. When using a carriage, move the carriage assembly with the product carefully to avoid damage from falling over.

[FR] Utiliser uniquement avec son chariot de transport, support, trpied, console ou table spcifis par le fabricant ou vendu avec le produit. Lors de l'utilisation d'un charriot, dplacez l'ensemble chariot avec le produit avec soin pour viter tout dommage de chute. Unplug this apparatus during lightning storms or when it is not being used for long periods.

[FR] Dbrancher cet appareil durant les orages ou lorsqu'il n'est pas utilis pendant de longues priodes. Refer all servicing to qualified service personnel. A technical intervention is required when the apparatus has been damaged in any way, for example if the power cord or plug is damaged, liquid has been spilled or objects have fallen inside the unit, if the product has been exposed to rain or moisture, if it does not operate normally or if it has been dropped.

[FR] Confier toute rparation du personnel qualifi. Une intervention technique est ncessaire lorsque l'appareil a t endommag de quelque faon, par exemple si le cordon d'alimentation ou la fiche est endommag, du liquide a t renvers ou des objets sont tombs l'intrieur de l'unit, si le produit a t expos la pluie ou l'humidit, s'il ne fonctionne pas normalement ou s'il a t jet. 1.3 Handling and Maintenance General Guideline Guide Gnral Keep the product at least 13 cm (5 inches)away from electrical appliances that can generate a strong magnetic field such as TV, refrigerator, motor, or a large audio speaker.

[FR] Garder le produit au moins 13 cm (5 pouces) de distance des appareils lectriques qui peuvent gnrer un fort champ magntique comme une tlvision, un rfrigrateur, un moteur, ou un important haut-parleur. Do not place heavy objects on top of the tablet computer as this may damage the display.

[FR] Ne pas placer d'objets lourds sur le dessus de l'ordinateur tablette cela peut endommager l'cran. The screen surface can be easily scratched. Use with care. Do not use paper towels to clean the display but use the includedcleaning cloth. Avoidtouchingit with a pen or pencil.

[FR] La surface de l'cran peut tre facilement raye. Utiliser avec prcaution. Ne pas utiliser de serviette en papier pour nettoyer l'cran mais utiliser le chiffon de nettoyage inclus. viter de toucher avec un stylo ou un crayon. To maximize the life of the backlight in the display, allow backlight to automatically turn off as a result of power management. Avoid using a screen saver or other software that preventsthe power management from working.

[FR] Pour maximiser la dure de vie du rtroclairage de l'cran, autoriser le rtroclairage rsultant de la gestion de l'alimentation. viter d'utiliser un conomiseur d'cran ou un autre logiciel empchant la gestion de l'alimentation de fonctionner. Cleaning Guideline Guide de nettoyage Use a soft cloth moistened with water or a non-

alkaline detergent to wipe the exterior of the product.

[FR] Utiliser un chiffon doux humidifi avec de leau ou un dtergeant non alcalin pour essuyer l'extrieur du produit. Chapter 1: Read Me First 9 Gently wipe the display with a soft, lint-free cloth. Do not use alcohol or detergent on the product.

[FR] Essuyer dlicatement l'cran avec un chiffon doux non pelucheux. Ne pas utiliser d'alcool ou un dtergent sur le produit. Touchscreen Guideline Guide de l'cran tactile Use your finger or the stylus on the display. Using sharp or metallic object may cause scratches and damage the display, thereby causing errors.

[FR]Utiliser votre doigt ou le stylet sur l'cran. L'utilisation d'un objet pointu ou mtallique peut provoquer des rayures. Use a soft cloth to remove dirt on the display. The touchscreen surface has a special protective coating that prevents dirt from sticking to it. Not using a soft cloth may cause damage to the special protective coating on the touchscreen surface. To clean off hard to remove dirt, blow some steam on the particular area and gently wipe away using a soft cloth.

[FR]Utiliser un chiffon doux pour enlever la poussire sur l'cran. La surface de l'cran tactile a un revtement protecteur spcial empchant la salet de se coller lui. Ne pas utiliser un chiffon doux peut endommager le revtement spcial sur la surface de l'cran tactile. Pour nettoyer les salets plus difficiles enlever, souffler de la bue sur la zone particulire et essuyer doucement avec un chiffon doux. Do not use excessive force on the display. Avoid placing objects on top of the display as this may cause the glass to break.

[FR]Ne pas utiliser une force excessive sur l'cran. viter de placer des objets au dessus de lcran cela pourrait provoquer une cassure du verre. When there is a noticeable discrepancy in the operation of the touchscreen function (your touch does not correlate to the proper location on the screen), recalibrate the touchscreen display.

[FR]Lorsqu'il y a un cart sensible dans le fonctionnement de l'cran tactile (votre contact ne correspond pas la bonne position sur l'cran), recalibrer l'cran tactile. 10 8-inch Rugged Windows Tablet M900P User Guide 1.4 Declaration of Conformity (DoC) FCC Statement This device complies with part 15 FCC rules. Operation is subject to the following two conditions:

This device may not cause harmful interference. This device must accept any interference received including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a class "B" digital device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated 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 interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at him own expense. CE Notice (European Union) Electromagnetic Compatibility Directive (2014/30/EU) EN55024: 2010/ A1: 2015 o o o o o o o IEC61000-4-2: 2009 IEC61000-4-3: 2006+A1: 2007+A2: 2010 IEC61000-4-4: 2012 IEC61000-4-5: 2014 IEC61000-4-6: 2014 IEC61000-4-8: 2010 IEC61000-4-11: 2004 EN55032: 2012/AC:2013 EN61000-3-2:2014 EN61000-3-3:2013 Low Voltage Directive (2014/35/EU) EN 62368-1:2014+A11 This equipment is in conformity with the requirement of the following EU legislations and harmonized standards. Product also complies with the Council directions. Chapter 2: Getting Started 11 Chapter 2: Getting Started This chapter tells you step by step how to get the Rugged Tablet up and running. 12 8-inch Rugged Windows Tablet M900P User Guide 2.1 Introduction Thank you for purchasing 8-inch Rugged Windows Tablet Computer M900P. The M900P is a compact rugged tablet PC with robust set of features designed to withstand industrial use while providing high tech solutions that increase productivity, improve safety, and reduce operational costs. The processing power comes from Intel's Apollo Lake processor paired with genuine Intel graphics for high performance. The tablet features a brilliant projective capacitive touch screen, which is outdoor viewable and offers 1280 x 800 pixel resolution. Weighing at just 2.2 pounds (approx. 900 grams) the M900P delivers lightweight mobility in a rugged tablet. Highlights Intel Apollo Lake Pentium N4200 processor 8'' daylight readable panel with direct optical bonding Default D-sub for gateway connection 2.2Unpacking Check and identify the standard supplied accessories. Standard factory shipment list:

8-inch Rugged Tablet M900P Standard Battery Power Adapter Power Cord and Plugs Driver CD Your package may include other optional accessories based on your order. Gateway 2.3Description of Parts No 1 Item Camera Description 2 MP Webcam. 2 8 Touch Screen Display and act as one of the inputs for the rugged tablet. 3 Speaker 4 5 6 7 8 9 LED Indicators Light Sensor Mic Function Buttons 10 Mic 11 Kensington Security Slot 12 Optional Barcode Two 1 Watt speakers for audio output. Show the current status of the Tablet: power, battery, wireless communications, and storage. Light sensor helps to adjust display backlight. Use during video recordings and communications. Three programmable function key configured by Hottab Utility. Use during video recordings and communications. Insert the lock into the Kensington slot on the tablet and secure the lock with its key or its combination. Allows you to scan 1D/2D barcodes. Power Button Power on/off tablet. Menu Button Hottab quick access. Chapter 2: Getting Started 13 No 13 Item D-Sub Connector Description To connect a Gateway. 14 Mic In/Line Out Connect headset or headphone (Mic is only supported with 3.5mm 4-

pin headset). USB 3.0 port connects to USB devices, such as USB flash drive, mouse, keyboard, printer, etc. 5V/0.9A. High speed USB port connects to USB devices, such as mouse, keyboard, printer, etc.

*No ALT support, power output 5V/0.9A Hardware reset button. Power input 19V DC Protect I/O ports 8MP camera with autofocus and LED light. Latch to lock the battery in place once battery is inserted. 7.6V, typ. 4200 mAh Li Polymer Battery (2S2P). Slot for Micro SD insert.

(Behind the Battery) 15 USB 3.0 Type-A 16 USB 3.0 Type-C 17 18 19 20 21 Reset Button Power Jack I/O Cover Rear Camera Battery Lock Latch 22 Battery 23 Micro SD card slot. Front LED Indicator Details:

2.4Hotkeyfor Specific Functions For the physical buttons on the tablet computer, in addition to its dedicated functions detailed in the previous section, it can also be used to emulate commonly used keyboard key strokes. Under different scenario, a single physical button or acombination of physical buttons provide different keyboard key strokes, which are specified below:

14 8-inch Rugged Windows Tablet M900P User Guide In POST (Before Windows boots up):

Button Keystroke In Windows:

Button Keystroke Fn1 Fn2 Fn3 F6 to enter Recovery Menu F7 to enter BIOS setup screen Keyboard F3 Menu + Fn1 Enter Menu Fn1 Fn2 Fn3 Power Hottab Quick Access Default: Web Browser Default: Camera, Default: Notepad, or Barcode trigger (Note 1). Power ON/ OFF Note: Fn3 is trigger button when connected with barcode scanner. LED Indicators Description:

Indicator Icon Description Blue Tablet is on. Nolight Tablet is off. OrangeAC adapter is plugged in and charging. GreenAC adapter is plugged in and battery is full charged. Solid Red - Low battery (<10%). Blinking Red Battery is being hot swapped. No light Battery is in use and more than 10%. Green - Disk is active. No light - Disk is idle. Green Wi-Fi/BT/GPS is on. No light Wi-Fi/BT/GPS are all Off. Power Indicator Battery Status Disk Activity Indicator RF Communications Chapter 2: Getting Started 15 2.5First-Time Operation To get started:

1. Install storage card. 2. Install the battery. 3. Charge your tablet. 4. Start the tablet. 2.5.1 Installing Battery To install the battery pack:

1. Disconnect any cords connected to the tablet computer. 2. Turn the tablet over, back facing up. 3. Insert the battery on the connector-pins side first, and then lower the battery into the battery compartment. Continue to hold the latches before battery is fully inserted. 4. Make sure the battery is completely lowered into the compartment before letting go the latches. Battery will be flat against the housing once fully inserted. To remove the battery pack:

1. Shut down the tablet. Disconnect any cords connected to the computer. 2. Turn the tablet computer over, back facing up. 3. Hold the latches and lift the battery up to remove the battery. 16 8-inch Rugged Windows Tablet M900P User Guide 2.5.2 Charging Your Tablet The tablet operates either on external AC power or internal battery power. It is recommended to use AC power when you start up the Tablet for the first time. Caution: Use only the AC adapter included with your Tablet Computer. Using other AC adapters may damage the Tablet Computer and the Battery. To connect a tablet to AC power:

1. Open I/O protective cover by pulling out the latch. 2. Plug the DC cord of the AC adapter into the power jack of the tablet computer. 3. Plug the AC power cord into the AC adapter. 4. Plug the AC power cord into the electrical outlet. The battery LED indicator shows different battery states:

Orange- AC adapter is plugged in and battery is charging. Green- AC adapter is plugged in and battery is fully charged. Solid Red- Low battery level (<10%). Blinking Red Battery is being hot swapped. No light Battery is in use and charged (>10%). Item Standard Battery Battery Operation Time Battery Charging Time 6-7 Hours 2.5 Hours 2.5.3Starting the Tablet Important: When powering on the device for the first time, please make sure theres no interruption during the Windows setting up process, for example, accidentally powering off. If it happened, please access the recovery menu by pressingFn1 button on the front bezel to initiate recovery process. Press and hold the power button for 3 seconds until the blue LED power indicator light up. Note:Do not press the power button repeatedly. Do not perform the following operations until the Disk Activity Indicator off Connecting or disconnecting the AC adapter Pressing the power button Touching the tablet buttons, screen, or external keyboard/mouse To power off the Tablet Computer:

1. Make sure you have closed any programs that are open on the Desktop. Start Screen apps dont need to be closed. 2. Tap on the Settings charm. 3. Tap on Power. 4. Tap on Shut Down. 5. Wait for Tablet Computer to power off. Note: The computer will forcibly be powered off if the power button is pressed and held for 6 seconds or longer. Chapter 3: Setting Up Windows 17 Chapter 3: Setting Up Windows This chapter details how to setup the Windows that may be installed on the tablet for the first time. 18 8-inch Rugged Windows Tablet M900P User Guide 3.1 Operating System Introduction The M900P Tablet Computer operates on Windows 10 IoT Enterprise operating system. Caution: Make sure the battery is full charged before starting the Tablet Computer for the first time with internal battery power. Public network: Select this location if you do not recognize all the computers on the network. (For example, you are in a coffee shop or airport, or you have mobile broadband.) This is a public network and is nottrusted.Select the location where you will most often use the computer. 3.2Setting Up Windows 10 IoT Enterprise Follow the steps below to complete the Windows 10 IoT Enterprise setup process. 1. Press the power button to turn on the computer. 2. First, select your country/region, your preferred app language, your preferred keyboard layout, and your time zone, then tapNext. 3. On the Here's the legal stuff screen, read through the disclosures, then tapAccept. Chapter 3: Setting Up Windows 19 4. Windows will then try to connect to network.TapSkip this step to continue without a wireless connection as you can then set up the network later. 5. On the Get going fast screen, click Use Express settingsfor the fastest setup. If you would like more information, tapLearn more, or if you would like to select your own options, click Customize settings. 20 8-inch Rugged Windows Tablet M900P User Guide 6. To create a local account, type your User name, password, and Password hint in the fields provided, thentapNext. 7. The initial setup screens are complete, and the desktop is displayed. 8. Read any introductory screens describing features of your computer, and tapNext upon completing each. You are now done with the initial setup process. Chapter 4: Operating the Device 21 Chapter 4: Operating the Device This chapter describes how to operate the M900P Rugged Tablet, including camera, Hottab, wireless communications, and barcode scanner. 22 8-inch Rugged Windows Tablet M900P User Guide 4.1 HottabIntroduction Hottab provides quick access to the tablets functions and features, such as setting up shortcuts, powering on/off built-in devices, programming function key, and changing power management. Note:

Please download the SDK from Winmate Download Center.

>>M900P>>Development Kit or check the Driver CD which is shipped with the tablet. Please notice that Barcode reader is optional module, please make sure user have ordered the module before using the SDK. As Windows starts up, Hottab starts and runs in the background. To display the Hottab control utility, press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application.

(Menu) Button on the Front Panel:

HottabUtility Icon:

The main user interface islocated on the right side of the screen. There are 4 main menu options: Shortcuts, Device ON/OFF, and Settings. Operations and functions on each menu options is explained in detail in the coming section. Icon Description Allows users to configure short cut to quickly access programs with a few tabs. Enables/disables tablet computers hardware functions. The configurable functions are Wi-Fi, GPS, Bluetooth, LED indicators, Barcode Reader, and GPS Antenna routing options. Provides users information such as PC Information, Battery status, and also device settings such as power management setting, and function key mappings. Shortcuts Device ON/OFF Settings Chapter 4: Operating the Device 23 4.2Settings This Hottab menu option provides users information such as PC Information, Battery status, and also device settings such as power management setting, and function key mappings. Perform the following procedure to access the Hottab Setting menu:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Settings button. 3. Below show the items listed in Settings Menu. 4.2.1PC Information This section provides user device information in regards to BIOS Version, EC Versions, Hottab Versions, OS Versions, as well as Unit Serial Number, shown in the picture sample. This section provides user battery Information. Main Battery:

The main battery icon displays the battery level in percentages

(0 to 100%). Battery Charge Time:

The Battery Information also displays estimated time needed to fully charge the main battery when AC adapter is plugged in. 4.2.2Battery Information 24 8-inch Rugged Windows Tablet M900P User Guide 4.2.3 Using thePhysical Function Keys (Hotkeys) The function key mapping menu option allows user to change the physical function buttons, Fn1 and Fn2. Users can change what application will be launched with short press or long press of keys. To configure function key mapping, perform the following:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Setting button. 3. Tap on function key icon for the corresponding key that you want to change. 4. At top of utility, it will say Short Press or Long Press to indicate what type of press is being configured 5. You can switch what type of press you want to configure by tapping on the Short Press or Long Press icon at the bottom of the utility window. 6. Pick from list of preset applications by tapping on the application icons OR customize which application to execute using the picker. Using the Custom picker:

1. Tap the 2. Navigate to the desired executable to map to function key 3. Tap on Done to save selection. icon to reveal browser window To map the function key to another application:

1. Tap on the icon to remove connection to the original application, and pick again tapping on icon. Using the physical function keys:

1. While operating the tablet, click on the physical function keys to activate functions mapped via the setup in this section. 4.3Shortcuts Chapter 4: Operating the Device 25 HottabShortcuts Menuprovides an user-friendly interface to configureon-screensoftware short cuts and allow users to quickly access programs with a few tabs. The Shortcuts menu offers 8 empty slots to store users desired quick access. Shortcuts can be mapped to any of the executable files (.exe) installed on the tablet. Short Cut Menu:

To store a new shortcut:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Shortcuts button. 3. Tap on button of any empty slot. 4. An on screen file browser will appear. 5. Browse to find the desired application to have shortcut. 6. Click Open to save the shortcut. To remove an saved shortcut:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Shortcuts button. 3. Tap on the 4. Shortcut will be removed, and once again show Empty to indicate button of any saved slot to remove slot is empty. Tap on the button will hide the Hottab Utility Menu. Using the Hottab shortcuts:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab. 2. Tap on the Shortcuts button. 3. Tap on the saved shortcut items to access saved programs. 4.4Changing Touchscreen Modes The tablet computer supports three built-in operating modes for different usage scenarios:

Bare fingertips Active stylus with palm rejection Usage Scenario In Hand/Rain mode the touchscreen rejects false inputs from liquid drops. When the liquid is removed, the touchscreen accepts touch inputs from bare fingertips. Supportsinput by:

Rubber tip passive stylus In Stylus mode, the touchscreen supports inputs from the fine-tip passive capacitive stylus (shipped with tablet). Support input by:

Rubber tip passive stylus In Glove mode, the touchscreen supports inputs while the user is operating the touchscreen with gloves on. Supports input by:

Glove Rubber tip passive stylus Fine-tip passive stylus with palm rejection Active stylus with palm rejection Bare fingertips Bare fingertips Mode Hand/Rain

(Default) Stylus Glove 26 8-inch Rugged Windows Tablet M900P User Guide In screen lock mode, the screen will be locked unless users finger slides the unlock bar. User can also use mouse to unlock the screen. To change touch mode:

(1) Shortly press Function Key 1 (To define the function key refer to User Manual, Chapter 4).

(2) Press

(Menu) button on the front to open HotTab, or launch HotTab Utility application.Choose Device ON/OFF,and then click Touch Set icon. 4.4.1 Switch via Built-in HotTab Utility To switch touchscreen mode via the HotTab:

1. Open HotTab utility by pressing

(Menu) Button located on the front panel, OR launching HotTab Utility application. 2. Choose Device ON/OFFand then click on Touch Set icon 3. The Touch Mode Select utility will be shown as below 4. Under the Touch Mode, select the desired touch modes by tapping on the radio button. 5. Heres also additional Touch related setting to switch the touchscreen input between mouse mode with cursor, or with multi-touch mode:

Mouse Mode:Single touch point supported, with mouse cursor shown. Multi-touch Mode:The default setting of the touch screen supports multi-touch mode (up to 10 points) 4.4.2 Switch via Programmable Function Buttons To switch between the different touchscreen modes via the programmable function buttons, make sure the touchscreen mode switching is set to the programmable function buttons first. 1. Open HotTab utility by pressing

(Menu) Button located on the front panel, OR launching HotTab Utility application. 2. Tap on the Setting button. 3. Tap on F1 icon. 4. Tap on the Long Press icon. 5. Change the Long Press function to Touch Mode as shown below:

Once the touchscreen mode switching is set to the programmable function button, Long Press on F1 function button to cycle through the different touchscreen modes. When touchscreen mode is switched, an icon will temporarily overlay on the lower center of the screen to indicate current touchscreen mode:

Chapter 4: Operating the Device 27 4.5Using Wireless Communications This section describes how to get a quick access to set-up built-in devices, including turning on/off, setting up barcode reader, and expansion modules. 4.5.1 Using theWireless LAN (Wi-Fi) To use the wireless LAN(Wi-Fi) feature to connect to the network, perform the following procedure:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Device ON/OFF button. 3. Check the status color of the Wi-Fi icon:

28 8-inch Rugged Windows Tablet M900P User Guide Item Status Color Description Orange White Wi-Fi is enabled. Wi-Fi is disabled. Wi-Fi 4. If the Wi-Fi feature is disabled (white), tap on the Wi-Fi icon to enable it (orange). 5. Click the wireless network connection status icon in the Windows notification area. A list of available wireless networks is displayed. 6. Double-click a network to connect to it. Provide required authentication information if needed. 7. To check the connection status, observe wireless network connection status icon in the Windows notification area. The more bars the icon shows, the better the wireless LAN connection strength is. 8. Now wireless LAN connection is setup, try connection to the network with a internet browser such as Internet Explorer. 4.5.3 Using the GPS To enable the GPS:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Device ON/OFF button. 3. Check the status color of the GPS icon:

Item Status Color Description Orange White GPS is enabled. GPS is disabled. GPS 4. If the GPS feature is disabled (white), tap on the GPS icon to enable it (orange). 5. Now the GPS feature is ready to be used with an application utilizing the GPS. 4.5.4 Using the Bluetooth To enable the Bluetooth:

1. Open the Hottab utility by press the

(Menu) Button located on the front panel, OR launching the Hottab Utility application. 2. Tap on the Device ON/OFF button. 3. Check the status color of the Bluetooth icon:

Item Status Color Description Orange White Bluetooth is enabled. Bluetooth is disabled. BT 4. If the Bluetooth feature is disabled (white), tap on the Bluetooth icon to enable it (orange). Chapter 4: Operating the Device 29 5. Click the Bluetooth icon in the Windows notification area. A contextual menu for Bluetooth is displayed. 6. To add a device, tap on Add a Bluetooth Device. Windows will search any Bluetooth device automatically 7. Choose the Bluetooth device to connect and follow onscreen prompt to continue the pair procedure and use the Bluetooth device. 4.6TurningOn/OffLED Indicators The LED Indicators for Power Status, Battery Status, and RF Communication can be turned on/off from Hottab menu. Toenable/disable the LED indicators:

1. Open the Hottab utility by pressing the

(Menu) button or launching the Hottab. 2. Tap on the Device ON/OFF button. 3. Check the status color of the Indicator icon:

Item Status Color Description Orange White LED indicator is enabled. LED indicator is disabled. Indicator 4. If the indicator is disabled (white), tap on the Indicator icon to enable it (orange). 4.7TurningOn/ Off the Light Sensor The Light Sensor can be turned on/off from Hottab menu. To enable/disable the Light Sensor:

1. Open the Hottab by press the

(Menu) button located on the front or launching the Hottab. 2. Tap on the Device ON/OFF button. 3. Check the status color of the Light Sensor icon:

Item Status Color Description Light Sensor Orange Light Sensor is enabled. White Light Sensor is disabled. 4.8Using Barcode Reader The Barcode Reader is an optional feature of M900P Tablet PC and is not re-workable by the end user. To enable the Barcode Reader:

1. Open Hottab utility by pressing

(Menu) button located on the front panel or launching Hottab. 2. Tap on theDevice ON/OFFbutton. 30 8-inch Rugged Windows Tablet M900P User Guide 3. Check the status color of the Barcode icon. Item Status Color Description Orange Barcode Reader is enabled. Use Fn3 button to trigger. White Barcode Reader is disabled. Barcode 4. Open the application where barcode reader will be displaying the scanned barcode. 5. Trigger the barcode reader by pressing Fn2 function key. Tap Disconnect button to stop the connection with Barcode Reader.

*To recover the connection, please tap on the button again to re-connect with Barcode Reader. 4.8.1 Device Configuring and Setting 1.Click on Windows and search for EZConfig-Sttcanning from the Start menu. Chapter 4: Operating the Device 31 2.Click on EZConfig-Scanning v4_IE and allow the blocked content if browser is blocking the content. 3.Click on Connected Device icon and wait for system to discover the device (Honeywell N660X). 4.Once Honeywell N660X is discovered please click Configure Device button as shown. 32 8-inch Rugged Windows Tablet M900P User Guide 4.4.6.2 Scanning mode Settings 1. Click on Device Settings under the Input/Output settings section. Chapter 4: Operating the Device 33 2. Select the desire scanning mode from the drop-down menu shown as below. 3. After selecting a desire scanning mode, click on the Save to Device on the side bar. 34 8-inch Rugged Windows Tablet M900P User Guide Scanning mode Manual Trigger Presentation Mode Streaming Presentation Mode Host Notify Mode Snap and Ship Mode Description When in manual trigger mode, the scanner scans until a bar code is read, or until the trigger is released. Two modes are available, Normal and Enhanced. Normal mode offers good scan speed and the longest working ranges (depth of field). Enhanced mode will give you the highest possible scan speed but slightly less range than Normal mode. Enhanced mode is best used when you require a very fast speed and dont require a long working range. Default = Manual Triger-Normal. Presentation Mode uses ambient light and scan engine illumination to detect bar codes. When in Presentation Mode, the LEDs remain dim until a bar code is presented to the scan engine, then the aimer turns on and the LEDs turn up to read the code. If the light level in the room is not high enough, Presentation Mode may not work properly. When in Streaming Presentation mode, the scan engines aimer goes out after a short time, but the scan illumination remains on all the time to continuously search for bar codes. Two modes are available, Normal and Enhanced. Normal mode offers good scan speed and the longest working ranges (depth of field). Enhanced mode will give you the highest possible scan speed but slightly less range than Normal mode. Enhanced mode is best used when you require a very fast scan speed and dont require a long working range. Host Notify Mode bypasses the decoder and notifies the host that there has been a hardware trigger pull. When in Host Notify Mode, it is up to the host to initiate an Image Snap and/or an Image Ship command. It is also up to the host to switch to another trigger mode. Snap and Ship mode, allows you to bypass the decoder and ship an imagedirectly to the host. In this mode, an image is taken and shipped upon eachtrigger pull, instead of being sent to the decoder. Snap and Ship is useful whenyou are using your own decoder. 4.8.2 Setting the 1D/2D Barcode Scanner Symbologies The barcode scanner is shipped with default settings shown below. If the default setting suits the usage requirement, setting symbologies is not necessary. Chapter 4: Operating the Device 35 Symbologies Default Settings:

Symbologies UPC-A UPC-E EAN/JAN-8 EAN/JAN-13 UPC-E1 UPC-A/EAN-13 Extended Coupon Code GS1 DataBar Omni-Directinal GS1 DataBar Limited GS1 DataBar Expanded Linear 2D Code 39 Code 128 ISBT 128 GS1-128 Interleaved 2 of 5 Matrix 2 of 5 NEC 2/5 IATA 2/5 Code 2/5 Codabar Code 93 Code 11 MSI Telepen Trioptic Code Postal Code Planet Code Korea Psot China Post Australian Post Data Matrix PDF 417 Micro PDF 417 Codablock A Codablock F Maxicode QR Code Aztec Composite Code Han Xin Default setting Enable Enable Enable Enable Disable Disable Enable Enable Enable Enable Enable Disable Enable Enable Disable Enable Disable Disable Enable Enable Disable Disable Disable Disable Disable Disable Disable Disable Disable Enable Enable Enable Disable Disable Disable Enable Enable Disable Disable Changing default setting of symbologies or the advanced setting There are two methods tochange the default setting of symbologies or other advanced setting:

Method (1). Click on the Symbologies symbology to the default setting or make advanced setting by its category.After setting, click on the Save to Device on the side bar. on the top, then you can change the Method (2). Click on the reset to default button on the side as shown blow:

36 8-inch Rugged Windows Tablet M900P User Guide Warning 1. The reset to default button will change all setting to default. 2. N660X could disconnect with system after clicking the reset to default button. If the Disconnection happened please scan barcodes below in the following steps. Step 1. Frist please scan the USB HID barcode:

Step 2. Then please scan the USB Keyboard barcode:

Step 3. Please run EZConfig-Scanning again by following Device Configuring and Setting 4.8.3 Adding a Prefix or Suffix 1. To add a Prefix or Suffix please click on Data Formatting icon. Chapter 4: Operating the Device 37 2.Click on Editor button under the Prefix or Suffix section and create Prefix/Suffix value by typing in the block or select desire characters in the Control chars, Printable chars, and Extended ASCII. as shown below:

38 8-inch Rugged Windows Tablet M900P User Guide 3. When you finish creating Prefix/Suffix, please click on Save to Device on the side bar. 4. For checking the functionality of Prefix/Suffix, please chick on Scan Data Window icon on the top. Then scan a barcode to verify if the Prefix/Suffix appear correctly. Chapter 5: Frequently Used Settings 39 Chapter 5: Frequently Used Settings This chapter frequently used settings such as changing resolution and scaling, using recovery wizard and D-Sub port description, also contain basic troubleshooting guide. 40 8-inch Rugged Windows Tablet M900P User Guide 5.1 Screen Resolution Scaling and Setting The M900Ps 1280 x 800 high resolution display is perfect for viewing image, video, or other applications, however, Windows user interface (icons, buttons, and other user interface elements) may be too small to read and operate at the default Windows settings. By changing the display scaling or the display resolution setting of the device, you can adjust the size of the text and other items on the desktop for optimal viewing. Display scaling is the recommended method because it has the effect 1280 x 800. This section will explain how you can adjust the built-in windows display scaling setting and resolution setting. Note:

The Tablet computer is shipped with display scaling set at Larger - 150%. We recommend the users set the scaling to this setting for optimal text and image viewing. Before proceeding to change the scaling option, make sure any opened document is saved and close, and all running applications are closed before proceeding to change the display scaling, because this procedure requires users to log out of their account to apply display scaling change. 5.1.1 Changing Display Scaling (Recommended) Perform the following to change display scaling setting:

1. Tap and hold anywhere on the desktop for 3 seconds and release to bring up the context menu, and select Display settings option as shown below:

1. A Display Window will show up. Click on the dropdown option under the Scale and layout section and change the scaling option to 150% (Recommended) or any other desired display scaling. Chapter 5: Frequently Used Settings 41 5.1.2 Changing Screen Resolution Alternatively, instead of changing the display scaling setting, user may choose to change the overall resolution setting to make screen elements bigger. 1. Tap and hold anywhere on the desktop for 3 seconds and release to bring up the context menu, and select Display settings option as shown below:

42 8-inch Rugged Windows Tablet M900P User Guide 2. Click on the dropdown option next to Resolution and select the desire resolution by tapping on the scale:

3. Hit Apply. A prompt Display Settings prompt will show up to ask the user if the applied resolution is usable. 4. If the new resolution is the desired display setting hit Keep changes and continue to next step. If the new resolution is not desirable, hit Revert and select a different resolution to change to, and start again from step 2. 5. The user may now use the device with the new resolution setting. 5.2 Replacing Battery The M900P Tablet does not support hot-swap, meaning the tablet need to be powered off to replace the main battery. Perform the following to replace the batteries:

1. Turn off the tablet. Chapter 5: Frequently Used Settings 43 44 8-inch Rugged Windows Tablet M900P User Guide 5.3 Using Recovery Wizard to Restore Computer M900Prugged tablet has a dedicate recovery partition stored on the hard drive of the tablet to enable quick one-key recovery process. This partition occupies about 11GB of the storage space, and comes built-in to each M900Prugged tablet. Warning!

Before starting the recovery process, be sure to backup all user data, as all data will be lost after the recovery process. To enable quick one-key recovery procedure:

1. Plug-in the AC adapter to the tablet computer. Make sure the tablet computer stays plugged in to power source during the recovery process. 2. Power on the tablet computer, and when the boot screen shows up, press the Fn1 button

(Recovery Key) on the front bezel OR press F6when using an external USB keyboard to initiate the Recovery Wizard. 3. The following screen shows the Recovery Wizard. Click on Recovery button to continue. 4. A warning message about data loss will show up. Make sure data is backed up before recovery, and click on Yes to continue. Chapter 5: Frequently Used Settings 45 46 8-inch Rugged Windows Tablet M900P User Guide 5. Wait till the recovery process to complete. During the recovery process, a command prompt will show up to indicate the percent of recovery process. 6. After recovery is completed, please press any key to continue, and the tablet computer will Shut down automatically. 5.4 D-sub Pin Definition Chapter 5: Frequently Used Settings 47 M900P tablet computer has one D-sub port for Gateway connection. The D-sub port can also support optional accessory D-sub power cable. Warring The input source must be 12V when using D-sub cable as power input. Wrong power range input can cause serious damage to the tables. 15 Pin D-sub Connector Description VD_OUT_L Pin No. 1 2 3 4 5 6 7 8 9 10 VD_DET GND VD_TXD VD_PWR VD_OUT_R AUGND_VD VD_USB_D-

VD_RXD VD_DET Pin No. Description 11 12 13 14 15 LINE_JD VD_USD_D+

VD_+5V GND VD_PWR 5.5COM Port Definition M900P rugged tablet uses Hottab utility for built-in peripherals control. All the COM port numbers have been defined in the OS image coming with the package. COM Port COM 1 COM 4 COM 9 Device RS232 at D-Sub15 Bluetooth Auto Pairing GPS For some special applications, user might re-install OS and lose the COM port settings. To make sure the features works properly with Hottab utility, please follow the procedure below to re-define the COM port numbers:

1. Go to "Device Manager", right click on the COM number need to be changed, and tap on"Properties"

to open the setting page. 48 8-inch Rugged Windows Tablet M900P User Guide 2. Tap on "Port Setting" tab and click on "Advanced" button. Chapter 5: Frequently Used Settings 49 3. Tap on the dropdown list and choose the correct COM Port Number (refer to the COM Port Definition Table), and click "OK". 4. Double check "Device Manager" to make sure the COM Port number has been re-defined successfully, and then restart the system. 50 8-inch Rugged Windows Tablet M900P User Guide 5.6 Pairing with a Wireless Bluetooth Barcode Scanner The computer is affixed with a Bluetooth MAC (Media Access Control) address barcode label that enables wireless Bluetooth Barcode Scanner to quickly establish Bluetooth connection with the computer. It is encoded with leading characters to instruct the wireless Bluetooth barcode scanner to initial Bluetooth Serial Port Profile pairing request. 5.6.1 Setup Computer for Bluetooth Pairing To start the pairing process, first perform the following steps to ensure the computer is properly setup for pairing:

1. Locate the Bluetooth icon in the Notification Area 2. Bring up the Contextual Menu by performing long press on the icon with touchscreen or right-click on the icon with a mouse, and select Open Settings. 3. Once the Bluetooth & other devices Menu appears, click More Bluetooth options under Related settings section as shown below. Chapter 5: Frequently Used Settings 51 Click OK to continue. 4. go to Options tab, and make sure that in the Discovery section, the computer is set to Allow Bluetooth devices to find this computer, as shown below:

Click OK to continue. 5. In theBluetooth Settingsmenu, go to COM Ports tab. COM port has to be setup for the wireless Bluetooth Barcode Scanner to communicate via the Bluetooth Serial Port Profile. Click on the Add button. 52 8-inch Rugged Windows Tablet M900P User Guide

. 1. You are in Add COM Port window. Choose Incoming (device initiates the connection), and click OK. 2. The computer will automatically assign COM Port to the Bluetooth connection. In the screenshot below, COM4 is allocated. Chapter 5: Frequently Used Settings 53 Click OK to continue. 3. Next, the user has to configure the application that is used to accept the scanned data from the wireless Bluetooth Barcode Scanner. The application has to be configured to accept the same COM Port that has been assigned for the Bluetooth Serial Port Profile in the previous step. Important:

Make sure the application stays open while pairing. 4. Now the computer is ready for pairing process to start. 54 8-inch Rugged Windows Tablet M900P User Guide 5.6.2 Set up the Barcode Scanner for Bluetooth Pairing Important The wireless Bluetooth Barcode Scanner has to be configured as Bluetooth Serial Port Profile Master device to establish connection via Bluetooth MAC address barcode label. For a more detailed instruction, please refer to the User Guide for the wireless Bluetooth Barcode Scanner you are using for paring. Now the Barcode Scanner is ready for pairing process to start. 5.6.3 Perform Bluetooth Pairing After you finish setting up both the Computer and Barcode Scanner you are ready to start pairing. 1. Open aprogram that is used for paring. 2. Perform scanning procedures. A Bluetooth notification window pop-up on the right hand side of the desktop. Left click on the mouse to enter Add a device menu. 3. Locate the Bluetooth icon in the Notification Area. 4. Click Add Bluetooth Device. 5. In Add a Bluetooth Device window, click Next to connect the Barcode Scanner to the Computer. Chapter 5: Frequently Used Settings 55 In order to ensure that Bluetooth Device is successfully pared to the Computer, follow the steps below:

1. Locate the Bluetooth icon in the Notification Area. Select Show Bluetooth Devices. You can access this menu in the Control Panel:

Windows Control Panel Devices and Printers Bluetooth Devices 2. Make sure your device is connected to the Computer. 56 8-inch Rugged Windows Tablet M900P User Guide 5.7Basic Troubleshooting Problem Solution The removable battery is not charging. Make sure the AC adapter is properly connected, and that the removable battery is properly inserted. Nothing appears on the screen. The tablet computer may be in sleep mode. Press the power The screen suddenly turns blank and the power indicator goes off. Wireless LAN signal quality is poor. button to wake up the display. The brightness level may be too low. Increase brightness. Make sure that LED indicator is not powered off in Hottab. Make sure the AC adapter is properly connected. If running on battery power, the battery may be depleted, charge the battery. The tablet computer may be out of range. Move the tablet computer closer to the access point or another wireless LAN device associated with it. Check if your surroundings have interferences, such as microwave ovens, cordless phones. Move the tablet computer away from objects causing interference. I cannot connect to another wireless LAN device. Make sure that wireless LAN feature is powered on. Make sure that the SSID setting is the same for every I cannot connect to another device with Bluetooth. wireless LAN device in the network. Restart the tablet computer Make sure the IP address or subnet mask setting is correct. Make sure that both devices have Bluetooth powered on

(For the Tablet Computer, check Hottab to see if Bluetooth is powered on). Make sure that the distance between the two devices is within 10 meters and there are no walls or large obstructions between the devices. Make sure the both devices are powered on and configured to be discoverable. Make sure that both devices are compatible. The GPS application cannot find my location. Make sure that GPS is powered on in Hottab. Make sure that GPS receiver and the location sensor are enabled in Control Panel. The tablet computer may be out of coverage area. Move your tablet computer outdoors or closer to a window. Check if your surroundings have interferences, such as microwave ovens, cordless phones. Move the tablet computer away from objects causing interference. Adjust volume of the tablet computer by pressing on the volume rocker. If using an external audio device, make sure that the cable is properly connected. Make sure the VGA driver is installed. Make sure the output setting selected is correct. No sound is produced. I cannot project the tablet computer display to another monitor. Chapter 5: Frequently Used Settings 57 Problem Solution Barcode scanner does not emit laser beam and does not seem to work. Barcode scanner emits laser beam but does not read barcode presented to it. I am having GPS accuracy issue Battery leaking or swollen Make sure the Barcode scanner device is enabled in Hottab utility. Make sure under Windows, the Barcode Reader is set to COM 15 port, so that Hottab can trigger the Barcode Reader hardware. Adjust the distance between barcode scanner of the device and the barcode being scanned. Make sure the barcode code type is enabled in the tablet. To enable/disable a specific barcode code type, go through the Barcode Scanner Configuration section. When utilizing the GPS function, we recommend disabling the Barcode Reader in Hottab to reduce interference. The lithium battery used in this tablet may swell after being charged/ discharged many times, but there is no problem regarding safety. Continued use in such a state may result in the battery getting jammed, so please stop using the battery, and purchase a new one. 58 8-inch Rugged Windows Tablet M900P User Guide Chapter 6: Accessories This chapter listsavailable accessories and describes how to install accessories to M900P rugged tablet. 6.1 Accessories Introduction Chapter 6: Accessories 59 The M900P accessories provide a variety of product support capabilities. Table below lists the accessories available. Accessory Standard Part Number Description Adapter and Power Cord 922D072W19V2 Standard Battery Pack 98KA00000002 Optional Gateway VG-100 98DA00000004 Provides power 100-240VAC to 19VDC@3.78A 7.6V, typ. 4200 mAh Li Polymer Battery (2S2P) Use to connect a tablet computer to the Gateway. 60 8-inch Rugged Windows Tablet M900P User Guide 6.2 Installing Gateway VG-100 VG-100 is a gateway designed to be integrated into another system. It provides communications across in another system by the CANbus, RS485 and GPIO interfaces. It can also control I/O based upon message and signals received from the network. Application Diagram Appendix 61 Appendix This chapter provides additional information about M900P rugged tablet. 62 8-inch Rugged Windows Tablet M900P User Guide Appendix A: Specifications Size Resolution Brightness Contrast Ratio Viewing Angle Touch CPU System Memory Storage OS USB Audio D-Sub Power Input Microphone Speaker Model Name M900P 8-inch 1280 x 800 510 nits 800:1 85/85/85/85 10-point projected capacitive multitouch Intel Pentium N4200 Apollo Lake, 1.10 GHz, up to 2.50 GHz with turbo boost technology 4 GB LPDDR4 64 GB M.2 solid state drive (SSD) (up to 128GB) Windows 10 IoT Enterprise (64 bit) 1 x USB3.0 (Type-A), 1 x USB3.0 (Type-C) 1 x Audio Combo connector (Mic in or Line Out) 1x D-Sub for Gateway 1 x Power Jack Build-in 2 x 1Watt Speaker Front Camera 2MP Webcam Rear Camera 8MP Rear Camera with Autofocus and LED Light Display Specification System Specification Interface Audio Camera Data Capture Barcode 1D/2D Barcode Scanner (Optional) Security Function Security Keyboard and Input Wireless Communications Buttons LED Indicators Touch WLAN Bluetooth GPS Power Input TPM v2.0, computrace ready (Optional) On-screen QWERTY Keyboard Buttons: 1 x Power, 1 x Home, 3 x function key Power, Charging Indicator, HDD, RF 10 point multitouch 802.11 a/b/g/n Bluetooth 5.0 GPS, GLONASS 19V DC, 3.78A Power Management Mechanical Specification Environment Battery 7.6V, typ. 4200 mAh Li Polymer Battery (2S2P) Battery Operating Time 6~7 hours AC Adapter 100-240V, 50~60Hz Dimensions 225 x 148 x 20.5 mm Weight 0.9 kg Operating Temp. Storage Temp. Operating, Storage and Transportation Atmospheric pressure Humidity Shock Vibration Drop

-20C to 60C (AC mode), -10C to 50C (Battery mode)

-20C to 40C (Adapter mode)

-30C to 70C (-22F to 158F) 700hPa~1013hPa 10% to 90% RH, non-condensing MIL-STD-810G Method 516.6 Procedure I MIL-STD-810G Method 514.6 Procedure I 5 feet to concrete Certificates EMC & Safety CE, FCC Appendix B: Statement Appendix 63 Federal Communication Commission Interference Statement This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one of the following measures:

-

-

-

-

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. FCC Caution: Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate this equipment. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter. This device meets all the other requirements specified in Part 15E, Section 15.407 of the FCC Rules. Radiation Exposure Statement The product complies with the FCC portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available. These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body is 1.266 W/kg. 64 8-inch Rugged Windows Tablet M900P User Guide Industry Canada Equipment Standard for Digital Equipment (ICES) Canada This Class B digital apparatus complies with Canadian ICES-003. Cet appareil numrique de la classe B est conforme la norme NMB-003 du Canada. Innovation, Science and Economic Development Canada (ISED) Canada Statement:

This device complies with ISED license-exempt RSS standard(s). Operation is subject to the following two conditions:

(1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Le prsent appareil est conforme aux CNR d' ISED applicables aux appareils radio exempts de licence. L'exploitation est autorise aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'utilisateur de l'appareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible d'en compromettre le fonctionnement. For product available in the USA/Canada market, only channel 1~11 can be operated. Selection of other channels is not possible. Pour les produits disponibles aux tats-Unis / Canada du march, seul le canal 1 11 peuvent tre exploits. Slection d'autres canaux n'est pas possible. the device for operation in the band 5150-5250 MHz is only for indoor use to reduce the potential for

(i) harmful interference to co-channel mobile satellite systems;

the maximum antenna gain permitted for devices in the bands 5250-5350 MHz and 5470-5725 MHz shall

(ii) comply with the e.i.r.p. limit.

(iii) the maximum antenna gain permitted for devices in the band 5725-5825 MHz shall comply with the e.i.r.p. limits specified for point-to-point and non point-to-point operation as appropriate. the worst-case tilt angle(s) necessary to remain compliant with the e.i.r.p. elevation mask requirement set

(iv) forth in Section 6.2.2(3) shall be clearly indicated. users should also be advised that high-power radars are allocated as primary users (i.e. priority users) of the

(v) bands 5250-5350 MHz and 5650-5850 MHz and that these radars could cause interference and/or damage to LE-LAN devices. Appendix 65

(i) les dispositifs fonctionnant dans la bande 5150-5250 MHz sont rservs uniquement pour une utilisation lintrieur afin de rduire les risques de brouillage prjudiciable aux systmes de satellites mobiles utilisant les mmes canaux;

le gain maximal dantenne permis pour les dispositifs utilisant les bandes 5250-5350 MHz et 5470-5725 MHz

(ii) doit se conformer la limite de e.i.r.p. le gain maximal dantenne permis (pour les dispositifs utilisant la bande 5725-5825 MHz) doit se conformer

(iii) la limite de e.i.r.p. spcifie pour lexploitation point point et non point point, selon le cas. les pires angles dinclinaison ncessaires pour rester conforme lexigence de la p.i.r.e. applicable au

(iv) masque dlvation, et nonce la section 6.2.2 3), doivent tre clairement indiqus.

(v) de plus, les utilisateurs devraient aussi tre aviss que les utilisateurs de radars de haute puissance sont dsigns utilisateurs principaux (c.--d., quils ont la priorit) pour les bandes 5250-5350 MHz et 5650-5850 MHz et que ces radars pourraient causer du brouillage et/ou des dommages aux dispositifs LAN-EL. Operations in the 5.25-5.35 GHz band are restricted to indoor usage only. Les oprations dans la bande de 5.25-5.35 GHz sont limits un usage intrieur seulement. Radiation Exposure Statement The product complies with the Canada portable RF exposure limit set forth for an uncontrolled environment and are safe for intended operation as described in this manual. The further RF exposure reduction can be achieved if the product can be kept as far as possible from the user body or set the device to lower output power if such function is available. Dclaration d'exposition aux radiations Le produit est conforme aux limites d'exposition pour les appareils portables RF pour les Etats-Unis et le Canada tablies pour un environnement non contrl. Le produit est sr pour un fonctionnement tel que dcrit dans ce manuel. La rduction aux expositions RF peut tre augmente si l'appareil peut tre conserv aussi loin que possible du corps de l'utilisateur ou que le dispositif est rgl sur la puissance de sortie la plus faible si une telle fonction est disponible. These requirements set a SAR limit of 1.6 W/kg averaged over one gram of tissue. The highest SAR value reported under this standard during product certification for use when properly worn on the body is 1.266 W/kg. Ces exigences tablissent une limite SAR de 1,6 W / kg en moyenne sur un gramme de tissu. La valeur SAR la plus leve dclare selon cette norme lors de la certification du produit utiliser lorsqu'il est correctement port sur le corps est de 1.266 W / kg.

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Winmate Inc. 9F, No.111-6, Shing-De Rd., San-Chung District, New Taipei City 24158, Taiwan, R.O.C www.winmate.com Copyright Winmate Inc. All rights reserved.

 

 

BIS Advance Monitor Operators Manual PN: PT00117631 Rev A 0123 Introduction Copyright Information 2022-01 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. TM* Trademark of its respective owner. All other brands are trademarks of a Medtronic company. COVIDIEN, COVIDIEN with logo, and Covidien logo and Positive Results for Life are U.S. and internationally registered trademarks of Covidien AG.* brands are trademarks of their respective owners. Other brands are trademarks of a Covidien company. Covidien is a Medtronic company. US Patents: www.covidien.com/patents All information in this manual is believed to be correct. Medtronic shall not be liable for errors contained herein with the performance or use of this manual. ii BIS Advance Monitor Table of Contents 1. 1.1. 1.2. Introduction Introduction 1.1.1. Safety Symbol Definitions Safety Information Electrical Issues Battery Cautions Burn Hazards EMC Issues General 1.2.1. 1.2.2. 1.2.3. 1.2.4. 1.2.5. 1.2.6. 1.2.7. 1.2.8. 1.2.9. Notes Alarms Sensors Cautions 1.3. 1.4. 1.4.1. 1.4.2. 1.4.3. 1.4.4. Device Description Intended Purpose BIS Monitor BISx and BISx4 Modules BIS Sensors BIS Cables 1.5. 1.6. 1.7. 1.8. 1.9. 1.10. 1.11. Patient Target Groups Intended Users Essential Performance Adverse Events (Residual Risks) The BIS Advance Parameters Symbols BIS Advance Monitor BIS Advance Monitor System Indications and Contraindications 25 1.8.1. EEG Particular Standard (IEC 60601-2-26, 3rd Edition) Introduction 13 13 13 13 13 15 16 18 18 19 19 20 21 23 25 25 25 25 25 26 26 27 28 29 29 34 iii Introduction The BIS Advance Monitor Equipment and Supplies The BIS Advance System Parts of the System 2. 2.1. 2.2. 3. 3.1. 3.2. 3.3. 3.4. 3.5. 3.6. 3.7. 3.8. 3.9. iv BIS Monitor Adapter Cable 2.2.1. 2.2.2. 2.2.3. Docking Station 2.2.4. 2.2.5. 2.2.6. BISx Module BIS Sensors The BIS Sensor Simulator Installation and Preparation for Use Operating Environment Power Requirements and Battery Use Battery Operation Battery Pack General Information Battery Pack Removal and Installation Battery and Power Usage Mounting the Docking Station Preparing the Docking Station Preparing the Monitor Connecting the Monitor Connecting a Sensor to a Patient Sensor Check Case ID Start Procedure Terminating Monitoring with the Monitor 3.3.1. 3.3.2. 3.3.3. 3.6.1. 3.6.2. 3.6.3. 3.6.4. 3.6.5. 3.6.6. Home Screen Four-Channel Monitoring Home Screen Trend Graphs 3.9.1. 3.9.2. BIS Trend Graph Secondary Variables 40 40 43 43 48 51 54 56 59 60 60 60 60 60 61 63 64 68 71 71 78 82 86 87 87 88 92 96 96 97 BIS Advance Monitor 3.9.3. EEG Display 3.9.4. DSA Display 3.9.5. ASYM Graph 3.10. Home Screen Numeric Section 3.10.1. BIS Number 3.10.2. EMG 3.10.3. SQI (Signal Quality Indicator) 3.10.4. Burst Count 3.10.5. SR (Suppression Ratio) 3.10.6. ST (Suppression Time) 3.10.7. SEF (Spectral Edge Frequency) 3.10.8. MF (Median Frequency) 3.10.9. Home Screen Indicators and Messages 3.11. Home Screen Menus 3.11.1. Main Menu Settings 3.11.2. Left Bar Menu 3.11.3. Alarm Status Displayed on Home Screen Home Screen Options Secondary Trend Selection Home Screen Audio Alarm Settings Settings and Maintenance 3.15.1. Setting up Language, Date and Time 3.15.2. MPM Configuration 3.15.3. Advanced User Settings 3.15.4. Maintenance 3.12. 3.13. 3.14. 3.15. 3.16. 3.17. 4. 4.1. 4.2. Info Options Quick Reference Checklist Preparing for Operation Cases Operating the BIS Advance Monitoring System BIS Advance Monitor Introduction 98 100 102 104 106 107 108 109 110 111 112 113 114 115 115 118 119 121 125 126 128 129 130 131 135 135 136 138 138 138 v 4.3. Alarms and Messages Alarm and Message Types Introduction 4.2.1. 4.2.2. Case Storage Case Review Alarms 4.3.1. 4.3.2. 4.3.3. Messages 4.3.4. 4.3.5. 4.3.6. 4.3.7. Alarm Display Alarm Limits Chart Data Menu Map Audio Alarms Pause and Silence Changing Alarms Settings Institutional Settings Data Storage, Transfer, and Export Cybersecurity and Data Integrity Monitor Data Memory BISx Data Memory Types of Exported Data Live Case Export Saved Cases Export Recording a Snapshot Event BIS Saved Data Files 4.4. 4.5. 4.6. 5. 5.1. 5.2. 5.3. 5.4. 5.5. 5.6. 5.7. 5.8. 5.9. 5.10. 6. vi BISx Module Connection History Sensor Connection History Logs Export 5.9.1. 5.9.2. 5.9.3. Monitor Log 5.9.4. System Log Viewing and Printing Saved Data in PDF Format Service and Maintenance BIS Advance Monitor 138 139 143 143 145 152 162 166 167 168 173 176 180 186 186 186 187 188 188 192 195 197 199 199 200 201 202 203 206 Introduction Introduction Servicing the BIS Advance Monitor Battery Handling Cleaning the BIS Advance Monitor Cleaning the BIS Advance Monitor and BISx Module 6.4.1. 6.4.2. Disinfecting the BIS Advance System 6.4.3. Cleaning the Monitor Display 6.5. Instrument Identification 6.5.1. 6.5.2. Permanent Identification Marking Configuration Data on Monitor Diagnostics and Troubleshooting 6.1. 6.2. 6.3. 6.4. 7. 7.1. 7.2. 7.3. 7.4. 7.5. 7.6. Diagnostics EEG Filters 7.1.1. DSC Self-Test 7.1.2. 7.1.3. 7.1.4. Artifact Detection Impedance Checking Troubleshooting Administrator Mode 7.3.1. 7.3.2. Accessing Administrator Mode Administrator Mode Actions Demo Mode Glossary Specifications General Specifications 7.6.1. 7.6.2. Operating Environments 7.6.3. Power Supply 7.6.4. 7.6.5. 7.6.6. Alarms 7.6.7. Display Controls and Connectors Battery Specifications BIS Advance Monitor 206 206 206 208 208 209 210 210 210 210 212 212 212 213 213 213 214 218 218 221 223 223 227 227 229 231 231 232 232 233 vii Introduction Sound Pressure Data 7.6.8. 7.6.9. BIS Specifications 7.6.10. EEG Specifications 7.6.11. BISx Module Specifications 7.6.12. Software/GUI Specifications 7.7. 7.8. 7.9. 7.10. 7.11. Electromagnetic Compatibility Specifications Product Compliance BIS Advance Components, Accessories, and Documentation 251 Warranty Software License Agreement 234 234 235 236 237 237 249 260 262 viii BIS Advance Monitor List of Figures Introduction Figure 1. BIS Range Guidelines Figure 2. BIS Advance Monitor Components Figure 3. The BIS Monitor Figure 4. BIS Monitor Connectors Figure 5. BIS Tablet LEDs Figure 6. BIS Advance Adapter Cable Figure 7. Attaching the Adapter Cable to the Monitor Figure 8. Detaching the Adapter Cable from the Monitor Figure 9. BIS Advance Docking Station, Front View Figure 10. BIS Advance Docking Station, Back View Figure 11. BIS Advance Docking Station Connectors Figure 12. BISx Module with Integral Cables Figure 13. BIS Advance Sensors Figure 14. Battery Assembly/Disassembly Figure 15. Setup with GCX Clamp Mount Figure 16. Setup with GCX Desktop Mount Figure 17. Docking Station Installation Step 1 Figure 18. Docking Station Installation Step 2 Figure 19. Docking Station Removal Figure 20. Attaching the BISx Module to the BIS Advance Monitor Figure 21. Connecting the sensor to the BISx module Figure 22. Disconnecting the sensor from the BISx module Figure 23. BIS Advance Monitor Setup Figure 24. BIS Advance Monitor Setup - Back Figure 25. Sensor Positioning for Two-channel Sensor Figure 26. Sensor Positioning for Four-channel Sensor Figure 27. Sensor Check Window: In progress and Completed Figure 28. Case ID Indicator on Home Screen Figure 29. Sample 2-channel BIS Screen Figure 30. Sample 4-channel BIS Screen Figure 31. BIS Trend Graph Figure 32. EEG Display Figure 33. DSA Trend Display Figure 34. ASYM Graph Figure 35. Home Screen Numeric Section BIS Advance Monitor 30 41 44 46 47 48 49 50 52 53 54 55 58 62 66 67 68 69 71 73 74 75 76 77 80 81 85 86 90 94 96 99 101 103 105 ix Introduction Figure 36. BIS Numeric Figure 37. EMG Display on Home Screen Figure 38. SQI Indicator Figure 39. Burst Count Numeric Figure 40. SR Display on Home Screen Figure 41. ST Display on Home Screen Figure 42. SEF Display on Home Screen Figure 43. MF Numeric Figure 44. Main Menu Icon Figure 45. Main Menu on Home Screen Figure 46. Left Bar Menu Figure 47. Display Settings Selection Figure 48. Secondary Trend Selection Figure 49. Alarm Control Figure 50. Expanded Alarm Control with Alarm Volume Figure 51. Case List Window Figure 52. Case Review Screen Figure 53. Message Bar Figure 54. Home Screen with Active Alarm Figure 55. Alarms List Figure 56. Alarm Settings Screen Figure 57. Graph/Chart Toggle Icon Figure 58. Chart Data Screen for 2-Channel Monitor Figure 59. Home Screen Main Section Menu Map Figure 60. Main Menu - Menu Map Figure 61. Administrator Section Menu Map Figure 62. Live Case Recording Screen Figure 63. Snapshot Window Figure 64. Administrator Mode Login Screen x 107 108 109 109 110 111 112 113 116 117 118 121 126 127 127 139 141 152 165 166 171 173 175 178 178 180 190 196 220 BIS Advance Monitor List of Tables Introduction Table 1. The BIS Advance Monitor Parameters Table 2. Symbols that Appear on the Monitor and its Packaging Table 3. BIS Advance Monitor Components Table 4. Sensor/BISx/Use Case Matrix Table 5. Home Screen Indicators Table 6. Main Menu Selections Table 7. Home Screen Left Menu Bar Icons Table 8. Home Screen Display Settings Options Table 9. Expanded Alarm Control Icons Table 10. EEG Display Scale Options Table 11. Info Window Options Table 12. Alarm Messages Table 13. Information Messages Table 14. Alarm Indicators Table 15. Alarm Enabled and Alarm Disabled Indicators Table 16. Alarm Limits Options Table 17. Audio Alarm Options Table 18. Information on Chart Data Screen Table 19. Institutional Settings Table 20. Live Data Export File Names Conventions Table 21. Monitor Saved Cases Export Options Table 22. Data Export Files Table 23. BIS Advance Reports in PDF format Table 24. Monitor Configuration Data Table 25. BIS Advance Monitor Troubleshooting Scenarios Table 26. Administrator Mode Settings Table 27. Administrator Mode Actions Table 28. OR Configurations Table 29. Guidance and Manufacturer's Declaration - Electromagnetic Emissions Table 30. Guidance and Manufacturer's Declaration - Electromagnetic Immunity 240 Table 31. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the BIS Advance Monitor 244 246 Table 32. Proximity Field Immunity Compliance BIS Advance Monitor 31 34 42 78 114 116 119 122 127 132 136 145 153 163 163 169 173 174 181 191 194 197 203 211 214 221 222 229 239 xi Introduction Table 33. BIS Advance Monitor Components and Sensors Table 34. BIS Advance Accessories 252 252 xii BIS Advance Monitor 1. Introduction 1.1. Introduction Carefully read this operators manual and the Directions for Use that accompany the BIS sensors in order to use the BIS Advance Monitor (henceforth referred to as the monitor) and the BIS BISx module or BIS BISx4 module (henceforth the term BISx will refer to both modules) correctly and safely. Use of the monitor requires full understanding and strict observance of these instructions, the precautionary information, and the specifications. 1.1.1. Safety Symbol Definitions WARNING: A Warning is inserted to call attention to dangerous or hazardous conditions inherent to the operation, cleaning, and maintenance of the equipment which may result in personal injury or death of the operator or patient. Caution: A Caution is inserted to call attention to a procedure which, if not followed exactly, can lead to damage or destruction of the equipment. Note: A Note is inserted to point out procedures or conditions which may otherwise be misinterpreted or overlooked and to clarify apparently contradictory or confusing situations. 1.2. Safety Information 1.2.1. General WARNING: Fire hazard: do not use the BIS Advance monitor in a flammable environment or where concentrations of flammable anesthetics may occur. BIS Advance Monitor 13 Safety Information WARNING: Be sure the monitor is mounted securely in place to avoid personal or patient injury. WARNING: The BIS Advance monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the monitor should be observed to verify normal operation in the configuration in which it will be used. WARNING: To minimize the risk of patient strangulation, the patient interface cable (PIC) (which is an integral part of the BISx module) must be carefully placed and secured. WARNING: Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Place contaminated materials in a container designated for regulated waste. The BISx module and the monitor should be cleaned using approved cleaning materials only. WARNING: The monitor is not designed for use in MRI environment. WARNING: The software shall reset all settings with defined default values to Institutional Defaults upon the end of each case, excluding Institutional Default Language settings. The software will also reset all settings (including language) to Institutional Defaults upon the restart of the monitor. However, if a sensor for which certain settings were set (as described in 3.15.3 Advanced User Settings on page 131, and whether changes were performed by a user or administrator) is re-attached, the monitor will apply the settings that were in place when that sensor was used last time. WARNING: When no longer in use, this electronic equipment must be recycled or disposed of properly. Follow local ordinances for the safe disposal of electronic equipment. WARNING: No modification of this equipment or its accessories is allowed. WARNING: BIS Advance monitoring technology is intended for use as an adjunct to clinical judgment and training. Clinical judgment should always be used when interpreting BIS values in conjunction with other available clinical signs. Reliance on BIS values alone for intraoperative anesthetic management is not recommended. As with any monitored parameter, artifacts and poor signal quality may lead to inappropriate BIS values. Potential artifacts may be caused by poor skin contact (high impedance), muscle activity or rigidity, head and body motion, sustained eye movements, improper sensor placement and unusual or excessive electrical interference. BIS values should also be interpreted cautiously with certain anesthetic combinations, such as 14 BIS Advance Monitor Safety Information those relying primarily on either ketamine or nitrous oxide/narcotics to produce unconsciousness. Due to limited clinical experience in the following applications, BIS values should be interpreted cautiously in patients with known neurological disorders and those taking other psychoactive medications. Caution: Do not autoclave the BISx module or monitor. Autoclaving will seriously damage both components. Caution: Avoid liquid ingress to the Patient Interface Cable (PIC), which is an integral part of the BISx module. Contact of fluids with the PIC sensor connectors can interfere with PIC performance. 1.2.2. Electrical Issues WARNING: Use only the power cord and power supply supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet. WARNING: U.S.A. requirement: For proper grounding, the power receptacle must be a three-wire grounded outlet. A hospital grade outlet is required. Never adapt the three-prong plug from the monitor to fit a two-slot outlet. If the outlet has only two slots, make sure that it is replaced with a three-slot grounded outlet before attempting to operate the monitor. WARNING: To avoid the risk of electric shock, the BIS Advance monitor must only be connected to an AC power source with protective ground/earth. WARNING: If the integrity of the AC power source with protective ground/earth is in doubt, the BIS Advance monitor shall be operated from its internal battery power source only. WARNING: Electric Shock Hazard: Do not attempt to disconnect the power cord with wet hands. Make certain that your hands are clean and dry before touching the power cord. WARNING: Electrical Shock Hazard: Do not remove battery compartment cover during operation or while power is connected to monitor. WARNING: Electrical Shock Hazard: The manufacturer's inspection of this apparatus verified that the ground leakage current and the patient safety current were less than the specified limits established by the applicable safety standards. As a matter of safe practice, the institution should conduct periodic tests to verify these currents. BIS Advance Monitor 15 Safety Information WARNING: Whenever an event such as spillage of blood or solutions occurs, re-

test ground leakage current before further use. WARNING: Power supply is internally fused. Replace power supply only with the power supply designated for this monitor, Medtronic PN PMB4000PWS. WARNING: When connecting external equipment (e.g., data capture computer), the system leakage current must be checked and must be less than the IEC 60601-1-1 limit. Only approved medical devices which comply to 60601-1 (or USB flash drives) shall be connected to the monitor or docking station. WARNING: Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS Advance monitor. WARNING: The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

oUse of the accessory in the patient vicinity. Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. Caution: Keep power cord, plug and socket clear in case an urgent power supply disconnection is required. Caution: When connecting or disconnecting the BISx module, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result. 1.2.3. Battery Cautions WARNING: Charge the monitor fully before your first use of the monitor, by attaching the monitor to AC power with the battery installed. See 3.3 Battery Operation on page 60. WARNING: The monitor should always be operated with the battery installed in order to provide back-up power in the event of a momentary or temporary power outage. WARNING: Improper operation may cause damage to the battery or endanger the user. 16 BIS Advance Monitor Safety Information WARNING: Do not place the battery near any heat source. WARNING: Do not try to disassemble or short circuit the battery. WARNING: Only the battery pack provided with this monitor should be used for the monitor. Use of another battery or a refurbished battery may cause damage to the monitor or endanger the user. Reference Table 34. BIS Advance Accessories on page 252 regarding the battery pack. WARNING: The BIS Advance monitor contains an internal lithium ion battery. The battery must be disposed of or recycled based on national and local waste disposal legislation and requirements. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. WARNING: Never soak the battery in liquid such as water, drink, or oil. WARNING: Use, store, and transport the battery only under the designated temperature conditions. Reference 7.6.4 Battery Specifications on page 231. WARNING: If the monitor is to be stored for three months or more, store the battery outside the monitor. WARNING: If the battery has not been in use for an extended period, charge the battery before use to a level of at least 80% charge. Battery capacity indicators are described in 3.3.3 Battery and Power Usage on page 63. Caution: There should always be a battery installed in the device. If the battery is not installed, the monitor will operate properly on AC power, but if AC power is lost for any reason, the monitor will cease to function. Caution: Replace the removable battery if an on-screen message informs you that this is required, or if more than seven years have passed since the production date marked on the battery, whichever comes first. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. Caution: Check the battery annually by operating a BIS Advance monitor that has been disconnected from the wall socket and that has been charged for 4 hours when the monitor is powered off or 8 hours when the monitor is functioning. The monitor should function for at least one hour on battery power only. BIS Advance Monitor 17 Safety Information 1.2.4. Burn Hazards WARNING: Due to elevated surface temperature, do not place the BISx module in prolonged direct contact with patients skin, as it may cause discomfort. WARNING: The conductive parts of electrodes or sensor and connectors should not contact other conductive parts, including earth. WARNING: To reduce the hazard of burns during use of high-frequency surgical equipment (in the event of a defect in the neutral electrode connection of the high frequency surgical equipment), the sensor or electrodes should not be located between the surgical site and the electro-

surgical unit return electrode. WARNING: To reduce the hazard of burns during use of brain-stimulating devices (e.g., transcranial electrical motor evoked potential), place stimulating electrodes as far as possible from the BIS sensor and make certain that sensor is placed according to package instructions. The sensor must not be located between defibrillator pads when a defibrillator is used on a patient connected to the BIS Advance monitor. 1.2.5. EMC Issues WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the BIS Advance monitoring system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNING: The proximity of an AC/DC power supply can significantly reduce the performance of the BISx module. All power supplies, including the dedicated power supply provided with the BIS Advance monitor, must be placed at least 30 cm away from the BISx module, the cables connected to the BISx module, the BIS sensor, and the patient. WARNING: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment, especially during use with a defibrillator, could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 18 BIS Advance Monitor Safety Information 1.2.6. Alarms WARNING: Check Target Range alarm limits to ensure they are appropriate for the patient being monitored with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the institution. WARNING: If you plan to monitor the patient using alarms, do not set the Target Range alarm limits to extreme values that render the monitoring system ineffective. Ensure Target Range alarm limits are appropriate for each patient. WARNING: If you plan to monitor the patient using alarms, do not pause, disable or decrease the audible alarm volume until you verify that the patient is being monitored by other means, such as direct observation, as this could compromise patient safety. WARNING: If you plan to monitor the patient using alarms, do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm volume below ambient levels might impede operator recognition of the audible alarm, which might lead to patient harm during an alarm situation. WARNING: BIS monitoring is intended for use as an adjunct to clinical judgment and training. Clinical judgment should always be used when interpreting BIS in conjunction with other available clinical signs. Reliance on BIS alone for intraoperative anesthetic management is not recommended. 1.2.7. Sensors WARNING: Please note that the sensors are consumable products with a defined lifetime and expiry date. An expired sensor or a sensor that has been used beyond its defined lifetime may pass the sensor check (depending on various use parameters), but it is strongly recommended to avoid use of expired sensors and replace sensors after 24 hours. Use of expired or over-

used sensors may cause degraded performance. WARNING: Use of the BIS Advance system with sensor during external defibrillation may lead to shunting of defibrillator energy, causing defibrillation to be ineffective. In emergency use when defibrillation is required to save a patient's life, ineffective defibrillation may result in death. WARNING: The sensor is not intended to collect EEG, ECG, or other electrophysiological signals for interpretation; the signals collected are intended for use solely for calculating the BIS parameter. BIS Advance Monitor 19 Safety Information WARNING: Use of the host system with sensor during electroconvulsive therapy (ECT) may result in a corrupted EEG signal. Caution: Dispose of the sensor in accordance with current medical standards and applicable national regulations for biologically hazardous waste. 1.2.8. Cautions Caution: Do not block inlet holes on the monitor as this may prevent ventilation constriction or affect the audio output of the monitor. Caution: Do not open the BISx unit for any reason. The seal to prevent liquids from entering the BISx unit may be damaged if it is opened. Caution: Service or repairs must be performed only by qualified biomedical technicians. Caution: Any changes or modifications not expressly approved by the grantee of this device could void the user's authority to operate the equipment. Caution: The USB port on the monitor and the USB port on the docking station are intended only for the connection of a USB flash drive; do not use these ports for any other use. Caution: The BIS Advance monitor has been validated for use only with the BIS sensor. The sensor is a silver/silver chloride electrode array that utilizes Covidien's connector and Zipprep technology. Electrodes or sensors that are not validated for use with the monitor may not work properly and may not produce the expected results. Also, electrodes or sensors that are not validated for use with the monitor have not undergone a data integrity analysis and may potentially pose a data security risk. For a list of sensors, reference Table 33. BIS Advance Monitor Components and Sensors on page 252. Caution: To completely remove power from the monitor: disconnect power cord from the power receptacle of the monitor, then remove the battery from the monitor. Caution: Continuous impedance checking may need to be disabled if the 1 nanoampere 128 Hz impedance check signal interferes with other equipment

(e.g., evoked potential monitors). Caution: Considerations when using Electro-Convulsive Therapy (ECT) equipment during BIS monitoring: Place ECT electrodes as far as possible from the BIS sensor to minimize the effect of interference. Certain ECT 20 BIS Advance Monitor Safety Information equipment may interfere with the proper function of the BIS Advance monitor. Check for compatibility of equipment during patient setup. Caution: The BIS Advance monitor complies with the electromagnetic compatibility requirements of IEC 60601-1-2. Operation of this device may affect or be affected by other equipment in the vicinity due to electromagnetic interference (EMI). If this occurs:

Increase separation between devices. Re-orient device cabling. Plug devices into separate outlet circuit branches. Reference 7.7 Electromagnetic Compatibility Specifications on page 237. Caution: When connecting or disconnecting the BISx module, take care not to touch the exposed contacts of either connector. Damage due to electrostatic discharge may result. 1.2.9. Notes Note: Important: The BIS Advance monitor complies with the MDR- EU Medical Device Regulation 2017/745 and applicable regulatory requirements of the country distributed to and carry the CE Marking. Declarations of Conformity provided upon request where appropriate. Note: Read this entire manual carefully before using the monitor in a clinical setting. The monitor shall be used only according to the instructions that appear in this manual. Note: Use of the host system with sensor along with a neurostimulator may cause neurostimulator malfunction or diminished neurostimulator effectiveness. Note: The system provides protection against defibrillation, without loss of any operator settings or stored data, and shall continue to perform its intended functions within 30 seconds after exposure to defibrillation voltage, as specified in IEC 80601-2-26 and IEC 60601-2-26. Note: The battery pack supplied with this monitor should not be used with other devices. Note: Since the case storage capacity of the monitor is limited, it is recommended to download cases when the case ends, to avoid accidental erasure of case data. BIS Advance Monitor 21 Safety Information Note: Please select the date and time format in common use in your locality to enhance clarity for users of the monitor. Note: Medtronic recommends use of the 24-hour clock option in all clinical settings, to avoid situations in which the current time may be misunderstood by users. Note: The screenshots seen in this manual do not represent actual patient data and are provided for illustrative purposes only. Note: FEDERAL COMMUNICATIONS COMMISSION INTERFERENCE STATEMENT:

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/ TV technician for help. Note: RF Exposure Information (SAR):

This device meets the governments requirements for exposure to radio waves. This device is designed and manufactured not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission of the U.S. Government. The exposure standard employs a unit of measurement known as the Specific Absorption Rate, or SAR. The SAR limit set by the FCC is 1.6 W/kg. Tests for SAR are conducted using standard operating positions accepted by the FCC with the EUT transmitting at the specified power level in different channels. Note: Canada, Industry Canada (IC) Notices:

This device complies with Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 22 BIS Advance Monitor Device Description Note: Canada, avis d'Industry Canada (IC) Cet appareil est conforme avec Industrie Canada exemptes de licence RSS standard(s). Son fonctionnement est soumis aux deux conditions suivantes : (1) cet appareil ne doit pas causer d'interfrence et (2) cet appareil doit accepter toute interfrence, notamment les interfrences qui peuvent affecter son fonctionnement. Note: Radio Frequency (RF) Exposure Information The radiated output power of the Wireless Device is below the Industry Canada (IC) radio frequency exposure limits. The Wireless Device should be used in such a manner such that the potential for human contact during normal operation is minimized. This device has been evaluated for and shown compliant with the IC Specific Absorption Rate (SAR) limits when operated in portable exposure conditions. Note: Informations concernant l'exposition aux frquences radio (RF):

La puissance de sortie mise par lappareil de sans fil est infrieure la limite d'exposition aux frquences radio d'Industry Canada (IC). Utilisez lappareil de sans fil de faon minimiser les contacts humains lors du fonctionnement normal. Ce dispositif a t valu pour et dmontr conforme la Taux IC d'absorption spcifique ("SAR") des limites lorsqu'il est utilis dans des conditions d'exposition portatifs. Note: This device complies with part 15 of the FCC rules. Operation is subject to the following conditions:

The device may not cause harmful interference, and This device must accept any interference received, including interference that may cause undesired operation. Note: This Class B digital apparatus meets all requirement of the Canadian Interference-Causing Equipment Regulations. Cet appareil numrique de la classe B respecte toutes les exigences de Rglement sur le matriel brouilleur du Canada. 1.3. Device Description The BIS Advance monitor is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. The monitor processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the BIS Advance Monitor 23 Device Description patient's level of hypnosis. The device is for use by medical personnel only. The monitor and the BISx unit are designed for use for multiple patients, multiple uses. The BIS Advance monitor display consists of:

The current BIS number Raw EEG waveforms in real time Various signal quality indicators (EMG, SQI) Trend graphs of processed EEG variables Processed EEG variables, including suppression ratio (SR), suppression time

(ST), and burst count (the latter available when a 4-channel BIS system and a BIS bilateral sensor or an Extended sensor are in use) Alarm Indicators and Messages The system shall perform computations on the acquired EEG signals in order to produce the following processed variables in addition to the BIS number:

Electromyography (EMG) Signal Quality Index (SQI) Suppression Ratio (SR) Suppression Time (ST) Spectral Edge Frequency (SEF) Median Frequency (MF) Burst Count - for Extend Sensor and four-channel monitoring only (BURST) EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only) The BIS Advance monitor can work with a BISx module, which records and displays two channels of patient EEG information, or with a BISx4 module, which records and displays four channels of EEG, two from each side of the brain. For more information about the four-channel system, listing the unique aspects of four-channel monitoring, reference 3.8 Four-Channel Monitoring on page 92. BIS Advance Monitor 24 BIS Advance Monitor System Indications and Contraindications For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows: A sensor placed on the patients head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording. A list of the processed variables and a description of each is provided in Table 1. The BIS Advance Monitor Parameters, on page 31. This data is displayed on the screen according to the preferences set by the user in the menu system. 1.4. Intended Purpose The ELECTROENCEPHALOGRAPHY INSTRUMENTS are intended to monitor the state of the brain and may be used to guide anesthetic administration. 1.4.1. BIS Monitor The ELECTROENCEPHALOGRAPHY INSTRUMENTS are intended to monitor the state of the brain and may be used to guide anesthetic administration. 1.4.2. BISx and BISx4 Modules The ELECTROENCEPHALOGRAPHY INSTRUMENTS HARDWARE ACCESSORIES calculate parameters which are used to support monitor functions. 1.4.3. BIS Sensors The ELECTROENCEPHALOGRAPHY INSTRUMENTS CONSUMABLES collects electrical signals which are used to support monitor functions. 1.4.4. BIS Cables The ELECTROENCEPHALOGRAPHY INSTRUMENTS HARDWARE ACCESSORIES transmits electrical signals which are used to support monitor functions. 1.5. BIS Advance Monitor System Indications and Contraindications BIS Advance Monitor 25 Intended Users The BIS Advance monitor system is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system, and all its associated parameters, is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS index, one of the BIS Advance monitor system output parameters, may be used as an aid in monitoring the effects of certain anesthetic agents; and its usage with certain anesthetic agents may be associated with a reduction in primary anesthetic use and a reduction in emergence and recovery time. Use of the BIS index for monitoring to help guide anesthetic administration may be associated with the reduction of incidence of awareness with recall in adults during general anesthesia and sedation. No known contraindications are listed in either the BIS Advance monitor operator's manual or in the BIS Sensor IFUs. 1.6. Patient Target Groups The BIS Extend and Bilateral Sensors are intended for adult patients, while the BIS Pediatric Sensor is intended for pediatric patients. These sensors are designed for application to the frontal/temporal area to enable recordings of electrophysiological signals, such as EEG. They are low impedance, single patient use, disposable electrode sensors, intended to be used in conjunction with the rest of the BIS Advance monitor system. 1.7. Intended Users The BIS Advance monitor and BISx and BISx4 modules are intended to be used under the direct supervision of a licensed healthcare practitioner, or by personnel trained in their proper use. The system (and all of its associated parameters) is intended for use on pediatric and adult patients within a hospital or medical facility. It provides patient care to monitor the state of the brain by data acquisition of EEG signals. The BIS education site, www.biseducation.com, offers relevant information and published articles on the clinical use of the BIS Advance system. In addition, there is a Monitoring Consciousness Using the Bispectral Index during Anesthesia Clinicians Pocket Guide in English available on the website and through your local Medtronic representative. 26 BIS Advance Monitor For more information and technical support, contact BISTechnicalsupport@medtronic.com. Essential Performance 1.8. Essential Performance The essential performance of the monitor is the display of the BIS index and EEG in order to monitor a patient's level of consciousness. In addition, the monitor meets the essential performance requirements per IEC 80601-2-26:2019, as listed below. Requirement Subclause Results Accuracy of signal reproduction 201.12.1.102 2-channel max variation of the output signal is -13% of the input signal Input dynamic range and differential offset voltage 201.12.1.103 4-channel max variation of the output signal is -6.5% of the input signal 2-channel max deviation of the output signal with applied +300V DC (DC offset voltage) is 1.6% compared to the output signal without applied DC offset voltage 2-channel max deviation of the output signal with applied -300V DC (DC offset voltage) is 3.4% compared to the output signal without applied DC offset voltage 4-channel max deviation of the output signal with applied +300V DC (DC offset voltage) is 1.2% compared to the output signal without applied DC offset voltage 4-channel max deviation of the output signal with applied -300V DC (DC offset voltage) is 0.4% compared to the output signal without applied DC offset voltage 4-channel: The max measured signal noise is: 3.5V (peak-to-valley) 2-channel: The max measured signal noise is: 1.3V (peak-to-valley) 27 Input noise 201.12.1.104 BIS Advance Monitor Essential Performance Frequency response 201.12.1.105 The output at 0.5 Hz and 50 Hz is within 71 % to 110 % of the output obtained with a 5 Hz sine wave input signal:

4-channel: 101.7% at 0.5 Hz; 95.8% at 50 Hz 2-channel: 104.8% at 0.5 Hz; 90.4% at 50 Hz Common mode rejection 201.12.1.106 4-channel: max output signal is 39 v p-

v (peak to valley) 2-channel: max output signal is 47 v p-

v (peak to valley) 1.8.1. EEG Particular Standard (IEC 60601-2-26, 3rd Edition) With regard to immunity to electromagnetic interference, the standard states the following:

May show temporary degradation during discharges Shall resume normal operation after ESD within 30 seconds. Within this context, normal operation for the BIS monitoring system means the EEG wave shall appear on the BIS monitor within 30 seconds . Shall not lose operator settings or stored data Shall continue to perform its intended purpose It is possible, and acceptable per the standard, for the BIS monitoring system to experience a temporary loss of function, or degradation of behavior, due to an EMC Immunity, that could require operator intervention, provided that the system resumes normal operation (i.e., displays the EEG analog signal) within 30 seconds. Depending on the type of error the BIS system detects if exposed to significant electromagnetic interference, the following are examples of operator intervention:

Pressing a button on the touch-screen 28 BIS Advance Monitor The BIS Advance Parameters Disconnecting the Monitor Interface Cable of the BISx module from the BIS Advance monitor and then immediately reconnecting back to the BIS Advance monitor 1.9. Adverse Events (Residual Risks) Any serious incident that occurs in relation to the device or its accessories should be reported to Medtronic and to the national competent authority. Covidien is a Medtronic company. 1.10. The BIS Advance Parameters The BIS value (Bispectral Index) is a continuous processed EEG parameter that correlates to the patients level of hypnosis, where 100 = awake and 0 = flat line EEG. The BIS value was designed to correlate with hypnotic clinical endpoints

(sedation, lack of awareness, and memory) and to track changes in the effects of anesthetics on the brain. The BIS value is displayed as a number in the upper left corner of the screen and is plotted over time on the BIS Trend Graph. When signal quality is too low to accurately calculate a BIS value, the BIS number is not displayed. BIS Advance Monitor 29 The BIS Advance Parameters Figure 1. BIS Range Guidelines This chart reflects a general association between clinical state and BIS values. Ranges are based on results from a multi-center study of the BIS monitor involving the administration of specific anesthetic agents. BIS values and ranges assume that the EEG is free of artifacts that can affect its performance. Titration of anesthetics to BIS range should be dependent upon the individual goals established for each patient. These goals and associated BIS ranges may vary over time and in the context of patient status and treatment plan. For more detailed clinical information, reference the clinical quick guide cards supplied with your monitor. EEG data provides a real-time indication of brain status. The EEG waveform data recorded by the system data is used to create the processed variables BIS, SQI, SR, ST, Burst Count, SEF, MF, DSA, and ASYM. In addition, the raw EEG data is provided as a trend waveform on the BIS Advance monitor home screen. More details about the BIS Advance processed variables are listed in Table 1. The BIS Advance Monitor Parameters, below. For display of these variables, reference 3.9 Home Screen Trend Graphs on page 96 and 3.10 Home Screen Numeric Section on page 104. 30 BIS Advance Monitor The BIS Advance Parameters Table 1. The BIS Advance Monitor Parameters Processed Parameter Description Bispectral Index (BIS number) The BIS number is a processed EEG value representing the depth of sedation. It is a continuously processed EEG parameter that correlates to the patient's level of hypnosis, where 100 = awake and 0 = flat line EEG. BIS was designed to correlate with "hypnotic" clinical endpoints and to track changes in the effects of anesthetics of the brain. This value is computed based on computations on the acquired 2 or 4 EEG channels. For the standard system with 2-channel sensors, the system shall produce one BIS value; for 4-channel sensors, the system shall produce 2 BIS values, one for each brain hemisphere. The EEG number of channels feature enables the user to view the primary measured electrodes of each brain hemisphere, only one brain hemisphere, or all of them. A BIS value above 90 typically represents an awake state. As the drugs cause deeper sedation, this value will decrease. You can set the BIS value limits to cause an alarm if the level of consciousness exceeds the desired limits. A BIS value below 60 indicates a high probability of drug-induced unconsciousness. A BIS value below 30 indicates an increasing level of EEG suppression. Both the BIS number and the BIS trend are displayed on the Home screen. For more details, reference 3.7 Home Screen on page 88. Smoothing rate is the time over which the BIS value is averaged. The smoothing rate can be adjusted by the user; for the Extend sensor it is automatically 30 seconds. A shorter smoothing rate provides increased responsiveness to state changes, such as induction or awakening. A longer 31 BIS Smoothing Rate BIS Advance Monitor The BIS Advance Parameters smoothing rate provides a smoother trend with decreased variability and sensitivity to artifact. EEG

(Electroencephalogram) A visual representation of the rhythmic fluctuations of electric potential between parts of the brain (brain waves). EEG

(Electroencephalogram) Amplitude The maximum absolute voltage of the waveform. The EEG waveform amplitude is typically conveyed in microvolts (V). EMG (electromyogram) A measurement technique indicating forehead muscle activity and other high-frequency artifacts. The EMG numeric indicates the absolute power in the 70-110 Hz range. This frequency range contains power from muscle activity as well as power from other high-frequency artifacts. It is conveyed in decibels (dB) relative to 0.0001V2. Significant forehead muscle activity may cause the BIS value to increase, so when EMG is high, the BIS value should be interpreted with caution. SQI measures the signal quality of the EEG. It represents the percentage of good epochs and suppressed epochs in the last 120 (61.5 seconds) that could be used in the BIS calculation. It is calculated based on impedance, artifact presence, and other variables. An icon with 5 green bars represents the optimal SQI. The number of EEG bursts per minute, where a burst is defined as a short period of EEG activity preceded and followed by periods of inactivity

(suppression). Burst count represents the number of bursts in the last minute. Burst count is displayed as a trend and as a numeric value. This type of electroencephalography (EEG) pattern, which is characterized by periods of high-

voltage electrical activity alternating with periods of no activity in the brain, is a pattern found in patients with inactivated brain states, due to BIS Advance Monitor SQI (Signal Quality Indicator) Burst Count 32 SR (Suppression Ratio) The percentage of time during the last 63 seconds in a state of isoelectric EEG. The BIS Advance Parameters factors such as general anesthesia, coma, or hypothermia. Burst count is activated by connection of an Extend Sensor or Bilateral Sensor. Thus, the burst count parameter will appear on the screen only when an Extend and Bilateral sensor is used. For example, SR=10% represents 6.3 seconds of the last 63 seconds. When set, the SR limit appears as a purple dashed line on the SR trend. The accumulated time in this case that the patient was in a state of suppressed (isoelectric) EEG. It is provided in hours, minutes and seconds as HH:MM:SS. The amplitudes of the power spectrum are represented by varying colors. Red indicates high power, and blue indicates low power. The frequency below which 50% of the total EEG power lies. It is displayed as a purple line on the DSA graph. The MF Number shall be displayed on the main monitoring screen in 2-channel mode; for the 4-

channel mode, the Left MF Number or Right MF Number shall be displayed, according to the user's selection of the brain hemisphere side. DSA (Density Spectral Array) A graphic display of the EEG power at each frequency over time. ST (Suppression Time) MF (Median Frequency) SEF (Spectral Edge Frequency) The frequency below which 95% of the total EEG power lies. It is displayed as a white line on the DSA graph. BIS Advance Monitor 33 Symbols ASYM (Asymmetry) The difference in EEG power between the left and right hemispheres of the brain over time. ASYM is displayed as a value between 20% and 100%. It represents the ratio of EEG power present in one hemisphere to the total EEG power (total power = left power + right power). ASYM is displayed only during four-channel monitoring. 1.11. Symbols The following symbols appear on the body of the monitor and on its packaging

(including labels). Table 2. Symbols that Appear on the Monitor and its Packaging Symbol Description Location Packaging Packaging Packaging Packaging For prescription use only Consult instructions for use Consult instructions for use Caution, consult accompanying documents for warnings and precautions 34 BIS Advance Monitor Symbols Packaging Caution, consult accompanying documents for warnings and precautions Follow Instructions for Use (in blue on device) MR Unsafe Atmospheric pressure limit for storage and transport for monitor and docking station;

values for BISx unit seen in 7.6.1 General Specifications on page 227 Humidity limit for storage and transport, for monitor, docking station and BISx unit Temperature limit for storage and transport, for monitor, docking station and BISx unit This side up Keep dry Packaging Packaging Packaging Packaging Packaging Packaging Packaging BIS Advance Monitor 35 Symbols Packaging Fragile China ROHS CB symbol (for BISx unit only) Packaging China RoHS symbol (indicating no hazardous substances above restriction limits) Packaging China RoHS symbol (indicating Environment Friendly Use Period of 50 years) Packaging Directive on waste from electrical and electronic equipment UL recognized component certification symbol for Canada and the USA (on BISx unit and adapter cable) Defibrillation-proof type BF applied part (on BISx unit) IP (liquid ingress) level Non-ionizing electromagnetic radiation on packaging;

Wireless functionality on device Packaging Packaging Packaging Packaging Packaging and device Direct current Packaging 36 BIS Advance Monitor Symbols Packaging Packaging Packaging Packaging Caution, hot surface (on BISx unit) Latex free (on BISx unit only) Medical Device UL registration mark. Complies with 21CFR 1040.10 and 10410.11 except for deviation pursuant to Laser Notice No.50, dated June 24 2007. MEDICAL - GENERAL MEDICAL EQUIPMENT AS TO ELECTRICAL SHOCK, FIRE AND MECHANICAL HAZARDS ONLY IN ACCORDANCE WITH ANSI/AAMI ES 6061-1 (2005) +

AMD (2012) and CAN/CSA-

C22.2 No.6060-1 (2014) Federal Communications Commission certification mark. Packaging Contains: FCC ID:

PX9-AC9260NGW Contains: IC:

9911A-AC9260NGW Australia wireless symbol Packaging BIS Advance Monitor 37 Symbols CE mark Authorized representative in the European Community Catalog number Manufacturer Importer Serial number Date of manufacture Battery charging icon USB port indicator on docking station and monitor Packaging Packaging Packaging Packaging Packaging Packaging Packaging Device Device Device Network port indicator on docking station On/Off button and On/Off indicator Device 38 BIS Advance Monitor Symbols Battery compartment cover locked Battery compartment cover unlocked Home button Function button Device Device Device Device Device Earphones/microphone port indicator on monitor Reset button on monitor (Not for user/operator use) Device HDMI port indicator on monitor (Not for user/operator use) Device DC power port indicator on monitor RS-232 port indicator on docking station Device Device VGA port indicator on docking station Device BIS Advance Monitor 39 2. The BIS Advance Monitor Equipment and Supplies 2.1. The BIS Advance System All of the items listed below are required in order to operate the BIS system:

BIS monitor: The monitor processes collected data and provides an interface for the user, in which results are displayed, settings are inputted, and data is recorded for download. The monitor is supplied with a removable battery. Docking station: The docking station provides power and communication for the monitor. It is required for mounting the monitor and thus is strongly recommended for all use cases of the monitor. The docking station is provided with the monitor and is also sold separately. It uses the power supply and power cord supplied with the monitor. Adapter cable: Connects between the tablet and the BISx module integral cable

(MIC). The adapter cable is sold separately, and should be connected to the monitor before use. BISx or BISx4 module: The BISx module acquires and processes EEG signals and processes collected data. Monitoring with BIS system requires both the tablet and the BISx module. The BISx module includes an integral cable to connect to the adapter cable on one side (the MIC), and connects to the patient (via a cable the PIC - and a sensor) on the other side. The BISx module is sold separately. Monitor Interface Cable (MIC): Connects between the BISx module and the monitor. The monitor interface cable is an integral part of the BISx module. BIS Advance Monitor 40 Patient Interface Cable (PIC): Connects between the BISx module and the sensor. The patient interface cable is an integral part of the BISx module. The BIS Advance System BIS sensor: The appropriate BIS sensor is used to connect the system to the patient and acquire patient data for analysis. Figure 2. BIS Advance Monitor Components 1 2 3 6 7 8 41 4 5 BIS Advance Monitor The BIS Advance System Number Component 1 2 3 4 5 6 7 8 Monitor Docking station Adapter cable MIC Sensor PIC GCX mounting accessory (the selected accessory will depend on the use case) BISx module/BISx4 module For a list of these parts and their part numbers, reference Table 3. BIS Advance Monitor Components, below. A list of sensors for use with the BIS Advance monitor appears in Table 34. BIS Advance Accessories on page 252. Table 3. BIS Advance Monitor Components Product Name Legacy Product Name Description or Application BIS Advance Monitor BIS Vista Monitor or BIS Complete Monitor BIS monitor that can be used with either a BISx or BISx4 module. NA BIS Advance docking station 42 Docking station to permit easy mounting of monitor Part Number of BIS Advance Product PMB4000 (in some cases, an additional suffix will denote region) PMB4000DOC BIS Advance Monitor Product Name Legacy Product Name Description or Application BIS Advance Adaptor cable NA Parts of the System Part Number of BIS Advance Product PMB4000ACBL BISx module LoC 2 Channel 186-1095-xxx Adapter cable used to connect monitor to BISx module Processes 2 channels of EEG information (one brain hemisphere) to work with BIS Advance Monitor. The MIC (monitor interface cable) and PIC (patient interface cable) are integral to this module. The monitor can work with a BISx module or a BISx4 module. Processes 4 channels of EEG information (both hemispheres of the brain) to work with BIS Advance Monitor. The MIC (monitor interface cable) and PIC (patient interface cable) are integral to this module. BISx4 module LoC 4 Channel 186-0224-xxx 2.2. Parts of the System 2.2.1. BIS Monitor The tablet processes collected data and provides an interface for the user, in which results are displayed, settings are inputted, and data is recorded for download. BIS Advance Monitor 43 Parts of the System It includes three hard keys, three LEDs, a brightness sensor, a touch screen for display and interface, a camera (which is disabled), and a series of connectors as described below. The BIS monitor does not have wireless functionality. Figure 3. The BIS Monitor 1 2 3 4 1 2 3 4 44 5 6 7 8 Number Item Description Camera The camera is disabled and is not used for BIS monitor functionality. Brightness sensor Senses ambient level of brightness Indicator LEDs Indicates status of various connectivity functions. Reference Figure 5. BIS Tablet LEDs on page 47. Power and connectivity connectors (on Ports for (from left to right when seen with the bottom edge of the monitor at the left): power, microphone/

BIS Advance Monitor Number Item Description Parts of the System monitors right edge, not seen) earphones, USB, mini USB, reset button, HDMI. Only the USB port is intended for end-user use. Docking station connector (on monitors bottom edge, not seen) Used to connect the monitor to the docking station in order to provide power and connectivity to the monitor via the docking station. Function button Will open the main menu when pressed Home button Will open the home screen when pressed Power On/Off button Will turn on and off the monitor when pressed 5 6 7 8 The monitor includes a series of power and connectivity connection ports on its right side, behind a door. Reference Figure 4. BIS Monitor Connectors on page 46. These are connection ports for (from left to right when seen with the bottom edge of the monitor at the left): power, microphone/audio connection, USB, mini USB, reset button, and HDMI. The microphone is disabled. The power and USB connection ports on the monitor are provided for power connection and attachment of a USB flash drive for download of data. These ports can be used at any time; however, they are intended for a use case in which the monitor is used without a docking station, when the power and USB ports on the docking station are not available to the user. The USB port is intended only for the connection of a USB flash drive; do not use it for any other use. The other ports behind the door on the right side of the monitor are not for user/operator use. The power and USB connection ports on the monitor are not intended for use during monitoring. The monitor is shipped with a power supply for use with the monitor. WARNING: Use only the power cord and power supply supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet. BIS Advance Monitor 45 Parts of the System Figure 4. BIS Monitor Connectors 1 2 3 4 5 6 Number Item Description Power connector Used to connect monitor directly to power (when used without a docking station) Microphone/audio connection Not for user/operator use USB Used for downloading data Mini USB Not for user/operator use Reset button Not for user/operator use HDMI Not for user/operator use The tablet includes three LEDs at the top right of the screen, as well as a brightness sensor, as seen in Figure 5. BIS Tablet LEDs, below. The meaning of these LEDs are described in the table below, listed from left to right. 1 2 3 4 5 6 46 BIS Advance Monitor Figure 5. BIS Tablet LEDs 1 2 3 4 Parts of the System 1 2 3 Number LED Description Functioning Brightness Brightness sensor Detects ambient brightness Wireless reception Green LED Charging Yellow/green LED Wireless reception detected; as the BIS Advance monitor does not have wireless functionality, this will always be off. Will appear yellow when the monitor is attached to mains power and the tablet battery pack is charging, will appear green when battery pack is fully charged. If the monitor is not attached to mains power, a blinking yellow LED will be displayed if the battery charge level is under 10%. Will appear blue when the monitor is turned on 47 4 Power Blue LED BIS Advance Monitor Parts of the System The monitor can be viewed from any viewing angle up to 140 degrees from either side and up to 120 degrees from above or below the tablet. The BIS value is visible at up to 4 meters from the monitor, the EMG data at up to one meter, and graphs and status data at up to 45 cm from the monitor. The adapter cable is seen in Figure 6. BIS Advance Adapter Cable, below. 2.2.2. Adapter Cable Figure 6. BIS Advance Adapter Cable 1 2 3 Number Description Connector to monitor Adapter cable marking Connector to BISx module 1 2 3 48 The adapter cable must be connected to the monitor for use. Attach the adapter cable to the back of the monitor as follows:

BIS Advance Monitor Parts of the System Place the adapter cable in place at the back of the monitor, lining up the arrow on the cable port and the red dot on the adapter cable. Push the cable into the port. Reference Figure 7. Attaching the Adapter Cable to the Monitor on page 49. Once this connection is made, the adapter cable can stay connected to the monitor, whether the monitor remains on or is turned off between uses. To remove the adapter cable from the monitor, grasp the metal part of the adapter cable connector and twist it to the left (towards the closer outer edge of the tablet), in the direction of the red arrow, and pull out the cable. Reference Figure 8. Detaching the Adapter Cable from the Monitor on page 50. Figure 7. Attaching the Adapter Cable to the Monitor 1 2 3 4 1 2 Number Description Adapter cable port on monitor Adapter cable port marking BIS Advance Monitor 49 Parts of the System Adapter cable connector to monitor Adapter cable marking (appears on metal part of adapter cable) Figure 8. Detaching the Adapter Cable from the Monitor Number Description Adapter cable port on monitor Adapter cable marking (appears on metal part of adapter cable) Adapter cable BIS Advance Monitor 3 4 1 2 3 1 2 3 50 Parts of the System 2.2.3. Docking Station A docking station is provided in order to permit the mounting of the monitor on a variety of surfaces, as required by user preference. For a list of operating configurations, reference 7.6.2 Operating Environments on page 229. The docking station is provided with the monitor and is also sold separately. It uses the power supply and power cord supplied with the monitor. WARNING: Use only the power cord and power supply supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet. To attach the monitor to the docking station, reference 3.5 Preparing the Docking Station on page 68. The docking station includes a series of connectors used to connect the docking station to power and communications. These are located at the bottom of the docking station and are not seen in either of the docking station views in the figures below. For an illustration and description of the docking station connectors, reference Figure 11. BIS Advance Docking Station Connectors on page 54. Note: Please note that the network connector on the docking station is for development, production and service use only. It is not intended for use for any other purpose. BIS Advance Monitor 51 Parts of the System Figure 9. BIS Advance Docking Station, Front View 1 2 3 Number Feature Description Clasp for top edge of tablet The clasp, when pushed into place, holds the monitor in place in the docking station Connection pins Monitor groove Docking station connection pins, which connect with pins at the bottom edge of the monitor to provide power and communication to the monitor via the docking station Groove in which to place the monitor when docking the monitor in the docking station BIS Advance Monitor 1 2 3 52 Figure 10. BIS Advance Docking Station, Back View Parts of the System 1 2 1 2 Number Feature Description Clasp for top edge of tablet The clasp, when pushed into place, holds the monitor in place in the docking station Docking station mounting connectors Used to attach the docking station to the required mounting solution BIS Advance Monitor 53 Parts of the System Figure 11. BIS Advance Docking Station Connectors 1 2 3 4 5 1 2 3 4 5 54 Number Feature Description Power For connecting docking station to AC power USB For data download only RS-232 (serial) port For connection to monitoring systems, including hospital data systems. Only approved medical devices may be connected. For connection to display data on an additional screen For development, production and service use only VGA Network 2.2.4. BISx Module There are two versions of this module, the BISx module for use with two-channel monitoring, and the BISx4 module for use with four-channel monitoring (for both hemispheres of the brain). The designation for two-channel or four-channel monitoring appears on the BISx module. In this document, when the term BISx module is used, it refers to both modules; use the correct module for your monitoring situation. If using a BISx4 module for four-channel monitoring, please note that the appropriate sensor must also be used in order to enable four-channel monitoring. BIS Advance Monitor The BISx module receives, filters, and processes patient EEG signals. It is located close to the patient's head where the EEG signal is less subject to interference from other medical equipment. Parts of the System Its integral Monitor Interface Cable (MIC) connects to the interface cable which should be attached to the monitor. Its integral Patient Interface Cable (PIC) connects the BIS sensor to the BISx module. (It is possible to remove the PIC from the BISx module without special tools, by pulling the parts apart, but it is supplied securely attached to the BISx module.) The attachment clip on the BISx module is used to secure it in a convenient location near the patient's head. Figure 12. BISx Module with Integral Cables 3 1 4 2 1 2 Number Feature Description MIC cable Connects between the BISx module and the monitor Monitor connector This end of the MIC cable connects to the monitor adapter cable BIS Advance Monitor 5 55 Parts of the System Number Feature Description 3 4 5 56 BISx module Unit which collects, processes and stores data as part of the functionality of the BIS Advance monitoring system. PIC cable Connects between the BISx module and the patient sensor Sensor connector This end of the PIC cable connects to the sensor. Note the button on the connector; when connected, press this button to release the sensor. This clip at the back of the BISx module permits the mounting of the BISx module on a pole or other item as required. NA Clip (not seen) WARNING: Due to elevated surface temperature, do not place the BISx module in prolonged direct contact with patients skin, as it may cause discomfort. Caution: Do not open the BISx module for any reason. The seal to prevent liquids from entering the BISx module may be damaged if opened. Caution: Service or repairs must be performed only by qualified biomedical technicians. 2.2.5. BIS Sensors WARNING: Please note that the sensors are consumable products with a defined lifetime and expiry date. An expired sensor or a sensor that has been used beyond its defined lifetime may pass the sensor check (depending on various use parameters), but it is strongly recommended to avoid use of expired sensors and replace sensors after 24 hours. Use of expired or over-

used sensors may cause degraded performance. WARNING: Use of the BIS Advance system with sensor during external defibrillation may lead to shunting of defibrillator energy, causing BIS Advance Monitor Parts of the System defibrillation to be ineffective. In emergency use when defibrillation is required to save a patient's life, ineffective defibrillation may result in death. WARNING: The sensor is not intended to collect EEG, ECG, or other electrophysiological signals for interpretation; the signals collected are intended for use solely for calculating the BIS parameter. WARNING: Use of the host system with sensor during electroconvulsive therapy (ECT) may result in a corrupted EEG signal. Caution: Dispose of the sensor in accordance with current medical standards and applicable national regulations for biologically hazardous waste. Note: Use of the host system with sensor along with a neurostimulator may cause neurostimulator malfunction or diminished neurostimulator effectiveness. Select the appropriate sensor. A list of sensors appears in Table 34. BIS Advance Accessories on page 252. The sensors are also seen in Figure 13. BIS Advance Sensors on page 58. It is important to use the correct sensor for your current patient and monitoring situation; a Quatro, Extend or Pediatric sensor for use with a BISx module or a BISx4 to monitor patients on two channels, or a Bilateral sensor for use with a BISx4 module to monitor patients on 4 channels (in both hemispheres of the brain). The patient sensor is intended for single patient use. The sensors are consumable products with a defined lifetime and expiry date. An expired sensor or a sensor that has been used beyond its defined lifetime may pass the sensor check (depending on various use parameters), but it is strongly recommended to avoid use of expired sensors and replace sensors after 24 hours. Use of expired or over-used sensors may cause degraded performance. When a sensor is attached to the system, the system will automatically perform a sensor check. All of the sensors electrodes must receive a pass grade in order for the sensor check to pass and measurement to proceed. BIS Advance Monitor 57 Parts of the System Figure 13. BIS Advance Sensors 1 2 3 4 Number Description Part Number Bilateral sensor Extend sensor Pediatric sensor Quatro sensor 186-0212 186-0160 186-0200 186-0106 1 2 3 4 58 BIS Advance Monitor Parts of the System 2.2.6. The BIS Sensor Simulator In addition to patient sensors, the BIS Sensor Simulator is also available. It is a service tool that allows for the verification of proper impedance values being detected by the BIS Advance monitor during the sensor check. This sensor is used for testing purposes only. If the sensor does not pass the sensor check process, check the following:

1. 2. 3. Ascertain if the PIC cable is functioning properly by running the sensor check with the Sensor Simulator attached to the patient end of the PIC cable instead of a sensor. If the PIC cable functions correctly with the Sensor Simulator, and the Sensor Simulator passes the sensor check process, replace the sensor. If the Sensor Simulator does not pass the sensor check process, replace the PIC and/or the entire BISx module. For more information about the sensor check process, reference 3.6.3 Sensor Check on page 82. BIS Advance Monitor 59 3. Installation and Preparation for Use 3.1. Operating Environment The system is designed for use in operating rooms and in transit following procedures. For more details regarding specific operating environments and the recommended mounting options, reference 7.6.2 Operating Environments on page 229. 3.2. Power Requirements and Battery Use The BIS Advance monitor should always be operated with a battery installed, to permit for continued use following interruption of supply mains. Following interruption of power supply, including interruptions exceeding 30 seconds, the monitor will continue to function, drawing power from the battery. 3.3. Battery Operation 3.3.1. Battery Pack General Information The monitor includes one lithium-ion battery pack. When fully charged, the battery pack will provide power to the tablet for use for at least one hour, if the tablet is not receiving power from wall power via the docking station. BIS Advance Monitor 60 a Battery Operation WARNING: Charge the monitor fully before your first use of the monitor, by attaching the monitor to AC power with the battery installed. See 3.3 Battery Operation on page 60 for more information. WARNING: The monitor should always be operated with the battery installed in order to provide back-up power in the event of a momentary or temporary power outage. WARNING: Improper operation may cause damage to the battery or endanger the user. WARNING: Do not place the battery near any heat source. WARNING: Do not try to disassemble or short circuit the battery. WARNING: The BIS Advance monitor contains an internal lithium ion battery. The battery must be disposed of or recycled with national and local waste disposal legislation and requirements. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. WARNING: Never soak the battery in liquid such as water, drink, or oil. WARNING: Use, store and transport the battery only under the designated temperature conditions. Reference 7.6.4 Battery Specifications on page 231. WARNING: If the monitor is to be stored for three months or more, store the battery outside the monitor. WARNING: If the battery has not been in use three months or longer, charge the battery before use to a level of at least 80% charge. Battery capacity indicators are described in 3.3.3 Battery and Power Usage on page 63. 3.3.2. Battery Pack Removal and Installation Remove or install the battery pack as follows:

1. The device is shipped with a battery that is not fully charged. Before first use, charge the battery in the monitor until the battery indicator indicates that it is fully charged (as described in in 3.3.3 Battery and Power Usage on page 63). BIS Advance Monitor 61 Battery Operation To remove or switch the battery pack (#2 in Figure 14, below) , open the battery pack compartment of the monitor as follows:

Pushing the lower lock lever at the back of the tablet (#5 in Figure 14, below) towards the lower edge of the tablet. Note that this lock lever is indicated by locked and unlocked symbols above the lever. The lower lock will remain in the open position until moved again to the center of the tablet to close the lock. Push the upper lock (#3 in Figure 14, below) into the open position and hold it in this position while you perform the next step. With the lock open, pull the tab (#4 in Figure 14, below) to remove the battery pack. To put a battery pack in the tablet, place the bottom edge of the battery pack, which fits in the center of the back of the monitor into the battery connector pins (#1 in Figure 14, below), into position. Push the top of the battery pack into the battery compartment and the battery pack will click into place. Re-lock the battery compartment completely by moving the lower battery lock into the locked position, towards the center of the tablet; the locked position is marked by a lock icon on the tablet. Figure 14. Battery Assembly/Disassembly 3 4 5 BIS Advance Monitor 2. 3. 4. 5. 6. 7. 1 2 62 Battery Operation Label Function Description 1 2 3 4 5 Connector pins area Battery connector pins are located under this panel Battery pack Removable battery pack Upper Battery pack lock This lock must be held in the open position while removing the battery. Pull this tab out to remove the battery pack Tab to open battery pack Lower Battery pack lock Slide this lock to the open position; it will remain in the open position until moved again to the center of the tablet to close the lock. WARNING: Only the battery pack provided with this monitor should be used for the monitor. Do not use another battery or a refurbished battery. Use of another battery or a refurbished battery may cause damage to the monitor or endanger the user. Reference Table 32. BIS Advance Accessories on page 250 regarding the battery pack. Caution: There should always be a battery installed in the device. If the battery is not installed, the module will operate properly on AC power, but if AC power is lost for any reason, the monitor will cease to function. Note: The battery pack supplied with this monitor should not be used with other devices. The battery icons indicate the charge level of the batteries. Reference Table 5. Home Screen Indicators on page 114 for more details. 3.3.3. Battery and Power Usage If power is lost when the monitor is operating from AC power, the monitor will automatically switch to the battery pack for power. If the battery pack is empty and the device is not connected to AC power, the device will shut down. BIS Advance Monitor 63 Mounting the Docking Station Therefore, ensure that a battery is always installed in the device, to ensure that the monitor maintains power and can continue to function when disconnected from an AC power source. A low priority battery alarm (BATTERY LOW) will be triggered when the battery reaches a level below 30% state of charge (state of charge is current capacity/maximum capacity) and the battery is not charging (that is, if the monitor is not connected with a cable to AC power or charging is faulty). A medium priority battery alarm (BATTERY IS CRITICALLY LOW) will be triggered when the change level falls to a critical charge level. In both cases, attach the device to AC power to begin charging or replace the battery. For the critical alarm, do so immediately to avoid a loss in coverage. Battery change status is indicated by the indicators described in Table 5. Home Screen Indicators on page 114. The battery will charge when the monitor is attached to AC power, either directly through a power cable from the monitor to AC power, or through a power cable from the docking station to AC power, when the monitor is docked in the docking station. Charging time is up to 8 hours when the tablet is powered on, and up to 4 hours when the tablet is powered off. The monitors battery indicators are shown in Table 5. Home Screen Indicators on page 114. For additional battery specifications, reference 7.6.4 Battery Specifications on page 231. 3.4. Mounting the Docking Station A number of mounting options are available for mounting the docking station. The caregiver should select the mounting option that best fits his desired location. For more information about selecting the most appropriate option, reference 7.6.2 Operating Environments on page 229. Before mounting the docking station, ensure that you have the following components ready:

Monitor with adapter cable connected, ready for placement in the docking station. The docking station may be mounted (on a GCX clamp mount or a 1. 64 BIS Advance Monitor Mounting the Docking Station GCX desktop mount) before or after you place the monitor in the docking station. GCX clamp mount or GCX desktop mount with required screws (screws are packaged with the mount) If desired, IV pole, anesthesia mount, or other hardware for mounting medical devices for use To set up the monitor with the GCX clamp mount:

Place the docking station on a stable surface. If your docking station has four round black supports attached to its back

(to the four screw holes seen in Figure 15. Setup with GCX Clamp Mount on page 66), remove these supports and set them aside in case you need them in the future for other mounting solutions. Locate the four screws supplied with the GCX clamp mount. Using a standard screwdriver, attach the GCX clamp mount to the back of the docking station using these four screws, by inserting the screws through the four holes in the GCX clamp mount and into the four screw holes on the back of the docking station (from which the four supports were removed). Reference Figure 15. Setup with GCX Clamp Mount, below. Once the GCX clamp mount and the docking station are firmly attached, mount the GCX clamp mount to an IV pole, anesthesia mount or other hardware, following the instructions supplied with that hardware. The monitor can now be placed in the docking station and attached to a BISx module and sensor to begin monitoring. 2. 3. 1. 2. 3. 4. 5. BIS Advance Monitor 65 Mounting the Docking Station Figure 15. Setup with GCX Clamp Mount 1 2 3 1 2 3 1. 2. 66 Label Description Docking station Clamp mount Screw holes for attaching clamp mount to docking station To set up the monitor with the GCX desktop mount:

Stand the GCX desktop mount on a stable surface. Prepare the docking station. If your docking station has four round black supports attached to its back (to the four screw holes seen in Figure 16. Setup with GCX Desktop Mount on page 67), remove these supports and set BIS Advance Monitor them aside in case you need them in the future for other mounting solutions. Mounting the Docking Station 3. 4. 5. Locate the four screws supplied with the desktop mount. Using a standard screwdriver, attach the GCX desktop mount to the back of the docking station using these four screws, by inserting the screws through the four holes or indentations in the desktop mount and into the four screwholes on the back of the docking station (from which the four supports were removed). Reference Figure 16. Setup with GCX Desktop Mount on page 67. Once the GCX desktop mount and the docking station are firmly attached, place the GCX desktop mount on the work surface. The monitor can now be placed in the docking station and attached to a BISx module and sensor to begin monitoring. Figure 16. Setup with GCX Desktop Mount 1 2 3 Label Description 1 2 3 BIS Advance Monitor Screw holes for attaching desktop mount to docking station Docking station Desktop mount 67 Preparing the Docking Station 3.5. Preparing the Docking Station Follow the instructions below to place the monitor in the docking station:

1. Place the monitor in the docking station so that the connectors on the monitors bottom edge fit into the connectors in the groove at the inside of the bottom of the docking station (#3 in Figure 17). Reference Figure 17. Docking Station Installation Step 1 on page 68. Figure 17. Docking Station Installation Step 1 1 2 3 4 Number Description Monitor Docking station 1 2 68 BIS Advance Monitor 3 4 2. 1 2 3 3. Preparing the Docking Station Connector pins in docking station groove Docking station groove to hold monitor Push the top edge of the monitor inwards to fit it into the docking station. Reference Figure 18. Docking Station Installation Step 2 on page 69. Figure 18. Docking Station Installation Step 2 1 2 3 69 Number Description Top edge clasp Monitor Docking station The top edge clasp will now click into place and hold the monitor in place inside the docking station. BIS Advance Monitor Preparing the Docking Station 4. 5. If required, use the four supports connected to the back of the docking station to attach the docking station to the required mounting solution. For more information, reference 3.4 Mounting the Docking Station on page 64. Attach the power supply connector to the power port on the docking station and to mains AC power. Attach your selected communications cable to provide communication with the docking station. Options include an RS-232 cable, a network cable, a VGA cable, and a USB flash drive. The docking station connectors are located at the bottom of the docking station. The docking station connectors are seen in Figure 11. BIS Advance Docking Station Connectors on page 54. WARNING: Use only the power cord and power supply supplied by the manufacturer. Never adapt the plug from the monitor to fit a non-standard outlet. Once the docking station is connected as required and the BIS Advance Monitor is placed into the docking station, the monitor will receive both power and communication via the docking station. To position the docking station for use after placing the monitor in the docking station and connecting as required, mount the docking station using your selected mounting accessory, as described in 3.4 Mounting the Docking Station on page 64. The available accessories are listed in Table 34. BIS Advance Accessories on page 252. To remove the monitor from the docking station, push top edge clasp lever at the top of the docking station (as seen in Figure 19. Docking Station Removal on page 71);

this will release the connectors. Grasping the monitor from its top edge, pull it towards you and up to remove the monitor from the docking station. 70 BIS Advance Monitor Figure 19. Docking Station Removal Preparing the Monitor 1 2 3 1 2 3 Number Description Top edge clasp Monitor Docking station 3.6. Preparing the Monitor Follow the steps described below to prepare the monitor for use. 3.6.1. Connecting the Monitor Ensure that you have all of the required components, as described in 2.1 The BIS Advance System on page 40. BIS Advance Monitor 71 Preparing the Monitor The adapter cable should already be connected to the monitor, as described in 2.2.2 Adapter Cable on page 48. If you want to mount the docking station, do so now. Follow the instructions in 3.4 Mounting the Docking Station on page 64. Connect the docking station and the monitor as described in 3.5 Preparing the Docking Station on page 68. The BIS Advance monitor may be used without the docking station, but use of the docking station with an appropriate mount is strongly suggested in order to suit the device to the requirements of the monitoring environment. If you are required to use the monitor without the docking station, a power cable may be connected to the monitor at its right side; reference Figure 3. The BIS Monitor on page 44. Power on the device as described in 3.6.5 Start Procedure on page 87. Connect the BISx or BISx4 module to the monitor, as follows:

Locate the monitor end of the MIC, which is an integral part of the BISx module. Connect the monitor end of the MIC to the adapter cable which is connected to the BIS Advance monitor. Once connected, the BISx module need not be disconnected again. If you wish to disconnect the BISx cable from the monitor, carefully grasp the BISx module connector, push the button on the BISx module MIC connector (#3 in Figure 20, below), and pull the adapter cable connector and the BISx module connector apart. DO NOT pull on the cable. 1. 2. 3. 72 BIS Advance Monitor Figure 20. Attaching the BISx Module to the BIS Advance Monitor Preparing the Monitor 1 2 3 4 5 1 2 3 4 5 Label Description Monitor Adapter cable BISx module BIS Advance Monitor MIC push button (used to disconnect MIC and adapter cable) MIC (monitor interface cable, an integral part of the BISx module) If the BIS Advance initialization is completed before the BISx or BISx4 module is connected, an on-screen message will indicate Connect BISx to start monitoring. Connect the BISx or BISx4 module, and an on-screen message will indicate Initializing BISx. 73 Preparing the Monitor If the BISx or BISx4 module is connected but no sensor is connected, an on-screen message will indicate Connect sensor to start monitoring. Ensure that you are using a BISx module or a BISx4 module with a Quatro, Extend or Pediatric sensor to conduct two-channel monitoring, or a BISx4 module with a Bilateral sensor to conduct four-channel monitoring. Connect the appropriate sensor (reference Figure 21. Connecting the sensor to the BISx module, below) to the PIC on the BISx module to begin sensor initialization. To insert the sensor into the PIC, line up as shown and insert the sensor tab into the PIC sensor connector without pausing, until an audible click is heard. The blank side of the sensor tab (i.e. the side without the visible computer chip) should be facing up. Reference Figure 21. Connecting the sensor to the BISx module, below. Figure 21. Connecting the sensor to the BISx module 1 2 Label Description PIC (patient interface cable, connected to BISx module) connector Sensor connector To disconnect a sensor from the BISx module, grasp the sensor and the PIC (patient interface cable) which is attached to the BISx module. Press the button on the PIC as seen in Figure 22. Disconnecting the sensor from the BISx module on page 75, and, while pressing the button, pull apart the two connectors. 1 2 74 BIS Advance Monitor Figure 22. Disconnecting the sensor from the BISx module Preparing the Monitor 1 2 Label Description 1 2 PIC (patient interface cable, connected to BISx module) connector Sensor connector To begin monitoring, connect the sensor to the patient; reference 3.6.2 Connecting a Sensor to a Patient, below. When the system identifies that a sensor has been connected to the BISx module, the system will perform Sensor Initialization to check that the sensor is supported and that impedance values are in the acceptable range. BIS Advance Monitor 75 Preparing the Monitor The automatic sensor check is described in 3.6.3 Sensor Check on page 82. The BIS Advance monitor setup should now appear as seen in Figure 23. BIS Advance Monitor Setup and Figure 24. BIS Advance Monitor Setup - Back, both below. Figure 23. BIS Advance Monitor Setup 7 1 2 6 3 4 5 Label Description Docking station Monitor Adapter cable BISx module 1 2 3 4 5 76 MIC (monitor interface cable, an integral part of BISx module) BIS Advance Monitor Preparing the Monitor Label Description PIC (patient interface cable, attached to BISx module) BIS sensor Figure 24. BIS Advance Monitor Setup - Back 2 7 1 6 3 5 6 7 BIS Advance Monitor 4 8 77 Preparing the Monitor Number Description 1 2 3 4 5 6 7 8 78 Sensor PIC BISx module MIC Adapter cable Monitor Docking station GCX mounting accessory (the selected accessory will depend on the use case) 3.6.2. Connecting a Sensor to a Patient Select the appropriate sensor. A list of sensors appears in Table 34. BIS Advance Accessories on page 252. It is important to use the correct sensor for your current patient and monitoring situation, as follows:

Table 4. Sensor/BISx/Use Case Matrix Sensor BISx module Monitoring Type Quatro, Extend or Pediatric sensor BISx module or a BISx4 module Bilateral sensor BISx4 module Two-channel monitoring

(in one hemisphere of the brain) Four-channel monitoring

(in both hemispheres of the brain). BIS Advance Monitor Preparing the Monitor Before applying the sensor to the patient, view the sensor application animation video. To open the video, click Sensor Application Guide on the Connect sensor to begin monitoring screen. Apply the sensor to the patient as described in the video. Please note that this video, the instructions, and the sketch below describe applying the sensor to the left side of the patients head; the sensor may also be applied to the right side of the patients head. To apply to the right side of the patients head, follow the instructions below, starting to apply the sensor from the middle of the patients forehead, and following the instructions in reverse, applying the sensor towards the right side of the patients face. Note the sequence of the application of the sensor the patients forehead, as follows:

1. 2. 3. 4. 5. Clean the patients forehead with a disinfectant wipe. Hold the sensor over the patients forehead to ascertain where to place the sensor. Note that the section labeled with a target circle and the number 1 should be placed on the forehead directly above the bridge of the nose, and the other sections of the sensor should be located in succession towards the left side of the patients face, so that the last section of the sensor, labeled with a target circle and the number 4, will be placed on the left side of the patients face at the level of his eye. See the sketch below.

(For the pediatric sensor, the sections of the sensor are marked by numbered sketches rather than by circles.) If preferred, the sensor may be placed on the right side of the patients forehead, by simply following these instructions in reverse. Each sensor section contains both adhesive (in the ring of the target circle) and conductive gel (in the center of the target circle). For each section of the sensor, place it in its proper position on the patients forehead and press the white ring around the target circle to seal the adhesive to the skin. Repeat with each section of the sensor. Once the adhesive portion of all of the sensors sections has been firmly adhered to the patients forehead, press the center of each target circle and hold for 5 seconds to push the conducting gel into position. For a 4-channel system using a Bilateral sensor, position the sections of the sensor on the patients face as seen on the sensor packaging, with the target circle marked with the letter C above the bridge of the patients nose, and seal the adhesive and push the conductive gel into position for each section of the sensor as described above. BIS Advance Monitor 79 Preparing the Monitor 6. Sketches displaying sensor placement for both two-channel monitoring and four-channel monitoring appear below. Figure 25. Sensor Positioning for Two-channel Sensor 1 2 3 4 Label Function Description Electrode 1 Place lined up to bridge of nose Electrode 2 Place as seen in sketch Electrode 3 Place as seen in sketch Electrode 4 Place aligned with left eye (or right eye, if placing the sensor on the right side of the patients forehead) 1 2 3 4 80 BIS Advance Monitor Figure 26. Sensor Positioning for Four-channel Sensor Preparing the Monitor 4 1 2 3 5 6 Label Function Description Electrode C Place lined up to bridge of nose Electrode RE Place above right eyebrow Electrode RT Place aligned with right eye Electrode G Place as seen in sketch Electrode LE Place above left eyebrow Electrode LT Place aligned with left eye 1 2 3 4 5 6 BIS Advance Monitor 81 Preparing the Monitor 3.6.3. Sensor Check Ensure that the BISx or BISx4 module is connected to the monitor, as described in 3.6.1 Connecting the Monitor on page 71. Attach the selected sensor to the BISx or BISx4 module. Please note that the sensors are consumable products with a defined lifetime and expiry date. An expired sensor or a sensor that has been used beyond its defined lifetime may pass the sensor check (depending on various use parameters), but it is strongly recommended to avoid use of expired sensors and replace sensors after 24 hours. Use of expired or over-used sensors may cause degraded performance. Connect the sensor to the patient as described in 3.6.2 Connecting a Sensor to a Patient on page 78. The device will begin an automatic sensor check when a sensor is connected to the BISx module. The sensor check process tests impedance at each sensor section; it is designed to assess the functionality of the sensor and the quality of the contact (to the patient) and connection (to the monitor) of the sensor, to determine whether the sensor can be used in patient monitoring. The sensor check will then begin. Reference Figure 27. Sensor Check Window: In progress and Completed on page 85 for the appearance of the sensor check window. The auto sensor check process, during which the system checks that the sensor is connected properly to the patient, takes a few seconds. The system provides an indication for this process: Sensor check in progress. The automatic sensor check will detect any sensor problems. The sensor check window will show the status of the sensor check. If Display Sensor Check Values is selected (at the top left of the window) the impendence value of each electrode will be displayed. (For more information, reference 3.15.3.4 Sensor Check Values on page 134.) If it is not selected, PASS, NOISE, HIGH or POOR CONTACT labels for each electrode will be displayed. The sensor check window will indicate Sensor check completed successfully and then automatically close. If the sensor check result is PASS (whether the sensor check was manual or automatic), the system shall exit the manual sensor check mode and begin monitoring. If the sensor check does not pass the test, i.e., at least one of the electrodes is not within the defined impedance range, the sensor check results will display the resulting icons and/or values, and you will not be able to begin monitoring with that sensor. 82 BIS Advance Monitor The system will display the sensor check test result for each electrode as follows:

Preparing the Monitor Result Icon Description Value color in sensor check screen Green PASS HIGH Red NOISE Gray POOR CONTACT Red BIS Advance Monitor An electrode PASSES the sensor check if the impedance for that electrode is less than 7.5 kiloohms. The ground electrode (electrode 2 for a two-channel sensor and electrode G for a four-

channel sensor) must be less than 30 kiloohms to pass. An electrode is labeled HIGH if its impedance value is above 7.5 kiloohms

(30 kiloohms for the ground electrode). If the sensor check displays this result for a particular electrode, pushing the electrode to create better contact between the electrode and the patients skin may help the electrode pass the sensor check. If the signal from the electrode goes beyond the measurable range, NOISE will be displayed. This notification may appear if pressing sensor during check or in the presence of large external stimulus. If the impedance check indicates that the electrode is not in contact with the patient, the sensor check will indicate that that electrode is in POOR CONTACT. If the sensor check displays this result for a particular electrode, pushing the electrode to create better contact between the electrode and the 83 Preparing the Monitor patients skin may help the electrode pass the sensor check. The sensor check will determine if the sensor will pass the sensor check based on the impedance of the electrodes and the ground electrode. If the sensor passes the sensor check, monitoring will begin automatically. If the sensor fails, monitoring will not begin. If the sensor does not pass the sensor check process, check the functionality of the PIC cable by running a sensor check using a Sensor Simulator. If the sensor check does not pass with the Sensor Simulator, replace the PIC or the BISx module. If the sensor check passes with the Sensor Simulator, replace the sensor with a new appropriate sensor. That sensor will then undergo an automatic sensor check upon attachment. If it passes the sensor check, monitoring will commence. For the 2-channel system, the electrodes will be labeled as follows, starting from the left-most electrode when viewing the sensor from the front: 1,2,4,3. For the 4-channel system, the electrodes shall be labeled as follows, starting from the left-most electrode when viewing the sensor from the front: LT, LE, G, C, RE, RT. The user can determine if he wants to display the sensor check values or just a PASS, HIGH, NOISE or POOR CONTACT indicator. By default, Display Sensor Check Values is disabled, so PASS, HIGH, NOISE or POOR CONTACT will appear for each sensor section. To enable sensor check values, reference 3.15.3.4 Sensor Check Values on page 134. If the sensor is supported and impedance values are in the acceptable range, the system shall display patient data based on the information collected by the sensor. If there are issues that prevent the system from reading information from this sensor, an on-screen message will display this information. 84 BIS Advance Monitor Figure 27. Sensor Check Window: In progress and Completed Preparing the Monitor Manual Sensor Check The user can start a sensor check manually when a sensor is already connected to the monitor, if desired, perhaps because the user is actively monitoring a patient, but no BIS value is displayed, or if the clinician suspects that the BIS value does not align with the clinical assessment of the patient. This option is available only when a BISx module and a sensor are connected to the monitor or when the monitor is in DEMO mode. (In the latter case, this is just for demonstration purposes.) Click the Sensor Check button in the left bar menu (on the left side of the screen) to begin a sensor check. The sensor check will proceed as described in 3.6.3 Sensor Check on page 82. As with the automatic sensor check, if the sensor passes the sensor check, monitoring will begin automatically. If the sensor fails, monitoring will not begin, and the sensor should be replaced. An on-screen message will display this information. BIS Advance Monitor 85 Preparing the Monitor Ground Check and Combined Sensor Check The monitor automatically performs a ground check every ten minutes during monitoring, to ensure that the sensor is positioned correctly on the patient. During the ground check (duration approximately 5 seconds), EEG values will not be collected, but the BIS value will continue to be displayed. If the results of the ground check indicate a problem with the sensor, an on-screen message will display this information; if there is no issue, monitoring will resume automatically. Combined sensor check mode is the performance of ground check and sensor check at the same time. The monitor automatically performs this combined check during monitoring. If the results of the ground check indicate a problem with a specific electrode on the sensor, an on-screen message will display this information (so that this can be corrected, perhaps by adhering that sensor section better to the patient);

if there is no issue, monitoring will resume automatically. 3.6.4. Case ID A unique Case ID will be generated automatically by the BISx module when a sensor is attached to the system and passes the sensor check. To view the current Case ID, click on the ID icon or the small arrow to its right; it appears just to the right of the time on the upper right side of the screen. The ID window will open, displaying the Case ID. If required, record the Case ID in your institutional records. This window will automatically close in one minute. In Figure 28. Case ID Indicator on Home Screen, below, the ID window is seen next the ID icon. If there is no sensor connected to the BIS system, no Case ID is assigned and the ID window is disabled and cannot be viewed. If a sensor is attached to the system, and then detached and re-attached, the monitor will automatically resume the case with the same Case ID. Figure 28. Case ID Indicator on Home Screen 86 BIS Advance Monitor Preparing the Monitor 3.6.5. Start Procedure To start the monitor, press and hold the ON/OFF button at the lower right side of the monitor for up to 3 seconds. The system will indicate that it is initializing. If no BISx module is connected to the monitor, the monitor will indicate Connect BISx to start monitoring. In this case, the operator can enter Demo mode or review recorded case data in Case Review mode. Monitoring cannot take place without a BISx module. If a BISx module is connected without a sensor, the system will indicate Connect sensor to start monitoring. In a case where the system identifies that a BISx module and a sensor have been connected, the system shall perform sensor initialization and a sensor check. If the sensor is supported (reference Table 33. BIS Advance Monitor Components and Sensors on page 252) and impedance values are in the acceptable range, the system shall display patient data based on the information collected by the sensor. If there are issues that prevent the system from reading information from this sensor, an on-

screen message will display this information. Monitoring will now commence. After the sensor has been connected, make any desired changes in settings, such as setting alarm limits. Reference 4.3.7 Changing Alarms Settings on page 168 for alarm settings or 3.15 Settings and Maintenance on page 128 for other settings. The settings set when a sensor is connected will remain valid for that sensor (i.e., that case), but the system will revert to institutional defaults when another sensor is connected and another case starts. 3.6.6. Terminating Monitoring with the Monitor In most use case scenarios, the caregiver will terminate monitoring with the BIS system when BIS monitoring is no longer needed for the patient, as the patient starts to awaken. If the patient is no longer sedated, the parameters will indicate that status. To end the case and terminate monitoring, remove the sensor from the patient and disconnect the sensor from the monitor. Record the Case ID and download any relevant patient data (reference 5.4 Types of Exported Data on page 188) to ensure that your documentation is complete. Press the ON/OFF button at the front of the monitor. (Reference Figure 3. The BIS Monitor on page 44 for the location of this button.) If you press the button for 1.5 seconds, a dialog box will ask if you want to shut down, restart or cancel the action. BIS Advance Monitor 87 Home Screen Click Shutdown to shut down the monitor. If you press the ON/OFF button for 4 seconds, the monitor will shut down without requiring a response in the dialog box. 3.7. Home Screen The BIS standard graphical home screen includes four main screen sections, as follows:

1. 2. 3. 4. 88 Trend Section: The screen may display one trend that covers most of the screen, or display two or three trends on the screen at the same time. For the two-channel system, the default display is a two-trend display in which the upper trend section will display the BIS trend, and the lower trend section will display the EEG waveforms. Selection of other options for this section can be done via Main Menu>Display Settings>Select desired trend>Apply>close window. Reference 3.12 Home Screen Options on page 121 for more information. The trend section is generally viewed in graph format as described in 3.9 Home Screen Trend Graphs on page 96 . The trend section of the screen may also be viewed in chart format; for more information, reference 4.4 Chart Data on page 173. Numeric section: The numeric section, which always appears at the right side of the screen, will differ based on the type of monitoring taking place;

the display will appear as seen in Figure 29. Sample 2-channel BIS Screen on page 90 for 2-channel monitoring, and will appear as seen in Figure 30. Sample 4-channel BIS Screen on page 94 for 4-channel monitoring. This section will show real-time BIS parameters, indicating parameter name, number and alarm range numbers (alarm range will be seen only if an alarm has been set) for each parameter. For two-channel monitoring, the values shown will be BIS, SQI, EMG, SR, ST, SEF and MF, as well as BURST count if using an Extend sensor. For 4-channel monitoring, BIS, SQI, EMG, SR, ST, SEF, MF, BURST count and ASYM data will also be shown. For more information about these values and their meaning, reference 1.10 The BIS Advance Parameters on page 29. Title/top bar section: The title/top bar section will indicate the date and time, the Case ID, and alarm and connections status. Reference 3.14 Home Screen Audio Alarm Settings on page 126 and 3.10.9 Home Screen Indicators and Messages on page 114 for more information about alarms and connections indicators. Bottom message bar: The bottom message bar will show one or more messages initiated by user activity and or displayed by the system. If there BIS Advance Monitor Home Screen is more than one message, they will appear in succession, and a message count will appear at the right side of the message bar. To view the next message more quickly, click the NEXT button on the right side of the message bar. For a list of messages that may appear in this section of the screen, reference Table 13. Information Messages on page 153. BIS Advance Monitor 89 Home Screen Figure 29. Sample 2-channel BIS Screen 6 7 8 9 0 1 4 1 1 5 4 3 2 1 90 2 1 3 1 4 1 BIS Advance Monitor Label Function Description Home Screen 1 2 3 4 5 6 7 8 9 10 11 12 13 Left menu bar Reference 3.11.2 Left Bar Menu on page 118 BIS graph Reference 3.9.1 BIS Trend Graph on page 96 Audio alarm indicators area Reference 3.14 Home Screen Audio Alarm Settings on page 126 Case ID information Reference 4.2 Cases on page 138 Indicators area Reference 3.10.9 Home Screen Indicators and Messages on page 114 EMG numeric Reference 3.10.2 EMG on page 107 SQI indicator BIS numeric SR numeric ST numeric Reference 3.10.3 SQI (Signal Quality Indicator) on page 108 Reference 3.10.1 BIS Number on page 106 Reference 3.10.5 SR (Suppression Ratio) on page 110 Reference 3.10.6 ST (Suppression Time) on page 111 MF numeric Reference 3.10.8 MF on page 113 SEF numeric Reference 3.10.7 SEF on page 112 EEG graph Reference 3.9.3 EEG on page 98 14 Message bar Reference 4.3.3 Messages on page 152 Not seen Burst count (not seen;

appears only when Reference 3.10.4 Burst Count on page 109 BIS Advance Monitor 91 Four-Channel Monitoring Label Function Description using an Extend sensor or monitoring with four-channel monitoring) 3.8. Four-Channel Monitoring The monitor provides the option of monitoring both hemispheres of the brain, using a Bilateral sensor. This is known as four-channel or bilateral monitoring. The option may provide useful information to the clinician. The bilateral system consists of the BIS Advance monitor, the BISx4 module, the PIC-

4 (which is an integral part of the BISx4 module) and a BIS Bilateral Sensor. This section describes the additional features and options available when performing four-channel monitoring. During four-channel monitoring, the BIS Advance monitor acquires four channels of EEG data, calculates BIS numbers and other variables for the left and right sides of the brain, and reports them to the monitor for display. The user selects which side of the brain is shown most prominently on the screen. The designation L (left) or R (right) denotes which side of the brain is displayed. In addition, data from the left side of the brain display in pink, while data from the right side display in blue. BIS is calculated the same way as for the two-channel sensors

(e.g. Quatro), using two EEG channels from the left side of the brain for BIS L and two EEG channels from the right side for BIS R. If a Bilateral sensor and a BISx4 module are connected to the monitor, the monitor will detect the sensor and automatically move to four-channel monitoring mode. The four-channel (bilateral) screen (reference Figure 30. Sample 4-channel BIS Screen on page 94) will provide information on both hemispheres of the brain, as follows:

) enabling the selection of the hemisphere which will be A L/R button (

displayed more prominently will appear on the upper left side of the screen under the menu button. Some data will appear for both hemispheres no matter which hemisphere is selected with this button, while other information will appear only for the selected hemisphere. By default, the left hemisphere is selected for more prominent display. 92 BIS Advance Monitor Four-Channel Monitoring The BIS graph will display the left hemisphere by default; if the right hemisphere is selected with the L/R button, it will display the right hemisphere. If selected, the ASYM graph will display the left side at the top of the graph and the right side at the bottom of the graph. The EEG graph will display the left side at the top of the graph and the right side at the bottom of the graph. The upper numeric panel (BIS, EMG, SR and ST) will display data from the left hemisphere. The middle numeric panel (BIS, EMG, SR and ST) will display data from the right hemisphere. The lower numeric panel (SEF and MF) will display left or right hemisphere data, depending on the selection of hemisphere in the L/R button at the top left side of the screen (under the main menu button). Note the L and R indicators in the numeric panel next to the numeric values, indicating the hemisphere to which these values refer. BIS Advance Monitor 93 Four-Channel Monitoring Figure 30. Sample 4-channel BIS Screen 6 7 8 9 5 4 3 2 1 94 0 1 1 1 2 1 BIS Advance Monitor Label Function Description Four-Channel Monitoring Left menu bar Reference 3.11.2 Left Bar Menu on page 118. Note the L/R icon at the top of the menu bar, just under the Main Menu icon. BIS graph Reference 3.9.1 BIS Trend Graph on page 96 Audio alarm indicators area Reference 3.14 Home Screen Audio Alarm Settings on page 126 Case ID information Reference 4.2 Cases on page 138 Indicators area Reference 3.10.9 Home Screen Indicators and Messages on page 114 Hemisphere indicator L hemisphere indicator, indicating that the data in this section is derived from the left hemisphere Upper numeric panel BIS, EMG, SR and ST data from the left hemisphere. Note L hemisphere indicator. Middle numeric panel BIS, EMG, SR and ST data from the right hemisphere. Note R hemisphere indicator. Lower numeric panel SEF and MF data from left or right hemisphere (depending on user selection). Note L hemisphere indicator. EEG graph Reference 3.9.3 EEG on page 98 ASYM graph Reference 3.9.5 ASYM Graph on page 102 Message bar Reference 4.3.3 Messages on page 152 1 2 3 4 5 6 7 8 9 10 11 12 BIS Advance Monitor 95 Home Screen Trend Graphs 3.9. Home Screen Trend Graphs 3.9.1. BIS Trend Graph The BIS trend graph is provided as a default graph on the monitor main screen, both in the 2-channel and 4-channel systems. This graph enables the user to view changes in the BIS value for the patient over time, which is useful in patient monitoring. This information provides added value for the caregiver, beyond the BIS number that appears on right side of the screen. Figure 31. BIS Trend Graph 2 1 3 4 5 6 1 2 3 96 7 8 9 10 Label Function Description BIS scale Left side vertical Y axis showing BIS scale, from 0 to 100 BIS SET RANGE selection arrow Selection arrow to select BIS alarm limit range (will open the same window as the ALARMS>BIS selection opens) BIS trend line BIS value at each point of time on the graph BIS Advance Monitor Label Function Description Home Screen Trend Graphs 4 5 6 7 8 9 10 Secondary variable drop-down arrow Selection drop-down arrow to select secondary variable to appear on BIS graph

(will open the same window as the Display Settings>BIS graphs>

Secondary section opens); see description below Secondary variable scale Right side vertical Y axis indicating the scale of the secondary variable, in this case EMG in orange Display time scale selection Indication of time scale in current use and drop-down arrow for selection of scale;

options are 1hr, 6hr, 12hr, and 24hr. When the time scale is changed, this affects all graphs on the screen (for example, BIS, DSA and ASYM). The EEG display is not affected by a time scale change. Monitoring start indicator Indicator showing the time of monitoring start Secondary variable trend line Secondary trend value at each point of time on the graph (will be seen if a secondary value is selected). This graph shows the EMG trend line in orange. Time scale Horizontal X axis showing time scale Current time cursor Small blue vertical line on the horizontal axis indicates the current time of monitoring 3.9.2. Secondary Variables One of the following secondary variables can be overlaid onto the BIS trend graph. When this is done, the BIS trend graph shows both the BIS trend and the secondary variable trend. The secondary variable options are:

BIS Advance Monitor 97 Home Screen Trend Graphs EMG Suppression ratio (SR) Signal quality (SQI) Burst count (for bilateral and Extend sensors only) (BURST) BIS number of the non-selected hemisphere (for 4-channel mode only) The user can also choose NONE for the secondary variable; in this case, no secondary variable will be shown on the BIS trend graph, and no secondary variable scale will be seen on the right Y axis of the graph. Reference Figure 48. Secondary Trend Selection on page 126. When a secondary variable is displayed on the BIS trend, the vertical Y axis scale for the secondary variable is displayed on the right side of the graph, while the BIS scale is displayed on the left side. The color of the secondary variable trend line on the graph and its vertical Y axis scale will match, and will differ from the BIS trend graph and scale color, to enhance clarity. To select a secondary variable, open the secondary variable drop-down menu that can be reached by the following methods:

Main Menu>Display Settings>select a trend display that includes the BIS graph>Secondary drop-down menu>select your preferred secondary variable>click APPLY. BIS trend graph on home screen>EMG (or currently selected secondary variable) drop-down menu>select your preferred secondary variable Any change made with either of these methods will be reflected in all BIS trend screens. For an example of a secondary variable on the BIS graph, reference 3.9.1 BIS Trend Graph on page 96. The EEG display is provided to enable the caregiver to view raw EEG data. 3.9.3. EEG Display 98 BIS Advance Monitor On the home screen, the user can select one of the following EEG scales: 2, 5, and 10

[V/mm]. When a 2 V/mm scale is used, only one EEG channel is seen on the graph;

with other scales, 2 channels are seen. Not all scales are available in all screen layouts. Home Screen Trend Graphs By default, the graphs default display will show EEG amplitude of up to 50 microVolt

(V); in full screen EEG layout (when only the EEG display is seen on the home screen) the display can show an EEG amplitude of up to 100 microVolt (V). The scale and amplitude can also be adjusted in the Settings and Maintenance>Settings>Advanced>EEG Trends section. Figure 32. EEG Display 1 2 3 4 1 2 3 Label Function Description 5 EEG scale Display of EEG scale in use on display Area of one second on trend graph EEG sweep speed indicator and drop-down arrow Indicates the width of 1 second of data on the displayed graph Indicator of current EEG sweep speed and selection arrow to select BIS Advance Monitor 99 Home Screen Trend Graphs Label Function Description 4 5 Y axis Y axis showing the EEG amplitude EEG trend line/s One EEG trend line is seen if scale is 2V/mm;

with other scales, one graph will be displayed for each channel 3.9.4. DSA Display To display DSA on the home screen, select a display option that includes DSA as described in 3.12 Home Screen Options on page 121. The DSA reflects the EEG as a function of frequency (in Hz, on the Y vertical axis), time

(on the X horizontal axis), and power (indicated by color). Blue shading indicates low EEG power and red shading indicates high EEG power. The color guide at the top of the DSA graph provides detailed shading information. Power indicates the strength of a particular frequency in the EEG signal, so, for example, if the DSA graph shows red shading at a specific frequency, say at the Delta wave frequency, it would mean that the EEG signal is largely composed of Delta waves at those points that show red (that is, high power) shading. The frequency range (bandwidth) indicated by the DSA graph on the Y axis is 0.5 - 30 Hz, with each vertical line corresponding to frequencies for Delta (0.5-4Hz), Theta (4-

8Hz), Alpha (8-13Hz) and Beta (13-30 Hz) waves respectively. For the 4-channel system, the graph is shown for each brain hemisphere. The DSA graph also displays the MF and SEF trend lines:

MF is the line under which 50% of the EEG power lies. This information helps identify the frequency of the EEG signal. SEF is the line under which 95% of the EEG power lies. This information helps identify the dominant frequency/s of the EEG signal. In four-channel monitoring, a DSA graph is displayed for each hemisphere. 100 BIS Advance Monitor Figure 33. DSA Trend Display 1 2 Home Screen Trend Graphs 3 1 2 3 4 4 5 6 7 8 Label Function Description 7 Y vertical axis -

frequency The vertical axis indicates the frequency of the EEG signal in Hz. Power legend Legend explaining the colors demonstrating the level of power; blue indicates lower power and red lighter power. Spectral Edge Frequency (SEF) The white line on the graph indicates the SEF, the line under which 95% of the EEG power lies. Time scale drop-down menu Use the small arrow next to the time scale indicator to change the time scale of the graph. Options are 1 hours, 6 hours, 12 hours, and 24 hours. When the time scale is changed, this affects all graphs on the screen (for example, BIS, DSA and ASYM). BIS Advance Monitor 101 Home Screen Trend Graphs Label Function Description Case start indicator The EEG display is not affected by a time scale change. The small grey triangle on the horizontal axis time line indicates the case start, if the case start occurred during the period seen on the screen Median Frequency

(MF) The purple line on the graph indicates the MF, the line under which 50% of the EEG power lies. X horizontal axis - time The horizontal axis indicates the time at each point on of the DSA graph Current time indicator Small blue vertical line on the horizontal axis indicates the current time of monitoring 3.9.5. ASYM Graph To display ASYM on the home screen, select a display option that includes ASYM as described in 3.12 Home Screen Options on page 121. ASYM is the asymmetry between EEG power between the left and right hemispheres of the brain, over time. The value provided is calculated as EEG power present in the one hemisphere as compared to total (left and right) EEG power. ASYM is displayed on the graph as a value between 100 left and 100 right. Asymmetry data less than 20% are not displayed on the graph, but are available in the Chart Data screen. In a situation in which EEG power is equivalent in both hemispheres of the brain, ASYM = 0. A value with the indicator LEFT, for example, 70% LEFT, indicates that the left hemisphere has more power, and a value with the indicator RIGHT indicates that the right hemisphere has more power. In the graph, ASYM values are shown at each point in time. Thus, the ASYM value can appear either in the upper (left) part of the graph, indicating that most of the EEG power resides in the left hemisphere, or in the lower (right) part of the graph, indicating that most of the power resides in the right hemisphere. BIS Advance Monitor 5 6 7 8 102 Home Screen Trend Graphs ASYM is displayed only for four-channel monitoring. Two examples are show in Figure 34. ASYM Graph on page 103:

A value of 60 LEFT for ASYM at a certain point in time would mean that the EEG power in the left hemisphere is 60% higher than it is in the right hemisphere at that point in time. On the graph, it would be displayed as a peak at the line representing the level of 60 in the upper part of the graph;

the upper part of the graph is indicated by an L icon, representing the left side of the brain. A value of 32 RIGHT for ASYM (at a different point in time) would mean that the EEG power present in the right hemisphere is 32% higher than it is in the left hemisphere at that point in time. On the graph, it would be displayed as a trough at the line representing the level of 32 in the lower part of the graph; the lower part of the graph is indicated by a R icon, representing the right side of the brain. Figure 34. ASYM Graph 1 2 3 4 5 6 Label Function Description 1 Y vertical axis -

percent 9 8 7 The Y vertical axis indicates the power of the EEG signal, with lines indicating levels for power in each hemisphere. The ASYM value can appear either in the upper (left) part of the graph, indicating that most of the EEG power resides in the left hemisphere, or in the lower (right) part of the graph, indicating that most of the power resides in the right hemisphere. Indicates a point at which the EEG power in the left hemisphere is 60% higher than the EEG power in the right hemisphere 103 2 60 LEFT indicator BIS Advance Monitor Home Screen Numeric Section Time scale drop-down menu Use the small arrow next to the time scale indicator to change the time scale of the graph. Options are 1 hours, 6 hours, 12 hours, and 24 hours. When the time scale is changed, this affects all graphs on the screen (for example, BIS, DSA and ASYM). The EEG display is not affected by a time scale change. Case start indicator The small grey triangle on the horizontal axis indicates the case start (not seen on this screen) X horizontal axis - time The horizontal axis indicates the time at each point on the ASYM graph Current time indicator The small blue vertical line on the horizontal axis indicates the current time 60 RIGHT indicator Right hemisphere data Left hemisphere data Indicates a point at which the EEG power in the right hemisphere is 60% higher than the EEG power in the left hemisphere ASYM data for the right hemisphere. The waveform will appear in this section when the EEG power in the left hemisphere is at least 20% higher than the EEG power in the left hemisphere. ASYM data for the left hemisphere. The waveform will appear in this section when the EEG power in the left hemisphere is at least 20% higher than the EEG power in the right hemisphere. 3.10. Home Screen Numeric Section BIS Advance Monitor 3 4 5 6 7 8 9 104 The home screen numeric section, seen in Figure 35. Home Screen Numeric Section, below, displays the parameters listed in this section. Home Screen Numeric Section Figure 35. Home Screen Numeric Section 1 3 4 6 2 5 7 BIS Advance Monitor 105 Home Screen Numeric Section Label Function Description 1 2 3 4 5 6 7 106 SQI data Reference 3.10.3 SQI (Signal Quality Indicator) on page 108 EMG data Reference 3.10.2 EMG on page 107 BIS data SR data ST data SEF data MF data Reference 3.10.1 BIS Number on page 106 Reference 3.10.5 SR (Suppression Ratio) on page 110 Reference 3.10.6 ST (Suppression Time) on page 111 Reference 3.10.7 SEF on page 112 Reference 3.10.8 MF on page 113 8 (not seen) Burst Count data Not seen; only seen in use with an Extend sensor. Reference 3.10.4 Burst Count on page 109. The BIS number is a processed EEG value representing the depth of sedation. 3.10.1. BIS Number The current BIS number is displayed in the numeric section of the home screen, as one number for the 2 channel mode, and as two numbers, for the left and right hemispheres, for the 4-channel mode. The user may set a BIS range alarm, which sets the system to alarm if the patients BIS value falls below or exceeds the set range. For example, if the range is set at 40-

60, a BIS value of 35 or of 70 will trigger the BIS range alarm. To set this alarm, reference 4.3.7 Changing Alarms Settings on page 168. If the BIS target range alarm is enabled, the BIS target range will appear next to the numeric. If the alarm is disabled, the alarm disabled icon will appear instead of the target range. BIS Advance Monitor Home Screen Numeric Section If measuring with a 4-channel system, the BIS display will appear for each hemisphere. Figure 36. BIS Numeric 1 22 3 Label Function Description 1 2 3 BIS disabled icon If range alarm is disabled, the Alarm Disabled icon will be displayed BIS range Current BIS range; this will be displayed only if BIS range alarm has been enabled BIS numeric Current BIS value of patient 3.10.2. EMG EMG is displayed with three indicators: as a numerical value, as a bar (30-55 dB), and, if selected as a secondary trend on the BIS graph, as a trend (30-80 dB) in the form of a solid orange line. To view the EMG trend line, see 3.9.1 BIS Trend Graph on page 96. BIS Advance Monitor 107 Home Screen Numeric Section Figure 37. EMG Display on Home Screen 2 3 1 1 2 3 108 Label Function Description EMG numeric EMG numeric EMG bar Displays EMG in graphic format EMG units Units in which EMG is measured If measuring with a 4-channel system, the EEG display, including both the numeric and the bar, will appear for each hemisphere. 3.10.3. SQI (Signal Quality Indicator) SQI appears on the home screen on the main monitoring screen, as a graphical indicator, displayed as one SQI indicator for 2 channel mode, and as two SQI indicators, for the left and right hemispheres, for 4-channel mode. SQI is indicated in graphic format and can range from 0-100 percent. It can also be displayed as a solid green line on the BIS trend graph (0-1000 dB), if selected as a secondary trend on the BIS trend graph. BIS Advance Monitor Figure 38. SQI Indicator Home Screen Numeric Section A high SQI will be indicated by five complete green bars, as seen in the figure above. Lower values will be indicated by fewer green bars, two orange bars (denoting excessive artifacts in the EEG signal), or one red bar only (denoting a very low SQI value). If measuring with a 4-channel system, the SQI display will appear for each hemisphere. 3.10.4. Burst Count Burst count is displayed with two indicators: as a numerical value, and as a trend, if selected as a secondary trend on the BIS graph. Burst count is activated by connection of an Extend Sensor or Bilateral Sensor. Thus, the burst count will appear as a numeric and become available as an option for a secondary trend on the BIS graph only when an Extend or Bilateral sensor is used. If measuring with a 4-channel system, the Burst Count display will appear for each hemisphere. Figure 39. Burst Count Numeric 1 BIS Advance Monitor 2 109 1 2 110 Home Screen Numeric Section Label Function Description Burst Count numeric Burst Count numeric Burst units Units in which Burst Count is displayed 3.10.5. SR (Suppression Ratio) SR is displayed as a numeric in percent units, and, if selected as a secondary trend on the BIS trend graph, also as a solid purple line on the BIS trend graph (0-100%). If an SR alarm limit is set, the SR limit will be displayed as a dashed purple line on the BIS trend graph, and the SR limit will be displayed near the SR Label. The SR limit is an SR high limit; if SR surpasses the level set in the alarm limit, an alarm will be triggered. For 4-channel monitoring, two SR Numbers, for the left and right hemispheres, will be displayed. Figure 40. SR Display on Home Screen 1 2 3 4 BIS Advance Monitor Home Screen Numeric Section Label Function Description 1 2 3 4 SR alarm disabled indicator When the SR alarm is disabled, the alarm disabled icon will be displayed SR alarm level When the SR alarm is enabled, its level will be displayed SR numeric SR numeric SR units Units for SR (percent) 3.10.6. ST (Suppression Time) ST is displayed as a time value in units of seconds and minutes (or sec, min, hr if ST time exceeds 59 minutes and 59 seconds). The ST Number shall be displayed as a numeric on the home screen, with two ST Numbers displayed, for left and right hemispheres, for the 4-channel mode. The ST Number value will begin at 00:00 [MM:SS] at the start of each case and move to 0:00:00 [H:MM:SS] if the case exceeds 59:59. The maximum ST that can be displayed is 9:59:59. Figure 41. ST Display on Home Screen 1 BIS Advance Monitor 2 111 Home Screen Numeric Section Label Function Description 1 2 ST numeric ST numeric in minutes and seconds (and hours, if required) ST unit markers If ST is over 59 minutes and 59 seconds, an hour section will appear as well 3.10.7. SEF (Spectral Edge Frequency) SEF, the Spectral Edge Frequency (indicated in Hz) , is displayed as a numeric in the numeric section and as a white line on the DSA graph. If no SEF range is set, the alarm disabled icon will appear; if an SF range is set, the alarm range will appear and an alarm will be triggered if the SEF is too high or too low. For 4-channel mode, the Left SEF Number or Right SEF Number shall be displayed, according to the user's selection of the brain hemisphere side. Figure 42. SEF Display on Home Screen 1 2 112 3 4 BIS Advance Monitor Home Screen Numeric Section 1 2 3 4 Label Function Description Alarm disabled icon Since no alarm is set, an alarm disabled icon will appear SEF alarm range Alarm range will display when an alarm is set SEF numeric SEF numeric in Hz SEF units SEF unit is Hz 3.10.8. MF (Median Frequency) MF (Median Frequency) (indicated in Hz) represents the frequency below which 50%

of the total EEG power lies. It is displayed as a purple line on the DSA graph. The MF Number is displayed at the bottom of the numeric section of the home screen in 2-channel mode; for the 4-channel mode, the Left MF Number or Right MF Number shall be displayed at the bottom of the numeric section, according to the selected brain hemisphere. Figure 43. MF Numeric 1 BIS Advance Monitor 2 113 Home Screen Numeric Section Label Function Description 1 2 MF numeric MF numeric in Hz MF units MF unit is Hz 3.10.9. Home Screen Indicators and Messages The monitor provides a number of power and connectivity indicators on the top bar of the home screen, as described in Table 5. Home Screen Indicators, below. At the bottom of the home screen, monitor messages are displayed. If more than one message is active, the messages will appear consecutively, with an indicator on the icon and at the right that another message is also available. Both the top bar and the monitor messages can be seen in the home screens displayed in Figure 29. Sample 2-channel BIS Screen on page 90 and Figure 30. Sample 4-channel BIS Screen on page 94. Table 5. Home Screen Indicators Icon Description Icons on indicators bar at the top of the screen USB flash drive is connected 114 Monitor is connected to the docking station and communicating via the RS-232 (serial) port RS-232 (serial) port connection not identified by monitor; either tablet is not docked in the docking station, or tablet is docked in docking station but the monitor does not identify RS-232 port connection BIS Advance Monitor Home Screen Menus Power cable is connected Current battery capacity Battery is charging Battery is installed, but not charging; charge is over 50%

Battery is installed, but not charging; charge is 25%

to 50%

Battery is installed, but not charging; charge is under 25%

The monitor is currently recording a live case Icons on message bar at the bottom of the screen Message active (in this case, 2 messages are active) 3.11. Home Screen Menus 3.11.1. Main Menu Settings To access the main menu, click on the Main Menu icon at the top left side of the touch screen. BIS Advance Monitor 115 Home Screen Menus Figure 44. Main Menu Icon The main menu will open a drop-down menu, with options as described in Table 6. Main Menu Selections, below. Using the touch screen, select the desired sub-menu. Table 6. Main Menu Selections Menu Button Description ALARMS DISPLAY SETTINGS SETTINGS & MAINTENANCE DOWNLOAD Set alarm settings, including alarm enabling and disabling, alarm limits, alarm volume, and audio off reminder. For a description of alarms options, reference 4.3.7 Changing Alarms Settings on page 168. Select desired display setting; reference 3.15.3.5 Display Settings on page 134 for more information. Set various settings and maintenance options;

for a full list of options, reference 3.15 Settings and Maintenance on page 128. Download using Live Case recording, Monitor Saved Cases, or BISx Saved Cases download options. Download options are described in 5 Data Storage, Transfer, and Export on page 186. Permits opening of Demo Mode and describes various BIS parameters. For more information, reference 3.16 Info Options on page 135. INFO 116 CASE REVIEW Permits Case Review; for more information, reference 4.2.2 Case Review on page 139. BIS Advance Monitor Figure 45. Main Menu on Home Screen Home Screen Menus If no sensor is connected to the BISx module connected to the monitor, or if no BISx module is connected, all of these options are available. In monitoring mode, that is, when a BISx module and a sensor are attached to the system, the Alarms and Case Review sub-menus are disabled. In Demo Mode, the Download and Case Review sub-menus are disabled. BIS Advance Monitor 117 Home Screen Menus 3.11.2. Left Bar Menu The left menu bar provides quick access to some important features directly from the home screen. It includes the options listed in Table 7. Home Screen Left Menu Bar Icons, below:

Figure 46. Left Bar Menu 1 3 5 2 4 6 118 BIS Advance Monitor Table 7. Home Screen Left Menu Bar Icons Label Function Description Home Screen Menus 1 2 3 4 5 6 7 Main Menu button Opens the main menu, described in 3.11.1 Main Menu Settings on page 115 Trend view toggle button Toggles the screen view from graph view to a data chart view ALARMS SNAPSHOT SENSOR CHECK INFO Opens the Alarm setting window; for more information, reference 4.3.7 Changing Alarms Settings on page 168. Enables recording of a Snapshot; for more information, reference 5.7 Recording a Snapshot on page 195. Note that the SNAPSHOT option is not available in Demo Mode. Starts the sensor check process; for more information about sensor check, reference 3.6.3 Sensor Check on page 82. Opens the INFO window; for more information, reference 3.16 Info Options on page 135. EXIT DEMO MODE

(not seen) This button will appear only if the monitor is in Demo Mode; in that case, use this button to exit Demo Mode. 3.11.3. Alarm Status Displayed on Home Screen On the home screen, an indicator will provide the alarm status, as follows:

BIS Advance Monitor 119 Parameter Indicator Meaning Home Screen Menus Alarm Enabled BIS target range BIS target range seen in numeric section. Message shown when alarm range exceeded. BIS target range alarm is enabled; target range is as shown; target range stripe seen on BIS graph;

message indicates that the alarm has been triggered SR alarm is enabled; SR alarm limit is as shown;

message indicates that the alarm has been triggered SEF alarm is enabled; SEF alarm range is as shown;

message indicates that the alarm has been triggered SR parameter Alarm limit seen in numeric section. Message shown when alarm range exceeded. SEF Alarm range seen in numeric section. Message shown when alarm range exceeded. Alarm Disabled Alarm Disabled Indicator The appearance of the indicator will differ depending on the priority level of the alarm. A high priority alarm will appear with two lines to the right of the triangle and a medium priority alarm will appear with one line to the right of the triangle. BIS parameter range Alarm Disabled icon seen in numeric section BIS target range alarm is disabled SR parameter Alarm Disabled icon seen in numeric section SR alarm is disabled 120 BIS Advance Monitor Home Screen Options Parameter Indicator Meaning SEF Alarm Disabled icon seen in numeric section SEF alarm is disabled 3.12. Home Screen Options By default, the home screen will appear as seen in Figure 29. Sample 2-channel BIS Screen on page 90 or as seen in Figure 30. Sample 4-channel BIS Screen on page 94, depending on the selected type of monitoring (two-channel or four-channel). The software also provides the option to set a different layout and different parameter display for the home screen. To set a different layout and parameter display, select Main Menu>Display Settings>select desired setting option. Figure 47. Display Settings Selection BIS Advance Monitor 121 Home Screen Options Table 8. Home Screen Display Settings Options Symbol Display Icon Description Layouts for 2-channel mode:

BIS, EEG (default layout) The BIS and EEG trends occupy the graph/trend area, with each occupying half of the area BIS only BIS, DSA BIS, DSA, EEG 122 The BIS trend occupies the whole graph/trend area The BIS and DSA trends occupy the graph/trend area, with each occupying half of the area The BIS, DSA and EEG trends occupy the graph/trend area, with each occupying a third of the area BIS Advance Monitor Symbol Display Icon Description Home Screen Options DSA, EEG DSA only EEG only BIS, EEG Layouts for 4-channel mode:

The DSA and EEG trends occupy the graph/trend area, with each occupying half of the area The DSA trend occupies the whole graph/trend area The EEG trend occupies the whole graph/trend area;

sometimes referred to as full screen EEG layout The BIS and EEG trends occupy the graph/trend area, with each occupying half of the area. The BIS L (left) trend will be shown by default; this can be changed to show the BIS R (right) trend. Both EEG L

(left) and EEG R (right) trends are shown. BIS Advance Monitor 123 Home Screen Options Symbol Display Icon Description BIS only BIS, ASYM, EEG BIS, DSA, ASYM DSA, ASYM, EEG 124 The BIS trend occupies the whole graph/trend area. The BIS L (left) trend will be shown by default; this can be changed to show the BIS R

(right) trend. The BIS, ASYM and EEG trends occupy the graph/trend area, with each occupying a third of the area. The BIS and EEG L

(left) trends will be shown by default; this can be changed to show the R (right) trends. The BIS and DSA+ASYM trends occupy the graph/trend area, with each occupying half of the area. The ASYM graph is shown between the two DSA graphs. The BIS L (left) trend will be shown by default; this can be changed to show the BIS R

(right) trend. The EEG and DSA+ASYM trends occupy the graph/trend area, with each occupying half of the area. The ASYM graph is shown between the two DSA graphs. Both EEG L (left) and EEG R

(right) trends are shown. BIS Advance Monitor Symbol Display Icon Description Secondary Trend Selection EEG only DSA,ASYM The EEG trend occupies the whole graph/trend area. Both EEG L (left) and EEG R (right) trends are shown. Two DSA graphs, one for each hemisphere, and the ASYM trend occupies the graph/trend area, with each occupying approximately one third of the area 3.13. Secondary Trend Selection In screens that display the BIS trend, a secondary trend may also be shown on the BIS trend graph, so that both trend lines , the BIS trend line and the secondary trend line, appear on the same graph. Selection of the secondary trend is done on the Display Settings screen, by selecting Menu>Display Settings>select the BIS trend or, in a trend display that includes the BIS trend: Select Secondary Trend>click Apply. BIS Advance Monitor 125 Home Screen Audio Alarm Settings Figure 48. Secondary Trend Selection The options for the secondary trend on the BIS trend graph are None, SR, EMG, SQI or Burst Count (the latter only when using an Extend Sensor). For four-channel monitoring, the BIS value for the hemisphere not shown on the graph (R or L) or Burst Count can also be selected as a secondary trend. When a secondary trend is shown on the BIS trend screen, the scale for that variable appears on the right side Y axis of the BIS trend graph, in the same color as the secondary trend. Reference Figure 31. BIS Trend Graph on page 96 for an example of a BIS trend graph displaying a secondary variable. 3.14. Home Screen Audio Alarm Settings The home screen allows easy access to alarm controls, with two easy options, alarm control and expanded alarm control, both seen in figures below. The default alarm setting is an alarm that sounds for all audio alarms. Clicking on the bell seen in Figure 49. Alarm Control, below, will activate temporary alarm silence (for 120 seconds, with a count-down) with one click and permanent alarm silence with an additional click. The icons that will appear for temporary and permanent alarm silence are shown in Table 9. Expanded Alarm Control on page 127. 126 BIS Advance Monitor Figure 49. Alarm Control Home Screen Audio Alarm Settings To open the expanded alarm control window, click the drop-down arrow on the right side of the window in Figure 49. Alarm Control, above. The options seen in Figure 50. Expanded Alarm Control with Alarm Volume, below, will appear. Select your desired option and click to activate. With both methods of setting alarm silence, alarms will still continue to occur during temporary and permanent alarm silence, but an audible alarm indicator will not sound. The alarms for which the audible indicator is paused or silenced will continue to occur and will continue to be indicated by visual indicators and recorded in case records. In the expanded alarm control window, the current audio status of the alarms will appear with a yellow background, and the other status options will appear with a white background. In the example seen in Figure 50. Expanded Alarm Control with Alarm Volume, below, the audio alarm status is On. Figure 50. Expanded Alarm Control with Alarm Volume The expanded alarm control options are as described in Table 9. Expanded Alarm Control , below. Table 9. Expanded Alarm Control Icons Symbol Description Details Alarm Audio Active Default state with active audio alarm BIS Advance Monitor 127 Settings and Maintenance Alarm Pause (Temporary Alarm Silence) Pauses the audio alarm for default time of 120 seconds, with countdown Alarm Off (Permanent Alarm Silence) Turns off the audio alarm, until it is turned on again or device is restarted Alarm Volume adjustment Opens window in which alarm volume can be adjusted For more information about alarm settings, reference 4.3 Alarms on page 143. 3.15. Settings and Maintenance The monitor provides a number of settings adjustments that can be performed in the Settings and Maintenance screen by the user. Please note that these changes will be in force only for the current case or until restart of the monitor (whichever comes first). Once the monitor is shut down and restarted or a new case is started, the monitor will default to institutional Defaults. To change institutional Settings on a more permanent basis, reference 7.3 Administrator Mode on page 218. WARNING: The software will reset all settings with defined default values to Institutional Defaults upon the end of each case, excluding Institutional Default Language settings. The software will also reset all settings (including language) to Institutional Defaults upon the restart of the monitor. However, if a sensor for which certain settings were set (as described in 3.15.3 Advanced User Settings on page 131, and whether changes were performed by a user or 128 BIS Advance Monitor Settings and Maintenance administrator) is re-attached, the monitor will apply the settings that were in place when that sensor was used last time. Please note that all display settings will affect the display only, and will not affect the resolution of the patient data saved in the monitor. 3.15.1. Setting up Language, Date and Time Enter Main Menu>Settings and Maintenance>Settings>Global>Time and Language. The options that can be changed are as follows:

Feature Options Factory Default Option Language English Bulgarian, Chinese, Croatian, Danish, Dutch, English, French, German, Greek, Hungarian, Italian, Japanese, Macedonian, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovenian, Spanish, Swedish Selection via calendar

(October 26 2020 to October 26 2099) (but not before the monitor manufacture date). Available only when a BISx module is not connected. 0-23 or 0-11, depending on time format (available only when a BISx module is not connected) 0-59 (available only when a BISx module is not connected) NA NA NA Date Time (hours) Time (minutes) BIS Advance Monitor 129 Settings and Maintenance Date format DD MMM YYYY, MMM DD YYYY MMM DD YYYY Time format 24 hours, 12 hours (AM/PM) 24 hours Medtronic recommends use of the 24-hour clock option in all clinical settings, to avoid situations in which the current time may be misunderstood by users. Select the desired choice for each option and click Apply. Please select the date and time format in common use in your locality to enhance clarity for users of the monitor. Date and Time cannot be modified when a BISx module is connected (during active case monitoring) or during Demo Mode. If time and/or date is changed after a case ends and the same case is resumed afterwards, an extended Case with the same Case ID and a different suffix will be created instead of a new case. Time and Date will remain in force even when institutional defaults are restored. 3.15.2. MPM Configuration MPM (Multi-parameter Monitor) Configuration setup can be accessed by clicking Main Menu>Settings and Maintenance>Settings>Global>MPM Configuration. Under MPM Configuration Setup, the user can choose between the following serial communication port protocols:

Binary ASCII Legacy binary 130 BIS Advance Monitor Settings and Maintenance If MPM configuration is changed during a case to a configuration which is different from the factory default setting, the change will be valid only for the current active case. The factory default setting is Binary. MPM Configuration cannot be adjusted during Demo Mode.. The advanced user settings are described in the section below. 3.15.3. Advanced User Settings BIS Smoothing Rate Setup This option permits the user to adjust the BIS Smoothing Rate. The factory default value is 15. To access the BIS Smoothing Rate screen, click Main Menu>Settings and Maintenance>Settings>Advanced>BIS Smoothing Rate. To make changes to the BIS Smoothing Rate, make the desired changes and click Apply to apply the changes. Option Description 10 15 30 Sets BIS Smoothing Rate to 10 Sets BIS Smoothing Rate to 15 (default level) Sets BIS Smoothing Rate to 30 When an Extend Sensor is connected to the system, the software shall automatically set the BIS Smoothing Rate to 30. EEG Display This option permits the user to adjust a number of parameters related to the EEG Trends graphical display, as listed below. The EEG Trends graphical display is seen in Figure 32. EEG on page 99. The EEG trend parameters that can be set on the EEG Trends screen relate to this graph. To access the EEG Trends screen, click Main Menu>Settings and Maintenance>Settings>Advanced>EEG Trends. To make changes to the EEG BIS Advance Monitor 131 Settings and Maintenance Trends graphical display, make the desired changes on this screen and click APPLY to apply the changes. The EEG Trends Graphical Display may be changed only when a sensor is attached to the monitor and the current display settings include an EEG waveform display. Parameter Options EEG Amplitude

+/- 50 [V]

Default

+/- 50 [V]

+/- 100 [V] (only when full screen EEG layout is selected as described in 3.12 Home Screen Options on page 121) EEG Scale See Table 10. EEG Display Scale Options on page 132 See Table 10. EEG Display Scale Options on page 132 Number (#) of Channels 1,2,4 Depends on EEG scale and selection of 2-

channel or 4-channel monitoring EEG Filters On/Off, using slide button to toggle On The software shall allow the user to choose the EEG display scale per number of channels, according to the details seen in Table 10. EEG Display Scale Options, below. Table 10. EEG Display Scale Options Display Scale Full Screen (1:1) Half Screen (1:2) One Third Screen (1:3) 2 Channel Display Scale 2 V/mm 1 (no. of channels) 1 5 V/mm 1,2 1,2 NA 1 132 BIS Advance Monitor Settings and Maintenance One Third Screen (1:3) Display Scale Full Screen (1:1) Half Screen (1:2) 10 V/mm 1,2 1,2 4 Channel Display Scale 2 V/mm 1,2 5 V/mm 1,2,4 10 V/mm 1,2,4 1 1,2 1,2,4 1,2 NA 1 1,2 When the user applies a change to the EEG scale from the Home Screen, the same change will be displayed in the EEG scale as accessed from the Settings menu. If filters are set, the values will be as follows:

2 (2.0 [Hz]) for the high pass filter 3 (70 [Hz]) for the low pass filter 3 (50 [Hz] and 60 [Hz]) for the notch filter If the filters are OFF, no filtering shall take place. Filter setting is set to ON each time the monitor starts up, a case ends, the user resets the monitor to Institutional Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180) or an administrator resets the monitor to Factory Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180). Impedance An automatic impedance check is performed by the monitor each time a sensor is connected (during auto sensor check) or during a manual sensor check. For more information, reference 7.1.3 Impedance Checking on page 213. The Impedance option in the Settings>Advanced menu (described in 4.6 Institutional Settings on page 180) will permit the user to turn the automatic impedance check off or on. Impedance setting is set to ON each time the monitor starts up, a case ends, BIS Advance Monitor 133 Settings and Maintenance the user resets the monitor to Institutional Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180) or an administrator resets the monitor to Factory Defaults (using the RESET SETTINGS button as described in 4.6 Institutional Settings on page 180). To enter the screen, click Main Menu>Settings and Maintenance>

Settings>Advanced>Impedance. To change the status of this option, slide the switch left to turn OFF (switch will then appear grey) or to the right to turn ON

(switch will then appear green) and click APPLY. This option is available only when a sensor is attached to the monitor. Sensor Check Values The Sensor Check Values screen will permit the user to turn the display of sensor check values on the sensor check screen off or on. By default, display of the values is off. To enter the screen, click Main Menu>Settings and Maintenance>Settings>Advanced>Sensor Check Values. To change the status of this option, slide the switch left to turn OFF (switch will then appear grey) or to the right to turn ON (switch will then appear green) and click APPLY. This option is available whether or not a sensor is connected to the monitor. Display Settings The Display Settings screen will permit the user to select a particular trend display layout. By default, the layout for a 2-channel system is a 2-trend layout with BIS and EEG. For a 4-channel system, the default layout is a 3-trend layout with BIS, ASYM and EEG shown. The defaults can be adjusted in the Administrator Mode; reference 4.6 Institutional Settings on page 180. To enter the screen, click Main Menu>Settings and Maintenance>

Settings>Advanced>Display Settings. To change the layout, click Change. This will open the Display Settings screen (also accessible by clicking Main Menu>Display Settings). To change the display , select a layout from the bar at left, and click Apply. For a description of available layouts, reference 3.12 Home Screen Options on page 121. 134 BIS Advance Monitor Info Options When a BIS trend is selected, the default secondary variable (EMG) will appear in all layouts. For more information about secondary variables, reference 3.12 Home Screen Options on page 121. If enabled in Administrator mode (reference 7.3.2 Administrator Mode Actions on page 221), EEG Test layout will be an additional option available for display. This will display two EEG trends on the screen at the same time in 2-channel mode and four EEG trends in four-channel mode. The EEG Test layout will only be available until a new case is started or the monitor is turned off and restarted. While test layout is the selected display, EEG settings cannot be changed by the user. Each trend graph can be viewed with a choice of time ranges. The selected time range of the trend display will not affect the resolution of the saved data. Administrator Mode Login The user can log in to the Administrator Mode in the Settings and Maintenance window, by clicking on Administrator Mode. For more information, reference 7.3 Administrator Mode on page 218. Enter Main Menu>Settings and Maintenance>Maintenance. 3.15.4. Maintenance The available options are as follows:

Logs: reference 5.9 Logs Export on page 199 for more information Configuration: reference 6.5.2 Configuration Data on Monitor on page 210 for more information. DSC Self-Test: reference 7.1.1 DSC Self-Test on page 212 for more information. For Administrator options under Maintenance, reference 7.3 Administrator Mode on page 218. 3.16. Info Options BIS Advance Monitor 135 Quick Reference Checklist The INFO button on the main menu and the INFO button on the left menu bar both open the same window, which provides the options listed in Table 11. Info Window Options, below. Table 11. Info Window Options Button Description Demo Mode BIS, EMG, SQI, BURST, SR, ST, EEG, DSA, SEF, MF, ASYM Opens Two-channel or Four-channel Demo Mode, per user selection. For more information about Demo Mode, reference 7.3.2.2 7.4 Demo Mode on page 223. Describes each parameter and provides graphical display of each parameters display on BIS Advance monitor screens. For description of the parameters, reference 1.10 The BIS Advance Parameters on page 29. 3.17. Quick Reference Checklist This Quick Reference Checklist is intended only as an operating checklist for users already familiar with the BIS Advance monitor. Do not proceed unless you have read 1.2 Safety Information on page 13. You may print out this Quick Reference Checklist for caregiver use. Step 1: Basic Operation If the BIS Advance system has already been installed, proceed as follows:

Verify that all power and other cables are connected properly. Ensure that the BISx MIC cable is connected to the BISx adapter cable connector on the monitor. Step 2: Turn On 136 BIS Advance Monitor Press the button in the bottom right corner of the monitor to turn the monitor and BISx module on. The system will initiate a self-test to ensure that all equipment is operating properly. The monitor home screen will appear. Quick Reference Checklist Step 3: Attach sensor to patient Prepare sensor site and place BIS sensor on the patient in accordance with the sensor instructions. Step 4: Set up the BISx module and connect the sensor to the BISx module Using the attachment clip, secure the BISx module to a convenient location near the patients head. Insert the BIS sensor tab into the PIC connector on the BISx module until fully engaged. Step 5: If you want to make any changes to monitoring parameters, such as setting an alarm limit, do so now. You are now ready to begin monitoring. For detailed operating instructions and software configuration, read 4 Operating the BIS Advance Monitoring System on page 138. Current settings may be viewed at any time by viewing the appropriate menu. BIS Advance Monitor 137 4. Operating the BIS Advance Monitoring System 4.1. Preparing for Operation Ensure that the system, including the monitor, docking station, BISx module, sensor, and all connecting cables are set up as described in 3.5 Preparing the Docking Station on page 68 and 3.6 Preparing the Monitor on page 71. If you want to mount the monitor, do so before operation, following the instructions in 3.4 Mounting the Docking Station on page 64. The BIS parameters and their meaning appears in Table 1. The BIS Advance Monitor Parameters on page 31. 4.2. Cases A new case will be created automatically by the BISx module when a BISx module and a sensor are attached to the system. Once a sensor is connected, a sensor check will take place, the case will begin, and its CASE ID will appear on the screen as seen in Figure 28. Case ID on page 86. If the sensor is briefly removed and reattached to the BISx module, the same case will continue. 4.2.1. Case Storage The monitor will store a maximum of 50 cases which will be available for Case Review. When the maximum number of saved cases has been stored, any new case will delete the oldest case in the monitors memory. The software shall store a maximum of 30 snapshots per case, and a maximum of 24 hours of Case Review data per case data file. When a case exceeds 24 hours, a new case data file shall be created, with the same file name and a different suffix. (The suffix is an integer indicating 1, 2, etc.) 138 BIS Advance Monitor Cases Note: Since the case storage capacity of the monitor is limited, it is recommended to download case data when a case ends, to avoid accidental erasure of case data. 4.2.2. Case Review Case Review is available only when no sensor is attached to the monitor. If a sensor is connected, the option is greyed out. A BISx module may be connected during Case Review. To select a case for review, click Main Menu>Case Review. A list of saved cases will appear, by their date and time of creation, where the first case in the selection menu shall be the most recently created. The arrows at the top of the chart next to Case Start, Case ID and Duration can be used to reverse the order of the case list. Cases may be filtered by Case ID. When filtering, the desired Case ID may be inputted without differentiation between upper and lower case letters; the software will still be able to find the correct case. Figure 51. Case List Window 1 2 BIS Advance Monitor 3 4 5 139 Label Function Description Case Start Date and time of case start Case ID Filter Case ID assigned by system Cases may be filtered by Case ID; when a valid Case ID is inputted, only cases with that Case ID will appear on the case list Blue arrow Clicking on the blue arrow will open the selected case Duration Duration of case in hours and minutes Select a case and open the case review screen by clicking on its Case ID or on the blue arrow at the right side of each row. A Case Review graphical trend screen will appear, displaying the data saved for that case in trend format, and, in the numeric section, the data for that case at the point in time indicated by the cursor. A sample Case Review screen is shown below. Cases 1 2 3 4 5 140 BIS Advance Monitor Figure 52. Case Review Screen 4 3 2 1 Cases 5 6 7 8 BIS Advance Monitor 141 Cases Label Function Description 1 2 3 4 5 6 7 8 142 Case data Cursor Indicates date, start time, duration and Case ID of displayed case Red line indicates point on graph for which numerical data is displayed at the right side of the screen Cursor time indicator Indicates time at cursor location Graphical data Graphical data for displayed case Numeric Data Case start time indicator Numeric data of case in review, at the point in time represented by the cursor Small grey triangle indicator indicates the point on the graph at which the currently displayed case started Horizontal (time) axis Time axis for graph, with scale as determined by displayed time scale on graph Resolution display drop-down menu Select desired resolution for graphs using this arrow The Case Review display for a 2-channel case will be a layout with the BIS graph with EMG as a secondary variable in the top graph, and DSA in the bottom graph. The Case Review display for a 4-channel case will be a layout with the BIS graph with EMG as a secondary variable in the top graph, and DSA with ASYM as a secondary variable in the bottom graph. The user can select a display of either Right BIS or Left BIS data (using the R/L toggle switch at the upper left side of the screen). Case Review can also be displayed in Chart format, using the graph/chart toggle button at the upper left side of the screen. While viewing a case in Case Review, the user can select a different secondary variable for the BIS graph, from the standard list of available secondary variables on this graph (reference 3.12 Home Screen Options on page 121.) BIS Advance Monitor Alarms and Messages During Case Review, the user can scroll through the trend in the displayed Trend window through a specific case time, by swiping the monitor's touch screen left or right to scroll through the available data. A cursor indicates the point in time on the graph for which the data appears in the numeric window. During Case Review, Alarms which were active during the specific case being reviewed will not be displayed and will not sound. However, if a real-time alarm (not connected to monitoring, since no monitoring takes place during Case Review) occurs during case review, it will be displayed and will sound. To save data from Case Review in a format for printing, reference 5.10 Viewing and Printing Saved Data on page 203. The monitor also provides an option to view a Case Log, by clicking the Case Log button at the middle of the left bar of the Case Review screen seen in Figure 52. Case Review Screen on page 141. This case log will list all events that occurred during the case, with the time, Event ID, type of event (such as Alarm or Info [message]) and a description of that event. 4.3. Alarms and Messages A full list of alarm messages appears in Table 12. Alarm Messages on page 145.. 4.3.1. Alarm and Message Types By default, the BIS, SR, SEF and SQI alarms are off. To set an alarm, reference 4.3.7 Changing Alarms Settings on page 168. To change audio settings for alarms, reference 3.14 Home Screen Audio Alarm Settings on page 126. The alarms are categorized as High Priority, Medium Priority and Low Priority alarms. High Priority alarms will be indicated by a flashing red background for the alarming parameter (if the alarm refers to a parameter) and a red background in the alarm bar. Medium Priority and Low Priority alarms will be indicated by a yellow background for the alarming parameter (if the alarm refers to a parameter) and a yellow background in the alarm bar. For Medium Priority alarms, the yellow background for the alarming parameter will flash. The Priority status of an alarm also defines its appearance in the alarm bar and alarm list; reference 4.3.4 Alarm Display on page 162 for more details. The alarms and messages are also defined by categories both in terms of their audible status and their appearance in the message area, as follows:

BIS Advance Monitor 143 Alarms and Messages Alarm/Message Categories 1. 2. 1. 2. Periodic alarms will sound and be displayed continuously as long as the alarm condition continues to exist. If the alarm condition is cleared, the alarms will cease to sound and display. All alarms are periodic. Once information messages will sound and display once for approximately 5 seconds, whether or not the condition continues to exist. Message Area Display Categories Non-latching items can be Periodic alarms or information messages; these items will appear on the screen continuously, but will disappear once the condition is cleared. Latching information messages will continue to appear until the user acknowledges the alarm. Once the user acknowledges a latching information message, it will no longer appear. Alarms are never latching. In addition to the display of Non-latching and Latching information messages, both Non-latching and Latching messages will also sound once when they first occur. WARNING: Check Target Range alarm limits to ensure they are appropriate for the patient being monitored with each use. Ensure Target Range alarm limits do not exceed the standard thresholds set by the institution. WARNING: If you plan to monitor the patient using alarms, do not set the Target Range alarm limits to extreme values that render the monitoring system ineffective. Ensure Target Range alarm limits are appropriate for each patient. WARNING: If you plan to monitor the patient using alarms, do not pause, disable or decrease the audible alarm volume until you verify that the patient is being monitored by other means, such as direct observation, as this could compromise patient safety. WARNING: If you plan to monitor the patient using alarms, do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm volume below ambient levels might impede operator recognition of the audible alarm, which might lead to patient harm during an alarm situation. 144 BIS Advance Monitor Alarms and Messages 4.3.2. Alarms The monitors alarm messages are listed in Table 12. Alarm Messages, below. All alarms listed in this table are Periodic and Non-latching. Table 12. Alarm Messages Alarm Message Possible Causes Corrective Actions Alarm Priority BIS ALARM BIS below defined range BIS ALARM BIS above defined range The BIS has fallen below the target range set by the user. The BIS has risen above the target range set by the user. 1. Check patient. HIGH 2. Take note of BIS limit set by user. 1. Check patient. HIGH 2. Take note of BIS limit set by user. ISOELECTRIC EEG No discernible EEG activity is detected for sixty-three seconds; SR = 100. If unintended:

HIGH Note: This message notifies user of a flatline EEG. This is a normal condition when sensor simulator is connected. 1. Check patient vital signs, dosage, etc. 2. Check leads for proper connection and possible shorts. 3. Verify Sensor Check passes. 4. Verify DSC Self-test passes. 5. Verify PIC, using the sensor simulator and Sensor Check. LEFT ISOELECTRIC EEG No discernible EEG activity is detected for sixty-three seconds; SR = 100. Note: This message notifies BIS Advance Monitor If unintended:

HIGH 1. Check patient vital signs, dosage, etc. 145 Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority RIGHT ISOELECTRIC EEG If unintended:

HIGH user of a flatline EEG. This is a normal condition when sensor simulator is connected. No discernible EEG activity is detected for sixty-three seconds; SR = 100. Note: This message notifies user of a flatline EEG. This is a normal condition when sensor simulator is connected. 2. Check leads for proper connection and possible shorts. 3. Verify Sensor Check passes. 4. Verify DSC Self-test passes. 5. Verify PIC, using the sensor simulator and Sensor Check. 1. Check patient vital signs, dosage, etc. 2. Check leads for proper connection and possible shorts. 3. Verify Sensor Check passes. 4. Verify DSC Self-test passes. 5. Verify PIC, using the sensor simulator and Sensor Check. SENSOR OVERCURRENT Sensor is using too much current. 1. Disconnect and examine sensor connection. Clean any contamination. HIGH 2. Replace sensor if necessary. 3. Replace PIC. 4. Replace BISx. 146 BIS Advance Monitor Alarms and Messages Alarm Priority HIGH Alarm Message Possible Causes Corrective Actions Problem is detected relating to sensor ground element. A continuous ground fault has occurred for longer than 8 seconds. 1. Disconnect and examine sensor connection. Clean any contamination present. 2. Replace sensor if necessary. 3. Replace PIC. 4. Replace BISx. Monitor temperature limit has been exceeded. If the problem persists, the monitor may need to be replaced. Contact technical support. MEDIUM SENSOR GROUND FAULT MONITOR TEMPERATURE LIMIT EXCEEDED If the problem persists, consider replacing monitor BATTERY IS CRITICALLY LOW Monitor may shut down at any time There are only a few minutes of battery usage time left. Monitor may shut down at any time. SR ALARM SR above defined threshold SR value is above the defined threshold. Restore AC power to avoid automatic shutdown and continue working. MEDIUM Check patient status. LOW SEF value is above the defined range. Check patient status. LOW SEF value is below the defined range. Check patient status. LOW SEF ALARM SEF above defined range SEF ALARM SEF below defined range BIS Advance Monitor 147 Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority SENSOR DISCONNECTED o Disconnected sensor. 1. Connect the sensor. LOW 2. Connect/clean connection between sensor and PIC. 3. Connect the PIC. 4. Replace the PIC. 5. Replace the BISx. o Poor or contaminated connection between sensor and PIC. o Disconnected PIC. o Defective PIC. o Defective BISx. Battery temperature limit has been exceeded. If the problem persists, the monitor may need to be replaced. Contact technical support. LOW SENSOR EXPIRED Replace sensor. LOW Sensor is past its normal usability date, based upon date of manufacture. Sensor has been connected and disconnected too many times. Replace sensor. LOW SENSOR USED MORE THAN 24 HOURS Sensor was attached to 148 Replace sensor. LOW BIS Advance Monitor Connect sensor or cable BATTERY TEMPERATURE LIMIT EXCEEDED If the problem persists, consider replacing monitor Replace the sensor SENSOR MAXIMUM USES EXCEEDED Replace the sensor Alarm Message Possible Causes Corrective Actions Alarms and Messages Alarm Priority Replace the sensor system for more than 24 hours. UNRECOVERABLE MONITOR ERROR Restart the monitor A system error has occurred. The monitor may stop operating. 1. Follow on-screen instructions (if any). 2. Turn the monitor off, then on again. 3. Replace monitor. LOW LOW BISx UNRECOVERABLE ERROR Disconnect and reconnect BISx o Poor connection between BISx module monitor cable and monitor. 1. Disconnect and reconnect the host cable. Unplug and connect the host cable. o Defective BISx module. o Defective monitor. 2. Follow on-screen instructions. If necessary, power OFF and unplug power cord to shut down monitor completely. Then plug in and restart monitor. 3. Replace the BISx. 4. Replace the monitor. SQI MEDIUM Excessive artifacts in signal SQI value is medium, indicating that there are excessive artifacts in the EEG signal. 1. Attempt to identify and eliminate artifact source. LOW 2. Verify Sensor Check passes. If not, replace PIC. 3. Replace BISX. SQI LOW Due to poor signal quality some parameters are not available SQI value is low, indicating that no data is available due to poor EEG signal quality. 1. Attempt to identify and eliminate source of poor signal quality. 2. Verify Sensor Check passes. If not, replace PIC. LOW 3. Replace BISX. BIS Advance Monitor 149 Alarms and Messages Alarm Message Possible Causes Corrective Actions Alarm Priority BATTERY LOW Connect to power supply There is only a short amount of battery usage time remaining. Restore AC power to avoid automatic shutdown. LOW DSC SELF-TEST FAILED The DSC Self-Test process failed. Replace the BISx module. LOW Replace BISx BISx INITIALIZATION ERROR Disconnect and reconnect BISx o Poor connection between BISx module monitor cable (MIC) and monitor. o Defective BISx. o Defective monitor. UNABLE TO READ SENSOR Replace the sensor UNSUPPORTED SENSOR TYPE Replace the sensor The monitor is unable to read data from the BIS sensor. The sensor is not compatible with the monitor configuration. LOW 1. Disconnect and reconnect the adapter cable. Unplug and connect the adapter cable. 2. Follow on-screen instructions. If necessary, power OFF and unplug power cord to shut down monitor completely. Then plug in and restart monitor. 3. Replace the BISx. 4. Replace the monitor. Replace the sensor. LOW LOW Replace sensor. Reference Table 33. BIS Advance Monitor Components and Sensors on page 252 for a list of approved sensors. Ensure that the sensor used is compatible with the monitor configuration. 150 BIS Advance Monitor Alarm Message Possible Causes Corrective Actions Alarms and Messages Alarm Priority LOW Press the center of the electrode listed on the BIS sensor to initiate contact and enable monitoring. If the issue does not correct itself, replace the sensor. LOW 1. Test another PIC with sensor simulator. LOW 2. If failure persists, replace simulator and retest. 3. If failure persists, replace PIC. 1. Test another PIC with sensor simulator. LOW 2. If failure persists, replace simulator and retest. 3. If failure persists, replace PIC. PRESS CENTER OF ELECTRODES

{0} TO ENABLE MONITORING TEMPORARILY UNABLE TO MEASURE ELECTRODES {0}

POSSIBLE PIC PROBLEM Replace PIC or check cable using sensor simulator POSSIBLE PIC PROBLEM Replace PIC One (or more) of the sensor electrodes is not in contact. The relevant electrode number will appear instead of the parentheses. The system is temporarily unable to measure data from one of the electrodes on the sensor. The relevant electrode number will appear instead of the parentheses. Ground electrode impedance is high and impedance of other electrodes is low. Defective PIC. One of the electrodes (other than ground) has high impedance. Defective PIC. Defective sensor simulator. BIS Advance Monitor 151 Alarms and Messages 4.3.3. Messages All information messages will sound once and be displayed in the information message section at the bottom of the home screen. For an example of this display, reference Figure 54. Home Screen with Active Alarm on page 165. The information messages displayed on the message bar at the bottom of the screen are described in Table 13. Information Messages on page 153. 3 4 5 Figure 53. Message Bar 2 1 Label Function Description Number of messages Number of current messages Current message Text of message currently displaying Message number Number of message currently displaying /

total number of messages Next button Click to view next message in list Check mark Click to dismiss currently displaying message, if it is a Latching message If more than one message is active, the messages will be displayed in succession. To view the messages more rapidly, click the NEXT button or the arrow to its right. To dismiss a Latching message (so that it will no longer appear), click the check mark. Information messages are listed in Table 13. Information Messages, below. The message display types are described in 4.3.1 Alarm and Message Types on page 143. 1 2 3 4 5 152 BIS Advance Monitor Table 13. Information Messages Message Meaning Suggested Action Alarms and Messages Message Display Type Non-

latching Replace the sensor This is the last time this sensor can be used The sensor attached to the monitor has already been used, and the current use is the last use for this sensor. The monitor is not connected to AC power and therefore is running on battery power AC power disconnected Non-

latching The AC power has been lost and the monitor is running on the battery. The battery keeps the monitor operating for approximately 60 minutes

(when the battery is fully charged). 1. Restore the AC power. 2. Verify power cord. 3. Replace power supply. Testing alarm volume Currently testing alarm volume Once None. Informational message only. Date and time changed Date and time have been changed Once None. Informational message only. Once None. Informational message only. Smoothing rate changed to 10 seconds Smoothing rate was changed to 10 seconds, based upon the type of sensor connected, or the user changed the smoothing rate. BIS Advance Monitor 153 Alarms and Messages Message Meaning Suggested Action Message Display Type Once None. Informational message only. Smoothing rate was changed to 15 seconds, based upon the type of sensor connected, or the user changed the smoothing rate. Smoothing rate was changed to 30 seconds, based upon the type of sensor connected, or the user changed the smoothing rate. Monitor has adjusted the number of EEG channels to 1 based upon the sensor connected. Monitor has adjusted the number of EEG channels to 2 based upon the sensor connected. Monitor has adjusted the number of EEG channels to 4 based upon the sensor connected. Smoothing rate changed to 15 seconds Smoothing rate changed to 30 seconds Number of channels for EEG changed to 1 Number of channels for EEG changed to 2 Number of channels for EEG changed to 4 154 Once None. Informational message only. Once None. Informational message only. Once None. Informational message only. Once None. Informational message only. BIS Advance Monitor Alarms and Messages Message Meaning Suggested Action Message Display Type Alarm Silent Mode On Audio Alarm Silent Mode is on Once None. Informational message only. Alarm Silent Mode Off Audio Alarm Silent Mode is off Once None. Informational message only. Audio Reminder is On Audio Reminder is Off Audio Off alarm reminder signal is on Audio Off alarm reminder signal is off Once None. Informational message only. Non-

latching None. Informational message only. Alarm Pause Mode On Alarm Pause Mode is on Once None. Informational message only. Export failed -

USB drive removed Removable drive was removed from USB port during download Latching Place USB flash drive in USB port and try again, do not remove drive until a message indicating that the download is completed appears. For Live Case download, stop live data recording and then remove drive. Reference 5.5 Live Case Export on page 188 for more information regarding Live Case download. Export failed -

USB drive full Drive is full. Latching 1. Check connection. 2. Replace drive. Snapshot created Snapshot was created Once None. Informational message only. BIS Advance Monitor 155 Alarms and Messages Message Meaning Suggested Action Message Display Type EEG Filtering On EEG filters are on Once EEG Filtering Off EEG filter are off Latching None. Informational message only. None. Informational message only. Live data export in progress Live data export is in progress Non-

latching None. Informational message only. Live data export stopped Live data export has been stopped Once None. Informational message only. Monitor Saved Cases export in progress Monitor case history export is in progress Non-

latching None. Informational message only. Monitor Saved Cases export completed Monitor case history export has been completed Once None. Informational message only. Monitor Saved Cases export failed BISx Saved Cases export in progress Monitor case history export has failed Latching Same as other export failed BISx module history export is in progress Non-

latching None. Informational message only. BISx Saved Cases export completed BISx module history export has been completed Once USB flash drive may be removed. BISx Saved Cases export failed 156 BISx module history export was not successful. Removable drive is not connected Latching 1. Check connection. 2. Verify write protect switch on the drive is set to unlock position. BIS Advance Monitor Message Meaning Suggested Action Alarms and Messages Message Display Type 3. Replace drive. BISx connection history export completed BISx module connection history export has been completed Once USB flash drive may be removed. BISx connection history export failed Latching 1. Check connection. 2. Verify write protect switch on the drive is set to unlock position. 3. Replace drive. properly to USB port. Drive write protect is locked. Drive is incompatible or defective. Drive is full. BISx module connection history export was not successful. Removable drive is not connected properly to USB port. Drive write protect is locked. Drive is incompatible or defective. Drive is full. Sensor connection history export in progress Sensor connection history export is in progress Non-

latching None. Informational message only. BIS Advance Monitor 157 Alarms and Messages Message Meaning Suggested Action Message Display Type Once USB flash drive may be removed. Latching 1. Check connection. 2. Verify write protect switch on the drive is set to unlock position. 3. Replace drive. Sensor connection history export has been completed Sensor connection history export was not successful. Removable drive is not connected properly to USB port. Drive write protect is locked. Drive is incompatible or defective. Drive is full. Monitor log export has been completed Sensor connection history export completed Sensor connection history export failed Monitor log export completed Monitor log export in progress 158 Once USB flash drive may be removed. Monitor log export is in progress Non-

latching None. Informational message only. Monitor log export failed Monitor log export was not successful. Latching 1. Check connection. Removable drive is not connected properly to USB port. 2. Verify write protect switch on the drive is set to unlock position. 3. Replace drive. BIS Advance Monitor Message Meaning Suggested Action Message Display Type Alarms and Messages System log export completed System log export in progress Once USB flash drive may be removed. System log export is in progress Non-

latching None. Informational message only. System log export failed System log export was not successful. Latching 1. Check connection. 2. Verify write protect switch on the drive is set to unlock position. 3. Replace drive. Drive write protect is locked. Drive is incompatible or defective. Drive is full. System log export has been completed Removable drive is not connected properly to USB port. Drive write protect is locked. Drive is incompatible or defective. Drive is full. DSC Self-Test in progress DSC Self-Test is in progress Non-

latching None. Informational message only. BISx connection history export in progress BISx module connection history export is in progress Non-

latching None. Informational message only. BIS Advance Monitor 159 Alarms and Messages Message Meaning Suggested Action Message Display Type Factory settings restored Factory settings have been restored Latching Message appears at each power-up after a normal shutdown. No action, informational message. Impedance Checking Off User has disabled impedance checking. Non-

latching None. Informational message only. Last case resumed - User settings restored Case resumed -

settings previously set for that case have been restored System recovered from unexpected shutdown System has recovered from an unexpected shutdown Once None. Informational message only. Latching None. Informational message only. Sensor simulator is connected Non-

latching None. Informational message only. Sensor simulator connected Replace battery Non-

latching Replace battery Battery does not charge completely after a full charge session, or has reached the maximum amount of charging cycles. DSC Self-Test timeout DSC Self-Test timeout Once None. Informational message only. DSC Self-Test passed Monitor has passed DSC Self-Test Once None. Informational message only. 160 BIS Advance Monitor Alarms and Messages Message Meaning Suggested Action Message Display Type Institutional settings have been restored Once None. Informational message only. Institutional settings restored Monitor software update failed Monitor software update complete BIS alarm enabled BIS alarm disabled SR alarm enabled SR alarm disabled SEF alarm enabled SEF alarm disabled Monitor software update has failed Latching Contact technical support Monitor software update is complete Latching USB flash drive may be removed. BIS alarm has been enabled by user Once None. Informational message only. BIS alarm has been disabled by user Once None. Informational message only. SR alarm has been enabled by user SR alarm has been disabled by user Once Once None. Informational message only. None. Informational message only. SEF alarm has been enabled by user Once None. Informational message only. SEF alarm has been disabled by user Once None. Informational message only. Testing PIC with sensor simulator Testing PIC with sensor simulator Non-

latching None. Informational message only. PIC test successful PIC test was successful Once None. Informational message only. BIS Advance Monitor 161 Alarms and Messages Message Meaning Suggested Action Message Display Type Fan malfunction

- replace docking station Fan malfunction has occurred. Non-

latching Replace the docking station. Battery not installed Battery is not installed. Non-

latching Install a battery in the monitor. System is in Demo Mode The monitor is currently running a demo case. Non-

latching None. Informational message only. Monitor Overheat -

Recovered The monitor has recovered from an overheat scenario. Latching None. Informational message only. Once None. Informational message only. System recovery

- System trying to restore communication between BISx and monitor The system identified disconnection between BISx module and the monitor and is trying to reconnect. The system identified a lack of communication between BISx module and the monitor and is trying to restore communication. System Recovery system identified lack of communication between BISx and monitor and is trying to restore communication. Once None. Informational message only. The system displays alarms using the following indicators:

4.3.4. Alarm Display 162 BIS Advance Monitor Alarms and Messages Table 14. Alarm Indicators Parameter Alarm Indicators BIS SR SEF SQI Alarm Red square indication in numeric panel (since BIS is a High Priority alarm), alarm message Alarm yellow square indication in numeric panel (since SR is a Low Priority alarm), alarm message Alarm yellow square indication in numeric panel (since SEF is a Low Priority alarm), alarm message SQI display color (orange or red depending on SQI level) and number of bars in numeric panel, alarm message will appear. Technical alarms Technical alarm messages in the alarm message area at the top of the screen The system uses the following enabled/disabled indicators to indicate the status of the alarms. When an alarm is marked as disabled, this means that it is completely disabled, and will not display audio or visual indicators. Therefore, when an alarm is disabled, no alarm indicators will be seen or heard and no alarm will be recorded in the record of the case. In addition, please note that an enabled alarm can be silenced using the audio alarms pause and silence options described in 4.3.6 Audio Alarms Pause and Silence on page 167. In such a case, visual alarm indicators will appear on the screen, as well as the enabled indicator seen in the table below, but audible alarm indicators will not occur. Table 15. Alarm Enabled and Alarm Disabled Indicators Indicator Meaning High Priority alarm is enabled and will provide audible and visual indicators. If all alarms are silenced, an enabled alarm will still show visual indicators and be recorded in the case records, but will not provide an audible indicator. High Priority alarm is disabled. There will be no record of alarms in case records, and neither audible nor visual indicators will be provided. BIS Advance Monitor 163 Alarms and Messages Indicator Meaning Medium Priority alarm is enabled and will provide audible and visual indicators. If all alarms are silenced, an enabled alarm will still show visual indicators and be recorded in the case records, but will not provide an audible indicator. Medium Priority alarm is disabled. There will be no record of alarms in case records, and neither audible nor visual indicators will be provided. In addition to the numeric panel display for the BIS, SR, SEF and SQI alarms, all alarm messages (both alarms that warrant a display in the numeric panel and those that do not) will appear in the alarm message bar at the top of the screen as long as they are active (all alarms are periodic alarms) with the appropriate alarm indicator (High Priority Enabled or Medium Priority Enabled, as relevant). If there is more than one alarm occurring at the same time, the system will display the highest priority level alarm message in the alarm message bar. In case of multiple alarms in the highest priority level, the system shall toggle between all the alarms in that level, displaying each message in turn. If there are multiple alarms in high, medium and low levels, the system shall toggle only the high alarms; the medium and low alarms can be viewed using the alarms list. The alarms list is a list of current alarms (of all priority levels) that will appear if more than one alarm is currently active. To view the alarms list, click on the arrow at the left side of the alarm bar. Reference Figure 55. Alarms List on page 166. An example of a screen with an active alarm appears in Figure 54. Home Screen with Active Alarm, below. 164 BIS Advance Monitor Figure 54. Home Screen with Active Alarm 1 2 Alarms and Messages BIS Advance Monitor 3 165 Alarms and Messages Label Function Description 1 2 3 Alarm message BIS range alarm in alarm message bar Alarm numeric BIS range alarm as seen in numeric section Information message Information message in information message area Figure 55. Alarms List 4.3.5. Alarm Limits An alarm limit is a target level or target range within which the patients value for that parameter should ideally remain at all points during monitoring. If the patients value for that parameter exceeds or falls below the target level or target range, that patient may be at risk and should be checked by a caregiver. An alarm may be enabled to indicate this situation. Thus, these alarms can alert the caregiver to possible patient risk. By default, all of these alarms are off. To set an alarm, reference 4.3.7 Changing Alarms Settings on page 168. The monitor proposes a target alarm range for the BIS parameter only. Target alarm ranges or limits may be set by the user for the other alarms, as described below. As soon as the user sets a range for an alarm, it is automatically enabled. 166 BIS Advance Monitor Alarms and Messages The proposed BIS target range is as follows:

Parameter Recommended Target Range BIS 40-60 For other alarms, there is no recommended target range, but the user can set the limit in the available range, as follows:

Parameter Available Range SR High: 1 to 100, in increments of 1 0 to 29 for Low SEF limit, 1 to 30 for High SEF limit (there must be a gap of at least 1 between the Low and High limits) SR SEF In order to verify operator-set alarm limits, attach a sensor to the system (as described in 3.6.2 Connecting a Sensor to a Patient on page 78) and make a note of the SEF value shown on the screen during monitoring. Then, remove the sensor and set the SEF target range (as described in 4.3.7 Changing Alarms Settings on page 168) to a range that excludes that number. For example, if the sensor is showing SEF numbers between 27 and 28, set SEF High at 20. Re-attach the sensor and start monitoring. If the system is working correctly, an SEF High alarm should sound. This will verify that the monitors alarm limits function is working correctly. Remove the sensor. Once you have finished verifying the alarm limits, set the alarms as desired, or inactivate the alarms if desired, and begin monitoring. 4.3.6. Audio Alarms Pause and Silence Alarms may be paused or turned off in one of two ways:

Temporary Audio Alarm Paused Permanent Audio Alarm Off BIS Advance Monitor 167 Alarms and Messages In both cases, alarm paused or off affects only the audible alarms. Visual alarms are not affected. Temporary audio alarm paused may be set for the device using the alarm keys. Temporary alarm silence will be for a period of 120 seconds; a countdown until the return of the alarm will appear in the Alarm area on the Home screen. Audio volume can be set in the Alarm window, accessible using Main Menu>ALARMS or Left Menu bar>ALARMS on the home screen. Reference 3.11.3 Alarm Status Displayed on Home Screen on page 119 for the appearance of the home screen alarm touch keys. If the alarms are silenced using the Permanent Audio Alarm Off option, it is recommended that the Audio Off Reminder be implemented. The Audio Off Reminder must be enabled in Administrator Mode in order for it to be available; by default, it is not available to the user. The Audio Off reminder sounds every 180 seconds, reminding the user that auditory alarms are silenced. To implement the Audio Off Reminder, open the Alarm window, accessible using Main Menu>ALARMS or Left Menu bar>ALARMS on the home screen. Click Audio Off Reminder and slide the switch left to the right to turn the Audio Off option ON (switch will then appear green) and click APPLY. This will turn on the reminder which will sound every three minutes when the alarm audio is silenced. The on screen message may indicate NOTE: Audio OFF Reminder is currently disabled. To enable it, contact your administrator. In this case, contact the administrator in your institution to turn on this option. WARNING: If you plan to monitor the patient using alarms, do not pause, disable or decrease the audible alarm volume until you verify that the patient is being monitored by other means, such as direct observation, as this could compromise patient safety. WARNING: If you plan to monitor the patient using alarms, do not decrease the adjustable alarm volume below ambient sound levels. Decreasing the alarm volume below ambient levels might impede operator recognition of the audible alarm, which might lead to patient harm during an alarm situation. Alarms Settings can be accessed using one of four methods:

4.3.7. Changing Alarms Settings 168 BIS Advance Monitor 1. 2. 3. 4. SR SEF 1. Alarms and Messages Main Menu>Alarm Settings Left Menu bar>Alarms button Alarm Settings button that appears when a BISx module but not a sensor is connected to the monitor, on the Connect sensor to start monitoring window The BIS target range can also be set using Home Screen>BIS Graph, Set Range>BIS Range In the first three cases, the same Alarm Settings window will open. The BIS range setting choice will open a window that shows BIS range choices only. Table 16. Alarm Limits Options Alarm Range BIS range None Low: 5 -95 High: 10-100 None, 1-100 None Low: 1-29 High: 2-30 Factory Default Alarm Level None; suggested level is 40-60 None None Follow the steps listed below to change alarm settings:

By factory default, set when the monitor leaves the factory, all alarms are set to OFF. If the alarms have been changed by the administrator in your institution, some or all of the alarms may already be set to ON. You can still change the alarm settings for your current monitoring session, but the monitor will revert to its institutional default settings (or factory default settings if institutional defaults have not been set) when a new case is started or when the monitor is turned off and turned on again. 2. Attach the BISx module to the monitor. BIS Advance Monitor 169 Alarms and Messages Open the Alarms Settings screen. The Alarm Settings screen can be reached via the options described above. To enable an alarm, select a parameter at the left. Set limit by dragging alarm setting handle to the desired level. Once you make any change to the limit, the alarm will become enabled. Alternatively, you can slide the Alarm Disabled slider from the left side (Alarm Disabled) to the right side

(Alarm Enabled) and then change the limit. Once this is done, the alarm indicators in this window (the ON or OFF text next to the alarm name and the slider in the middle of the window) will automatically indicate that the alarm is ON. Note that you will not be able to apply the enabling of the alarm limit until a limit is set. Click APPLY to save these changes. Attach a sensor to begin monitoring. Once a new sensor is attached to the monitor, a new case with a unique case ID will begin. This case will use the alarm settings that you have just set. Alternatively, a sensor can be attached first, and then the alarm adjustment can be made. However, for recording purposes, best practice would be to set all alarms and then begin monitoring. Once a sensor is attached to the monitor, the settings valid at the time the sensor was attached (if changes were made before attaching the sensor), or the changes made while the sensor was attached (if changes were made after attaching the sensor) will remain valid for that sensor. This will hold true even if the sensor is removed and replaced. If alarm changes are made when no sensor is attached to the monitor, the alarm changes that have just been made will be valid until the monitor Is turned off. They will be valid for all sensors attached to the monitor, except for the following situation:

If a sensor was previously attached to the monitor at a point when the settings were different, the sensor and its case will retain the previous settings. 3. 4. 5. 6. 7. 170 BIS Advance Monitor Figure 56. Alarm Settings Screen 1 2 3 4 5 6 Alarms and Messages 7 8 9 10 Label Function Description 1 Parameters Parameters for which alarms can be set; if an alarm limit has been set (even if it has been set in the past and is not currently enabled, but the Reset to Default button has not yet been pressed) that limit will appear on this line. 2 ON/OFF indicator This text indicates if the specific alarm is currently ON or OFF BIS Advance Monitor 171 Alarms and Messages BIS RANGE text and icon Indicates the alarm which is currently displayed in this window Alarm Enabled text Indicates if the alarm is currently enabled;

if the alarm being displayed is disabled, this text will indicate Alarm Disabled. Alarm Disabled icon 6 Alarm Enabled icon Alarm Limits setting section If black, indicates that the alarm highlighted with a white background on the list at left and displayed at the top of the screen is disabled. If grey, indicates that the alarm is enabled. When the alarm is disabled, the slider section between the disabled and enabled icons will be grey. If black, indicates that the alarm the alarm highlighted with a white background on the list at left and displayed at the top of the screen is enabled. If grey, indicates that the alarm is disabled. When the alarm is enabled, the slider section between the disabled and enabled icons will be green. Set the desired limits in this section. The numbers seen in the middle of the section in black are the current limits (if the alarm in enabled) or the limits that will be set when APPLY is pressed (if you are now setting limits). Down alarm setting handle The up and down handles are used to set desired alarm limits Reset to Defaults Resets the alarm limits to institutional defaults, or, if no institutional defaults have been set, to factory defaults. 10 APPLY button Click to apply limits that have been set. When active, the button will be blue. BIS Advance Monitor 3 4 5 7 8 9 172 Chart Data An example of the alarm settings screen is seen in Figure 56. Alarm Settings Screen on page 171. The other alarms are set using the same procedure. If an alarm is enabled, its range will display on the numeric panel of the home screen, next to the parameter name. If an alarm is disabled, the disabled icon will show on the numeric panel of the home screen, next to the parameter name. Reference Figure 36. BIS Numeric on page 107 for an example. Audio alarm options are as seen in Table 17. Audio Alarm Options, below. Both alarm volume and the Audio Off reminder can be set in the alarm limits screen. The alarm volume can also be set on the Home screen; reference 3.14 Home Screen Audio Alarm Settings on page 126. Table 17. Audio Alarm Options Feature Options Factory Default Option Audio Alarm Volume 7 audio levels, from very low to very high Level 4 Audio Off Reminder ON, OFF OFF 4.4. Chart Data The monitor provides the option of viewing data in the form of a chart rather than as graphs. In both chart and graphical display, live data in numerical format will appear at the right side of the screen. To view chart data, click the chart icon at the top left of the home screen. The chart icon appears in Figure 57. Graph/Chart Toggle Icon, below, at the right. If you are currently viewing chart data, click the graph icon to return to the graphical display. Figure 57. Graph/Chart Toggle Icon Chart data of the live current case, or chart data of a past case in Case Review, can be selected for viewing instead of graphical data. BIS Advance Monitor 173 Chart Data Chart data can be seen at a selection of intervals: 1 minute, 5 minutes, 10 minutes, 15 minutes, 30 minutes, 60 minutes. The default interval is 15 minutes. To adjust the interval, click the CHANGE button next to the Interval text at the top of the chart and select the desired interval. If there is no active case and the system is not in Case Review mode, chart data will not be available. The information available on the Chart Data screen is listed below. Table 18. Information on Chart Data Screen Parameter Description 2-channel system Time of indicated row of chart BIS at selected time EMG in dB at selected time SR in % at selected time SQI in % at selected time Time of indicated row of chart 4-channel system BIS L and BIS R BIS left and right at selected time EMG L and EMG R EMG left and right at selected time SR L and SR R SR left and right in % at selected time ASYM ASYM at selected time SQI L and SQI R SQI left and right in % at selected time Time BIS EMG SR SQI Time 174 BIS Advance Monitor Figure 58. Chart Data Screen for 2-Channel Monitor 2 4 1 3 Chart Data 5 6 7 175 BIS Advance Monitor Menu Map Label Function Description 1 2 3 4 5 6 7 176 Case ID display Click to see Case ID of current case Interval display and selection Displays interval used for table, or click to change interval displayed Table headings Displays headings of each column in table Current numeric data Numeric data at current point in time Scroll bar Scroll up or down to see other lines of data Table data Table data for displayed case Start case icon Icon indicating start date and time of current case The top area also includes start date and time and the chart interval selected, along with a drop-down menu that can be used to change the chart interval. The start case icon on the bottom row, which is the earliest row of the chart, will indicate that this is the first time period shown on the chart. Each additional row of chart data shall push the other rows down, so the most recent time period is always seen at the top of the chart. If the chart exceeds the space on the screen, scroll down to see earlier data. If a chart data view is used to view a case in case review, the chart will show case review data and the numeric section will show the case review data at the cursor point. 4.5. Menu Map For clarity, the menu map is provided in three sections:

1. Map of the menu items accessible from the main home screen BIS Advance Monitor Map of the menu items available upon pressing the main menu button (at the top left of the main screen) Menu Map Map of the menu items available in the Administrator Mode (which is password-protected) 2. 3. All three are seen in Figure 59, Figure 60, and Figure 61. BIS Advance Monitor 177 Menu Map Figure 59. Home Screen Main Section Menu Map Figure 60. Main Menu - Menu Map 178 BIS Advance Monitor Menu Map 179 BIS Advance Monitor Institutional Settings Figure 61. Administrator Section Menu Map 4.6. Institutional Settings The monitor is provided to the users with a defined set of factory defaults for various settings and alarms. These defaults will remain in force unless:

1. 2. 180 The user adjusts one or more settings for the current use of the monitor; in this case the new adjusted settings will remain in force until a new case is started, or the monitor is shut down and then restarted. The Administrator adjusts one or more settings in the Administrator Mode. In this case, the new settings will remain in force until the Administrator changes the settings or resets the monitor to factory defaults. The settings set by the Administrator for a particular monitor are called the Institutional BIS Advance Monitor Institutional Settings settings, and they shall appear as default settings to the regular (non-

Administrator) user. If the user clicks Reset to Default in any Alarm Settings screen, the settings will return to the Institutional Default settings, not the Factory Default settings. The institutional default settings will remain in force even after the monitor is shut down and then restarted. If the monitor loses power for any reason, settings that have been set for the current sensor (including alarm settings) will remain active when the monitor is turned on again, as long as the same sensor is attached to the monitor. If a different sensor is attached to the monitor, the monitor will use the default settings when it is turned on again. Note: Note that changes can be made to the System Default settings by the user only when a BISx module and sensor are connected to the monitor. Exceptions to these rules are as follows:

After monitor restart, the Chart Data time interval will revert to its last value before the monitor restarted. After monitor restart, Live Data Recording setting (On/Off) shall revert to its last value before the monitor restarted. When sensor is disconnected while recording and then reconnected, the recording is not resumed automatically. If a user applies changes to a System Default (e.g. Filters are set to Off) during a case, the new settings will remain for the current case. At the start of the following case, the user will be notified that these settings do not match the Institutional Defaults. The System Default settings are not accessible when no monitoring is taking place. To adjust Institutional settings, enter Administrator mode, and then click Main Menu>Settings and Maintenance>Settings. Select the desired setting and make changes as required. Table 19. Institutional Settings Feature Options Language BIS Advance Monitor Bulgarian, Chinese, Croatian, Danish, Dutch, English, French, German, Greek, Hungarian, Italian, Japanese, Macedonian, Factory Default Option English 181 Institutional Settings Date NA Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovenian, Spanish Swedish Selection via calendar

(October 26 2020 to October 26 2099) (but not before the monitor manufacture date). Available only when a BISx module is not connected. Not adjustable in Administrator Mode Date & Time Options Not adjustable in Administrator Mode MPM/Partner Configuration ASCII, Binary and Legacy Binary Binary Advanced User Settings BIS Smoothing Rate

(excluding Extend sensor) 10, 15, 30 15 EEG Display Amplitude

+/-50 V

+/-50 V, +/-100 V (+/-

100 V available only in full-screen EEG layout). Not adjustable in Administrator Mode Not adjustable in Administrator Mode EEG Filters On, Off On 182 BIS Advance Monitor EEG Sweep speed 25 mm/sec Institutional Settings 6.25 mm/sec, 12.50 mm/sec, 25 mm/sec, 50 mm/sec Not adjustable in Administrator Mode 2 V/mm, 5 V/mm, 10 V/mm Not adjustable in Administrator Mode Not adjustable in Administrator Mode EEG scale EEG number of channels 1, 2, 4 2 V/mm for 2 channels 10 V/mm for 4 channels 1 for 2 channels at 2 V/mm 2 for 2 channels at 5 V/mm and 10 V/mm, 4 for 4 channels EEG Testing (if enabled in Administrator Mode) Enable/Disable display of EEG test layout (+/- 1000 V) Disabled On, Off On Enabled/Disabled Disabled Impedance check (not available in Administrator Mode) Sensor Check Values (not available in Administrator Mode) Institutional Defaults (in User Mode) RESET SETTINGS Factory Defaults (in Administrator Mode) RESET SETTINGS Display Settings Click CHANGE to select the default layout BIS Advance Monitor 183 Institutional Settings 2-Channel Default Layout BIS, EEG BIS, EEG;

BIS;

BIS, DSA;

BIS, DSA, EEG;

DSA, EEG;

DSA;

EEG BIS, EEG;

BIS;

BIS, ASYM, EEG;

BIS, DSA, ASYM;

DSA, ASYM, EEG;

EEG;

DSA, ASYM;

4-Channel Default Layout BIS, ASYM, EEG Alarms Settings (accessible from ALARMS window) Alarm Limits BIS Target Range Alarm Enable Enabled, Disabled Disabled BIS Target Range Low 5 to 95 40-60 High 10-100 SR Limit Alarm Enable Enabled, Disabled Disabled SR Limit 1 - 100 NA SEF Target Range Alarm Enable Enabled, Disabled Disabled SEF Target Range Low 1 to 29 NA 184 BIS Advance Monitor Institutional Settings High 2 to 30 Audio Alarm Volume 1-7 Level 4 of 7 Audio Off Reminder Access On/Off Enabled, Disabled (OFF) Off (can be changed only in Administrator Mode) Other Settings Live Data recording

(accessible on DOWNLOAD window) Chart Data time interval

(accessible on Home Screen) BIS graph display scale

(accessible on Home Screen) On, Off On 1, 5, 10, 15, 30, 60 minutes 15 minutes 1 hour, 6 hours, 12 h, 24 hours 1 hour BIS Advance Monitor 185 5. Data Storage, Transfer, and Export 5.1. Cybersecurity and Data Integrity Caution: Do not connect any device to RS-232 (serial) port on the docking station (reference 2.2.3 Docking Station on page 51) other than an approved RS-232 cable. RS-232 cable is supplied by the customer. Caution: Do not connect any USB cables to the USB port on the monitor

(reference 2.2.1 BIS Monitor on page 43) or to the USB port on the docking station (reference 2.2.3 Docking Station on page 51). The USB ports are intended only for the connection of a USB flash drive. USB flash drives that can be used with the monitor must have a capacity of at least 0.5 GB. Caution: The BIS Advance monitor has been validated for use only with the BIS sensor. Electrodes or sensors that are not validated for use with the monitor have not undergone a data integrity analysis and may potentially impose a data security risk. For a list of sensors, reference Table 33. BIS Advance Monitor Components and Sensors on page 252. Caution: For software updates, only use Medtronic's authorized software. 5.2. Monitor Data Memory The following events are continuously logged in the monitor data memory with a unique ID for easy identification. This data is used to generate the various logs available for export, as described in 5.9 Logs Export on page 199. BIS Advance Monitor 186 BISx Data Memory Alarm Messages (messages displayed in alarm bar) Modal Messages (messages displayed in message windows, i.e., Connect BISx to start monitoring) Information messages (messages displayed in message bar) 1. 2. 3. 4. 5. 6. 7. 8. User Event Marking System Events BISx module Errors Monitor Errors User GUI Events (events in which user performed a GUI-related action) The system log can hold up to 1,000,000 records or up to 50 cases, whichever is smaller. (The system log differs from the monitor log in that it includes data about the system as well as data about the patient.) If the log reaches a capacity of 50 cases, the earliest complete case will be deleted upon the opening of a new case. If the log reaches a capacity of 1,000,000 records, records (but not a complete case) will be deleted upon the addition of new records. Data recorded in the log will be retained even if the monitor battery has been discharged and will be retained when the monitor and BISx are powered off. 5.3. BISx Data Memory The BISx stores processed EEG parameters, including the BIS value, with time and date of acquisition. History data saved in the BISx can be accessed by exporting it to a removable drive using the Download function. The duration of BISx data saved is approximately 1200 hours. To view BISx history for a specific case, the user must first identify which BISx was in use during the case by looking up the BISx serial number, as follows: Main Menu>Settings and Maintenance>Maintenance>Logs>BISx Connection log. The appropriate serial number BISx can then be connected to any monitor to export its History Data. To download BISx history, connect the relevant BISx unit, but do not connect a sensor. Attach a USB flash drive to the monitor. Select Main Menu>Download>BISx Saved Cases>Download. The BISx memory will be downloaded. BIS Advance Monitor 187 Live Case Export When the BISx memory is full, the oldest data are automatically erased as new data are saved. Memory will be retained even if the monitor battery has been discharged and will be retained when the monitor and BISx are powered off. 5.4. Types of Exported Data The types of data that can be exported from the monitor include the following:

Live Case Data Saved Cases on the monitor Saved Data on the BISx module 1. 2. 3. 4. Snapshot (if recorded, a Snapshot is exported as part of Monitor Saved Data) To enable any data export from the monitor, insert a USB flash drive. USB flash drives that can be used with the monitor must have a capacity of at least 0.5 GB. To export data, see the descriptions for export of each type of data. In each case, an export will create a folder with a series of files on the USB flash drive to which the data has been exported. Some of the files are pdf files or txt files which are easily viewable. For a better understanding of the files that cannot be viewed easily, consult the BIS Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com. 5.5. Live Case Export Live recordings of data, including unfiltered EEG waveforms, may be downloaded to a USB flash drive during monitoring. Live Case data cannot be downloaded from a Demo Case. To export Live Case data:

1. 188 Attach a USB flash drive to the USB flash drive port on the monitor or the docking station. (For location of the ports, reference Figure 3. The BIS on page 44 and Figure 9. BIS Advance Docking Station, Front View on page 52.) BIS Advance Monitor 2. 3. 4. 5. 7. 8. Live Case Export Download of Live Case data cannot commence unless a USB flash drive is connected to the monitor or the docking station. Live Case data can be exported during monitoring only, only when a USB flash drive is connected to the monitor (either directly to the monitor or via the docking station). Commence monitoring. Click Main Menu>DOWNLOAD. Select Live Case. The left button in the middle of the screen will display a grey circle. Click this button , so that it will display a red circle and the word REC in red will appear next to Live Case at the left side of the window. When Live Case recording is on, and a flash drive is connected to receive the Live Case recording, the Live Case icon will appear at the top right side of the home screen (reference 3.10.9 Home Screen Indicators and Messages on page 114). Live Case data will begin recording onto the USB flash drive. The Live Case icon at the top right side of the home screen (reference 3.10.9 Home Screen Indicators and Messages on page 114) will indicate that Live Case recording is on. 6. Live Case data download will continue until one of the following occurs:

The monitor is shut down The USB flash drive is removed Live Case data download is stopped by turning Live Recording off by clicking the right square in the Live Case DOWNLOAD window. The case ends The operator removes and reinserts or switches the sensor or the BISx module (which will start a new case). If the operator removes and reinserts or switches the sensor or the BISx module (which will start a new case), Live Recording must be set to ON again before download can commence. The Live Recording default setting is OFF. Live Recording should be set to ON as described above before each new case. BIS Advance Monitor 189 Live Case Export 9. To terminate Live Case Recording, best practice is to first terminate the case by removing the sensor from the patient, and then to remove the USB flash drive from USB flash drive port on the monitor or the docking station. Figure 62. Live Case Recording Screen 1 2 3 4 5 1 2 190 Label Function Description Download Options List of download options. In this case, Live Case is the selected option Recording indicator text The word REC in red indicates that Live Case recording is going on BIS Advance Monitor Live Case Export Live Case main recording indicator The Live Case icon in the middle of the screen indicates that Live Case recording is going on Not-recording indicator CLOSE button Click this icon to turn off Live Case recording Click this button to close this window. Closing this window will not affect downloading. Upon Live Case download, a folder with the name LMMDDHHMM (for description of file name, reference Table 20. Live Data Export File Names Conventions, below) will be created in the root folder of the USB flash drive. The folder will contain 9 files for each live export, as listed in the table below. Table 20. Live Data Export File Names Conventions Variable in File Name Explanation 3 4 5 L MM DD HH MM a

.ar .e .f .h .m .o .r2 .sp .t Live Data Month of recording Day of recording Hour of recording Minute of recording Fixed suffix, depending on file type. Each file in the folder will have its relevant suffix. The last letter of the file name extension

(a) is the default option. If a file with the same base name exists, a will be changed to the next available letter. BIS Advance Monitor 191 Saved Cases Export The Live Data Export file will include the information described in Table 22. Data Export Files on page 197. 5.6. Saved Cases Export Both the monitor and the BISx module will contain saved data, and both types of saved data may be downloaded. To download either type of data, monitoring must not be taking place. Thus, to download data from the monitor, remove the sensor from the BISx unit or remove the BISx unit from the monitor. To download saved data from the BISx module, ensure that the BISx module is connected to the monitor (but no sensor is connected to the BISx module). For information on the data that is available in saved cases export, reference 5.8 BIS Saved Data Files on page 197. To export saved cases:

1. 2. 3. 4. 5. 6. 192 Ensure that the monitor is not currently monitoring a patient - that is, there is no current open case. If there is an open case, remove the sensor or the BISx module to end the case. Attach a USB flash drive to the USB flash drive port on the monitor or the docking station. (For location of the ports, reference Figure 3. The BIS on page 44 and Figure 9. BIS Advance Docking Station, Front View on page 52.) If you want to download data from the BISx module, connect the BISx module to the monitor. Click Main Menu>DOWNLOAD. Select Monitor Saved Cases or BISx Saved Cases, as desired. Download from the monitor or the BISx module is disabled during monitoring. To download Monitor Saved Cases, select the desired case by checking the check box next to the desired Case ID on the Monitor Saved Cases screen that will open. The list of cases can also be searched by Date &

Time or Case ID, using the Filter function. Click Next. Select the desired data types to download by clicking in the checkboxes to display check marks in the checkboxes for the selected data types. Click DOWNLOAD and the download will begin. Please note that the USB flash drive must remain connected during download. BIS Advance Monitor Saved Cases Export 7. 8. 9. To download BISx module saved cases, attach a BISx module to the monitor, but do not attach a sensor. Select the BISx SAVED CASES option. Click DOWNLOAD to download all data on the BISx module. When the download is complete, the Monitor Saved Cases or BISx Saved Cases window will display a message indicating that the download has been successfully completed. At this point the USB flash drive may be removed from the USB flash drive port on the monitor or the docking station. The data types which can be exported for Monitor Saved Cases are listed in Table 21. Monitor Saved Cases Export, below. Monitor saved cases folder names are created according to the following convention:

Folder name is M-CCCC-MMDDHHmm M = Monitor CCCC = case ID MM = month (01-12) DD = day (01-31) H = BISx module MM = month (01-12) DD = day (01-31) SN = Serial number BIS Advance Monitor HHmm = hour (00-23) and the minute (00-59) (Date and time info refer to the case start time, except for Snapshot folders, for which the refenced time is the snapshot event time.) For BISx module saved cases, the following folder name conventions are used:

Folder name is HMMDDHHmm_SNXXXXXXX HHmm = hour (00-23) and the minute (00-59) (All date and time info refer to the download time) 193 Saved Cases Export XXXXXXX = serial number of BISx module Table 21. Monitor Saved Cases Export Options Option Description Folder Name DHMMDDHHmm Case History data A folder containing 9 files with case history data. The types of files are described in Table 22. Data Export Files on page 197.

(For a better understanding of the files, consult the BIS Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic. com.) Snapsh ot A snapshot file will only be created if a snapshot event is created during the case. For description of the snapshot file, reference 5.7 Recording a Snapshot on page 195. A BIS report in pdf format showing BIS graphical and tabular data for the period covered in the export. The report also provides SQI and EMG data for each point in time alongside the BIS data in the table, as well as ASYM data for a report covers 4-channel monitoring. The data in the table shall be displayed in 1-minute intervals. Table 194 ScrCap_CCCC_DDMMYYYHHmm SS.pdf

(CCCC is a four character case ID, DD is a day [1-31], MM is a month

[01-12], YYYY is a four digit year, mm is 2 digit minute [00-59], and SS is a 2 digit second [00-59]. The timestamp represents the time of the snapshot event.) BIS_CCCC_DDMMYYYY_N-M

(CCCC is a 4-character case ID, DD is a day [1-31], MM is a month [01-

12], YYYY is a four digit year, N is the first page [1], M is the last page [2]) BIS Advance Monitor Recording a Snapshot Event DSA_CCCC_DDMMYYYY_N-M.pdf

(CCCC is a 4-character case ID, DD is a day [1-31], MM is a month [01-

12], YYYY is a four digit year, N is the first page [1], M is the last page [2]) DSA Report A DSA report in pdf format showing DSA chart data and BIS data for the period covered in the export. The data included in this report include:

1. SEF, MF 2. Frequency band scale labels 3. For 2-channel monitoring: DSA and BIS Trend 4. for 4-channel monitoring:

ASYM, DSA left and right, and BIS trend All date and time info refer to the case start time. Download of BISx module Saved Cases will download all data saved in the BISx module at once. The BISx module Saved Cases export will include the following files:

HMMDDHHmm_SNXXXXXX.m_a MMDDHHmm_SNXXXXXX.spa The data includes data saved in the BISx module: BIS values, SQI, EMG, and other related data at one-minute intervals. Data is identified by date and time (not by case IDs). For an explanation of the file types, reference 5.8 BIS Saved Data Files on page 197. For a better understanding of the files, consult the BIS Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com. 5.7. Recording a Snapshot Event The Snapshot feature is used to capture a current screen shot as well as the preceding 10 minutes of case data, at any time during a case. The Snapshot feature is BIS Advance Monitor 195 Recording a Snapshot Event available only during a currently running case. A Snapshot cannot be recorded during Demo Mode. If a snapshot is recorded as described in this section, the snapshot files will become part of the record for that case. Thus, if you download case data for a case for which a Snapshot has been recorded as described, the downloaded case data will include a Snapshot folder. To create a Snapshot event:

Create a Snapshot from a currently running case by clicking the SNAPSHOT button in the left Menu bar. Click OK to save the data with the automatically generated Snapshot name, or change the Snapshot name and then click OK to save the snapshot with a file name of your choice. If you select a name, please note that, as the monitor uses an English keyboard only, all inputted letters must be available on the English keyboard. Figure 63. Snapshot Window When the user presses OK in the SNAPSHOT window, the system will create a separate sub folder for every Snapshot, named SNAP_EVENT_ID-MMDDHHmmss, in the Monitor's Saved Cases folder. For each Snapshot event, it will create three folders, as follows:

A screen capture of the BIS home screen at the time of the snapshot event

(in pdf format) A page displaying EEG charts from the 10 minutes preceding the snapshot event (in pdf format) named EEG_CCCC_DDMMYYYYHHmmSS where CCCC is case ID, YYYY is a four digit year, MM is 2 digit month (01-12), DD is a 2 digit day (1-31), HH is 2 digit hour, mm is 2 digit minute and SS is 2 digit second. (e.g., EEG_Wv2I_19062007141744). The timestamp represents the earliest time of the EEG snapshot. A Snapshot data sub-folder named SMMDDHHMM with BIS data files as described in 5.8 BIS Saved Data Files on page 197. BIS Advance Monitor 1. 2. 1. 2. 3. 196 The records are written from the earliest time to the latest time. BIS Saved Data Files 5.8. BIS Saved Data Files Each type of export will create a folder with a series of files on the USB flash drive to which the data has been exported. The folders will include pdf files (described in the relevant sections) and a series of data files. For a more detailed explanation, consult the BIS Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com. Table 22. Data Export Files File Type File Suffix Explanation Artifact ar The Artifact binary file contains all the artifact flags from the period covered by the Processed Data file, and a Marker file, containing data regarding the monitor upon which the data was recorded, including its serial number, revisions, etc., as well as impedance messages and sensor check messages. The Error file lists errors that may occur during the case, including the following: Alarms Messages, Information Messages, System Event

- Raw EEG missing packets (ID=25003), System Event - ProcVars missing packets (ID=25004), drop in RAW EEG or ProcVars data packets. The Spectra file is a readable text file displaying raw spectra values for 2 or 4 channels. It includes: "S_HDR3", Platform name, Software version, "Time", "Spectra"- for 2 channels or "Left Spectra","Right Spectra" - for bilateral, and time. The Header binary file includes the following data: Hours, minutes and seconds of Monitor current time, software revision 4 numbers followed by -1, Raw EEG data file size, current time in Epoch/Unix time. 197 Error Spectra Header e f h BIS Advance Monitor BIS Saved Data Files Marker file m Processed variables file sp 198 Date - Month Day Year Time - HH:MM:SS - in 24-hour format Log type - ALARM or CLEAR Name of Event User Initialed event unique ID The Marker file will include the following data:

BIS R2 Revision Information, BIS R2 Serial Number, Application revision, Platform revision, Serial protocol revision, Hardware revision, BISx module Revision Information, BISx module serial number, BISx module Software revision, BISx module Hardware revision, BISx module Serial protocol revision, Algorithm revision, Case ID, and current time for each line in marker file. A Raw EEG data file (named LMMDDHHMM.r4a for the 4-channel system and LMMDDHHMM.r2a if using a 2-channel system). For snapshots, raw EEG data records are included in the Raw EEG file for 10 minutes preceding the Snapshot, or less than 10 minutes if less than 10 minutes have between the start of the case and the Snapshot. Processed data file, listing the BIS system processed variables, including (but not limited to): Spectral Edge Frequency (SEF 95), SEF 50, Bispectral Index , Alternate BIS Value , Second Alternate BIS Value, EMG, Signal Quality Index

(SQI), IMPEDANCE, Second artifact, BURST BIS Advance Monitor Offset o The Offset File will include the following data:

BIS R2 Revision, SAD, Delimiter Tab, NaN, SAD, and Time Raw EEG r2 or r4 count, and, for 4-channel monitoring, ASYM, Standard BIS, and Standard EMG. Logs Export Time t The Time File includes current monitor time. 5.9. Logs Export The user can download various logs to aid in troubleshooting and other analysis. The logs that are available for download are listed in the sections below. The BISx module Connection, Sensor connection, and System logs are provided in English only. The Monitor log will be in the current monitor GUI language. To download any of these logs, click Main Menu>Settings and Maintenance>

Maintenance>Logs. Download of the logs is not available during monitoring. Thus, disconnect the sensor from the BISx unit or disconnect the BISx module from the monitor before log download. However, note that the sensor connection log can be downloaded only with a BISx module (without a sensor) connected to the monitor. Any of the four logs listed in the sections below can be selected. The logs can be accessed both in User mode and in Administrator Mode. The monitor data memory is used to generate the various logs available for export. If the monitor data memory is full, the records of the earliest case will be deleted. Memory will be retained even if the monitor battery has been discharged and will be retained when the monitor and BISx are powered off. 5.9.1. BISx Module Connection History The BISx Connection History log provides a list of BISx modules that have been connected to the monitor (including the monitor currently connected, if a BISx unit is currently connected), with the following details for BISx connection events:

Date and time of connection BISx module/BISx4 module Serial number BISx module/BISx4 module Serial software version Date and time of start case BIS Advance Monitor 199 Logs Export

"Demo Case," if this display was display of a demo case The file name of the BISx connection history file will be as follows:

nx_bisxcDDMMYYYYHHMMSS_SNNNNNNNNN.log, on the basis of the same variables used in the system log file name, except that nx_bisxc for BISx Connection will replace s. 5.9.2. Sensor Connection History The sensor connection history log provides information about all sensors that have been connected to the BISx module. Sensor Connection History may be downloaded only when a BISx module is connected to the monitor but not sensor is connected. The log will be created in a folder named SDMMDDHHmm_SNXXXXXXXX in the root of the connected USB drive, on the basis of the same variables used in the system log file name, except that SD for Sensor Connection will replace s. The downloaded information will include:

BISx module serial number BISx software revision Number of data records expected 200 Log date/time Sensor LOT CODE Shelf life Usage count Sensor type Checksum Time in seconds, minutes, hour, day, month, year BIS Advance Monitor Logs Export 5.9.3. Monitor Log The Monitor Log includes the serial number of the monitor, SW Revision Number, and all saved events on the monitor, displayed in tabular format. The listed events include:

Alarm Messages (messages displayed in alarm bar) Modal Messages (messages displayed in message windows, i.e., Connect BISx to start monitoring) Information messages (messages displayed in message bar) User Event Marking For each line, the following data is provided:

Date - in the format DD MM YYYY (day month year) Time - HH:MM:SS - using 24 hour clock format Message ID Message Message status for alarms only (initiated, cleared) The file is named m_logDDMMYYYYHHmmSS_SN_NNNNNNNN.log, based on the following:

1. 2. 3. 4. 1. 2. 3. 4. 5. m preset, denotes monitor _log preset DD Download day MM Download month YYYY Download year HH Download hours mm Download minutes BIS Advance Monitor 201 Logs Export SS Download seconds SN preset, denotes serial number NNNNNNNNNN monitor serial number The data in the Monitor Log is included in the System Log. 5.9.4. System Log The System Log include identifying data (serial number of monitor and software revision number), as well as the records listed below. It differs from the monitor log in that it includes data about the system as well as data about the patient. The System Log includes the following data:

Alarm Messages (messages displayed in alarm bar) Modal Messages (messages displayed in message windows, i.e., Connect BISx to start monitoring) Information messages (messages displayed in message bar) Message status for alarms only (initiated, cleared) User Event Marking System Events BISx module Errors Monitor Errors User GUI Events (events in which user performed a GUI-related action) The System Log file is named s_logDDMMYYYYHHmmSS_SN_NNNNNNNN.log., on the basis of the same variables used in the monitor log file name, except that s for system will replace m. This file will appear in a folder that will be created, titled:

System_DDMMYYYYHHMMSS_SN_XXXXXXXXXX (where DD=day, MM=month, YYYY=year, HH=hour, MM=minute, SS=second, XXXXXXXXXX=serial number). BIS Advance Monitor 1. 2. 3. 4. 5. 6. 7. 8. 9. 202 Viewing and Printing Saved Data in PDF Format 5.10. Viewing and Printing Saved Data in PDF Format Some of the reports downloaded in the process described in 5.5 Live Case Export on page 188 and 5.6 Saved Cases Export on page 192 can be viewed in pdf format (with no need for additional processing). For a better understanding of the files that cannot be viewed with a pdf viewer, consult the BIS Advance Monitor Export Data Technical Specification document, available via BISTechnicalsupport@medtronic.com. The reports in pdf format are listed and described in Table 23. BIS Advance Reports in PDF format, below. Table 23. BIS Advance Reports in PDF format Option Description Snapshot: folder name SNAP_X_CCCC_ DDMMHHmmss

(X is a consecutive number numbering the snapshot and mmss denotes the minutes and seconds of the snapshot time) Snapshot screen capture pdf file name is : ScrCap_CCCC_ DDMMYYYYHHmmss Screen shot of BIS Advance home screen at the time the Snapshot was recorded, along with identifying data, including Serial number of the monitor, Monitor software version, BISx module software version, and case ID identifying data, date in which the report is generated, Case ID, Event ID

- # of snapshot event, and Snapshot time - date and time. Snapshot EEG report in the EEG Report sub-folder in the Snapshot folder: named EEG_CCCC_YYYYMMDD_N-

M.pdf where CCCC is a case ID, YYYY is a four digit year, MM is 2 digit month (01-12), and DD is a 2 Each pdf 2-Channel EEG graph displays 10 seconds of EEG data, and includes 2 EEG sub graphs (channel #1 EEG sub-graph and channel #2 EEG sub-graph) for 2-

channel monitoring and 4 BIS Advance Monitor Download Options As part of the Snapshot folder in a download of a Monitor Saved Case, if a Snapshot event was created during monitoring As part of the Snapshot folder in a download of a Monitor Saved Case, if a Snapshot event was 203 Viewing and Printing Saved Data in PDF Format Option Description digit day (1-31), N is the first page

(1), M is the last page(2). EEG sub-graphs for 4-

channel monitoring mode. Download Options created during monitoring Each 2-channel EEG PDF page includes 3 EEG graphs with different time slots, all of which will display time labels at 1 second spacing. The pdf includes identifying data, including date in which the report is generated, Case ID, Start and end date and time, Serial number of the monitor, Monitor software version, and BISx module software version. A BIS report in pdf format showing BIS graphical and tabular data for the period covered in the export. The report also provides SQI and EMG data for each point in time alongside the BIS data in the table, as well as ASYM data for a report covers 4-

channel monitoring. The data in the table shall be displayed in 1-minute intervals. For 4-channel monitoring, the pdf displays two side-by-

side charts for the left and right hemispheres respectively. Data in the chart and table PDF report will include: Date in which the report is As part of Monitor Saved Cases BIS Advance Monitor Table (in Monitor Saved Cases) Upon activation of Chart and Table export, the software shall create sub folder named BIS_CCCC _ DDMMYYYYHHmmSS in the Case History folder. For the 2-channel system: the PDF report is named BIS_CCCC_YYYYMMDD_N-

M.pdf For the 4-channel system, the Chart/Trend PDF reports, are named BIS_L_CCCC_YYYYMMDD_N-

M.pdf and BIS_R_CCCC_YYYYMMDD_N-

M.pdf for the left and right hemispheres respectively. 204 Option Description Viewing and Printing Saved Data in PDF Format Download Options DSA Report The DSA report is named DSA_CCCC_YYYYMMDD_N-

M.pdf A DSA report in pdf format showing DSA chart data and BIS data for the period covered in the export. The data included in this report include:

As part of Monitor Saved Cases generated, Case ID, Case start - date and time, Case end - date and time, Serial number of the monitor, Monitor software version, Copyright data and copyright symbol , BISx module software version. 1. SEF, MF trend lines (on DSA graph) 2. Frequency band scale labels 3. DSA and BIS Trend for 2-

channel monitoring 3. ASYM (for 4-channel monitoring) 4. DSA left and right (for 4-

channel monitoring) 6. BIS trend for 4-channel monitoring BIS Advance Monitor 205 6. Service and Maintenance 6.1. Introduction This section describes the steps required for service and maintenance of the monitor. 6.2. Servicing the BIS Advance Monitor Any type of service other than battery replacement may be performed only by authorized service technicians. Information regarding service is provided to service technicians in a separate service manual. For more information regarding servicing the monitor, contact BISTechnicalsupport@medtronic.com. For battery replacement, reference 6.3 Battery Handling, below. WARNING: When no longer in use, this electronic equipment must be recycled or disposed of properly. Follow local ordinances for the safe disposal of electronic equipment. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. Note: Do not service the device when it is attached to a patient. 6.3. Battery Handling Check the battery annually by operating a BIS Advance monitor that has been disconnected from the wall socket and that has been charging the battery for at least 4 hours when the monitor is powered off or 8 hours when the monitor is functioning. If the monitor fails to operate reliably from the battery for at least one hour, battery replacement is required. BIS Advance Monitor 206 Battery Handling After storage for three months or longer, charge the battery until it reaches at least an 80% charge level; battery charge will be indicated by the battery indicators. Battery capacity indicators are described in 3.3.3 Battery and Power Usage on page 63. If the monitor fails to operate reliably from the battery for at least one hour when fully charged, battery replacement is required. To charge the battery, place the battery in the monitor battery compartment as seen in 3.3.2 Battery Pack Removal and Installation on page 61, and attach the device to AC power, either directly or via the docking station, via the power connectors described in 2.2.1 BIS Monitor on page 43 and 2.2.3 Docking Station on page 51. To provide battery power sufficient to power the monitor for at least 1 hour, charging time is up to 4 hours when the monitor is powered off and up to 8 hours when the monitor is functioning. Note: It is recommended to use a protected ESD environment when replacing the battery pack. The battery can be replaced by the user, as follows:

Remove the monitor from the docking station. Obtain a replacement battery, as listed in Table 34. BIS Advance Accessories on page 252. Remove the battery in the tablet, as described in 3.3.2 Battery Pack Removal and Installation on page 61. Place the new battery in the monitor, as described in 3.3.2 Battery Pack Removal and Installation on page 61. If your institution maintains an equipment log, record the replacement of the battery and the identifying data of the new battery in this log. Dispose of the original battery in accordance with national and local waste disposal legislation and requirements. WARNING: Electrical Shock Hazard: Do not remove battery compartment cover during operation or while power is connected to monitor. WARNING: Only the battery pack provided with this monitor should be used for the monitor. Do not use another battery or a refurbished battery. Use of another battery or a refurbished battery may cause damage to the monitor or BIS Advance Monitor 207 1. 2. 3. 4. 5. 6. Cleaning the BIS Advance Monitor endanger the user. Reference Table 34. BIS Advance Accessories on page 252 regarding the battery pack. Caution: Check the battery annually by operating a BIS Advance monitor that has been disconnected from the wall socket and that has been charged for 4 hours when the monitor is powered off or 8 hours when the monitor is functioning. The monitor should function for at least one hour on battery power only. Caution: The BIS Advance monitor contains an internal lithium ion battery. The battery must be disposed of or recycled with national and local waste disposal legislation and requirements. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. Caution: Replace the removable battery if an on-screen message informs you that this is required, or if more than seven years have passed since the production date marked on the battery, whichever comes first. To obtain a new removable battery, contact BISTechnicalsupport@medtronic.com. The manufacture date of the battery can be identified as follows:

The battery's serial number appears on a label that is affixed to the battery just above the main label on the right side. The first three alphanumeric characters in the serial number are letters. The next four characters are numerals which make up the date code, in which the first two numerals indicate the year of manufacture (22 for 2022, for example) and the next two numerals indicate the week of manufacture (01 for the first week of the year, for example). 6.4. Cleaning the BIS Advance Monitor 6.4.1. Cleaning the BIS Advance Monitor and BISx Module WARNING: Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Contaminated materials should be disposed of in accordance with national and local waste disposal legislation and requirements. The BISx module and the monitor should be cleaned using approved cleaning materials only. 208 BIS Advance Monitor Cleaning the BIS Advance Monitor Clean any spillage of blood or solutions on the surfaces of the monitor, docking station, adapter cable or BISx module as soon as possible. Dried blood is very difficult to remove. Use lint-free absorbent towels for spill cleanups. Dampen the towel with detergent and lukewarm water to aid in cleaning. After cleaning, wipe the PIC connector ends with alcohol and allow to dry completely. Residual moisture inside the connector may affect BISx module performance. The surfaces of the tablet, docking station, adapter cable, and power supply may also be cleaned using the following materials:

Lint-free cloths for use with cleaning agent Appropriate cleaning agent, as follows:

Ethanol 70%

Isopropanol 70%

o o o o Hydrogen Peroxide solution 0.5-1% concentration Sodium Hypochlorite solution 6500 ppm (household bleach diluted approximately 1:10) 6.4.2. Disinfecting the BIS Advance System Use lint-free absorbent towels dampened with a 10% bleach solution, or a commercial disinfectant (e.g., Lysol* Professional Disinfectant Foam Cleaner Spray or PDI Germicidal Disposable Wipes) to clean the surfaces of the monitor, docking station, adapter cable and BISx module. After cleaning, dry all areas except the monitor display screen (see 6.4.3 Cleaning the Monitor Display on page 210) with a lint-free absorbent paper towel. Wipe the BISx module and PIC connector ends with alcohol and allow to dry completely. WARNING: Whenever an event such as spillage of blood or solutions occurs, re-

test leakage current before further use. Caution: Do not autoclave the BISx module or monitor. Autoclaving will seriously damage both components. Caution: Avoid liquid ingress to the Patient Interface Cable (PIC), which is an integral part of the BISx module. Contact of fluids with the PIC sensor connectors can interfere with PIC performance. BIS Advance Monitor 209 Instrument Identification 6.4.3. Cleaning the Monitor Display Clean the monitor display screen with a mild solution of detergent and warm water or a commercial display screen cleaner, available through personal computer dealers. To avoid scratching the screen, never use abrasive cleaning materials. 6.5. Instrument Identification 6.5.1. Permanent Identification Marking The BIS Advance monitor identification information is permanently marked on the rear panel of the monitor. The information includes instrument model, GTIN, serial number, and date of manufacture. The BISx module identification information is permanently marked on the rear panel of the BISx module. The information includes instrument model and serial numbers and year of production. 6.5.2. Configuration Data on Monitor Configuration data regarding the monitor, BISx module, and sensor is available on the monitor. BISx configuration data will appear on screen only if a BISx module is connected, and the SENSOR CONFIGURATION screen will display information about the currently connected sensor only if a sensor is connected to the monitor. Take the following steps to access the Configuration Information screens:

Click the Main Menu button and select the Settings and Maintenance option. Select Maintenance>Configuration. Select either Monitor Configuration, Language, BISx Configuration, or Sensor Configuration. The data listed in Table 24. Monitor Configuration Data on page 211 will appear. 1. 2. 210 BIS Advance Monitor Instrument Identification Table 24. Monitor Configuration Data Configuration Type Available Data Monitor Configuration Monitor software, BIOS, OS, OS image version, Monitor serial no., Demo file, Serial port (MPM) protocol revision, BISx protocol revision, Hardware revision, Splash screen revision Language Configuration Displays Version of language pack for each installed language BISx Configuration BISx/BISx4, Serial Number, Software Revision, Software Checksum, FPGA Revision, SIC Revision, Hardware Revision, Protocol Revision, Algorithm Revision Sensor Configuration Lot Code, Serial Number, Sensor Type BIS Advance Monitor 211 Diagnostics 7. Diagnostics and Troubleshooting 7.1. Diagnostics 7.1.1. DSC Self-Test The Digital Signal Conversion (DSC) Self-Test verifies the signal acquisition and conversion functions of the BISx module, and tests the entire signal processing chain inside the BISx module. It does not test the PIC or the sensor. The BISx module must be connected to perform DSC self-test; a sensor may be connected but is not required. The DSC Self-Test analyzes Noise, High-Pass Blocked, High Pass Normal, and Gain data from two channels or four channels, depending on the type of system (two-

channel or four-channel). All results are in microvolts. The DSC Self-Test will return a PASS result if all channels pass the test, and a FAIL result if one or more channels fails the test. The numerical values for any channel that passes the DC self-test shall be displayed. To perform the DSC Self-Test, follow the steps listed below:

Click Main Menu>Settings and Maintenance>Maintenance>DSC Self-Test. Click START. The DSC Self-Test will proceed; an on-screen message will indicate DSC Self-Test is in progress. The DSC Self-Test cannot be stopped during the process. When the process is complete, the screen will either indicate DSC Self-

Test PASS or DSC Self-Test Failed at the bottom of the screen. If the BIS Advance Monitor 1. 2. 3. 4. 212 monitor fails the DSC Self-Test, consult BISTechnicalsupport@medtronic.com for the next steps to take to continue working with the monitor. Diagnostics 7.1.2. EEG Filters The monitor automatically turns on EEG filters in order to filter out undesirable interference from the raw EEG signals. The notch filter handles both 50 and 60 Hz interference. The EEG filters for the display support the following modes: ON: 2 - 70 [Hz]; OFF: 0.25-100 [Hz]. The EEG filters also include high and low pass filters. The user may want to view the EEG signals without filters, to aid in troubleshooting in case of problems. If so, the filters may be turned off by the user. For instructions on how to turn off the filters, reference 3.15.3.2 EEG Display on page 131. 7.1.3. Impedance Checking When a BISx module and sensor are connected to the monitor, the BIS Advance monitor continually checks impedance levels automatically by generating a 128 Hz test signal. If the user is actively monitoring a patient, but is experiencing interference from other equipment, the user may want to turn off this 128 Hz impedance test signal to reduce the interference. For instructions on how to turn off the automatic impedance check, reference 3.15.3.3 Impedance on page 133. For additional information about impedance , reference 7.5 Glossary on page 223. 7.1.4. Artifact Detection The BIS Advance monitor automatically performs artifact detection. There are no user-changeable settings regarding artifact detection. If no artifacts are detected, monitoring will proceed. If the monitor detects an artifact, a message indicating Excessive artifacts in signal will appear on the message bar at the bottom of the screen. For four-channel monitoring, the message shall appear if artifacts are found in data from at least one of the hemispheres. BIS Advance Monitor 213 Troubleshooting 7.2. Troubleshooting In order to perform troubleshooting for issues that occur with use of the monitor, the following steps are recommended:

1. 2. 3. If a message appears on the monitor screen, locate that message in 4.3 Alarms and Messages on page 143, and follow the relevant instructions in that section. Check the list of issues in Table 25. BIS Advance Monitor Troubleshooting Scenarios, below, which covers issues which are not listed in the manual sections covering alarms and information messages (reference 4.3 Alarms and Messages on page 143). If the problem occuring on your monitor appears in this table, follow the relevant instructions in the table. If these steps do not resolve the problem, or if a problem which is not listed appears, contact BISTechnicalsupport@medtronic.com. Table 25. BIS Advance Monitor Troubleshooting Scenarios Scenario Possible Cause Recommended Action Sensor does not fit into PIC. Monitor does not turn on. Monitor does not turn on when placed in docking station. 214 The sensor may have been inserted into the PIC in the wrong direction. The monitor may not be receiving power, or battery may not be charged. Power supply may not be attached to docking station, or monitor may not be securely Turn the sensor over and reinsert the sensor. Reference illustration in manual. If the sensor still does not fit, contact BISTechnicalsupport@medtronic.com. Check cable, socket power status, power status of docking station, and charge level of battery. If needed, contact BISTechnicalsupport@medtronic.com. Check that power supply is attached to docking station and that monitor is securely placed in docking station. Reference 3.5 Preparing the Docking Station on page 68. If needed, contact BISTechnicalsupport@medtronic.com. BIS Advance Monitor Troubleshooting placed in docking station. Sensor may not be compatible with the BIS Advance monitor and the BISx module. Sensor may be expired or used up. Pins may need cleaning. Do not attempt to clean the pins. If needed, contact BISTechnicalsupport@medtronic.com. Use only sensors supplied by Medtronic. Use the correct sensor for the specific patient and BISx module. For more information about sensors, reference 2.2.5 BIS Sensors on page 56. Replace sensor. Monitor is not monitoring even though all components are connected. Sensor may not be adhered correctly to patient. Ensure all electrodes are securely fixed on patient and perform sensor check. If sensor does not pass the sensor check, replace sensor. PIC (the end of the BISx module that connects to the sensor) may be disconnected or faulty. If replacing the sensor does not solve the issue, disconnect and reconnect the PIC. If this does not solve the issue, replace the PIC and the entire BISx module. If needed, contact BISTechnicalsupport@medtronic.com. MIC (the end of the BISx module that connects to the monitor) may be disconnected or faulty. If replacing the sensor and/or the PIC does not solve the issue, ensure that the MIC is connected correctly to the monitor. If it is connected properly, replace the entire BISx module (the MIC is an integral part of the BISx module). If needed, contact BISTechnicalsupport@medtronic.com. BIS Advance Monitor 215 Troubleshooting Adapter cable does not connect to monitor The connection may have been performed incorrectly. Arrow on monitor and red dot on adapter cable must be lined up in order to connect. Reference Figure 7. Attaching the Adapter Cable to the Monitor on page 49. Touch screen not functioning properly:

Screen does not respond at all; discernable delay in use of touch screen;

touch screen is mis-aligned. Download not working Touch screen problem. Clean the touch screen with an approved cleaning solution. Restart the monitor. If needed, contact BISTechnicalsupport@medtronic.com. USB flash drive is full. USB flash drive does not fit into the USB port. Try to download using another USB flash drive. USB flash drives that can be used with the monitor must have a capacity of at least 0.5 GB. Try to download using another USB flash drive. LIVE DATA download option is not turned on. Check that live download is turned on

(reference 5.5 Live Case Export on page 188). Monitor is placed in docking station but connected to power via the power port on the monitor ; in this case a USB flash drive attached to the docking station will not work. Disconnect the monitor power connector, place the monitor securely in the docking station, and connect the docking station to AC power in order to use a USB flash drive in the docking station USB port. 216 BIS Advance Monitor Sensor check fails, even after the sensor has been replaced EMC interference Sensor check fails, even after the sensor has been replaced Faulty PIC Information from monitor does not appear on MPM, even though physical setup is correct The incorrect protocol is being used, or the docking station is not receiving power. Troubleshooting Read EMC guidance in manual (reference 7.7 Electromagnetic Compatibility Specifications on page 237) and readjust monitor and nearby appliances. 1. Ascertain if the PIC cable is functioning properly by running the sensor check with the sensor simulator attached to the patient end of the PIC cable instead of a sensor. 2. If the PIC cable functions correctly with the sensor simulator, and the sensor simulator passes the sensor check process, replace the sensor. 3. If the sensor simulator does not pass the sensor check process, replace the PIC and/or the entire BISx module. Check that serial communication port protocol in use is correct for the MPM

(reference 3.15.2 MPM Configuration on page 130). Check that the docking station

(to which the MPM cable is connected) is receiving power. (Data transfer to an MPM will not work when the docking station is not connected to AC power.) For docking station setup, reference 3.5 Preparing the Docking Station on page 68. Screen is dark and difficult to read Screen is in "sleep mode"

Touch the screen or one of the hard keys to revert to a brighter screen. If needed, contact BISTechnicalsupport@medtronic.com. Unexpected shutdown during operation Device port door is open and liquid has entered the device via this door BIS Advance Monitor IPX2 status is retained only if the monitor port door is closed. Ensure that monitor port door remains closed at all times. 217 Administrator Mode Audio output is not clear Stickers may be covering the device speakers. Software update failed Flash drive not connected correctly, flash drive not readable by monitor, incorrect file on flash drive Remove any stickers covering the device speakers. Stickers should be placed only on the battery area at the back of the monitor or on the docking station. If needed, contact BISTechnicalsupport@medtronic.com. If you are an administrator performing a software update, ensure that you have the correct files loaded onto a USB flash drive that is readable by the monitor and that the flash drive is connected to the docking station USB port or the monitor USB port;

the location of these ports is described in 2.2.3 Docking Station on page 51 and 2.2.1 BIS Monitor on page 43. If needed, contact BISTechnicalsupport@medtronic.com. For any questions regarding service or troubleshooting, please contact BISTechnicalsupport@medtronic.com. 7.3. Administrator Mode 7.3.1. Accessing Administrator Mode To enter the Administrator Mode screen, click Main Menu>Settings and Maintenance>Administrator Mode. There must be no sensor attached to the monitor in order to enter Administrator Mode. An Administrator password is required. Upon your first entry to the Administrator Mode, you will be asked to create an Administrator password. The selected password shall include eight to ten (8-10) characters, including at least one character from each of the following types: Upper case English letters, lower case English letter, and digits (0-9). An underscore symbol may also be used in the password. As the monitor uses an English keyboard only, all inputted letters must be available on the English keyboard. 218 BIS Advance Monitor Administrator Mode Record the selected password in a safe place. Input the selected password twice as requested by the software. Click SET PASSWORD and then CLOSE. The new password has now been set. Use this password for future entry to the Administrator section of the software. Record the selected password in a safe place; reset of the Administrator password will require a service technician. For more information, contact BISTechnicalsupport@medtronic.com. The Administrator Mode cannot be accessed when a sensor is connected. If a sensor is connected while the monitor is in Administrator Mode, the software shall exit Administrator mode and begin initializing the sensor for monitoring. In this case, the software shall automatically save all changed settings to Institutional Defaults and only then exit Administrator Mode. (If settings were changed but the Apply button was not clicked, the setting changes will not be saved.) If the Administrator user sets changes to the Institutional Default settings, the software shall set the new values as Institutional Default values. The Institutional Default settings will now replace the factory default settings, and appear as defaults at the start of each case, until they are changed again in Administrator mode. To exit Administrator Mode, click LOGOUT in the left bar menu. Please note that the monitor will also automatically exit the Administrator mode after 180 seconds of inactivity while in Administrator mode. A warning will appear after first 90 seconds of inactivity with a countdown. WARNING: The software shall reset all settings with defined default values, to Institutional Defaults upon the end of each case, excluding Institutional Default Language settings. The software will also reset all settings (including language) to Institutional Defaults upon the restart of the monitor. However, if a sensor for which certain settings were set (as described in 3.15.3 Advanced User Settings on 131, and whether changes were performed by a user or administrator) is re-attached, the monitor will apply the settings that were in place when that sensor was used last time. BIS Advance Monitor 219 Administrator Mode Figure 64. Administrator Mode Login Screen 1 2 3 4 Label Function Description Administrator Mode Select Main Menu>Settings and Maintenance>Administrator Mode to enter this screen Set Password field Input desired unique password into this field Verify Password field Re-input desired unique password into this field Close button Select Close (or select the X at the top right of the window) to close this window and work in Administrator Mode. 1 2 3 4 220 BIS Advance Monitor 7.3.2. Administrator Mode Actions Administrator Mode After the user enters a valid password and applies it, the software shall open the Administrator Settings and Maintenance menu and enable the Administrator user to perform the functions listed in this section. Administrator Mode Settings The user can modify defaults for the parameters listed in Table 19. Institutional Settings on page 181 while in Administrator Mode (except for those items listed in that table as not available in Administrator Mode). To adjust Institutional settings, enter Administrator mode, and then click Main Menu>Settings and Maintenance>Settings. Select the desired setting and make changes as required. The same settings can be adjusted by the user in standard mode, but in that case the settings will revert to defaults when a new case is started or when the monitor is turned off and on again. If changes are made and applied while in Administrator Mode, the changes will remain as active defaults on the monitor (that is, the institutional defaults) unless Factory Defaults are restored or changes are made in Administrator mode, even if the monitor is turned off and on again. In addition, some settings can be adjusted in Administrator Mode only. The settings and actions that are available only in Administrator Mode are listed below. For other settings, reference 4.6 Institutional Settings on page 180. Table 26. Administrator Mode Settings Feature Options Factory Default Option Enabled, disabled Disabled Settings EEG Testing (enable display of EEG test layout for EEG testing) (when ON, EEG Testing will appear in Display Settings list, until the current case ends or the currently used BIS Advance Monitor 221 Administrator Mode sensor is disconnected) Actions Erase Case Data Table 27. Administrator Mode Actions Screen Text Action Result Erase Data:

Cancel/Erase Data Will permanently clear all previous case data Factory Defaults Reset Settings:

Cancel/Apply Will reset all settings to factory defaults Users cannot enable/disable the Audio Off Reminder Audio Off Reminder

(in ALARM SETTINGS screen if entered while in Administrator Mode) Checkbox: check the checkbox to Allow users to disable/enable this reminder for their own sessions. Leave unchecked so that users cannot enable this reminder. Administrator Mode Maintenance In the Administrator Mode, the administrator can perform the same maintenance activities as the user, as described in 3.15.3.6 Administrator Mode Login on page 135. In additional, the Administrator can perform a software update, as follows;

Enter the Administrator Mode as described in 7.3.1 Accessing Administrator Mode on page 218. Select Settings and Maintenance>Maintenance>Software Update. A USB flash drive that fits the device and contains the required software update files should be prepared. Fit this flash drive into the USB port on the docking station. 1. 2. 3. 222 BIS Advance Monitor Glossary 4. Click NEXT and follow the instructions on the screen to update your monitor software. Caution: Do not disconnect the BISX unit during a software update. For more information regarding software updates, contact BISTechnicalsupport@medtronic.com. 7.4. Demo Mode The user can view either a 2-channel or a 4-channel Demo case. Demo cases can be viewed only if there is no BISx module connected to the monitor. In addition, please note that Demo Mode cannot be accessed while in Administration Mode. To view a Demo case, enter Demo Mode as follows: Click Main Menu>INFO>Demo Mode or INFO on left menu bar>Demo Mode. Select Initiate Demo 2-Channel or Initiate Demo 4-Channel, as desired. To exit Demo Mode, click the Exit Demo Mode button at the bottom of the left bar on the screen. Alternatively, connect a BISx module with a sensor connected to exit the Demo Mode. 7.5. Glossary Term Definition Administrator Institutional support personnel who perform BIS monitor configuration and sets Institutional Defaults. Administrator is responsible to configure Global Settings, User Advanced Settings, Alarms Settings and User Defined Layouts for an institute or a department. A temporary induced state with one or more of:

analgesia, paralysis, amnesia and/or unconsciousness. A patient under the effects of anesthetic drugs is referred to as being anesthetized. Anesthesia enables the painless performance of medical procedures that 223 Anesthesia BIS Advance Monitor Glossary Asymmetry Bilateral Sensor BISx module BIS Bilateral Sensor BISx4 224 would cause severe or intolerable pain to an un-

anesthetized patient. The percentage of total EEG power that resides in the left hemisphere of the brain. Available only with BISx4 and Bilateral Sensor. Calculated by BISx4 as: (Total Power Left / (Total Power Left + Total Power Right)) *

1000. The same calculation is performed for the right side of the brain, with (Total Power Right / (Total Power Right + Total Power Left)) * 1000. The brand name for the 4-channel sensor used with the BIS Monitoring system, used to monitor both sides of the brain hemisphere ("bilateral" = 2 sides). The small module that attaches to the BIS Advance monitor via its own monitor cable and to a BIS sensor via the Patient Interface Cable (PIC). It acquires and processes EEG information and sends it to the monitor for display. A module similar to BISx module that is used during 4-channel monitoring with BIS Bilateral Sensor. It can be used in place of a BISx module with other sensors as long as it is used with the PIC-4. A single patient use, disposable, pre-gelled 6-

electrode array that is applied directly to the patients forehead and temple to record and display four channels of EEG, two from each side of the brain. The BIS sensor tab contains an electric smart card memory device that stores configuration and Identification information. BIS Advance Monitor BIS Complete Monitor, BIS Vista Monitor Previous versions of the BIS Advance monitor BIS Sensor Extend Sensor Factory Defaults Impedance Glossary A single patient use, disposable, pre-gelled 4-

electrode array that is applied directly to the patients forehead to record electrophysiological signals. The BIS sensor tab contains an electric smart card memory device that stores configuration and Identification information. The brand name for the 2-channel (unilateral) sensor for use in the ICU. It is the same sensor as Quatro, but has space for time/date to be written on it, is smart chip detected, automatically sets smoothing rate to 30 seconds, and displays burst count. Default settings values defined by manufacturer. Factory Defaults are loaded as Institutional Defaults on the first system boot or when restored through Administrator Mode. The measure of the quality of the sensor electrodes contact; the amount of resistance that the electrical current encounters. Impedance is continuously monitored to ensure adequate signal quality. Institutional Defaults The default values for various settings which are defined by the Administrator for an institution or a certain department according to its requirements and policies. Isoelectric EEG Electrocerebral silence (flat EEG) or no significant electrical activity in the brain. Specifically, periods BIS Advance Monitor 225 Glossary

>240 msecs during which the electroencephalographic voltage did not exceed 5 V. Level of Consciousness

(LoC) Level of consciousness (LoC) is a measurement of a person's ability to be aroused and responsiveness to stimuli from the environment. Monitor Interface Cable

(MIC) The portion of the cable the connects the BISx module to the Monitor. It is integral to the BISx module. Patient Interface Cable

(PIC) The cable that connects the BIS sensor to the BISx module. It is integral to the BISx module. Patient Interface Cable-4

(PIC-4) A Patient Interface Cable that must be used when using the BISx4 module. It connects the BISx4 module to the BIS sensor. Pediatric Sensor The brand name for the 2-channel (unilateral) sensor used with the BIS Advance monitor for pediatric patients. The Pediatric sensor is suited for pediatric patients ages 4 and above. Quatro Sensor The brand name for the 2-channel (unilateral) sensor used with the BIS Advance monitor Sensor Simulator 226 The BIS Sensor Simulator is a service tool that allows for the verification of proper impedance values being detected by the BIS Monitoring System during the sensor check. This sensor is used for testing purposes only. BIS Advance Monitor Specifications 7.6. Specifications Specifications listed below are current for the time of manual printing. To obtain the most recent specifications, consult BISTechnicalsupport@medtronic.com. In case of any discrepancy, the data in the product specification to be supplied by BISTechnicalsupport@medtronic.com is considered authoritative. 7.6.1. General Specifications Item Value Unit Dimensions Monitor: 27.6cm (w) x 20.1cm (h) x 4.6cm (d) Docking station: 28.4 cm (w) x 23.8 cm (h) x 7.3 cm (d) Unit Weight Monitor: 1.2kg (2.6 lb) (1212g) Packaged Dimensions Docking station: 0.7 kg (1.5 lb) (743g) Monitor: 32.6 cm (w) x 24.9cm (l) x 10.5cm (h)

[12.8in (w) x 9.8in (l) x 4.1in (h)]

Docking station: 35.1 cm (w) x 27cm (l) x 10cm

(h) [13.8in (w) x 10.6in (l) x 3.9in (h)]

Packaged Weight Monitor: 2.3kg (5.1lb) Docking station: 1.1kg (2.4lb) Operating Temperature 0 C to +35 C (32F to 95F) 0C to +40C (32F to 104F) for BISx Operating Pressure and Altitude 107kPa (430m [1410ft] below sea level) to 54kPa

(5000m [16400ft] above sea level) for monitor, docking station and adapter cable BIS Advance Monitor 227 Specifications Item Value Operating Humidity 800 mm Hg (-457 [1500ft] below sea level) to 360mm Hg (6100 [20,000ft] above sea level) for BISx module 10% to 95%, non-condensing for monitor, docking station, adapter cable, power supply and removable battery Storage and Transport Temperature

-20 C to +60 C (-4 F to 140 F) for monitor, docking station and adapter cable

-10 C to +60 C (14 F to 14 F) for BISx module Storage and Transport Pressure and Altitude 107kPa (430m [1410ft] below sea level) to 54kPa

(5000m [16400ft] above sea level) for monitor, docking station and adapter cable Storage and Transport Humidity 10% to 95%, non-condensing, for monitor, docking station, adapter cable, power supply and removable battery 15% to 95% for BISx module Start-up Time Up to 2 minutes Ingress Protection marking Ingress Protection marking of the tablet, docking station, adapter cable, and power supply is IPX2;

this is applicable only if the door on the right edge of the tablet is closed. IPX2 protection of the docking station is applicable only if the tablet is connected to the docking station. For BISx and BISx4 modules, IP rating is IPX4 228 BIS Advance Monitor Specifications Item Value Protection Type Internally powered when operating on internal battery Class II with isolated functional earth when operating on AC power Degree of Protection Type BF (defibrillator-proof) Mode of Operation Continuous Isolation Electromagnetic Compatibility The system includes 2MOPP isolation in its power supply (PMB4000PWS), as well as 1MOPP isolation in the BISx module. IEC 60601-1-2 (3rd and 4th Edition) 7.6.2. Operating Environments The user should determine what mounting and use configuration best fits his needs, and order the relevant mounting accessories based on this decision. A list of the available mounting accessories appears in Table 34. BIS Advance Accessories on page 252. Table 28. OR Configurations Configuration BISx/BISx4 Unit Required Accessory Tablet Mounted in Docking Station 1 - OR Pole Mounted to a pole using clamp mount Clamped to the IV pole /

Clamped to the bed frame GCX clamp mount

(PMB4000PMT) BIS Advance Monitor 229 Specifications 2 - OR Anesthesia Machine Mounted to the post using a clamp mount Clamped to the IV pole /

Clamped to a handle on the anesthesia machine /

Attached to the bed frame 3 OR Desk Top Mounting Mounted to the tablet desktop mount Clamped to the IV pole /

Attached to the bed frame 4 - Transit IV Pole Mounted to a pole using clamp mount 5 - Transit on Patient's Bed NA Placed on the patient's bed or clamped to the IV pole Clamped to the patient's bed or placed on the patient's bed. Monitor and BISx unit should not touch the patient directly. One of the below, depending on requirements:

GCX clamp mount

(PMB4000PMT) Channel mount

(standard mount to be purchased separately) Pivot arm (standard mount to be purchased separately) Post (standard mount to be purchased separately) Desktop mount

(PMAC71STAND ) GCX clamp mount

(PMB4000PMT) GCX clamp mount

(PMB4000PMT) or no mount 230 BIS Advance Monitor Specifications Item Input 7.6.3. Power Supply Value 100-240 VAC, 10% 50-60 Hz, 1.5A Output Voltage and Power 19V DC, 3.15A ~ 4.73A Maximum System Power consumption Up to 25W Power supplied to system 60W 7.6.4. Battery Specifications Item Value Battery Type 2S1P -Lithium-ion Polymer Battery pack nominal voltage and energy Nominal Voltage -7.4V Nominal energy -38.036Wh Battery Operational Temperature During battery charging (when connected to AC power): 0 to 45 C Battery Charging Time When battery is not charging (when not connected to AC power): -20 to 60 C To provide battery power sufficient to power the monitor for at least 1 hour, charging time is up to 4 hours when the monitor is powered off and up to 8 hours when the monitor is functioning. Battery Storage Batteries may be stored for up to three months at

-20 C to + 45 C. BIS Advance Monitor 231 Specifications For time periods over three months, batteries should be stored at 253 C If the monitor is to be stored for three months or more, store the battery outside the monitor. 7.6.5. Controls and Connectors Item Value Monitor Front Panel Function button Home button ON/OFF button Connectors Power, microphone/earphones, USB, mini USB, reset button, HDMI, docking station connector Docking station RS-232, VGA, Network, USB, Power, dock for tablet RS-232 232 Serial port Baud rate:

9600 for ASCII protocol 57,600 for binary protocol 7.6.6. Alarms Item Audible Alarm Visual Alarm High Priority Alarm Beep pattern repeated every 5 1 seconds. Flashing red square under alarming parameter Medium Priority Alarm Beep pattern repeated every 7 1 seconds Flashing yellow square under alarming parameter BIS Advance Monitor Specifications Low Priority Alarm Single beep repeated every 17 1 seconds Yellow square under alarming parameter Messages Single beep None 7.6.7. Display Item Value Display size 10.1 Inch IPS Display with LED Backlight Active Display Area: 216.81 (horizontal) 135.50

(vertical) mm Display characteristics Multi-touch projected capacitive display Contrast Ratio 800:1 Brightness 600 nits TYP. Screen resolution 1920 (horizontal) x 1200 (vertical) pixels PPI (pixels per inch) 224.17 pixels per inch Pixel Pitch 0.11292 x 0.11292 mm Viewing angle Viewing angle (side) 140 Viewing angle (above/below) 120 Operator position for visibility BIS value: visible at up to 4 meters from the monitor EMG data: visible at up to 1 meter Graphs and status data: visible at up to 45 cm BIS Advance Monitor 233 Specifications 7.6.8. Sound Pressure Data Sound pressure values when measured at a microphone positioned in a distance of 1 m, behind the monitor, are as follows (higher value is when used with a docking station):

Item Minimum Volume Setting Maximum Volume High priority alarms 60-63 dB(A) Medium priority alarms 53-56 dB(A) Low priority alarms 47-50 dB(A) Info messages 47-50 dB(A) Setting 81-84 dB(A) 75-78 dB(A) 68-71 dB(A) 68-71 dB(A) 7.6.9. BIS Specifications Parameter Range Units Bispectral Index

(BIS) 0-100 Integer, absolute number SQI Number 0-100, where each bar is 20%

ASYM EMG 0-100%

decibels (dB)

30-80 dB as a trend 30-55 dB as a bar SR ST MF 234 0-100%

Percent Hours, minutes, seconds 00:00 to full case; case is up to 24 hours 1 Hz-30 Hz Frequency - [Hz] units BIS Advance Monitor SEF DSA EEG Specifications 1 Hz-30 Hz Frequency - [Hz] units NA (graphic representation) NA (graphic representation) V/mm Display gain 2, 5, or 10

[V/mm]

Burst Count Bursts/Minute 0 - 30 7.6.10. EEG Specifications Item Value Epoch Duration 2 seconds Artifact Rejection Automatic Input Amplifier Range 1 mV EEG Amplitude Default for all layouts which include an EEG graph: 50 V (full scale) In full screen layouts, option to view graph with 100 V amplitude In two-channel mode, 2 or 5 V/mm:

2 V/mm is default for full screen or screen EEG graph, and 5 V/mm is default for 1/3 screen EEG graph) 2 V/mm for full screen EEG graph 5 V/mm for screen EEG graph 10 V/mm for 1/3 screen EEG graph EEG Scale In four-channel mode, 2, 5, or 10 V/mm:

EEG Sweep Speed 6.25, 12.5, 25, or 50 mm/sec BIS Advance Monitor 235 Specifications Default 6.25 mm/sec Computed Parameters Bispectral Index, Suppression Ratio, Suppression Time, EMG, Signal Quality Indicator, and Burst Count User-defined Displays Trend and real-time EEG waveforms Update Rate 1 second for BIS number, 10 seconds for Trend Alarms Filters Mode Item Weight Auditory and visual, user adjustable limits ON (2-70 Hz with notch) or OFF (0.25-100 Hz) Sensor Automatically selects mode two-channel or 4-channel) 7.6.11. BISx Module Specifications Value 10.0 oz (0.284 kg) including integral cable Dimensions 3.75 in. (9.5 cm) diameter x 2.5 in. (6.3 cm) thick Cable Length 9 ft (2.7 m) Integral BISx Cable 4 ft (1.4 m) from BISx to sensor connector Analog to Digital Converter Noise-shaped sigma-delta Sampling Rate 16,384 samples/second Resolution 16 Bits at 256 samples/second Input Impedance 50 M ohms typical (DC) 5 M ohms typical (at 10 Hz) Noise 236

< 0.3 V RMS (2.0 V peak-to-peak);

BIS Advance Monitor Electromagnetic Compatibility Specifications 0.25 Hz to 50 Hz Common Mode Rejection 110 dB at 50/60 Hz to earth ground

(Isolation mode) 0.16100 Hz 7.6.12. Software/GUI Specifications Item Screen refresh rate Value 60 Hz GUI languages Case storage Bulgarian, Chinese, Croatian, Danish, Dutch, English, French, German, Greek, Hungarian, Italian, Japanese, Macedonian, Norwegian, Polish, Portuguese, Romanian, Russian, Serbian, Slovak, Slovenian, Spanish, Swedish Case limited to 24 hours (a new case will open if monitoring time exceeds 24 hours) Monitor can store up to 50 cases 7.7. Electromagnetic Compatibility Specifications The BIS Advance monitor complies with the requirements of IEC 60601-1-2 (3rd and 4th Editions) when used with the accessories listed in this manual (reference Table 34. BIS Advance Accessories on page 252). In addition, the BIS Advance monitor must be used only with the power cord provided. When using a removable drive to load new versions of software into the BIS Advance monitor, no cables or other accessories should be connected to the device. The BIS Advance monitor should be connected to AC power through the appropriate power cord, and the removable drive should be plugged into the USB-A connector on the monitor or the docking station. For location of those ports, reference Figure 4. BIS Monitor Connectors on page 46 and Figure 11. BIS Advance BIS Advance Monitor 237 Electromagnetic Compatibility Specifications Docking Station Connectors on page 54. These ports are for use with a USB flash drive only. WARNING: Using accessories other than those specified may result in increased electromagnetic emissions or decreased electromagnetic immunity of the BIS Advance monitor system. WARNING: The BIS Advance monitor should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the BIS Advance monitor should be observed to verify normal operation in the configuration in which it will be used. WARNING: The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include:

Use of the accessory in the patient vicinity. Evidence that the safety certification of the accessory has been performed in accordance to the appropriate IEC 60601-1 and/or IEC 60601-1-1 harmonized national standard. The monitor complies with the applicable requirements of IEC 60601-1-2. This section provides the appropriate specification tables for the BIS Advance monitor as per IEC 60601-1-2 (3rd and 4th Editions), IEC 60601-2-26 (2nd and 3rd Edition), and 80601-2-26:2019. The monitor is suitable for use in the specified electromagnetic environment. The user of the monitor should assure that it is used in an electromagnetic environment as described below. Working in an environment other than the environment described below can result in a considerable reduction in device performance and is not recommended. Note: Emissions characteristics of this equipment make it suitable for use in industrial areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for which CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. 238 BIS Advance Monitor Electromagnetic Compatibility Specifications Table 29. Guidance and Manufacturer's Declaration - Electromagnetic Emissions The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment Guidance RF Emissions CISPR 11 Group 1 The BIS Advance monitor uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The BIS Advance monitor is suitable for use in all establishments, other than domestic and those directly connected to the public low-

voltage power supply network that supplies buildings used for domestic purposes. RF Emissions CISPR 11 Class A Harmonic Emissions IEC 61000-3-2 Class A Voltage Fluctuations/

Flicker Emissions IEC 61000-3-3 Complies The recommended electro-magnetic environment for operation of the monitor is described in 7.7 Electromagnetic Compatibility Specifications on page 237. For all immunity tests, the system is set up to recover within 30-50 seconds with no operator intervention and no data loss. BIS Advance Monitor 239 Electromagnetic Compatibility Specifications Table 30. Guidance and Manufacturer's Declaration - Electromagnetic Immunity The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge

(ESD) IEC 61000-4-2 8 kV contact 8 kV contact 2 kV, 4 kV, 8 kV, 15 kV air 2 kV, 4 kV, 8 kV, 15 kV air Electrical fast transient/burst IEC 61000-4-4 2 kV for power supply lines. 1 kV for input/output lines. 2 kV for power supply lines. 1 kV for input/output lines. Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical hospital environment. Surge IEC 61000-4-5 0.5 kV, 1.0 kV, and 2.2 kV, line to earth. 0.5 kV, 1.0 kV, and 2.2 kV, line to earth. Mains power quality should be that of a typical hospital environment. 0.5 kV and 1.1 kV, line to line. 0.5 kV and 1.1 kV, line to line.

(0, 90, 180, and 270 degrees)

(0, 90, 180, and 270 degrees) Voltage dips IEC 61000-4-11 UT = 0%, 0.5 cycle (0, 45, 90, 135, 180, 225, 270, and 350 degrees) UT = 0%, 0.5 cycle (0, 45, 90, 135, 180, 225, 270, and 350 degrees) 240 Mains power quality should be that of a typical hospital environment. If the user of the BIS Advance monitor requires continued operation BIS Advance Monitor Electromagnetic Compatibility Specifications The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level UT = 0%, 1 cycle UT = 0%, 1 cycle UT = 70%, 25/30 cycles (0 degrees) UT = 70%, 25/30 cycles (0 degrees) UT = 0%, 250/300 cycles UT = 0%, 250/300 cycles 30 A/m, 60 Hz 30 A/m, 60 Hz Short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Power frequency

(50/60 Hz) magnetic field. IEC 61000-4-8 BIS Advance Monitor Electromagnetic environment guidance during power mains interruptions longer than 45 minutes, it is recommended that the BIS Advance monitor be powered by an uninterruptible power supply. Mains power quality should be that of a typical hospital environment. If the user of the BIS Advance monitor requires continued operation during power mains interruptions longer than 45 minutes, it is recommended that the BIS Advance monitor be powered by an uninterruptible power supply. Power frequency magnetic fields should be at levels characteristic of typical location in a typical hospital environment. 241 Electromagnetic Compatibility Specifications The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Note: UT is the AC mains voltage prior to the application of the test level. Conducted RF IEC 61000-4-6 3 Vrms, 150 kHz to 80 MHz 3 Vrms, 150 kHz to 80 MHz 6 Vrms (ISM Bands) 6 Vrms (ISM Bands) Radiated RF IEC 61000-4-3 3 V/m 80 MHz to 2.7 GHz 3 V/m 80 MHz to 2.7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the BIS Advance monitor, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2 P d = 1.2 P, 80 MHz to 800 MHz d = 2.3 P, 800 MHz to 2.5 GHz where P is the maximum output power rating of the transmitter in watts according to the transmitter manufacturer and d is the recommended separation distance in meters (m). BIS Advance Monitor 242 Electromagnetic Compatibility Specifications The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Field strengths from fixed RF transmitters, as determined by electromagnetic site surveya, should be less than the compliance level in each frequency range.b Interference may occur in the vicinity of equipment marked with the following symbol:

Note:

At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio

(cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BIS Advance monitor is used exceeds the applicable RF compliance level above, the BIS Advance monitor should be observed to verify normal operation. If abnormal performance is observed, additional measures may by be necessary, such as reorienting or relocating the BIS Advance monitor. BIS Advance Monitor 243 Electromagnetic Compatibility Specifications The BIS Advance monitor is intended for use in the electromagnetic environment specified below. The customer or user of the BIS Advance monitor should assure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance b less than 3 V/m. Over the frequency ranges 150kHz to 80 MHz field strength should be The BIS Advance monitor is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The customer or user of the monitor can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the monitor as recommended below, according to the maximum output power of the communications equipment. Table 31. Recommended Separation Distances between Portable and Mobile RF Communications Equipment and the BIS Advance Monitor Rated maximum output power of equipment Separation distance according to frequency of transmitter m 0.12 0.38 1.2 W 0.01 0.1 1 244 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz d = 1.2 P d = 1.2 P d = 2.3 P 0.12 0.38 1.2 0.23 0.73 2.3 BIS Advance Monitor Electromagnetic Compatibility Specifications Rated maximum output power of equipment Separation distance according to frequency of transmitter m 3.8 12 3.8 12 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note: At 80 MHz and 800 MHz, the separation distance for the higher frequency ranges applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. W 10 100 BIS Advance Monitor 245 Electromagnetic Compatibility Specifications Table 32. Proximity Field Immunity Compliance Guidance and Manufacturers DeclarationElectromagnetic Immunity

(IEC/EN 60601-1-2, 4th Edition) Test Frequ ency

(MHz) Ban d

(MH z) Service Modulati on Dist anc e

(m) Max

. Po wer

(W) Immuni ty Compli ance Level

(V/m) Immu nity Test Level

(V/m) 385 TETRA 400 1.8 0.3 27 27 Pulse Modulatio n 18 Hz 380 to 390 430 to 470 704 to 787 704 to 787 704 to 787 800 to 960 450 710 745 780 810 246 GMRS 460, FRS 460 FM 5kHz deviation 1 kHz sine 2 0.3 28 28 LTE Band 13, 17 Pulse Modulatio n 217 Hz 0.2 0.3 9 LTE Band 13, 17 Pulse Modulatio n 217 Hz 0.2 0.3 9 LTE Band 13, 17 Pulse Modulatio n 217 Hz 0.2 0.3 9 9 9 9 GSM 800/900, TETRA 800, Pulse Modulatio n 18 Hz 2 0.3 28 28 BIS Advance Monitor Electromagnetic Compatibility Specifications Guidance and Manufacturers DeclarationElectromagnetic Immunity

(IEC/EN 60601-1-2, 4th Edition) Test Frequ ency

(MHz) Ban d

(MH z) Service Modulati on Dist anc e

(m) Max

. Po wer

(W) Immuni ty Compli ance Level

(V/m) Immu nity Test Level

(V/m) iDEN 820, CDMA 850, LTE Band 5 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 Pulse Modulatio n 18 Hz Pulse Modulatio n 18 Hz 870 930 800 to 960 800 to 960 2 0.3 28 28 2 0.3 28 28 1720 1700 to 1990 Pulse Modulatio n 217 Hz GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS 2 0.3 28 28 BIS Advance Monitor 247 Electromagnetic Compatibility Specifications Guidance and Manufacturers DeclarationElectromagnetic Immunity

(IEC/EN 60601-1-2, 4th Edition) Test Frequ ency

(MHz) Ban d

(MH z) Service Modulati on 1845 1700 to 1990 1970 1700 to 1990 2450 2400 to 2570 Pulse Modulatio n 217 Hz Pulse Modulatio n 217 Hz Pulse Modulatio n 217 Hz GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 Dist anc e

(m) Max

. Po wer

(W) Immuni ty Compli ance Level

(V/m) Immu nity Test Level

(V/m) 2 0.3 28 28 2 0.3 28 28 2 0.3 28 28 5240 WLAN 802.11 a/n 5100 to 5800 Pulse Modulatio n 217 Hz 0.2 0.3 9 9 248 BIS Advance Monitor Product Compliance Guidance and Manufacturers DeclarationElectromagnetic Immunity

(IEC/EN 60601-1-2, 4th Edition) Test Frequ ency

(MHz) Ban d

(MH z) Service Modulati on Dist anc e

(m) Max

. Po wer

(W) Immuni ty Compli ance Level

(V/m) Immu nity Test Level

(V/m) WLAN 802.11 a/n WLAN 802.11 a/n 5100 to 5800 5100 to 5800 Pulse Modulatio n 217 Hz Pulse Modulatio n 217 Hz 0.2 0.3 9 0.2 0.3 9 9 9 5500 5785 Note:

The distance values represent the recommended separation distance between interfering equipment and the monitor. 7.8. Product Compliance Standard RoHS 3 Directive 2015/863 WEEE 2012/19/EU PSE Act. Compliance (Batteries) BIS Advance Monitor 249 Product Compliance PSE Marking for power supply FCC ID, FCC CFR 47 Part 15 Directive 2006/66/EC UL 2054, 2nd edition (batteries) IEC 62133-2 2017-02. (batteries) UN 38.3 EU 2017/999 (REACH) IEC 60601-1:1988 +A1/A2 & EN 60601-1:1990 +A11/A12/A13 Medical Electrical Equipment Part 1: General Requirements for Safety (China) IEC 60601-1:2005 + A1:2012 (medical devices in general) 2012.08 Medical electrical equipment Part 1: General requirements for basic safety and essential performance EN 60601-1:2006 + A12:2014 CAN/CSA-C22.2 No. 60601-1:14 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance (Adopted IEC 60601-

1:2005, 2005-12), includes Corrigendum 1:2011. EN/IEC 60601-1-2: 2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance Collateral Standard:

Electromagnetic disturbances Requirements and tests, and the following requirements defined in the EEG particular standard:

1. For Electrostatic Discharge (ESD) tests, ME Equipment may show temporary degradation during discharges. Within 30 [seconds] the system shall resume normal operation in the previous operating mode, without loss of any operator settings or saved case data, and shall continue to perform its intended function. 2. For Radiated electromagnetic fields immunity - the test level shall be 3 V/m. 3. During Electrical Fast Transients (EFT) test, the system shall continue to display the EEG waveform. 250 BIS Advance Monitor BIS Advance Components, Accessories, and Documentation EN/IEC 60601-1-6: 2010 +A1: 2015 - Medical Electrical Equipment Part 1-6:

General requirements for basic safety and essential performance Collateral Standard: Usability. EN/IEC 62366-1:2015 Medical Devices Application of usability engineering to medical devices IEC 60601-1-8: 2006 + A1: 2012 - Medical electrical equipment: General requirements for basic safety and essential performance, Collateral Standard, General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. EN 60601-2-26: 2012- Medical Electrical Equipment Part 2-26: Particular Requirements for the Safety of Electroencephalographs. EN 80601-2-26: 2019 - Medical Electrical Equipment Part 2-26: Particular Requirements for the Safety of Electroencephalographs. EN 60601-2-26: 2003- Medical Electrical Equipment Part 2-26: Particular Requirements for the Safety of Electroencephalographs (China). ANSI / AAMI ES 60601-1:2005+A1:2012 Medical electrical equipment Part 1:

General requirements for basic safety and essential performance IEC 60601-1:2012 Section 11.6.6, Cleaning and disinfection of ME equipment 7.9. BIS Advance Components, Accessories, and Documentation A list of the components of the BIS Advance system appears below. BIS Advance Monitor 251 BIS Advance Components, Accessories, and Documentation Table 33. BIS Advance Monitor Components and Sensors Product Name Description or Application Part Number BIS Advance Monitor BIS monitor that can be used with either a BISx or BISx4 module PMB4000 (an additional suffix may denote region) BIS Advance docking station Docking station to permit easy mounting of monitor PMB4000DOC BIS Advance Adaptor cable Adapter cable used to connect monitor to BISx module PMB4000ACBL BISx module 186-1095-xxx BISx4 module 186-0224-xxx Processes 2 channels of EEG information (one brain hemisphere) to work with BIS Advance Monitor Processes 4 channels of EEG information (both side of the brain) to work with BIS Advance Monitor A list of BIS Advance accessories appears below. Some of these are components which are also available for purchase separately. Table 34. BIS Advance Accessories Product Name Description or Application Part Number BIS Advance docking station Docking station to permit easy mounting of monitor PMB4000DOC BIS Advance Adaptor cable Adapter cable used to connect monitor to BISx module PMB4000ACBL GCX clamp mount PMB4000PMT Clamp mount for docking station with monitor. For purchase directly from GCX. 252 BIS Advance Monitor BIS Advance Components, Accessories, and Documentation Product Name Description or Application Part Number GCX desktop mount Desktop mount for docking station with monitor. For purchase directly from GCX. PMAC71STAND GCX mount for anesthesia machine Mounting accessories for mounting monitor with docking station to anesthesia machine. The clamp mount can be purchased from Medtronic. The other parts are for purchase directly from GCX. Requires one or more of the following parts:

Channel mount (GCX PN OH-0010-80) Pivot Arm (GCX PN PQ-

0008-03) Post (GCX PN PQ-0008-

11 12 [inch]) GCX clamp mount

(PMB4000PMT) Power supply PMB4000PWS Used to connect the docking station to AC power; may also be used directly with the monitor Removable battery Used to supply battery power to the monitor PMB4000BAT North America power cord Power cord used with monitor for connection to AC power in North America PT00059589 Japan power cord PT00059590 Power cord used with monitor for connection to AC power in Japan South Korea power cord Power cord used with monitor for connection to AC power in South Korea PT00059576 Continental Europe power cord Power cord used with monitor for connection to PT00059577 BIS Advance Monitor 253 BIS Advance Components, Accessories, and Documentation Product Name Description or Application Part Number Israel power cord PT00059579 UK power cord PT00059578 AC power in continental Europe Power cord used with monitor for connection to AC power in the United Kingdom Power cord used with monitor for connection to AC power in Israel Power cord used with monitor for connection to AC power in Australia Power cord used with monitor for connection to AC power in China Power cord used with monitor for connection to AC power in Argentina Power cord used with monitor for connection to AC power in Denmark Power cord used with monitor for connection to AC power in Italy Power cord used with monitor for connection to AC power in Brazil Australia power cord PT00059581 China power cord PT00059582 Argentina power cord PT00059583 Switzerland power cord Power cord used with monitor for connection to AC power in Switzerland PT00059584 Denmark power cord PT00059585 Italy power cord PT00059586 Brazil power cord PT00059587 254 BIS Advance Monitor BIS Advance Components, Accessories, and Documentation Product Name Description or Application Part Number South Africa power cord Power cord used with monitor for connection to AC power in South Africa PT00059588 BISx (previously known as LoC 2 Channel) BISx4 (previously known as LoC 4 Channel) Processes 2 channels of EEG information (one brain hemisphere) to work with BIS Advance Monitor. Processes 4 channels of EEG information (both side of the brain) to work with BIS Advance Monitor. 185-1014-xxx 185-1016-xxx Sensor Simulator Simulated sensor, to test system functioning 186-0137 Quatro Extend Pediatric Bilateral Quatro Sensor for adult patients undergoing general anesthesia or sedation. 186-0106 186-0160 Extend Sensor for adult patients undergoing general anesthesia or sedation in environments such as the ICU. Pediatric Sensor for pediatric patients ages four and up. 186-0200 186-0212 Bilateral Sensor that detects hemispheric differences in the brain (for advanced monitoring applications). Requires use of the LoC 4 Channel device. The system may be operated on a desktop, mounted to the patients bed, a pole, or other mount in the patients environment or mounted on an anesthesia machine. The user should consider the use case environment. Reference Table 28. OR BIS Advance Monitor 255 BIS Advance Components, Accessories, and Documentation Configurations on page 229 and determine which solution is best for the specific environment. To purchase accessories, please contact BISTechnicalsupport@medtronic.com. The BIS Advance monitor is packaged with a manual and clinical quick guide cards in English and other languages in soft copy on a flash drive. A list of documentation available in multiple languages in hard copy is listed below. These items may be ordered from your local Medtronic representative. Item Language Part Number Operators Manual Brazilian Portuguese PT00136161 Operators Manual Bulgarian PT00136162 Operators Manual Chinese (simplified) PT00136165 Operators Manual Croatian Operators Manual Czech Operators Manual Danish Operators Manual Dutch Operators Manual English Operators Manual Estonian Operators Manual Finnish Operators Manual French Operators Manual German Operators Manual Greek Operators Manual Italian 256 PT00136166 PT00136167 PT00136168 PT00136169 PT00117625 PT00136170 PT00136171 PT00136172 PT00136173 PT00136175 PT00136174 BIS Advance Monitor BIS Advance Components, Accessories, and Documentation Item Language Part Number Operators Manual Macedonian PT00136183 Operators Manual Hungarian Operators Manual Japanese Operators Manual Kazak Operators Manual Korean Operators Manual Latvian Operators Manual Lithuanian Operators Manual Norwegian Operators Manual Polish Operators Manual Portuguese Operators Manual Romanian Operators Manual Russian Operators Manual Serbian Operators Manual Slovak Operators Manual Slovene Operators Manual Spanish Operators Manual Swedish Operators Manual Turkish Operators Manual Ukrainian BIS Advance Monitor PT00136176 PT00136177 PT00136178 PT00136180 PT00136181 PT00136182 PT00136184 PT00136185 PT00136186 PT00136187 PT00136179 PT00136188 PT00136189 PT00136190 PT00136191 PT00136192 PT00136193 PT00136194 257 BIS Advance Components, Accessories, and Documentation Item Language Part Number Clinical quick guide cards Brazilian Portuguese Clinical quick guide cards Bulgarian Clinical quick guide cards Chinese (simplified) Clinical quick guide cards Croatian Clinical quick guide cards Czech Clinical quick guide cards Danish Clinical quick guide cards Dutch Clinical quick guide cards English Clinical quick guide cards Estonian Clinical quick guide cards Finnish Clinical quick guide cards French Clinical quick guide cards German Clinical quick guide cards Greek 258 PT00134375 PT00134376 PT00134377 PT00134378 PT00134379 PT00134404 PT00134406 PT00134374 PT00134408 PT00134409 PT00134410 PT00134411 PT00134412 BIS Advance Monitor BIS Advance Components, Accessories, and Documentation Item Language Part Number Clinical quick guide cards Italian Clinical quick guide cards Hungarian Clinical quick guide cards Japanese Clinical quick guide cards Kazak Clinical quick guide cards Korean Clinical quick guide cards Latvian Clinical quick guide cards Lithuanian Clinical quick guide cards Macedonian Clinical quick guide cards Norwegian Clinical quick guide cards Polish Clinical quick guide cards Portuguese Clinical quick guide cards Romanian Clinical quick guide cards Russian BIS Advance Monitor PT00145105 PT00145106 PT00145107 PT00145108 PT00145110 PT00145111 PT00145112 PT00145113 PT00145114 PT00145115 PT00145116 PT00145118 PT00145109 259 Warranty Item Language Part Number Clinical quick guide cards Serbian Clinical quick guide cards Slovak Clinical quick guide cards Slovene Clinical quick guide cards Spanish Clinical quick guide cards Swedish Clinical quick guide cards Turkish Clinical quick guide cards Ukrainian PT00145119 PT00145120 PT00145121 PT00145122 PT00145123 PT00145124 PT00145125 7.10. Warranty Covidien warrants to the initial Purchaser that the BIS Complete monitor and the BISx (Warranted Product) will be free from defects in workmanship or materials, when given normal, proper, and intended usage for a period of three years

(Warranty Period) from the date of its initial shipment to Purchaser. Excluded from this warranty are expendable components and supply items such as, but not limited to, electrodes, cables, and prep solutions. Covidiens obligations under this warranty are to repair or replace any Warranted Product (or part thereof) that Covidien reasonably determines to be covered by this warranty and to be defective in workmanship or materials provided that the Purchaser has given notice of such warranty claim within the Warranty Period and the Warranted Product is returned to the factory with freight prepaid. Repair or replacement of Products under this warranty does not extend the Warranty Period. 260 BIS Advance Monitor Warranty To request repair or replacement under this warranty, Purchaser should contact Covidien directly (see contact information on the back cover of this manual). Covidien will authorize Purchaser to return the Warranted Product (or part thereof) to Covidien. Covidien shall determine whether to repair or replace Products and parts covered by this warranty and all Products or parts replaced shall become Covidiens property. In the course of warranty service, Covidien may but shall not be required to make engineering improvements to the Warranted Product or part thereof. If Covidien reasonably determines that a repair or replacement is covered by the warranty, Covidien shall bear the costs of shipping the repaired or replacement Product to Purchaser. All other shipping costs shall be paid by Purchaser. Risk of loss or damage during shipments under this warranty shall be borne by the party shipping the Product. Products shipped by Purchaser under this warranty shall be packaged in the original shipping container or equivalent packaging to protect the Product. If Purchaser ships a Product to Covidien in unsuitable packaging, any physical damage present in the Product on receipt by Covidien (and not previously reported) will be presumed to have occurred in transit and will be the responsibility of Purchaser. This warranty does not extend to any Warranted Products or part thereof: that have been subject to misuse, neglect, or accident; that have been damaged by causes external to the Warranted Product, including but not limited to failure of or faulty electrical power; that have been used in violation of Covidiens instructions; that have been affixed to any nonstandard accessory attachment; on which the serial number has been removed or made illegible; that have been modified by anyone other than Covidien; or that have been disassembled, serviced, or reassembled by anyone other than Covidien, unless authorized by Covidien. Covidien shall have no obligation to make repairs, replacements, or corrections which result, in whole or in part, from normal wear and tear. Covidien makes no warranty (a) with respect to any products that are not Warranted Products, (b) with respect to any products purchased from a person other than Covidien or an Covidien-authorized distributor or (c) with respect to any product sold under a brand name other than Covidien. THIS WARRANTY IS THE SOLE AND EXCLUSIVE WARRANTY FOR COVIDIENS PRODUCTS, EXTENDS ONLY TO THE PURCHASER, AND IS EXPRESSLY IN LIEU OF ANY OTHER EXPRESS OR IMPLIED WARRANTIES INCLUDING WITHOUT LIMITATION ANY WARRANTY AS TO MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. COVIDIENS MAXIMUM LIABILITY ARISING OUT OF THE SALE OF THE PRODUCTS OR THEIR USE, WHETHER BASED ON WARRANTY, CONTRACT, TORT, OR OTHERWISE, SHALL NOT EXCEED THE ACTUAL PAYMENTS RECEIVED BY COVIDIEN IN CONNECTION THEREWITH. COVIDIEN SHALL NOT BE LIABLE FOR ANY INCIDENTAL, SPECIAL, OR CONSEQUENTIAL LOSS, DAMAGE OR EXPENSE (INCLUDING WITHOUT LIMITATION LOST PROFITS) DIRECTLY OR INDIRECTLY ARISING FROM THE SALE, INABILITY TO SELL, USE OR LOSS OF USE OF ANY PRODUCT. EXCEPT AS SET FORTH BIS Advance Monitor 261 Software License Agreement HEREIN, ALL PRODUCTS ARE SUPPLIED AS IS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED. 7.11. Software License Agreement The computer software (Licensed Software) loaded on the BIS Complete monitor

(System) is licensed, not sold, to you for use only under the terms of this license. Covidien (Covidien) reserves any rights not expressly granted to you. You own the System, but Covidien retains all ownership rights and title to the Licensed Software itself. 1. LICENSE: You are hereby granted the non-exclusive right to use the Licensed Software solely with the specific System on which the Licensed Software was provided to you. 2. RESTRICTIONS: You shall not transfer the Licensed Software in any manner from the System to any other computer or system without the prior written consent of Covidien. You shall not distribute copies of the Licensed Software or its related documentation to others. You shall not modify or translate the Licensed Software or its related documentation without the prior written consent of Covidien. The Licensed Software contains trade secrets and to protect them you may not decompile, reverse engineer, disassemble, or otherwise reduce the Licensed Software to a human-perceivable form. If you transfer the System, you have the right to transfer the Licensed Software provided that the transferee agrees to be bound by the terms and conditions of this License Agreement. 3. TERMINATION: This License remains effective until terminated. This License will terminate automatically without notice from Covidien if you fail to comply with any term or provision of this License. Upon termination of this License, you may not make any further use of the Licensed Software. 4. LIMITED WARRANTY: THE LICENSED SOFTWARE IS PROVIDED AS IS WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY WARRANTY WITH RESPECT TO ITS MERCHANTABILITY OR ITS FITNESS FOR ANY PARTICULAR PURPOSE. COVIDIEN DOES NOT WARRANT THAT THE FUNCTIONS CONTAINED IN THE LICENSED SOFTWARE WILL MEET YOUR REQUIREMENTS OR THAT THE OPERATION OF THE LICENSED SOFTWARE WILL BE UNINTERRUPTED OR ERROR FREE OR THAT SUCH ERRORS IN THE LICENSED SOFTWARE WILL BE CORRECTED. 262 BIS Advance Monitor Software License Agreement 5. LIMITATION OF REMEDIES AND DAMAGES: COVIDIENS ENTIRE LIABILITY TO YOU FOR ACTUAL DAMAGES FOR ANY CAUSE WHATSOEVER, AND REGARDLESS OF THE FORM OF THE ACTION, AND YOUR EXCLUSIVE REMEDY SHALL BE LIMITED TO THE MONEY PAID FOR THE SYSTEM, WHICH INCLUDED THE LICENSED SOFTWARE. IN NO EVENT SHALL COVIDIEN BE LIABLE TO YOU (i) FOR ANY INCIDENTAL, CONSEQUENTIAL, OR INDIRECT DAMAGES (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS, BUSINESS INTERRUPTION, LOSS OF BUSINESS INFORMATION, AND THE LIKE) ARISING OUT OF THE USE OF OR INABILITY TO USE ANY LICENSED SOFTWARE EVEN IF COVIDIEN OR ANY AUTHORIZED COVIDIEN REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, OR (ii) FOR ANY CLAIM BY ANY OTHER PARTY. 6. OPEN SOURCE SOFTWARE DISCLOSURE This document identifies the Open Source Software that may be separately called, executed, linked, affiliated, or otherwise utilized by this product. Such Open Source Software is licensed to users subject to the terms and conditions of the separate software license agreement for such Open Source Software. Use of the Open Source Software by you shall be governed entirely by the terms and conditions of such license. The source/object code and applicable license for any Open Source Software can be obtained at the following site(s):

Log4Ne https://logging.apache.org/log4net/;

http://logging.apache.org/log4net/license.html Reactive Extensions (Rx) http://reactivex.io/;

https://github.com/Reactive-Extensions/Rx.NET/blob/master/LICENSE Caliburn.Micro https://caliburnmicro.com/;

https://raw.githubusercontent.com/Caliburn-

Micro/Caliburn.Micro/master/License.txt HIDAPI http://www.signal11.us/oss/hidapi/;

https://github.com/signal11/hidapi Auto Mapper library http://automapper.org/;

https://github.com/AutoMapper/AutoMapper/blob/master/LICENSE.txt OPEN SANS https://www.fontsquirrel.com/fonts/open-sans ROBOTO https://www.fontsquirrel.com/fonts/roboto LATO https://www.fontsquirrel.com/fonts/lato?q%5Bterm%5D=LATO&q%5Bsear ch_check%5D=Y RUBIK -

https://www.fontsquirrel.com/fonts/rubik?q%5Bterm%5D=rubik&q%5Bsea rch_check%5D=Y BIS Advance Monitor 263 Software License Agreement 7. GENERAL: This License Agreement will be construed under the laws of the Commonwealth of Massachusetts. If any provision of this License Agreement shall be held by a court of competent jurisdiction to be contrary to law, that provision will be enforced to the maximum extent permissible, and the remaining provisions of this Agreement will remain in full force and effect. Should you have any questions concerning this License Agreement, you may contact Covidien by writing to Covidien, at the address listed on the back cover of this manual. THIS LICENSE AGREEMENT IS THE COMPLETE AND EXCLUSIVE STATEMENT OF THE AGREEMENT BETWEEN YOU AND COVIDIEN AND SUPERSEDES ANY PROPOSAL OR PRIOR AGREEMENT, ORAL OR WRITTEN, AND ANY OTHER COMMUNICATIONS BETWEEN YOU AND COVIDIEN RELATING TO THE SUBJECT MATTER OF THIS AGREEMENT. 264 BIS Advance Monitor Covidien IIc, 15 Hampshire Street, Mansfield, MA, 02048 USA Medtronic BV, Earl Bakkenstraat 10, 6422 PJ Heerlen, The Netherlands BIS Advance Monitor 265

 

 

 

 

 

 

 

 

 

 

Product Name : Medical Tablet PC Model No : M101MDT Rating :+19V = 3.15A For use only Power Supply :

GlobTek (GTM96600-6019-T3) Input : 100-240Vac, 50-60Hz, 1.5A, Output : 19 VDC 3.15A Max. Tablet PC Input Rating : 19 VDC 3.15A Manufactured Date :

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and

(2) This device must accept any interference received, including interference that may cause undesired operation. This Class B digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. Cet appareil numrique de la classe B respecte toutes les exigences du Rglement sur le matriel brouilleur du Canada. MEDICAL - GENERAL MEDICAL Saree Cy. EQUIPMENT AS TO ELECTRICAL Bocaling patrations yg SHOCK, FIRE AND MECHANICAL i y, Operating HAZARDS ONLY IN ACCORDANCE 489236 WITH ANSI/AAMIES 60601-1 (2005) Complies with 21CFR 1040.10 and + AMD (2012) and CAN/CSA-C22.2 1040.11 except for deviations pursuant _'Y-6060-1 (2014) to Laser Notice No.50,dated June 24 2007 Contains FC FCC ID : PX9-AC9260NGW IC :9911A-AC9260NGW Winmate Inc. 9F, No.111-6, Shing-De Rd., San-Chung Dist., New Taipei City 24158, Taiwan Part number of this label 91D00000344H MADE IN TAIWAN

S a 3 LABEL HERE

 

 

Winmate Inc. Class II change Letter Date: 2021/12/10 on 2018/11/21 following antenna:

This is an application for a class II permissive change for FCC ID : PX9-AC9260NGW, Original granted We change the following points from the original model; the other is identical to the previously certified device 1.AdditionalChassisadded,Productname:MedicalTabletPC, Modelnumber:M101MDT with the Winmate/90RF05000011/PIFAAntenna/1.84dBifor2.4G,3.58dBifor5G Themaximumantennagainislessthantheoriginal. 2.Reduceoutputpowerviasoftware. Sincerely, Title: Manager On behalf of: Winmate Inc. Lindon Lin ______________________________ _______________________________ Signature Printed

 

 

RF_ 160, Issue 04 Wit SINCE 1996 Declaration of Authorization We Name: FCC: Winmate Inc./ IC: Winmate Communication Inc. Address: 9F, No.111-6, Shing-De Rd., San-Chung Dist., City: |New Taipei City Country:Taiwan Declare that:

Name Representative of agent: Chenz Ker Agent Company name: MRT Technology (Taiwan) Co., Ltd Address: No. 38, Fuxing Second Rd., Guishan Dist., City: Taoyuan Country Taiwan is authorized to apply for Certification of the following product(s):

Product description: Intel Wireless-AC 9260 FCC ID: PX9-AC9260NGW IC: 9911A-AC9260NGW Type designation: 9260NGW Validity/ expiry date: 2022/3/10 on our behalf. Date: 2021/12/10 City: New Taipei City Name: Lindon Lin Function: Manager yi Signature; eee (XA...

 

 

FCC, Request for non-disclosure Date: 19-Oct-10 RF_501, Issue 7 Page 1 of 1 Company Name: Winmate Inc. Address: 9F, No.111-6, Shing-De Rd., San-Chung Dist., City: New Taipei City Country: Taiwan To: Telefication B.V., Dept. FCC TCB Edisonstraat 12A 6902 PK ZEVENAAR The Netherlands Subject: Request for confidentiality FCC ID: PX9-AC9260NGW Reference number: ########

Dear FCC TCB, 1. Long-Term Confidentiality Pursuant to 47 CFR Section 0.459(a) & (b), we hereby requests non-disclosure and confidential treatment of the following materials submitted in support of FCC certification application:

C1 Bill(s) of Material XX] Block Diagrams Operational Description [X] Schematic Diagrams C1 Tune-up Procedure Above materials contain secrets, proprietary and technical information, which would customarily be guarded from competitors under 47 CFR, section 0.457(d)(2). Disclosure or publication or any portion of this company confidential material to other parties could cause substantial competitive harm and provide unjustified benefits for competitors. 2. Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with the marketing regulations in 47 CFR 2.803 and the importation rules in 47 CFR 2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (note 1):

CJ Internal Photos [] Users Manual CJ Test Set-up Photos LJ External Photos JUStICALIOM. oes ccasessssessessecsecsecsscsecsscsssesessscsussussscsscssesecsusssssussussussuessecsessecsecsussuseneeneesecseeseeneeaneens Planned Release Date STC: (notes 2,3, 4,5). If no date is given, 45 days from grant date will be used. Date: 2021/12/10 Name and signature of applicant: Lindon Lin ~

Notes:

1) A document or type of document can only have ONE type of confidentiality!

2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.)!

3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Telefication does not remind you of this!

5) Request for extension or for release must be received by Telefication at least 7 days before date of actual marketing or before expiration of the STC period

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

a Cla Winmate Inc. ll change Letter Chini Liao en N es evan orn) Signature Beale |-1g On behalf of:Winmate Inc. This is an application for a class ii permissive change for FCC ID PX9-AC9260NGW, Original granted on 2018/11/21 We change the following points from the original model; the other is identical to the previously certified fo feWa(en 1.Additional Chassis added, Product name: Rugged Tablet PC, Model number : M116P with the following antenna:

Talat 1k-7e-101,1 2010100 ON RM Lew e-layAt eee [ot Amare eel aa eT em ara aR) A U0]

2. Reduce 802.11a/b/g/n/ac output power via software. 3. Disable U-NiI802.11ac80 and 802.11ac160 mode via software. 4. Disable U-NII-2A, U-NII-2C Band via software. Also please note the following with respect to this application:

SAR testing is performed to demonstrate compliance. Software security remains unchanged from the original application. This RF module is electronicallyand mechanically identical as the original application. Except for the changes mentioned above, no other modification is performed. Date: 2020/2/24