{gga Foxglove 6/26/01 2:45 Page 2 side Front cover—for Position On ot.
ELECTRONIC CONFIDENTIAL REFEREE UF HR0_EN book Page Tuesday, June 36, 2001 3:37 PM Explanation of Symbols C€ Reformists European {European Conformity). This symbol means that the device fully complies with European Directive AMID 80/385/EEC. Lot number Storage temperature og Attention. See accompanying documents Caution A IEC 606011, Gyps BF Equipment Relative Humidity [TE Atmospheric Pressure i The following is communications regulation information on the Model 8B40 N'Vision Clinician Programmer.
ELECTRONIC CONFIDENTIAL BENEFICENCE DURHAM_ EN book Page tit Tuesday, ine 26, 2001 3.37 PM How to Use This Guide How to Use This Guide About the Mode! 8840 N'Vision Clinician Programmer Guide “This guide presents information for users of the N'Vision Clinician Programmer: ® Programmer overview ® Programmer description ® Programmer use *® Programmer maintenance Mediocrity N'Vision Clinician Programmer Guide iil UG200101473 EN ix release.
ELECTRONIC CONFIDENTIAL REMEMBRANCE H40_EN book Page iv Tuesday, June 26.
ELECTRONIC CONFIDENTIAL REFERENCE {#40 EN book Page v Tuesday, June 26, 2001 3:37 PM ” Table of contents Table of contents Explanation of Symbols | How to Use This Guide iif 1. Programmer Overview Advice Description 1.2 Supply and Accessories 1-2 indications for Use 1-2 Warnings and Precautions 1-3 Warnings 1-3 Precautions 1-4 2.
ELECTRONIC CONFIDENTIAL REPENTANCE Page vi Tuesday. June 26, 2001 3:37 PM Table of contents Platform Session Data Management 3.20 Navigation Tab Bar 3-21 Programmer Connections 3-22 Communicating with a Printer 3-22 Printing 3-22 Telemetry Module Use 3-23 Using the Telemetry Module Attached to the Programmer 3-23 Using the Telemetry Module Detached from the Programmer 3-23 Positioning the Telemetry Head 3-24 Reeling in the Telemetry Head 3-28 Connecting the Magnet to the Telemetry Module 3-28 4.
ELECTRONIC CONFIDENTIAL 3 EN.
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y ELECTRONIC CONFIDENTIAL F870_EN book Page 3 Tuesday. Jun 26. 2001 3:37 PM HEFNER Programmer Overview Warnings and Precautions Warnings and Precautions Warnings Refer to the appropriate implanted/device manual for instructions on specific therapy applications and a complete listing of warnings, precautions, contraindications and instructions for use for applications.
ELECTRONIC CONFIDENTIAL REFEREE HELENE book Page 4 Tuesday, June 26,2001 3:37PM Programmer Overview Warnings and Precautions * |i the display is not waking, do not use the N'Vision Programmer. Return the device to Medicament for repair. * The N'Vision Programmer is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitro us oxide. Precautions * Power failures during programmer use wil reinitialize the programmer, and application state data will be lost.
850_EN book Pages Tuesday, Fame 26, 2001 3:37 ELECTRONIC CONFIDENTIAL REFEREE s | @ Programmer Overview Warnings and Precautions * The THERAPY-STOP function does not operate unless an application card is in place in the programmer and a therapy has been selected.
ELECTRONIC CONFIDENTIAL REFEREE bask Page 6 Tuesday, Tune 26.
ELECTRONIC CONFIDENTIAL. HEFNER FRED _EN book Page 7 Tuesday, uve 26.2001 337 PM Programmer Description Component identification Component Identification The front of the Model 8840 N'Vision Clinician Programmer is equipped with a touchscreen display and a THERAPY.STOP “hard key” {Figure 2-1).
ELECTRONIC CONFIDENTIAL REFEREE Page 3 Tuesday. June 26. 2001 3:37 PM Programmer Description Component identification THERAPY-STOP rem IR PRE Hard Key VISION Scroll Sheet Programming Key Application Card Port Application Card Eject Button Figure 2-1.
| | A ELECTRONIC CONFIDENTIAL REF R18 5 14@r {830 _2ENSfm Page 4 Tuesday, June 26, 2001 Programmer Description Component Identification On the back of the N'Vision Programmer are the telemetry module and magnetite (optional), cable reel for the telemetry module, audio speaker, and battery compartment {Figure 2-2). The stylus is stored in a recessed area on the right side of the device. Magnet.
¥ ELECTRONIC CONFIDENTIAL Kitten book Page 3 Tuesday, Jane 26. 2001 3:37 PM REFEREE Programmer Description Interactive Features Interactive Features Graphical Display The touchscreen of the programmer displays text and graphical messages that guide the user through all programmer functions. The display is divided into five sectors: ® Programmer status bar = Title bar * Application tabs ® Primary application area ® Secondary application area The significance of gate sector is unique.
ELECTRONIC CONFIDENTIAL REFEREE HARDEN book Page 6 Tuesday. June 26. 2001 3:37 PM = Programmer Description interactive Features * Programmer Status Bar: The programmer status bar provides information on the status of various programmer functions {Figure 2-8}. The following “inactive” icons present information on the status of the: connection; printer; telemetry function; and battery, | ® I Figure 2-3.
ELECTRONIC CONFIDENTIAL REFEREE S840_ENbook Page 7 Tuesday, June 26. 2001 337 PM Programmer Description Interactive Features Title Bar and Application Tabs: When an application is active on the N'Vision Programmer, the Title Bar identifies the application tab in use, along with the print and close program icons {Figure 2-4). Application tabs are application-specific “active” icons, each representing a separate function of the application in use.
ELECTRONIC CONFIDENTIAL Aer pts | — Page 8 Tuesday. June 26. 200) 3:37 PM Programmer Description interactive Features = Primary Application Area: Active application information comprises the largest area of the display screen (Figure 2-5). Note: The parameters displayed in Figure 2-5 are generic and do not represent data from any specific pump or overstimulate. Lhe Active Application Area Dio] still TER Figure 2-5.
| PN ELECTRONIC CONFIDENTIAL REFEREE | “®F gga en book Page Tuesday. June 26, 2001 3:37PM Programmer Description Interactive Features » Secondary Application Area: A secondary window at the bottom of the display houses the calculator function that is accessed through the Slider Bar {Figure 2-8). The secondary application area may at times be covered by these tools. Secondary Application Area Figure 2-6.
ELECTRONIC CONFIDENTIAL REFEREE rs FRESHEN book Page 10 Tuesday. unc 26. 2001 3:37 PM i Programmer Description interactive Features Display Feature The entire area of the display is functional. Each operative sector of the display can be activated by stylus (provided with the N'Vision Programmer) or fingertip. All therapy applications available for use with this device can be selected through use of the display, as can programmer parameters such as date, time, and language.
DRESDEN book Page 11 Tuesday. June 26. 2001 3:37 PM Programmer Description Connection Paris and Other Features Connection Ports and Other Features Application Card Port Therapy applications hosted on the N'Vision Programmer are stored on application cards. The interface between the programmer and the application card is contained within the application card port (Figure 2-7). Application Card Port Application Card Eject Button Figure 2-7.
ELECTRONIC CONFIDENTIAL REF _R18 MENHADEN book Page 17 Tuesday, June 26, 2001 3:37 PM Programmer Description Connection Ports and Other Features Telemetry Module The M Vision Programmer is comprised of a base module and a telemetry module (TM). The telemetry module is attached to the base module by a 1-meter long cable that retracts onto a spool in the back of the base module. The telemetry module can be used while extended or while housed on the device.
| ELECTRONIC CONFIDENTIAL REFEREE ®5H0_EN book Page | Tuesday. fume 26, 2001 337 How to Use the N’Vision Programmer The first few pages of this chapter present basic information an use of the N'Vision Programmer. Specific operational instructions begin on page 3-11.
i ELECTRONIC CONFIDENTIAL REF _R18 ® —i®r gin rv book Page? Tuesday. June 26,2001 3.37 198311001 How ta Use the N'Vision Programmer Powering Up the Programmer Powering Up the Programmer The power key for the Model 8840 N'Vision Clinician Programmer is located on the left side of the device, toward the bottom (Figure 3-1). The power key toggles the power on or oft. Slide the key backward and hold in position momentarily to apply power or to shut off the programmer, Power Key Figure 3-1.
ELECTRONIC CONFIDENTIAL REFEREE RADIOMEN book Page 1 Tuesday, June 26,2001 3:37 PM How to Use the N'Vision Programmer Powering Up the Programmer The first time that the programmer is turned on, the user will be directed to choose localization parameters for date, time, and number format (Figure 3-2). These parameters appear automatically only the first time the programmer is powered up, or when the back-up lithium battery is changed.
. ELECTRONIC CONFIDENTIAL REFEREE $840_EN book Page 4 Tuesday, June 26, 2001 3:37 PM How to Use the N'Vision Programmer Powering Up the Programmer if a failure is encountered during the self test, a failure mods screen may be displayed (Figure 3-8), accompanied by an audible beep. The failure mode screen, if displayed, will indicate the nature of the problem. Contact Electronic for further instructions. ERR #2 100% TCB: Error Handling T X=100 © @ =3800108a “= 800073c “t= ag17dcad tht =D “srs Figure 3-3.
| J ELECTRONIC CONFIDENTIAL REFEREE TREATMENT book Page 5 Tuesday. June 26, 2001 3.37PM How to Use the N'Vision Programmer Inserting the Application Card Inserting the Application Card The N'Vision Programmer uses only compatible Electronic application cards through a card slot on the left side of the device (Figure 3-4). Insert the application card into the N'Vision Programmer before turning on the programmer. Application Card Riot Application Card, Ejection Button Figure 3-4.
ELECTRONIC CONFIDENTIAL REFEREE HRA _EN book Page 6 lusty, June 26,2001 3:37 PM How to Use the N'Vision Programmer Inserting the Application Card Insert a single application card into the programmer (Figure 3-5); insertion is complete when the application card “clicks” inch place and the ejection button is closed. To eject the application card, depress the ejection button just behind the card slot on the left side of the programmer. Figure 3-5.
ELECTRONIC CONFIDENTIAL REF _R18 WB40_EN book Page T Tuesday, June 26, 2000 3:37 PM How to Use the N'Vision Programmer inserting the Application Card Stand-by Mode When the N'Vision Programmer is powered up and in use, the programmer enters Stand-by Mode if no input is received during a continuous 8-minute period of time, During Stand-by Mode, the programmer screen goes blank.
ELECTRONIC CONFIDENTIAL REFEREE bj 5d0_EN hook Page 8 Tucson. Tune 26, 2001 137 PM How to Use the N'Vision Programmer Navigating Menu Options Navigating Menu Options The Programmer Display Figure 3-6 is a representation of the N'Vision Programmer display. VISION: fr Ped Programmer Status Indicator fn Title Bar with Current Function Displayed Application Tabs Primary Application Area em wes ves Secondary Application Area Figure 3-6.
| 4 ELECTRONIC CONFIDENTIAL REFEREE . 8 S440_EN book Page 9 Tuesday. June 26.2001 3:37 PH a ? How to Use the N'Vision Programmer Navigating Menu Options Using the Display Most user input to the N'Vision Programmer is via the display, which is the preferred mode of access to configure programmer settings and to operate applications housed on the application card. The display responds to stylus or finger tip touch.
ELECTRONIC CONFIDENTIAL REF _R18 8 | > FEH0_EN book Page 10 Tuesday, Jane 26, 2001 3:37 PM How to Use the N'Vision Programmer Navigating Menu Options Scroll Wheel Programming Key Figure 3-7. Scroll Wheel and Programming Key Locations The programming key (Figure 3-7) is positioned just below the scroll wheel. Depression of the key initiates a telemetry operation (interrogate and/or program) that is dependent upon the application and the operating context.
ELECTRONIC CONFIDENTIAL REFEREE BEEN bask Page 11 Tuesday, June 26. 3001 3.37 PM or How to Use the N'Vision Programmer Programmer Operation Programmer Operation Start-up and Self-test Sequence ‘When the power key is activated on the N'Vision Programmer, a series of serif-tests are initiated. These self-tests are designed to ensure the programmer is functioning properly.
ELECTRONIC CONFIDENTIAL REF R18 7 §80_EN book Page 12 Tuesday, Sane 26, 2000 337 PM. How to Use the N'Vision Programmer Programmer Operation Status Bar Icons Telemetry Status See Telemetry inactive Telemetry present | Telemetry present (Telemetry status is successful) Telemetry present (Telemetry status is not successful) Telemetry (magnet present) | Telemetry (magnet present) {Telemetry status is successful) i "Telemetry (magnet present} § {Telemetry status is not successful) Figure 3-8.
ELECTRONIC CONFIDENTIAL REFEREE 7 ERE EN souk Page 13 Tuesday. June 26. 2001 3:37 PM How to Use the N'Vision Programmer Programmer Operation Battery Status Printer Status nig | Very High WE inactive bl — Will [= High i’ Printing fo Hogwarts & | Low Connection Status. End of Life (EOL) Lo inking Printer error Figure 3-9. Status Bar cons--Frinter, Connection, and Battery Status Software Application Selection On the selection menu of the N'Vision Programmer, a list of available applications is displayed.
ELECTRONIC CONFIDENTIAL REF R18 {8407 EN hook Page 14 Tuesday, June 26, 2001 3.37 PM How to Use the N'Vision Programmer Programmer Operation Using the Slider Bar At times, the user may choose to interrupt a software application to reconfigure settings on the N'Vision Programmer. The Snider Bar function allows an application to be put on hold in order to perform other tasks. Activating the Slider Bar Access the Slider Bar on the touch screen from the Programmer Status Bar.
ELECTRONIC CONFIDENTIAL REFEREE R40 End book Page 15 Tuesday, June 26, 2001 3:37 PM ” How to Use the N'Vision Programmer Programmer Operation *® The information Control icon gives information about the device, including: model number; hardware version; platform firmware version; telemetry module mods! number; telemetry module hardware version; telemetry module firmware version; application names and versions; and printer driver names and versions, sh EMBROIDERER 3880 (81.
ELECTRONIC CONFIDENTIAL REFEREE "E830 EN book Page 16 Tuesday, June 26,2001 3:37 PM How to Use the N'Vision Programmer Programmer Operation ® The Settings Control icon allows adjustment of the display contrast, speaker volume and display calibration, Use the stylus to slide the contrast and volume bars to the desired settings. Touch the key click icon to turn the key click sound off or on, Ta initiate display calibration, select the calibrate button with the stylus.
ELECTRONIC CONFIDENTIAL REFEREE 7 8RH0_EX bok Page 17 Tuesday, unc 26. 2000 3:37 PM o How ta Use the N'Vision Programmer Programmer Operation = The Localization Control function allows changes to language preference and date and time formats. Select the desired options using the stylus. Figure 3-13.
REAGAN book Page I$ Tuesday, June 26, 3001 3:37 PM 8 l® ELECTRONIC CONFIDENTIAL REFEREE ) | How ta Use the N'Vision Programmer Programmer Operation = The Printer Control icon gives access to printer options, Using the stylus, select the appropriate printer from the available list {Figure 3-14), The N'Vision Programmer interfaces with the Seiko™ Model DPU 3445. Other printers with IR capability may be supported, also.
ELECTRONIC CONFIDENTIAL REFEREE En book Page 19 Tuesday, Son 26, 2001 3.37 £4 How to Use the N'Vision Programmer Programmer Operation * The device calculator is accessed through the Calculator Control icon. The calculator is capable of all functions typically available on small, hand-held calculators. Use the style to select numbers and functions within the calculator. Figure 3-15.
ELECTRONIC CONFIDENTIAL REFEREE ES ©5550 Ex book Page 20 Tuesday, Tyre 26, 200) 3:37 PM 9 How to Use the N'Vision Programmer Programmer Operation Platform Session Data Management The Printer Control icon also gives the user access to patient session reports that have been compiled during previous patient sessions. information from as many as 100 patient sessions can be stored and accessed. To retrieve patient data, select the Printer Control icon (Figure 3-10).
ELECTRONIC CONFIDENTIAL REF _R18 4 8 “BRETHREN book Page 21 Tuesday. June 26. 2001 3:37 How to Use the N'Vision Programmer Programmer Operation Navigation Tab Bar Each application loaded on the N'Vision Programmer is comprised of various operations and functions that are represented by icons on the Navigation Tab Bar (Figure 3-16). Tabs on the bar contain icons that correspond with application screen selections available to the user. Figure 3-16.
Jk ELECTRONIC CONFIDENTIAL REFEREE | “Ohio in book Page 22 Tuesday, June 26. 2001 3:37 PM How to Use the N'Vision Programmer Programmer Connections Programmer Connections Communicating with a Printer The N'Vision Programmer supports printing with the Seiko Model DPU 3445 printer and various other desktop printers. The desktop printer must have IR capability or must be fitted with a commercially available IR converter.
ELECTRONIC CONFIDENTIAL REF _R18 “Y/BRHD EN.book Page 23 Tuesday. June 26, 2001 3:37 PM — How fo Use the N'Vision Programmer Telemetry Module Use Telemetry Module Use The telemetry module located on the back of the N'Vision Programmer may be used white locked in place on the programmer or while extended, Refer to the appropriate therapy manual for specific device programming and interrogation instructions. FAN Caution: The programmer, cable, and telemetry head are non sterile.
i A MONOTONIC CONFIDENTIAL REFEREE | book Page 24 Tuesday, hme 26, 2001 3:37 PM How to Use the N'Vision Programmer Telemetry Module Use Positioning the Telemetry Head The following graphics demonstrate proper positioning of the programmer and telemetry head in various scenarios: Sterile Plastic Pouch Figure 3-18.
ELECTRONIC CONFIDENTIAL REFEREE H58_EN book Page 25 daresay, June 26,2001 3:57 PM How to Use the N'Vision Programmer Telemetry Module Use Sterile Plastic Pouch Figure 3-20.
| A MEDICATION CONFIDENTIAL REFEREE book Page 26 Tuesday. June 26. 2001 3:37PM How to Use the N'Vision Programmer Telemetry Module Use Figure 3-21. Telemetry Head Locked on Programmer, Patient Upright Reeling in the Telemetry Head To return the telemetry head to a locked position on the programmer, place one forefinger in the depression on the cable wheel and turn the whit clockwise until the telemetry head begins to slide root the back of the programmer (Figure 3-22}.
REFEREE @ How to Use the N'Vision Programmer Telemetry Module Use | i Figure 3-22.
1 ELECTRONIC CONFIDENTIAL Sa BE30_EN book Page 28 Tuesday. June 26, 2001 3:37 PM How to Use the N'Vision Programmer Telemetry Module Use Connecting the Magnet to the Telemetry Module The telemetry module includes a molded area for magnet containment, and the magnet “locks” into the telemetry head with a clockwise turn (Figure 3-23). The magnet is device specific.
| 198311001 i Rev A 8 4 ELECTRONIC CONFIDENTIAL 8 REFEREE 4 B84 EN book Page 29 Tuesday. June 26, 2001 3:37 How te Use the N'Vision Programmer Telemetry Module Use Caution: Do nat allow the magnet to come in contact with magnetic substances. Do not place the magnet on or near computer monitors or magnetic storage devices, disks, or tapes.
A ELECTRONIC CONFIDENTIAL REF _R18 AL & [85530 book Page 30 Tuesday. ume 26.
Io ELECTRONIC CONFIDENTIAL REFEREE 8 “9 gm 6x book Page § Tuesday, June 26, 2001 2:37 pM Programmer Maintenance Changing the Programmer Batteries 4-2 Cleaning the Display 4.
7 BEAD EN book Page 2 Tornadoes, June 26. 2001 3:37 PM 8 ® ELECTRONIC CONFIDENTIAL REFEREE 4 {Y — Programmer Maintenance Changing the Programmer Batteries Changing the Programmer Batteries The N'Vision Programmer operates on four “AA” alkaline batteries. (Do not use rechargeable batteries.
ELECTRONIC CONFIDENTIAL REFEREE Page 3 Tuesday, June 26, 2001 3.27 PM A Programmer Maintenance Cleaning the Display Battery Replacement Batteries should be replaced after every 40 hours or when the battery status shows low battery, Batteries must be replaced when the battery status indicates EOL (blinking). Caution: Dispose of depleted batteries in accordance with local regulations.
ELECTRONIC CONFIDENTIAL REFEREE | $V R840_EN souk Page 4 Tuesday, June 26, 3001 3:37 PM Programmer Maintenance Display Calibration Display Calibration The display of the N'Vision Programmer may require periodic calibration. To calibrate the display, access the Platform Status Bar, followed by the Snider Bar Mode. On the Slider Bar, select “Programmer Settings” {Figure 4-2) then calibrate button.
ELECTRONIC CONFIDENTIAL REF _R18 A B830_EN souk Page § Thursday, June 26. 2001 3:37 PM Programmer Maintenance Display Calibration If display calibration fails, the programmer will re initiate the calibration procedure until it is successfully completed. Figure 4-3. Screen calibration target Cleaning the Telemetry Module Do not use abrasive or nonabrasive cleansers on the telemetry module.
ELECTRONIC CONFIDENTIAL REF _R18 BEI0_ENbuok Page 6 Tuesday, June 76, 2001 3:37 PM Programmer Maintenance Display Calibration 2. Testing for penetrability 2.1 Selfless 2.2 Programming head 2.3 Testing of display 2.4 Testing of functional keys 2.5 Testing of telemetry 3, Electrical safely in accordance with IEC 60601-1 3.
ELECTRONIC CONFIDENTIAL REFEREE P | 440_EN book Page | Tuesday, June 26. 2001 3.37 Troubleshooting Troubleshooting Reference Guide 5-2 Electronic N'Vision Clinician Programmer Guide 5.1 .
ELECTRONIC CONFIDENTIAL REFEREE 430, EN book Page 2 Tuesday, Tune 26,2001 337 PM —er S Troubleshooting Troubleshooting Reference Guide Troubleshooting Reference Guide Table 5-1. Quick Reference Troubleshooting Guide Problem Possible Solution « Power is ON, but there is no self test » Turn the programmer off and tum it or display back on « The programmer cannot be operated» Check fo ensure batteries are.
8 | ELECTRONIC CONFIDENTIAL HEF R18 | @ "5i0_EN book Page | Tuesday, June 26, 2001 337 PM @ Specifications N'Vision Programmer Specifications 6-2 Electronic N'Vision Clinician Programmer Guide 5-1 Size inches {Olympic LIC200101473 198311001 zz Rev A Define as desired
ELECTRONIC CONFIDENTIAL REFEREE §840_EN book Page 2 Tuesday, June 26, 2001 3:37 PM Specifications N'Vision Programmer Specifications N'Vision Programmer Specifications Electrical and Operating Characteristics Power source: 4 “AA” commercially available alkaline batteries (IEC 86-1) Battery life (with fresh batteries): Approximately 40 hours Clock back-up battery: Type BR1225 lithium coin cell Length: 22 om {8.75 in} Width: 10 em {3.75 in} Height: 4 em {1.
ELECTRONIC CONFIDENTIAL REFEREE BH4b_EEN book Page 3 Tuesday, June 26, 2001 3:37 PM = Specifications N'Vision Programmer Specifications Programmer Storage and Operating Conditions Table 6-1. Programmer Storage and Operating Conditions Parameter Storage Operating Minimum temperature -40°C 94°C (49°F) Maximum temperature 65°C (149°F) 43.3°C (110°F) Minimum humidity 30% (non-condensing) 30% (non-condensing) Maxima humidity 75% (non-condensing) 76% (non-condensing) Minimum Atmospheric pressure 700 hPa (20.7in.
ELECTRONIC CONFIDENTIAL REFEREE “BADEN book Page 4 Tuesday, June 26.
She ELECTRONIC CONFIDENTIAL REFEREE 8 P 7 gd0_EN hook Page 1 Tuesday.
ELECTRONIC CONFIDENTIAL REFEREE en HE40_EN book Page 2 Tuesday, June 26, 2001 3:37 PM Q@ Glossary Active icon — A graphical representation of a button that, when selected, initiates an operation or action. Application card — A small computer disk on which Electronic Neurological therapy applications are housed. Hard key — A programmer button that, when depressed, initiates an operation or action, inactive icon ~ A graphical representation of a bunion that offers status information.