NATO RECOMMENDED PRODUCTS LIST (NRPL)

JANUARY 2007

Military Committee Communications and Information Systems Security and Evaluation Agency (SECAN) Central U.S. Registry 2530 Crystal Drive Room 3190 Arlington, VA 23202-3938
TABLE OF CONTENTS GENERAL INTRODUCTION. 1 PRODUCTS NO LONGER PRODUCED. 2 COMPANY ADDRESSES AND POINTS OF CONTACT. 3-5 NRPL EQUIPMENT INDEX (By Company). 6-12
PART I SECTION I. I-1 thru I-73 AMSG-720 ACCREDITED EQUIPMENT AND SYSTEMS
PART II SECTION III.III-1 thru III-41 AMSG-788 ENDORSED EQUIPMENT AND SYSTEMS
INTRODUCTION TO THE NATO RECOMMENDED PRODUCTS LIST
The NATO Recommended Products List (NRPL) is published and distributed by the Military Committee Communications and Information Systems Security and Evaluation Agency (SECAN). Products in the NRPL satisfy the requirements of the NATO TEMPEST Standard AMSG-720B for listings in PART I and AMSG-788A for listings in PART II. Approval for a listing on the NRPL is given by SECAN for the specific product and manufacturer described and cannot be extended to include similar products of the same or other manufacturers. Contracting and procurement officers are urged not to reference the NRPL in official procurement actions. Contracting and procurement officers should specify AMSG-720B or AMSG-788A, and not the NRPL. The NRPL is not the only source of information regarding equipment which meet AMSG-720B and AMSG-788A. If there is any uncertainty concerning the applicability of the above two TEMPEST Standards, the reader should consult their recognized TEMPEST or COMSEC Authority. Users of equipment listed on the NRPL are warned that equipment/ systems that interconnect with NRPL-listed equipment may not meet the specified TEMPEST standard. The NRPL is published twice a year in January and July. Only the current issue should be used. Previous issues are null and void. In order for the timely printing and subscription distribution, the NRPL submission must be delivered to SECAN two months prior to the publication month. Manufacturers who have products listed on the NRPL may forward a Marketing Point of Contact and telephone number to their National TEMPEST Authority. This information will be included in future issues of the NRPL.
PRODUCTS NO LONGER BEING PRODUCED
No products were removed for this time period.
Companies with AMSG-720 and AMSG-788 Equipment Systems
Advanced Programs, Inc. (formerly DRS Advanced Programs, Inc. NAI Technologies) Systems Division 7125 Riverwood Drive Columbia, MD 21046 ATTN: Mr. Joe OBanion TEL: (410)312-5845 FAX: (410)312-5850 BAE Systems (formerly Digital Net, Inc.) 836 North Street Tewksbury, MA 01876-1253 ATTN: Kevin Squires TEL: (978)856-1730 FAX: (978)856-1744 Blazepoint Limited Unit 2 Tower Estate Warpsgrove Lane Chalgrove, Oxon United Kingdom, OX44 7XZ ATTN: Mr. J. Kelday TEL: (01865) 891666 Candes Systems Incorporated 3131 Detwiler Road Harleysville, PA 19438 ATTN: Daniel J. Signore TEL: (215)256-4130 CIS Secure Computing 43671 Trade Center Place, Suite 152 Dulles, VA 20168 ATTN: Dale E. Collins TEL: (703)996-0500, x111 Cryptek Secure Communications 1501 Moran Road Sterling, VA 20166 ATTN: John H. Booher TEL: (571)434-2107 FAX: (571)434-2001 Digital Park Worton Grange Imperial Way Reading, Berkshire RG2 0TE ATTN: Mr. T. Aston TEL: (0118) 9203147 DRS Rugged Systems (Europe) Ltd. The Trading Estate Farnham Surrey, Great Britain GU9 9NN ATTN: Mr. D. Cockarill TEL: (01252) 734488 Emcom Emanation Control Limited 11 Tristan Court Nepean, Ontario, Canada K2E 8B9 ATTN: Mr. Peter Doig TEL: (613)723-1838 FAX: (613)723-2752 EMAIL: peter.doig@emcon.com European Data Systems, Ltd. Cornbrash Park Bumpers Farm Chippenham, Wiltshire United Kingdom, SN14 6RA Getronics Lab Via Campi Flegrein Pozzuoli (Napoli)-Italy P.IVA 05360750631 ATTN: Domenico Mazzacane TEL: 8665456 FAX: 8664469 HETRA Secure Solutions Corp. (formerly Cycomm Secure Solutions) 2350 Commerce Park Drive Suite 1 Palm Bay, FL 32905 ATTN: Steve Rasbach TEL: (321)953-3033, x230 FAX: (321)953-6465
Digital Equipment Co. Ltd. 3
INTELECT Europe Ltd. Ryton Street
Worksop, Nottinghamshire United Kingdom S802 2AU TEL: (01909) 488766 FAX: (01909) 488767 International Computers Ltd. Jays Close Viables Industrial Estate Basingstoke, Hampshire Great Britain RG22 4BY ATTN: R. Beckingsdale TEL: (01256) 359222 Joyce-Loebl, Ltd. Post Design & Engineering Services 390 Princesway Team Valley, Gateshead United Kingdom NE11 0TU ATTN: Mr. M Cattle TEL: (0191) 4203000 Larimart S.P.A. Selec Communications Larimart S.p.A Via di Torresvecchia, Roma, Italia TEL: +39-06303431 FAX: +39-0630343386 Lindgren-Rayproof Boulton Road Pin Green Industrial Area Stevenage Herts SG1 4TH ATTN: Mr. C. Castro FAX: (01438) 747477 Mas-Hamilton Group, Inc. 805 D Newston Circle Lexington, KY 40511 ATTN: R. Tim True TEL: (540)338-5117 FAX: (540)338-7832 NFT CRYPTO A.S. N-0212 P.O. Box 294, SKOYEN Oslo 2, Norway ATTN: Robert Kokkerud TEL: (472) 502180 FAX: (472) 500439 Nordpartner A.S. Olaf HelsetsVEI 6 Postboks Secure Systems Production, Ltd. (SSPL) 0621 Oslo 6 Etterstad, Norway ATTN: Mr. G. Sorensen TEL: Presentey Engineering Prod. Ltd 2784 Fenton Road, Box 91, RR#5 Ottawa, Ontario, Canada K1T 3T7 ATTN: Nicole Presentey TEL: 613-822-1251 SAIC Limited 26 Craven Court Stanhope Road Camberley, Surrey Great Britain GU15 3BW ATTN: Mr. C. Hartington TEL: Secure Systems & Technologies Ltd. Henley House Barnett Way Barnwood, Gloucester Great Britain GL4 3RT ATTN: F. Foskett TEL: Secure Systems Group (US) 45150 Business Court Suite 400 Sterling, VA 20166 ATTN: Dave Jones TEL: (703) 742-0611 FAX: (703)742-0863 Secure Systems Group (UK) 24 Merling Croft Northchurch, Herts HP4 3XB ATTN: Mr. R. Womack TEL: 01442 866892

The system supports 1.2MB or 1.44MB floppy diskette drive formats. The system has Flash AMIBIOS. The system chassis is powered by a 300 watt switching-regulated power supply. The AC input voltage is as follows: Volts Minimum Nominal Maximum Frequency Hz 132 47-47-63
The YT1-PEN/90-TW3 system tower chassis is 23 1/2 high, 23 deep and 10 wide. The chassis accommodates seven full length cards, five half height storage device bays (one diskette bay and four removable hard, media removable optical, CDROM, or fixed tape drive bays). Located on the front panel are the on/off switch with indicator LED and the disk activity indicator LED.
Configured Options: Model YT1-PEN/90-TW3
Basic Unit With Included Options 90MHZ Pentium/PCI/8MB Memory/Combination 1.2/1.44MB Floppy Diskette Drive/724 keyboard/7 Slots Country Kit (includes 724 Keyboard). The YT1-PEN/90-TW3 comes with a TEMPEST 724 keyboard witch has all the necessary keys to run any Getronics Government Solutions or industry-standard application program. The unique layout of the 724 keyboard satisfies both U.S.(109-key) and international (110-key) requirements. This is accomplished by selectively keycapping over unused keys. The xx represents (AE) Azerty English, (AS) Australian, (AZ) French/Belgium, (CA) Canadian English, (CF)) Canadian French, (FL) Flemish, (GE) German, (IT) Italian, (UK) United Kingdom, (US) United States. Upgrade Option Upgrade from Tower 2 to Tower 3 Memory Option 4 MB Memory Module (1x36) 8 MB Memory Module (2x36) 16 MB Memory Module (4x36) 4 MB Memory Module (8x36) Replace 8 MB (two 4MB) with two 8MB Replace 8 MB (two 4MB) with two 16 MB Replace 8 MB (two 4MB) with two 32 MB IDE Drive, Drive Tray & Cable Options 540 MB Removable IDE Drive Version GB Removable IDE Drive Version 2 IDE Docking Drive Tray Version 2

YT1-TW3-CK-xxT

Model YT1-UJ-TW2-TW3 Model YT1-QUAD-SIM-04 YT1-QUAD-SIM-08 YT1-QUAD-SIM-16 YT1-QUAD-SIM-32 YT1-R-8MB-2/8MB YT1-R-8-2/16MB YT1-R-8-2/32MB Model YT1-IDE-540-2T YT1-IDE-1GB-T YT1-DDTRAY-VER2 YT1-ITW-IDE IDE Cable Model YT1-1GBSHD-ET YT1-2GB-SDD-T YT1-4GB-SDD-T YT1-TDAT-TW YT1-4GB-DAT-TW3 YT1-4XCDROM-TW3 YT1-DDTRAY-2T YT1-ITW-SCSI YT1-PCI-SCSI-T

The QFOCV24T TEMPEST Remote Peripheral is a Fibre Optic Converter operating at 600bd to 19.2Kbd data rates.

FIBER OPTIC CONVERTER

DRS Rugged Systems (Europe) Ltd

QFOCX21T

The QFOCV21T TEMPEST Remote Communications is a Fibre Optic Converter operating at 600bd to 19.2Kb/s data rates. FIBER OPTIC HUB Trend Communications Ltd. 643A
The 643A provides a fibre optic interface between terminals and the Ethernetbus. The hub comprises up to 15 modules, each of which may be connected to a terminal cascaded to another 643A if connectivity to more than 15 terminals is required. FIBER OPTIC TRANSCEIVER Lindgren-Rayproof L2840/005T
The Rayproof L2840/005T RS232 to Fibre Optic Transceiver is designed to plug directly into a 25-way Dtype connector on a peripheral host device from which it derives its 12V d.c. power. Signals are transferred between two transceivers via fibre optic cables. The EUT can be configured for use as either a DTE or a DCE communications interface and operates at data rates of between 1.2kb/s and 19.2kb/s. The circuitry of the EUT is contained within a soldered metal case, and two ST bayonet-type fibre optic connections are mounted to the opposite end. HUB HETRA Secure Solutions Corporation 10BASE-FL Hub
The HETRA Secure Solutions Corporation Model 5208T is a 10BASE-FL, 8 port fiber hub based on the OEM version of the LANart 10BASE-FL Fiber Star Hub. The Hub is a low-profile 10BASE-FL multiport repeater which provides eight fully compliant IEEE 802.3 ports. The hub is supplied with a fully compliant IEEE 802.3 10BASE-FL backbone port which can be set to implement LANarts LinkALERT technology. When this port is used as an uplink to another hub, LinkALERT will detect 100 percent of physical link failures that occur between the hubs. The power supply is a autosensing 25 Watt internal 100-240 VAC 60 or 50 Hz. Options: 220V version with Italian Power Plug 220V version with Danish Power Plug 220V version with Austalian Power Plug 220V version with United Kingdom Power Plug 220V version with Continental European Power Plug DATE ADDED TO NRPL: July 1999
INTERFACE Interface Expander INTERFACE, COVERTER

Siemens AG

SVV 8906Z
Secure Systems Group (UK)

SSG933T

The SSG933T TEMPEST Interface Converter connects and converts from V.24 DTE to X.21 DCE. The 933T can be installed between a V.24 terminal and an X.21 secure telephone. The unit operates without mains power by using ultra low power from the standard RS-232C/V.24 data, and control signal voltages up to 200kb/s. INTERFACE, FIBER OPTIC Fiber Optic Data Link INTERFACE, FIBER OPTIC Lindgren-Rayproof L2839/005T Lindgren-Rayproof L2243/CT/004
The L2839/005T is an 8 Channel fibre optic distribution unit for RS-232 transmission to 19.2Kb/s per channel. INTERFACE, FIBER OPTIC X21 Fibre Optic Data Link. INTERFACE, FIBER OPTIC Lindgren-Rayproof Y21882/T Lindgren-Rayproof Y21881/T

- 1024x 768/75 Hz Maximum Resolution - AC100-240V Universal Power The basic monitor configuration is a table top model. The packaging includes a tilt/swivel base. All controls are accessible from the front of the monitor. Part Number T15LCD-Te Where Configured Options: A - Power Configurations. Values are 1 - 110, US plug 2 - 220, UK plug 3 - 220, ER plug 4 - 220, SF plug 5 - 220, DM plug 6 - 220, AZ plug 7 - 220, US plug B - Operating configuration. Values are 1 - PC 2 SUN DATE ADDED TO NRPL: January 2002 MONITOR, LCD 17 TFT Advanced Programs, inc,

DMT-107E

The Advanced Programs, Inc. TEMPEST Level I, 17 LCD is based on the Sharp LL-172A color LCD. The screen is equipped with a high performance TFT that achieves a contrast ratio of 450:1, so pictures and even small letters are clearly legible. The basic monitor configuration is a tabletop model. The packaging includes a tilt base. All controls are accessible from the front of the monitor. The 17 LCD display includes the following features: LCD Size Resolution Contrast Brightness View Angle Backlight Power Cons. H-Frequency V-Frequency Interface Dimensions DATE ADDED TO NRPL: July 2006 MONITOR, LCD 17 TFT Monitor 17 TFT LCD Color: Resolution: 800*600 up to 1280*1024 Pixel Pitch: 0.264x0.264mm N. colors: 16,7M Automatic Scanning Horizontal freq. 31,47KHz to 80KHz Automatic Scanning Vertical freq. 60Hz to 75Hz. Dimensions: (HxWxD; mm): 426x444x546 (HxWxD; inches): 16,7x17,5x21,5 Weight: (Kg): 14/ (Lbs): 6,3 DC Input: 12V from Back Panel of PC with Custom Connector Power Max. (W): SCGA @ 1280 x 1024-1.3 Megapixels 450:cd/m2 Horizontal 160/Vertical 160 50,000 hrs rated 30 Watts 31.5-81.1 kHz 60-75 Hz Analog 16.2 in x 15 in. X 8.7 in. (HxWxD)

Getronics Lab

LCD15TE
DATE ADDED TO NRPL: January 2006 MONITOR, LCD 19 TFT HETRA Secure Solutions HT-4190-T1-PH
The HT-4190-T1-PH is the TEMPEST Level I Version of the Philips 190S 19" LCD Monitor. The 190S is a 19-inch TFT-LCD monitor delivering a 500:1 contrast ratio, pixel pitch of 0.294mm, 1280 x 1024 maximum resolution, and a scanning frequency of 30-82 kHz horizontal and 56-76 Hz vertical. Options: Video cable: 6 feet with 15 pin to 15 pin sub-miniature D type connector with right angle to straight shells. Video cable: 6 feet with 15 pin to 9 pin sub-miniature D type connector with right angle to straight shells. US Power Plug United Kingdom Power Plug Continental European Power Plug Italian Power Plug Danish Power Plug Australian Power Plug DATE ADDED TO NRPL: January 2006 MONITOR, LCD HETRA Secure Solutions 4815T
The 4815T is a version of the Samsung SyncMaster 570b TFT 15" Monitor. The monitor is Plug & Play compatible and it has Samsung's exclusive "Wide Viewing Angle Technology" that lets people see clear and sharp images from any angle. The new "EDA" (Easy Display Adjustment) panel lets the users control all display functions at a touch of a button.Samsung's TFT technology delivers screen images that are richer and brighter than traditional CRT monitors. Additionally, the OEM SyncMaster 570b TFT is Energy Star / NUTEK and TCO'99 certified. OPTIONS: Video cable: 6 feet with 15 pin to 15 pin sub-miniature D type connector with right angle to straight shells. Video cable: 10 feet with 15 pin to 15 pin sub-miniature D type connector with right angle to straight shells. Video cable: 6 feet with 15 pin to 15 pin sub-miniature D type connector with right angle shells. Video cable: 10 feet with 15 pin to 15 pin sub-miniature D type connector with right angle shells; Video cable: 6 feet with 15 pin to 9 pin sub-miniature D type connector with right angle to straight shells. Video cable: 10 feet with 15 pin to 9 pin sub-miniature D type connector with right angle to straight shells. 220V version with Italian Power Plug 220V version with Danish Power Plug 220V version with United Kingdom Power Plug 220V version with Continental European Power Plug 220V version with Australian Power Plug DATE ADDED TO NRPL: January 2002 MONITOR, LCD HETRA Secure Solutions 4821-T1-DL

Ruggedized, battery operated, miniature printer. RS 232 interface X/DTR + optical interface to PACE crypto equipment. Data rate:2400b/s; power supply: Nicad. Weight 1.7Kg, size 70 x 163 x 170mm. PRINTER, LASER Cordsen Engineering GmbH ATS-4100Te
The ATS-4100Te, is a TEMPEST modified version of the Hewlett Packard 4100 Laserjet Printer. The ATS4100Te standard features include: 48Mbyte of RAM 24 ppm print speed 300dpi to 1200dpi print resolution HP JetDirect printer server card and matching copper to fibre converter card.
100Mb/s fibre Ethernet interface Paper tray capable of holding 500 sheets Supply voltage 230V 50/60Hz a.c. DATE ADDED TO NRPL: July 2002 PRINTER, LASER Advanced Programs, Inc. LaserJet V-Te
The Advanced Programs, Inc. LaserJet V-Te is based on Hewlett Packards LaserJet 5 Printer. The printer offers 4MB RAM standard, prints at 12 pages-per- minute, and features 600 dpi resolution in text and graphics. The printer offers HPs hot I/O technology. This technology permits users to utilize the printers standard Serial and Parallel interfaces simultaneously. Optional interfaces are available with the printer that include Fiberoptic, AUI and Coax. The LaserJet V-Te provides Postscript as an option. When the printer is ordered with Postscript, the printer automatically senses whether applications are PCL or Postscript and switches to the appropriate printer language. Standard paper input capacity is 250-sheets. A 500-sheet lower cassette tray maybe ordered optionally with the printer. Separate base models must be specified for 115V, or 220/240V AC options. Ordering Information: Base Printer LASER5-BASEUS 110/120 VAC Laser 5-Te Base Printer LASER5-BASE220 220/240 VAC Laser 5-Te Base Printer Memory and Postscript Options: LASER5-MEM01 1MB SIMM Module (HP C3130A) LASER5-MEMMB SIMM Module (HP C3131A) LASER5-MEMMB SIMM module (HP C3132A) LASER5-MEMMB SIMM Module (HP C3133A) LASER5-MEMMB SIMM Module (HP C3146A) LASER5-FLASHMB Flash SIMM (HP C3930A) LASER5-FLASHMB Flash SIMM (HP C3931A) LASER5-POST Postscript Level 2 SIMM with 2 MB Memory (HP C3918A) Interface Options: LASER-ENETAUI LASER5-ENETBNC LASER5-FIBER Software Options: LASER5-HPUX HP-UX LASER5-SUNUNIX
Ethernet AUI Port (HP J2552A plus Converter Board) Ethernet BNC Port (HP J2552a) Fiber Optic Port (HP J2552A plus Converter Board)
Software for ENET and FIBER Options (HP J2374C) Sun UNIX Software for ENET and FIBER Options (HP J2375C)
Line Cord Options (for LASER5-BASE220): LINECRDSHLD-ER 220/240 VAC Line Cord for Europe LINECRDSHLD-UK 220/240 VAC Line Cord for United Kingdom LINECRDSHLD-DM 220/240 VAC Line Cord for Denmark LINECRDSHLD-SF 220/240 VAC Line Cord for Switzerland Accessories: HC3926A HC3921A HC3923A H92298A HC3927A HC3920A PRINTER, LASER

Options:

30ppm print engine 64MB Synchronous Dynamic Random Access Memory (SDRAM) 600 to 1200 dots per inch (dip) print resolution HP PCL6, HP PCL 5e and HP Postscript Level 3 emulation 100 sheet multi-purpose and 250 sheet input paper trays IEEE 1284 compliant bi-directional parallele port operating at 111.1PIU Built-in automatic two-sided printing 240V ac power supply operation
USB 2.0 interface operating at 1.5Mb/s, 12Mb/s or 480Mb/s Ethernet interface operating at: " 10Mb/s via ST Fibre Optic connecting using a Volamp TP to fibre optic converter (Model: UFM-F) " 100Mb/s via ST Fibre Optic connection using a Volamp UTP to fibre optic converter (Model: 100-FU-M-BKT/ST) " 100Mb/s via SC Fibre Optic connection using a Volamp UTP to fibre optic converter (Model: 100-FU-M-BKT/SC) Memory upgrade to 320MB max " 64MB (HP Part No. Q2625A) " 128 MB (HP Part No. Q2626A) " 256MB (HP Part No. Q2627A) Additional 500-sheet paper tray (HP Part No. Q5963A) DATE ADDED TO NRPL: January 2006 PRINTER, LASERJET BAE Systems YT1-LJ4250-XX-C
The BAE Systems TEMPEST HP LaserJet 4250 is a 45 ppm, 1200 dpi, RISC based laser printer. Two basic models; -60 for 110 volts and 50 for 220 volts are available for domestic or internal use. The -C designation included in the model number is reserved for those models that have contract specific requirements. Standard features include 64MB of resident memory, expandable to 512MD, and a 100 or 500 sheet paper trays. Printer connectivity is provided via a bi-directional IEEE-1284 compliant parallel interface, two EIO option slots and a USB 2.0 jack. Available options include: Expanded memory, duplex printing, expanded paper tray, 10/100 fiber optic interface. DATE ADDED TO NRPL: July 2006 PRINTER, MULITFUNCTION HETRA Secure Solutions Corporation HT-3380-T1-HP
Description: The Hetra Secure Solutions HT-3380--T1-HP is a high=performance multifunction printer with quality printing, legalsize copying and color scanning based on the HP LaserJet 3380 All-in-One Series. The fax capability of the HP 3380 has been disabled in the HT-3380-T1-HP for security reasons. The fax options will be present on the control panel and software options but the physical connection will not be possible due to the removable of the RJ-11 connection. The HT-3380-T1-HP uses a 240MHz processor for fast file processing and has a 20 page per minute print qapability with a maximum resolution of 1200 x 1200 dpi resolution for printing, 500 cx 600 dpi for copying, and enhanced 9600 dpi and 24-bit color for color scanning. The HT-3380-T1-HP can be networked for easy sharing, and features an automatic document feeder with a 50-sheet capacity and legal -size flatbed document glass for scannuing and copying books and other bound dcuments. The scanner uses Readiris PRO Text Recognition Software increases accuracy when scanning text while industry-standard TWAIN 1.9 and WIA scanner drivers enable consistent image quality. The base unit comes with 32MB of SDRAM, expandable to 96MB. Interfaces to the host system are via IEEE 1284 compliant parallel port, IEEE 802.3 100Base-FX I/O or USB 2.0 port. OPTIONS: Memory Expansion to 96MB Parallel Port with a 6-Foot I/O Cable Parallel Port with a 10-Foot I/O Cable IEEE 802.3 100Base-FX

The DRS Rugged Systems (Europe) Ltd. LS20T Terminal is a diskless terminal consisting of a system unit and keyboard. The system contains both the colour and the terminal logic circuitry. The terminal may be used with either of two Rotec keyboards, a type SK636T or a type QK102/000TB. TERMINAL Tandberg Data A/S TDV 2241-Z
Video Display Terminal; Honeywell-Bull VIP 7802/7813 emulation; 15" monochrome display; 121-key keyboard with 16 programmable keys; optical printer interface; optical line interface or V.24 wire.

TERMINAL

Tandberg Data A/S

TDV 2244-Z

Video display terminal; DEC VT220 emulation; 15" monochrome display; 121-key keyboard with 16 programmable keys; optical printer interface; optical line interface or V.24 wire. TERMINAL Tandberg Data A/S TDV 2270-Z
Video Display Terminal; DEC VT100 and TDV 2215 emulation; 15" monochrome display; 121-key keyboard with 16 programmable keys; optical printer interface; optical line interface or V.24 wire. TERMINAL, COLOR GRAPHICS Secure Systems Production Ltd. (SSPL) VT370
370 FT ANSI/ASCI high performance 14 colour graphics Terminal. The Terminal has 64 programmable palette fore ground and background colours with a selectable frame speed of 60/65/74 Hz. The Terminal has a duplex fibre-optic data link which can operate up to 76.8 kb/s. Emulations provided are: VT320/220/100/52 Tektronix 4010/4014 - Intercolour 220 TV1950-Adds VP A2-ESPRIT 111 WY-350 TERMINAL, COMMUNICATIONS Siemens AG T1285Z
The T1285 Z is a flexible communication terminal with an operation system secure against manipulation (VIRUS PROOF). It is easy to use and is suitable for various networks (TARE, ISDN, X.25, AFD-BW, ETC.) The T1285 Z consist of a System Unit STE with built-in Disk Drive, VDU and Keyboard. Printer and tape punch is available. Line Interface: RS-232-C Data Rates: ITA2 50-300 BAUD / ITA5 100-9600 BIT/S Power Supply: AC 115V, 127V, 230V, 240V, 42 to 70HZ or 400HZ DC 24V (19 to 33V). TERMINAL, THIN CLIENT HETRA Secure Solutions HT-220MC-T1-WY
The HT-220-T1-WY Thin Client is based on the Wyse Winterm 9450XE and Microsoft Windows XY Embedded operating system. The device supports either 192MB or 256MB of Flash and 256MB of DRAM, PS/2 mouse and keyboard ports, and a BGA type video output. The unit has optional I/O ports such as one serial, one parallel, two USB ports, and a 100Base-FX (SC) port.
Standard freatures of the HT-220MC-T1-WY: Microsoft Windows XP Embedded Operating System 192MB FLASH 256MB DRAM VESA monitor support, Selectable up to 1600 x 1200 104-Key PS/2 Keyboard 2-Button Scroll PS/2 Mouse 15" Color TEMPEST LCD 50-Watt External DC Power Adapter OS Compatibility / Support: Windows 2000, Windows NT Server 4.0 Terminal Server Edition, Citrix WinFrame(R), Citrix MataFrame(R), Microsoft.NET Server ready Optional freatures of the HT-220MC-T1-WY: Memory Expasion to 512MB 100Base-FX NIC, No external media converter Two USB 2.0 Ports One Serial Port One Bi-directional Parallel Port(DB25) 105-Key International Windows Compatible Keyboard International Power Plugs 17" TEMPEST LCD DATE ADDED TO NRPL: January 2004 WORKSTATION DRS Rugged Systems (Europe) Ltd J438T

The Advanced Programs, Inc. S20Te-xx family of workstations is based on the Sun Microsystems, Inc. SPARCstation 20 family of computers. The S20Te-xx chassis is a rackmountable TEMPEST enclosure that measure 5.25" high and 24" deep and weighs 37 pounds. The front panel includes access to four peripheral bays (three removable) via a door, a power on/off switch, a Sun standard 0.25 inch 600 ohm stereo headphone jack and power and SCSI activity indicators. The processor baseboard includes two 64-bit busses, the 50 Mhz Mbus for CPU modules and the 25 Mhz Sbus for I/O boards. There are a total of two Mbus and four Sbus expansion slots. The basic unit configuration includes the Sun SPARCengine 20 baseboard, internal floppy controller with support for internal 3.5 1.44MB floppy drive, internal SCSI-2 controller with support for 3 internal and four external devices, an autoranging 250 Watt power supply, a Sun Type 5 UNIX keyboard and mouse and 15-pin AUI Ethernet, external SCSI-2, two 25-pin RS-232C serial ports, keyboard/mouse, microphone, audio input and audio output ports. All systems can be expanded to a total of 512 Mbytes of ECC system memory. Configured Options: Part Number Basic Unit With Included Options

S20TE-61-BASEGX

Basic Unit with Model 61 CPU module based on Sun Microsystems, Inc. 60 Mhz SuperSPARC processor with 1 NM of external cache a Turbo GX accelerated graphics providing 8-bit color and up to 1280 x 1024 resolution. Turbo GX card occupies one Sbus expansion slot.

S20TE-514BASEGX

Basic Unit with Model 514 Quad CPU module based on Sun Microsystems 50 A4hz SuperSPARC processors with 1MB of external cache and Turbo GX accelerated graphics providing 8-bit color and up to 1280 x 1024 resolution. Turbo GX card occupies one Sbus expansion slot.
Options For All Models: S20Te-MEM16 S20Te-MEM32 S20Te-MEM64 S20Te-PAR S20Te-SER4 S20Te-IEEE488 S20Te-ATM S20Te-PS4T S20Te-FD144 S20Te-SC4294 S20Te-TP0150 S20Te-TP3500 S20Te-TP7000 S20Te-CDROM S20Te-TMON20 S20Te-RMON20 S20Te-RMON20KIT S20Te-TMON20KIT S20Te-KBDT5UNIX S20Te-RACKKBD S20Te-PCCARD WORKSTATION
16 MB system memory 32 MB system memory 64 MB system memory Parallel printer port Serial ports, four RS-422 Sbus IEEE-488 GPIB interface Sbus ATM adapter, OC3,ST connector Peripheral subsystem, rackmount, 4-bay Hard disk drive, 3.5 inch, 2.14 GB, removable Hard disk drive, 3.5 inch, 4.294 GB, removable Tape drive, cartridge, 150/250 MB Requires PS4T subsystem enclosure 8mm tape drive, 3.5 GB 8mm tape drive, 7.0 GB uncompressed (Requires S20Te-PS4T subsystem enclosure) CD-ROM drive (Requires S20Te-PS4T subsystem enclosure Requires PS4T subsystem enclosure Tabletop 20" color monitor, Energy Star compliant, up to 1280 x 1024 resolution, 0.30mm dot pitch Rackmount version of S20Te-TMON20 Rackmount kit for S20Te-TMON20 Tabletop kit for S20Te-RMON20 Keyboard, Sun Type 5 UNIX, with mouse Rackmount kit for keyboard and mouse PCMCIA Card Reader Advanced Programs, Inc. TCQ-xxx

The SC6865AT-900 Personal Computer is the latest variant of the SC6000AT Series Personal Computer. The SC6865AT-900 is based on the Compaq Evo Desktop Convertible Minitower D530 Series PC, providing the following features. Tower and Desktop Configurations Support for 2.4GHz to 3.0GHz Intel Pentium 4 Processors Intel 865G chipset supporting 800MHz system buses 512MB of PC2700 DDR-SDRAM expandable to 4GB 2MB SRAM cache 3x 5.25 half height front accessible drive bays Seagate ST340014A Ultra ATA/100 40GB Hard Disc Drive 1.44MB Floppy disk drive Compaq LTN-486S 48x CD-ROM Drive
Intel Extreme on-board Graphics 48MB (integrated with Intel 865G chipset) One RS232 serial port (50b/s to 115.2kb/s) and one parallel port Integrated AC97 Audio connection to an external speaker (for multimiedia/unclass use only) HP 2-button Scroll Mouse SK105UKAT-006 Keyboard PSU 115/230V, 50/60Hz (externally switchable) Options: Data Express S21B104 removable Metal Drive Carrier Seagate ST380011A Ultra ATA/100 80GB Hard Disc Drive NVIDIA GeForce FX5200 128MB Graphics Card One RS232 serial port (50b/s to 115.2kb/s) Brainboxes UC-324 One-Port RS422 PCI Card (50b/s to 115.2kb/s) Adaptec 29160N SCSI Card with external connection Six USB 2.0 ports (12Mb/s and 480Mb/s) Allied Telesyn AT-2450 FTX/ST or FTX/SC 10Base-FL Ethernet Fibre-Optic card Allied Telesyn AT-2701 FX/ST or FX/SC 100Base-FX Ethernet Fibre-Optic card Allied Telesyn AT-2746 FX 10/100Mb/s ST/SC Ethernet Fibre-Optic Interface card Seagate STT220000A TapeStor Travan 20GB Tape Streamer Sony CRX230E CD-RW Drive (52x/32x/52x) HP GCC-4480 CCD-RW/DVD-ROM Combo Drive (48x/24x/48x/16x) Smart cover lock security solenoid DATE ADDED TO NRPL: July 2005 COMPUTER, PERSONAL Secure Systems & Technologies Ltd SC8000T
The SC8000T personal computer with the Intel SE440BX-2 motherboard and Pentium III processor provides the following features: Support for Pentium III 500-800 MHz Intel SE440BX-2 chipset 128MB SDRAM expandable to 769MB 512kB second level cache 3 x 5.5 half height front accessible drive bays Kingston Removable Drive Carrier Fujitsu 6.5Gbyte Hard Disk Drive 16MB Diamond Speedstar A200 Accelerated Graphics Port (AGP) Video Card 2 x RS232 serial ports and 1 x bi-directional parallel port PS/2 mouse 105 key keybaord (SC105UKT-002) PCI based 3COM 3C900-COMBO 10 MHz Ethernet card with a Volamp 8000P Fibre Optic Interface PCI based Intel EtherExpress Pro/100+ 100BaseT FTP Interface Options: Digiboard PC2/e Async serial port adapter (COM3 & COM4) Digiboard PC64 Async serial port adapter providing support for up to 40 RS232 serial ports in conjunction with 8 or 16 port external Port Expansion Module Digiboard PC8r Async serial port adapter providing support for up tp 8 RS232 serial ports Additional bi-directional parallel port (LPT2) ATI Xpert 98 AGP Video Card Seagate U10 15GB Hard Disk Drive Seagate STT8000A IDE Digital TapeStor tape backup device (8GB) 32X CD-ROM drive Toshiba DATE ADDED TO NRPL: January 2001

SC8800T-024 A Variant of SC8000T Series The SC8000T series is an additon to the successful ENTERPRISE range of TEMPEST personal computers providing enhanced features. The SC8000T with the Intel SE440BX-2 motherboard and Pentium III processor provides the following baseline features: Support for Pentium III 500-800 MHz Intel SE440BX-2 chipset 128MB SDRAM expandable to 769MB 512kB second level cache 3 x 5.5 half height front accessible drive bays Kingston Removable Drive Carrier 2 x RS232 serial ports and 1 x bi-directional parallel port PS/2 IntelliMouse 105 key keybaord (SC105UKT-002) Options: Accelerated Graphics Port (AGP) Video Card; ATI Expert 2000 Pro or ATI Xpert 98 or 16MB Diamond Speedstar A200 Hard Disk Drives: IBM Deskstar 30.7GB, Seagate U10 15GB, Fujitsu 6.4GB Ethernet 100BaseT Network Interface Card PCI based Intel EtherExpress Pro/100+ with either FTP interface or Transition J/FE-CF-01(ST) 100BaseFX fibre optic transceiver Ethernet 10Mbps Network Interface Card PCI based 3COM 3C900-COMBO card with a Volamp 8000P fibre optic interface Digiboard PC2/e Async serial port adapter (COM3 & COM4) Digiboard PC64 Async serial port adapter providing support for up to 40 RS232 serial ports in conjunction with 8 or 16 port external Port Expansion Module Digiboard PC8r Async serial port adapter providing support for up tp 8 RS232 serial ports Additional bi-directional parallel port (LPT2) Adaptec 29160N SCSI Card Seagate STT8000A IDE Digital TapeStor tape backup device (8GB) 32X CD-ROM drive Toshiba 12x/8x/32x LG Electronics CED-8120B CD ReWrite drive (CD-RW) Quadtech PCD2-F/PCI PCMCIA card reader Harris Corporation PCMCIA Type II Communications Interface Card (Part Number 10562-0050-03) for RS232 data transfer utilising Harris Universal Image Transmission Software (HUITS) application. DATE ADDED TO NRPL: January 2002 COMPUTER, PERSONAL Trend Communications Ltd. 635B 386SX
A high performance IBM compatible TEMPEST personal computer based on the Intel 386SX 16 bit microprocessor running at 20MHz with zero wait state interleaved memory. The CPU has 1 Mbyte of dynamic RAM expandable to 2 or 5 Mbytes (on board) with zero wait state. Features colour VGA Graphics, ROM BIOS by QUADTEL, 40 Mbyte removable hard (SCSI) disk drive, 3.5in 1.44 Mbyte or 5 1/2 1.2 Mbyte drive, Logitech mouse port for Trend Trackerball, 2 off V28 compatible Async ports, Centronics printer interface, 4x16 bit IBM compatible expansion slots, 102 key keyboards types 631B and 631C. Options 80287 Maths co-processor, Streaming tape drive, Micronyx trispan security card, Trackerball, Fibre optic Ethernet (3-COM), TS232/Fibre optic adaptor for Async ports, floor mounting kit. COMPUTER, PERSONAL Trend Communications Ltd. 645

The SM17AT-Color Monitor is based on the Compaq V720 Color Monitor and satisfies the need of professional users. Its innovative technology design delivers outstanding display quality, brightness and contrast via a state of the art image processor. It is a small footprint display that takes minimal desk space. The display is compatible for use with systems running Windows NT, 2000, 98, 95, and MS-DOS operating systems. It has a maximum resolution of 1600 x 1200 pixels with a 0.24mm dot pitch combined with a wide viewing angle and anti glare coating that produces a clear crisp display. Features: Screen Size: 16 viewable area Maximum resoluton: 1600 x 1200 at 60Hz 1280 x 1024 at 85Hz Dot pitch 0.2mm (Horizonal)/0.24mm (Diagonal) Horizontal Frequency: 30kHz 85kHz Vertical Frequency: Hz On screen display for screen adjustments and intuitive user controls. Power requirement: 100W max Energy Star Compliant: TC099 DATE ADDED TO NRPL: January 2003 MONITOR, COLOR Secure Computer Systems Ltd SM17AT-007
The SM17AT-Color Cathode Ray Tube (CRT) Monitor is based on the Compaq V7550 model and satisfies the need of professional users. The SM17AT series is a small footprint display that takes minimal desk space. The display is has a maximum resolution of 1600 x 1200 pixels with a 0.25mm to 0.28mm (vriable) dot pitch combined with a wide viewing angle and anti-glare coating that produces a clear crips display. It is compatible for use with systems running Windows NT, 2000, 98, 95 and MS-DOS operating systems. Features: Viewable screen size: 16 Maximum resoluton: 1600 x 1200 at 65Hz refresh rate Dot pitch 0.25mm to 0.28mm (Variable) Horizontal Frequency: 30kHz 86kHz

III-22

Vertical Frequency: Hz Power requirement: <100W Energy Star Compliant TCO99 On screen display for screen adjustments and intuitive user controls. DATE ADDED TO NRPL: January 2003 MONITOR, COLOR Secure Systems Production Limited (SSPL) HM-114B
TEMPEST variant of Phillips 4CM4279-20t 14" colour SVGA monitor. Resolution up to 1280 x 1024 and 1024 x 768 (non-interlaced). The mmodifications have been incorporated so as to preserve the look and functionality of the original equipment. The monitor is Energy Star compliant and meets the emission requirements of MPR-II.
Secure Systems Production Limited (SSPL)

The OSPL PL-119B LED Printer is a variant of the OKI Systems OL410ex LED non impact printer. Printing throughput is four pages per minute. Resolution is 300 x 300 dots per inch as standard, with "MicroRES 600" this becomes effectively 600 x 600 dpi. Printer language is HP LaserJet III (PCL5) emulation. The memory is upgradeable from 1Mbyte to 5Mbytes. Inputs are Centronics parallel and RS-232C serial with autosense. Dimensions are height 160mm, width 320 mm, depth 360mm and weight 8 kg. PRINTER PL-137 B600dpi LED PRINTER The OSPL PL-137B LED Printer is a TEMPEST version of OKI Systems OL 810ex LED printer. High speed personal printer with 8ppm performance and true 600dpi quality output from the LED print head. The standard 2 Mb memory can be upgraded to 34 Mb with user installable SIMMS. Eight pages per minute. Automatic parallel/serial interface switching. Trend Communications Ltd. 636A Secure Systems Production Limited (SSPL)

PRINTER

The Trend 636A printer has IBM compatible parallel interfaces and is based on the OKI 182 printer. PRINTER, COLOR INKJET Secure Systems & Technologies Ltd SP990AT

III-26

The SP990AT TEMPEST Color Inkjet Printer is based on the Hewlett Packard (HP) DeskJet Professional Series 990 Cxi Printer providing unparalledl quality and reliability. The SP990AT TEMPEST Color Inkjet Printer combines a 17 page per minute (ppm) print engine with a a 96MHz RISC processor for data formatting and image processing. Standard features of the SP990AT TEMPEST Color Inkjet Printer include: Up to 17ppm mono, 13ppm color print speed 8MB Random Access Memory (RAM)/96MHz RISC processor Up to 2400x1200 dots per inch (dpi) resolution using HP PhotoRet III precision technology on photo quality paper 150 sheet input standard Automatic two-sided printing module IEEE 1284 compliant bi-directional parallel port Universal Serial Bus (USB) port Infrared Data Associated (IrDA) Port 100V 250V a.c. operation via 30V d.c. power module Compatible with Microsoft Windows (3.1x, 95, 98, NT 4.0, 2000 PRO, ME) DATE ADDED TO NRPL: January 2003 PRINTER, DRS Rugged Systems (Europe) Ltd CP8240 DOT MATRIX A 24-pin dot matrix printer, 19V-32Vdc operation, parallel centronics interface. PRINTER, NFT Crypto A.S. FP100
DOT MATRIX Ruggedized, battery operated, miniature printer. RS232 interface x/DTR + optical interface to pace crypto equipment. Data rate: 2400 B/S, power supply: internal rechargeable Nicad. Weight 1.7 kg, size 70x 163x170.mm. PRINTER, DOT MATRIX Secure Systems Production Ltd. (SSPL) 280T
The OSPL 9 pin dot matrix printer is based upon the OKI ML 280 lightweight printer. It has two options one with serial interface working from 110b/s to 19.2k/s. The other is a parallel interface working from 2kPIU. Both options are powered at 120V 50Hz. PRINTER, DOT MATRIX Trend Communications Ltd. 636C
The Trend 636C personal dot matrix colour printer, 200 cps with centronics I/F. PRINTER, DOT MATRIX Trend Communications Ltd. 636F

The HP 2200DN, is a TEMPEST modified version of the Hewlett Packard 2200DN LaserJet Printer. The HP 2200DN standard features include: 16Mbyte of Random Access Memory (RAM) 18ppm print speed 300 dpi to 1200 dpi print resolution HP JetDirect 610N printer server ard providing a 10/100Mb/s Ethernet interface USB Version 1.1. Interface (Operati9ng at 12Mb/s) IEEE-1284B compliant parallel interaface Two paper trays capabile of holding 100/250 sheets Supply voltage 220V-240V 50/60Hz a.c.

III-29

DATE ADDED TO NRPL: January 2003 PRINTER, LASER

SC4000 T

The SC400T TEMPEST Laser Printer is based on the HP4000 series providing unparalleled quality, reliability and compatibility. The SC4000T combines a 17 page per minute print engine with a 100MHz RISC processor for fast throughput. This together with enhanced paper handling, superior print quality and optical network connections provides a versatile solution to todays workgroup laser printing requirements. SC400T standard features include the following: 7ppm print engine 4MB RAM upgradeable to 100MB Up to 1200dbi resolution HP PCL6, HP PCL 5e, Adobe Postscript 2 emulation 65,000 page monthly volume 600 page input IEEE 1284 compliant bi-directional parallel port HP Jetdirect internal print server with 100Mbps FOIRL ethernet ransceiver (ST11) 220Va.c. operation (SC400T-001) 110Va.c. operation (SC400T-002) Options: Envelope feeder (up to 75 envelopes) Memory upgrade to 100MB max Optional addition high capacity paper tray Duplexer option DATE ADDED TO NRPL: July 1999 PRINTER, LASER Secure Systems & Technologies Ltd SP1300AT
The SP1300AT TEMPEST Laser Printer is based on the Hewlett Packard (HP) LaserJet 1300 Printer providing unparalled quality, reliability and compatibility. The SP1300AT TEMPEST Laser Printer combines a 19 page per minute (ppm) print engine with a 133MHz processor for fast throughput. This, together with enhanced paper handlingand superior print quality provides a versatile solution to todays laser printing requirements. Standard features of the SP1300AT Laser Printer include: 19ppm print engine 16MB Synchronous Dynamic Random Access Memory (SDRAM) 600 to 1200 dots per inch (dpi) print resolution HP PCL6, HP PCL 5e, Adobe Postscript 3 emulation 250 sheet input standard USB interface operating from 1.6Mb/s or 12Mb/s IEEE 1284 compliant bi-directional parallel port operating at 86.2kPIU 230vac power supply operation Options: Optional additional 250-sheet paper tray Memory upgrade to 80MB max DATE ADDED TO NRPL: January 2005 PRINTER, LASER Secure Systems & Technologies Ltd SP4100AT

NIM-Pulse NERVE INTEGRITY MONITOR
Intraoperative EMG Monitor

USERS GUIDE

NIM-Pulse Helpline 1-800-874-5797 For Questions and Service
Copyright 2002 Medtronic Xomed All Rights Reserved Made in U.S.A.
MEDTRONIC XOMED, INC. 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA www.xomed.com
HP DeskJet is a trademark of Hewlett Packard Company
This device complies with Medical Device Directive 93/42/EEC Authorized Representative (for EC regulatory matters) Medtronic B.V. Wenckebachstraat NC Kerkrade The Netherlands phone: 011-31-45-566-8000 fax: 011-31-45-566-8668
are trademarks and are registered marks of Medtronic Xomed, Inc.

CONTENTS

Symbols..... ii Warnings And Precautions... iii-iv Customer Service.... v Warranty.... vi

1 Getting Started... 1

Device Description.... 1 Intended Use.... 1 Indications... 1 Contraindications... 1 Components.... 1 Operating Room Set-up.... 2 Location.... 2 Front Panel... 2 Rear Panel.... 3-4 Patient Interface Box... 4 Muting Probe.... 5-6 Software Set-up.... 7 Monitoring Screen... 7 Event Threshold... 8 Auto Event Threshold... 8 Main Menu.... 10 Electrode Placement.... 11 Tools.... 11 Quick Help... 11 Reference Channel... 12 Quick Set-up Menu... 13 Customize Menu.... 14 Stimulus Submenu.... 14-15 Voices Submenu... 15-16 Tones Submenu... 16-17 Clock Submenu.... 17 Research Tools Submenu... 18 Output..... 18
2 Using The NIM-Pulse.. 19
Anesthesia Requirements... 19 Electrode Selection.... 19 Electrode Placement.... 19 Stimulator Probe Connection... 20 System Checks And Tests.... 20 Electrode Impedance Checking... 20-21 Adjusting The Event Threshold... 21-22 When Electrocautery And Cusa Are Used.. 22 Understanding What You Hear... 22-23 Interpreting The Alarms... 24 When The Case Is Complete... 24 When Monitoring Is Complete... 24
3 Troubleshooting.... 25-Maintenance And Service... 27
Preventive and Corrective Maintenance... 27-28

Appendices.... 29

Appendix A Glossary & Quick Reference Terms... 29-32 Appendix B Nerve Monitoring Accessories... 33-34 Appendix C Approved Output Devices... 35 Appendix D Technical Specifications... 36-37 Appendix E Agency Approvals.... 38 Appendix F References... 39

SYMBOLS

A C N D U 2 E B
ATTENTION, SEE INSTRUCTIONS FOR USE CATALOG NUMBER SERIAL NUMBER DATE OF MANUFACTURE USE BY DATE DO NOT REUSE STERILIZED BY ETHYLENE OXIDE. DO NOT USE IF PACKAGE IS OPENED OR DAMAGED. LOT NUMBER CE MARK OFF ON OFF ON VOLUME RELATIVE SCALE INDICATOR EXIT POP-UP WINDOW
HELP TYPE BF APPLIED PART PATIENT CABLE FUSE INPUT OUTPUT FOOTSWITCH CONNECTION
It is important that you read this entire manual before you use the NIM-Pulse Monitor. It is unsafe to use this device before you have read and are thoroughly familiar with this document.

NOTICE

A WARNINGS AND PRECAUTIONS
It is important that the NIM-Pulse operator be familiar with this manual: its precautions, procedures and safety issues. Three labels are used in this manual to identify important concerns, conditions, or procedures: A WARNING Identifies conditions or practices that present a risk of injury to the patient and/or user. A CAUTION / PRECAUTIONS Identifies conditions or practices that could result in damage to the equipment. A IMPORTANT Identifies conditions or practices which require attention for most desirable monitoring results.

A WARNINGS

USE OF PARALYZING ANESTHETIC AGENTS WILL SIGNIFICANTLY REDUCE, IF NOT COMPLETELY ELIMINATE,
RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION.
AUDITORY AND VISUAL MONITORING ARE DISABLED WHILE MUTING IS IN EFFECT. THIS SYSTEM IS NOT EXPLOSION-RESISTANT. THEREFORE, IT IS NOT TO BE USED IN THE PRESENCE OF FLAMMABLE ANESTHETICS. TO MINIMIZE THE RISK OF BURNS TO THE PATIENT INCLUDING CASES WHERE MORE THAN ONE SURGEON IS OPERATING (I.E. FAT HARVESTING), NEVER LEAVE THE STIMULATOR IN THE FIELD, ON A MAGNETIC TRAY, OR IN THE ELECTROSURGICAL HOLDER DURING ELECTROSURGICAL USE. TO AVOID EYE INJURY DURING ELECTRODE PLACEMENT, THE ELECTRODE NEEDLES SHOULD BE DIRECTED AWAY FROM THE ORBIT WHEN INSERTED FOR ORBICULARIS OCULI MONITORING. DO NOT TURN POWER TO THE NIM-PULSE ON WHEN THE STIMULATOR IS IN THE FIELD. UPON APPLICATION OF POWER, A PULSE OF 5 MA MAY BE DELIVERED FOR LESS THAN 0.01 S. THIS MAY BE EXCESSIVE FOR SOME MONITORING APPLICATIONS. ANY CONNECTIONS MADE TO LPT1 OTHER THAN THE THOSE RECOMMENDED IN THIS MANUAL, MAY NOT BE ISOLATED AND MAY RESULT IN INJURY TO THE PATIENT OR OPERATOR. THE NIM-PULSE DOES NOT PREVENT THE SURGICAL SEVERANCE OF NERVES. MONITORING IS ONLY A TECHNICAL AID TO IDENTIFICATION AND LOCATION OF NERVES; IT DOES NOT REPLACE THE SURGICAL SKILLS, EXPERIENCE, AND ANATOMICAL KNOWLEDGE NECESSARY TO VISUALLY LOCATE NERVES AND SURGICALLY AVOID THEIR SEVERANCE.

A PRECAUTIONS

DO NOT CONNECT ANY DEVICE OTHER THAN NIM-PULSE MUTING PROBES INTO ANY OF THE FOUR MUTING PROBE INPUTS ON THE REAR PANEL OF THE NIM-PULSE. SYSTEM DAMAGE MAY RESULT. DO NOT MODIFY THE NIM-PULSE OR EXTEND THE CABLES OF THE MUTING PROBE OR PATIENT INTERFACE. SUCH MODIFICATIONS OR EXTENSIONS COULD SIGNIFICANTLY AFFECT SYSTEM PERFORMANCE. TURN OFF POWER TO THE NIM-PULSE OR NIM-PULSE PRINTER BEFORE CLEANING. TO PREVENT CLEANING SOLUTIONS FROM SEEPING INTO THE ELECTRONIC PORTIONS OF THE INSTRUMENT, SPRAY CLEANER LIGHTLY ON A COTTON CLOTH, THEN WIPE THE INSTRUMENT WITH THE CLOTH. BE ESPECIALLY CAREFUL AROUND THE CONTROLS, CONNECTORS AND PANEL EDGES. DO NOT USE ABRASIVE CLEANERS. ATTEMPTED REPAIR OR EVIDENCE OF ATTEMPTED REPAIR BY ANYONE OTHER THAN QUALIFIED MEDTRONIC XOMED SERVICE PERSONNEL WILL VOID THE EQUIPMENT WARRANTY.
WARNINGS AND PRECAUTIONS (CONTINUED) A IMPORTANT
IT IS IMPORTANT TO DISTINGUISH BETWEEN THE PULSED SOUND EVENT TONES WHICH INDICATE EMG ACTIVITY THAT IS OVER THRESHOLD AND THE WARBLE SOUND CURRENT DELIVERED TONE WHICH INDICATES THE SET CURRENT IS BEING DELIVERED. WHENEVER THE ALARM FOR PROLONGED MUTING OCCURS, THE CAUSE MUST BE IDENTIFIED AND ELIMINATED IMMEDIATELY. IF THE CAUSE IS NOT ELIMINATED, IT MAY BE IMPOSSIBLE TO PERFORM VALID MONITORING FOR THE REMAINDER OF THE PROCEDURE. ALWAYS ATTACH THE MUTING PROBE AROUND THE ELECTROCAUTERY CORD. A FALSE LEAD OFF ATTENTION! ALERT MAY RESULT FROM NON-MUTED, OVERLOADED EMG SIGNALS ENTERING THE NIM-PULSE. IF NO CURRENT DELIVERED TONE SOUNDS AND THE MEASURED STIMULUS CURRENT FLOW IS LESS THAN 80% OF THE SET AMOUNT, EITHER NO CURRENT OR NOT ENOUGH CURRENT IS BEING DELIVERED TO THE NERVE. FACTORS WHICH MAY CONTRIBUTE TO THIS INCLUDE: HIGH IMPEDANCE, IMPROPER FLUSH CONTACT BETWEEN THE PROBE AND THE NERVE; STIMULATOR RETURN ELECTRODE NOT CONNECTED OR OTHER INCOMPLETE ELECTRICAL CONNECTION BETWEEN THE NIM-PULSE AND THE STIMULATOR PROBE; AND STIMULUS SET TO 0.00 MA. PATIENT CABLE FUSE BLOWN (MEDTRONIC XOMED PART NUMBER 11270048). THE PROPER SETUP AND USE OF THE MUTING DETECTOR IS NEEDED FOR OPTIMUM MONITORING. SHOULD YOU EXPERIENCE ANY DIFFICULTY WITH THE SENSITIVITY OF THE MUTING DETECTION, RESULTING IN EITHER A CONSTANT MUTING SITUATION OR NOT ENOUGH MUTING WHEN THE ELECTROSURGICAL UNIT IS ACTIVATED, ADJUST THE MUTING PROBE INPUT TO EITHER LESS MUTING (LOWER MUTING PROBE GAIN REPRESENTED BY LOWER JACK NUMBER) OR MORE MUTING (HIGHER MUTING PROBE GAIN REPRESENTED BY HIGHER JACK NUMBER) AS REQUIRED BY THE SITUATION. STIMULUS ARTIFACT MAY BE SPURIOUSLY DETECTED AS EMG EVENTS IF THE RECORDING ELECTRODES AND THE STIMULATOR (+) OR (-) CABLING BECOME TANGLED. BE CAREFUL TO ROUTE THE RECORDING ELECTRODES AWAY FROM STIMULATOR CABLES. OTHER MONITORING EQUIPMENT, SUCH AS THAT USED BY THE ANESTHESIOLOGIST, MAY PICK UP THE SMALL CURRENTS USED DURING MUTING OR ELECTRODES CHECK FOR ONGOING ELECTRODE IMPEDANCE CHECKS. IN MOST CASES, THEIR PRESENCE CAN BE ACCOMMODATED BY THE ANESTHESIOLOGIST OR OTHER MONITOR OPERATOR. PROPER PLACEMENT AND SETUP OF THE ECU AWAY FROM THE MONITOR WILL REDUCE, OR MINIMIZE MUTING, OFF SETS AND INTERFERENCE. DO NOT LET THE CONDUCTIVE PARTS OF APPLIED NEEDLE ELECTRODES CONTACT EACH OTHER. PROPER DETECTION OF EMG ACTIVITY MAY NOT OCCUR. PROPER NIM-PULSE OPERATION CANNOT BE GUARANTEED IF YOU DO NOT USE MEDTRONIC XOMED STIMULUS PROBES, STIMULUS-DISSECTION INSTRUMENTS OR ELECTRODES. AFTER NEEDLE INSERTION AND BEFORE THE PATIENT IS DRAPED, AFTER THE INCISION IS CLOSED AND BEFORE THE SURGICAL DRAPES AND ELECTRODES ARE REMOVED, CHECK THE ELECTRODE INTEGRITY BY PRESSING ELECTRODES CHECK. THIS CONFIRMS THAT RECORDING ELECTRODE CONTINUITY WAS MAINTAINED THROUGHOUT THE ENTIRE PROCEDURE.

CUSTOMER SERVICE

U.S. CUSTOMER SERVICE General customer service and technical support are available toll-free: 800-874-5797 or 904-296-9600 Monday-Friday 8:00 AM - 6:00 PM E.S.T. www.xomed.com
MICROELECTRONICS REPAIR Technical Support: 800-872-9877 904-296-6448 (FAX) Monday - Friday 8:00 AM - 5:00 PM E.S.T. Return Address: Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, FL 32216-0980 USA Attention: Repair Department
INTERNATIONAL CUSTOMER SERVICE International customers should contact their local Medtronic Xomed office: AUSTRALIA: 61-2-9879-5999 CANADA: 905-826-6020 FRANCE : 33-4-7067-9800 U.K.: 44-1454-619555 GERMANY: 49-89-32140060 THE NETHERLANDS: 31-40-2333888 BELGIUM: 32-2-4560900 or their local distributor. NIM-PULSE HELPLINE Should you need immediate help with a technical question or guidance through the appropriate protocol, just call the NIM-Pulse Help Line at 1-800-874-5797.
NOTE: When contacting our Customer Service and Technical Support, please have the appropriate product number, product serial number, date of purchase, and nature of inquiry available. Product Number __________________________________________________________ Serial Number ____________________________________________________________ Date of Purchase _________________________________________________________

WARRANTY

This product is sold by MEDTRONIC XOMED under the warranty herein set forth. The warranty is extended only to the buyer purchasing the device directly from MEDTRONIC XOMED. MEDTRONIC XOMED warrants this product to be free from defects in workmanship and material under normal use and service and shall conform to its original specifications for a period of one (1) year from the date of delivery. The liability under this warranty is limited, as is sole discretion, to replacing, repairing, or issuing credit (adjusted to reflect the age of the product) for a system or a portion thereof provided that (a) MEDTRONIC XOMED is notified in writing within thirty (30) days following discovery of a defect by the buyer, (b) the defective device is returned to MEDTRONIC XOMED, and MEDTRONIC XOMEDs examination of the device shall disclose to its satisfaction that (I) the device has not been repaired or altered by anyone other than MEDTRONIC XOMED, (II) any defect has not been caused by misuse, neglect or accident, (III) the device has not been operated under conditions other than normal use, and (IV) prescribed periodic maintenance and services have been performed with respect thereto. THIS WARRANTY IS IN LIEU OFALLOTHER WARRANTIES, EXPRESSED OR IMPLIED WHETHER STATUTORY OR OTHERWISE, INCLUDINGANY IMPLIED WARRANTY OR FITNESS FOR A PARTICULAR PURPOSE. In no event shall MEDTRONIC XOMED be liable for any incidental defect, failure, or malfunction of the product, whether a claim for such damage is based upon the warranty, contract, negligence or otherwise.

OPERATING ROOM SET-UP

LOCATION
Set the NIM-Pulse on a table or cart located about 10 feet from the surgical field but as far as possible from the electrosurgical unit. Also consider traffic patterns and sterile areas. The surgeon may have further preferences as to location and visibility. Clip the PATIENT INTERFACE box to the surgical bed near the head of the patient and within reach of the sterile electrode leads and sterile stimulator cable (s). Keep the PATIENT INTERFACE cable and electrodes away from other operating room cords. When wires must cross, they should cross at right angles. Never run operating room cords parallel to any of the NIM-Pulse wires. Lay the PATIENT INTERFACE cable out of busy traffic patterns and secure it to the floor as needed. Attach the MUTING PROBE to the electrosurgical unit and plug it into one of the MUTING PROBE INPUT jacks on the rear panel of the NIM-Pulse. Each MUTING PROBE has a cable, which may be taped to the floor.

FRONT PANEL

NIM-Pulse Monitor Front Panel
DISPLAY The touch screen displays both EMG waveforms and controls many functions of the monitor. The complete description of these controls are in the Software Set-up section. SPEAKER The SPEAKER provides audio alarms and acoustic EMG monitoring.

REAR PANEL

NIM-Pulse Monitor Rear Panel
LPT1 OUTPUT The LPT1 OUTPUT is a centronix type connector for a PRINTER, LS120, or Zip Drive. VGA OUTPUT A VGA OUTPUT is available through the standard VGA 15 pin connector on the back panel. The NIM-Pulse can be connected directly to a VGA monitor. The VGA output can also be converted to SVIDEO format for use with S-VIDEO VCR, the LandmarX Image Guided Surgery System, or other S-VIDEO devices. FOOTSWITCH CONNECTOR (OPTIONAL) The two pedal footswitch adjusts the Stimulus up and down. MUTING PROBE INPUTS There are four MUTING PROBE INPUTS on the NIM-Pulse Monitor. One MUTING PROBE is shipped with the system. Plug the MUTING PROBE into MUTING PROBE INPUT #3. POWER CORD The POWER CORD plugs into the back of the NIM-Pulse Monitor. Plug the power cord into the A/C power outlet. POWER SWITCH The POWER SWITCH turns the power ON or OFF. FUSE ACCESS Replace with Type F 250V fuses only. For 100-120V wall power, use 4.0 A fuses. For 220-240V wall power, use 2.0 A fuses. PATIENT INTERFACE CONNECTOR The PATIENT INTERFACE CONNECTOR is a 25-pin D-sub connector which accepts the cable from the PATIENT INTERFACE BOX. Plug the PATIENT INTERFACE CABLE securely into the back of the NIM-Pulse at the PATIENT INTERFACE CONNECTOR and tighten the thumb screws. LANGUAGE SWITCH The LANGUAGE SWITCH is set to English by default. It may be switched to French, Italian, German, or Spanish, or Dutch as needed.

10. FACTORY / CUSTOM MODE SWITCH The FACTORY/CUSTOM MODE SWITCH allows the unit to be returned to original factory settings. To reset the software to Factory mode, move the switch to F and then power the unit ON. The normal mode is Custom (C) which allows the user to save Custom configurations. 11. ACCESSORY POWER OUTLET The ACCESSORY POWER OUTLET powers perpipheral devices used with the NIM-Pulse System.

PATIENT INTERFACE BOX

Stimulator Fuse
Patient Interface Box and Cable
The PATIENT INTERFACE BOX and CABLE link the patient to the NIM-Pulse. CAUTION THE COLOR CODES ON THE NIM-PULSE PATIENT INTERFACE ARE DIFFERENT FROM THOSE ON THE NIM-2 AND THE NIM2XL PATIENT INTERFACE. CHANNEL 1 IS NOW BLUE AND CHANNEL 2 IS RED. PLEASE NOTE THAT THE COLOR CODES FOR THE PATIENT INTERFACE CHANNELS MATCH THE COLORS ON THE FRONT OF THE NIM-PULSE. IT IS NOT RECOMMENDED THAT THE PATIENT INTERFACE BE INTERCHANGED BETWEEN THESE UNITS.
ELECTRODE INPUTS Two electrodes per monitoring channel and one ground electrode are required. The positive (+) and negative (-) electrodes for each channel plug into color coded input jacks on the PATIENT INTERFACE BOX. Channel 1 is blue and channel 2, red. Plug the patient Ground into the green input jack, and the anode for the probe into the red/blk STIM1 or STIM2 input jack of the stimulator. STIMULATOR OUTPUT The NIM-Pulse System supports the use of two stimulation probes. Each stimulator requires two leads, one from the probe and one from the patient, to provide a complete circuit. The lead from the stimulator is the cathode and is plugged into the black, negative (-) jack. The lead from the patient is the anode and is plugged into the red, positive (+) jack. Plug the connections for the stimulator probe into the STIMULATOR OUTPUT jacks on the PATIENT INTERFACE BOX.

A WARNING

DO NOT TURN POWER TO THE NIM-PUSLE SYSTEM ON WHEN THE STIMULATOR IS IN THE FIELD. UPON APPLICATION OF POWER, A PULSE OF 5 MA MAY BE DELIVERED FOR LESS THAN 0.01 S. THIS MAY BE EXCESSIVE FOR SOME MONITORING APPLICATIONS. STIMULATOR FUSE Replace with Type F, 32 mA, 250V fuse only (Medtronic Xomed part number 11270048).

MUTING PROBE

Channel 1 & 2 and Reference Channel.. Auto. Manual Time Scale..50 mS.. 10 S Vertical Scale..500 V. 200 V, 2000 V Stimulus.. 0.00 mA. 0.01 mA to 3.00 mA Event Threshold..100 V. 20 V to 2500 V Auto Event Threshold.. Off.. On Event Capture..On.. Off Volume... 50%.. 0-100%

MAIN MENU

The Main Menu is displayed on the right-hand side of the screen while the unit is in monitoring mode. The Main Menu allows the user to adjust many of the software features.

Main Menu

ELECTRODES ELECTRODES displays the impedance of electrodes and difference of their impedances for Channel 1and 2 electrodes, as well as Ground electrode. While the ELECTRODES screen is displayed, monitoring does not occur and the speaker is muted. The words WARNING! MONITORING IS DISABLED blink in reversed text to alert the user. After 30 Seconds, the MUTING voice is heard.

Electrodes Screen

ELECTRODE PLACEMENT
ELECTRODE PLACEMENT displays the electrode placement to monitor cranial motor nerves by touching the corresponding cranial nerve number. Monitoring continues in the background while these menus are displayed. Press the Cranial Nerve number and electrodes appear. The exact placement of electrodes is based on the physicians knowledge of the procedure and the Cranial Nerves that are to be monitored during the procedure.

Electrode Placement

PRINT / SAVE PRINT sends the screen displayed to the printer.
TOOLS button allows access to advanced features of the NIM-Pulse. CUSTOMIZE MENU CUSTOMIZE provides menus used to configure many of the NIM-PULSE features. QUICK SET-UP MENU QUICK SET-UP menu provides the ability to create and select surgeon or procedure preferences for feature controls and settings. QUICK HELP After selecting QUICK HELP, pressing any feature on the Main Monitoring Screen displays an explanation of that feature. TIME SCALE TIME SCALE toggles between two different display time scales: 50 mS and 10 S. Selection is displayed on the right middle portion of the screen in the main menu.
VERTICAL SCALE VERTICAL SCALE selects the range of the EMG data display from 200, 500 or 2000 V scale. Selection is displayed on the right-middle portion of the screen in the main menu. Changing the VERTICAL SCALE only affects the way the data is presented on the screen. It does not modify the sensitivity of the unit.

STIMULUS VOICES STIMULUS VOICES can be configured as SETTING, STIMULUS, TONE, or OFF. The default is STIMULUS VOICE set to ON and SETTING selected. Stimulus Voice The stimulus voice verifies delivery of current to the surgical field. The STIMULUS VOICE will not sound for stimulus current levels below 0.05 mA. Setting Voice The SETTING VOICE announces the value of the STIMULUS. It also announces the new stimulus setting when it is adjusted. Example: 0.50 mA is announced as Point Five. Tone Stimulus delivered through the probe to the surgical field is confirmed by a tone. The STIMULUS TONE will not sound for stimulus current levels below 0.05 mA.
Help Voices... On.. Off Check Electrode.. On.. Off Muting... On.. Off Stimulus Voices... On.. Tone Setting... Off.. On Stimulus.. On.. Off Tone.. Off.. On Volume... 20%.. 10-100%

Tones Submenu

The TONES submenu controls the raw audio and tones produced by the NIM-Pulse. The EMG Audio and EMG Tones cannot be turned OFF simultaneously. EMG AUDIO The EMG Audio can be turned ON or OFF. When it is ON, EMG activity can be heard as a static-like grinding sound. The volume can be turned up or down using the Volume Control keys. When it is OFF, the EMG audio cannot be heard. The default setting is EMG audio on. EVENT TONES The Event Tones can be turned ON or OFF. When it is ON, an EMG event above the set EVENT THRESHOLD is heard as a beep tone. The tone reflects on which channel the event occurred. A lower pitched beep represents Channel 1 and a higher pitched beep represents Channel 2. STIMULUS WARBLE TONES The STIMULUS WARBLE TONE sounds whenever electrical current is being delivered to the surgical field, through the stimulus probe that is greater than 80% of the set current. The current delivered TONE or VOICE is not active below.05 mA. The duration of the STIMULUS TONE is adjustable as follows: OFF, BRIEF, CONTINUOUS, OR VOICE.
TONE VOLUME May be set by touching along the graphical volume control bar, with FULL volume to the far right.
Volume Control For Event Tones
EMG Audio.. On.. Off EMG Tones.. On.. Off Stimulus.. Brief. Continuous,Voice Tone Volume.. 0.30.. 0.10 1.00

Clock Submenu

The CLOCK submenu allows the correct time and date to be entered into the NIM-Pulse. Time is displayed in 12 hour and 24 hour formats. The date format is U.S. (mo/day/yr) or CO (day/mo/yr) with leap year compensation valid up to 2100.

Clock Adjustment Window

Research Tools Submenu
OUTPUT MENU The Output Menu is used to select whether information is documented to a HPGL compatible printer, LS120 SuperDisk drive, or a ZIP drive. The information is formatted according to Output. Menu selections are sent to the Printer/Data Output on the back panel of the NIM-PULSE. EVENT CAPTURE When the EVENT CAPTURE button on the Main Menu is ON, it holds each Event on the screen until it is replaced by the next Event. When EVENT CAPTURE is OFF, the current EMG activity waveform is displayed. LARGEST LARGEST displays each EVENT as it occurs and at the end of a series of events, displays the LARGEST of these waveforms. The screen continues to display each EVENT and holds the LARGEST at the end of the series of Events. FREEZE When Freeze button on the Main Menu is turned ON, it will hold the waveform until Freeze is turned OFF. When Freeze is OFF, the current EMG activity waveform is displayed. CHANNEL MUTE When channel mute is selected, a speaker icon appears with each selected channel. Pressing the channel select button cycles through channel on, channel mute (speaker icon blank), and channel off.

ADJUSTING THE EVENT THRESHOLD
BASELINE ACTIVITY Typically, when the nerve to be monitored is not being electrically stimulated or manipulated by the surgeon, there is little or no EMG activity detected. Therefore, the magnitude of the on-going quiet baseline signals may be quite small. These signals may be 30 V or less and are shown on the left side of the screen near the appropriate channel microvolts (V) only when Event Capture is Off. If Event Capture is On, the microvolts (V) will reflect the amplitude of the last event on the channel (s) being monitored.
Peak-to-Peak Voltage Reading
SETTING THE STIMULUS LEVEL Press the STIMULUS setting button in the upper left corner to adjust the stimulus output to the desired level. The stimulation level is displayed on the button.
Stimulus Control and Indicator
At present, there is no complete agreement on the optimal level for facial nerve stimulation (Beck and Benecke, 1990). The absolute stimulus intensity required to adequately stimulate any cranial motor nerve is determined by a complex combination of several factors including (but not limited to) the following: The functional health of the nerve itself. The type of stimulation probe used (monopolar or bipolar). How well the stimulator probe makes contact with the nerve. Whether cerebral spinal fluid is covering the nerve, etc. The duration of the stimulus.
You may want to use the smallest amount of stimulus necessary to elicit a detectable EMG event. Typically, stimulus current levels of 0.3 mA are high enough for adequate direct monopolar stimulation of the facial nerve. The best guideline for setting the stimulus intensity level is to use the lowest amount of stimulation that produces an EMG response large enough for monitoring.
WHEN ELECTROCAUTERY AND CUSA ARE USED
When the electrocautery is in use, the NIM-Pulse mutes. After 60 seconds of muting due to electrocautery, you hear MUTING and WARNING: MONITORING IS DISABLED is displayed. The bleedle alarm sounds every 60 seconds. Whenever electrocautery is in use or is in the standby mode, the electrocautery tip should be isolated from the NIMPulse stimulator probe and electrodes. When CUSA (cavitron (ic) ultrasonic aspirator) is in use, effective monitoring cannot take place. The baseline may rise on one or both channels to 200-500 V. You may compensate by adjusting the Event Threshold up and then down after the CUSA is off. The baseline may still linger at 40-80 V. However, an increase in the baseline right after use of CUSA may indicate nerve irritation. Another example of when prolonged muting might occur is when a radio-frequency signal of unknown origin occurs in the surgical environment without the knowledge of the surgical team.

Touching the screen has unexpected results.
Touch screen out of calibration.
Electrode impedance is too high. >10K for subdermal electrodes >25K for Prass Paired electrodes >10K for EMG Tube >40K for hookwire electrodes Electrode impedance = 0.0 K
Electrode dislodged from patient, but not completely out. High resistance in electrode. Electrode pin not firmly inserted into patient interface.
Remove and replace with new electrode. Check connection at Patient Interface box.
Positive and negative electrodes touching below surface of skin. Extremely low impedance, particularly in EMG tubes.
Remove and relocate electrodes.
Use tap test near electrodes to evoke EMG or artifact. If activity is noted on channel in question, proceed. Re-insert electrode in question.
Channel button is flashing. Electrode laying on skin surface. Electrode reading is K Electrode placement insecure. or OFF. Dirty electrode tip. Electrode cable broken. Electrode pin disconnected from patient interface. Electrode difference is Dirty electrode. greater than 2K (subdermal Mismatched pair. electrodes) or 10K (Prass Unequal placement. Paired electrodes). Electrosurgical interference. Muting Probe not connected. Muting Probe input insufficient. Electrosurgical grounding inadequate. Source of interference unidentified.
Remove and replace electrode in question.
Check connection to Patient Interface box.
Remove and replace electrode for appropriate channel with highest impedance reading first. Remove and replace electrode in question.
Check Muting Probe connections. Move input to MORE MUTE. Check electrosurgical grounding pad on patient Identify source of interference; then eliminate or separate from the NIM-Pulse system. Maintain separation between electrosurgical cable and the NIM-Pulse system. For less coupling, coil up the Muting Probe next to the NIM-Pulse system. Anesthesia try alternate electrode channel. Turn stimulator to 0.0mA when not stimulating. Move the Muting Probe connector to a lower number unit until it stops muting. If it still mutes in position 1, disconnect the muting detector completely.
NIM-Pulse system or Patient Interface cable too close to ESU or its cables.
Interference on anesthesia equipment. Excessive muting.
Lead checking current near anesthesia electrodes. Unit receiving excessive signal into the Muting Probe or electrode leads.

Inadequate muting.

Signal from ESU is inadequate to cause muting.
Move the Muting Probe connector to a higher number until it mutes. If it still does not mute in position 4, loop the ESU cable and clip the muting detector over the doubled cable. Increase stimulus intensity. Eliminate paralyzing anesthetic. Check that Stimulus Measure is approximately the same value as the Stimulus setting. Re-insert electrode in question. Secure all recording and stimulating electrode connections and check the impedance values. Check stimulator anode (+) and cathode (-) connections.
No response to direct stimulation.
Inadequate stimulus intensity. Paralyzing anesthetic in use. White stimulation (+) electrode has fallen out or is not connected.

Probe not connected.

Patient safety fuse blown.
Check fuse in Patient Interface box (32 mA, 250V). Replace if necessary (Medtronic Xomed part number 11270048). Hold probe tip to nerve for at least 1 S. Check stimulator tip for obstruction. Replace if necessary. Check location of stimulation. Check and correct all settings: volume, event threshold, stimulus intensity. Remove fluids from surgical stimulating area. Place channel electrodes in muscle to be monitored.
Not holding probe on nerve long enough. Nerve not contacted.
Volume control too low. Event threshold set too high. Excessive current shunting in surgical field. No electrodes in innervated muscle. Nerve not stimulable. Unexpected responses when not directly stimulating nerve. Unexplained continuous train EMG response.
Identify and eliminate possible source of train stimulation: Cold irrigation Laser heat Retraction on nerve or muscles being recorded. Patient waking from anesthesia Nerve drying Ultrasonic aspirator Identify and eliminate source of inadvertent manipulation.
Nerve or monitoring area being stimulated or manipulated by thermal or mechanical means. Metal-to-metal discharge artifact.
Determine response type from waveform pattern on 50 mS screen. Disentangle recording electrode and stimulator cables.
Intertwined recording electrode and stimulator wires. Inadvertent manipulation of electrode wires, Patient Interface cable, or recording area on patient. Electrical interference from other equipment.
Check area near recording electrodes for excessive stretching from tape, drapes, etc.
Check for intermittent stimulation from anesthesiologist (i.e., hand-held electrical stimulator). Move NIM-Pulse system away from source of interference. Make sure Patient Interface cable and electrode wires do not cross other electrical equipment or cables.

4 MAINTENANCE AND SERVICE
This section of the Users Guide describes how to care for your NIM-Pulse and what to do when you have problems. Preventive maintenance does not require access to the interior of the instrument and may be performed by the technician/operator. For the safe and warranted use of the unit, corrective maintenance and internal adjustments should be left to qualified MEDTRONIC XOMED service personnel.
PREVENTIVE AND CORRECTIVE MAINTENANCE
Preventive maintenance for the NIM-Pulse System consists of visual inspection, periodic cleaning and running a general checkout using the PATIENT SIMULATOR. Follow the preventive maintenance schedule outlined below. Your own schedule may vary from this schedule based upon the type and amount of system use. CLEANING THE NIM-PULSE SYSTEM Remove dust on the outside of the instrument with a soft brush or cloth. Remove any remaining debris with a soft cloth that has been slightly dampened with alcohol. VISUAL INSPECTION Check the NIM-Pulse System occasionally for exterior damage. Only qualified MEDTRONIC XOMED service personnel should replace damaged parts. AFTER EACH USE Wipe the PATIENT INTERFACE CABLE, MUTING PROBE CABLE (S), and NIM-Pulse clean, and visually inspect for any damage. Clean any substance from the PATIENT INTERFACE BOX, making sure that nothing is forced into the electrode connector sockets. SERVICE AND REPAIR PROCEDURES MEDTRONIC XOMED is committed to provide the highest standard of workmanship in manufacturing the NIMPulse System. Your NIM-Pulse requires a minimal amount of maintenance: however, MEDTRONIC XOMED recommends preventive maintenance and calibration scheduled at yearly intervals. The Mainframe Biomedical Verification Test Procedures should be performed at least annually and whenever a problem is suspected. Comprehensive testing and calibration should be performed by returning the entire system, including the patient interface and muting probe to: Medtronic Xomed Repair Department 6743 Southpoint Drive North Jacksonville, FL 32216-0980 IF YOU SUSPECT A PROBLEM WITH THE NIM-PULSE NOTE: When contacting our Customer Service and Technical Support, please have the appropriate product number, product serial number, date of purchase and nature of inquiry available. Product Number Serial Number Date of Purchase
PREVENTIVE AND CORRECTIVE MAINTENANCE (CONTINUED)
A system that is not functioning properly SHOULD NOT BE USED AT ALL until all necessary repairs have been made and the unit has been tested to ensure that it is functioning in accordance with published MEDTRONIC XOMED specifications. To avoid negating the warranty, repairs should be performed by MEDTRONIC XOMED. You have sole responsibility for any malfunction resulting from improper maintenance or repair by anyone other than qualified MEDTRONIC XOMED personnel. U.S. CUSTOMERS Should your monitor or related equipment malfunction, MEDTRONIC XOMED provides, at no charge, loaner equipment shipped to your facility by UPS or Federal Express for use while your equipment is being repaired by MEDTRONIC XOMED. Please adhere to the following guidelines: When a loaner mainframe is ordered (REF 53-8250031), please reuse the shipping material and carton when you return your monitor to MEDTRONIC XOMED. Insure the unit. When a loaner is not ordered, please package the monitor as safely as possible and insure. A return goods authorization number is not required on repairs. A copy of your purchase order is required. Make certain the purchase order includes the following: Shipping and billing information Purchase order number Contact person Phone number Description of malfunction Your MEDTRONIC XOMED account number

Please indicate preferred method of return shipment. Otherwise the unit will be shipped back via UPS ground. When the malfunctioning unit is not covered by warranty, MEDTRONIC XOMED will contact your facility promptly with a repair cost estimate if requested. The customer will be responsible for freight charges on nonwarranted units. When you have loaner equipment and you receive your repaired unit, please package the loaner equipment as safely as possible using the foam provided with your repaired equipment. Include paperwork indicating the unit is a loaner, and MEDTRONIC XOMED will credit your account. Loaner equipment not received by MEDTRONIC XOMED within 30 days from the date repaired equipment is shipped will be invoiced at full purchase price. THE PRINTER The Printer, if purchased through Medtronic Xomed, should be returned directly to Hewlett-Packard for repairs or service. The Hewlett-Packard U.S. Customer Support phone number is (208) 323-2551. Additional telephone numbers, addresses, and other details may be found in the Hewlett-Packard Printer Users Manual shipped with the printer. Concerns or question regarding second party printers should be directed to the respective manufacturer. Second party printers must comply with FCC Part 15.1B. STORAGE Always store the NIM-Pulse in a cool, dry place.

APPENDICES

APPENDIX A GLOSSARY & QUICK REFERENCE TERMS
ampere Unit of measure for electrical current. One (1) milli-amp will flow when one volt is connected across 1 K Ohm of resistance. amplitude Quantitative (microvolts) measurement of the peak-to-peak height of EMG response. anode The positive (+) pole or electrode of an electrical stimulator, remote needle in the case of a monopolar stimulator, and one of two poles on a bipolar stimulator. See cathode. artifact Any audio response or recorded visual display transmitted by the recording electrodes caused by something other than true EMG activity. See stimulus artifact. baseline EMG activity Ongoing, low level EMG activity (auditory and visual) elicited from the target muscle (s) at rest. biphasic waveform An EMG visual display with contiguous components which lie on either side (positive and negative) of the baseline. See monophasic waveform. bipolar stimulation Near-field (closely adjacent) cathode and anode contact to neural tissue and current delivery which minimizes current spread to other structures or tissue. Recommended for specific identification of close proximity of neural tissue (s). burst response Asynchronous, non-evoked response. cathode The negative (-) electrode of an electrical stimulator circuit. The NIM-Pulse delivers stimulating current in the cathode-to-anode (negative-to-positive) direction. constant current stimulation Electrical stimulation which is controlled by the amount of current desired at the site of stimulation independent of the electrode (stimulator) impedance characteristics. constant voltage stimulation Electrical stimulation controlled by setting the voltage which delivers unknown levels of current, dependent upon electrode (stimulator) impedance characteristics. current The movement of electrons through a conductor. It is measured in milli-amperes by the NIM-Pulse.

APPENDIX F REFERENCES

Beck, Douglas L., MA, and Benecke, James E. Jr., MD, FACS, Intraoperative Facial Nerve Monitoring Technical Aspects, Otolaryngology Head & Neck Surgery, 1990;102:270-272. Kartush J., Electroneurography and Intraoperative Facial Monitoring in Contemporary Neurotology, Otolaryngology Head & Neck Surgery, 1989; 101:496-503. Kartush J., and Bouchard, K, eds., Neuromonitoring in Otology and Head and Neck Surgery, New York: Raven Press, 1992. Mller, A.R. Evoked Potentials in Intraoperative Monitoring, Baltimore: Williams & Wilkins, 1988. Shallop J., Seventh and Eighth Nerve Monitoring During Acoustic Tumor Surgery, Seminars in Hearing, 1989; 10:346-355.
Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216-0908 USA

68E3481 B 04/02

REF # 8250212