Boston Scientific CRM312004 3120 User Manual prm

Boston Scientific Corporation 3120 prm

Contents

User Manual

Draft Literature/Labeling Review002169 Rev BYou are being asked to review product literature/labeling because of your particular expertise. To minimize the number of review cycles, please review the attached draft thoroughly and provide any comments, changes, or concerns at this time. • Please provide any comments on the attached draft by the due date indicated above.• A non-response will be taken to mean that you accept the draft content "as is." • Use the grid on the reverse side of this form to help focus your review efforts. • Your signature is not required.Note: After receiving comments and making any revisions that are required, Technical Communications will useWindchill to route a final version of this literature/labeling to obtain required electronic signatures.We appreciate your efforts and value your feedback. Thank you!Reason for review / Writer’s comments: Please review the operator’s manual carefully. Pay particular attention to any content that should not appear in the US manual (OUS manual will be routed later). Note: there is at least one outstanding issue having to do with the On/Off button and its description. Thanks. WWSProject: ZOOM LATITUDE operator’s manual USMonday, July 26Date due: Tuesday, July 27Draft Review Return to:Mail Stop:Department Mail StopReviewers For Tech Comm Use Only FYI Reviewers(Return not necessary)Mail StopRec’d OK Chgs TransEngineering Scott FreebergRegulatory Karen AlsopTech Comm Nathan Quanbeck
Instructions For Review The table below was designed to help streamline the literature review process, to reduce the number of reviews per piece of literature, to reduce the amount of time you need to spend reviewing each piece, and to help you focus your attention while reviewing literature.Suggested Areas of Focus Clinicals TechCommDesign Engineer Legal Marketing Package DesignProject Manager Reg FCEVerify against clinical protocol X X XProduct description, product handling (sterilization, shipping, storage) X XProduct specifications, units of measure (in tables and throughout text) X XProduct features—appropriate features highlighted? described correctly? any features overlooked? XXXX XXIllustrations appropriate to corresponding text and labeled correctly? X X X X XTables and text relating to parameters, tolerances, product functions correct? X X XReview cautions and notes—appropriate? necessary? any missing? X X X X X XImplant procedures correct? X X XEquipment hook-up procedures, lead-to-PG connections, etc. X X X XAre references to other Guidant products still correct and relevant? X X X X XIs info in this literature consistent with other related literature (leads, pg)? X X X X X XReferences to other products affect other submissions? X X X XLiability issues based on claims made in literature X X XWarranty information correct? XXHas any information that should be included been overlooked (features, specs, government requirements, legal requirements)? XX XXX X XXXList of items packaged with product (is the list correct? anything missing?) X X XDoes the piece of literature match the documentation specs? correct size? X X XVerify part number of literature. Labels: appropriate mfg codes, ACNs, etc. X XVerify copyright and trademark notations X X XAdherence to literature/communications standards XPunctuation, consistency in treatment of product names, parameter, etc. XGuidant address, phone numbers, warranty layout formats correct? X
Operator’s ManualZOOM® LATITUDE™ProgrammingSystemMODEL 3120 PRMRESTRICTED DEVICE: Federal law (USA) restricts the sale, distribution, or use of this device to, by, or on the lawful order of a physician.
CONTENTSDESCRIPTION AND USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4SYSTEM FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5Optional External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . 5Optional External Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 5PREPARING THE PRM FOR USE . . . . . . . . . . . . . . . . . . . . . . 6Prepare the Telemetry Wand . . . . . . . . . . . . . . . . . . . . . . . 6Make External Cable Connections . . . . . . . . . . . . . . . . . . . 7Start the PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8USING THE PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Startup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9Indicator lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9ECG Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11Monitoring/Recording Functions . . . . . . . . . . . . . . . . . . . . 12Using an External Recorder . . . . . . . . . . . . . . . . . . . . . . . 13Using an External Printer . . . . . . . . . . . . . . . . . . . . . . . . . 13Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13The Utilities Menu on the Startup Screen . . . . . . . . . . . . . 14The Select PG Option on the Startup Screen . . . . . . . . . . 15Changing Parameter Values . . . . . . . . . . . . . . . . . . . . . . 16MAINTENANCE AND HANDLING . . . . . . . . . . . . . . . . . . . . . 17Loading the Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Thermal Paper Storage . . . . . . . . . . . . . . . . . . . . . . . . . . 18Cleaning the PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18Patient Data Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19Operation and Storage Conditions . . . . . . . . . . . . . . . . . . 20PRM Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21EXTERNAL CABLE CONNECTIONS . . . . . . . . . . . . . . . . . . . 22
Surface ECG Connections . . . . . . . . . . . . . . . . . . . . . . . . 23Patient–Recorder–PRM Connection . . . . . . . . . . . . . . . . 24Patient–PRM–Recorder Connection . . . . . . . . . . . . . . . . 25Parallel Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27LABEL SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29WARRANTY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . 32ORDERING ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . 32SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32PREVENTIVE MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . 32ENVIRONMENTAL PROTECTION . . . . . . . . . . . . . . . . . . . . . 32SPECIFICATIONS (Nominal) . . . . . . . . . . . . . . . . . . . . . . . . . 33
3DESCRIPTION AND USEThe ZOOM® LATITUDE™ Programming System, which includes the Model 3120 Programmer/Recorder/Monitor (PRM), is a portable cardiac rhythm management system designed to be used with Guidant implant-able pulse generators.For programming instructions, refer to the System Guide for the Guidant pulse generator being interrogated.Intended UseThe Model 3120 PRM is intended to be used as a complete system to communicate with Guidant implantable pulse generators. The software in use controls all communication functions for the pulse generator. For detailed software application instructions, refer to the Sys-tem Guide for the Guidant pulse generator being interrogated. ContraindicationsFor contraindications for use, refer to the System Guide for the Guidant pulse generator being interrograted.The Model 3120 PRM is contraindicated for use with any pulse generator other than a Guidant device.PrecautionsGeneral• Use the appropriate Guidant programmers equipped with the appro-priate software to program Guidant pulse generators.• The Model 3120 PRM is designed to be used only with the Model 6577 Sterilizable Telemetry Wand. Do not use the Model 6575 Telemetry Wand with the Model 3120 PRM.• Use only the supplied stylus with the Model 3120 PRM; the use of any other object could damage the touchscreen.NOTE: Use of the stylus is recommended for accuracy; however, touch-ing an item on the screen with your finger will also activate a selection.Preparation for Use• Remove the telemetry wand from all packaging material before steril-izing it.• Avoid establishing telemetry communication between the PRM and the pulse generator when the PRM is in close proximity to monitors, high-frequency electrosurgical equipment, and strong magnetic fields, such as magnetic resonance imaging (MRI) devices. The telemetry link may be impaired and, in the case of MRI, may interfere with the PRM.Maintenance and Handling• Do not use an abrasive cloth or volatile solvents to clean any portion of the PRM.
4• Keep disks away from magnets and magnetized objects, including telephones, power-supply adapters, and monitors.• Do not place a magnet on the PRM.• The PRM is not water-proof or explosion-proof. It should not be used in the presence of flammable gas mixtures including anesthetic mix-ture with air, oxygen, or nitrous oxide.Adverse EffectsNone known.SYSTEM FEATURESThe PRM communicates with Guidant pulse generators via telemetry us-ing the Guidant Model 6577 Sterilizable Telemetry Wand to perform the following functions:• Interrogates the programmable pulse generator.• Programs detection and therapy parameters for an implantable Guidant pulse generator.• Displays, records, and stores patient data and allows the physician to evaluate alternative prescription modes.• Stores patient data that can be recalled later in the patient session for analysis. (For certain applications only)• Stores patient data on a disk that can be accessed at later sessions.• Generates printed reports that detail pulse generator functions, stored patient data, and test results.• Allows the physician to perform tests in an electrophysiology (EP) lab-oratory, in an operating room, in an emergency room, or at a patient’s bedside.In addition, the PRM has the following capabilities:• Provides a direct interface between an external stimulator and an im-planted Guidant pulse generator for programmed electrical stimula-tion (PES) during EP studies.• Provides use without device telemetry as an electrocardiogram (ECG) display and recorder for patient diagnosis.• Simultaneously prints real-time surface ECG and telemetered signals (intracardiac electrograms and event markers) via the internal printer/recorder.The PRM is equipped with the following features:• PRM function keys, including PROGRAM, STAT PACE, STAT SHOCK, DIVERT THERAPY, and INTERROGATE.• Printer/recorder function keys, including paper speed, calibrate, zero to baseline, and paper feed.• Touchscreen with tethered stylus.
5• Color display screen.• One floppy disk drive.• Internal hard drive.• High-speed four-inch (110 cm) thermal printer/recorder.• Connections for slaved stimulation via an external signal source.• Connection for recording data on an external FM tape recorder or strip chart recorder or both.• Connection for an optional external printer.• USB port for software installation by Guidant personnel.System AccessoriesThe ZOOM LATITUDE programming system consists of the Model 3120 PRM and the following accessories:• Model 2902 AC Power Cord• Model 6577 Sterilizable Telemetry Wand• Model 6627 Patient Data Disks (10)• Model 6750 Surface ECG Patient Cable• Model 6979 Printer Paper (4)• AntennaOther accessories for use with the PRM that can be ordered from Guidant include the following:• Model 6809 Accessory Kit• Model 6892 Controller-Stimulator Cable• Model 6750 Surface ECG Patient Cable• Model 6924 External Recorder Cable• Model 6629 ECG-BNC Slave Cable• Model 6930 Stimulation Input Cable Adapters• Model 6934 Phono-BNC Adapters• Model 6977 VGA Extension CableOptional External PrinterThe use of an external printer is optional. Only compatible external print-ers that have been tested and qualified for use should be used with the Model 3120 PRM. Contact your Guidant sales representative to deter-mine which printer(s) can be used. CAUTION: Although the external printer meets leakage-current require-ments for commercial products, it may not meet the reduced leakage requirements for medical products. Consequently, the external print-er must be kept outside the patient environment (at least 1.5 meters away from the patient).Optional External MonitorThe use of an external monitor is optional. Contact your Guidant sales representative to determine which monitor(s) can be used.
6CAUTION: Although the external monitor meets leakage-current require-ments for commercial products, it may not meet the reduced leakage requirements for medical products. Consequently, the external mon-itor must be kept outside the patient environment (at least 1.5 meters away from the patient).PREPARING THE PRM FOR USEPrepare the Telemetry Wand1. If the telemetry wand is to be used in a sterile field when using the PRM, it first must be sterilized with ethylene oxide or steam. To sterilize it, follow the instructions in the product literature for the wand. CAUTION: Remove the telemetry wand from all packaging material be-fore sterilizing it.2. Plug the telemetry wand into the connector on the right side of the PRM (Figure 1).Figure 1. Right side panel of the PRM.CAUTION: Avoid establishing telemetry communication between the PRM and the pulse generator when the PRM is in close proximity to monitors, high-frequency electrosurgical equipment, and strong magnetic fields, such as MRI devices. The telemetry link may be im-paired and, in the case of MRI, may interfere with the PRM.This device complies with Part 15 of the Federal Communications Com-mission (FCC) rules. Operation is subject to the following two conditions:1. This device may not cause harmful interference, and2. This device must accept any interference received, including interfer-ence that may cause undesired operation.CAUTION: Changes or modifications not expressly approved by Guidant could void the user’s authority to operate the equipment.ECG ConnectorTelemetry Wand ConnectorAnalog Output ChannelStimulator Inputs
7Make External Cable Connections1. Connect the Model 6750 Surface ECG Patient Cable to the ECG connector on the right side of the PRM (Figure 1). This patient con-nection is electrically isolated. Attach the surface electrodes to the patient in a standard three-wire or five-wire configuration.NOTES: • If the PRM is in close proximity to high-frequency electrosurgical equipment, the surface ECG traces may exhibit noise interference. Refer to the troubleshooting section for corrective action.• The ECG subsystem may be sensitive to ambient noise when the ECG inputs are not terminated.2. Connect the Model 6924 External Recorder Cable to the analog out-put channel on the right side of the PRM (Figure 1). Connect the oth-er end to the multichannel recorder or external strip chart recorder. The Model 3120 PRM has high-level analog outputs.3. Connect the Model 6892 Controller-Stimulator Cable to the pacing stimulation source connector marked “Stimulator Input” on the right side of the PRM (Figure 1) and then into the corresponding terminal on the electrical stimulation source.4. (Optional) Connect the external printer to the PRM using the parallel cable provided with the printer (Figure 2). The external printer must be connected and activated to allow external reports to be printed.5. (Optional) Connect the external monitor to the PRM using a standard VGA cable (Figure 2). The Model 6977 VGA Extension Cable is available from Guidant as an accessory.Figure 2. Left side panel of the PRM.Power ButtonExternal VGA Monitor ConnectorExternal Printer Connector
8Start the PRMPerform the following steps to start the PRM:1. Connect the power cord into the AC connector on the rear panel (Figure 3).2. Plug the power cord into the appropriate AC outlet.Figure 3. Rear panel of the PRM.3. Raise the screen to a comfortable viewing angle.4. Press the Power button (Figure 2).5. Wait for the Guidant startup screen (Figure 4) to appear.Figure 4. The startup screen is displayed when the programmer is powered On.USING THE PRMStartup ScreenThe startup screen (Figure 4) displays the following information:• The Utilities button allows access to programmer information and set-up functions prior to accessing the application software.Grounding Connector AC ConnectorButtonsHeart-rateIndicatorECG Icon
9• The Select PG button allows the desired application to be chosen and started.• The ECG icon changes the screen display to an ECG display avail-able for patient diagnosis.• The heart-rate indicator displays the intrinsic ventricular rate of the pa-tient.•The Quick Start® button is an automated method for starting the ap-propriate application.• The bottom left corner of the screen displays the date, time, and pro-grammer information.TouchscreenThe Model 3120 PRM has a touchscreen. You can select a button or icon on the touchscreen by touching the desired item with the stylus attached to the PRM and lifting the stylus from the screen. Only one button or icon may be selected at a time. Menu and parameter selection buttons will ac-tivate when selected; the buttons in the parameter value palettes will ac-tivate when the stylus is lifted from the screen. To move from one screen to another, select the navigation buttons at the bottom of the screen.CAUTION: Use the supplied stylus with the Model 3120 PRM; the use of any other object could damage the touchscreen.NOTE: Use of the stylus is recommended for accuracy; however, touch-ing an item on the screen with your finger will also select that item.Indicator lightsThe Model 3120 PRM has three indicator lights on the upper left corner, above the screen:NOTE: ZIP telemetry is a wandless, two-way radio frequency (RF) com-munication option that allows the PRM system to communicate with the pulse generator.Symbol Indicator light FunctionFor future use. For future use.Inductive telemetryLit when inductive, wanded telemetry has been established and interrogation or programming is occurringOn Lit when the PRM is On.
10ECG DisplayTo display surface ECG signals on the PRM without device interrogation, select the ECG icon on the startup screen (Figure 5). Connect the patient leads; for instructions on proper patient cable connections, refer to “EX-TERNAL CABLE CONNECTIONS” on page 22. The PRM can display three surface traces of up to six limb leads or one chest lead. The top dis-played lead will be annotated with the pacing spike marker if that feature is selected. To display the pacing spike markers correctly, the Lead II electrodes must be connected to the patient regardless of which lead is displayed. The heart-rate indicator in the upper-right corner of the startup screen will display the intrinsic ventricular rate as the trace runs. Figure 5. The ECG screen, as accessed from the startup screen.The following screen buttons can be used to change the values and ap-pearance of the traces:•Lead Selection Buttons—Select the lead traces to be displayed.•Speed Buttons—Select the desired speed button on the ECG display: Pause (||) (to freeze the trace), Play (>), or Fast-Forward (>>).•Printed Surface Gain—Select the appropriate value to adjust the surface gain of the traces that are captured on printouts.•Filter—Select On to minimize noise on the surface ECG.•Pacing Spike Display—Select On to show detected pacing spikes, annotated by a marker on the top waveform.NOTE: The values as set up on the startup screen will be the defaults used for the application traces. The corresponding values can be changed from the Trace Selections screen while in the application. For detailed application programming instructions, refer to the System Guide for the Guidant pulse generator being interrogated.Speed Buttons
11KeysFor specific instructions on how to operate the PRM keys and use the te-lemetry wand, refer to the System Guide for the Guidant pulse generator being interrogated. General key functions are summarized below.The key pad on the right side of the PRM is shown in Figure 6.Table 1 Key FunctionsLeft side of key pad:0 (stop), 10, 25, 50, and 100 mm/sec (paper-speed keys)Press the speed keys to specify the paper speed for the internal printer/recorder. The printout will show the date and time, lead(s) being printed, gain setting, chart speed, and filter setting. To stop the printer/recorder, press the speed key labeled “0” (zero).Press the paper-feed key to scroll the printer paper on the internal printer/recorder.Press this key to cause the internal printer/recorder to print a one-mV calibration pulse.Press this key to force the trace back to the baseline after a defibrillation shock.Right side of key padPress STAT PACE when in telemetry communication with the pulse generator to program predetermined parameters for emergency bradycardia pacingPress DIVERT THERAPY when in telemetry communication with the pulse generator to divert tachycardia therapy delivery.STAT PACEDIVERT THERAPY
12Figure 6. Model 3120 PRM right-side keypad.Monitoring/Recording FunctionsSurface ECGPressing any speed key will run a surface ECG if the surface ECG patient cable is connected to the PRM and electrodes are attached to the patient (unless a report is being printed). For detailed instructions, refer to “ECG Display” on page 10.Press STAT SHOCK when in telemetry communication with the pulse generatorto program predetermined high-energy parameters for emergency shock delivery.Press PROGRAM when in telemetry communication with the pulse generator to transmit new parameter values to the pulse generator.Press INTERROGATE when in telemetry communication with the pulse generator to obtain information stored in the pulse generator’s memory.Table 1 Key FunctionsSTAT SHOCKPROGRAMINTERROGATESTAT PACE STAT SHOCKDIVERT THERAPYPROGRAM INTERROGATE
13Intracardiac ElectrogramIntracardiac electrograms may be printed or displayed and event markers may be printed by the PRM. For detailed instructions, refer to the System Guide for the Guidant pulse generator being interrogated.Using an External RecorderTo view the surface ECG traces on an external recorder, press the de-sired speed key on the external printer/recorder while the traces are dis-played on the PRM screen. See “EXTERNAL CABLE CONNECTIONS” on page 22 for instructions on connecting the PRM to the external record-er. Refer to the external recorder manual for instructions specific to its op-eration.Using an External PrinterIf supported by the software application currently running, an optional ex-ternal printer can be used. To print reports to an external printer, first con-nect the printer to the Model 3120 PRM using the parallel cable. The ca-ble connects the external printer to the PRM via the external printer con-nector (Figure 2). The external printer must be connected and activated to allow external reports to be printed. For more information, see “Optional External Printer” on page 5.Equipment connected to the external connections must comply with the respective IEC standards (e.g. IEC 950 for data processing equipment and IEC 601-1 for medical equipment). Furthermore all configurations shall comply with the system standard IEC 601-1-1. Everybody who con-nects additional equipment to the signal input part or signal output part configures a medical system, and is therefore responsible that the system complies with the requirements of the system standard IEC 601-1-1. If in doubt, Guidant Technical Services department or your local Guidant Rep-resentative.Quick StartThe Quick Start button is used to automatically identify and interrogate the implanted pulse generator. Place the telemetry wand over the pulse gen-erator, and select the Quick Start button. A message window will appear, indicating one of the following conditions, based on the implanted device:•Application Startup in Progress—If the software for the implanted device is installed on the PRM, the PRM will identify the device, open the correct application, and automatically interrogate the pulse gener-ator.•Software not installed—If the software application for the implanted device is available for the PRM but not installed on it, a message win-dow will appear, identifying the device and stating that the software is not installed on the PRM.•Software not available on PRM—If an older model of Guidant device is identified, a message window will appear, informing the user that he or she must use a Model 2035 or 2901 programmer to interrogate and/
14or program the device. The model number of the software module or application will also be identified.•PG not identified—If a non-Guidant or one of certain older models of Guidant pulse generators is implanted, a message window will ap-pear, notifying the user that the wand is out of range, telemetry noise is present, or the device is not identified.To access the demonstration (DEMO) mode (or the Read Disk feature, which is available in some applications), use the Select PG button at the top of the screen to choose the pulse generator family instead of using the Quick Start button.The Utilities Menu on the Startup ScreenIf desired, before accessing the pulse generator software application, the version numbers of the system software and software applications can be displayed, the programmer clock can be modified, the institution name can be changed, and data disks can be copied and formatted. (To access the startup screen from within a software application, select the Quit op-tion from the Utilities button to exit the software application and return to the startup screen.)1. On the startup screen, select the Utilities button.2. Select the About option to view the version numbers of the system software and application software residing on the programmer.3. Select the Set Programmer Clock option to change the programmer date and time (24-hour clock), which is displayed in the lower left cor-ner of the startup screen. The Set Date and Time window will appear (Figure 7).a. Change the values by selecting an up or down arrow. b. To reset the seconds display to zero, select the box containing two digits (shown as 00 in Figure 7). c. When the desired values are displayed, select the Set Program-mer Clock button to confirm the new date and time. (To cancel any changes prior to confirming the new values, select the Cancel but-ton; the window will close without changing the values.)Figure 7 The Set Date and Time window.
15NOTE: The programmer and pulse generator clocks may be synchro-nized once the application is accessed. Refer to the “Set Clock” section in the System Guide for the Guidant pulse generator being interrograted.4. Select the About option to update the institution name. If the pro-grammer has been moved to a different institution, the name of the institution as it appears on the startup screen can be changed. For instructions on entering new data, refer to “Changing Parameter Val-ues” on page 16.NOTE: The institution name also is displayed in the heading of printed reports.5. Select the Format Disk option to erase all data from a Model 6627 Patient Data Disk and reformat it so new data can be saved on the disk. Follow the directions displayed in the message windows. 6. Select the Copy Disk option to copy patient data from one disk (the source disk) to another (the destination disk). Do not use a destina-tion disk that contains patient data, because the existing data will be lost. Follow the directions displayed in the message windows. (This function performs in the same manner as the Copy Disk function of the software application; refer to the “Utilities Button on the Main Ap-plication Screen” section of the System Guide for the Guidant device being interrogated.The Select PG Option on the Startup ScreenThis option allows the software application to be selected manually. Use this option to access the DEMO mode (or the Read Disk feature, which is available in some applications). (You can also use this option to interro-gate a pulse generator, but you may find it more convenient to use the Quick Start feature described earlier in this manual.)1. To access the desired software application without using the Quick Start feature, select the Select PG button.2. The names of the available software applications will appear. Select the applicable software application. Each application communicates with its pulse-generator family.3. A screen will appear with options to interrogate the pulse generator or use the DEMO mode. (Some applications will also display the op-tion to read a patient data disk).4. To become familiar with the software without interrogating a pulse generator, select the DEMO button; the main application screen will be displayed and the DEMO logo will appear at the top of the screen. The screens displayed during the DEMO mode reflect the software application family’s device features and programmable values.NOTE: STAT PACE, STAT SHOCK, and DIVERT THERAPY commands are functional in DEMO mode only if the telemetry wand is positioned over the pulse generator.
165. To exit the DEMO mode, depending on which application you are us-ing, select the New Patient or Quit options from either the Utilities but-ton or the Exit button. For more information about these options, refer to the System Guide for the Guidant pulse generator being interro-gated.6. To proceed with an interrogation session or read data from a patient data disk (which is a feature that is available in some applications), refer to the System Guide for the Guidant pulse generator being in-terrogated.Changing Parameter ValuesThe screens for many of the features contain parameter information, in-cluding parameter names, values for the present parameter settings, val-ue boxes to accommodate value changes, and buttons to cancel chang-es. Many screens display two columns next to the parameter names: the Present column and the Change column. The Present column displays the currently programmed value for each parameter, and the Change col-umn displays value boxes that allow the clinician to make changes to the parameters. If a particular parameter is not applicable in the current mode, dashes will be displayed in the Present column. If a particular pa-rameter is not applicable to the mode in the Change column, that param-eter’s value box is not displayed.Palette Window: To change the parameter values, first select the appro-priate parameter’s value box in the Change column. A palette window will appear (as shown in Figure 8). Select a value from the palette window (by touching the desired value and lifting the stylus from the screen). Touch-ing the screen outside a window will close it without making a selection. When changes have been made to parameter values, the data appear in the Change box until programmed into the pulse generator.Figure 8 Types of windows enabling value changes.Palette Window Keyboard Window
17In some screens (e.g., Patient Data screens), data are not displayed in Present and Change columns. These screens display value boxes that re-quire unique data to be entered. Typically, the data are entered from a keyboard window (as shown in Figure 8). The values entered will remain in the value boxes when programmed; they will not move from a Change column to a Present column.Keyboard Window: Touch the first character of the new value; it will ap-pear in the data-entry box in the graphic keyboard. Continue until the en-tire new entry appears in the box. To delete one character at a time, start-ing with the last character, select the left arrow key on the graphic key-board. Each time the left arrow key is selected, a character will be deleted in the box. To cancel any deletions or additions just made, select the Can-cel Changes button. When all the appropriate characters have been se-lected, select the Close button on the graphic keyboard.NOTE: If, when the graphic keyboard initially appears, it contains data in the value box, select the Clear button to delete all the characters in the value box.Copy button: On screens that contain a Copy button, you can simply copy parameter values from one screen to another. Select the Copy but-ton. A window will appear with a Copy From column and a Copy To col-umn, with buttons below the columns. Select the desired buttons in both columns, and then select the Copy button.To program the device, follow the instructions in the System Guide for the Guidant pulse generator being interrogated.NOTE: If additional parameters require reprogramming, repeat these steps. Multiple parameter changes can be programmed at one time (batch programming).MAINTENANCE AND HANDLINGLoading the PaperThe internal printer/recorder uses four-inch wide (110 mm) thermosensi-tive printing paper. Model 6979 Printer Paper refills can be ordered from Guidant.Use the following procedure to load paper into the internal printer/recorder:
181. Open the printer door.2. If any sheets from the previous pack remain but did not feed, remove them and rotate the roller with clean fingertips to remove any small pieces of paper still under the printhead.3. Unfold one sheet of paper and orient the pack such that the sensitive side is up and the pagination mark is at the bottom of the paper. In-sert the pack into the printer/recorder.NOTE: You must use paper with pagination markings. Paper will not paginate properly if paper does not have markings.4. Allow the unfolded sheet to lay straight between the guides on the right side of the printer/recorder.5. Close the printer door completely. The printer/recorder will automat-ically begin the paper-loading sequence and will stop at the first pag-ination mark after paper is detected. If the paper’s edges are wrin-kled, wait for four or five pages to feed through the printer. The printer will self-align the paper to its proper position.The printer/recorder is now ready to resume printing.For information regarding loading paper into the optional external printer, refer to the user manual for the printer.Thermal Paper StorageStore the heat-sensitive paper for the internal printer/recorder in a cool, dark environment. Do not attempt to erase the printer/recorder paper. Printed paper will last approximately 30 days under direct fluorescent light. To ensure the permanence of a patient’s record, store the printed paper away from direct sunlight, heat, or fumes from organic com-pounds. Storage temperatures above 65°C, sustained exposure to direct sunlight, or exposure to high humidity, acetone, ammonia, alcohols, or other organic compounds may cause the paper to discolor.NOTES: • If printed reports are to be kept for prolonged periods, you must make a photocopy of the thermosensitive paper as this paper is not intended for long-term retention and will lose legibility over time. • Some brands of adhesive tape applied to a printed report will fade the printing after 30 days.Cleaning the PRMClean the housing and touchscreen of the PRM with a soft cloth lightly dampened with water.Clean the printer/recorder with a dry, soft brush to eliminate dust and par-ticles that may accumulate during printing and storage.
19CAUTION: Do not use an abrasive cloth or volatile solvents to clean any portion of the PRM. The cables used with the PRM are not sterile when packaged. When nec-essary, clean the cables with a soft cloth dampened with a mild cleaning solution (e.g., Liqui-nox for the sterilizable telemetry wand; Borax or a 1:10 bleach solution for other cables). Using the same method, wipe them completely with sterile water and towel- or air-dry. DO NOT use an ultra-sonic cleaner NOR immerse the cables. Clean the sterilizable telem-etry wand in the same manner, allowing no fluids to enter the wand cavity. See “Prepare the Telemetry Wand” on page 6 for sterilization instructions.Patient Data DiskThe Model 6627 Patient Data Disk must be inserted with the arrow on the top left side and pointing into the disk drive (Figure 9).Figure 9. Disk drive on the right side of the PRM.Be certain that the write-protect tab is closed on the disk (Figure 10). In-sert a patient data disk firmly into the disk drive on the right side of the PRM until the disk ejection button protrudes.NOTE: For complete instructions on using the patient data disk, refer to the System Guide for the Guidant pulse generator being interrogated.Figure 10. Floppy disk (3.5 inch) with write-protect tab closed.Caring for DisksFloppy disks can be damaged easily, making them unusable. To prevent damage to the disks:• Write on labels before applying them to disks.Arrow on top and pointing to the disk driveDisk Drive Disk Ejection ButtonPatient Data Disk Write-protect tab closed(black tab covering hole)Sliding Shutter
20• Use only a felt-tipped pen to write on a label that is already applied to a disk.• Keep food and beverages away from disks and away from the PRM.• Keep disks away from heat or direct sunlight. Disks should be stored at temperatures between 5° and 60°C (41°–140°F).• Keep disks dry and stored in a dry area (with a relative humidity be-tween 8 percent and 80 percent).• Do not bend disks.• Do not attach paper clips, staples, or rubber bands to disks.• Do not try to open the sliding shutter that covers the disks (Figure 10).• Never touch the exposed disk area beneath the sliding shutter.NOTE: The write-protect tab must be closed in order to record data to the disk and to print reports. If data cannot be recorded to the disk, check to see that the tab is positioned to cover the hole (Figure 10).CAUTION: Keep disks away from magnets and magnetized objects, in-cluding telephones, power supply adapters, and monitors.Operation and Storage ConditionsThe Model 3120 PRM requires careful handling. The hard-disk drive and the floppy-disk drive must be protected from abusive handling. To protect the PRM from damage:• Do not turn off the PRM while the drive is accessing data.• Do not subject the PRM to abusive shocks or vibrations.• When transporting the PRM from a cold environment to a warm envi-ronment, allow the PRM to warm to ambient temperature before use.• Do not place heavy objects on the PRM surface when closed or when in operation.• Do not place a magnet on the PRM.• Do not pour or splash liquid into or onto the PRM.• Do not strike, scratch, nick or otherwise abuse the touchscreen sur-face.• Do not disassemble the PRM.• Remove any disks from the drive prior to transporting the PRM.• Turn off the PRM, close all covers and doors and put down the anten-na prior to transporting the PRM. • Unplug all external cables and cords prior to transporting the PRM.Operate the PRM within a temperature range of 10° to 40°C and a humid-ity between 20 and 95 percent. Transport and store the PRM at tempera-tures between –40× and 70×C, humidity of 5–95 percent, and pressure of 500–1,060 hPa. If the PRM has been stored in cold conditions (less than 10°C), turn it on and let the fan run for at least one hour before use.
21Safety and EMC Compliance StandardsThis equipment has been tested and found to comply with applicable safety portions of the following standards: • EN60601-1:1990 + A1:1993 + A2:1995• UL60601-1:2003• CAN/CSA-C22.2 No. 601.1-M90This equipment has been tested and found to comply with the limits for medical devices to IEC 60601-1-2: 2001 [or EN 60601-1-2: 2001 or Med-ical Device Directive 93/42/EEC]. This testing shows the device provides reasonable protection against harmful interference in a typical medical in-stallation. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interfer-ence to other devices or is negatively impacted by other devices, the user is encouraged to try to correct the interference by one or more of the fol-lowing measures:• Reorient or relocate the devices• Increase the separation between the devices• Connect the equipment to an outlet on a different circuit• Consult the manufacturer or field service technician for help.This equipment has been tested an and found to comply with the following EMC standards:FCC Part 15CEN 300 330 -2 V 1.1The PRM is capable of continuous operation and will not shut off automat-ically if it is unused for an extended time or if it runs out of paper. Keep the air intake and outlet free from obstruction.CAUTION: The PRM is not water-proof or explosion-proof. It should not be used in the presence of flammable gas mixtures including anes-thetic mixture with air, oxygen, or nitrous oxide.PRM Storage1. If using a patient data disk, remove disk from the disk drive by pressing the disk ejection button (Figure 9), and store the disk in a safe place.2. Exit the current software application.3. Press the Power button to turn the power off (Figure 2).NOTE: Before unplugging the power cord to move the PRM, always exit the software application and press the Power button to turn off the PRM; otherwise, your system may lock up completely or have boot errors.
224. Unplug the power cord from the wall.5. Unplug the cables from the back and side panels and other equip-ment.6. Lower the screen until the front latch locks in place.NOTE: The programmer is not intended to be rested or stored in an up-right position (resting on rear panel with handle on top).EXTERNAL CABLE CONNECTIONSThe following cables are required for use with the Model 3120 Program-mer/ Recorder/Monitor when using the configurations described in this section.• Model 6924 External Recorder Cable: a six-channel DIN – six BNC cables (color-coded and numbered) for connection of the PRM analog output signals to another strip chart recorder or monitor.• Model 6750 Surface ECG Patient Cable: a six-pin amphenol ECG ca-ble for connecting the patient directly to the PRM.• Model 6629 ECG-BNC Slave Cable: used for input of patient ECG sig-nals to the PRM from an external monitor or recorder.• Model 6577 Sterilizable Telemetry Wand.The PRM also has two adapter kits that adapt cables with BNC connec-tors to fit other sockets:• Model 6930:BNC–dual banana plug BNC–pin tip BNC–alligator clip adapters• Model 6934:BNC–phono adapterRefer to Figure 11 for cable connections.
23Figure 11. Cable connections for the Model 3120 PRM.Surface ECG ConnectionsThree cable–electrode configurations frequently used to generate surface ECGs include the following:• Patient to external recorder to PRM (Figure 12)• Patient to PRM to external recorder (Figure 13)• Simultaneous connections from patient to PRM and patient to external recorder (Figure 14)NOTE: Annotated event markers cannot be sent to an external recorder.Patient ECG Cable orECG BNC Slave CableExternal Recorder Cable:Channel 1 (red) - surface ECGChannel 2 (orange) - telemetered signal 1Channel 3 (green) - telemetered signal 2Channels 4, 5, 6 - not activeTelemetry Wand ConnectorAnalog Output Channel ECG ConnectorTelemetry Wand
24Patient–Recorder–PRM ConnectionTo display a tracing on an external recorder and the PRM without using the patient ECG cable, set up equipment as shown in Figure 12.Figure 12. External recorder gets surface signal and sends it to the PRM. PRM sends electrograms to the external recorder.1. Connect the external recorder’s patient ECG leads to the appropri-ate electrodes.2. Route the surface ECG channel to the PRM using the ECG–BNC slave cable. (Use the Model 6930 or 6934 adapter cables, if neces-sary.)3. Connect the orange and green connectors of the external recorder cable to the external recorder for telemetered signals.4. Adjust gain and filters on the external recorder.5. Connect the telemetry wand and verify proper position. Make sure the wand cord does not cross other cables.Setup is now complete.PATIENT > RECORDER > PRMTele m et r y Wa ndPatient ECG CableExternal RecorderECG-BNC Slave CableExternal Recorder CablePRMConnectorsECG INWandINAnalogOUTSurface INSurface OUTChannels 2 and 3(orange and green)
25Patient–PRM–Recorder ConnectionTo display a tracing on the PRM and an external strip chart recorder using the patient ECG cables, set up equipment as shown in Figure 13.Figure 13. PRM receives surface signal via the patient cable and then sends surface and telemetered channels to the external strip chart recorder.1. Connect the external recorder cable from the PRM to the external recorder input ports.• Channel 1 (red) for a surface trace• Channel 2 (orange) for telemetered signal 1• Channel 3 (green) for telemetered signal 22. Connect the patient ECG cable to the patient electrodes.3. Verify proper telemetry wand position.Setup is now complete.Telemetry WandPatient ECG CableExternal RecorderExternal Recorder CablePATIENT > PRM > RECORDERChannel 1 (red)PRMConnectorsECGINWandINAnalogOUTSurface INChannels 2 and 3 (orange and green)Patient ECG Cable
26Parallel ConnectionTo display traces on both PRM and ECG recorders using two different pa-tient ECG leads, set up the equipment as shown in Figure 14.Figure 14. Parallel connection of PRM surface leads and external surface monitor.1. Connect the external recorder patient ECG leads to the appropriate limb electrodes.2. Connect the patient ECG cable to the patient electrode.3. Connect the external recorder cable from the PRM to the external re-corder.NOTE: This configuration will add the most noise to the tracings of the two PRM–recorder configurations.4. Adjust gain and filters on the external recorder.Setup is now complete.NOTE: The right leg electrode conductor on the patient ECG cable is a driven ground. When connecting the PRM and an external ECG monitor in parallel, the driven grounds for the two instruments must be connected to the same patient limb (e.g. right leg electrode); otherwise, noise prob-lems will occur.Telemetry WandPatient ECG CableExternal RecorderExternal Recorder CablePRMConnectorsECG INWandINAnalogOUTSurface INPatient ECG CablePATIENT > RECORDERPATIENT > PRMChannels 2 and 3 (orange and green)
27TROUBLESHOOTINGIf the PRM does not operate properly, check that electrical cords and ca-bles are securely connected and that cords and cables are in good work-ing order (i.e., free of visible defects). Table 2 indicates possible causes and corrective actions for PRM problems. For external printer problems, refer to the manual for the external printer.Table 2. Possible Causes and Corrective Actions for PRM ProblemsSymptom Possible Cause Corrective ActionInternal printer/recorder does not functionNo AC line voltageCheck that power cord is plugged securely into the rear panel of the PRM.Change to a different electrical outlet.Paper jam Clear paper path of any obstruction.Internal printer/recorder: paper-feed problemsPaper misaligned Reload paper.Paper-feedobstruction Clear obstruction from around the paper supply.Internal printer/recorder: no print visiblePaper loaded upside downReload paper. (See “Loading the Paper” on page 17.)No analog outputUsing incorrect output port and/or connectionsRecheck connection of the Model 6924 External Recorder Cable.Patient data disk errorUsing disk created for a previous model of PRM or unformatted floppy diskUse only Guidant Model 6627 Patient Data Disks.Write-protect tab open Close write-protect tab.Noise problems: ECGImproper patient connectionsRecheck patient leads for adequate skin contact and correct limb lead placement.“Noisy” equipmentCheck surrounding area for equipment with excessive radio frequency emissions. Move unneeded equipment away from patient and/or PRM, or turn off unneeded equipment. Consult ECG textbooks for additional ECG techniques.
28Telemetry: no communicationIncorrect application software or incorrect PRM for pulse generatorInstall proper application software for pulse generator in use.Incomplete telemetry communicationReposition wand over the device; repeat interrogation.Te l em e tr y: intermittent communicationIncorrect telemetry wandUse only the Guidant Model 6577 Sterilizable Telemetry Wand.“Noisy” equipmentCheck surrounding area for equipment with excessive radio frequency emissions. Move unneeded equipment away from patient and/or PRM, or turn off unneeded equipment.Incomplete telemetry communicationReposition wand over the device; repeat interrogation.Displayed clock does not consistently keep time after settingLow battery Return to Guidant for replacement of clock battery.Table 2. Possible Causes and Corrective Actions for PRM ProblemsSymptom Possible Cause Corrective Action
29LABEL SYMBOLSTable 3 illustrates the symbols used on the Model 3120 PRM and in-cludes an explanation of each symbol.Table 3. Label Symbols and Their MeaningsSymbol MeaningAlternating currentNeed graphic.Power button: <<<DECISION PENDING WITH TUV>>>USBParallel connector for printerVGA output for external monitorAnalog outputTelemetry wand inputIndicates defibrillator-proof CF-type patient ECG cable connectorPaper form feedCalibration pulseBring trace to baselineIndicates the potential equalization conductor. This connection allows a common ground with other equipment in a clinical setting.
30Mark for nationally recognized testing for safety standards.See instruction manual.Radio, Telecommunications and Terminal Equipment (RTTE) symbol. Indicates that device does not operate in a harmonized bandwidth.General warning.Dangerous voltage. Refer servicing to Guidant.Indicates the risk of electric shock; do not remove the cover (or back). Refer servicing to Guidant.Indicates separate collection for electrical and electronic equipment (i.e., do not throw this device in the trash).For future use.Inductive telemetry indicator lightOn indicator lightVVoltageS/N Serial numberTable 3. Label Symbols and Their MeaningsSymbol Meaning
31A/N Assembly numberThis side upFragile, handle with careKeep dryDo not use hooksTemperature limitationsHumidity limitationsTable 3. Label Symbols and Their MeaningsSymbol Meaning
32WARRANTY INFORMATIONA limited one-year warranty and a warranty registration card for the Guidant PRM is packaged with the PRM. Unless otherwise agreed, the PRM remains the property of Guidant and Guidant must perform all nec-essary servicing and repair work.ORDERING ACCESSORIESTo order accessories, contact the nearest Guidant sales representative or contact Guidant Corporation at the address or phone number on the back cover of this manual.SERVICEFor questions regarding operation or repair of the PRM, call the nearest Guidant representative or call Guidant Technical Services at the phone number on the back cover of this manual. The PRM must be serviced by Guidant personnel only.If the Guidant PRM malfunctions and requires repair, help to ensure effi-cient service by following these guidelines:1. Leave the configuration of the instrument exactly as it was at the time of malfunction. Contact the nearest Guidant representative or call Guidant Technical Services at the phone number on the back cover of this manual.2. Write a detailed description of the malfunction(s).3. Save printouts or other materials that illustrate the problem.4. If the PRM must be returned to Guidant for service, pack it in the ship-ping container in which it was received or in a shipping container pro-vided by Guidant.5. Send the PRM to Guidant at the address on the back cover of this manual.For problems or questions that arise regarding operation or repair of the optional external printer, contact the printer manufacturer or agent.PREVENTIVE MAINTENANCENo preventive maintenance is needed by the user or service personnel.ENVIRONMENTAL PROTECTIONReturn the programmer to Guidant af the end of its useful life for appro-priate disposal.
33SPECIFICATIONS (Nominal)Safety classification Class I, Type CF, Defibrillation protectedDimensions 19 in (48.3 cm) deep, 14.5 in (36.8 cm) wide, 4.75 in (12.1) cm highWeight (approximate) 21.5 lb (9.8 kg)Power rating 100–120/200–240 V and 50–60 Hz 3.8/1.9 APower cord8 ft. 100–240 V. Reliable grounding is achieved only when equipment is connected to receptacle marked with “Hospital only” or “Hospital grade.”Operating temperature 50–105°F (10–40°C)Transport and storage temperature –40 to 160°F (–40 to 70°C)Relative humidity• Transport and storage 5–95%• Operating 20–95%Atmospheric pressure 500–1,060 hPaExternal printer support DB 25 parallel port connectorExternal monitor support DB 15 VGA port connectorAnalog output + 1 V output via seven-pin DIN connectorECG performance• Lead selection I, II, III, aVR, aVL, aVF, V• Intrinsic ventricular rate display 30–240 bpm + 6 bpm• Input impedance > 2.5 M Ω• Electrode offset tolerance 300 mV• Storage resolution 800 samples/sec, 4.56 µV• Filter settings ON: 0.5–25 Hz, + 0.2 dB; OFF: 0.05–100 Hz + 0.2 dB• Gain settings 1, 2, 5, 10, 20 mm/mV + 25%Internal printer• Paper type Thermo-sensitive• Paper width 4 in (110 mm) • Chart speed 10, 25, 50, 100 mm/secBattery type DL 2450 or equivalentSafety features• Leakage current < 10 µA (patient); < 100 µA (chassis)• Defibrillator protection to 5,000 V, 400 J
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Guidant Corporation 4100 Hamline Avenue North St. Paul, MN 55112-5798 USA24-Hour Consultation 1-800-CARDIAC (227-3422)Worldwide: +1.651.582.4000www.guidant.com© 2004 Guidant CorporationAll rights reserved. 357043-001 A US 07/04

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