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Project: ZOOM LATITUDE operator’s manual

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Operator’s Manual

ZOOM® LATITUDE™

Programming

System

MODEL 3120 PRM

RESTRICTED DEVICE: Federal law (USA) restricts

the sale, distribution, or use of this device to, by, or

on the lawful order of a physician.

CONTENTS

DESCRIPTION AND USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Intended Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Adverse Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

SYSTEM FEATURES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

System Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Optional External Printer . . . . . . . . . . . . . . . . . . . . . . . . . . 5

Optional External Monitor . . . . . . . . . . . . . . . . . . . . . . . . . . 5

PREPARING THE PRM FOR USE . . . . . . . . . . . . . . . . . . . . . . 6

Prepare the Telemetry Wand . . . . . . . . . . . . . . . . . . . . . . . 6

Make External Cable Connections . . . . . . . . . . . . . . . . . . . 7

Start the PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

USING THE PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Startup Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Touchscreen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Indicator lights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

ECG Display . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Monitoring/Recording Functions . . . . . . . . . . . . . . . . . . . . 12

Using an External Recorder . . . . . . . . . . . . . . . . . . . . . . . 13

Using an External Printer . . . . . . . . . . . . . . . . . . . . . . . . . 13

Quick Start . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

The Utilities Menu on the Startup Screen . . . . . . . . . . . . . 14

The Select PG Option on the Startup Screen . . . . . . . . . . 15

Changing Parameter Values . . . . . . . . . . . . . . . . . . . . . . 16

MAINTENANCE AND HANDLING . . . . . . . . . . . . . . . . . . . . . 17

Loading the Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Thermal Paper Storage . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Cleaning the PRM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

Patient Data Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Operation and Storage Conditions . . . . . . . . . . . . . . . . . . 20

PRM Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

EXTERNAL CABLE CONNECTIONS . . . . . . . . . . . . . . . . . . . 22

Surface ECG Connections . . . . . . . . . . . . . . . . . . . . . . . . 23

Patient–Recorder–PRM Connection . . . . . . . . . . . . . . . . 24

Patient–PRM–Recorder Connection . . . . . . . . . . . . . . . . 25

Parallel Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

TROUBLESHOOTING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

LABEL SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29

WARRANTY INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . 32

ORDERING ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . 32

SERVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

PREVENTIVE MAINTENANCE . . . . . . . . . . . . . . . . . . . . . . . 32

ENVIRONMENTAL PROTECTION . . . . . . . . . . . . . . . . . . . . . 32

SPECIFICATIONS (Nominal) . . . . . . . . . . . . . . . . . . . . . . . . . 33

DESCRIPTION AND USE

The 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 Use

The 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.

Contraindications

For 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.

Precautions

General

• 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.

• 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 Effects

None known.

SYSTEM FEATURES

The 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.

• 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 Accessories

The 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)

• Antenna

Other 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 Cable

Optional External Printer

The 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 Monitor

The use of an external monitor is optional. Contact your Guidant sales

representative to determine which monitor(s) can be used.

CAUTION: 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 USE

Prepare the Telemetry Wand

1. 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, and

2. 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 Connector

Telemetry Wand Connector

Analog Output Channel

Stimulator Inputs

Make External Cable Connections

1. 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 Button

External VGA Monitor Connector

External Printer Connector

Start the PRM

Perform 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 PRM

Startup Screen

The 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 Connector

Buttons

Heart-rate

Indicator

ECG Icon

• 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.

Touchscreen

The 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 lights

The 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 Function

For future use. For future use.

Inductive telemetry

Lit when inductive, wanded telemetry has

been established and interrogation or

programming is occurring

On Lit when the PRM is On.

ECG Display

To 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

Keys

For 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 Functions

Left 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 pad

Press STAT PACE when in telemetry communication

with the pulse generator to program predetermined

parameters for emergency bradycardia pacing

Press DIVERT THERAPY when in telemetry

communication with the pulse generator to divert

tachycardia therapy delivery.

STAT PACE

DIVERT THERAPY

Figure 6. Model 3120 PRM right-side keypad.

Monitoring/Recording Functions

Surface ECG

Pressing 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 Functions

STAT SHOCK

PROGRAM

INTERROGATE

STAT PACE STAT SHOCK

DIVERT THERAPY

PROGRAM INTERROGATE

Intracardiac Electrogram

Intracardiac 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 Recorder

To 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 Printer

If 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 Start

The 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/

or 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 Screen

If 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.

NOTE: 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 Screen

This 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.

5. 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 Values

The 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

In 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 HANDLING

Loading the Paper

The 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:

1. 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 Storage

Store 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 PRM

Clean 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.

CAUTION: 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 Disk

The 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 Disks

Floppy 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 drive

Disk Drive Disk Ejection Button

Patient Data Disk

Write-protect tab closed

(black tab covering hole)

Sliding Shutter

• 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 Conditions

The 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.

Safety and EMC Compliance Standards

This 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-M90

This 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 15C

EN 300 330 -2 V 1.1

The 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 Storage

1. 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.

4. 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 CONNECTIONS

The 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 adapter

Refer to Figure 11 for cable connections.

Figure 11. Cable connections for the Model 3120 PRM.

Surface ECG Connections

Three 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 or

ECG BNC Slave Cable

External Recorder Cable:

Channel 1 (red) - surface ECG

Channel 2 (orange) - telemetered signal 1

Channel 3 (green) - telemetered signal 2

Channels 4, 5, 6 - not active

Telemetry Wand Connector

Analog Output Channel ECG Connector

Telemetry Wand

Patient–Recorder–PRM Connection

To 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 > PRM

Tele m et r y Wa nd

Patient ECG

Cable

External Recorder

ECG-BNC Slave Cable

External Recorder

Cable

PRM

Connectors

ECG

Wand

Analog

OUT

Surface IN

Surface

OUT

Channels 2 and 3

(orange and green)

Patient–PRM–Recorder Connection

To 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 2

2. Connect the patient ECG cable to the patient electrodes.

3. Verify proper telemetry wand position.

Setup is now complete.

Telemetry Wand

Patient ECG

Cable

External Recorder

Cable

PATIENT > PRM > RECORDER

Channel 1 (red)

PRM

Connectors

ECG

Wand

Analog

OUT

Surface

Channels 2 and 3

(orange and green)

Patient ECG

Cable

Parallel Connection

To 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 Wand

Patient ECG

Cable

External Recorder

Cable

PRM

Connectors

ECG

Wand

Analog

OUT

Surface

Patient ECG

Cable

PATIENT > RECORDER

PATIENT > PRM

Channels 2 and 3

(orange and green)

TROUBLESHOOTING

If 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 Problems

Symptom Possible Cause Corrective Action

Internal printer/

recorder does

not function

No AC line voltage

Check 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 problems

Paper

misaligned Reload paper.

Paper-feed

obstruction

Clear obstruction from around

the paper supply.

Internal printer/

recorder: no

print visible

Paper loaded upside

down

Reload paper. (See “Loading

the Paper” on page 17.)

No analog

output

Using incorrect output

port and/or

connections

Recheck connection of the

Model 6924 External Recorder

Cable.

Patient data disk

error

Using disk created for a

previous model of PRM

or unformatted floppy

disk

Use only Guidant Model 6627

Patient Data Disks.

Write-protect tab open Close write-protect tab.

Noise problems:

ECG

Improper patient

connections

Recheck patient leads for

adequate skin contact and

correct limb lead placement.

“Noisy” equipment

Check 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.

Telemetry: no

communication

Incorrect application

software or incorrect

PRM for pulse

generator

Install proper application

software for pulse generator in

use.

Incomplete telemetry

communication

Reposition wand over the

device; repeat interrogation.

Te l em e tr y:

intermittent

communication

Incorrect telemetry

wand

Use only the Guidant

Model 6577 Sterilizable

Telemetry Wand.

“Noisy” equipment

Check 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

communication

Reposition wand over the

device; repeat interrogation.

Displayed clock

does not

consistently

keep time after

setting

Low battery Return to Guidant for

replacement of clock battery.

Table 2. Possible Causes and Corrective Actions for PRM Problems

Symptom Possible Cause Corrective Action

LABEL SYMBOLS

Table 3 illustrates the symbols used on the Model 3120 PRM and in-

cludes an explanation of each symbol.

Table 3. Label Symbols and Their Meanings

Symbol Meaning

Alternating current

Need

graphic.

Power button: <<<DECISION PENDING WITH TUV>>>

USB

Parallel connector for printer

VGA output for external monitor

Analog output

Telemetry wand input

Indicates defibrillator-proof CF-type patient

ECG cable connector

Paper form feed

Calibration pulse

Bring trace to baseline

Indicates the potential equalization conductor. This

connection allows a common ground with other equipment in

a clinical setting.

Mark 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 light

On indicator light

VVoltage

S/N Serial number

Table 3. Label Symbols and Their Meanings

Symbol Meaning

A/N Assembly number

This side up

Fragile, handle with care

Keep dry

Do not use hooks

Temperature limitations

Humidity limitations

Table 3. Label Symbols and Their Meanings

Symbol Meaning

WARRANTY INFORMATION

A 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 ACCESSORIES

To 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.

SERVICE

For 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 MAINTENANCE

No preventive maintenance is needed by the user or service personnel.

ENVIRONMENTAL PROTECTION

Return the programmer to Guidant af the end of its useful life for appro-

priate disposal.

SPECIFICATIONS (Nominal)

Safety classification Class I, Type CF, Defibrillation protected

Dimensions 19 in (48.3 cm) deep, 14.5 in (36.8 cm) wide,

4.75 in (12.1) cm high

Weight (approximate) 21.5 lb (9.8 kg)

Power rating 100–120/200–240 V and 50–60 Hz 3.8/1.9 A

Power cord

8 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 hPa

External printer support DB 25 parallel port connector

External monitor support DB 15 VGA port connector

Analog output + 1 V output via seven-pin DIN connector

ECG 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/sec

Battery type DL 2450 or equivalent

Safety features

• Leakage current < 10 µA (patient); < 100 µA (chassis)

• Defibrillator protection to 5,000 V, 400 J

Guidant Corporation

4100 Hamline Avenue North St. Paul, MN 55112-5798 USA

24-Hour Consultation

1-800-CARDIAC (227-3422)

Worldwide: +1.651.582.4000

Boston Scientific CRM312004 3120 User Manual prm

Boston Scientific Corporation 3120 prm

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