St. Jude Medical 3085 User Manual
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St. Jude Medical 3085 User Manual

St. Jude Medical 3085 User Manual

Dual chamber (ddd) external pulse generator
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Model 3085
Dual Chamber (DDD)
External Pulse Generator
User's Manual
5I-17-020X-B-19
© Osypka Medical 2011

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  • Page 1 Model 3085 Dual Chamber (DDD) External Pulse Generator User’s Manual 5I-17-020X-B-19 © Osypka Medical 2011...

  • Page 3: Table Of Contents

    Writing Conventions of this Manual Product Description Indication Contraindication Possible Complications Precautionary Measures and Warnings Patient Safety Electromagnetic Compatibility Use and Application of MODEL 3085 Design Overview of the Display, Dials and Keys 9.2.1 Upper Parameter Display 9.2.2 Lower Mode / Menu Display 9.2.3 Dials 9.2.4...
  • Page 4 Enable and Disable Atrial Trigger Function 9.12.5.4 Setting the User Language 9.12.5.5 Setting CTRL.OUT Interface 9.13 Emergency Stimulation 9.14 Pause Function 9.15 Connecting the Leads to MODEL 3085 9.15.1 Lead Types 9.15.1.1 Lead Connection Terminals 9.15.2 Connection Configurations 9.15.3 Connecting the Leads 9.16 Determining the Sensitivity Threshold 9.17...
  • Page 5 MODEL 3085 – User’s Manual 9.20.5 Premature Ventricular Contraction (PVC) 9.20.5.1 Isolated PVC, or Initial PVC 9.20.5.2 Subsequent PVCs 9.20.5.3 Absolute and relative PVARP 9.20.6 Runaway Protection 9.20.7 Protection Against Abnormal Settings 9.20.7.1 Possible Conflicts 9.20.7.2 Mode Switching 9.20.8 Effects from Therapeutic and Diagnostic Energy Sources 9.20.8.1...
  • Page 6 MODEL 3085 – User’s Manual 6 / 74 5I-17-020X-B-19...

  • Page 7: Preface

    The product may only be placed in service when its Main Menu, START proper use can be assured. According to U.S. Standards, MODEL 3085 is a Class Helpful hints and notes on the usage of the device III device (21 CFR 862-892 [807.87(c)]).

  • Page 8: Product Description

    PVARP is available. acoustically. An automatic mode for adjusting the sensitivity in The functional design of MODEL 3085 allows safe and both the atrium and ventricle may be chosen. easy operation for all requirements of DDD stimulation. A Pause function is available for easy determination In addition, MODEL 3085 offers the following features: and measurement of the patient’s intrinsic heart...

  • Page 9: Indication

    MODEL 3085 – User’s Manual 3 Indication The MODEL 3085 DDD External pulse generator is designed to be used with cardiac stimulation lead systems for temporary atrial, ventricular or A-V sequential stimulation. MODEL 3085 has applications where such stimulation modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

  • Page 10: Contraindication

    MODEL 3085 – User’s Manual 4 Contraindication There are no contraindications with regards to the use of MODEL 3085 for temporary cardiac stimulation for therapy and prevention of arrhythmia. The state of health of the patient, however, can restrict the choice of operational mode and stimulation parameters.

  • Page 11: Possible Complications

    Erroneous lead connection Device does not function properly. Chaotic rhythm. Failure to stimulate as intended. Influence of defibrillation and RF See chapter 8 for the effects while simultaneous use of MODEL 3085 with surgery. defibrillators or electro-surgical instruments. Table 1: Possible Complications...

  • Page 12: Precautionary Measures And Warnings

    High current amplitudes can also damage the 6 Precautionary Measures and pacemaker. Warnings 13. If MODEL 3085 is to be used for a long period of The following list presents important precautionary time on a patient, the stimulation threshold should measures and warnings. Additional important...
  • Page 13 The patient should not be left unattended by the medical staff and should always be supervised 28. Use only 9 V primary batteries for MODEL 3085. by a monitoring system. Re-chargeable batteries (accumulators) should not...

  • Page 14: Patient Safety

    MODEL 3085 – User’s Manual 7 Patient Safety The external pulse generator MODEL 3085 meets all applicable international standards for patient safety: IEC 60601-1 Medical electrical equipment. General requirements for safety IEC 60601-1-2 Medical electrical equipment. Electromagnetic compatibility IEC 60601-2-31 Medical electrical equipment.

  • Page 15: Electromagnetic Compatibility

    Special electromagnetic compatibility (EMC) 8 Electromagnetic Compatibility precautions should be taken7 when using electrical The external pulse generator MODEL 3085 meets all medical equipment such as MODEL 3085: applicable international standards with respect to Portable and mobile RF communications equipment, electromagnetic compatibility (EMC).

  • Page 16: Use And Application Of Model 3085

    MODEL 3085 – User’s Manual 9 Use and Application of MODEL 3085 9.1 Design MODEL 3085 with its displays, keys, dials and terminals is shown in Figure 1. Figure 1: External Pulse Generator MODEL 3085 Display Face 16 / 74...
  • Page 17 MODEL 3085 – User’s Manual Figure 2: External Pulse Generator MODEL 3085 Rear View On the rear side of the device (see Figure 2) there is a metal hanger. This hanger deploys in three snap-in positions. Thus, it can be used as a hanger, as a table-top stand, or it can be folded away. To adjust the hanger, grasp it from the sides and pull away from the pacemaker frame.

  • Page 18: Overview Of The Display, Dials And Keys

    MODEL 3085 – User’s Manual 9.2 Overview of the Display, Dials and Dial Function Keys (HI-) RATE Adjusting the basic rate and the overdrive stimulation rate. 9.2.1 Upper Parameter Display A-SENSE Adjusting the atrial sensitivity. The six parameters, basic rate, atrial sensitivity, atrial...

  • Page 19: Display Backlight

    Table 5. 9.3 Powering On MODEL 3085 Main Menu 1 Key No. MODEL 3085 is powered on by pressing the key labeled ON. High-Rate Subsequently, MODEL 3085 performs a self-test. If the device was set to Stand-by (see chapter 9.5) it...

  • Page 20: Locking/Unlocking Model 3085

    MODEL 3085 begins to function with the 9.5 Powering Off MODEL 3085 Turn-on program (see chapter 9.11.5). Upon shipping MODEL 3085 is powered off by pressing the key from the manufacturer, a DDD mode with high labeled OFF. sensitivity and moderate stimulation amplitudes is preset.

  • Page 21: Modes Of Operation

    In VVI mode, window. It is determined by the A-V Delay and by the MODEL 3085 is refractory for a period after a paced or Maximum Tracking Rate (MTR). sensed ventricular event, the ventricular refractory The A-V interval is the measured time interval between period.

  • Page 22: Dual-Chamber Pacing And Sensing With Inhibition And Tracking (Ddd)

    A-V Delay is initiated. If no ventricular activity is In this mode, sensing is enabled in all channels but not sensed before the A-V Delay terminates, a ventricular pacing. MODEL 3085 is ‘listening’ to intrinsic atrial and pacing stimulus is delivered (P-synchronous ventricular ventricular events only.

  • Page 23: Adjustment Of Rate, Stimulation Amplitude, Sensitivity And A-V Delay

    Note: If conflicts (because of abnormal settings) occur a dial belonging to parameter without pacing function in as a result of a mode change, MODEL 3085 will make the mode selected is set, the respective previously blanked section will be switched on. A numeric value will be briefly displayed, whereupon it will disappear in Bernstein AD, Camm AJ, Fletcher RD, et al.

  • Page 24: Adjustment Of Basic Rate

    MODEL 3085 – User’s Manual 9.8.1 Adjustment of Basic Rate Parameter Range (Step Width) Unit Rotating the RATE clockwise will increase the basic 0.1 (0.1) 2.0 rate in the range shown in Table 12. The actual rate value and the intensity bar diagram can be seen in the 2.0 (0.2) 6.0...

  • Page 25: Using The Automatic Features

    A-V Delay 5, 10 (10) 400 MODEL 3085 then adjusts the A-V Delay depending on Table 16: Range and step width (in parenthesis) for the basic rate according to the formula in Table 18, and...

  • Page 26: Automatic Setting Of Mtr With The Setting Of Rate

    MODEL 3085 then adjusts the MTR to a value 34 ppm higher than the basic rate, but with a minimum of sensitivity 100 ppm and a maximum of 230 ppm, according to the formula and the range in Table 20.

  • Page 27: Activation Of Auto Sense

    Ventricular  Auto Sense MODEL 3085 stops pacing as long as this key is held down. However, MODEL 3085 continues to sense and attempts to detect a regular intrinsic activation of the patient’s heart. While doing this, the lower display appears as shown in Table 23.

  • Page 28: Notes For The Initialization Of The Auto Sense Function

    The user can decide if another attempt shall be made to If the user continues to press the softkey labeled find an intrinsic rhythm, or if the procedure shall be Initiate, MODEL 3085 will continue to search for intrinsic ↑_ terminated using the key.

  • Page 29: High-Rate / Overdrive Stimulation

    9.10 High-Rate / Overdrive Stimulation Range Parameter Unit (Step Width) MODEL 3085 provides a function for atrial High-Rate stimulation, also known as atrial overdrive stimulation, Atrial High-Rate 70 (10) 1000 or rapid atrial pacing. The Atrial High-Rate standby is accessed by pressing...

  • Page 30: Atrial High-Rate Stimulation With Ramp Function

    High-Rate stimulation rate. This feature allows the user Recall XXX to manually set a ramp function for atrial High-Rate standard stimulation. Manufacturer’s- Note: MODEL 3085 ignores any rotation of the HIGH- default RATE dial beyond the defined minimum or maximum settings. ↑_ Table 31: Standard Menu...

  • Page 31: Store Standard Programs

    (see chapter 9.11.4). If the question 9.11.2 Store Standard Programs Overwrite standard XXX program? is answered with “NO”, MODEL 3085 returns to the By pressing the softkey labeled (previous) Standard Menu. Save as XXX standard ↑_...

  • Page 32: Recall Manufacturer's Defaults

    Standard Menu (Table 31), the manufacturer’s default for the current primary mode (as shown in Table 34) becomes the actual setting. After pressing the softkey Manufacturer’s default, MODEL 3085 abandons the Standard Menu and returns to the Mode Menu. Parameter Unit Basic Rate –...

  • Page 33: Changing The Turn-On Program

    After storing the user defined Turn-on Program, i.e. 100 MODEL 3085 abandons the Turn-On Menu and returns – Automatic Sensing to the Mode Menu. If answered with "NO", MODEL 3085 returns to the – Atrial Trigger Option (previous) Standard Menu. Table 36: Manufacturer’s Turn-on Program ↑_...

  • Page 34: Parameters/Options Setting

    Any limitation of the PVARP setting will be indicated by a transient warning message in the lower display. PVARP & MTR Note: MODEL 3085 divides the PVARP into two parts: ARP & VRP an absolute part and a relative part. In the absolute part (90 ms) no atrial events are recognized.

  • Page 35: Adjustment Of Pulse Duration

    MODEL 3085 – User’s Manual Parameter Range (Step Width) Unit Parameter Range (Step Width) Unit 80 (2) 230 Atrial Pulse 0.05 (0.05) 1.50 Duration Table 41: Range and step width (in parenthesis) for manual setting of MTR Ventricular 0.05 (0.05) 1.50...

  • Page 36: Setting Options

    By pressing the softkey labeled Options in the Parame- the upper display, as well. ters/Options Menu, the Option Menu 1 for enabling and Upon powering off MODEL 3085, it retains the enabled disabling acoustic signals (beep), alarms and atrial / disabled status of the acoustic indicator. Thus, the trigger appears, as shown in Table 47.

  • Page 37: Enable And Disable Atrial Trigger Function

    EL 3085 will solve possible conflicts caused by abnor- mal settings using its Automatic setting feature. The fact 9.12.5.5 Setting CTRL.OUT Interface that MODEL 3085 adapted a parameter to the set Basic Rate is indicated by a message temporarily shown in By pressing the softkey labeled the lower display (see chapter 9.20.7 and 9.9).

  • Page 38: Pause Function

    9.14 Pause Function independent if the user continues to hold the key labeled Pause. MODEL 3085 allows the user to temporarily interrupt Warning: Because pacing is interrupted, the user must the current stimulation therapy in order to monitor the be aware that the patient receives no stimulation patient’s intrinsic cardiac activity.

  • Page 39: Connecting The Leads To Model 3085

    (see Figure 1). situations, a defibrillator must always be in a ready-to- Viewing the top of MODEL 3085, as shown in Figure 9, use state. The user must ensure that all devices in the the ventricular connections are located to the left and vicinity of the patient are properly grounded.

  • Page 40: Determining The Sensitivity Threshold

    1. Set the stimulation amplitude (in dual-chamber Warning: If MODEL 3085 is to be used for a longer mode: both channels) to the smallest value so that period of time on a patient, the stimulation threshold...

  • Page 41: Interfacing With Electrical Cardiometry™ Monitors (Option)

    The communication between MODEL 3085 and the EC™ monitor is established via a custom interface cable connected at one end to the CTRL.OUT terminal Language of MODEL 3085 and at the other end to the EC™ monitor. Upon successful communication,  ...

  • Page 42: Internal Surveillance And Safety Features

    Atrial lead disconnected or Ventricular lead disconnected. appear in the lower If MODEL 3085 is switched off, or to the stand-by state display (only if the lower display is switched on). Once after the first request to change the battery has...

  • Page 43: Interference And Mode Switching

    No change while the pacemaker is not connected to the pacing leads. However, upon proper connection of No change MODEL 3085 to the pacing leads and, thus, the patient, No change No change MODEL 3085 enables lead-breakage surveillance after three successfully sensed or paced events.

  • Page 44: Ventricular Blanking Period

    Note: Pacemaker mediated tachycardia has been defined as a reentry arrhythmia in which the dual- To prevent crosstalk, MODEL 3085 initiates, after an chamber pacemaker acts as the antegrade limb of the atrial stimulus, a brief ventricular blanking period. As a...

  • Page 45: Runaway Protection

    V-A delay. MODEL 3085 continuously monitors the setting of MODEL 3085 avoids this effect by dividing the PVARP parameters so that abnormal settings, as shown in in two periods, the absolute PVARP and the relative Table 55, can be detected and avoided.
  • Page 46 MODEL 3085 – User’s Manual The acronyms in the tables have the following definitions: "" Value to be increased "" Value to be decreased "A" Parameter is set to "Automatic Setting" "M" Parameter is set to "Manual Setting" Basic Rate Message ...

  • Page 47: Mode Switching

    MODEL 3085 should PVARP and A-V Delay are set to ”manual”, be set to an asynchronous pacing mode (without any MODEL 3085 will, first, set the PVARP to the automatic sensing). value (see chapter 9.9.2). If this does not solve the...
  • Page 48 MODEL 3085 – User’s Manual MODEL 3085 Meaning / Cause Measures to Eliminate the Warning Message Conflict / Error Chapter Increase The user has attempted to increase the rate. This Increase MTR or set to "Auto MTR" before 9.20.7 MTR to led to a conflict (type a), because MTR is set at an further increase of rate.
  • Page 49 MODEL 3085 – User’s Manual MODEL 3085 Meaning / Cause Measures to Eliminate the Warning Message Conflict / Error Chapter Decrease The user has attempted to decrease the rate. This Decrease PVARP or set to "Auto PVARP" 9.20.7 PVARP led to a conflict (type b), because the sum of before further decrease of rate.

  • Page 50: Warning Messages Related To Application Errors

    Unlock/Lock switches the backlight on and unlocks problem has been solved, or after confirmation by the MODEL 3085. A second press of the key Unlock/ then user. The user can confirm the error message by confirms the error message.

  • Page 51: Warning Messages Related To Device Errors

    Unlock/Lock switches the backlight on and unlocks user, i.e. device related error messages must be MODEL 3085. A second press of the key Unlock/Lock confirmed. (The acoustic error signal will, however, then confirms the error message.

  • Page 52: Informative Messages

    (Press Unlock) 30 sec after turning on the pacemaker. key Unlock/ Lock must be pressed within 30 sec after pressing the key Note: MODEL 3085 will turn itself off after this labeled ON. message. Auto AVD The automatic A-V Delay setting has been If the automatic A-V Delay setting is to 9.9.1...

  • Page 53: Storage

    MODEL 3085 – User’s Manual 10 Storage Warning In case MODEL 3085 is not to be used for longer periods of time, the battery must be removed in The storage temperature range of MODEL 3085 is order to prevent damage from possible battery acid leakage.

  • Page 54: Care And Maintenance

    11.1 Care and Cleaning If MODEL 3085 is switched off or to stand-by mode after the request to change the battery appears, the As a precision electronic device, MODEL 3085 must be battery must be changed before MODEL 3085 is turned handled with corresponding care.

  • Page 55: Safety Check-Ups Of The Pacemaker

    Annual Functional and Safety Check 11.3 Safety Check-Ups of the Pacemaker Measuring the auxiliary currents In order to assure safe operation of MODEL 3085, the Measuring the stimulation parameters (amplitude, following check-ups must be carried out on a regular pulse width) in the atrial and ventricular channels basis.

  • Page 56: Customer Service

    MODEL 3085 – User’s Manual 12 Customer Service If you have any questions, our customer service can be reached at: St. Jude Medical USA: 15900 Valley View Court Sylmar, CA 91342 + 1 (818) 362 6822 Europe: + 46 (8) 474 4147...

  • Page 57: Delivery Unit

    MODEL 3085 – User’s Manual 13 Delivery Unit MODEL 3085 is delivered in a carrying case with the following content: MODEL 3085 DDD external pulse generator 9 V Battery MODEL 3085 User’s Manual MODEL 3085 Quick Reference Guide Contact your local St. Jude Medical representative for temporary stimulation electrodes / pacing wires and accessories such as extension cables and adaptors.

  • Page 58: Technical Data

    MODEL 3085: non-sterile Extension cables connecting to pacing electrodes / wires: sterile No protection against inflammable MODEL 3085 must not be used in the presence of inflammable mixtures of anesthesia supplies: anesthesia supplies and air, oxygen or nitrous oxide (N...
  • Page 59 MODEL 3085 – User’s Manual Parameter 0.2 … 20 mV ± 20 % ± 0.1 mV, Atrial sensitivity: 1.0 … 20 mV ± 20 % ± 0.1 mV, Ventricular sensitivity: 22 k ± 20 % Input impedance: Output impedance: < 10 200 …2000...
  • Page 60 MODEL 3085 – User’s Manual Safety > 4.5 Hz ± 5 % (> 273 bpm) Interference detection frequency: Basic Rate + 10 ppm ± 2 % Interference rate: (max. MTR and max. 220 ppm) Defibrillation protection: According to IEC 60601-2-31 238 ppm ±...
  • Page 61 MODEL 3085 – User’s Manual Dimensions, Weight, Terminals Housing dimensions (L W D): Approx. 200 mm 96 mm 38 mm Overall dimensions (L W D): Approx. 212 mm 96 mm 51 mm (with terminals and dials) Weight without battery: Approx. 445 g Weight with battery: Approx.

  • Page 62: Appendix A: Glossary

    MODEL 3085 – User’s Manual 15 Appendix A: Glossary Atrial escape interval Time between ventricular sensed beat or a ventricular pulse and the succeeding non-triggered atrial pulse of a pulse generator, i.e. the time when the pacemaker waits for a P-wave.
  • Page 63 (PVARP) synchronous ventricular pacing is disabled, regardless of any atrial event. MODEL 3085 divides the PVARP into two periods: an absolute period and a relative period. In the absolute period (90 ms) no atrial events are recognized. In the relative period (the remaining) atrial events are registered, but not tracked. This algorithm prevents misinterpretation of ventricular events after premature atrial events as extrasystoles (PVCs).

  • Page 64: Appendix B: Menu Tree

    MODEL 3085 – User’s Manual 16 Appendix B: Menu Tree Figure 15: Map of Menu Tree (Part 1) 64 / 74 5I-17-020X-B-19...
  • Page 65 MODEL 3085 – User’s Manual Figure 16: Map of Menu Tree (Part 2) 5I-17-020X-B-19 65 / 74...

  • Page 66: Appendix C: Conformity According To Iec 60601-1-2

    Manufacturer guidelines and declarations: Electromagnetic Radiation Standard: IEC 60601-1-2: Table 1 MODEL 3085 is intended for use in an electromagnetic environment as described below. The user should make sure that MODEL 3085 is used in such an environment. Emissions Test...
  • Page 67 Electromagnetic Immunity for External Cardiac Pacemakers Standard: IEC 60601-1-2: Table 3 MODEL 3085 is intended for use in an electromagnetic environment as described below. The user should make sure that MODEL 3085 is used in such an environment. Testing the...
  • Page 68 Standard: IEC 60601-1-2: Table 3 MODEL 3085 is intended for use in an electromagnetic environment, in which the RF interference is under control. There user of the MODEL 3085 can help to prevent electromagnetic interference by maintaining a safety distance to mobile RF communication equipment (transmitters) –...

  • Page 69: Appendix D: List Of Figures

    MODEL 3085 – User’s Manual 18 Appendix D: List of Figures Figure 1: External Pulse Generator MODEL 3085 Display Face ..................16 Figure 2: External Pulse Generator MODEL 3085 Rear View ................... 17 Figure 3: Upper Display..............................18 Figure 4: Lock Symbol ..............................20 Figure 5: The Auto Sense function increases sensitivity ....................

  • Page 70: Appendix E: List Of Tables

    MODEL 3085 – User’s Manual 19 Appendix E: List of Tables Table 1: Possible Complications ............................11 Table 2: Dials and their functions ............................18 Table 3: Fixed labeled keys and their functions ........................ 18 Table 4: Mode Menu ................................. 19 Table 5: Main Menu ................................
  • Page 71 MODEL 3085 – User’s Manual Table 51: Pause Menu. (with example values) ......................... 38 Table 52: Options Menu 2 (BPI enabled) .......................... 41 Table 53: Options Menu 2 (PMC enabled) ........................41 Table 54: Mode Switching Due to Interference ......................... 43 Table 55: Abnormal Settings .............................
  • Page 72 MODEL 3085 – User’s Manual 72 / 74 5I-17-020X-B-19...

  • Page 73: Appendix F: Declaration Of Conformity

    12489 Berlin Germany declare under our sole responsibility, that the medical device Dual Chamber External Pulse Generator MODEL 3085 including Accessories is in conformity with the act on Medical Devices, the Medical Device Directive 93/42/EEC amended by 2007/47/EC with reference to Directive 2006/42/EC on Machinery and the applicable medical device standards IEC 60601 - 1 and IEC 60601-2-31.
  • Page 74 MODEL 3085 – User’s Manual Manufacturer: Distributor: USA: 7855 Ivanhoe Avenue, Suite 226 USA: St. Jude Medical La Jolla, CA 92037, USA 15900 Valley View Court Phone: +1 858 454 0021 Sylmar, CA 91432, USA Fax: +1 858 454 0064 Phone: +1 818 362 6822 E-mail: mail@osypkamed.com...

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