PACE 203H Instructions for Use 5I-17-016X-B-22

PACE 203H – Instructions for Use

Table of Contents 1

Preface

9

1.1

General

9

1.2

Checking the Delivery

9

1.3

Optional Accessories

9

1.4

Writing Conventions of this Manual

9

2

Product Description

11

3

Indication

13

4

Contraindication

13

5

Possible Complications

14

6

Precautionary Measures and Warnings

17

7

Patient Safety

21

8

Electromagnetic Compatibility

21

9

Use and Application of PACE 203H

23

9.1

Design

9.2

Overview of the Display, Dials and Keys

26

9.2.1 9.2.2 9.2.3 9.2.4 9.2.5 9.2.6 9.2.7 9.2.8

Upper Parameter Display Lower Mode / Menu Display Dials Fixed Labeled Keys Softkeys and Menus Display Backlight LEDs for Sensing and Stimulation Acoustic Indications

26 26 27 27 27 28 28 29

9.3

Powering On PACE 203H

29

9.4

Locking/Unlocking PACE 203H

30

9.5

Powering Off PACE 203H

31

9.6

Modes of Operation

31

9.6.1

Ventricular Asynchronous (V00) Pacing

32

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9.6.2 9.6.3 9.6.4 9.6.5 9.6.6 9.6.7 9.6.8 9.6.9 9.6.10 9.6.11 9.6.12

Atrial Asynchronous (A00) Pacing A-V Sequential Asynchronous (D00) Pacing Ventricular Inhibited (VVI) Pacing Atrial Inhibited (AAI) Pacing Atrial Synchronous (P-Tracking) (VDD) Pacing Dual-Chamber Pacing and Sensing with Inhibition and Tracking (DDD) The A-V Sequential, Atrial Inhibited (DAI) Pacing The A-V Sequential, Ventricular Inhibited (DVI) Pacing Atrial Sensing Atrial Synchronous (P-Tracking) (VAT) Pacing Non-Pacing Mode 0D0 (Pause) Atrial Trigger Modes AAT, DDD+AT and DAT

32 32 32 33 33 33 33 34 34 34 34

9.7

Changing the Mode of Operation

35

9.8

Adjustment of Rate, Stimulation Amplitude, Sensitivity and A-V Delay

36

9.8.1 9.8.2 9.8.3 9.8.4

Adjustment of Basic Rate Adjustment of Stimulation Amplitude Adjustment of Sensitivity Adjustment of A-V Delay

37 38 38 39

9.9

Using the Automatic Features

40

9.9.1 9.9.2 9.9.3 9.9.4 9.9.4.1 9.9.4.2 9.9.4.3 9.9.4.4 9.9.4.5 9.9.4.6

Automatic Setting of A-V Delay with the Setting of Rate Automatic Setting of PVARP with the Setting of Rate Automatic Setting of MTR with the Setting of Rate Automatic Adjustment of Sensitivity (Auto Sense) How the Auto Sense Function Works Important Notes Using the Auto Sense Function: Activation of Auto Sense Notes for the Initialization of the Auto Sense function Re-Initialization of Auto Sense Deactivation of Auto Sense

40 41 42 42 42 43 43 45 46 47

9.10

High-Rate / Overdrive Stimulation

48

9.10.1 Atrial High-Rate Standby 9.10.1.1 Atrial High-Rate Stimulation with Ramp Function 9.10.2 Ventricular Rapid Pacing Standby 9.10.2.1 Ventricular Rapid Pacing with Ramp Function

48 50 51 53

9.11

54

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Standard Programs

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9.11.1 9.11.2 9.11.3 9.11.4 9.11.5

Parameters Stored in a Standard Program Store Standard Programs Recall Standard Programs Recall Manufacturer’s Defaults Changing the Turn-On Program

54 56 56 56 58

9.12

Parameters/Options Setting

59

9.12.1 Adjustment of PVARP 9.12.2 Adjustment of MTR 9.12.3 Adjustment of Pulse Duration 9.12.4 Adjustment of Atrial (ARP) and Ventricular (VRP) Refractory Period 9.12.5 Setting Options 9.12.5.1 Enable and Disable Acoustic Indicator 9.12.5.2 Enable and Disable Alarms 9.12.5.3 Enable and Disable Atrial Trigger Function 9.12.5.4 Setting the User Language 9.12.5.5 Setting CTRL.OUT Interface

60 61 61 62 63 64 64 65 66 66

9.13

Statistics

67

9.14

Emergency Stimulation

69

9.15

Pause Function

70

9.16

Connecting the Leads to PACE 203H

72

9.16.1 Lead Types 9.16.1.1 Lead Connection Terminals 9.16.2 Connection Configurations 9.16.3 Connecting the Leads

72 72 72 73

9.17

Determining the Sensing Threshold

75

9.18

Determining the Cardiac Capture Threshold

76

9.19

AC Power Supply (Option)

77

9.20

Controlling an Intra-Aortic Balloon Pump (Option)

78

9.21

Interfacing with Electrical Cardiometry™ Monitors (Option)

80

9.22

Internal Surveillance and Safety Features

81

9.22.1 9.22.2

Battery Surveillance Lead Surveillance

81 82

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9.22.2.1 Short Circuit in Pacing System 9.22.2.2 Interruption in Pacing System 9.22.3 Interference and Mode Switching 9.22.4 Crosstalk and Ventricular Safety Pacing 9.22.4.1 Ventricular Blanking Period 9.22.4.2 Crosstalk Sensing Window and Ventricular Safety Pacing 9.22.5 Premature Ventricular Contraction (PVC) 9.22.5.1 Isolated PVC, or Initial PVC 9.22.5.2 Subsequent PVCs 9.22.5.3 Absolute and relative PVARP 9.22.6 Runaway Protection 9.22.7 Protection Against Abnormal Settings 9.22.7.1 Possible Conflicts 9.22.7.2 Mode Switching 9.22.8 Effects from Therapeutic and Diagnostic Energy Sources 9.22.8.1 Defibrillation 9.22.8.2 RF Surgery 9.22.9 Summary of Text Messages 9.22.9.1 Warning Messages Related to Conflicting Parameter Settings 9.22.9.2 Warning Messages Related to Application Errors 9.22.9.3 Warning Messages Related to Device Errors 9.22.9.4 Informative Messages

82 82 83 84 85 85 85 86 86 87 87 87 88 90 91 91 91 91 91 95 97 99

10

Storage

101

11

Care and Maintenance

103

11.1

Care and Cleaning

103

11.2

Changing the Battery

103

11.3

Safety Check-Ups of the Pacemaker

105

11.4

Product Return Policy

105

12

Customer Service

107

13

Technical Data

109

14

Conditions of Guarantee and Liability Restrictions

115

15

Appendix A: Glossary

117

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16

Appendix B: Menu Tree

121

17

Appendix C: EMC Guidance and Manufacturer’s Declaration

123

18

Appendix D: List of Figures

129

19

Appendix E: List of Tables

131

20

Appendix F: Accessories

135

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PACE 203H – Instructions for Use

1 Preface 1.1 General Read these instructions carefully before using the product described within. Should you have any questions about these instructions or the use of this product, please contact the customer service department before using the product: Phone: +49 (7623) 7405-0 The product may only be placed in service when its proper use can be assured. According to U.S. Standards, PACE 203H is a Class III device (21 CFR 862892 [807.87(c)]). According to European Standards, PACE 203H is a Class IIb medical product (Council Directive 93/42/EEC of 14 June 1993 (‘Medical Device Directive’), Annex IX).

The optionally available medical grade AC power supply (100 ... 240 V / 50 ... 60 Hz) allows the operation of PACE 203H while conserving battery power. The optionally available BPI 202™ intraaortic balloon pump interface provides reliable ECG synchronization for intraaortic balloon pumps (IABP) which otherwise rely on a surface ECG obtained from three ECG electrodes.

1.4 Writing Conventions of this Manual In this instruction manual, certain conventions are used. Keys and displays are represented in the text as follows: •

ON, OFF, Pause, Unlock/Lock •

Texts in the upper display are marked with bold style: AUTO, A-TRIG.

•

1.2 Checking the Delivery Unpack the product and carefully check to see if any damage has occurred during shipment. Check to see if everything was delivered as listed on the shipping list. Please inform Osypka Medical GmbH immediately if something is missing or damaged. Claims that are filed afterwards will not be considered.

Fixed labeled keys and dials are marked with bold style:

Text in the lower display and softlabeled keys are marked in italics: Main Menu, START

•

Helpful hints and notes on the usage of the device and for understanding the modes of operation will be introduced by: Note: …

•

Important facts and warnings to be observed are introduced by: Warning: …

1.3 Optional Accessories (Not available in USA and Japan.)

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•

A non-volatile memory keeps any desired stand-by program ready for use, even if the device is shut off.

•

An individualized standard program is available for each primary pacing mode.

•

An emergency program can be “called up” by pressing the emergency key.

•

A burst- and a ramp function are available for atrial overdrive-stimulation.

•

An Unlock/Lock button protects against accidental change of the set parameters.

•

The set parameters and (error) messages are shown on a liquid crystal display.

•

The detection of the intrinsic heart activity as well as the emission of stimulation impulses are shown separately by blinking LEDs for both atrium and ventricle. Additionally, a beep-tone can be switched on whenever desired.

•

System malfunctions that occur are indicated optically and acoustically.

•

A lead surveillance system indicates interruptions and short circuits.

•

When a battery change is required, optical and acoustic alerts are provided.

•

During dual chamber pacing, an automatic mode for adapting A-V Delay, maximum tracking rate (MTR), and PVARP is available.

•

An automatic mode for adjusting the sensitivity in both the atrium and ventricle may be chosen.

2 Product Description PACE 203H is a dual chamber external cardiac pacemaker with atrial controlled timing for routine temporary heart stimulation. All the usual modes of stimulation are available for treatment of acute brady-arrhythmia and for pre-, intra-, and post-operative stimulation of the heart. The stimulation parameters are easily adjustable by rotating dials through a wide range of values. PACE 203H offers the possibility for atrial overdrive stimulation, or rapid atrial pacing, for terminating supra-ventricular tachycardia. The rate of the overdrive stimulation is adjustable within a wide range and is independent of the selected stimulation rate. The overdrive rate can be determined before, and changed during overdrive therapy. If required, overdrive stimulation can be initiated with the touch of a button. The overdrive stimulation is indicated optically and acoustically. A medical grade AC power supply allows AC operation of the pacemaker while preserving the battery energy. During AC operation a fully charged battery must be in the battery compartment as a backup for AC power failure. (The AC power supply option is not available in USA and Japan.) The functional design of PACE 203H allows safe and easy operation for all requirements of DDD stimulation. In addition, PACE 203H offers the following features: •

During battery changes, stimulation will be maintained for at least 30 seconds (provided fully charged internal capacitors).

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PACE 203H – Instructions for Use

•

A Pause function is available for easy determination and measurement of the patient’s intrinsic heart activity.

•

PACE 203H is designed to protect against accidental liquid spills. Insulation between the upper and lower housing, battery compartment lid, and sealed dial mountings allow for a high level of spillage protection.

All further technical functions of PACE 203H will be described in detail in the following chapters.

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3 Indication

4 Contraindication

The PACE 203H DDD Temporary Cardiac Pacemaker is designed to be used with cardiac stimulation lead systems for temporary atrial, ventricular or A-V sequential stimulation. PACE 203H has applications where such stimulation modes are indicated for therapeutic, prophylactic, or diagnostic purposes. Specific indications include, but are not limited to, the following:

There are no contraindications with regards to the use of PACE 203H 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. For example, a mode of operation with atrial sensing is not suitable or appropriate when atrial fibrillation occurs. This is due to the excessive and chaotic frequency of detected fibrillation waves. Overdrive-stimulation therapy must only be used in the atrium. Overdrivestimulation in the ventricle could cause life threatening ventricular fibrillation.

•

Sick sinus syndrome;

•

Bradycardia with congestive heart failure;

•

Complete heart block;

•

Acute myocardial infarction complicated with heart block;

•

Sinus bradycardia;

•

Cardiac arrest with ventricular asystole;

•

Atrial and/or ventricular ectopic arrhythmia;

•

Postoperatively after cardiac surgery;

•

Temporary application during implantation or exchange of a permanent pacemaker.

Indication for atrial overdrive stimulation: •

Supra-ventricular tachycardia

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PACE 203H – Instructions for Use

5 Possible Complications When using an external pacemaker such as PACE 203H, the following complications can arise:

Complication

Result

Infection

Sepsis

Thrombosis and pulmonary embolism

Death

Perforation of the heart

Hemopericardium, Hemothorax, Cardiac tamponade

Muscle and nerve stimulation

Patient discomfort

Dislocation of lead

System malfunction. Failure to stimulate.

Disconnection or breakage of Intermittent or complete failure of effective stimulation lead contact problems at connec- and/or sensing. tion sites. Insufficient tightening of the collets. Dislocation of ventricular lead near atrium.

Atrial oversensing and ventricular inhibition.

Significant rise in the stimulation threshold.

Loss of effectiveness of the stimulation (exit block).

Significant drop of the ECGsignal amplitude after lead dislocation or ingrown lead.

Loss of sensing (entrance-block).

Abnormal pacemaker settings

Erratic rhythm. Compromise in stroke volume / cardiac output

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Complication

Result

Inappropriately high sensitivity setting. Sensing of R or T waves in the atrium or P waves in the ventricle. Detection of interference (noise, electromagnetic interference).

Ventricular tachycardia, ventricular fibrillation, and death, if not recognized immediately.

Time mismatch between intracardiac conduction and pacemaker settings.

Pacemaker mediated tachycardia. (In order to prevent this, some decision overrides are implemented in PACE 203H. However, it is not possible to completely prevent the possibility of a pacemaker mediated tachycardia.)

Overdrive stimulation in the atrium = rapid atrial pacing

Accidental conduction into the ventricle can create ventricular arrhythmia

Battery failure or exhaustion

Failure of impulse emission. Failure to stimulate.

Technical defect, failure of components

Failure or change in the impulse emission, changed (or no) sensing, incorrect displays. Failure to stimulate.

Undetected programming errors

Chaotic rhythm

Erroneous lead connection

Device does not function properly. Chaotic rhythm. Failure to stimulate as intended.

Influence of defibrillation and RF surgery.

See chapter 8 for the effects while simultaneous use of PACE 203H with defibrillators or electro-surgical instruments.

Table 1: Possible Complications

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PACE 203H – Instructions for Use

6 Precautionary Measures and Warnings The following list presents important precautionary measures and warnings. Additional important precautionary measures and warnings will be found in the following chapters. 1. In order to prevent unnecessary complications, PACE 203H should only be applied and used by medical personnel with extensive experience in cardiac stimulation therapy. Additionally, the person using the device should be thoroughly familiar with the contents of this instruction manual. 2. All lead systems are to be connected to type CF devices only, because of the danger of current being diverted to the heart. Devices that are connected to a main supply pose increased danger for current diversions to the heart. 3. Make sure that all devices in the vicinity of the patient are properly grounded. 4. The stimulation leads provide a direct, low-resistance current path to the heart. Therefore, it is absolutely necessary that the connector plug is not touched with bare hands or come in contact with electrically conductive or wet surfaces. All possible static electricity sources must be kept away from the stimulation system. 5. While the lead is being inserted and connected to the pacemaker, continuous ECG monitoring is mandatory. For emergency situations, a defibrillator should always be available in a ready-to-use state.

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6. ECG monitoring should be continued during all times PACE 203H is in use to signal possible complications of different reasons immediately to the medical staff. 7. In either case it is necessary to monitor the patient and to be prepared for a failure of the pacemaker function. A back-up device for the pacemaker must be available. 8. Error messages and conflict warnings of PACE 203H do not replace an ECG monitoring. 9. During atrial overdrive-stimulation an accidental conduction into the ventricle is possible and may cause ventricular tachycardia. Therefore, continuous ECG-monitoring is mandatory. A defibrillator should always be available in a ready-to-use state. 10. If PACE 203H operates in an asynchronous mode, the pacing pulses may occur during the vulnerable phase of the patient’s intrinsic activity (corresponds approximately in the ECG to the T-wave); and may cause ventricular fibrillation and ventricular flutter. 11. It is mandatory to continuously monitor the patient and to be prepared for a possible failure or malfunctioning of the pacemaker when PACE 203H is used in conjunction with electrosurgical instruments or defibrillators. 12. To protect the patient and the pacemaker from current passing through the pacemaker/lead-circuitry caused by defibrillation discharges, the stimulation circuit should always be opened during defibrillation if possible. Current flows caused by defibrillator discharges can endanger the

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patient. High current amplitudes can also damage the pacemaker. 13. If PACE 203H is to be used for a long period of time on a patient, the stimulation threshold should be checked from time to time (the first time after a few hours, then daily), since an increase of the threshold may occur. 14. An unnecessarily high sensitivity (small sensitivity value) increases the probability that proper pacemaker functioning will be affected by external interference and the device will switch to asynchronous stimulation (see also chapter 9.22.3). If there are strong electromagnetic fields caused by telecommunication devices (like mobile phones) or other sources, an asynchronous mode should be set with a higher than the patient’s intrinsic rate. 15. During dual chamber pacing there is an inherent potential risk of crossstimulation which is a cross-talk of an atrial stimulation or depolarization impulse into the ventricle or vice versa. PACE 203H is designed in such a way that this cross-talk is minimized. Furthermore, the distance between atrial and ventricular lead system should be not less than 4 cm. 16. Due to differences in the anatomy, electro-physiological conditions and the location of the electrodes, crossstimulation cannot be completely prevented. Therefore, when the device is switched on or when the stimulation parameters are changed, the user must make sure that no crossstimulation occurs. If crossstimulation occurs, one can try to eliminate the effect by adjusting the stimulation amplitudes or by ex18 / 139

changing the polarity of the leads. If this is not possible, the pacemaker must, in this special case, be used in a single-chamber mode without connection of the leads of the other channel. 17. PACE 203H prevents abnormal settings (see chapter 9.22.7). 18. In order to provide continuous operation of the pacemaker during battery changes, the battery must not be left in the device until it is completely drained (see also 9.22.1). 19. If the device is switched off or to stand-by after the request to change the battery appears, the battery must be changed before the pacemaker is turned on again. 20. In case that PACE 203H is not used for long periods of time, the battery must be removed in order to prevent damage from possible battery acid leakage. (Such damage will not be compensated under the guarantee). 21. The pacemaker must not be submerged in either water or any other cleaning solution. Do not use any scrubbing powder/liquid on the device. 22. The device must not be sterilized in an autoclave. Sterilization with plasma, ultrasound, ethylene oxide or gamma radiation is also not allowed. PACE 203H can be damaged by such procedures. 23. Connector cables, intended for single use, cannot be re-sterilized and reinserted into a patient. 24. Only the manufacturer, or facilities authorized by the manufacturer, can perform repairs or calibration of PACE 203H.

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25. All automatic settings provided by PACE 203H are only a guide to assist the user in finding the appropriate settings. It is the responsibility of the operator to determine if these settings are correct. 26. All battery powered devices can lose their function due to normal discharge of the battery. It must also be considered that the pacemaker can stop operating as a result of an unpredictable component failure. The patient should not be left unattended by the medical staff and should always be supervised by a monitoring system. 27. If the battery must be replaced while the device is being used on a patient, ensure that PACE 203H was turned on and operated for at least one hour, allowing sufficient time to recharge the internal capacitors which will maintain device operation for up to 30 s while the battery is being replaced. If it is planned to replace the battery during use of the device on a patient, then prior use PACE 203H must be checked for sufficient battery backup time. 28. Use only 9 V primary batteries for PACE 203H. Re-chargeable batteries (accumulators) should not be used (possibly low capacity and unstable charge condition may cause a malfunction of the pacemaker). 29. When used as intended, PACE 203H does not contain any parts which are subject to wear and tear. 30. PACE 203H must not be modified.

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7 Patient Safety The temporary cardiac pacemaker PACE 203H meets all applicable international standards for patient safety:

8 Electromagnetic Compatibility The temporary cardiac pacemaker PACE 203H meets all applicable international standards with respect to electromagnetic compatibility (EMC).

IEC 60601-1

Medical electrical equipment. General requirements for safety

IEC 606011-2

Medical electrical equipment. Electromagnetic compatibility

IEC 606011-2

Medical electrical equipment. Electromagnetic compatibility

IEC 606012-31

Medical electrical equipment. External cardiac pacemakers

CISPR 11

Industrial, scientific and medical radio-frequency equipment. Electromagnetic disturbances

IEC 61000

Electromagnetic compatibility

In the event that the patient is connected to multiple electrical devices, the sum of leakage currents may exceed the allowable limits.

Some sources of radiated emissions may impact the proper function of PACE 203H: •

Electrosurgical instruments operating with radio frequency,

•

Devices for diathermy therapy,

•

Magnetic resonance imaging (MRI);

•

Medical telemetry systems;

Special electromagnetic compatibility (EMC) precautions should be taken when using electrical medical equipment such as PACE 203H:

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PACE 203H – Instructions for Use A

Portable and mobile RF communications equipment, such as mobile phones, can affect the function of PACE 203H. Mobile phones with a rated maximum output power of 2 Watt and a transmitter frequency up to 2.5 GHz should be used no closer to any part of PACE 203H (including patient cables and sensors) than a recommended separation distance of 10 m (30 ft).

B

Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic materials, the relative humidity should be at least 30%.

C

Power frequency magnetic fields should be at levels characteristic of typical commercial or hospital environments.

Please find further information and guidance regarding EMC in chapter 17 on page 123.

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9 Use and Application of PACE 203H 9.1 Design PACE 203H with its displays, keys, dials and terminals is shown in Figure 1.

Figure 1: Temporary Cardiac Pacemaker PACE 203H Display Face

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PACE 203H – Instructions for Use

Figure 2: Temporary Cardiac Pacemaker PACE 203H 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. The rear side features a battery compartment release button, which opens the battery compartment. The battery compartment is located at the bottom of the device. A button cover prevents the release button from being unintentionally pressed (see chapter 11.2).

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The internationally recognized pictograms have the following meaning:

Classification: CF (cardiac floating) applied part, defibrillation protected Symbol: Follow instruction for use.

Symbol: Follow the instruction for use ! PACE 203H is marked with the symbol of a crossed-out garbage. The symbol indicates that the European WEEE1 guideline applies to the disposal method of the device.

IP 43

IP Code (Ingress Protection) classifies the degree of protection provided against touching or intrusion of solid objects (first digit 4: Protection against intrusion with a wire) and against water (second digit 3: Protection against spraying water) Symbol for Conformité Européenne (device and manufacturer meet all requirements of European guideline 93/42/EWG)

1 European Guideline on Waste Electrical and Electronic Equipment (WEEE)

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