ERA 300 Pacing System Analyzer Technical Manual April 2009

CAUTION Federal (U.S.A.) law restricts this device to sale by, or on the order of, a physician. ©2009 BIOTRONIK, Inc., all rights reserved.

ERA 300 Technical Manual i

Contents 1. General Description ... 1 1.1 Device Description ... 1 1.2 Contraindications ... 1 2. Warnings and Precautions ... 3 2.1 Warnings ... 3 2.2 Precautions ... 3 3. Detailed Device Description ... 5 3.1 Accessories ... 7 3.2 Control Elements ... 7 3.2.1 Display ... 8 3.2.2 Command Keys... 9 3.2.3 Control Wheel ... 9 3.3 Pace/Sense Indicators ... 9 4. ERA 300 Operation ... 11 4.1 The Battery Pack ... 11 4.1.1 Low Voltage Warnings ... 11 4.1.2 Changing the battery pack ... 11 4.1.3 Charging the battery pack ... 12 4.2 Accessories ... 13 4.2.1 Cleaning, Disinfection, and Sterilization ... 13 4.2.2 Connecting the Cables ... 14 4.2.3 EK-4-E Cable Connection ... 15 4.3 Loading the Printer ... 16 4.4 The On/Off Switch... 16 4.5 The Display Contrast and Audio Signal... 18 4.6 Memory and Printing Functions ... 18 4.6.1 Threshold Test Result Printing ... 18 4.6.2 Real-time IEGM Printing ... 18 4.6.3 IEGM Test Result Printing ... 18 4.6.4 Pacemaker Test Result Printing ... 18 5. Stimulation Window Functions... 19 5.1 Pacing Programs... 19 5.2 Softkey Functions ... 19 5.3 Setting Parameters ... 19 5.3.1 Setting the Mode... 20 5.3.2 Switching Between Atrial and Ventricular Parameters ... 20

ii ERA 300 Technical Manual 5.3.3 Direct Access to Single Parameters... 20 5.4 Constant-Current versus Constant-Voltage Pacing ... 21 5.5 Threshold Measurement ... 21 5.6 Threshold Data ... 21 5.6.1 Storage ... 21 5.6.2 Printing ... 21 5.7 Maximum Amplitude Pacing ... 22 5.8 “Safe Program” Pacing ... 23 5.9 Standard Program Pacing ... 23 5.9.1 Factory-defined Standard Program ... 23 5.9.2 User-defined Standard Program ... 23 5.10 High-Rate Pacing ... 24 6. IEGM Functions ... 25 6.1 IEGM Softkey Functions ... 25 6.1.1 Chamber Selection ... 25 6.1.2 Intracardiac Complex Analysis ... 25 6.1.3 Sweep Speed Adjustment... 26 6.1.4 Vertical Scale Adjustment ... 26 6.2 Printing an IEGM ... 26 7. Measuring Intracardiac Signals ... 29 7.1 The IEGM Window ... 29 7.1.1 IEGM Measurement Setup ... 29 7.1.2 Opening the IEGM window... 29 7.1.3 IEGM Softkeys ... 29 7.1.4 Printing IEGM Test Results ... 29 7.2 P/R Potential, R-R, P-P, and P-Q Intervals ... 30 7.3 Slew Rate... 31 7.4 Wenckebach Point ... 31 7.5 Retrograde Conduction Time ... 32 8. Pacemaker Testing ... 33 8.1 Performing the Pacemaker Test ... 33 9. System Functions ... 35 9.1 Time and Date ... 35 9.2 IEGM Measurement Sensitivity ... 36 9.3 Back Up Pacing ... 36 9.4 IEGM Printout Length ... 37 9.5 Standard Program Definition ... 37

ERA 300 Technical Manual iii 10. Maintenance ... 39 10.1 Cleaning the ERA 300 ... 39 10.2 Maintenance ... 39 11. Technical Data ... 41 11.1 Symbols used ... 43 11.2 Electromagnetic Compatibility (Compliance with EN 60601-1-2) ... 43 12. The ACD 300 ... 49 12.1 Cleaning... 49 12.2 Maintenance ... 49 12.3 Safety Information ... 50 12.4 Technical Data ... 51 13. System Messages... 53

iv ERA 300 Technical Manual

ERA 300 Technical Manual 1

1. General Description 1.1 Device Description The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as a temporary external pulse generator during the above procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources and employs PK-67-S, PK-67-L and PK-155 (or Model 301-CG) cables and PA-4 adapters. Indications The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: • Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. • Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. • Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.

1.2 Contraindications The ERA 300 is not intended for use as a long-term temporary external pacemaker. Its pacing feature is intended for use only as temporary pacing support during pacemaker implantation. • Single chamber atrial pacing is contraindicated for patients with impaired AV nodal conduction. • Single chamber atrial pacing is contraindicated for patients with chronic refractory atrial tachyarrhythmias. • Potential complications related to the use of temporary external pacing include, but are not limited to, asystole following abrupt cessation of pacing or pacemaker dependency.

2 ERA 300 Technical Manual

ERA 300 Technical Manual 3

2. Warnings and Precautions 2.1 Warnings • Do not connect the ERA 300 to a wall plug or socket. The ERA 300 is intended to be powered by the BIOTRONIK AKKU-1 battery only. • The initial performance check lasts for approximately 15 seconds after turning on the ERA 300. The analyzer cannot be used during this period. Do not switch the ERA 300 off during an examination. • Do not connect the ERA 300 to a patient receiving treatment by electrosurgical instruments (e.g., electrocautery). This may damage the electronics of the apparatus and may result in function inappropriate for the patient. (If electrocautery is necessary, the current path (grounding pad) should be kept as far away from the pulse generator and leads as possible.) • The High-Rate Burst feature may cause reversion from ventricular tachycardia to ventricular fibrillation. An external defibrillator should be present when the analyzer is used in this mode. • The EK-4-E and PK-67-L cables are provided non-sterile and require steam sterilization before use. • Do not insert the EK-4-E cable into a wall outlet. The EK-4-E cable is intended as a connection between an ERA 300 and pacemaker only. • Do not perform the Wenckebach test on patients without AV conduction. Because the ERA 300 automatically switches to AAI pacing during this test, such patients might be harmed by the lack of ventricular pacing. • Disconnect the ERA 300 unit from the patient if a defibrillator is used. Defibrillation may damage the ERA 300 circuitry. • Disconnect the ERA 300 from the patient before opening the printer compartment. Touching the metal parts contained in the printer compartment may cause current conduction and endanger the patient.

2.2 Precautions • Use the ERA 300 unit only as described in this manual. The ERA 300 may be used only with BIOTRONIK parts and accessories specifically designed and tested for use with the apparatus. • The ERA 300 may only be opened or repaired by BIOTRONIK or by personnel authorized to do so by BIOTRONIK. • If the analyzer is malfunctioning or receives a mechanical shock, contact BIOTRONIK or your local BIOTRONIK representative.

4 ERA 300 Technical Manual • Always select a mode that corresponds with the electrode configuration to ensure appropriate function. • Pacing may be interrupted during IEGM measurements unless backup pacing has been activated. • Monitor the patient's heart rate with an ECG monitor while using the ERA 300. • Use only the rechargeable AKKU-1 battery pack provided by BIOTRONIK. • The battery pack should be fully charged before use. • Do not remove any of the labels from the ERA 300. • Do not operate the unit in the presence of explosive or flammable gases. • The ERA 300 is not intended as a long-term, temporary, external pacemaker. Clinical use of the ERA 300 requires the ongoing supervision of a physician and ECG monitoring of the patient's heart rate. • Fully recharge batteries prior to use, especially after 5 to 6 hours of operation or long periods of no usage (due to battery selfdischarge). • Do not bend the contact springs manually. Damage to these springs may result in a total loss of function of the ERA 300. • Use batteries with a minimum temperature of at least 10 °C. Allow batteries that have been cooled down to below 10 °C to equilibrate to room temperature. • BIOTRONIK recommends inspection or exchange of batteries that are used frequently for 3 years or longer after the date indicated on the battery.

ERA 300 Technical Manual 5

3. Detailed Device Description The ERA 300 is a portable microprocessor-controlled pacing system analyzer used for the measurement of pacing lead characteristics and the testing of implantable pulse generators during invasive pacemaker procedures. Eight pacing modes are available for single and dual chamber pacing. The measured data can be stored in memory and printed out on the built-in printer. The ERA 300 can display and print high-resolution IEGM (intracardiac electrogram) for both atrial and ventricular chambers. Pacing pulse capture can be monitored on the screen display during a threshold measurement.

Figure 1. ERA 300 The ERA 300 combines the functions of a multi-mode external pulse generator, a digital measuring device, and a data processor to provide the following capabilities: • External dual or single chamber pacing in one of eight modes (DDD, DDI, DOO, VVI, VDD, VOO, AAI, AOO) to support the patient during pacemaker implantation and test procedures • Measurement of cardiac stimulation thresholds with regulated voltage or current and programmable pulse width • P-wave/R-wave measurement for cardiac signal evaluation as detected by the pacing lead system. Available information includes filtered voltage amplitude, unfiltered slew rate of the detected depolarization signal, and an intracardiac electrogram received from the pacing lead

6 ERA 300 Technical Manual • A test for retrograde conduction during evaluation of a dual chamber lead system • Automatic calculation of lead resistance from measured pulse parameters and the resulting current (with regulated voltage output) or voltage (with the regulated current output) • Implantable pulse generator tests determining the pacing mode and pacing parameter measurements Other capabilities of the ERA 300 include rapid atrial or ventricular stimulation (to 1000 ppm), total output inhibition in any pacing mode, and an emergency VVI pacing feature that provides immediate ventricular demand pacing by a single keystroke command. The ERA 300 can be programmed either as a constant voltage or as a constant current device. In the former, the pulse voltage is held constant at the adjusted value with the resultant current flow a function of lead system impedance (output load). In the latter, the pulse current is held constant at the adjusted value, while the resultant voltage potential is a function of lead system impedance. External features of the ERA 300 include an integrated keyboard from which all ERA functions are controlled, a multifunction liquid crystal display (LCD), and a thermal printer. Connectors on the back of the ERA allow connection of cables linking the ERA to the lead system for pacing and lead system tests or to the implantable pulse generator for parameter measurements. Implantable pulse generator tests may be conducted without interruption of the ERA pacing function. A rechargeable battery pack allows the unit to operate up to 18 hours per charge.

ERA 300 Technical Manual 7

3.1 Accessories Table 1: ERA 300 Accessories Description

Cat. No.

Qty*

PK-67-S Patient Cable (760 mm)

123 438

1

PK-155

123 985

Model 301-CG**

Disposable Surgical Cable, 2-Pin -orDisposable Surgical Cable, 2-Pin

1 301-CG

PK-67-L Patient Cable (2640 mm)***

123 672

N/A

PA-4

Adapter***

123 090

N/A

EK-4-E

Pacemaker Test Cable***

118 803

N/A

ERA-P

Paper Rolls for Printer

111 743

2

ACD 300

Battery Pack Recharger (115 V)

111 745

1

AKKU-1

Rechargeable Battery Pack (8 V)

111 742

2

NK-9

Power Supply Cord

128 364

1

115 492

1

Transportation and Storage Case Technical Manual

* The number of accessories provided with the analyzer. ** These two cable models are identical. Either the PK-155 or Model 301-CG will be distributed with the ERA 300 system. *** Available from your local BIOTRONIK representative.

CAUTION Use the ERA 300 unit only as described in this manual. The ERA 300 may be used only with BIOTRONIK parts and accessories specifically designed and tested for use with the apparatus.

3.2 Control Elements The ERA 300 control panel consists of an interactive liquid crystal display (LCD), a control wheel, and a keypad with command keys. An acoustic signal indicates each time a command key is pressed or a parameter is altered with the control wheel. Parameters are selected with a combination of the control wheel and cursor arrows. More important parameters (e.g., rate, amplitude, pulse width) are accessible directly via dedicated command keys.

8 ERA 300 Technical Manual

3.2.1 Display The ERA 300 liquid crystal display (LCD) is divided into several screen sections dedicated to specific tasks. Figure 2 shows the display design.

Figure 2. The ERA 300 Display

3.2.1.1 Status Screen Analyzer status is displayed on the three lines in the top left corner of the display. Line 1: Current pacing mode (e.g., VVI) Line 2: Pacing status (e.g., ACTIVE or STOP) Line 3: - Pacing output (U/Volt or I/ma); - Battery pack replacement warning (- ACCU -); - Stored data/results indication (flashing - MEMO -)

3.2.1.2 Softkey Screen The right side of the display assigns variable functions to the adjacent softkeys.

3.2.1.3 Main Screen The central part of the screen displays parameter lists, measured values, etc. The IEGM appears in this section of the display. The current parameter value is displayed in the upper middle of the display.

3.2.1.4 Message Screen The bottom line contains the following messages for the atrium as well as for the ventricle. See Section 12.4, for further details.

ERA 300 Technical Manual 9

3.2.2 Command Keys The ERA 300 has twenty-five command keys on the control panel. These command keys fall into the following categories:

3.2.2.1 Hardkeys

z

Solid command keys trigger a function when pressed. Command keys with a border open a specific function window.

{

Open command keys operate as momentary switches for the identified function. P/R Measure command key Divided keys operate as toggle switches for the identified functions. Cursor arrows allow the selection of parameters.

3.2.2.2 Softkeys Softkey functions are variable and are listed on the opened screen immediately adjacent to the function they control.

3.2.3 Control Wheel The control wheel is used in conjunction with the LCD and cursor arrows to: • change the value of the displayed parameter, or • sequence through multiple steps of an analyzer test function.

3.3 Pace/Sense Indicators Four pace/sense indicator lights are located directly above the LCD, two for the atrium (A) and two for the ventricle (V). The red lights indicate pacing and the green lights indicate sensing.

10 ERA 300 Technical Manual

ERA 300 Technical Manual 11

4. ERA 300 Operation 4.1 The Battery Pack Two AKKU-1 rechargeable battery packs and the ACD 300 battery recharger are included with the ERA 300 Pacing System Analyzer.

CAUTION The ERA 300 is not intended as a long-term, temporary, external pacemaker. Clinical use of the ERA 300 requires the ongoing supervision of a physician and ECG monitoring of the patient’s heart rate.

4.1.1 Low Voltage Warnings The ERA 300 continually monitors the operating voltage supplied by the rechargeable battery pack. The analyzer indicates low voltage and a need for battery pack replacement/recharging with one of two warnings. Initial Warning: The message “ACCU” blinks in the status line in the top left corner. In order to save energy, the ERA 300 will not be able to print from this point on. If the Print hardkey is pressed, the following message appears: “ACCU CHARGE TOO LOW, NO PRINTING POSSIBLE”. Although the ERA 300 is able to complete the on-going measurement, the battery pack should be replaced or recharged immediately. Urgent Warning: The message “ACCU” blinks alternately in blackon-white and white-on-black lettering. If this occurs, the battery pack must be replaced with a charged pack immediately. Otherwise, the ERA 300 may automatically switch off during the procedure. NOTE: Activate the printer function before connection of the device to the patient to check the battery for sufficient capacity and charge status.

4.1.2 Changing the battery pack The battery pack compartment is located on the back of the ERA 300 below the cable connectors on the right-hand side.

12 ERA 300 Technical Manual

Figure 3. The ERA 300 Back Panel 1. Press the snap lock on the cover of the battery pack compartment to open the cover. 2. Use the strap to help remove the AKKU-1 rechargeable battery pack from its compartment. 3. Insert the charged battery pack into the compartment so that the electrical contacts are oriented down and to the inside of the ERA 300. Snap the cover closed. The green dot on the battery pack should now be visible through the window in the cover. 4. Switch the ERA 300 on and verify proper function.

4.1.3 Charging the battery pack BIOTRONIK’s battery-pack recharger, the ACD 300, is supplied with the ERA 300 analyzer. The recharger can be used to charge two battery packs simultaneously. See Section 12, for further instructions.

CAUTION Fully recharge batteries prior to use, especially after 5 to 6 hours of operation or long periods of no usage (due to battery self-discharge).

ERA 300 Technical Manual 13

4.2 Accessories Patient Cables BIOTRONIK provides two configuration options for the patient cables: • PK-67-S (with either PK-155 or Model 301-CG): - The touch-proof PK-67-S cable is attached to the back of the ERA 300 (see Section 4.2.2). The PK-67-S is 760 mm in length. Because it is not used in the sterile field, the PK-67-S is provided non-sterile. The PK-67-S may be disconnected from the ERA 300 and replaced in the event of damage. - The PK-155 or Model 301-CG touch-proof disposable surgical cables (2-pin) are used with the ERA 300 for lead threshold/ IEGM measurements and supportive pacing. These cables are for single use only and are available from BIOTRONIK as sterile products. (The PK-155 and Model 301-CG cables are identical and only one will be supplied with the ERA 300 system.) • PK-67-L (with PA-4): - The touch-proof PK-67-L cable is 2640 mm in length and is attached to the back of the ERA 300 (see Section 4.2.2). The PK-67-L is provided non-sterile. Because the PK-67-L cable is used partially in the sterile field, it may be sterilized by steam sterilization. - The PA-4 adapter (4-pin) is used with the ERA 300 for lead threshold/IEGM measurements and supportive pacing. The PA-4 adapter is for single use only and is available from BIOTRONIK as sterile product. Pacemaker Test Cables EK-4-E cables are used with the ERA 300 for pacemaker test measurements. The EK-4-E and PK-67-L cables and PA-4 adapters are not provided with the ERA 300 system and may be ordered separately from BIOTRONIK. See Section 4.2.2 for cable connections for the ERA 300.

4.2.1 Cleaning, Disinfection, and Sterilization The ERA 300 cables can be cleaned and disinfected using a variety of methods and hospital cleaning agents. The cables must never be immersed, soaked, or cleaned with harsh chemicals such as acetone. The recommended cleaning method for the cables is a cloth wipe using

14 ERA 300 Technical Manual ordinary alcohol-free hand soap or USP green soap tincture. After cleaning, wipe the cables with water using a clean damp cloth and then with a clean dry cloth. When disinfection is required, use a cloth wipe lightly soaked in disinfectants such as a chlorine bleach : water solution (no stronger than a 1:10 mixture) or 2% glutaraldehyde solution. It is recommended to consult hospital policies to confirm these disinfectants are considered as means for infection control. • The PK-155 and Model 301-CG cables and the PA-4 adapter are for single use only and are available from BIOTRONIK as sterile product. • The non-sterile PK-67-S cable does not enter the sterile field and therefore needs no sterilization. • The PK-67-L cable does enter the sterile field and therefore must be steam sterilized between each use. • The EK-4-E cable must be steam sterilized before use.

WA R N I N G The EK-4-E and PK-67-L cables are provided non-sterile and require steam sterilization before use.

4.2.2 Connecting the Cables The connectors for connecting cables to the ERA 300 analyzer are located on the back panel (see Figure 4). PK-67-S or PK -67-L Cable Connector

Figure 4. ERA 300 Cable Connectors (Back Panel)

4.2.2.1 Cable Connection 1. Connect the PK-155 (or Model 301-CG) surgical cables to the PK-67-S cable. - OR Connect the PA-4 adapter to the PK-67-L cable.