M3022-K 4-09 - ERA 300 Manual

Biotronik
ERA 300 Analyzer

Technical Manual
ERA 300 Pacing System Analyzer

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
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.
• Always select a mode that corresponds with the electrode

configuration to ensure appropriate function.
• Pacing may be interrupted during IEGM measurements unless back-
up 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 self-
discharge).
• 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.
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
• 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.
3.1 Accessories
Table 1: ERA 300 Accessories
Description Cat. No. Qty*
PK-67-S Patient Cable (760 mm) 123 438 1
PK-155 Disposable Surgical Cable, 2-Pin 123 985
-or- 1
Model 301-CG** Disposable Surgical Cable, 2-Pin 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
Transportation and Storage Case 115 492 1
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.
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.
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.
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 black-
on-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.
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).
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
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.
NOTE:
Two PK-155 (or Model 301-CG) cables must be attached to the
PK-67-S cable to provide dual chamber sensing and pacing. Only
one PA-4 adapter may be attached to the PK-67-L cable for dual
chamber sensing and pacing.
NOTE:
The previously mentioned cable combinations are recommended
by the manufacturer. However, per the design, the PK-67-S and
PK-67-L cables may be used interchangeably.
2. Place a stylet guide, if one is available, onto the end of the lead to
protect the sealing rings from damage.
3. Connect the patient cable clip to the end of the lead.
Figure 5. Stylet Guide Placement
4.2.3 EK-4-E Cable Connection
WA R N I N G
The EK-4-E cables are provided non-sterile and require steam
sterilization before use.
WA R N I N G
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.
1. Insert the EK-4-E pacemaker test cable(s) into the lead port(s) of
the pacemaker.
2. Tighten the setscrews slightly to secure the electrical connection.
3. Connect the plug(s) of the pacemaker test cable(s) to the
connector(s) labeled PACER TEST on the back of the ERA 300 (see
Figure 4). Note the assignment of the connectors to the cardiac
chambers (A = Atrium; V = Ventricle).
4.3 Loading the Printer

The compartment for the printer’s paper is located on the back left-hand
side of the ERA 300 (see Figure 6). A colored marking indicates the end
of the paper roll. Insert a new roll of paper as follows.
Figure 6. Opened Paper Compartment

1. Open the cover in a downward direction.
2. Unfasten the starting edge of the paper roll.
3. Pull any remainder of the used roll from the spindle and insert the
new roll.
4. Pull the starting edge of the paper roll a few centimeters across
the transporting roller.
5. Close the paper compartment and tear the protruding paper
across the toothed cutting edge.
WA R N I N G
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.
4.4 The On/Off Switch

The On/Off hardkey switches the ERA 300 on or off. A series of initialization
tests are performed immediately after the analyzer is turned on. The
ERA 300 cannot be used during this 15 second period. The following tests
are run during the initialization period:
• Pacing pulse test
• Rate test
• AV delay test
• Atrial amplitude test

• Ventricular amplitude test
• High-rate-protection test at 180 ppm and limit set to 150 ppm set
limit
• Low-rate test at 25 ppm
The ERA 300 uses the following parameters to conduct the tests.
• Mode: DDD
• Rate: 180 ppm
• AV delay: 40 ms
• Upper Tracking Rate: 205
• Refractory period: 120 ms for A and V
• Amplitudes: 5.0 V for A and V
• Pulse width: 0.5 ms for A and V
A RAM test, a ROM test, an LED test, a runaway protection test and a
watchdog timer test are also conducted during the initialization period.
As soon as the tests are completed, the ERA 300 goes into operational
mode and displays the pacing program set when the analyzer was last
switched off.
NOTE:
The pacing pulse outputs are switched off internally during the
initialization period to prevent pacing during this period.
NOTE:
An error message will appear on the display when an error occurs
during the initialization period. If this happens, contact BIOTRONIK
or your local BIOTRONIK representative.
NOTE:
Place the ERA 300 on a solid, sufficiently supportive surface during
usage to prevent inadvertently switching off the device. It is not
recommended that the user hold the device in his or her hands.
If the command keys or control wheel have not been used for
approximately one minute, the display lighting is diminished in intensity
to reduce energy consumption. However, it will return to the original
intensity level when a command key is pressed or when the wheel is
turned.
4.5 The Display Contrast and Audio Signal

The display contrast can be adjusted by using the two Contrast hardkeys.
The ERA 300 utilizes the display contrast set when the analyzer was last
switched off.
When the analyzer is turned on, the audio signal indicating sensing and
pacing pulses is off. It can be switched on and off by pressing the Sound
hardkey.
4.6 Memory and Printing Functions

The ERA 300 stores and prints data results to provide the user with a
hard copy of pacing lead, threshold and pacemaker test measurements.
Important: Printing the data clears the analyzer memory of all stored
result data. Printing a hard copy does not affect any programming.
4.6.1 Threshold Test Result Printing
The ERA 300 can store and print up to 13 threshold test results. Threshold
test results are manually stored with the Store hardkey. Line 3 of the
status screen will flash −MEMO− to indicate stored data. Pressing the
Print hardkey in the Stimulation Menu window will generate a hard copy
of up to the last 13 threshold results stored since the Print hardkey was
last pressed. See Section 5.6, for further details.
4.6.2 Real-time IEGM Printing
The ERA 300 can print a hard copy of the IEGM. Printout length is
programmed in the System Functions window. See Section 6.2, for
further details.
4.6.3 IEGM Test Result Printing
The ERA 300 can store and print up to 13 results for each of the IEGM
analyses (P/R measurements, slew rate determinations, Wenckebach
determinations and retrograde conduction measurements). See
Section 7.1.4, for further details.
4.6.4 Pacemaker Test Result Printing
The ERA 300 does not store pacemaker test results. These data need to
be printed before either a new pacemaker test is run or the Pacemaker
Test window is closed. See Section 8, for further details.
5. Stimulation Window Functions

5.1 Pacing Programs
Press the hardkey Stimulation Menu to open the Stimulation Menu
window. The ERA 300 will automatically display the pacing menu with
the most recently used values. Pacing program parameters can be
changed at any time. Two predefined pacing programs can be accessed
by pressing a button.
1. The “Safe Program” for emergencies (see Section 5.8) and,
2. The Standard Program with user-defined parameters (see
Section 9.5, Standard Program Definition).
5.2 Softkey Functions

The uppermost softkey, SYSTEM, opens the System Functions window.
The cursor arrows and the control wheel are used to program back-up
pacing, IEGM printout length, as well as the date, time, and standard
program settings.
The lower middle softkey moves the cursor between the ATRIUM and
VENTR parameters on the main screen. (This softkey is only available
for dual chamber modes).
The lowest softkey enables the user to enter the Change MODE window.
In the Change Mode window, the lowest softkey changes to ENTER
MODE. This softkey must be pressed to enter the newly programmed
mode.
5.3 Setting Parameters

The following parameters and value ranges can be programmed (values
are only displayed when the parameter is relevant to the mode in use).
Available pacing modes are: DDD, DDI, DOO, VDD, VVI, VOO, AAI, AOO.
Rate 30...(1)...180 ppm
AV delay 15...(5)...300 ms
UTR 80...(1)...180 ppm
HR stim 60...(10)...1000 ppm
Burst 2...(1)...15 pulses
ATRIUM VENTRICLE
0.1...(0.1)...10.0 V 0.1...(0.1)...10.0 V
AMPL.
0.2...(0.1)...20.0 mA 0.2...(0.1)...20.0 mA
WIDTH 0.1...(0.1)...2.5 ms 0.1...(0.1)...2.5 ms
SENS. 0.3...(0.1)...20.0 mV 0.5...(0.1)...20.0 mV
REFR. 250...(50)...600 ms 200...(50)...400 ms
5.3.1 Setting the Mode

1. Press the softkey CHANGE MODE. A line will appear above the
RATE parameter with the available modes.
2. Use the control wheel to select the desired mode and confirm the
choice by pressing the softkey ENTER MODE.
Figure 7. Pacing Menu with Displayed Modes
NOTE:
Always select a mode that corresponds to the electrode configuration
to avoid analyzer malfunction.
5.3.2 Switching Between Atrial and Ventricular Parameters
If the single chamber mode has been selected, the cursor will move to
the chamber corresponding to the selected mode. If a dual chamber
mode has been selected, the softkey ATRIUM VENTR is displayed. Use
this softkey to switch between the parameters of the two chambers.
Select desired parameters for each chamber used with the control
wheel and cursor arrows.
5.3.3 Direct Access to Single Parameters
Three parameters can be accessed in either the Stimulation Menu or
IEGM windows by pressing the appropriate hardkey.
• Access the rate parameter by pressing Rate hardkey.
• Access the amplitude parameter by pressing the hardkey Amplitude/
Pulse Width. The pulse width parameter is also accessed with this
hardkey.
5.4 Constant-Current versus Constant-Voltage Pacing

Constant-current or constant-voltage pacing is selected with the
VOLTAGE/CURRENT softkey. The amplitude is displayed either in volts
(V) or in the corresponding value in milliamperes (mA).
5.5 Threshold Measurement

1. Set a rate that is higher than the spontaneous rate of the patient’s
heart (to avoid an inhibition of pacing).
2. Press hardkey IEGM On/Off to display the IEGM on the screen.
3. Press hardkey Start Stim to start pacing.
4. Select the desired amplitude or pulse width.
5. Decrease the desired parameter slowly by using the control wheel
until capture is lost.
6. Return to the previous parameter setting (amplitude and pulse
width) where capture was consistent.
7. Press the Store hardkey to save this threshold value in memory.
5.6 Threshold Data

5.6.1 Storage
Press the hardkey Store to store the current pulse amplitude and pulse
width. Each set of new values must be stored. A maximum of 13 pairs
of threshold values can be stored at any one time. Additional value sets
will be stored sequentially over the oldest stored value set.
The message -MEMO- blinks in the status screen to indicate stored
data.
5.6.2 Printing
Press Print to print a list of all data stored since the last hard copy was
generated. The ERA 300 prints all stored data indexed by the time of
day. If the IEGM is printed during the threshold measurement, pulse
amplitudes and widths will be listed below each output spike. (See
Section 7.1.4, Printing IEGM Test Results, for further information.)
NOTE:
Printing stored data clears the data stored in the analyzer memory.
NOTE:
To document an impedance value comparable to that available from
the diagnostics telemetry of a BIOTRONIK pulse generator, select
and store a threshold amplitude from the ERA 300 that is greater
than or equal to 2.5 V.
Figure 8. Printout of Threshold Values

The first complex in Figure 9 indicates ventricular capture. The next three
complexes demonstrate non-capture. Capture is once again indicated in
the last complex. The pulse amplitudes and widths are listed below each
spike.
Figure 9. Printout of an IEGM
5.7 Maximum Amplitude Pacing

The amplitude can be temporarily set to its maximum value by pressing
the hardkey Max Amplitude. As long as the hardkey is pressed, the
ERA 300 will pace with 10 volts (V) or 20 milliamperes (mA). This
function assists the user in determining whether the patient is prone to
pacemaker-induced diaphragm or pectoral muscle stimulation.
5.8 “Safe Program” Pacing

The “Safe Program” is a special program that overrides every other
function of the ERA 300 and paces with a high pulse amplitude and long
pulse width. To initiate the “Safe Program”, press the hardkey Safe
Program.
The following parameter values constitute the “Safe Program”.
• Mode: VVI • Ampl.: 7.5 V

• Rate: 90 ppm • Width: 2.0 ms
• HR Pacing: 250 ppm • Sensit.: 2.4 mV
• Burst: 10 pulses • Refr.: 300 ms
5.9 Standard Program Pacing

The Standard Program provides the user easy access to a set of
preprogrammed parameters from which to determine threshold values.
The ERA 300 comes from the factory programmed with a suggested
Standard Program. However, the user may redefine the Standard
Program to suit personal preferences.
Press the hardkey Standard Program to initiate the Standard Program.
5.9.1 Factory-defined Standard Program
The following parameter values are those set at the factory for the
Standard Program:
• Mode: VVI • Ampl.: 4.8 V

• Rate: 60 ppm • Width: 0.5 ms
• HR pacing: 250 ppm • Sensit.: 2.4 mV
• Burst: 10 pulses • Refr.: 300 ms
5.9.2 User-defined Standard Program

The ERA 300 allows the user to redefine the Standard Program. For
details on redefining the Standard Program, see Section 9.5.
NOTE:
Press the upper middle softkey, FACTORY PARAMETERS, to return
to the factory preset Standard Program. Confirm by pressing the
softkey SAVE STANDARD PROGRAM.
5.10 High-Rate Pacing

Asynchronous high-rate pacing, HR STIM, and the number of pulses,
BURST, can be set in the Stimulation Menu, Standard Program, and
Standard Program Definition windows.
High-rate pacing is indicated for the termination of supraventricular
tachyarrhythmias through overdrive pacing of the atrium at rapid
frequencies for short intervals. When supraventricular tachyarrhythmias
are encountered during permanent pacemaker implantation procedures,
atrial burst pacing may provide overdrive suppression of the ectopic
atrial focus, thus permitting restoration of normal sinus rhythm.
WA R N I N G
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.
NOTE:
High-rate pacing should only be used as a temporary means to
terminate supraventricular tachyarrhythmias. The patient’s ECG
should be continuously monitored.
Program desired values using the control wheel and cursor arrows.
1. Press the High Rate hardkey to initiate the high rate pacing mode.
The HR STIM parameter is highlighted and the softkey HIGH RATE
START appears.
2. Press the softkey HIGH RATE START to trigger one programmed
burst. To trigger high rate pacing continuously, press and hold the
HIGH RATE START softkey.
NOTE:
The high rate burst can be interrupted by either pressing the Stop
Stim or Safe Program hardkeys.
6. IEGM Functions
The IEGM On/Off hardkey activates the IEGM window. The IEGM is
displayed in the main screen. Test results appear in the upper section of
the main screen during P/R measurement.
Figure 10. IEGM Display
6.1 IEGM Softkey Functions

The four softkeys at the right of the display control various parameters
in the IEGM display.
6.1.1 Chamber Selection
The uppermost softkey allows selection of the following sensed chamber
combinations:
• ATRIUM (only atrial electrogram)
• VENTR. (only ventricular electrogram)
• ATR/VEN (both atrial and ventricular electrogram)
6.1.2 Intracardiac Complex Analysis

Four different types of analyses can be performed by the ERA 300 and
are selected with the upper middle softkey. These tests are described
thoroughly in Section 7. Results of the following four types of analyses are
viewed by pressing the P/R Measure hardkey:
• P/R-POT P- and R- wave potentials, PP/RR/PQ intervals
• SLEW-R. Unfiltered slew rate
• WENCKEB Wenckebach point determination
• RETROGR Retrograde conduction time
NOTE:
Only three of the four possibilities are shown at any one time due to
the size of the softkey area of the display.
Figure 11. P/R Measurement
6.1.3 Sweep Speed Adjustment

The sweep of the intracardiac signal on the display and the printout can be
adjusted with the lower middle softkey to the following widths and paper
transport speeds:
• 10mm/s • 25mm/s • 50mm/s
6.1.4 Vertical Scale Adjustment

A calibration marker with an amplitude equaling the mV range is shown
on the far left of the IEGM window and also appears on the printout as a
reference. The vertical scale can be adjusted to the following values with
the lowest softkey:
• 1mm/mV • 2mm/mV • 5mm/mV • 10mm/mV
6.2 Printing an IEGM

A printout of the real-time IEGM can be obtained at any time in the open
IEGM window as long as the P/R Measure hardkey is not pressed. The
following data will be printed just above the IEGM:
• Vertical scale (mm/mV) • Stimulated chamber

• Sweep Speed (mm/s) • Date and time
Pulse amplitude and pulse width are also listed on the IEGM printout
when the analyzer is used for pacing (see Figure 9).
6.2.4.1 Printing an IEGM
1. Press the Print hardkey to start IEGM printout.
2. Press the Print hardkey again to stop IEGM printout before the end
of the printout as defined in the system functions window.
Printout length is defined in the System Functions window
(see Section 9.4). Colored markings on the paper will indicate the end
of the paper roll.
NOTE:
The Start Stim program must be active in order to implement back
up pacing.
Printing an IEGM will not erase any previously stored threshold or IEGM
analysis data from the ERA 300 memory. These data are retained and
may still be printed from the Stimulation Menu window.
7. Measuring Intracardiac Signals

7.1 The IEGM Window
7.1.1 IEGM Measurement Setup
Prior to performing intracardiac measurements, the following parameters
must be set (see Section 5.3 for further details):
• Mode corresponding to the chamber(s) with the implanted
electrode(s)
• Sensitivity as appropriate
7.1.1.1 Mode Selection
Program the pacing mode corresponding to the chamber(s) with the
implanted electrode(s).
7.1.1.2 Measurement Sensitivity
The sensitivity used in determining the P or R wave corresponds to the
value set in the Stimulation Menu window. If P waves are not recording,
the atrial sensitivity parameter should be adjusted appropriately. If very
small amplitudes are anticipated frequently, the appropriate sensitivity
should be programmed in the System Functions window.
7.1.2 Opening the IEGM window
Press either P/R Measure or IEGM On/Off to open the IEGM window for
intracardiac measurements.
7.1.3 IEGM Softkeys
Refer to Section 6.1, for softkey function description.
7.1.4 Printing IEGM Test Results
IEGM test results are automatically stored when pressing the P/R
Measurement hardkey. Line 3 of the status screen will flash −MEMO− to
indicate stored data. Pressing the Print hardkey in the Stimulation Menu
window will generate a printout of up to the last 13 IEGM analysis results
for each IEGM test stored since the Print hardkey was last pressed.
1. Press the Stimulation Menu or the IEGM On/Off hardkey to enter
the Stimulation window. (Line 3 of the status screen will flash
-Memo- to indicate stored data.)
2. Press the Print hardkey for a printout of up to the last 13 results
of each test performed since the last IEGM analysis printout.
NOTE:
Printing stored data clears the analyzer memory.
Figure 12. Printout of Intracardiac Measurements
7.2 P/R Potential, R-R, P-P, and P-Q Intervals

The measured data are evaluated beat-to-beat, displayed and
automatically stored. The upper part of the main screen shows the
appropriate measured potentials and intervals as well as the calculated
spontaneous rate. The potentials and intervals displayed correspond to
the chamber(s) selected for analysis.
1. Select P/R-POT with the upper middle softkey.
2. Select the desired chamber(s) with the upper softkey.
3. Press the P/R Measure hardkey. The ERA 300 will continue to
provide the P/R measurement as long as the hardkey is pressed.
NOTE:
The P/R measurement test may interrupt ongoing pacing. If
necessary, switch on back up pacing (see Section 9.3).
7.3 Slew Rate

The slew rate (V/s) is the rise time of the intracardiac potential (P or R
wave). The unfiltered signal is measured.
1. Select SLEW-R. with the upper middle softkey.
2. Select the desired chamber(s) with the upper softkey.
3. Press the P/R Measure hardkey. The ERA 300 will continue to
provide the slew rate as long as the hardkey is pressed.
NOTE:
The slew rate test may interrupt ongoing pacing. If necessary, switch
on back up pacing (see Section 9.3).
7.4 Wenckebach Point

The Wenckebach point is determined with the atrial IEGM. While
increasing the pulse rate in the AAI mode, the subsequent ventricular
contractions are monitored via their far field potentials or on a separate
surface ECG.
WA R N I N G
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.
1. Select WENCKEB with the upper middle softkey. The

ERA 300 automatically selects pacing rate as the variable
parameter and displays the atrial IEGM.
2. Increase the rate to ensure an atrial paced rhythm.
3. Press and hold the P/R Measure hardkey. The ERA 300 automatically
switches to AAI pacing. A sweep speed of 50 mm/s and the previous
vertical scale are automatically set.
4. Increase the rate with the control wheel until the Wenckebach
point has been reached. Release the P/R Measure hardkey at this
point.
The ERA 300 automatically stores the rate settings beat-to-beat. The last
stored setting (the bottom setting on the printout) is the Wenckebach
point.
NOTE:
If the patient is not hooked up to another external ECG monitor,
change to atrial/ventricular IEGM on the ERA 300 prior to performing
the Wenckebach test to also monitor the ventricular channel.
7.5 Retrograde Conduction Time

The ERA 300 calculates retrograde conduction time from the IEGM. The
VA interval is automatically displayed in milliseconds (ms).
1. Select RETROGR with the upper middle softkey. The
ERA 300 automatically selects pacing rate as the variable
parameter and displays the IEGM from both chambers.
2. Press and hold the P/R Measure hardkey. The ERA 300 automatically
switches to VVI pacing. A sweep speed of 50 mm/s and the previous
vertical scale adjustment are automatically set).
3. Change the pacing rate with the control wheel to determine the
retrograde conduction time.
8. Pacemaker Testing
The ERA 300 is capable of assessing a pacemaker’s pacing rate,
ventricular and/or atrial pulse amplitude, pulse width and the AV delay
(dual chamber) as well as pacemaker inhibition or synchronization
(tracking) to atrial events.
8.1 Performing the Pacemaker Test

1. Press the PM Test hardkey.
2. Press the MEASURE START softkey to trigger the automatic
pacemaker test sequence. (If the pacemaker is not connected
correctly to the ERA 300, the message:
Pacemaker
No pulses detected
will appear on the LCD after test completion. Check all connections
and repeat the test.)
3. Press the Print hardkey to print out pacemaker test results. The
ERA 300 does not store results from this test. A printout of the
results needs to be printed before the Pacemaker Test window is
closed or before another pacemaker test is run.
9. System Functions
System functions include time and date settings, measurement
sensitivity, back up stimulation, IEGM printout length and Standard
Program definition. Changes made in the System Functions window do
not interrupt pacing.
1. Press the softkey SYSTEM in the Stimulation Menu window to open
the System Functions window.
2. Press either the Stimulation Menu, Standard Program, Safe
Program, High Rate, P/R Measure, IEGM On/Off or PM Test
hardkeys to exit the System Functions window at any time.
Figure 13. System Functions Window
9.1 Time and Date

Time and date appear on all printouts. Either European (EUROP.) or
American (USA) time/date formats may be chosen.
1. Press the lower middle softkey, SET TIME/DATE.
2. Select the desired values with the control wheel and cursor
arrows.
3. Press the SET softkey to confirm the modified value(s) and return
to the System Function window, or press the softkey, SYSTEM,
to return to the System Function window without confirming the
values.
Figure 14. Setting Time and Date
9.2 IEGM Measurement Sensitivity

A permanent sensitivity for measuring intracardiac potentials can be
programmed in the System Functions window. Use the cursor arrows and
control wheel to highlight the MEASUREMENT TRIGGER parameter and
choose one of the following options:
• 0.1/0.1 mV: Measurement sensitivity is 0.1 mV in the atrium and
0.1 mV in the ventricle.
• 0.4/0.8 mV: Measurement sensitivity is 0.4 mV in the atrium and
0.8 mV in the ventricle.
• VARIABLE: Measurement sensitivity is the same as that set in the
pacing menu.
9.3 Back Up Pacing

Back up pacing during a P/R measurement can be programmed in case
there is no detected spontaneous rhythm. Use the cursor arrows and
control wheel to highlight the Back Up Stimulation parameter and choose
one of the following options.
• Yes: Pacing at 30 ppm will occur during a P/R measurement if no
spontaneous action of the heart is detected.
• No: The P/R measurement will interrupt pacing during the
measurement.
NOTE:
The Start Stim program must be active in order to implement back
up pacing.
9.4 IEGM Printout Length

Position the cursor in the System Functions window onto the LENGTH
IEGM-PRINTOUT with the cursor arrows. Select a value ranging from
20 to 150 cm (in 10 cm increments) by using the control wheel.
9.5 Standard Program Definition

The ERA 300 allows the user to redefine the Standard Program. To redefine
the Standard Program:
1. Press the hardkey Stimulation Menu.
2. Press the softkey SYSTEM. The System Functions window will
open.
3. Press the softkey DEFINE STANDARD PROGRAM. The Standard
Program Definition window will open.
4. Use the control wheel and cursor arrows to select the desired
pacing parameters (Section 5.3). High rate pacing and burst
parameters may also be programmed for the Standard Program.
5. Press the lowest softkey Save Standard Program to save the new
Standard Program.
Figure 15. Standard Program Definition

The newly saved Standard Program is stored in the ERA 300 permanent
memory and is initiated automatically by pressing the Standard Program
hardkey. This Standard Program is retained in the permanent memory
until a new version is programmed.
NOTE:
Press the upper middle softkey FACTORY PARAMETERS to return
to the preset factory Standard Program. Confirm by pressing the
softkey SAVE STANDARD PROGRAM.
10. Maintenance
10.1 Cleaning the ERA 300
Use a cloth saturated with soapy solution or alcohol for cleaning the
analyzer. Do not use organic solvents such as ether or benzene (these
substances are harmful to the ERA 300’s plastic housing).
To disinfect the ERA 300, wipe it with a cloth that has been saturated with
DESOFORM solution. Follow the manufacturer’s instructions closely in
diluting the disinfecting solution. The ERA 300 cannot be sterilized.
10.2 Maintenance
The ERA 300 analyzer is a sensitive precision instrument. Mechanical
shock resulting from a drop or a fall can adversely affect its performance.
If the ERA 300 is malfunctioning or receives a mechanical shock, contact
BIOTRONIK or your local BIOTRONIK representative.
NOTE:
The ERA 300 may only be opened or repaired by BIOTRONIK or by
personnel authorized to do so by BIOTRONIK.
11. Technical Data

Table 2: ERA 300 Technical Data
Stimulation
DDD, DDI, DOO, VDD,
Modes
VVI, VOO, AAI, AOO
Pacing Rate 30...(1)...180 ppm
Pulse Amplitude
Constant Voltage 0.1...(0.1)...10 V
Constant Current 0.2...(0.1)...20 mA
Pulse Width (A/V) 0.1...(0.1)...2.5 ms
Sensitivity
Atrium (15 ms sin2) 0.3...(0.1)...20 mV
Ventricle (40 ms sin2) 0.5...(0.1)...20 mV
Refractory Period Atrium 250...(50)...600 ms
Ventricle 200...(50)...400 ms
AV Delay 15...(5)...300 ms
Max. Synchronization Rate (UTR) 80...(1)...180 ppm
Synch. Behavior: 2:1
Run-Away Protection 208 ppm
High Rate (A or V) 60...(10)...1000 ppm
2...(1)...15 pulses
High-Rate Burst
(Burst in set high rate)
Intracardiac measurements
R Amplitude (filter 40 ms sin2) 0.5...(0.1)...30 mV
2
P Amplitude (filter 15 ms sin ) 0.5...(0.1)...20 mV
Impedance* Atrium 100 – 3000Ω
Ventricle 100 – 3000Ω
Interval RR 400...(2)...2000 ms
PP (Single chamber) 340...(2)...2000 ms
Interval PQ 50...(2)...300 ms
Slew Rate 0.1...(0.1)...2.5 V/s
Retrograde Conduction Time 60...(2)...330 - 2000 ms**
Conduction Time after Atrial Pacing (for
60...(2)...330 - 2000 ms**
Wenckebach period)
* only when pulse width >0.3 ms
** rate-dependent
Table 2: ERA 300 Technical Data

Pacemaker Test (measurements at 500Ω load resistance)
Rate 30...(1)...180 ppm
Amplitude (A+V) 0.5...(0.1)...10 V
Pulse Width (A+V) 0.10...(0.01)...2.50 ms
AV Delay 15...(1)...320 ms
10 mV / 5 ms
Inhibition Test (A+V)
rectangular pulses
10 mV / 5 ms
Synchronization Test
rectangular pulses
Permitted Ambient Conditions (Storage and Operating)
Temperature 10°C - 40°C
Relative Humidity 30 - 75%
Barometric Pressure 700 - 1060 hPa
Additional Data
Catalog Number 123 174
Energy Supply 8V
~18 h (on fully charged
Operation Time
battery)
Warning message;
Low Battery Behavior
the printer switches off
biphasic; asymmetrical;
Pulse Form
cathodic with auto-short
CF (Cardiac Floating,
Degree of Protection
Defibrillator Protected)
23 × 20 × 11 (cm)
Dimensions (W×L×H)
9” × 7.9” × 4.3”
1610 g without battery
Weight pack
3.5 lbs
11.1 Symbols used
Please observe the instructions
Degree of protection: CF: (Cardiac Floating,

Defibrillator Protected)
11.2 Electromagnetic Compatibility (Compliance with

EN 60601-1-2)
Electromagnetic Emitted Interference (Table 3)

The device is intended for use in the electromagnetic environment. The
customer and/or device operator should ensure it is used in such an
environment.
Table 3: Electromagnetic Emitted Interference

Electromagnetic Environment
Emissions Test Compliance
- Guidelines
The device uses RF energy
only for its internal function.
High-frequency
Thus it is highly unlikely
transmissions Group 1
that its RF transmission
according to CISPR 11
will interfere with nearby
electronic equipment.
High-frequency
transmission Class B
according to CISPR 11 The device is suitable for use
in all areas, including living
Transmission of
Not space and those areas that are
harmonics according
applicable directly connected to a public
to IEC 61000-3-2
power supply system that also
Voltage fluctuations/ supplies buildings intended for
flicker emissions Not residential purposes.
according to applicable
IEC 61000-3-3
Resistance to Electromagnetic Interference (Table 4)

This device is intended for use in the specified electromagnetic
environment. The customer and/or device operator should ensure that it
is used in such an environment.
Table 4: Resistance to Electromagnetic Interference

Resistance to IEC Electromagnetic
Conformance
Interference 60601 Test Environment –
Level
Tests Level Guidelines
Floors should be wood
Discharge ± 6 kV ± 6 kV or cement, or have
of static contact contact ceramic tile. If the
electricity discharge discharge floor is covered with
(ESD)
± 8 kV air ± 8 kV air synthetic material, the
according to
discharge discharge relative humidity must
IEC61000-4-2
be at least 30%.
Quick transient
electric
interference
Not applicable
(bursts)
according to
IEC 61000-4-4
Surge voltage
(surges)
Not applicable
according to
IEC61000-4-5
Voltage drops,
short-term
disruptions,
and
fluctuations Not applicable
of the supply
voltage
according to
IEC61000-4-11

Conformance
Level
Magnetic fields
at AC frequency
should correspond
to the typical value in
business and hospital
environments.
The minimum
Magnetic field distance of the device
at the supply from portable and
frequency mobile radio devices,
3 A/m 3 A/m including the cables,
(50/60 Hz)
according to should correspond
IEC 61000-4-8 to the recommended
safe distance that is
calculated according
to the equation for the
suitable transmission
frequency.
Recommended Safe
Distance:
Conducted RF 3 Vrms
interference
10 kHz to 3 Vrms d = 1.17 √P
according to
IEC 61000-4-6 80MHz

Conformance
Level
d = 1.2 √P
for 80 MHz to 800MHz
d = 2.34 √P
for 800 MHz to 2.5GHz
With P as the
nominal output of
the transmitter in
Watts (W) according
to the information
from the transmitter
manufacturer, and d as
the recommended safe
Radiated RF 3 V/m distance in meters (m).
interference
800 MHz 3 V/m The field strength of
according to
to 2.5GHz stationary transmitting
IEC 61000-4-3
device must be
measured on site* and
must be lower than the
compliance level at all
frequencies**.
Interference can
be generated when
the device is near
equipment with the
following label:
Comment 1: The higher the frequency range applies at 80 MHz and 800 MHz.
Comment 2: These guidelines may not be applicable in all cases. The spread of
electromagnetic waves is influenced by absorption and reflection from buildings, objects,
and humans.

Conformance
Level
* The field strength of stationary transmitters such as the base of cordless phones and
mobile terrestrial transmitters, ham radios, AM and FM radio and television theoretically
can not be determined beforehand. It is beneficial to have the electromagnetic environment
of high-frequency transmitters assessed. If the measured field strength at the location in
which the device is to be used exceeds the above high-frequency compliance level, the
device must be observed to ensure that it functions properly. If odd behavior becomes
apparent, additional measures may be necessary, e.g. reorientation or a different location.
** The field strength should be lower than 3 V/m within the frequency range of 150 kHz to
80 MHz.
Recommended Safety Distances (Table 5 and Table 6)

This device is intended for use in the specified electromagnetic
environment in which the RF interference is carefully monitored. The
customer or device user can help prevent electromagnetic interference
by always complying with the stated minimum distance between portable
and mobile HF communication equipment (transmitters) and the device
– depending on the power output of the communication device, as stated
below.
NOTE:
At 80 MHz and at 800 MHz, the higher frequency range applies.
Table 5: Recommended Safety Distances

Transmission 150 kHZ to 80 MHz to 800 MHz to
Frequency 80 MHz 800 MHz 2.5 GHz
Maximum output Safety distance (m)
power of the
transmitter (W)
0.01 0.12 0.12 0.24
0.1 0.37 0.37 0.74
1 1.17 1.17 2.34
10 3.70 3.70 7.40
100 11.7 11.7 23.4
For transmitters whose maximum output power is not indicated in the

table, the recommended safety distance d can be calculated in meters
using an equation that is suitable for the respective transmission
frequency range. P is the maximum output power of the transmitter
in Watts (W) according to the specification of the transmitter’s
manufacturer.
Table 6: Recommended Safety Distances

Transmission 150 kHZ to 80 MHz to 800 MHz to
Frequency 80 MHz 800 MHz 2.5 GHz
Equation d = 1.17 √P d = 1.17 √P d = 2.34 √P
12. The ACD 300

The ACD 300 is an AC-powered recharging unit intended for use with the
AKKU-1 rechargeable battery packs. There are five LEDs on the front of
the ACD 300. Table 7 describes the LEDs and their significance.
Table 7: ACD 300 LED Description

LED Type Indication
Netz / Power (green) ACD 300 operational readiness.
1. Lights up when the battery pack
is recharging;
Laden / Charging* (yellow)
2. Goes out when the battery pack
is completely charged.
Lights up when the battery pack is
Teilgeladen / Partly charged
partially charged and can be used in
(yellow)
the ERA 300.
Insert either one or both of the rechargeable battery packs into the
recharger receptacles. The recharging process is totally automatic. The
battery packs can remain for an indefinite period in the recharging unit
(ACD 300 design protects from overcharging).
NOTE:
Make sure that the battery is fully charged before starting any
measurements.
12.1 Cleaning
Use a cloth saturated with soapy solution or alcohol for cleaning the
recharger. Do not use organic solvents such as ether or benzene (these
substances are harmful to the ACD 300’s plastic housing).
To disinfect the ACD 300, wipe it with a cloth that has been saturated
with disinfecting solution. Follow the manufacturer’s instructions closely
in diluting the disinfecting solution.
The ACD 300 cannot be sterilized.
12.2 Maintenance
The AKKU-1 battery packs do not require specific maintenance. The
battery packs must only be recharged with the ACD 300. Use the battery
packs with the ERA 300 within its operating temperatures. A battery
pack may be permanently stored in the ACD 300 without overcharging
* The LED lights up for a short period even when a fully charged battery pack is inserted.
and is protected against depletion caused by the charging circuitry if the

charging device is not connected to line power or in case of a power
failure.
NOTE:
Remove the battery from the device prior to transportation.
CAUTION
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.
The battery packs are designed for a high number of charging cycles. If
the charge indicator remains permanently on during recharge, the shut-
off voltage has not been reached and the battery pack does not have its
full capacity. This indicates an aged battery pack.
NOTE:
Replace and do not use aged battery packs!
NOTE:
Do not discard the battery packs with household waste! Recycle
damaged or aged battery packs in compliance with the local
regulations or contact your BIOTRONIK representative.
The ACD 300 recharging unit is a sensitive precision instrument.
Mechanical shock resulting from a drop or a fall can adversely affect its
performance. If the ACD 300 is malfunctioning or receives a mechanical
shock, contact BIOTRONIK or your local BIOTRONIK representative.
12.3 Safety Information

Please note the following:
• Do not operate the unit in the presence of explosive or flammable
gases.
• Starting with Serial Number 772 00000, the ACD 300 Battery Charger
(115 V-version only) is classified by Underwriters Laboratories
Inc. with respect to electric shock, fire, mechanical and other
specified hazards only in accordance with UL 2601-1 and CAN/
CSA-C22.2 No 601.1-M90.
• The devices are denoted accordingly:
• The ACD 300 can recharge the following 8V batteries: Panasonic

LCS082R1PG, LCS-218P, and pbq 2.2-8B. Although these batteries
are provided by different manufacturers, each of these three
batteries can be recharged with the ACD 300 because they have
identical technical specifications.
• The ACD 300s power cord (NK-9) is part of the original system. The
ACD 300 may only be used with this power cord.
• If the recharging unit appears to be malfunctioning, contact
BIOTRONIK or your local BIOTRONIK representative.
12.4 Technical Data

Table 8: ACD 300 Technical Data
Mains Voltage: 115 V
Frequency: 50-60 Hz
Fuse: T 315 mA
Energy Required: 24 VA
Safety Class: II
Charging Voltage: 9.8 V (DC)
Charging Current: 0.82 A (DC) (per battery)
Table 8: ACD 300 Technical Data

Charging Performance: 8 W (per battery)
Permitted Ambient
Temperature: 10 - 40°C
Conditions:
Relative Humidity: 30 - 75%
Barometric Pressure: 700 - 1060 hPa
Catalog Number 111 745
Dimensions (W×L×H): 125×200×115 mm
Weight (without battery
950 g
packs):
The following standardized symbols are used on the device:
Class II device, double insulation system
Read and observe the instructions of the accompanying

manual
Fuse
Alternating Current
Direct Current
13. System Messages

Table 9: ERA 300 System Messages
Message Explanation
Standard readout for constant-voltage
mA/Ω stimulation. The measured resistance and
resulting current are displayed.
Standard readout for constant-current
V/Ω stimulation. The measured resistance and
resulting voltage are displayed.
Displayed when the resistance < 100Ω (potential
short circuit in patient cable or lead). This
― indicator is also displayed when a pulse width
of < 0.4 ms is set (no resistance measurement
possible).
The value “<100” may be caused by an electrical
short between the two pacing electrodes or
cables.
< 100, or The value “>3000” may be caused by a
> 3000 (ohms) disconnected cable, a fractured lead, or a high
impedance lead tissue interface (this message
is only valid when the pulse width is larger than
0.4 ms; otherwise a “-” appears).
The pacing rate (internal) is higher than 200 ppm;
therefore, pulse output in the pertinent chamber
HR PROT.
has been discontinued. Notify BIOTRONIK or an
authorized BIOTRONIK representative.
Impedance > 3000Ω
ELECTRODE (potential lead fracture, loss of connection to the
lead, or high lead/tissue interface).
Electromagnetic interference has been detected.
* * EMI * * The chamber in question may be paced
asynchronously.1
Table 9: ERA 300 System Messages

Message Explanation
* ACCU * flashes in Line 3 of the status screen.
The ERA 300 will no longer print in order to save
energy. The message “ACCU CHARGE TOO LOW
/ NO PRINTING POSSIBLE” will appear when the
hardkey Print is pressed.
* ACCU *
* ACCU * flashes alternately on Line 3 of the
status screen in black-on-white and white-on-
black lettering. Replace the battery pack with a
fresh one immediately. If the battery pack is not
replaced, the ERA 300 may switch off.
1
The EMI indicator is displayed when a signal is sensed within a defined time period
immediately following a regular sense or pace event. The ERA 300 analyzer will provide
patient therapy under all conditions; the analyzer may pace asynchronously, however, when
exposed to EMI.
Should the EMI indicator appear frequently, the following actions may be taken to restore
proper operation of the device provided that this does not affect the safety of the patient:
• Verify correct cable connection between the device and leads.
• Decrease the sensitivity of the ERA 300. (Sensitivity settings are often appropriate if
the selected value is half of the mean measured signal amplitude.)
• Power off all unnecessary EMI-producing electrical equipment in close proximity to
the ERA 300.
• Contact your local BIOTRONIK representative if the EMI indication persists.
Manufactured by:
BIOTRONIK Gmbh & Co. KG
Woermannkehre 1
12359 Berlin Germany
Distributed By;
BIOTRONIK, Inc.
6024 Jean Road
Lake Oswego, OR 97035-5369
(800) 547-0394 (24-hour)
(800) 291-0470 (fax)
www.biotronik.com
© 2009 BIOTRONIK, Inc.

All rights reserved. M3022-K 4/09

M3022-K 4-09 - ERA 300 Manual

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M3022-K 4-09 - ERA 300 Manual

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Biotronik

ERA 300 Analyzer

ERA 300 Pacing System Analyzer

©2009 BIOTRONIK, Inc., all rights reserved.

5.3.3 Direct Access to Single Parameters........................................ 20

10. Maintenance .................................................................................. 39

2. Warnings and Precautions

• Always select a mode that corresponds with the electrode

3. Detailed Device Description

Figure 1. ERA 300

The ERA 300 combines the functions of a multi-mode external pulse

• A test for retrograde conduction during evaluation of a dual chamber

3.2 Control Elements

Figure 2. The ERA 300 Display

3.2.1.1 Status Screen

3.2.2 Command Keys

z Solid command keys trigger a function when pressed.

{ Open command keys operate as momentary switches for

P/R Measure command key

Divided keys operate as toggle switches for the identiﬁed

Cursor arrows allow the selection of parameters.

3.2.3 Control Wheel

3.3 Pace/Sense Indicators

4. ERA 300 Operation

4.1.1 Low Voltage Warnings

Figure 3. The ERA 300 Back Panel

4.1.3 Charging the battery pack

BIOTRONIK provides two conﬁguration options for the patient cables:

Pacemaker Test Cables

ordinary alcohol-free hand soap or USP green soap tincture. After

4.2.2 Connecting the Cables

Figure 4. ERA 300 Cable Connectors (Back Panel)

4.2.2.1 Cable Connection

Figure 5. Stylet Guide Placement

4.2.3 EK-4-E Cable Connection

4.3 Loading the Printer

Figure 6. Opened Paper Compartment

4.4 The On/Off Switch

• Atrial amplitude test

4.5 The Display Contrast and Audio Signal

4.6 Memory and Printing Functions

5. Stimulation Window Functions

5.2 Softkey Functions

5.3 Setting Parameters

5.3.1 Setting the Mode

Figure 7. Pacing Menu with Displayed Modes

5.4 Constant-Current versus Constant-Voltage Pacing

5.5 Threshold Measurement

5.6 Threshold Data

Figure 8. Printout of Threshold Values

Figure 9. Printout of an IEGM

5.7 Maximum Amplitude Pacing

5.8 “Safe Program” Pacing

• Mode: VVI • Ampl.: 7.5 V

5.9 Standard Program Pacing

• Mode: VVI • Ampl.: 4.8 V

5.9.2 User-deﬁned Standard Program

5.10 High-Rate Pacing

Figure 10. IEGM Display

6.1 IEGM Softkey Functions

6.1.2 Intracardiac Complex Analysis

Figure 11. P/R Measurement

6.1.3 Sweep Speed Adjustment