FIAB 4427 Easypace User manual

Cardiac stimulator 4427 Easypace - Instructions for use
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CONTENTS
1. INTRODUCTION ......................................................................................... 4
1.1. Classification, standards and regulations................................................... 4
2. CAUTIONS AND WARNINGS ..................................................................... 6
2.1. Electromagnetic compatibility – guidance and manufacturer’s declaration 9
3. DESCRIPTION ............................................................................................ 12
3.1. Block Diagram............................................................................................ 13
4. USE.............................................................................................................. 14
5. POSSIBLE COMPLICATIONS..................................................................... 14
5.1. Contraindications ....................................................................................... 14
6. TECHNICAL FEATURES............................................................................. 15
6.1. Graphic symbols ........................................................................................ 16
7. MATERIALS AND ACCESSORIES ............................................................. 17
8. CUSTOMER INTERFACE ........................................................................... 18
8.1. Commands and Controls ........................................................................... 18
8.2. Description of keyboard and display .......................................................... 19
8.3. Keyboard lock ............................................................................................ 22
9. OPERATING MODES.................................................................................. 24
9.1. STAND-BY mode....................................................................................... 24
9.2. V00, BURST x4 and DECREASING RAMP mode..................................... 24
9.3. VVI mode ................................................................................................... 26
9.4. EMERGENCY mode .................................................................................. 28
9.5. AUTO mode ............................................................................................... 28
10. CONNECTION TO THE PATIENT AND INSTRUCTIONS FOR USE ......... 30
10.1. Connection to the Patient........................................................................... 30
10.2. Instructions................................................................................................. 32
11. SPECIAL SAFETY FUNCTIONS ................................................................. 33
11.1. SELF-TEST program and error messages ................................................ 33
11.2. Checking the lead connection.................................................................... 33
11.3. Checking the maximum stimulation rate .................................................... 34
11.4. Protection against electro-magnetic interferences ..................................... 34
11.5. Checking the charge and replacing the batteries....................................... 35
11.6. Protecting against defibrillator discharges ................................................. 37
12. MAINTENANCE........................................................................................... 37
12.1. Controls...................................................................................................... 37
12.2. Cleaning..................................................................................................... 37

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1. INTRODUCTION
This manual forms an integral part of the product and must be stored for future
reference. It cannot be reproduced or photocopied, even partially, without prior
authorisation from FIAB. The use of the documentation material is reserved exclusively for
the Customer.
The present manual contains all the indications which should be observed in order to
guarantee correct use of the device. It is therefore recommended reading the entire
contents of this manual while observing the machine turned on and functioning, in the aim
of fully understanding its operation and gaining sufficient knowledge of its use in clinical
procedure.
1.1. Classification, standards and regulations
With regard to electrical safety the external 4427 Easypace pacemaker is classified
as an electromedical device with an internal power supply of the CF type seeing that it is
destined for application directly to the heart.
The heart stimulator 4427 Easypace is manufactured in compliance with the European
standards in force:
•EN 60601-1 “Medical electrical equipment - Part 1: General requirements for safety.”
File 4745 C (1998-12)
•EN 60601-2-31 "Medical electrical equipment - Part 2: Particular requirements for the
safety of external cardiac pacemakers with internal power source".
File 2689 E (1995-11)
•EN 60601-2-31/A1 "Medical electrical equipment - Part 2-31: Particular requirements
for safety of external cardiac pacemakers with internal power source".
File 5226 (1999-07)
•EN 60601-1-2 "Medical electrical equipment - Part 1: General requirements for safety
- Collateral standard: Electromagnetic compatibility - Requirements and tests".
File 6977 (2003-07)
•EN 14971 "Medical devices - Application of risk management to medical devices."
(2002-05).
•MDD 93/42/CEE.

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FIAB also declares that the information contained in this manual is complete and
congruous with the technical, functional and safety specifications of the device. Any
suggestions regarding errors detected or any eventual improvements will be greatly
appreciated.
FIAB shall only accept all liability for the effects of safety, reliability and performance of
the device if:
•repairs, calibrations or modifications of the device or one of its parts or any
accessories supplied with the device are be carried out by personnel either belonging
to the FIAB Technical Assistance Service or trained and explicitly authorised by the
same;
•the environment and the system in which the device is used is compliant with the
relative safety prescriptions;
•the device being used is compliant with these instructions for use.
In order to ensure the ongoing upgrading of its products FIAB reserves the right to carry out all
modifications without advance notice. All rights reserved.

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2. CAUTIONS AND WARNINGS
Indicated here below are the precautions to be taken for the correct use of the heart
stimulator 4427 Easypace. Further information can be found in other sections of this
manual.
The manufacturer shall hold responsible for the safety, reliability and performance of the
unit provided the following indications are strictly observed.
•The device must be used by physicians with extensive knowledge of cardiac
stimulation.
•The device must only be used in compliance with these instructions for use. It is
necessary to read every part of this manual, if possible in front of the device which is
turned on and operating, in order to fully understand its functioning.
•Before each use, especially if prolonged, it is firmly recommended replacing the main
(alkaline) batteries. The battery replacement will be indispensable if the stimulator has
been turned off after the request to change batteries.
•In the case of prolonged use it will be necessary to make periodic checks of the
stimulation parameters (sensing and pacing thresholds).
•It is indispensable to continuously monitor the patient during stimulation. In emergency
situations it will also be necessary to have a defibrillator on hand and ready for use.
•The programming of a low value for the sensing threshold increases the probability of
the 4427 Easypace operations being influenced by muscular tremors. The device may
interpret false signals as spontaneous cardiac activity, with consequent inhibition of the
stimulation.
•All the automatic functions offered by the 4427 device have been implemented to help
the User make a rapid search for the correct parameters. However, it will always be the
physician’s responsibility to evaluate the suitability of these values in each specific
case.
•In order to use components in contact with the Patient that have to be connected up to
the device, follow the instructions supplied with the same.
•In general, an endocavitary or epimiocardiac electrode connected to any type of
electro-medical device represents a pathway for direct current with low resistance
towards the myocardium. The risk of inducing threatening ventricular arrhythmias
resulting from the dispersion of alternate current increases considerably when a device

Cardiac stimulator 4427 Easypace - Instructions for use
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supplied by the mains is connected to a derivation system. The utmost care must
therefore be taken in earthing devices supplied from the mains and used in the vicinity
of the Patient.
•The heart stimulator 4427 Easypace may also be used within another system
consisting of other equipment. In this case the ascertaining of the compliance of the
equipment chosen and the specific system with the electrical safety and
electromagnetic compatibility provisions in force will be the responsibility of the
designer and manufacturer of the same.
In this eventuality it is always recommended taking great care in connecting all the
other equipment used in the procedure (electrocardiographs or polygraphs, monitors,
etc.) up to the equipotentiality node of the electrical system.
•It is also necessary to avoid touching any metallic parts of the terminals with bare
hands and/or letting them come in contact with wet or electrically conductive surfaces.
•As it is always good practice to equalise the potential between User and Patient, the
User is advised to touch the patient in a area that is not too close to the stimulation
derivations.
•Keep all possible sources of static electricity away from the stimulation system.
•The presence of an electrocatheter in contact with the heart wall may allow for the
radiofrequency generated by an electrotome to reach the heart wall itself, producing
possible arrhythmias or burns to the myocardium.
•Devices that generate ionising radiations (cobalt machines, linear accelerators, etc.)
could damage the electronic components inside the stimulator, especially following an
accumulation of a considerable quantity of radiations. In case of use in the above-
mentioned conditions it will be necessary to provide an efficacious shield for the
stimulator plus continuous monitoring of the Patient.
•The stimulator is protected from defibrillation discharges at the input. It is however
recommended wherever possible disconnecting the electrocatheter from the device
before defibrillating.
•Before each use in heart surgery, check that the locking jaws of the two sockets of the
heart surgery cable F7818/30 close evenly and firmly on the terminals. In case of doubt
do not use the device and contact FIAB.

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•Before each use check the integrity of the device and all its accessories. Particular
attention must be paid when inspecting the cables and connectors. In case of doubt do
not use the device and contact FIAB.
•Before each use check the compatibility of the pin of the electrocatheter with the
socket of the device.
In the event of using electrocatheters not fitted with protected pins, but instead with pins with male contacts with a
diameter of less than 2 mm, it is recommended using the heart surgery cable F7818/30 with screw-on sockets in
order to allow for stimulation.
•Insert the terminals of the electrode fully into each socket without forcing, following the
indications in chapter 10 - "Connection to the patient and Instruction for use”.
•Before each use check that the transparent protective cover of the keypad is correctly
inserted and that there are no breaks or tears. This protection must always be put back
into place after setting the parameters.
•Should the device be dropped, check its correct functioning and in case of doubt
contact FIAB before reusing. If there is any apparent mechanical damage avoid using
the device and contact FIAB.
•All operations to open the device, gain access to the internal parts, and repair
the same must only ever be carried out by authorized FIAB personnel.
•The environment where the device is used must be compliant with the safety
regulations.
•The device must never be immersed in water or any other liquids.
•It will be necessary to remove the batteries from their compartment if the stimulator is
stored for prolonged periods (longer than 4 weeks).
•After storing the 4427 device in environments with temperatures and/or humidity
unsuited to its use, before using again wait until a suitable temperature and humidity
have been reached as indicated on the “characteristics” card.
•Product not sterile and not sterilizable: the hygienic conditions of the device cannot be
guaranteed in the event of being placed inside a sterile field.
•In order to avoid damaging the device it must not be sterilized. To clean the device and
the accessories follow the indications in chapter 12.
•The accessories supplied with the device are not sterile.
IT IS RECOMMENDED HAVING THE 4427 DEVICE CHECKED AT LEAST ONCE A YEAR BY OUR
MEASURING LABORATORY.

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2.1. Electromagnetic compatibility – guidance and manufacturer’s declaration
The 4427 Easypace, like any other medical electrical equipment, needs special
precautions regarding EMC and needs to be used according to the information provided
below.
It’s important to understand that other devices (particularly portable and mobile RF
communications equipment) can affect a medical electrical device. The 4427 device
should not be used adjacent to or stacked with other equipment. In particular the
stimulator must never be used in the presence of high frequency therapeutic and
diagnostic energy sources (e.g.: electrotomes, diathermy devices, RMN etc.) which could
cause malfunctioning, temporary inhibitions of the stimulation, or asynchronous
stimulation.
Electromagnetic emissions
The 4427 device is intended for use in the electromagnetic environment specified below.
The User of the 4427 Easypace should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment - guidance
RF emissions CISPR 11 Group 1
Class B
The 4427 device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
Harmonic emissions
IEC 61000-3-2
Not applicable(a)
Voltage fluctuation/flicker
emissions IEC 61000-3-3
Not applicable(a)
The 4427 device is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply network that
supplies buildings used for domestic purposes.
Electromagnetic immunity
The 4427 device is intended for use in the electromagnetic environment specified below.
The User of the 4427 Easypace should assure that it is used in such an environment.
Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 6 kV contact
± 8 kV air
Compliant Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30%
Electrical fast
transient/burst
IEC 61000-4-2
± 2 kV for power
supply lines
± 1 kV for input/output
lines
Not Applicable(a) Mains power quality should be that of a
typical commercial or hospital environment.
Surge
IEC 61000-4-5
± 1 kV differential
mode
± 2 kV common mode
Not Applicable(a) Mains power quality should be that of a
typical commercial or hospital environment.

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Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT)
for 0,5 cycle
40% UT
(60% dip in UT)
for 5 cycle
70% UT
(30% dip in UT)
for 25 cycle
5% UT
(>95% dip in UT)
for 5 s
Not Applicable(a) Mains power quality should be that of a
typical commercial or hospital environment. If
the User of the 4427 Easypace requires
continued operation during power mains
interruptions, it is recommended that the
4427 device be powered from an
uninterruptible power supply (UPS) or a
battery.
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
3 A/m Not Applicable(a) Power frequency magnetic fields shold be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Conduced RF
IEC 61000-4-6
3 Vrms
150 kHz to 80 MHz
outside ISM bands(b)
10 Vrms
150 kHz to 80 MHz
in ISM bands(b)
Not Applicable(a)
Radiated RF
IEC 61000-4-3
10 V/m
80 MHz to 2,5 GHz
10 V/m(1)
Portable and mobile RF communications
equipment should be used no closer to any
part of the 4427 device, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance
Pd 2,1=80 MHz to 800 MHz
Pd 3,2=800 MHz to 2,5 GHz
where Pis the maximum output power rating
of the transmitter in watts (W) according to
the transmitter manufacturer and dis
recommended separation distance in metres
(m).(c)
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site
survey,(d) should be less than the compliance
level in each frequency range.(e)
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTES:
(a) The 4427 Easypace device is not mains powered but has an internal power source. UTis the a.c. mains
voltage prior to application of the test level.
(b) The ISM (industrial, scientific e medical) bands between 150 kHZ e 80 MHz are 6,765 MHz to
6,795 MHz; 13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz and 40,66 MHz to 40,70 MHz.
(c) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency
range 80 MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communications
equipment could cause interference if it is inadvertently brought into patient areas. For this reason, an
additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in
these frequency ranges.
(d) Field strengths from fixed transmitters, such as base station for radio (cellular/cordless) telephones and
land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted
theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an
electromagnetic site survey should be considered. If the measured field strength in the location in which
the 4427 Easypace is used exceeds the applicable RF compliance level above, the 4427 device should

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be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the 4427 device.
(e) Over the frequency range 150 kHz to 80 MHz, field strength should be less than 10 V/m.
(1) WARNING!
An electro-magnetic interference shielding system is embedded in the device in order to detect noise
signals with frequencies above 300 ppm: during VVI stimulation and with such interferences, the unit will
be set to V00 mode while the User is notified by means of an “EMI” warning on the display; the devices
switches to the VVI mode again once the interference is over (see § 11.4).
Besides that an electro-magnetic field, with frequency within the range (80 - 1000 MHz) and rate below
300 ppm, with an high sensitivity set on the device, could override the protection system: in that case the
device won’t switch to V00 mode causing random loss of the pacing pulse, for no longer than 2 pacing
periods; the complete functionality is regained when the interference is over. The afore mentioned event
can be considered extremely rare. In case of a VVI mode use it’s recommended to check that in the
environment where the device will be used there are no interferences like the one just described,
especially if the Patient is not constantly monitored. If not it’s advisable to find and possibly remove the
source of the interference before proceeding. If the removal of the source is not feasible it’s
recommended to pace in V00 mode.
A method of spotting the presence of the interferences is based on a pre-procedure check: before the
procedure set the device to sensing mode, preferably connecting it to a 500 Ωload. If such
electromagnetic fields are present in the environment, the ECG will detect an activity similar to the
spontaneous one and will show the correspondent ppm.
Recommended separation distances between 4427 device and portable and mobile
RF communication equipment
The 4427 Easypace is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The User of the 4427 device can help prevent
electromagnetic interference by maintaining a minimum distance between portable and
mobile RF communication equipment (transmitters) and the 4427 device, as
recommended below, according to the maximum output power of the communications
equipment.
Separation distance according to frequency of transmitter (m)
Rated maximum output power
of transmitter (W)
80 MHz to 800 MHz
Pd 2,1=
800 MHz to 2.5 GHz
Pd 3,2=
0,01 0,12 0,23
0,1 0,38 0,73
1 1,2 2,3
10 3,79 7,27
100 12 23
NOTE:
•At 80 MHz and 800 MHz the separation distance for the higher frequency range applies.
•These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
Data reported in this chapter are valid for the device used in the manner and with
accessories stated in this instructions for use. The use of accessories other than those
specified may result in increased emissions or decreased immunity.

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3. DESCRIPTION
External 4427 Easypace pacemaker is a compact, single-chamber, temporary heart
stimulator to be used in the pathologies of spontaneous generation and conduction of
impulses.
The unit’s main characteristics are :
•synchronous and asynchronous modes of operation
•fully microprocessor operated control allowing a high precision setting of stimulation
parameters and a complete and continuous check for correct operation of the unit
•back-lighted LCD display
•AUTO and EMERGENCY keys for a quick start-up of both synchronous and
asynchronous stimulation with safety parameters
•stimulation capability with quadruple rate and decreasing ramp to reduce
tachycardia events
•stand-by batteries for replacement of main batteries without interrupting the
stimulation
•a large number of safety functions: self-test at power on; on-line control of the
batteries level; turn-on inhibition with low battery charge; check for run-away and
lead connection; protection against defibrillation discharges and electromagnetic
interference. Dangerous situations are signalled to the operator by an acoustic
alarm and a suitable display message
•easy and safety connection of Patient cable or lead to sockets
•protected sockets coloured black for the – and red for the +; these are compatible
with protected pins fitted with Ø 2 mm electrical- contacts

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3.1. Block Diagram
The figure below is a block diagram of the heart stimulator 4427 Easypace.
Cardiac signal enters the unit through the lead and the connecting socketes. A suitable
circuit provides for the protection against the defibrillator discharge.
The sense channel consists of a chain of amplifiers and filters - schematically illustrated in
the figure below - for the cardiac signal acknowledgement:
The current (mA) controlled output stimulation is governed by the microprocessor
according to values entered via the keyboard and visualised on the display. The
stimulation impulse is followed by a short period of electrode depolarisation obtained
through a short-circuit of the two catheter poles.
Load
Resistance
& Clamp
Buffer Filtering Blanking Amplitude
Adjustment
Threshold
Detector
From MCU
To MCU

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4. USE
Heart stimulator 4427 Easypace is a versatile unit easy to use for single-chamber
temporary intracardiac stimulation. In particular it is recommended in:
•extreme bradycardia;
•paroxysmal atrial-ventricular block;
•interruption of paroxysmal tachycardia from atrial flutter;
•atrial-ventricular blocks of various types prior to implantation or replacement of a
definitive pacemaker.
5. POSSIBLE COMPLICATIONS
Complications likely to occur upon using heart stimulator 4427 Easypace are the
following:
•muscle stimulation causing contractions and pain;
•breaking or displacement of the catheter causing intermittence or lack of stimulation
•erroneous setting of stimulation parameters causing capture failure;
•erroneous adjustment of the stimulation rate causing induction and tachycardia;
•erroneous setting of sense parameters causing the stimulation to loose synchronism or
be inhibited.
5.1. Contraindications
There are no contraindications in relation to the use of 4427 Easypace for temporary
cardiac stimulation during a therapy or arrhythmia prevention. However the Patient's state
of health or the presence of electromagnetic interference can limit the choice of modes
and stimulation parameters.
The stimulator is provided with numerous and redundant safety circuits whose
simultaneous failure - unsigned to the User - is an event very unlikely to occur. However, it
is recommended that the use of the heart stimulator 4427 Easypace be restricted to
authorised medical staff and always accompanied by ECG monitoring.

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6. TECHNICAL FEATURES
Manufacturer FIAB SpA Via Costoli, 4 - 50039 Vicchio, Florence (ITALY)
Model 4427
Class and Type Portable unit with internal power supply
Applied part Type CF, protected against defibrillator discharges
Conditions for use Device for continuous functioning
Compliance to directives EN 60601-1 "Medical Electrical equipment - Part 1: general requirements for
safety" File 4745 C (1998-12)
EN 60601-2-31 "Medical Electrical equipment - Part 2: particular requirements for
the safety of external cardiac pacemaker with internal power source" File 2689
(1995-11)
EN 60601-2-31/A1 "Medical Electrical equipment - Part 2-31: particular
requirements for the safety of external cardiac pacemaker with internal power
source" File 5226 (1999-07)
EN 60601-1-2 "Medical Electrical equipment - Part 1: general requirements for
safety - Collateral standard: electromagnetic compatibility - Requirements and
tests" File 6977 (2003-07)
EN 6060-2-31 Electro-medical equipment - Part 2: rules for safety of external
cardiac stimulators with internal power supply
MDD 93/42/CEE
Destination for use Single-chamber temporary intracardiac heart stimulator
Sensitivity Adjustable with continuity by the couple of SENSE keys
Maximum sensitivity (
∗ )0.75 mV ± 5%, both for positive and negative polarities(1)
Detectable spontaneous rate 30÷300 ppm; the value is shown on the display during STAND-BY and VVI modes
Post-stimulation refractory
period (APRP) 3/8 stimulation period
Blanking width 48 ms
Input impedance Approx. 30 k
Ω
Input filtering Pass band filter tuned for recognition of R wave(1)
Sense signalling By flashing of the green LED at each recognition of R wave
EMI signalling Acustic (emission of a tone) and visual (turning on of LCD) for detected rate
values which exceed 300 ppm
Amplitude of stimulation
impulse Varying between 0.4 and 40 mA (by steps of 0.4 mA up to 10 mA, and then by
steps of 2 mA)
Maximum available current 40 mA @ 300
Ω , 25 mA @ 500 Ω
Waveform of the stimulation
impulse Rectangular
Length of stimulation
impulse 1.4 ms
± 10%
Local depolarisation Short-circuit of 16 ms length after the stimulus
Post-sense refractory period
(ASRP) 200 ms
Hysteresis 0 ms
Stimulation rate 30
÷ 180 ppm, with 1 ppm steps variation. High rate stimulation (up to 720 ppm)
for burst and ramp
Anti-runaway 200 ppm, with warning circuit independent of the microprocessor
Pace signalling By flashing of the red LED for each stimulus emitted
Stimulation output Black/red safety sockets for 2 mm pins
The neutral socket is of red colour; the active socket is black
Stimulation method Asynchronous (V00) and on demand (VVI) - A00, AAI (0,75 mV - see (
∗ ))
In the VVI mode, detected rate values which exceed 300 ppm are interpreted as
disturbance condition: the 4427 Easypace indicates EMI and change over V00
mode at the set rate
In the V00 mode, the sense signal is ignored and does not inhibit the stimulation
Additional functions BURST x4 (quadruple of set frequency rate stimulation)
RAMP (decreasing frequency rate of 8 ppm/stimulus)
EMERGENCY (V00, 72 ppm, 20 mA)
AUTO (VVI, automatic adjustment of sense, amplitude and frequency rate)
Special and safety functions device self-test at power on
Stand-by mode for setting stimulation and sense parameters under no-stimulation
condition
Protection against defibrillator discharges
Integrity checking of Patient connection during stimulation mode
Continuous checking of batteries charge level

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Default parameters at power
on Upon completion of self-test, the stimulator is set on mode Stand-by: frequency
rate 72 ppm, amplitude 10 mA, sense threshold 1 mV
Display liquid crystals type LCD, with back illumination, for monitoring stimulation and
sense parameters. 20 sec after the last key pressure, the display goes off, to be
switched on again at a touch of any key
Keyboard thermoformed, with EMI shielding, for setting stimulation and sense parameters
Power supply 2 main batteries: AA size 1.5 V alkaline (type LR6)
3 stand-by batteries: 1.4 V type PR44 or NR44 or 3 batteries of 1.5 V type D375H
Switch on On /Off button
Switching on signals Acustic (emission of a tone) and visual (turning on of LCD)
Max. input 11 mA
Autonomy Main batteries: > 10 days prior to low warning; at least 12 hours of residual
autonomy afterwards
The replacement can be done (within 120 seconds) without the
necessity of turning off the device
Stand-by batteries:> 350 main batteries replacements; batteries life > 12 months
When these batteries are dead, the replacement of main
batteries is prevented with the unit in operation (self-test of
charge level)
Signalling of batteries
discharge Acoustic and visual, with no variation of sensing and pacing set parameters
Operating conditions Temperature: +10 to +40
° C
Relative humidity: 30% to 70% RH uncondensed
ATM. pressure: 700 mbar to 1060 mbar
Storage and transportation
conditions (for 4 weeks
max.)
Temperature: 0 to +50
° C
Relative humidity: 20% to 80% RH uncondensed
ATM. pressure: 500 mbar to 1060 mbar
Packaging designed to prevent mechanical deterioration following the batteries
Dimensions 130 x65 x 32 mm
Weight Approx. 210 g (including batteries)
Note: (1) the accuracy of the measurements of the sensing values parameters has been calculated by using a
triangular signal 2 ms/13 ms (14708-2 Annex F)
The accuracy of the stimulation parameters has been calculated with a load of 500 Ω.
6.1. Graphic symbols
Symbol Meaning
caution, consult the attached documentation
defibrillator-protected apparatus of CF type
(Cardiac Floating, suited for direct cardiac
applications)
keyboard lock / unlock
NOTE: in heart stimulator 4427 the protection against the defibrillator discharge is inside
the device.

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7. MATERIALS AND ACCESSORIES
Electrocatheters for temporary stimulation avaiable from the range of FIAB
REF
SPIKE 2S REF SPIKE LC 2S/6F REF SPIKE LC 2S/5F REF SPIKE LC 2S/4F Extension cable REF
62166S 52166S 52165S 52164S F7817/30B
62126S 52266S 52265S 52264S F7818/30B
62106S 52366S 52365S 52364S F7817/30
62266S 52466S 52465S 52464S F7818/30
62226S 52126S 52125S 52124S
62206S 52226S 52225S 52224S
62366S 52326S 52325S 52324S
62326S 52106S 52105S 52104S
62306S 52206S 52205S 52204S
62466S 52306S 52305S 52304S
WARNING !
Using extension cables or others accessories, pay attention to the total
length (extension cable length + electrocatheter length) isn't longer than 3
m. Otherwise radiated RF could be increased or EMC immunity could be
decreased (cf. 11.4 and 2.1 - EMC immunity).
Therefore the use of listed FIAB extension cables is recommended only with
SPIKE LC 2S/4F electrodes.
QUANTITY DESCRIPTION CODE
2 Elastic strips 60002300
2 1,5 V alkaline battery, pen type (LR6) 26000010
3 1,4 V Stand-by battery, type PR44 or NR44 ( or 1,5 V type D357H). 26000003
1 Transparent cover 40202700
1 Protecting case 40209800
1 Sterile bipolar cable for heart surgery F7818/30 (only on request) 68518440
1 Sterile extension cable F7817/30 (only on request) 68518430

Cardiac stimulator 4427 Easypace - Instructions for use
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8. CUSTOMER INTERFACE
8.1. Commands and Controls
The figure below is an ensemble view of the heart stimulator 4427 Easypace
showing the following details:
•ON/OFF switches;
•LCD display for parameters setting and monitoring;
•signalling LED for stimulation (red) and sense (green);
•keyboard for setting the operation mode and regulating the stimulation impulse and
sense threshold;
•dedicated keys for quick access to stimulation, battery replacement and display
illumination;
•rubber external protection;
•doors for access to main and stand-by batteries housing.
Illustrated in the next part of this section are the unit’s operational functions and controls.

Cardiac stimulator 4427 Easypace - Instructions for use
19/40
8.2. Description of keyboard and display
The keyboard of 4427 Easypace has thermoformed keys providing an accentuated
sense of touch. Moreover, the pressing down of any key is confirmed by a short acoustic
signal.
The ON and OFF keys are for turning the stimulator on and off. The on
condition of the unit is signalled by the display (during the STAND-BY
mode of operation) and by the blinking of the LED (during the V00 and VVI modes which
include turning the display off).
The device can be switched off only by a prolonged pressure of the OFF key.
The emission of a stimulation pulse takes place upon entering one of the
two operating modes V00 and VVI and is signalled by the blinking of the
red LED PACE.
The capture of a spontaneous impulse occurs, instead, after the correct adjustment of the
threshold (cf. later on) and is signalled (in the STAND-BY or VVI mode) by the blinking of
the green LED SENSE.
The stimulator operating modes STAND-BY, VVI and V00 are
selectable by a touch of the relevant keys. The specific operations to
be carried out for each of these modes will be described in detail later in this manual.
As graphically indicated on the keyboard, the burst and decreasing ramp
programs can only be activated in the mode V00 by pressing at the same
time the keys V00 and burst x4 or V00 and ramp ▼.
Both functions are active only until the two keys (V00 + burst x4 or V00 + ramp ▼)are
kept pressed. When one is released, the stimulator returns to the previous program V00 at
the set rate.
Two automatic programs are also available for a quick entry into the
asynchronous mode V00 by a touch of the red key EMERGENCY and
into the synchronous mode VVI by pressing AUTO. Both modes also
allow the operator to adjust with precision all the set parameters. For a detailed illustration
of the EMERGENCY AND AUTO programs, reference is made to the relevant paragraph.

Cardiac stimulator 4427 Easypace - Instructions for use
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The adjustment of the stimulation rate is made by acting on the pair of keys
ppm ▲and ▼whose thus set value is shown on the display. The variation of the
rate by steps of 1 ppm takes place more quickly if the relevant key is kept pressed.
Keys ppm ▲and ▼are active in all the operation modes, V00 and VVI included.
The current (mA)-operated variation of the impulse is made by pressing keys
mA ▲and ▼; also in this case the keys are active in all the operating modes and
the set value is visualised on the display. The variation step of the current is 0.4
mA in the range of 0÷10mA, and then of 2 mA up to the maximum value of 40 mA.
In the STAND-BY and VVI modes the active keys are sense ▲, ▼and mV, for the
adjustment, respectively, of the sensitivity threshold of spontaneous activity and for
the visualisation of the threshold level (in mV).
For the mode VVI to be performed correctly, careful adjustment of the sensitivity level
should be made beforehand, when operating in the STAND-BY mode. At power on, the
default threshold is 1 mV. The keys sense ▲and ▼act on the amplification of the input
signal. Accordingly, an increase of the sensitivity will be obtained by pressing the key
sense ▲(which will cause the threshold to go down to the minimum value of 0.75 mV)
whereas a decrease of the same sensitivity will be set by the key sense ▼. The capture of
the spontaneous impulse is signalled both by the blinking of the green LED of sense, and
by the appearance on display of the spontaneous rate value which is updated after each
impulse. To graphically show the amplification level being
reached, the second line of the display is replaced - when
using the sensitivity adjustment keys - by a bar indicating the
volume (see figure at the side). At the end of setting, the
display will resume its usual configuration.
For a final verification of the threshold level being set, press the mV key to allow it
to be visualised in place of the spontaneous ppm figure, normally shown on the
display - the visualisation of the threshold value being active for the time this key is
depressed. A release of the same key causes the display to resume its normal
configuration.