Cardiac stimulator 4427 Easypace - Instructions for use
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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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