FIAB 4427 Easypace Instructions For Use Manual
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FIAB 4427 Easypace Instructions For Use Manual

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Summary of Contents for FIAB 4427 Easypace

  • Page 3: Table Of Contents

    Cardiac stimulator 4427 Easypace - Instructions for use CONTENTS INTRODUCTION ..................4 1.1. Classification, standards and regulations........... 4 CAUTIONS AND WARNINGS ..............6 2.1. Electromagnetic compatibility – guidance and manufacturer’s declaration 9 DESCRIPTION .................... 12 3.1. Block Diagram.................... 13 USE......................14 POSSIBLE COMPLICATIONS..............

  • Page 4: 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.
  • Page 5 • 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. 5/40...

  • Page 6: Cautions And Warnings

    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.
  • Page 7 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...
  • Page 8 • 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.

  • Page 9: Electromagnetic Compatibility - Guidance And Manufacturer's Declaration

    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...
  • Page 10 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. U is the a.c. mains voltage prior to application of the test level.
  • Page 11 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...

  • Page 12: Description

    Cardiac stimulator 4427 Easypace - Instructions for use 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 •...

  • Page 13: Block Diagram

    Cardiac stimulator 4427 Easypace - Instructions for use 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.

  • Page 14: Use

    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.

  • Page 15: Technical Features

    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...

  • Page 16: Graphic Symbols

    Cardiac stimulator 4427 Easypace - Instructions for use Default parameters at power 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.

  • Page 17: Materials And Accessories

    (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. 17/40...

  • Page 18: Customer Interface

    Cardiac stimulator 4427 Easypace - Instructions for use 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;...

  • Page 19: Description Of Keyboard And Display

    Cardiac stimulator 4427 Easypace - Instructions for use 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.
  • Page 20 Cardiac stimulator 4427 Easypace - Instructions for use 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.
  • Page 21 Cardiac stimulator 4427 Easypace - Instructions for use CAUTION ! For a correct synchronism it is recommended not to set a limit of the threshold, but to reduce the latter by approx. 20% (by acting on key sense ▼) in order to prevent possible fluctuation of spontaneous activity level.

  • Page 22: Keyboard Lock

    Cardiac stimulator 4427 Easypace - Instructions for use The field referring to the operating mode may be S-BY, VVI or V00. When in the V00 mode only, the program burst x4 is activated it will cause x4 to appear on the second line of the display, while program ramp ▼...
  • Page 23 Cardiac stimulator 4427 Easypace - Instructions for use From this moment all the function keys will be inhibited, with the exception of “EMERGENCY”, “LIGHT” and “OFF”. The device will show the operating parameters on the display and the keyboard locking status will be shown with the message “KEYBOARD LOCKED”...

  • Page 24: Operating Modes

    Cardiac stimulator 4427 Easypace - Instructions for use OPERATING MODES Described in the next chapter are the three modes - with relevant options - in which the 4427 Easypace is able to operate. 9.1. STAND-BY mode The STAND-BY mode is intended for setting stimulation and sense parameters under no-stimulation condition.
  • Page 25 Cardiac stimulator 4427 Easypace - Instructions for use The stimulus emission is signalled by a blinking of the red LED PACE, and takes place only if the set amplitude is other than 0 mA. The efficacy of the stimulation can be checked by using a normal monitor for ECG signals.

  • Page 26: Vvi Mode

    ▲ and ▼, as shown in the figure below: Patient Stimulation Stimulation period External stimulator 4427 Easypace acts as a common, implantable pacemaker with a basic period equivalent to the escape interval (that is, with no hysteresis). 26/40...
  • Page 27 Cardiac stimulator 4427 Easypace - Instructions for use For a correct synchronism function it is necessary to make an accurate adjustment of the unit’s sensitivity threshold by acting on keys sense ▲ and ▼ as described above. Proceed as follows: starting from a setting with a high value of sense (several sense bars switched on) and a safe capture, slowly decrease such setting by checking the synchronisation green LED.

  • Page 28: Emergency Mode

    Cardiac stimulator 4427 Easypace - Instructions for use CAUTION ! It is indispensable to check the efficacy of the stimulation and the correct setting of pace and sense parameters by means of an ECG monitor. In case of prolonged use of the stimulator, doctor should check periodically the device, to assess the constant correctness of these parameters.
  • Page 29 The display appears as shown in the figure on the right. In case of no spontaneous impulse for about 2 seconds, the 4427 Easypace sets itself to 72 ppm, 20 mA and 1.1 mV threshold, thereby ending the program.

  • Page 30: Connection To The Patient And Instructions For Use

    6,2 mm. (recommended thickness 0,8 mm). • An internal contact with a diameter of 2mm. The electrocatheters manufactured by FIAB that guarantee full compatibility with the outlet sockets of the 4427 device belong to the "Spike-S" and "Spike-LCS" families.
  • Page 31 FIAB MyopaceT, TZ and P epicardium needles.

  • Page 32: Instructions

    Cardiac stimulator 4427 Easypace - Instructions for use 10.2. Instructions A correct use of the stimulator 4427 Easypace requires the following instructions to be strictly observed: 1. Always replace the main batteries before re-using the stimulator (cf. 11.5), especially for an extended period of time. This operation may be suppressed only if you are certain of the optimal level of the battery charge and in case of a very short period of utilisation (for example as stand-by for replacement of a pacemaker).

  • Page 33: Special Safety Functions

    The unit is provided with a sentinel circuit intended to check the connection or disconnection between the catheter and the 4427 Easypace, by measuring the voltage at the terminals of the stimulation sockets. Such measurement is carried out only for impulses with amplitude in the range of 2.8 to 20 mA.

  • Page 34: Checking The Maximum Stimulation Rate

    11.4. Protection against electro-magnetic interferences The 4427 Easypace is provided of an embedded Patient's spontaneous heart activity detection circuit calibrated on the ventricular impulse. However, owing to the high...

  • Page 35: Checking The Charge And Replacing The Batteries

    Cardiac stimulator 4427 Easypace - Instructions for use In such case the stimulation mode automatically shifts from VVI mode to V00 mode with the parameters of stimulation set up before. The User is warned of electromagnetic interference by means of two signals, acoustic (a “beep” every 5 seconds) and visual (indication of EMI on the display).
  • Page 36 It is recommended to use alkaline batteries (as indicated in § 6) unless the autonomy could be lower than indicated. The replacement of the stand-by batteries must be made by skilled personnel, explicitly authorized by FIAB, and never during the use of the unit. 36/40...

  • Page 37: Protecting Against Defibrillator Discharges

    If any failures or bad state of connections are detected, do not use the device but contact FIAB. Moreover it is necessary having the 4427 device checked at least once a year by our measuring laboratory. Our technicians will do the following actions: replacing stand-by batteries;...
  • Page 38 Enclosed with the instructions you will also find the Compliance Certificate and the results of the electrical safety test which we invite you to keep with care. FIAB subjects all its products to strict quality and safety tests, however if in spite of all precautions taken your device should present any defects, please directly contact our Technical Assistance Department.
  • Page 40 Via Costoli, 4 - 50039 - Vicchio (Florence, ITALY) - www.fiab.it...

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