FIAB 4427 Easypace User manual

Cardiac stimulator 4427 Easypace - Instructions for use
3/40
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

Cardiac stimulator 4427 Easypace - Instructions for use
4/40
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.

Cardiac stimulator 4427 Easypace - Instructions for use
5/40
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.