Cristofoli Mini-incubator Manual

M I N I - I N C U B A D O R A
CRISTÓFOLI
M A N U A L D E I N S T R U Ç Õ E S
Cristófoli, Brazilian company importer and manufacturer of health
products certified by ISO 13485 - Medical Devices - Quality
Management System - Requirements for Regulatory Purposes,
and accordance to the requirements of *BPF - Boas Práticas
de Fabricação - ANVISA.
Cristófoli Mini-incubador
CRISTÓFOLI'S MISSION
Develop innovative solutions to protect life and promote health.
CRISTÓFOLI'S QUALITY AND ENVIRONMENTAL POLICY
Cristófoli Equipamentos de Biossegurança Ltda., established at Rodovia BR-158, nº 127,
Jardim Curitiba in Campo Mourão, Paraná, Brasil, manufactures biosafety equipment to
assist the health field having as policy: "Develop innovative solutions for the health field by
using agile, robust and objective processes to better serve its clients. Fulfill the requirements
for regulatory purposes of the applicable standards, promote the continuous improvement
of its quality and environmental systems, prevent pollution, reduce its environmental impacts
and continuous training of its employees, achieving this way, a sustainable profitability and
the maximization of the company's value". Rev. 2.
*BPF - Boas Práticas de Fabricação: Brazilian standard similar to the GMP - Good Manufacturing Practices (FDA / US).
"Cristófoli. Valuing life!"
Thanks for choosing us. You, our clients, are the reason of Cristófoli's commitment.
We put together this manual to guide you as best as possible, in the use and maintenance
of your Cristófoli Mini-incubador.
We would like to thank all our customers and partners for helping us to continually improve
and innovate our products and services.
Special thanks to Liliana J. P . Donatelli, Cristófoli's Biosafety Consultant who provides us a
valuable assistance in the coordination of the Cristófoli's Biosafety Project, complementary
products research, our employees, representatives and technicians trainings, and as a
lecturer of Biosafety Courses for professionals, academics and assistants.
For any complaints about our products, please get in touch with our CSD - Customer
Service Department, through the address below.
CONTENTS

Introduction .......................................................................................................................

Legend of Symbols ...........................................................................................................

Important Safety Information ............................................................................................

Installation Instructions .......................................................................................................
Safety Devices ..................................................................................................................
Mini-incubador Features ...................................................................................................
How to Use the Cristófoli Mini-incubador ...........................................................................
Requirements to be Observed for the
Possible Incubation Failures ...............................................................................................
Preventive Maintenance ...................................................................................................
Troubleshooting .................................................................................................................
Quality Control ..................................................................................................................
How To Identify Your Mini-Incubator ...................................................................................
Technical Data .................................................................................................................
Warranty Certificate ..........................................................................................................
How To Proceed When Service Is Needed ........................................................................
Guidance For The Final Disposal Of The Equipment ...........................................................
Links Of Interest ..................................................................................................................
Bibliographical References ...............................................................................................
PLEASE, READ ALL THE INSTRUCTIONS IN THIS MANUAL BEFORE USING YOUR CRISTÓFOLI
MINI-INCUBATOR. INCORRECT USE MAY RESULT IN INCUBATION FAILURE, INCORRECT
INTERPRETATION OF THE RESULTS AND/OR ACCIDENTS !
13485
Incubation Process ................................................
INTRODUCTION
This equipment was developed to assist you in the important procedure of incubating the
self-contained biological indicators used to monitor steam sterilization autoclave cycles. We
dedicated ourselves intensively to guarantee you the highest quality and safety. We hope to
obtain this way, the highest level of satisfaction from our clients.
The purpose of this manual is to familiarize you with the features and proper operation of
your Cristófoli Mini-incubator so you know how to take good care of it, obtain the best results
in the incubation process, as well as increase the equipment lifespan.
We recommend extra attention to this manual, the incubation process, although simple,
requires familiarization with the procedure.
All the data on biosafety in this manual were taken, fully or partially, from publications of
renowned biosafety professors based on the Brazilian Legislation or on International
Standards to offer updated information about the monitoring process.
It is important to know some aspects that can void this warranty as a result of negligence,
improper use, non-authorized repairs, etc.
You will find the Warranty Certificate on page 4.
Cristófoli Equipamentos de Biossegurança Ltda.
Rod. BR 158, nº127 - Campo Mourão - PR - Brasil
CNPJ 01.177.248/0001-95 - Inscr. Est. 90104860-65
www.cristofoli.com - e-mail: cristofoli@cristofoli.com
LEGEND OF SYMBOLS
Caution, consult
accompanying documents
135 ºC
Autoclavable
Boas Práticas
P
B F
de Fabricação
~
Alternate Current
Caution!
Hot Surface
Date of
Manufacture
Maximum Pile
5
Equipment
Class II
This Side Up
IMPORTANT SAFETY INFORMATION
01
01
The intended use of this equipment is to perform the incubation of the self-contained
biological indicators used to monitor the sterilization cycles in steam autoclaves.
01
that the operator reads attentively all the instructions before using the m
02
sure they are correctly understood.
02
02
SAFETY STEPS TO PROPERLY OPERATE YOUR CRISTÓFOLI MINI-INCUBATOR
02
02
WARNING! Always make sure you unplug the equipment to perform any kind of
03
maintenance or everyday cleaning.
03
We recommend reading this manual until it is fully understood. Keep it at hand and use it as
03
a constant reference source;
03
Do not allow patients or especially children to get close to the device;
03
03
Use only the self-contained biological indicator described in this manual;
04
Never touch the incubation area (Fig. 2, page 2) during or right after using the mini-
04
incubator. Improper use may cause burns. Cristófoli is not responsible for incorrect
04
procedures that may cause accidents;
04
Make sure the mini-incubator's lid is properly closed before using it. Not following this
04
procedure will prevent its correct functioning. See "How to Use the Cristófoli Mini-
04
incubator" (Page 2).
WARNING! Never put any kind of object inside the mini-incubator different than a self-
contained biological indicator or make any use other than the one described in this
manual.
Manufacturer
CEP 87309-650
Responsible Technician
Eduardo Luiz Soppa
CREA-PR: 109201/D
Fragile
Handle with Care
ISO 13485
13485
Keep Dry
Batch Number
LOT
Serial Number
SN
Keep Away from
Sunlight
Recyclable
Manufacturer
Manual Mini-incubadora Ingl. Rev.6 2018
It is essential
ini-incubator to make
01