03
The mini-incubator is not connected to the
electric outlet;
Plug the mini-incubator into the electric
outlet;
See “
How to Proceed when Service is
Needed
”
(Page 4);
Printed fuse burned out;
No power;
Check if there is a power outage in your
building;
SOLUTIONS
POSSIBLE CAUSES
THE MINI-INCUBATOR DOES NOT TURN ON
Defective circuit board;
See “
How to Proceed when Service is
Needed
”
(Page 4);
SOLUTIONS
POSSIBLE CAUSES
A MINI-INCUBADORA LIGA, MAS NÃO AQUECE
SOLUTIONS
POSSIBLE CAUSES
If the problem persists after the verification of all the items listed,
contact your local dealer.
The mini-incubator lid is open;
In case the lid of the incubation area is open,
close it properly;
Defective circuit board;
See “
How to Proceed when Service Is
Needed
”
(Page 4);
A TEMPERATURA DA MINI-INCUBADORA SOBE EXCESSIVAMENTE
All Cristófoli Mini-incubators are tested and monitored individually, according to the
parameters of the table below.
QUALITY CONTROL
NOTE:
Heating Time values are expressed considering the technical data chart regarding the
environment conditions, (temperature / altitude). Incubation time will depend on the
biological indicator used. (check the time needed for your BI by consulting its manufacturer
instructions.
A MINI-INCUBADORA DEMORA PARA ATINGIR TEMPERATURA OU NÃO A MANTÉM
SOLUTIONS
POSSIBLE CAUSES
The metallic identification label is located underneath the equipment. Its purpose is to
identify the
technical data.
mini-incubator
ATTENTION!
- Removing the Identification Label and/or any other stickers from the product will
cause automatic loss of the warranty.
HOW TO IDENTIFY YOUR MINI-INCUBATOR
Fig.5
* In case the altitude and/or temperature of your work place is different from the one
mentioned in this manual, contact Cristófoli by the e-mail: [email protected].
Note:
The manufacturer reserves the right to make changes and/or improvements to this
product at any moment without prior notice.
CERTIFICATIONS ..........
CAPACITY .....................................................
WEIGHT.........................................................
CYCLE .........................................................
OVERALL CLEARANCE ..................................
CLEARANCE REQUIRED TO OPEN THE LID ......
EXTERNAL DIMENSIONS (H x D) .....................
LID DIMENSIONS (H x D) ................................
VOLTAGE .....................................................
FREQUENCY .................................................
POWER ........................................................
POWER CONSUMPTION ................................
MAXIMUM TEMPERATURE ..............................
*PROPER WORKING TEMPERATURE ................
*PROPER WORKING ALTITUDE .......................
4 biological indicators
240 g
24 o 48 hours (steam)
15 cm for each side
12 cm
8,7 x 7,6 cm
3,3 x 7 cm
90 - 253V AC single-phase
50/60 Hz
10 Watts
10 Watts hour
60 ºC
15 ºC to 40 ºC
Up to 2.000 m
TECHNICAL DATA CHART
CRISTÓFOLI MINI-INCUBATOR
Cristófoli Mini-incubators are
manufactured by Cristófoli Biossegurança,
company which Quality Management System is certified by ISO
13485:2003, and in accordance with
BPF - Boas Práticas de Fabricação -
ANVISA (Brazilian standard similar to
GMP - FDA / US).
TROUBLESHOOTING
WARNING!
For any parts replacement, contact your local dealer or the manufacturer. We
listed below some possible problems and solutions you can try on your own.
TECHNICAL DATA
24 or 48 hours
(according to the B. I.)
55 ºC to 60 ºC
Cold or hot Mini-incubator
60 minutes
PREVENTIVE MAINTENANCE
Some preventive procedures are necessary for the best functioning and durability of your
mini-incubator:
Use
only
self-contained biological indicators, proper for steam sterilization;
incubator
the incubation area, use a cotton swab
Keep the mini-
clean. To clean
with
alcohol 70% or
peracetic acid at 1% and rub inside the indicators compartments some
times
cause d
s.
. The use of other materials and/or products may
amage
The external cleaning must be done daily using a soft cloth and biodegradable neutral
detergent, next, clean it thoroughly with a soft cloth and alcohol 70%or
peracetic acid at
1%.
Insufficient exposure time to the proper temperature;
Incorrect handling of the incubator or the biological indicators;
Inappropriate indicators for incubation (not proper for steam, incorrectly stored or overdue
shelf life);
Removal of the lid, causing the incubation temperature to drop beyond the ideal level;
Lack of preventive maintenance;
Power outage;
Defective incubator.
POSSIBLE INCUBATION FAILURES
1
2
3
4
6
7
5
ATTENTION!
- Failures during the incubation process are detected during monitoring.
must be repeated with a new control indicator.
AUTOCLAVE STERILIZATION MONITORING
The purpose of the Biological indicators is to monitor autoclave sterilization cycles, they are
considered the most accepted method for monitoring the sterilization process because they
assess it directly by killing known highly resistant microorganisms (e.g.,
Geobacillus
stearothermophilus
for steam and
Bacillus subtillis
for ethylene oxide), rather than merely
testing the physical and chemical conditions necessary for sterilization. Because spores used
in BIs are more resistant and present in greater numbers than the common microbial
contaminants found on patient-care equipment, an inactivated
*
BI indicates other potential
pathogens in the load have been killed. The articles must have been previously cleaned
before being sterilized, since the organic matter protects the microorganisms from the action
of the sterilizing agents.
“Correct functioning of sterilization cycles should be verified for each sterilizer by the
periodic use (at least weekly) of Bis”. (Centers for Disease Control and Prevention.
Guidelines for Infection Control in Dental Health-Care Settings - 2003. MMWR;52 (No. RR-
17): page 24). Each institution must also, according to the Brazilian Health Ministry,
establish a monitoring routine of its autoclaves, with the objective of detecting faults in
their equipment and /or process.
In hospitals, monitoring must be done on a daily basis (AORN, 1994). A biological
indicator must be used for every sterilizer load that contains an implantable device. The
load can only be released after the results of incubation are known.
The number of test indicators to be put in each piece of equipment must be
established according to its volume. A control BI, from the same lot as the test indicator
and not processed through the sterilizer, should be incubated with the test BI; the control BI
should yield positive results for bacterial growth and the results from the test BI should be
negative. The incubation process must begin from 15 minutes after the end of the
sterilization, and no later than two hours after it.
(
*
inactivated = negative).
Heating Time
Incubation Time
Temperature
CRISTÓFOLI
EQUIPAMENTOS DE BIOSSEGURANÇA LTDA
ROD BR 158 Nº 127 - CAMPO MOURÃO - PR - BRASIL
CNPJ 01.177.248/0001-95
INSCR. EST. 90.104.860-65
CEP 87303-327
TEL: 55 44 3518-3434
MADE IN BRAZIL
CAPACITY
4 Indicators
Cristófoli Mini-incubator
MODEL
50/60 Hz
S N
90 - 253V~ - 0,07 kW - 0,1A
VOLTAGE
RODUCT: INCUBATOR FOR BIOLOGICAL INDICATORS
USE INSTRUCTIONS, PRECAUTIONS, CONSERVATION AND STORAGE:
SEE INSTRUCTION MANUAL.
RESPONSIBLE TECHNICIAN
Eduardo Luiz Soppa
CREA-PR: 109201/D
ANVISA REGISTER
EXEMPT
According to Resolution RDC nº 260/02
LOT
FREQUENCY
