PHYSICAL INSTALLATION
Install the mini-incubator on a flat, leveled and firm surface, at an adequate height for the
operator to handle it. Leave enough room close to the mini-incubator for the proper handling
of the biological indicators to be incubated. The place where the mini-incubator will be
installed must be ventilated, clean and apart from the place where the patients are treated.
The ideal installation should be done in a separate sterilization and/or material processing
room.
Important!
Install your mini-incubator where it can be easily unplugged. This is the proper
way to turn the equipment off completely.
ELECTRICAL INSTALLATION
The voltage of the Cristófoli Mini-incubator is from 90V to 253V (automatic voltage
selection), as informed in the identification label located under the device (Fig. 3). Make
sure the wiring voltage where it will be installed is in accordance with the values marked in
the field
Voltage
of the Identification Label.
ATTENTION! Non compliance with this
requirement may damage your mini-incubator
.
Cristófoli is not responsible for
damages caused by inappropriate installations and/or voltage
.
Use a common outlet to plug it in (two pins, Figs. 1 and 1A).
Never
use extensions, voltage transformers or any kind of adapters
.
Your
Cristófoli Mini-incubator has the following safety devices:
The electrical installation must follow the data from the table below:
SAFETY DEVICES
LID -
It closes the incubation area during operation, helping to maintain the temperature
stable and protect the operator from accidental burns
(Fig. 2).
-
PRINTED FUSE
Built into the electronic circuit, it
s purpose is to protect the building electrical
wiring against peaks of energy
.
MAIN UNIT
- It is made with injected ABS plastic, white on the lower half and transparent on
the top half (Fig. 2).
LID -
Its function is to close the incubation area during operation to maintain the
temperature stable (Fig. 2).
POWER CABLE -
Used to connect the equipment to the electric outlet (Fig. 3).
INCUBATION AREA
- Screwed to main unit, it is where the indicators are inserted for
incubation. It has a capacity for 4 biological indicators (Fig. 2).
LED -
It indicates when the mini-incubator is on, it also illuminates the incubation area,
making the visualization of the results easy and clear (Fig. 2).
IDENTIFICATION LABEL -
Affixed under the device its function is to identify the mini-
,
incubator technical data (
).
Fig. 3
MINI-INCUBATOR FEATURES
1
2
HOW TO USE THE CRISTÓFOLI MINI-INCUBATOR
ATTENTION!
Before starting the incubation procedures, the operator must be using latex
gloves. Handle the biological indicators carefully. The mini-incubator must be installed in a
proper and exclusive sterilization and/or materials processing room.
The symbol 14 appears in the identification label of the mini-incubator, that means the
selected item requires special attention and that the user/operator must observe its
reference in the instruction manual provided with the equipment regarding the potential
hazard the device may offer and any actions to be taken should an adverse situation occur.
Cristófoli Equipamentos de Biossegurança Ltda., is not responsible for any failures and/or
accidents caused by the non-observance of this warning.
ATTENTION! Use only self-contained biological indicators for steam sterilization
with the
mini-incubator. Non-observance of this recommendation may cause incubation failure,
poor interpretation of the results and/or damage to the device, as well as loss of warranty.
“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.
Use only biological indicators for steam (56ºC)
1 - Plug the mini-incubator into the outlet. The white LED will light indicating the device is
on;
Note:
The incubation temperature is 56°C. Wait for the temperature adjustment which will
take from 40 to 60 minutes;
2 - After being sterilized according to its manufacturer instructions, remove the indicator
from the autoclave, wait 15 minutes, activate it and insert it into the incubation area,
activate also another indicator from the same batch that was not autoclaved to serve as
a control;
Note:
To activate the biological indicator, hold the mini-incubator firmly and insert it half
way in any of the available incubation orifices (Fig. 4), press it carefully in any direction
until you feel that the internal glass ampoule has broken, bring it back to its due position
and slide it into the incubation area.
3 - Wait for the correct incubation time according to the instructions of your biological
indicator manufacturer (24 or 48 hours);
Note:
It is important that during the incubation period, the lid is always closed to keep the
temperature steady, open it only when necessary (insert or remove the biological
indicators).
4 - After the time needed for the incubation has elapsed, remove the biological indicator
from the incubation area and check the results.
It is recommended to examine the biological indicators at regular intervals to verify the
color change (example, 12, 16, 20, 24 and 48 hours). Bacterial growth is indicated by the
color change of the biological indicator according to the manufacturer instructions.
Note:
To cancel the incubation process, simply unplug it from the electric outlet.
We suggest that the operator standardize the incubation process and prepare a written
routine to avoid leaving any requirement behind.
INDICATORS STORAGE
The storage of the biological indicators must follow the instructions from the manufacturer,
specially the temperature exposure limits. The cabinets must be easy to clean, located in a
dry room with fresh air, free from odors, disinfectants and/or sterilants.
BIOLOGICAL INDICATORS SHELF LIFE
The shelf life / expiration date is generally printed on the label and/or box of the biological
indicators, it is the date after which they cannot be used. We recommend the use of the
“
SporTest
” biological indicators which have an 18-month shelf life.
INCUBATION PROCESS MONITORING
Monitoring is nothing more than controlling the incubation with self-contained control
indicators. The control indicators (indicators that have not been sterilized), have the important
function of evaluating the viability of the test indicators, as well as the capacity of the
incubator in providing the ideal conditions to incubate them. In case the result from the
control is not positive, it is possible that there is some problem with that batch of indicators,
with their storage, or even with the incubator. Check if a power outage occurred during the
incubation process. If that is the case, perform the whole test again. That means a new cycle
must be performed in the autoclave, containing a test indicator and the incubation process
REQUIREMENTS TO BE OBSERVED FOR THE INCUBATION PROCESS
Fig.1A
Fig.1
Bipolar outlet and plug
(two pins) 10 A.
Fig.2
LID
INCUBATION AREA
BIOLOGICAL INDICATORS (illustrative)
MAIN UNIT
LED (located inside the
incubation area)
POWER CABLE
Fig.4
IDENTIFICATION L ABEL
Fig.3
2
3
02
MODEL
AMPERAGE
VOLTAGE
Cristófoli
Mini-incubator
0,07
90V - 253V AC
automatic
voltage selection
1
The storage/installation must be done in a place protected from the weather action
(indoors) in normal conditions of ambient temperature.
The Cristófoli Mini-incubator can be easily installed. Check if the wiring voltage of your
building is in accordance with the mini-incubator specifications
consulting the “
Technical
Data
” (Page 3) at the time of installation.
See “
Warranty Certificate
” and “
How to Proceed
When Service is Needed
” (Page 4).
INSTALLATION INSTRUCTIONS
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
PRODUCT: 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
