CALIBRATION PROCEDURES

INCUBATOR MODELS PC 01-800-055

1186C / 2186

TABLE FOR PRECALIBRATION OF THE MASTER CIRCUIT

Voltage in volts
Measurement point Trimpot
(+/- 0.01V)
Safety Sensor @ 36oC 0.81 Check
Trimpot - Safety Temperature Sensor - 38oC 0.77 R68
Trimpot - Safety Temperature Sensor - 40oC 0.73 R66
Trimpot - Air Circulation Failure Sensor,
Hot Sensor @ 36oC * 2.20 R67
Trimpot - Air Circulation Failure Sensor,
Cold Sensor @ 36oC * 2.00
Skin Sensor @ 36.1oC 1.02 Check
Air Sensor @ 34oC 1.08 Check
Auxiliary Sensor @ 25oC 1.39 Check
Trimpot Current Sensor 0.20 R69
Current Sensor Check
Comparator output 38oC Check Check
Comparator output 40oC Check Check
Battery Voltage Check
Reserve Sensor @ 42oC 0.86
Oxygen A @ 21% 0.52 +/- 0.3 Check
Oxygen B @ 21% 0.52 +/- 0.3 Check
Humidity Does not require calibration

* The Incubator must be on at 36oC with air circulation.

2. Special Functions
The special functions provide access to certain operating modes or enable certain actions.
 Press the MENU and SILENCE keys simultaneously => Screen for selecting optional
items;
 Press the MENU key => Screen to correct Air, Skin and Auxiliary Temperatures and
Humidity;
 Press the ENTER key => Calibration Mode.

Warning: If the optional item "Pulse Oximetry" is selected without the

oximeter board installed, the system will crash. In this situation,
turn the panel off and turn it on again, keeping the lower left key
pressed.

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Warning: The Calibration Mode, in all the models, will always be

deactivated when the Incubator is turned off.

3. Calibration

Warning: For field operations, before carrying out the calibration steps, it is
recommended to implement the verification procedures in accordance with
Section 4. If any parameter is not within the established ranges, it should be
calibrated as per the respective requirements in Section 3.

To perform the calibration (Section 3) or Verification (Section 4) procedures, it is recommended that

the Incubator be stabilized for at least two hours, before carrying them out.

3.1. Calibration of Air and Skin Temperature

a) Place a standard thermometer 10 cm over the center of the mattress;
b) Turn on the incubator and set the Air Temperature at 36ºC;
c) Wait for the temperature to stabilize;
d) Check the temperature on the standard thermometer and correct the Air Temperature indicated
on the display of the Incubator – Tolerance of +/- 0.3ºC;
Go into the calibration screen: press the SILENCE and MENU keys at the same time to access
the selection screen. Press the MENU key to go into the temperature correction screen. Select
the setting for Air Temperature and correct it by pressing the UP or DOWN keys;
e) Skin Temperature Correction:
f) Connect the temperature simulator into the skin sensor and set it at 36.1ºC. Check the
temperature indicated on the display and correct if necessary – Tolerance of +/- 0.2ºC.

3.2. Calibration of the “High Air Temperature” alarms for 38ºC and 40ºC
NOTE: To calibrate these alarms, the panel must be in Calibration Mode, as outlined above in "Air
Temperature Correction".
a) Fully rotate the 38oC and 40oC trimpots clockwise;
b) Set the Air Temperature of the incubator at 38oC (yellow LED >37 off). Wait for the temperature
to stabilize;
c) Set the trimpot at 38oC until the alarm is activated;
d) Set the Air Temperature at 40oC (yellow LED >37 on). Wait for the temperature to stabilize and
set the trimpot at 40oC until the alarm is activated. Tolerance of +/- 0.5ºC.

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3.3. Calibration of the “Air Circulation Failure” alarm

NOTE: To calibrate this alarm, the panel must be in Calibration Mode;
a) Turn on the Incubator and set the air temperature at 36ºC and wait at least 30 minutes for the
temperature to stabilize;
b) Turn off the ventilation motor;

c) Clock the time immediately after turning off the motor. After 40 seconds, adjust the R67 trimpot
(air circulation) to activate the "Air Circulation Failure" alarm;

d) Turn on the ventilation motor and note that the alarm should be deactivated;
Wait for the temperature to stabilize and repeat the procedure turning off the motor and clocking
the time. The alarm should be activated within 15 to 120 seconds. If it occurs outside this time
range, adjust the trimpot again and repeat the alarm activation test.

3.4. Calibration of the Oxygen Cells

a) The panel must be in Calibration Mode;
b) Connect the Multifunctional Simulator into the socket of the O 2 and Humidity sensors;
c) Select the Oxygen function on the panel and press the CAL. key, to go into the calibration
screen;
d) Press the key corresponding to 21% O 2 ;
e) Continue pressing the 100% O 2 key on the simulator and press the key corresponding to 100%
O 2 on the screen;
The concentration level of the two sensors will appear on the screen;
f) Connect the O 2 and Humidity sensor cables again into the corresponding socket;
g) Calibrate the oxygen at 21% with the O 2 cells;
h) Calibrate the oxygen at 100% with the O 2 cells by injecting O 2 directly into the cells. Wait for
stabilization to occur and perform the calibration again through the panel.

Warning: After oxygen calibration, turn off the panel and turn it on again to
exit Calibration Mode.

3.5. Calibration of the Current Sensor of the Heating Element

 Fully rotate the current sensor trimpot clockwise, and remain in this position.

3.6. Calibration of the Scale

 Use Calibration Procedure PC: 01-800-063

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Display Board Scale Board

4. Verification Procedures

4.1. Procedure to check the Relative Humidity Sensor

a) Use hygrometer with scale from 20% to 100%;
b) Place the hygrometer sensor 10 cm over the center of the mattress;
c) Set the Air Temperature of the Incubator from 34 to 36ºC;
d) Set the Relative Humidity of the Incubator at 70% and wait for the control to stabilize, which
could take 30 minutes;
e) Check whether the percentage measured on the panel of the Incubator is the same as the
instrument, with a tolerance of +/- 5 %.

4.2. Procedure to check Pulse Oximetry

 Use a Nellcor simulator

a) Turn on the Incubator;

b) Connect the extension cord into the DB9 socket on the side panel;
c) Wait until the display of the Incubator shows 75% for saturation and 60 BPM;
d) Change to 90% saturation and 200 BPM;

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e) Disconnect the simulator and check whether the dislodged sensor alarm is activated;
f) Disconnect the simulator cable and check whether the disconnected sensor alarm is
activated;
 Tolerance for saturation +/- 1 %;
 Tolerance for BPM +/- 1.

4.3. Procedure to check Air Temperature

a) Place a standard thermometer 10 cm over the center of the mattress;
b) Turn on the incubator and set the air temperature at 36ºC;
c) Wait for the temperature to stabilize (1 hour);
d) Check the temperature on the standard thermometer – Tolerance of +/- 0.5ºC.

4.4. Procedure to check Skin Temperature

a) Connect the temperature simulator into the skin sensor, and set the simulator at 36.1ºC.
Check the temperature indicated on the display;
 Tolerance of +/- 0.2ºC.

4.5. Procedure to check Auxiliary Temperature

a) Connect the temperature simulator into the auxiliary sensor, and set the simulator at 36.1ºC.
Check the temperature indicated on the display;
 Tolerance of +/- 0.2ºC.

4.6. Procedure to check the Scale

a) The Incubator must be turned on for 15 minutes to preheat the circuit;
b) Check that there is nothing on the platform;
c) Tare the scale and place the standard weight in the center of the platform;
 Tolerance of +/- 4 grams.

4.7. Procedure to check the “Air Circulation Failure” alarm

a) The air temperature of the Incubator should be stabilized at 36ºC;
b) The timer of this alarm should be deactivated (see the section: calibration of the “Air
Circulation Failure” alarm);
c) Turn off the motor;
d) Clock the time until activation of the alarm – 15 to 120 seconds.

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4.8. Procedure to check the “High Air Temperature” alarm

NOTE: To check this alarm, the Incubator must be in Calibration Mode (See Section 2.1).

a) Set the air temperature at 38ºC. When the air temperature reaches 38ºC, the “High
Temperature” alarm should be activated;
 Tolerance of +/- 0.5ºC.
b) Set the air temperature at 40ºC. When the air temperature reaches 40ºC, the “High
Temperature” alarm should be activated;
 Tolerance of +/- 0.5ºC.

4.9. Procedure to check the “Power Failure” alarm

a) Turn on the panel and disconnect the power cord from the equipment;
 The “Power Failure” alarm should remain on for at least 3 minutes.

4.10. Procedure to check Oxygen Control - Servo

a) The air temperature of the Incubator should be stabilized at 36ºC;
b) Connect the oxygen hose into the O 2 inlet (threaded nipple). Open the flow meter to
maximum;
c) Turn on the oxygen control and set at 50% concentration;
d) Regulate the O 2 inlet pressure valve so that the O2 flow is 15 l/min +/- 5 l/min. (Note: internal
valve);
e) Wait approximately 20 minutes for the O 2 concentration to stabilize inside the Incubator;
measure this concentration with a standard oximeter;
 Tolerance of +/- 4%.

4.11. Procedure to check Oxygen Control - Limited

a) Procedure - Presetting the O 2 Panel Flow Meter
Open the O 2 valve and connect the hose of the O 2 Panel Flow Meter into the inlet of the
standard O 2 Flow Meter;
With the help of the O 2 Panel Flow Meter, regulate the flow rate so that the O 2 Panel Flow
Meter shows a flow rate of 9 l/min;
Do not interfere with the regulation of the valve of the O 2 Panel Flow Meter, since it is
already preset at 9 l/min.
b) Measurement of Oxygen Concentration
The air temperature of the Incubator should be stabilized at 36ºC;

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Connect the oxygen hose into the "Limited Oxygen" inlet nipple and place the O 2 Analyzer
sensor into the cable insert opening on the hood of the Incubator;
After stabilization (approximately 20 minutes), the O 2 Analyzer should have an oxygen
concentration in the 50% to 70% range.

4.12. Procedure to check the Alarms

 “High and Low Air Temperature” alarms
Check the air temperature. Set it 1.5ºC lower and confirm that the high air temperature alarm
is activated.
Set the air temperature 3ºC higher. Confirm that the low air temperature alarm is activated.

 “High and Low Skin Temperature” alarms

Set it 1ºC lower than the temperature indicated on the display and check that the “High Skin
Temperature” alarm is activated.
Set it 1ºC higher and check that the “Low Skin Temperature” alarm is activated.

 “High Humidity Concentration” alarm

Set it 5% lower than the humidity indicated on the display and check that the alarm is
activated.

 “Low Water in the Humidifier Tank” alarm

Empty the water from the humidifier, and clock the low water time. The alarm should be
activated after 10 minutes when the concentration is 10% below the percentage indicated on
the display of the panel.

 “High and Low Oxygen Concentration” alarm

Set it 3% lower than the concentration indicated on the display. Confirm that the “High
Concentration” alarm is activated.
Set it 3% higher than the concentration indicated on the display and confirm that the “Low
Concentration” alarm is activated.

 “Power Failure” Alarm

With the Incubator turned on under normal conditions, proceed as follows:
Set the air and skin temperatures and relative humidity and oxygen. Turn on the air
temperature, humidity and oxygen. Jot down the settings, in order to check them later.
Disconnect the power cord.
Confirm that the audible and visible alarm is activated, which should remain on for 3
minutes.
Reconnect the power cord. Check whether the previous settings remain unchanged.

4.13. Procedure to check the Calendar Clock

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Set the clock as follows:

 Press the MENU key;
 Go into SET PARAMETERS;
 Enable the CLOCK function, and set the corresponding parameters;
 Return to the home screen.

Set a time of 10 minutes on the clock and check it with a chronometer in minutes and
seconds.

4.14. Procedure to check Noise

Place the sound level meter, set at 50 dBA, in a longitudinal direction, on the mattress, with the
sound sensor facing the left side of the Incubator (side where the air outlet is found).
With the Incubator turned on under normal conditions, without any oxygen input, measure the
internal noise level that should be approximately 55 dBA, although noise levels up to 60 dBA are
acceptable for an environment of 45 dBA.

5. Review Record

Person
No. Rev. Review Declaration Date
Responsible

02 Update according to SMT 7033 Sérgio Ledo 9/11/2012

03 Update according to SMT 7285 compl. Sérgio Ledo 2/15/2013

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