Professional Documents
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IT-158 TS
USER MANUAL
FANEM
SMTs: -
REF: 158.401.550
Fanem 2013. All rights reserved. Prohibited to copy or reproduce without permission.
Page Intentionally Blank
USER MANUAL Table of Contents
IT-158 TS
Notes
Identification of USER MANUAL
the Equipment
IT-158 TS
This User Manual provides general instructions on installation, use, maintenance, operation and
troubleshooting for the IT-158 TS Transport Infant Incubator, manufactured by FANEM .
FANEM will not be held liable if the user does not operate this Infant Incubator in accordance with its
instructions, does not follow the maintenance recommendations in this manual or makes repairs using
unauthorized components. Calibration and repairs should only be performed by qualified service
technicians and personnel. Any additional information will be assessed and forwarded through your
local distributor.
This manual should be carefully read and understood by users, as well as be readily accessible to the
entire service team and available in the location where the Infant Incubator is used.
If you have any questions, directly contact a FANEM representative to obtain answers and further
information.
6
USER MANUAL Identification of
the Equipment
IT-158 TS
TM
Option with integrated Babypuff 1020
7
Technical USER MANUAL
Specifications
IT-158 TS
2. Technical Specifications
2.1 Definitions
Control Zone: Central point located 10 Temperature Uniformity:
cm over the center of the mattress Measurement of the difference between
surface. the temperature at the control points and
the average temperature in the stabilized
Infant Incubator Temperature: Air
Infant Incubator.
temperature, measured in the Control
Zone. Temperature Variation: Difference
between Infant Incubator Temperature
Control Temperature: Temperature
and average Infant Incubator
set point of the controller selected by the
temperature during Stable Infant
user.
Incubator Condition.
Stable Infant Incubator Condition:
Temperature Overshoot: The amount
The condition achieved when the Infant
by which the internal temperature
Incubator Temperature does not vary by
exceeds the Infant Incubator
more than 1C over a period of one hour.
Temperature during Stable Infant
These measurements are taken with a
o Incubator Condition, after a change in
Control Temperature of 32 C and/or
o the temperature set point.
36 C.
ATC: Control mode where the air
Temperature Rise Time: The time
temperature is automatically controlled at
required for the Infant Incubator
a level set by the user, as measured by
temperature to rise 11C, when the Air
an air temperature sensor. Equivalent to
Control Temperature is set at least 12C
control in Air Mode.
above room temperature.
ITC: Control mode where the heating
Measurement Points: Measurements
of the air is automatically controlled to
are taken at five points on a parallel
maintain the skin temperature of the
plane 10 cm above the mattress surface.
newborn set by the user. Equivalent to
One point is located 10 cm over the
control in Skin Mode.
center of the mattress and the other four
points are located in the center of four Routine Calibration: Calibration of the
areas formed by lines that divide both the equipment and its functions, according to
width and height into two parts. standards previously established by the
manufacturer.
8
USER MANUAL Technical
Specifications
IT-158 TS
2.3 Fuses
Supply Voltage Fuse
External supply voltage 127V~ A Type F
External electric supply voltage 220V~ A Type F
---
Internal supply voltage 12 V 10 A Type F
9
Technical USER MANUAL
Specifications
IT-158 TS
2.5.1 Alarms
2.5.1.1 System Alarms
10
USER MANUAL Technical
Specifications
IT-158 TS
11
Technical USER MANUAL
Specifications
IT-158 TS
12
USER MANUAL Technical
Specifications
IT-158 TS
2.10 Symbols
IPX4 Equipment
Warning: Consult manual IPX4
Protected against water splashing
against the enclosure from any direction
Continually Operating
Silence
Equipment
13
Technical USER MANUAL
Specifications
IT-158 TS
14
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
ITEM DESCRIPTION
1 Acrylic Hood with Infant Incubator Base
2 Charging Module (Vital Module)
TM
3 Control Panel (optional with integrated Babypuff 1020)
4 Power Module
5 Air Filter Support
15
Parts, Pieces and USER MANUAL
Accessories IT-158 TS
3.1 Hood
Double-walled acrylic hood with three access The same procedure is applied to the inner wall
doors: frontal, back and side. The access doors of the hood that rests on the base of the Infant
open by tilting them downward. The frontal and Incubator.
back doors each have two access ports that
enable hand access to the hood. The side door
has two protected openings with silicone
double tube inserts or, as an option, an opening
with an elastic cuff, for introducing and
attaching tubes, circuits and connections. The
access doors also contain tube inserts for
introducing cables, sensors and/or catheters.
Special hood configurations in relation to
openings, doors and tube inserts can be
provided through a technical analysis.
To open the frontal and back doors, turn the
latches on the upper part of the door, as seen
in "A" in the drawing.
To remove the acrylic hood, release the rubber
rings that fasten the hood to the lower base, as
seen in "B" in the drawing, moving the auxiliary
lamp back. Then, with the help of two
professionals, one on each side, slowly lift the
hood until totally removed and place it on
another surface that is able to hold it.
16
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
3.3 Bed
The bed with the mattress can be shifted up to
24 cm outside the hood, through the side
access door, with the help of a safety
mechanism that controls its movement.
To completely remove the bed, slide it through
the side access door, pressing down the latch,
as seen in "C" in the drawing.
The bed has two adjustable safety straps with a
Velcro system that envelop the patient and
his "nest", in preparation for being transported,
as shown in "D" in the drawing.
Warning: The maximum load on the bed must not exceed 7 kg.
17
Parts, Pieces and USER MANUAL
Accessories IT-158 TS
18
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
3.5 Base
The base of the Infant Incubator is comprised
of two parts: Upper Base and Lower Base.
The upper base contains the bed, the bed
displacement latch and the passive
humidification sponge. The base can be
removed by unfastening the four side latches.
The lower base contains the heating element,
air circulation blower rotor, air temperature and
safety temperature sensor and the sensor
indicating inadequate air circulation. The lower
base is fastened to the structure of the Infant
Incubator.
ITEM DESCRIPTION
1 Inlet nozzle for air and/or mixture of air with oxygen
2 Temperature sensor and safety temperature sensor
3 Inadequate air circulation sensor
4 Air circulation blower rotor
5 Finned heating element
6 Latches for fastening the upper base
19
Parts, Pieces and USER MANUAL
Accessories IT-158 TS
Warning: A dirty air filter can affect the volume per minute of
ambient air admitted to the Infant Incubator and consequently
contribute to carbon dioxide (CO2) build-up in the microclimate.
Always check the condition of the air filter whenever the equipment
is cleaned for new use and make the necessary changes according
to the instructions contained in this manual.
Warning: The two apertures in the filter cover are for air intake and
must not be blocked under any circumstances.
Warning: Do not use the articulator when there are objects on the
shelf.
20
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
3.9 Blender
A blender for mixing compressed air and
oxygen, equipped with an output flow meter (0-
15 lpm) and delivery hoses, for providing the
exact oxygen concentration level, suggested for
TM
use with the manual Babypuff 1020 Infant
Resuscitator.
ANVISA Registration No.: 80.102.510.150
21
Parts, Pieces and USER MANUAL
Accessories IT-158 TS
22
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
TM
Note: For optimum use of the Babypuff 1020 Infant Resuscitator in
conjunction with the IT-158 TS Transport Infant Incubator, it is
recommended to use the auxiliary shelf, Babypuff Rail Fastener,
Oxygen Distribution Dual Strip installed on the rod of the auxiliary
shelf and the Blender kit.
24
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS
25
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
Check whether the electrical network to which the equipment will be connected is compatible with the
electrical specifications of the equipment (voltage and power), as indicated on the label affixed to the
unit.
The power cable must be plugged into a grounded socket that is permanently attached to the wall, in
accordance with the rules and legislation for low voltage electrical installations and electrical legislation
for Health Care Establishments. Never use extension cords.
When incorrectly used, the Transport Infant Incubator can cause serious risks to newborn patients. This
equipment should only be operated by trained and qualified personnel who understand the risks and
benefits of its use, under medical supervision.
This Infant Incubator should not be used if any of its functions are not operating correctly. Qualified
technical service should be requested.
The IT-158 TS Transport Infant Incubator was designed for use with only one patient at a time.
Warning: It is not recommended to use this equipment with more
than one patient at a time, since it will only be possible to monitor
one of them. There is also a risk of cross infection.
The Infant Incubator has filters for electromagnetic protection designed to meet the specifications of
electromagnetic compatibility standards. However, this equipment may be adversely affected and suffer
interference from other equipment, such as high-frequency surgical devices, defibrillators, shortwave
therapy equipment, cardiac pacemakers and other electrical stimulators.
Before starting to read the patient's skin temperature sensor, take note of all the information and
precautions regarding its operation and application, to avoid injury to the patient, such as burns and/or
electric shock, arising from a possible electrical discharge.
Warning: Patient cables and sensors are not protected against the
effects of defibrillation.
The temperature display may not accurately reflect the temperature of the Infant Incubator if the doors
of the hood are open. Do not leave the side doors of the hood open longer than necessary.
All the latches of the hood, access doors and access ports must be properly closed to prevent them
from accidentally opening.
For patient safety, never leave the newborn unattended when the doors of the hood or the access ports
are open.
26
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS
The use of additional comfort devices or other accessories inside the Infant Incubator can change the
air circulation pattern and affect the conditions set for its microclimate, such as temperature, humidity
and oxygen concentration.
Patient safety and the operation of the Infant Incubator can be impaired if the air circulation is
obstructed (blankets, diapers, etc.) during its use.
To avoid overheating the patient due to direct radiation, do not place the equipment in direct sunlight or
under other radiant heat sources. In such cases, temperature control can be compromised.
Do not use surgical drapes or blankets on the patient. This can cause excess heat and extreme
overheating of the patient.
Do not cover the hood of the Infant Incubator with blankets or towels that prevent viewing of the
newborn and/or block the air outlets. This can cause a buildup of carbon dioxide inside the hood and
impair the care given to the patient.
Never loosely place the skin temperature sensor underneath the newborn, or use it to measure rectal
and/or axillary temperature. Incorrect positioning of the sensor can cause reading and temperature
control errors.
The skin control sensor must be in direct contact with the skin to provide accurate monitoring of the
patient's temperature. If the sensor fails or is improperly placed on the patient, overheating or cooling
may occur. The temperature of the newborn must be checked frequently for signs of thermal changes
To prevent the equipment from sliding when stopped on an incline, make sure the casters are locked.
To assemble and transport the equipment, it is recommended that the procedure be performed by a
person with sufficient physical strength.
When using the shelves of the Intensive Care Unit, take the following precautions:
Always place the monitor in the center Avoid putting one monitor upon
of the shelf. another, installed on the shelf.
Make sure the monitor fits within the Respect the maximum load limits of the
boundaries of the shelf. shelves.
Do not place equipment or other accessories that are not equipped with hood attachment systems.
Any additional equipment connected to the patient must be properly grounded and comply with the
electrical safety standards for medical electrical equipment contained in NBR IEC 60601-1 and its
particular norms.
Do not activate the control keys using your fingernail or any other sharp object.
While boarding or removing the IT-158 TS Infant Incubator from aircraft and ambulances, as well as
during the duration it is on board, the Infant Incubator cart should be kept in the low position and locked.
The casters should also be locked. Adequate fastening conditions for different types of vehicles is the
responsibility of the user in charge of the transport operation.
Only use original FANEM parts and accessories to ensure optimum equipment performance and
safety.
Warning: This equipment should only be operated by trained and
qualified personnel who understand the risks and benefits of its use,
under medical supervision.
27
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
28
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS
In the configuration for feeding oxygen to the Infant Incubator through a flow meter, the oxygen flow
rates cannot be used as an accurate indication of the oxygen concentration in the microclimate of the
Infant Incubator, and should only be used as a guide. Oxygen concentration should be frequently
measured with a calibrated oxygen analyzer.
The supply of oxygen concentrations above 21% in the internal environment of the Infant Incubator can
be affected by any opening of the access ports or access doors of the hood or even as a result of
improper installation of fittings and protective tube inserts.
The use of separate cylinders for the supply of gases, such as oxygen, presents risks and should not be
used without the recommended precautions.
The oxygen concentration inspired by the newborn does not determine the partial pressure of oxygen in
the blood (pO2). Oxygen pressure in the blood should be monitored using appropriate techniques.
Accumulated dirt in the air filter can affect the volume per minute of ambient air admitted to the Infant
Incubator and consequently contribute to carbon dioxide (CO2) build-up in the microclimate. Always
check the condition of the air filter whenever the equipment is sanitized for new use and make the
necessary changes according to the instructions contained in this manual.
29
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
30
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS
31
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
The IT-158 TS Infant Incubator is designed for use in the electromagnetic environment specified below.
It is recommended that the customer or user of the Infant Incubator ensure that it is used in such an
environment.
Immunity Test Test Level ABNT NBR Compliance Electromagnetic Environment Guidance
IEC 60601 Level
Portable and mobile RF communications
equipment should be used no closer to
any part of the IT-158 TS Infant Incubator,
including cables, than the recommended
separation distance, calculated from the
equation applicable to the frequency of
the transmitter.
Recommended Separation Distance
1/2
d = 0.35 P
1/2
d = 0.35 P 80MHz - 800 MHz
Conducted RF 3 V ms 10 V
1/2
d = 0.7 P 800MHz - 2.5 MHz
IEC 61000-4-6 150 KHz - 80 MHz
where P is the maximum output power rating
of the transmitter in watts (W), according to
Conducted RF 3 V ms 10 V/m the transmitter manufacturer, and d is the
recommended separation distance in meters
IEC 61000-4-3 80 MHz - 2.5 GHz (m).
It is recommended that the field strengths
from fixed RF transmitters, as determined by
an electromagnetic site survey, a should be
less than the compliance level in each
b
frequency range.
Interference may occur in the vicinity of
equipment marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio, cellular/cordless
telephones, land-mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed-
RF transmitters, an electromagnetic site survey is recommended. If the measured field strength in the location
in which the IT-158 TS Infant Incubator is used exceeds the RF compliance level utilized above, observe the
Infant Incubator to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the Infant Incubator.
b
Over a frequency range of 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
32
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS
The Infant Incubator is intended for use in the electromagnetic environment in which radiated RF disturbances are
controlled. The user can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the Infant Incubator as recommended below,
according to the maximum output power of the communications equipment.
Rated maximum output Separation distance according to the frequency of the transmitter
power of the transmitter m
W
150 kHz - 80 MHz 80 MHz - 800 MHz 800 MHz - 2.5 GHz
1/2 1/2 1/2
d = 0.35 P d = 0.35 P d = 0.7 P
For transmitters rated at a maximum output not listed above, the recommended separation distance d in meters (m)
can be determined using the equation applicable to the frequency of the transmitter, where P is the maximum
output power rating of the transmitter.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
33
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
Electromagnetic Immunity
The IT-158 TS Infant Incubator is designed for use in the electromagnetic environment specified below.
The customer or user of the IT-158 TS Infant Incubator should ensure that it is used in such an environment.
< 5% UT (> 95% voltage < 5% UT (> 95% voltage Mains power quality should
dip in UT) for 0.5 dip in UT) for 0.5 be that of a typical hospital or
cycles cycles commercial environment. If
Voltage dips, short
interruptions and the user of the IT-158 TS
voltage variations on 40% UT (60% voltage dip 40% UT (60% voltage dip Infant Incubator requires
power supply input lines in UT) for 5 cycles in UT) for 5 cycles continued operation during
power mains interruption, it is
IEC 61000-4-11
70% UT (30% voltage dip 70% UT (30% voltage dip recommended that the Infant
in UT) for 25 in UT) for 25 Incubator be powered from
cycles cycles an uninterruptable power
supply or battery.
5% UT (95% voltage dip in 5% UT (95% voltage dip in
UT) for 5 seconds UT) for 5 seconds
NOTE: UT is the AC mains voltage prior to the application of the test level
34
USER MANUAL Installation of the
Equipment
IT-158 TS
Safety lever
Latches: Front
and Rear
Raise
Foot
support Knurled bolts
Mount the gas cylinders. To mount the oxygen and/or compressed air cylinders in their respective
brackets on the transport cart, as illustrated above, loosen the knurled bolts located on the front and
rear, insert the cylinders and tighten the bolts until the cylinders are securely fastened.
35
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings
REF: 158.195.600 Oxygen Cylinder Type E (DOT 3AL) in aluminum, without a control valve ABNT
218-1.
REF: 058.196.600 Compressed Air Cylinder Type E (DOT 3AL) in aluminum, without a control valve
ABNT 218-1.
REF: 058.197.600 Compressed Air Cylinder Type E (DOT 3AL) in aluminum, without a control valve
ABNT 204-1.
REF: 000.259.600 Oxygen Cylinder Type E (DOT 3AL) in aluminum, Yoke standard. Without a control
valve.
REF: 000.260.600 - Compressed Air Cylinder Type E (DOT 3AL) in aluminum, Yoke standard. Without
a control valve.
Note: The control valves can be:
REF: 000.601.020 Oxygen Control Valve with a flow meter 0-15 l/min for O2 and manometer.
REF: 000.617.020 Compressed Air Control Valve with a flow meter 0-15 l/min for air and manometer.
REF: 000.625.020 Control Valve for Compressed Air Cylinder with a manometer and flow meter,
ABNT 204-1.
REF: 000.620.020 Oxygen Control Valve, Yoke standard, with a flow meter 0-15 l/min for O2 and
manometer.
REF: 000.622.020 Compressed Air Control Valve, Yoke standard, with a flow meter 0-15 l/min for air
and manometer.
36
USER MANUAL Installation of the
Equipment
IT-158 TS
Insert the two 10 A type F fuses, packaged separately, in the fuse holder of the charging module.
Connect the AC power cable into the power inlet panel.
Plug the power cable into a 3-way socket.
Power Cable
Power Cable
NOTE: Upon request, the power cable can be supplied in accordance with local laws.
Warning: Do not switch on the Infant Incubator if the hospital grade
socket is not reliably grounded. Check that the voltage and power
into which the Infant Incubator is being plugged correspond to the
specifications on the nameplate of the unit.
Turn on the master switch located on the power inlet panel. The green LED battery charge indicator on
the control panel will light up indicating that the battery charger is operating.
Note: When the batteries are charged, the green LED indicator will remain off.
---
External power cable for 12 V .
---
Plug the cable for 12 V external voltage into its respective outlet on the charging module panel.
---
Plug the cable into an outlet in the vehicle that has a voltage of 12 V .
Warning: Before using the Infant Incubator, the equipment should be
thoroughly cleaned and sterilized according to the instructions found
in this manual and in compliance with the procedures adopted by the
Hospital Infection Control Committee.
37
Operation of the USER MANUAL
Equipment
IT-158 TS
After the auto-test, the display will indicate the air temperature read inside the Infant Incubator.
The LOW TEMPERATURE alarm will be silenced for 40 minutes, corresponding to the time
needed to heat the internal air of the Infant Incubator.
To set the AIR TEMPERATURE, press the AIR MODE key. An audible notification will confirm
the operation. The decimal point of the temperature display will continue blinking to indicate that
the number in the display corresponds to the air temperature set point.
To set the SKIN TEMPERATURE, press the SKIN MODE key. An audible notification will
confirm the operation. The decimal point of the temperature display will continue blinking to
indicate that the number in the display corresponds to the skin temperature set point.
Press the INCREASE or DECREASE keys to set the desired temperature. After four seconds, if
no key is pressed, the display will once again show the AIR and/or SKIN temperature, followed by
an audible notification.
Note: The AIR and/or SKIN temperature set point will be saved even
after Infant Incubator is switched off.
The power supplied to the heating element will be displayed in the four HEATING LEDs. When
the air temperature is equal to the temperature set point, the first LED will remain lit, indicating a
25% power supply.
Wait the time needed for the air temperature to stabilize inside the Infant Incubator.
6.1.2 Alarm and Safety System
Whenever the Control Unit is turned on, the electronic circuit will perform an auto-test to see if all the
LED indicators and the audible alarm are working properly. This verification should be done visually by
the operator of the Infant Incubator.
6.1.2.1 High Temperature Safety Alarm
This alarm is monitored by a circuit and a temperature sensor that are independent from the control
circuit. The air temperature is constantly being monitored, and if this temperature exceeds 40C, the
alarm will be triggered, activating the "high temperature" LED, and the supply of power to the heating
element will be cut. The sound of this alarm can be silenced for 10 minutes by pressing the "AUDIBLE
ALARM SILENCE" key. The LED indicator will remain on until the air temperature is restored.
6.1.2.2 High Temperature Alarm:
6.1.2.2.1 When in Air Mode:
The alarm is activated when the air temperature is at least 1C or more higher than the temperature set
point. The sound can be silenced for 10 minutes by pressing the "AUDIBLE ALARM SILENCE" key.
6.1.2.2.2 When in Skin Mode:
The alarm is activated when the skin temperature is at least 1C or more higher than the temperature
set point. The sound can be silenced for 10 minutes by pressing the "AUDIBLE ALARM SILENCE" key.
6.1.2.3 Low Temperature Alarm:
6.1.2.3.1 When in Air Mode:
The alarm is activated when the air temperature is at least 1C or more lower than the temperature set
point. The sound can be silenced for 10 minutes by pressing the "AUDIBLE ALARM SILENCE" key.
6.1.2.3.2 When in Skin Mode:
The alarm is activated when the skin temperature is at least 1C or more lower than the temperature set
point. The sound can be silenced for 10 minutes by pressing the "AUDIBLE ALARM SILENCE" key.
6.1.2.4 Air Circulation Alarm:
This alarm will be activated when the air flow circulating within the hood is interrupted, or when the
motor stops working or the ventilation circuit is obstructed.
39
General Operating USER MANUAL
Modes
IT-158 TS
The alarm will be triggered within 15 to 120 seconds after the failure occurs. When this alarm is
activated, the supply of power to the heating element will be cut off
The "air circulation" LED indicator will remain on and the sound can be silenced for 10 minutes by
pressing the "AUDIBLE ALARM SILENCE" key. The alarm will automatically cease once air circulation
returns to normal.
Note: During the heating cycle whenever the Infant Incubator is
turned on, the "air circulation" alarm will be silenced (deactivated)
for 40 minutes (the time necessary for the temperature to stabilize).
40
USER MANUAL General Operating
IT-158 TS Modes
Warning: The "No Sensor" alarm is only activated when the Infant
Incubator is in "Skin Mode".
6.2.1 Power
Indicates the type of power source being provided to operate the Infant Incubator. This source can be
---
AC power, internal batteries or external 12 V voltage.
Note: Whenever possible, keep the Infant Incubator plugged into the
wall so that the battery charge is not reduced unnecessarily.
41
General Operating USER MANUAL
Modes
IT-158 TS
Note: Always keep the Infant Incubator plugged into the wall and the
master switch in the "ON" position so that the batteries remain
charged.
Note: When the Infant Incubator is unplugged from the socket and
stored for a long period of time, remove the battery fuse located on
the Charging Module panel to prevent the batteries from
discharging.
Warning: Only use FANEM sensors.
The use of another type of sensor can lead to errors in the reading
of the temperature and harm patients. FANEM sensors are tested
and controlled to ensure repeated use and accuracy.
42
USER MANUAL General Operating
IT-158 TS Modes
FANEM also produces adhesives designed to
attach the skin sensor to the patient.
Warning: Never remove the sensor from the patient's skin by pulling
on the cable. First remove the adhesive and then the sensor.
Warning: Before attaching the sensor to the patient, ensure that the
body of the sensor is clean and does not contain any bits of
adhesive.
43
General Operating USER MANUAL
Modes
IT-158 TS
6.2.8 Humidification
The Transport Infant Incubator has a passive humidification mode for the air circulating within the hood.
This humidification is provided through a sponge moistened with distilled water. Its use is recommended
in situations where additional oxygen is used in the Infant Incubator.
To supply the microclimate with additional humidity, follow the instructions below:
Unlatch and open the frontal and side access doors.
Move the bed through the side door out of the hood to its maximum limit.
Place a new humidification sponge in the appropriate location on the base, underneath the bed
displacement latch, as shown in the drawing.
Wet the sponge located in the base with sterile distilled water.
Put the bed back in its original position and close the access doors.
44
USER MANUAL General Operating
IT-158 TS Modes
45
General Operating USER MANUAL
Modes
IT-158 TS
6.2.9 Oxygen
The IT-158 TS Transport Infant Incubator has a supplementary oxygen input located on the left side,
next to the hood release latches, as shown in the drawing below. The supply of oxygen must be made
by an oxygen cylinder connected to a control valve and flow meter. The oxygen that enters is filtered
and mixes with the air in the microclimate, to be heated and delivered to the hood, where it will be
passively humidified.
Warning:
Improper use of supplemental oxygen may be linked to serious side
effects, including blindness, brain damage and death. The risks vary
with each newborn. The method, concentration and duration of
oxygen administration must be prescribed by the physician.
Oxygen concentrations should always be continuously monitored to
meet patient needs, comply with the medical prescription and to
avoid potential risks.
Warning:
Do not use the equipment in the presence of flammable anesthetics.
Keep all ignition sources (for example, matches, cigarettes,
equipment that generates sparks, etc.) far away from the location
where the Infant Incubator is operating. Textiles, oils and other
combustibles easily ignite in oxygen enriched air.
46
USER MANUAL General Operating
IT-158 TS Modes
ADVERTNCIA
PERIGO DE EXPLOSO:
No use na presena de anestsicos inflamveis
PERIGO DE FOGO:
Mantenha qualquer fonte de ignio ( ex.: Fsforos, cigarros,
equipamentos que produzam fascas, etc. ) longe da sala
onde a Incubadora estiver operando.
Tecidos, leos ou outros combustveis entram em ignio
facilmente quando o ar est enriquecido com oxignio
ATENO:
Radiao trmica pode causar um aumento excessivo da
temperatura interna da Incubadora.
No permita que a Incubadora permanea durante muito
tempo sob as radiaes direta do sol ou outra fonte de calor.
6.3 BabypuffTM 1020 Infant Resuscitator integrated into the Control Panel
TM
The Babypuff 1020 Infant Resuscitator is used in neonatal transport protocols to provide support in
possible emergency situations requiring resuscitation.
TM
To facilitate its use, the Babypuff 1020 Infant Resuscitator can come integrated into the control panel,
as an option for the IT-158 Transport Infant Incubator.
Whenever the IT-158 Transport Infant Incubator is ordered to come with the Babypuff integrated into the
Control Panel, it has a gas strip to simultaneously supply oxygen for the Babypuff and the Infant
Incubator.
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General Operating USER MANUAL
Modes
IT-158 TS
The Babypuff 1020 Infant Resuscitator integrated into the Control Panel of the IT-158 Transport Infant
Incubator contains an analog mano-vacuum gauge for setting, measuring and monitoring pressures. It
uses three mechanical valves to regulate and control Maximum Pressure or Safety Pressure, Peak
Inspiratory Pressure (PIP) and Positive End Expiratory Pressure (PEEP). It also has two quick coupler
connections: a smooth one for the gas input/supply to the equipment and a corrugated one for the gas
output/supply to the patient adapted to an Ayre's T-piece. The connection to the patient can be done
using a tracheal tube or a silicone mask (round and transparent, in three sizes). The set comes with a
test lung and parameter settings to determine the parameters before use with the patient.
The integrated Babypuff 1020 Infant Resuscitator operates directly and exclusively through a gas
source that can be oxygen, compressed air or an Air/O2 mixture controlled by a blender or other type of
mixer.
The Babypuff inlet and outlet gas connections are located on the side of the control panel and on the
base of the Infant Incubator.
The operation of the equipment is the same as the standard Babypuff model. To adjust the pressure
delivered to the patient, the Maximum Pressure Relief and PIP valves are located next to the
manometer, and the PEEP valve, as in the standard model, is located on the Ayre's T-piece, of the
corrugated tube.
6.3.1 Babypuff integrated into the panel
The drawing below shows the items that are integrated into the Infant Incubator and used for the
resuscitation procedure:
ITEM DESCRIPTION
1 Mano-Vacuum Gauge
2 Maximum Pressure Relief (Safety Pressure) Control Valve
3 Inspiratory Pressure (PIP) Control Valve
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USER MANUAL General Operating
IT-158 TS Modes
The Babypuff gas inlet and outlet gas connections are located next to each other, on the side of the
base, close to the source module, as shown below.
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General Operating USER MANUAL
Modes
IT-158 TS
Gas Generation Source: Identify and determine the gas generation source, whether
compressed air, oxygen or an Air/O2 mixture controlled through a blender or administered
through another type of mixer or valve ("Y" type, example).
Ensure that the gas generation source has a calibrated flow meter to control inflow to the
Babypuff 1020 Infant Resuscitator.
Couple the corresponding connector of the gas inlet hose to the outlet of the flow meter of the
gas generation source and connect the other end of the gas inlet hose to the gas inlet port of the
Babypuff 1020 Infant Resuscitator.
Couple the corrugated tube to the gas outlet branch of the Babypuff 1020, with the Ayre's T-
piece on the other end, to which the Test Lung should be coupled.
Turn on the gas source and adjust the supply according to the desired flow, from 5 to 15 lpm.
Warning: A flow of 5-8 lpm is normally used for newborns and a flow of up
to 15 lpm for pediatric use.
Do not use flows greater than 15 lpm.
Safety Pressure Verification: Totally close the three values, starting with safety pressure, and
then inspiratory pressure (PIP) and PEEP, turning the knob clockwise, and then cover with your
finger the aperture in the center of knob of the PEEP valve next to the Ayre's T-piece. Check the
maximum pressure relief (safety pressure) on the manometer, obtained through the supply of gas
(which should be around 50 cmH2O) and then set it, turning the knob counter clockwise. After
this, adjust the opening pressure of the relief valve to the desired amount (up to 40 cmH2O is
recommended).
Regulating the PIP: Keep the PEEP valve next to the Ayre's T-piece closed and covered with
your finger on the aperture in the center of the setting knob. Then, turn the control knob of the
inspiratory pressure valve counter clockwise, until the desired peak pressure is reached Monitor
this setting on the manometer.
Setting the PEEP: To set the PEEP, remove your finger from the aperture in the center of the
PEEP valve setting knob, located next to the Ayre's T-piece. Then, turn the knob counter
clockwise and set the PEEP. Monitor the positive end expiratory pressure (PEEP) setting on the
manometer.
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USER MANUAL General Operating
IT-158 TS Modes
TM
Warning: The Babypuff 1020 Infant Resuscitator must be checked and
set before each use. Make sure that the correct pressures were checked
before authorizing its use for each case and patient.
Routine settings and checks must be in compliance with the resuscitation
protocol adopted at the local service level.
TM
Warning: The Babypuff 1020 Infant Resuscitator should only be used by
health professionals who are properly qualified and authorized to perform
this procedure. It is the responsibility of the health professional to operate
in compliance with current official safety standards and with the protocols
at the local service level when using this product for therapeutic
procedures on patients.
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Preventive and USER MANUAL
Corrective Maintenance
IT-158 TS
and Conservation
52
USER MANUAL Preventive and Corrective
Maintenance and
IT-158 TS
Conservation
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Preventive and USER MANUAL
Corrective Maintenance
IT-158 TS
and Conservation
Warning: If these pieces and parts are re-sterilized after use, the
strength of the materials and the maintenance of their integrity
should be taken into account in order not to jeopardize the
operation of the device in its next use.
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USER MANUAL Preventive and Corrective
Maintenance and
IT-158 TS
Conservation
Assemble the equipment and test that it works, keeping it preset and switched on in order to
maintain the cleaning and/or disinfection conditions, heating and battery charge.
7.2.4 Infection control applied to the use of the Infant Incubator:
Use the correct and complete procedure for terminal cleaning and/or disinfection of the
equipment between each use.
Keep the Infant Incubator on and running after terminal cleaning or disinfection to maintain its
internal sanitary conditions, through insulation, while waiting for new usage.
Warning:
The following should not be used:
Unsuitable products (alcohol, solvents, antiseptics, chlorine,
soaps and cleaning products in general)
Fabrics that may harm or scratch the hood
Sponges in general
Equipment that generates hot steam
Hose for wetting the equipment
Cleaning the equipment while it is plugged into the wall
Untrained employee to disassemble and assemble the
equipment
Plug the equipment into the wall and leave it switched on, presetting the temperature, such as at 36C,
or as per the operational procedures in the sector. This is necessary to maintain the heating,
disinfection and cleaning conditions through the filtration and forced circulation of the air, until the Infant
Incubator is used again, as well as to keep the batteries charged.
7.3 Air Filter
Warning: The Air Filter is a consumable and disposable item. It
should not be cleaned or placed with the dirty side facing inward. It
should always be changed when totally dirty, or at least every 45
days
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USER MANUAL Preventive and Corrective
Maintenance and
IT-158 TS
Conservation
When oxygen is delivered to the transport Infant Incubator by a flow meter (lpm), the concentration
table, on the front of the Infant Incubator, serves only as a guide for oxygen concentration in the Infant
Incubator's microclimate. Oxygen concentration should be frequently measured with a calibrated
oxygen analyzer.
Warning: Do not use a humidifier bottle on the flow meter supply
outlet, to not wet the oxygen filter, which can lead to a risk of
contamination.
The supply of oxygen concentrations above 21% in the internal environment of the Infant Incubator can
be affected by any opening of the access ports or side walls of the hood or even as a result of improper
installation of fittings and protective tube inserts.
The use of separate cylinders for the supply of gases, such as oxygen, presents risks and should not be
used without taking the recommended precautions.
Accumulated dirt in the air filter can affect the volume per minute of ambient air admitted to the Infant
Incubator and consequently contribute to carbon dioxide (CO2) build-up in the microclimate. Always
check the condition of the air filter whenever the equipment is sanitized for new use and make the
necessary changes according to the instructions contained in this manual.
7.5 Maintenance
7.5.1 Batteries of the Charging Module (Vital Module):
Check the state of the batteries before using the transport Infant Incubator, or every three months.
To confirm whether the batteries are charged, turn on the Transport Infant Incubator in battery power
mode (indicated as - - -) and keep the master switch in the off position. Set it a temperature that is
higher than room temperature so that all the LED power indicators will remain lit. Turn on the auxiliary
lighting and observe. If the "battery voltage" alarm is not triggered within five minutes, this means the
batteries are charged.
Note: Always keep the transport Infant Incubator plugged into the
wall with the master switch in the ON ( l ) position so that the
batteries remain charged.
The batteries can last up to 30 hours.
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Preventive and USER MANUAL
Corrective Maintenance
IT-158 TS
and Conservation
If the batteries need to be changed, this should only be done by a qualified and trained technician. The
procedure for removing the Charging Module is outlined in the section "Parts, Pieces and Accessories"
in this Manual.
7.5.2 Battery for the Power Failure Alarm
This battery should be changed after 12 months of use. Replacing the battery should only be performed
by a qualified technician.
Warning: Do not use normal or alkaline 9V batteries, due to the risk
of explosion. Only use only rechargeable NiCd batteries supplied by
FANEM.
The air filter should always be kept dry. If there are signs of moisture due to storage or misuse, the filter
must be changed to avoid contamination of the inner layers of the filter and subsequent contamination
of the inner environment of the Infant Incubator.
Use original filters specifically for the IT-158 TS Transport Infant Incubator, since they have a particular
area and thickness to properly cover the air flow duct. They cannot be cut or folded to be adapted to the
equipment, or scraped off for reuse.
If there is no air filter, or saturated or inappropriate filers are used, this can affect the air circulation
inside the Infant Incubator and the uniformity of the heating. It also alters the gas exchange levels, the
time needed to enrich the oxygen concentration, the carbon dioxide elimination levels, the imperceptible
loss of body water and the systematic transfer of heat, for which the Infant Incubator was designed.
7.5.4 Fittings and Elastic Cuffs:
Regularly check the integrity and conditions of use of the fittings and elastic cuffs to ensure full
operation of the equipment.
If the parts are dried or damaged through use, change them, always using original Fanem parts.
Replacement time depends on usage, the products used for cleaning and/or disinfection and the care
taken in handling the parts.
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USER MANUAL Preventive and Corrective
Maintenance and
IT-158 TS
Conservation
7.5.7 Calibration:
The air temperature sensors, as well as the safety temperature sensors, should be calibrated regularly
every 4 to 6 months.
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Preventive and USER MANUAL
Corrective Maintenance
IT-158 TS
and Conservation
7.6.1 Consumables
---
Warning: Do not use normal or alkaline 9V batteries, due to the
risk of explosion. Only use only rechargeable NiCd batteries
supplied by FANEM.
To replace the battery for the power failure alarm, remove the charging module, take out the battery and
change it. There is no risk of inadvertent connections, since the connector is polarized.
7.8 Disposal
Do not throw electronic devices or parts in the
trash when disposing of the equipment or its
parts.
To minimize pollution and ensure the utmost
protection of the environment, adopt the
indicated recycling measures. For more
information on the subject, research topics
related to Waste Electrical and Electronics
Equipment (WEEE).
If the equipment or parts need to be disposed of, and the customer has not defined a specific
destination for them, the item(s) in question should be sent to the manufacturer or its legal
representative, for appropriate disposal measures to be taken, in accordance with national laws.
Note: The equipment and/or its parts must be sent in clean and aseptic conditions.
Failure to do so releases the supplier from responsibility for potential impacts on the environment and/or
people.
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Preventive and USER MANUAL
Corrective Maintenance
IT-158 TS
and Conservation
It is the user's responsibility to establish a routine maintenance procedure, to ensure the correct and
safe performance of the equipment.
Part Frequency Performed by
Air Filter 45 days (replacement) User / Technician
3 months
7.10 Troubleshooting
The alarms on the Control Panel can be checked through performing a simulation. For system alarms
not listed below, consult an authorized service technician.
Warning: When the "AUDIBLE ALARM SILENCE" key is pressed to
deactivate the alarm, the alarm will remain deactivated for 10
minutes, after which it will return to normal mode.
B3 point on the power supply board. Within 120 seconds, the audible and visual "Air Circulation" alarm
should be activated.
Warning: When the Infant Incubator is switched on, this alarm will
remain deactivated for 40 minutes, after which it will go into active
working mode.
64
USER MANUAL Warranty and Technical
Assistance
IT-158 TS
Cinterqual LTDA
Travessa da Anunciada, 10 2 Esq-F
2900-238
Setbal Portugal
Phone: +351 265 238 237
FANEM LTDA.
Rua Arthur Carl Schmidt, 186
CEP 07222-050 Guarulhos SP Brasil
CNPJ 61.100.244/0001-30
www.fanem.com.br
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