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USER MANUAL

IT-158 TS

USER MANUAL

TRANSPORT INFANT INCUBATOR


IT-158 TS

FANEM

Technical Standard - NBR IEC 60601-1 Review: 14/13


NBR IEC 60601-1-2 Edition: 12/13
NBR IEC 60601-2-20

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

1. IDENTIFICATION OF THE EQUIPMENT .......................................................................................................... 6


2. TECHNICAL SPECIFICATIONS ........................................................................................................................ 8
2.1 DEFINITIONS .................................................................................................................................................. 8
2.2 ELECTRICAL SPECIFICATIONS .............................................................................................................................. 9
2.3 FUSES ........................................................................................................................................................... 9
2.4 CLASSIFICATION AND CHARACTERISTICS ............................................................................................................... 9
2.5 CONTROL FEATURES ...................................................................................................................................... 10
2.5.1 Alarms .............................................................................................................................................. 10
2.5.2 Silencing the Audible Alarm.............................................................................................................. 11
2.5.3 Temperature Adjustment Range ...................................................................................................... 11
2.5.4 Reading Range of the Temperature Indicators: ............................................................................... 11
2.6 TYPICAL SET POINTS ...................................................................................................................................... 11
2.7 PHYSICAL SPECIFICATIONS ............................................................................................................................... 12
2.7.1 Hood / Bed Specifications ................................................................................................................. 12
2.8 MAXIMUM LOADS......................................................................................................................................... 12
TM
2.9 INTEGRATED BABYPUFF 1020 INFANT RESUSCITATOR (OPTIONAL ITEM) ............................................................... 12
2.10 SYMBOLS ..................................................................................................................................................... 13
2.10.1 Symbols Packaging ........................................................................................................................ 14
2.11 CIRCUMSTANTIAL REQUIREMENTS .................................................................................................................... 14
3. PARTS, PIECES AND ACCESSORIES .............................................................................................................. 15
3.1 HOOD ......................................................................................................................................................... 16
3.2 CONTROL PANEL ........................................................................................................................................... 17
3.3 BED ............................................................................................................................................................ 17
3.4 CHARGING MODULE (VITAL MODULE) .............................................................................................................. 18
3.5 BASE........................................................................................................................................................... 19
3.6 AIR FILTER ................................................................................................................................................... 19
3.7 AUXILIARY LAMP ........................................................................................................................................... 20
3.8 AUXILIARY SHELF FOR MONITORS ...................................................................................................................... 20
3.9 BLENDER ..................................................................................................................................................... 21
3.10 DUAL STRIP FOR O2 DISTRIBUTION ................................................................................................................... 21
3.11 BABYPUFF RAIL FASTENER............................................................................................................................... 21
3.12 DOUBLE TUBE INSERTS ................................................................................................................................... 22
3.13 IRIS PORT SLEEVE .......................................................................................................................................... 22
3.14 SERUM HOLDER ............................................................................................................................................ 22
3.15 CARTS AND STRETCHERS ................................................................................................................................. 23
3.15.1 Transport Cart with X-shaped structure ........................................................................................... 23
3.15.2 Fixed-height transport cart .............................................................................................................. 23
3.15.3 Flat Ambulance Stretcher ................................................................................................................. 23
3.15.4 Retractable stretcher with head end elevation ................................................................................ 23
3.15.5 Flat Ambulance Stretcher with Bi-Articulated Feet .......................................................................... 24
3.16 MANUAL INFANT RESUSCITATOR MODEL 020 ..................................................................................................... 24
3.17 BABYPUFF 1020 INFANT RESUSCITATOR ......................................................................................................... 24
3.18 COMPRESSED AIR AND OXYGEN CYLINDERS ........................................................................................................ 25
3.19 CONTROL VALVES FOR CYLINDERS .................................................................................................................... 25
3.20 RELIEF VALVES FOR CYLINDERS ........................................................................................................................ 25
4. PRECAUTIONS, RESTRICTIONS AND WARNINGS ........................................................................................ 26
4.1 EXPLOSION HAZARD: PRECAUTIONS .................................................................................................................. 28
4.2 OXYGEN: PRECAUTIONS ................................................................................................................................. 29
Table of Contents USER MANUAL
IT-158 TS

4.2.1 Oxygen Administration: Precautions ................................................................................................ 29


4.3 ELECTROMAGNETIC COMPATIBILITY AND IMMUNITY............................................................................................. 30
5. INSTALLATION OF THE EQUIPMENT ........................................................................................................... 35
5.1 INSTALLATION PROCEDURE.............................................................................................................................. 35
6. OPERATION OF THE EQUIPMENT ............................................................................................................... 38
6.1 CONTROL PANEL ........................................................................................................................................... 38
6.1.1 Turning on the Infant Incubator ....................................................................................................... 38
6.1.2 Alarm and Safety System ................................................................................................................. 39
6.1.3 Battery Voltage Level Alarm:............................................................................................................ 40
6.1.4 Power Failure Alarm: ........................................................................................................................ 41
6.1.5 No Skin Sensor Alarm: ...................................................................................................................... 41
6.2 OPERATIONAL INDICATORS.............................................................................................................................. 41
6.2.1 Power ............................................................................................................................................... 41
6.2.2 Battery Charge ................................................................................................................................. 41
6.2.3 Heating Indicator.............................................................................................................................. 42
6.2.4 Temperature Indicator ..................................................................................................................... 42
6.2.5 Skin Temperature Sensor.................................................................................................................. 42
6.2.6 Temperature Control ........................................................................................................................ 43
6.2.7 Operating Mode with Newborns ...................................................................................................... 44
6.2.8 Humidification .................................................................................................................................. 44
6.2.9 Oxygen.............................................................................................................................................. 46
TM
6.3 BABYPUFF 1020 INFANT RESUSCITATOR INTEGRATED INTO THE CONTROL PANEL................................................... 47
6.3.1 Babypuff integrated into the panel .................................................................................................. 48
6.3.2 Pieces used with the Babypuff.......................................................................................................... 49
6.3.3 Installation of the pieces used with the Babypuff ............................................................................ 50
6.3.4 Operation of the Babypuff................................................................................................................ 51
7. PREVENTIVE AND CORRECTIVE MAINTENANCE AND CONSERVATION ....................................................... 52
7.1 CLEANING AND CONSERVATION ....................................................................................................................... 52
7.1.1 Acrylic Hood...................................................................................................................................... 52
7.1.2 Structure of the Infant Incubator ..................................................................................................... 52
7.1.3 Disassembly for Cleaning ................................................................................................................. 53
7.1.4 Heating Element, Blower Rotor and Thermostats ............................................................................ 53
7.1.5 Integrated Babypuff Parts ............................................................................................................. 54
7.2 CLEANING AND/OR DISINFECTION PROCEDURE ................................................................................................... 55
7.2.1 Adoption of the cleaning procedure: ................................................................................................ 55
7.2.2 Adoption of the disinfection procedure: ........................................................................................... 55
7.2.3 Mandatory aspects for performing cleaning and/or disinfection procedures:................................. 55
7.2.4 Infection control applied to the use of the Infant Incubator: ........................................................... 56
7.3 AIR FILTER ................................................................................................................................................... 56
7.3.1 Changing the Air Filter...................................................................................................................... 56
7.4 OXYGEN - PRECAUTIONS................................................................................................................................. 57
7.5 MAINTENANCE ............................................................................................................................................. 57
7.5.1 Batteries of the Charging Module (Vital Module): ........................................................................... 57
7.5.2 Battery for the Power Failure Alarm ................................................................................................ 58
7.5.3 Air Filter: ........................................................................................................................................... 58
7.5.4 Fittings and Elastic Cuffs: ................................................................................................................. 58
7.5.5 Humidifier Sponge: ........................................................................................................................... 59
7.5.6 Oxygen Cylinders and Valves: ........................................................................................................... 59
7.5.7 Calibration: ....................................................................................................................................... 59
7.6 SPARE PARTS................................................................................................................................................ 60
USER MANUAL Table of Contents
IT-158 TS

7.6.1 Consumables .................................................................................................................................... 60


7.7 BATTERY FOR THE POWER FAILURE ALARM ........................................................................................................ 60
7.8 DISPOSAL .................................................................................................................................................... 61
7.9 MAINTENANCE CHART ................................................................................................................................... 62
7.10 TROUBLESHOOTING ....................................................................................................................................... 62
7.11 CHECKING THE ALARMS .................................................................................................................................. 63
7.11.1 "No Sensor" Alarm............................................................................................................................ 63
7.11.2 "Air Circulation" Alarm ..................................................................................................................... 63
7.11.3 "High Temperature" Alarm .............................................................................................................. 64
7.11.4 "Low Temperature" Alarm ............................................................................................................... 64
7.11.5 "Power Failure" Alarm ...................................................................................................................... 64
8. WARRANTY AND TECHNICAL ASSISTANCE ................................................................................................. 65

Notes
Identification of USER MANUAL
the Equipment
IT-158 TS

1. Identification of the Equipment


The IT-158 TS Transport Infant Incubator is designed to safely transport newborns, including high risk
cases such as those born prematurely or with serious illnesses, whether internally between different
departments or externally to or between hospitals.
It also has an operating module with an automatic charger and two 12V rechargeable batteries, which
ensures transport for up to four hours. As an option, an adapter is provided for external 28V inputs.
The IT-158 TS Infant Incubator uses a microprocessor to control and monitor the parameters, which are
displayed on an easy-to-view and operate panel for adjusting the conditions of the microclimate
according to the clinical needs of each newborn and modes of transport. This enables protective
insulation through air microfiltration and positive internal air pressure, heating in Air Mode and Skin
Mode, different oxygen concentrations and passive relative humidity.
The double-walled hood provides full patient visibility and access, as well as effective thermal insulation,
and maintains a neutral thermal environment to receive and keep the patient warm.
Three access doors (side, front and back), four access ports and two double tube inserts facilitate the
performing of procedures on the newborn, when necessary, by even more than one professional.
The bed can be displaced and maintained outside the hood through rails, via the side door, enabling
access to the patient's head and torso for external care, as well as special procedures, in emergency
situations, ensuring in the process that adequate heating is provided.
The Infant Incubator is equipped with LED lighting to observe patients in low-light environments.
This Infant Incubator was designed to operate in a 127V~ or 220V~ electrical system, or with an
external 12 VCC power supply in ambulances or aircraft. It can also operate with internal batteries that
last four hours when fully charged and that are constantly being charged when the unit is plugged into
the wall.
This product should only be used by properly trained and qualified personnel to achieve the desired
results for internal and external transport, ensuring quality and safety for both the patient and user.

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.

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USER MANUAL Identification of
the Equipment
IT-158 TS

TM
Option with integrated Babypuff 1020

Warning: Carefully read this manual before turning on the unit.

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.

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USER MANUAL Technical
Specifications
IT-158 TS

2.2 Electrical Specifications


External supply voltage 127V~ or 220V~ 10%
---
Internal supply voltage (two rechargeable batteries) 12 V
Frequency 50 or 60 Hz
Leakage Current (for the cabinet) < 100 A
Power (external power supply) 180 W
Power (internal power supply) 115 W
Minimum Battery Charging Time (for fully discharged
30 hours
batteries)
Duration (when fully charged) 4 hours
200
Battery Life Expectancy
(charges and discharges)

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

2.4 Classification and Characteristics


Protection against electric shock Class l
Applied Part BF Type
Liquid Ingress Protection IPX4
Protection against Explosive Atmospheres Non-AP / Non-APG
Maximum % of CO2 < 0.2%
Air Velocity over the Mattress < 0.35 m/s
Sound level within the compartment (external environment <45
< 60 dBA
dBA)
Note: Values and classifications according to NBR IEC 60601-1 and NBR IEC 60601-2-20 standards

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Technical USER MANUAL
Specifications
IT-158 TS

2.5 Control Features

Temperature Display Resolution 0.1C

Temperature Rise Time (external ambient temp. = 25C) 45 min

Temperature Overshoot 0.8C


Temperature Uniformity < 0.6C

Air Temperature Variation 0.2C

Oxygen Concentration (% O2) 21% to 80%

2.5.1 Alarms
2.5.1.1 System Alarms

Power Failure Activated when the electricity is cut.


Activated within 15 to 120 seconds after an air
Air Circulation Failure
circulation stoppage.
Activated when the battery voltage reaches a
Battery Voltage Level
minimum level of 10.5 V.
Indicates that the polarity of the external voltage has
Reverse Polarity
been reversed.

2.5.1.2 Temperature Alarms

High Temperature (safety) Activated at 40C.


Activated when the air temperature is 1C or more higher
High Temperature
than the temperature set point.
Activated if the air temperature in the hood is 1C below
Low Temperature (ATC)
the set point.
Activated if the air temperature in the hood is 1C above
High Temperature (ATC)
the set point.
Activated if the skin temperature of the newborn is 1C
High Temperature (ITC)
above the set point.
Activated if the skin temperature of the newborn is 1C
Low Temperature (ITC)
below the set point.
Activated when the Skin Sensor plug is disconnected, or if
there is a bad connection in the sensor cable, or if it is not
Sensor Failure
properly attached to the patient's skin. Only operates in
Skin Mode.

Warning: The temperature set points will be memorized after being


set.

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USER MANUAL Technical
Specifications
IT-158 TS

2.5.2 Silencing the Audible Alarm


Silences the sound for 10 minutes, after which it will return to normal mode.

2.5.3 Temperature Adjustment Range

Air Mode 20C to 39C *


Skin Mode 34C to 38C
(*) Air temperatures ranging from 20C to 30C are used as a preheating parameter for the Infant
Incubator. The Transport Infant Incubator normally uses air temperatures from 30C to 39C. The
equipment can accommodate a range from 20C to 39C. Determining the control temperature is a
clinical decision.

2.5.4 Reading Range of the Temperature Indicators:

Air Mode (ATC) 20C to 45.5C


Skin Mode (ITC) 20C to 45.5C

2.6 Typical Set Points


Air Temperature 34C
Skin Sensor Temperature 34C

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Technical USER MANUAL
Specifications
IT-158 TS

2.7 Physical Specifications


Infant Incubator on transport cart
Width 56.5 cm
Depth 102 cm
Height with cart in upper position 118.7 cm
Height with cart in lower position 88.3 cm
Weight with accessories 86.7 kg
6" Swivel Caster with brake 4 units

2.7.1 Hood / Bed Specifications

Oval Access ports 4 units


Access Doors Frontal / Back / Side
Tube Inserts 4 units
Mattress Size 32 cm x 63 cm
Internal Height between the Mattress and the Hood 23 cm
Mattress Passage Height / Access Door 18 cm

2.8 Maximum Loads


Serum Holder 2 kg
Auxiliary Shelf 10 kg
Bed 7 kg

2.9 Integrated BabypuffTM 1020 Infant Resuscitator (optional item)


Operating Range of the Mano-Vacuum - 20 to 80 cmH2O (mbar)
Gauge
Accuracy of the Mano-Vacuum Gauge +/- 2% (upper range limit)
Maximum Pressure of the Mano-Vacuum 65 - 80 cmH2O (mbar) *
Gauge
Input flow 0 - 15 lpm
Input pressure of recommended gases 3.5 kgf
*depending on the input flow

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USER MANUAL Technical
Specifications
IT-158 TS

2.10 Symbols

Type BF Equipment Type BF Equipment


Class l Class l

IPX4 Equipment
Warning: Consult manual IPX4
Protected against water splashing
against the enclosure from any direction

Grounding required Protective grounding

Warning: Potential damage


to the equipment and its Warning: Risk of Electric Shock
parts

OFF (No Power Supply ON (With Power Supply


Voltage) Voltage)

Warning: Potential hazards


Alternating Current
for people

Equipment not suitable for use


Warning: Hot surface with inflammable anesthetic
mixtures

Continually Operating
Silence
Equipment

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Technical USER MANUAL
Specifications
IT-158 TS

2.10.1 Symbols Packaging

Fragile This Side Up

Protect from Sunlight Protect from Rain

Warning: Consult accompanying


Stacking Limit
documents

Temperature limit for


Prohibited to use a hook or to drill
transport and storage

2.11 Circumstantial Requirements


Storage Temperature Range 0C to 55C Ambient
Operating Humidity Range 15% to 95% Non-condensing
Storage Humidity Range 0% to 90% Non-condensing
Operating Temperature Range (Normal) 0C to 30C Ambient
Operating Temperature Range (Limited)* -5C to 0C and 30C to 40C Ambient
*Note: In the limited operating temperature range, temperature control in the Infant Incubator can be
affected by external ambient temperature conditions.
Warning: During external transport, expose the Infant Incubator to
adverse conditions the least time possible. In extreme ambient
temperatures, the Infant Incubator may not be able to maintain the
desired temperature.

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USER MANUAL Parts, Pieces
and Accessories
IT-158 TS

3. Parts, Pieces and Accessories


The materials used in the design of parts and accessories and consumables aim to ensure the perfect
operation of the equipment according to its original features, as well as safety in terms of the toxicity,
flammability and biocompatibility of the materials used.

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

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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.

Warning: When putting the acrylic hood back on the Infant


Incubator, do not forget to fasten it with the "B" rubber rings.

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USER MANUAL Parts, Pieces
and Accessories
IT-158 TS

3.2 Control Panel


Control of the equipment's parameters is
performed using a display panel that, as an
option, can come with the integrated
TM
Babypuff 1020 Infant Resuscitator.
The commands of the control panel enable the
air and skin temperature set points to be
determined, as well as the operating mode that
will be used (AC power or battery).
The alarm indications are displayed on the
same panel, as well as the indication of the
operating mode (AC mode wall power and
DC mode battery) and the heating power of
the Infant Incubator.

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.

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Parts, Pieces and USER MANUAL
Accessories IT-158 TS

3.4 Charging Module (Vital Module)


The Charging Module is comprised of a rack
- - -
which contains two 12V rechargeable
batteries and a charger. The module is
connected via a comb-type connector to
facilitate its removal.
The panel of this module contains the
protective fuses for the internal batteries and
those for external power supply, as well as the
outlet for the 12V external power supply cable.
It also has an audible and visual alarm
indicating reverse polarity if the external voltage
connection is reversed.
The charger keeps the batteries constantly
charged. The "battery charge" green LED on
the front panel indicates that the batteries are
being charged. The automatic circuit of the
charger allows the device to remain plugged in
the wall indefinitely without damage to the
batteries.

To remove the Charging Module, remove screw


"A", as shown in the drawing. Pull the module
slowly out to a distance of 15 cm
approximately. Hold the module firmly with both
hands and slowly remove it.

3.4.1.1 Converter Unit 28 V (optional)


This optional converter unit makes it possible to convert the 28 V voltage of aircraft and ambulances to
12 V, enabling the Infant Incubator to be powered by direct current during transport.

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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

Warning: The upper base can be removed in order to sanitize the


components of the lower base during the terminal cleaning and/or
disinfection procedures for the equipment, performed by the user.

3.6 Air Filter


The function of the air filter, located in the
compartment on the rear of the Infant
Incubator, is to prevent the passage of particles
larger than 0.5 microns and thereby supply
highly pure internal air.
To remove the air filter, unscrew the two
knurled "C" screws, shown in the drawing to the
right, remove the protective cover and take out
the filter.
Note Consumable item. Exclusive size for the
IT-158 TS.

Warning: The air filter should be changed every 45 days.


In more contaminated environments, it is recommended to change it
more frequently or whenever necessary. Check the filter regularly.

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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.

3.7 Auxiliary lamp


The auxiliary lamp is mounted on a flexible rod
and composed of high intensity white LEDs, for
the purpose of illuminating patients in low-light
environments.
It works on both AC power and batteries, and
has its own switch.

3.8 Auxiliary shelf for monitors


Safety equipment, such as monitors, infusion
pumps, ventilators and other peripherals, can
be placed on and fastened to the auxiliary
stainless steel shelf.
It is equipped with an articulator, which can be
lifted, to provide full access to the hood. It also
has suction cups that enable it to be placed on
the hood without damaging it or causing friction
or noise.

Warning: Optional item.

Warning: Do not use the articulator when there are objects on the
shelf.

Warning: Maximum shelf load: 10 kg

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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

Warning: Optional item.

3.10 Dual Strip for O2 Distribution


Mounted on the rod of the auxiliary shelf, this
dual strip enables the simultaneous supply of
oxygen to the Infant Incubator and serves as an
inlet for the blender to be used with the manual
TM
Babypuff 1020 Infant Resuscitator.

Warning: Optional item.

3.11 Babypuff Rail Fastener


A clamp for fastening the Babypuff to the
auxiliary shelf, ensuring safe coupling for the
standard model, as well as the Babypuff
models that come with the blender.

Warning: Optional item.

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Parts, Pieces and USER MANUAL
Accessories IT-158 TS

3.12 Double Tube Inserts


Located on the side door, the two double tube
inserts make it easier to introduce and position
devices, such as ventilator circuits, CPAP
circuits or other applications, for access to the
newborn's head.
Made of silicone, they are easy to remove and
facilitate cleaning and/or disinfection
procedures.

3.13 Iris Port Sleeve


As an option, the Iris Port Sleeve can be
provided to replace the two double tube inserts,
upon request.

Warning: Optional item.

3.14 Serum Holder


A serum holder can be installed on the side of
the Infant Incubator to facilitate the
administration of solutions, even during
transport.

Warning: Optional item.

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USER MANUAL Parts, Pieces
and Accessories
IT-158 TS

3.15 Carts and Stretchers


3.15.1 Transport Cart with X-shaped structure
X-shaped transport cart with aluminum
structure and shock absorbers. Equipped with
four 6" casters, with brake. Ideal for internal
and external transport, since it can be placed in
three positions: high, intermediate and low.

Warning: Optional item. When purchasing the kit, the height


between the ground and the floor of the vehicle must be provided in
order to correctly define the stretcher.

3.15.2 Fixed-height transport cart


Transport cart with aluminum structure.
Equipped with four 6" casters, with brake. Ideal
for internal transport, due to its high-only
position.

Warning: Optional item.

3.15.3 Flat Ambulance Stretcher


Transport stretcher with four 5" casters, with
brakes, and a set of casters to provide
assistance when placing and removing the
equipment from vehicles
The Infant Incubator is fastened to the
stretcher.
Warning: Optional item.
When the kit is purchased, the height between the ground and the
floor of the vehicle
vehicle must be provided in order to correctly define the
stretcher.

3.15.4 Retractable stretcher with head end elevation


Transport stretcher with four 5" casters, with Transport stretcher with four 5" casters, with
brakes, and a set of casters to provide brakes, and a set of four casters (two 5" ones
assistance when inserting and removing the and two 4" ones) for inserting and removing the
equipment from vehicles equipment from vehicles.
The stretcher is equipped with an Adaptation
Kit for coupling with the IT-158 TS Transport
Infant Incubator.
The quick coupling system facilitates assembly
and disassembly procedures of the unit.

Warning: Optional item.


When the kit is purchased, the height between the ground and the
floor of the vehicle must be provided in order to correctly define the
stretcher.
23
Parts, Pieces and USER MANUAL
Accessories IT-158 TS

3.15.5 Flat Ambulance Stretcher with Bi-Articulated Feet


Flat ambulance stretcher with an independent
double articulation system in the feet and
rubberized 7.5" casters to facilitate transport
over uneven terrain.
The Infant Incubator is fastened to the
stretcher.
Warning: Optional item. The height between the floor of the vehicle
and the ground must be provided in order to define the stretcher.

3.16 Manual Infant Resuscitator model 020


3.16 Manual Infant Resuscitator model 020,
made of silicone, with an oxygen accumulator
tube, size "0" mask, 40 cm H2O safety valve
and plastic case.
ANVISA Registration No.: 10.224.620.036

Warning: Optional item.

3.17 Babypuff 1020 Infant Resuscitator


This portable manual resuscitation device It comes with a gas inlet hose, a corrugated
enables the operator to adjust, execute and tube with an Ayre's T-piece, a set of three
monitor pressure and parameterize the silicone masks (sizes 00 /0 / 1) and a test lung.
resuscitation process of the newborn, through
ANVISA Registration No.: 10.224.620.065
three valves: safety or relief; PIP (peak
inspiratory pressure) control and PEEP
(positive end expiratory pressure) control in a
single precision mano-vacuum gauge on a
scale up to 80 cm/H2O, providing greater
safety, efficacy and effectiveness for the
patient, as well as operator comfort.
TM
The Babypuff 1020 Infant Resuscitator can
be operated through a flow meter with up to 15
liters/min of oxygen, or compressed air or
through a blender to administer the exact
prescribed oxygen concentration.

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.

Warning: Optional item.

24
USER MANUAL Parts, Pieces
and Accessories
IT-158 TS

3.18 Compressed Air and Oxygen Cylinders


To supply gas to the equipment, during
transport, compressed air and oxygen cylinders
are provided, with connections according to the
standards ABNT 204-1 (compressed air) and
ABNT 218-1 (oxygen). The cylinders are
arranged and fastened in the compartments for
this purpose, located on the lower part of the
base of the Transport Infant Incubator.

Warning: Optional items.

3.19 Control Valves for Cylinders


To use the cylinders, control valves are
provided that are compatible with the air and
oxygen cylinders, with connections in
accordance with the standards ABNT 204-1
(compressed air) and ABNT 218-1 (oxygen).

Warning: Optional items.

3.20 Relief Valves for Cylinders


To use the cylinders, pressure relief valves (3.5
kgf) are provided that are compatible with the
air and oxygen cylinders, with connections in
accordance with the standards ABNT 204-1
(compressed air) and ABNT 218-1 (oxygen).

Warning: Optional items.

25
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings

4. Precautions, Restrictions and Warnings


Warning: This section of the User Manual contains
extremely important information to ensure the
safety and integrity of the patient, user and
equipment. Read it CAREFULLY!

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.

Warning: Do not use extension cords or multiple sockets. If it is not


properly grounded, do not use the equipment.

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.

Warning: Any set point parameters of this equipment must be


according to medical instructions.
FANEM and its representatives shall not be liable for any damages
resulting from the improper use of the parameters established by
the user.

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.

Warning: To avoid overheating of the patient due to direct radiation, do


not place the transport Infant Incubator in direct sunlight or under other
radiant heat sources. In such situations, the temperature controlled
operating condition may be adversely affected.

27
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings

Warning: During transport, the protective devices designed to protect the


patient while in bed should be inspected regularly to ensure that they
are functioning properly.

Warning: It is recommended to monitor the patient's temperature with a


clinical thermometer to more accurately measure and detect hypothermia
or hyperthermia.

Warning: Unfavorable ambient conditions (such as air-conditioning,


positioning or opening of doors) can affect the thermal control of the
patient.

Warning: Never place the skin temperature sensor underneath the


newborn, or use it to measure rectal and/or axillary temperature.
The skin temperature sensor must always be in direct contact with
the skin to provide an accurate reading of the newborn's skin
temperature. Improper positioning of the skin sensor can cause
increased heat to be delivered to the patient, possibly resulting in
overheating and harm to the patient. Check the condition of the
newborn continuously to confirm that the sensor is correctly
attached and to monitor the skin temperature reading shown on
the display panel.

4.1 Explosion Hazard: Precautions


Never use this Infant Incubator in the presence of flammable anesthetics.
Make sure that the oxygen supply to the equipment is turned off and disconnected from the oxygen inlet
when cleaning or performing maintenance procedures. There is a risk of fire or explosion when cleaning
and/or maintenance procedures are performed in an oxygen enriched environment.
Keep matches, lighted cigarettes and all other possible ignition sources out of the location where the
Infant Incubator is operating. Textiles, oils and other combustibles easily ignite and burn in oxygen
enriched air.
Flammable agents left in the equipment can cause a fire when in contact with oxygen.
Equipment that may cause sparks, such as defibrillators or electrocautery devices, should not be used
when the oxygen supply to the Infant Incubator is being used.
Warning: Small quantities of flammable agents left in the equipment, such
as alcohol, may cause a fire when in contact with oxygen. Never use this
Infant Incubator in the presence of flammable anesthetics.

28
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS

4.2 Oxygen: Precautions


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 a physician.
Oxygen concentrations should always be continuously monitored to meet patient needs, comply with
the medical prescription and to avoid potential risks.

Warning: Always use an oxygen analyzer to verify the


concentration of oxygen being administered. It is recommended
to use the THOR 3620 Oxygen Analyzer for this purpose.

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.

Warning: There is a risk in administering oxygen at high


concentrations for extended periods of time to newborns. Strictly
follow the medical prescription and frequently monitor and
evaluate the concentrations supplied in comparison with the
clinical conditions and parameters of the patient.

4.2.1 Oxygen Administration: Precautions


The oxygen analyzers that are used must be properly calibrated.
The air filter must be changed on a routine basis, at least after 30 to 45 days of use, or whenever
necessary. Dirty filters affect air and oxygen administration in the Infant Incubator.

Warning: During the administration of oxygen, the noise level


may rise for the patient inside the Infant Incubator.

29
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings

4.3 Electromagnetic Compatibility and Immunity


This deals with the ability of equipment and/or systems to operate in an electromagnetic environment,
without introducing unacceptable electromagnetic disturbances to any object or person in the
environment and also perform without degradation in the presence of an electromagnetic disturbance.
This equipment was designed and tested to comply with the following electromagnetic compatibility
standards.
EN 60601-1-2 IEC 61000-4-3
NBR IEC 60601-1-2 IEC 61000-4-4
CISPR11 IEC 61000-4-5
IEC 61000-3-2 IEC 61000-4-6
IEC 61000-3-3 IEC 61000-4-8
IEC 61000-4-2 IEC 61000-4-11
Found within the parameters established for RF Emissions; Immunity; Electrostatic Discharge;
Irradiated Radio Frequency Electromagnetic Fields; and Transient (Bursts and Voltage Surges).

Warning: Portable and mobile RF communications equipment can


affect medical electrical equipment.

Warning: The use of accessories, transducers, sensors and network


cables that are not originals can result in increased emissions or
decreased immunity of the equipment.

Warning: The equipment can be used with saturation monitors,


ventilators, infusion pumps and other hospital equipment. It is
recommended to observe these devices to confirm that they are
operating normally in accordance with the configuration used.

30
USER MANUAL Precautions, Restrictions
and Warnings
IT-158 TS

Guidance and Manufacturer's Declaration Electromagnetic Emissions


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 this equipment ensure that it is used in such an
environment.
Emissions Tests Compliance Electromagnetic environment - guidance
The equipment uses RF energy only for its internal
RF Emissions functions. However, its RF emissions are very low and
Group 1
CISPR 11 are not likely to cause any interference in nearby
electronic equipment.
RF Emissions
Class B
CISPR 11 The IT-158 TS Transport Infant Incubator is suitable
for use in all establishments other than domestic and
can be used in all residential establishments and
Harmonic Emissions those directly connected to the public low-voltage
Class A power supply network that supplies buildings used for
IEC 61000-3-2
domestic purposes, provided the following warning is
observed:
Warning: This equipment is intended for use only by
health professionals.
Emissions due to voltage This equipment may cause radio interference or
fluctuations/flicker disrupt the operation of nearby equipment. It may be
Compliant
necessary to adopt mitigation procedures, such as
IEC 61000-3-3 reorienting or relocating the IT-158 TS Transport
Infant Incubator or local shielding.

31
Precautions, USER MANUAL
Restrictions and
IT-158 TS
Warnings

Guidance and Manufacturer's Declaration Electromagnetic Immunity

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

Recommended separation distances between portable and mobile RF communications


equipment and the IT-158 TS Infant Incubator

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

0.01 0.04 0.04 0.07

0.1 0.11 0.11 0.22

1 0.35 0.35 0.7

10 1.11 1.11 2.21

100 3.50 3.50 7.00

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.

Immunity test Test Level NBR Compliance Level Electromagnetic


IEC 60601 Environment Guidance
+ +
Electrostatic 6 kV by contact 6 kV The floors should be wood,
Discharge concrete or ceramic tile. If
+ +
8 kV by air 8 kV floors are covered with
IEC 61000-4-2 (ESD)
synthetic material, the
relative humidity should be at
least 30%.
+ +
Electrical Fast 2 kV in the power supply 2 kV for the power supply Mains power quality should
Transient/Burst lines line be that of a typical hospital or
IEC 61000-4-4 commercial environment.
+ +
1 kV in the input and 1 kV for the input and
output lines output line
+ +
Surges 1 kV line to line 1 kV line to line Mains power quality should
IEC 61000-4-5 be that of a typical hospital or
+ +
2 kV line to ground 2 kV line to ground commercial 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

Power frequency 3 A/m 3 A/m The power frequency


(50/60Hz) magnetic magnetic fields should be at
field the level characteristic of a
IEC 61000-4-8 typical location in a typical
commercial or hospital
environment.

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

5. Installation of the Equipment


The IT-158 TS Transport Infant Incubator comes factory assembled in a special packaging.
Unpack the Infant Incubator and follow the instructional drawing of the equipment, to proceed with
checking the different sets, parts and accessories.
5.1 Installation Procedure
Carefully unpack the Infant Incubator, taking proper care of the equipment.
Check that all the parts are in perfect condition and that the accessories that make up the unit are there
(accessories on the purchase order).
Place the Infant Incubator on a floor with a flat horizontal surface. Lock the casters of the transport cart.
Release the front and rear latches, located on the lower part of the transport cart.
Place the Infant Incubator in the upper position. With two operators positioned on both sides of the
equipment, the person who is on the side opposite the head end of the Infant Incubator should pull the
safety lever of the transport cart with his left hand, horizontally outward. The other person should place
his foot on the lower part of the transport cart to keep the wheels on the ground when the Infant
Incubator is raised. Having taken these precautions, the Infant Incubator should be slowly raised to the
upper position, under the direction of the person pulling the safety mechanism. The pressurized shock
absorbers assist in the upward and downward movement of the cart, by alleviating the weight.

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

Note: The oxygen and compressed air cylinders can be:

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.

Warning: Compressed gas cylinder. Risk of gas issuing


quickly from the valve. Handle the cylinder carefully so that
it is not bumped.

Mount the serum holder on the base of the


Infant Incubator on the bumper, as shown in
the drawing on the right.

Warning: When the serum holder is mounted, take the necessary


precautions to avoid accidents (bumps, traction) during transport.

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

6. Operation of the Equipment


The uniform microclimate of the transport Infant Incubator supplies microfiltered and heated air that can
be humidified and enriched with oxygen.
The forced air circulation system creates a slightly positive pressure within the hood, which promotes air
flow from inside to outside and ensures protective insulation even when the access ports are open to
perform a procedure on the newborn.
The microprocessor enables the temperature inside the hood to be accurately controlled, in addition to
providing information such as heating power, alarms and operating voltage mode: AC (wall power) or
DC (battery).
A highly visible red LED numerical display indicates air temperature inside the Infant Incubator and skin
temperature, in addition to the set points for these temperatures.
6.1 Control Panel

1 "POWER FAILURE" LED indicator 12 "BATTERY CHARGE" LED indicator


2 "AIR CIRCULATION" failure LED indicator 13 Control panel "OFF" key
3 "HIGH TEMPERATURE" LED indicator 14 Control panel "ON" key
4 "LOW TEMPERATURE" LED indicator 15 "AIR MODE" selection key
5 "NO SENSOR" LED indicator 16 "DECREASE" temperature set point key
6 "BATTERY VOLTAGE" LED indicator 17 >37.5C Mode selection key
"SKIN TEMPERATURE" numerical indicator
7 18 Key to select "SET POINT TEMPERATURE"
display
"AIR TEMPERATURE" numerical indicator
8 19 "INCREASE" temperature set point key
display
9 "AC POWER MODE" LED indicator 20 "SKIN MODE" selection key
10 "DC POWER MODE" LED indicator 21 "AUDIBLE ALARM SILENCE" key
11 "HEATING LED" indicator

6.1.1 Turning on the Infant Incubator


Turn on the master switch located on the power inlet panel. The battery charge green LED
indicator will light up.
NOTE: When the batteries are charged, the green LED indicator will remain off.
Press the ON key on the front control panel. The microprocessor will run an auto-test to verify
that all the audiovisual information on the panel is in perfect condition
The number 88.8 will be indicated on the display. All the LEDs will light up, except for the
POWER FAILURE and DC MODE LEDs, if the power will be supplied through 127V~ or 220V~.
38
USER MANUAL General Operating
IT-158 TS Modes

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.
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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).

6.1.3 Battery Voltage Level Alarm:


---
This alarm will be activated when the battery voltage reaches a critical level of 10.5 V . The "battery
voltage" LED indicator will remain on and the sound can be silenced for 10 minutes by pressing the
"AUDIBLE ALARM SILENCE" key. Both the LED indicator, as well as the sound, are intermittent.
Note: After the battery voltage level alarm has been activated, the
Infant Incubator will continue functioning for another 10 minutes,
maintaining its control functions. After this time elapses, the
temperature of the Infant Incubator will continue to drop until the
operating controls completely shut down.

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6.1.4 Power Failure Alarm:


This alarm will be activated when there is no supply of 127V~ or 220V~ power, or internal battery
--- ---
voltage of 12 V or external voltage of 12 V to power the Infant Incubator.
Note: This alarm will remain activated for 30 minutes and can be
turned off by pressing the "Off" key on the front panel.
The temperature set point will be saved and stored in the memory of
the microprocessor.
The silencing of the alarms via the "Audible Alarm Silence" key will
be for 10 minutes in total, regardless of whether the alarm condition
is resolved during this period of time.

6.1.5 No Skin Sensor Alarm:


Activated when the Skin Sensor plug is disconnected, or when there is a bad connection in the sensor
cable. In such a situation, the operating mode will automatically switch to Air Mode and the skin
temperature indicator will show three underscores __ __ __. If the sensor disconnects from the
patient's skin, the alarm will be triggered when there is a temperature variation equal to or greater than
0.3C in a short lapse of time.
The audible and visual indication of the No Sensor alarm differs according to the following situations.
Sensor disconnected from the outlet or damaged:
Sound and LED constantly on.
The skin temperature indicator will show three underscores __ __ __.
Sensor that occasionally disconnects from the patient's skin:
Intermittent sound and LED.
To restore the normal alarm detection mode, press the "AUDIBLE ALARM SILENCE" key and put the
sensor back on the patient properly. The alarm will stop and the no skin sensor detection will be
reactivated.

Warning: The "No Sensor" alarm is only activated when the Infant
Incubator is in "Skin Mode".

6.2 Operational Indicators

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.

6.2.2 Battery Charge


The green LED indicates that the batteries are being charged. This LED turns off once the batteries are
fully charged.

Note: It takes at least 30 hours to fully charge the batteries (for


totally discharged batteries).

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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.

6.2.3 Heating Indicator


Four yellow LEDs indicate the amount of power supplied by the heating element.
The lower LED indicates 1/4 power, the second indicates 1/2 power, the third indicates 3/4 power and
the fourth LED (upper) indicates full power. When the internal air temperature is equal to the
temperature set point, the 1/4 power LED will remain on.

6.2.4 Temperature Indicator


6.2.4.1 Skin Temperature:
This display indicates the temperature measured by the skin temperature sensor, in either Air or Skin
operating mode.
The reading range of this display is from 20C to 45.5C
Warning: When the skin temperature sensor is disconnected from
the side panel, the display will indicate __ __ __ C and the
operating mode will automatically switch to Air Mode.

6.2.4.2 Air Temperature:


This display constantly indicates the temperature measured by the internal air temperature sensor, in
either Air or Skin operating mode. The reading range of this display is from 20C to 45.5C
6.2.5 Skin Temperature Sensor


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.

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FANEM also produces adhesives designed to
attach the skin sensor to the patient.

Skin Temperature Sensor

Place the metal surface in contact with the


patient's skin.

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.

Warning: Do not use the sensor to measure rectal temperature.

6.2.6 Temperature Control


6.2.6.1 Air Mode:
In this operating mode, the temperature of the Infant Incubator can be set from 30C to 39C, selected
via the "Temperature Set Point" key on the front panel.
The temperature of the Infant Incubator is monitored through the air temperature sensor, located on the
base, and the temperature is indicated on the "Air Temperature" display.
6.2.6.2 Skin Mode:
In this operating mode, the skin temperature of the newborn can be set from 34C to 38C, selected via
the "Temperature Set Point" key on the front panel.
The infant's skin temperature is monitored via the skin temperature sensor.
The heating of the air will be controlled proportionally according to the newborn's temperature, to keep it
at the set point.
When "Skin Mode" is selected, the control of the temperature and alarm levels will be based on the
newborn's skin temperature. The air temperature will be continuously monitored by the "Air
Temperature" display.

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6.2.7 Operating Mode with Newborns


With the Infant Incubator previously preheated, set the air temperature at the level indicated to receive
the newborn that will be transported.
Once the air temperature inside the hood is stable, open the frontal access door, comfortably and safely
position the newborn on the mattress and close the access door.
Then, place and attach the skin temperature sensor to the newborn, preferably in the abdominal area.
Monitor the progression of the newborn's skin temperature.
In the case of transport over a long distance, once the patient's skin temperature has stabilized, switch
the temperature to Skin Mode, with the set point at an ideal temperature for the newborn, preferably
between 36.1C and 36.4C.
Warning: Keep the frontal access door and the access ports open
the least amount of time possible to avoid loss of temperature. Place
the skin temperature sensor preferably in the abdominal area of the
newborn, securing it with an appropriate adhesive.

Warning: If the temperature monitored by the skin temperature


sensor fluctuates rapidly, this would indicate that the sensor has
been dislodged from the body of the newborn. In such a situation,
the No Sensor alarm will be triggered in an intermittent fashion.
Press the "Audible Alarm Silence" key to cancel the No Sensor
alarm and check that the sensor is correctly positioned and attached
to the patient.

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.
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Warning: The humidification sponge is a single-use item and should


be discarded during the cleaning and/or disinfection process of the
Infant Incubator, conducted after the use of the latter.

Warning: Only use original FANEM parts.

Warning: In order to reduce risk of infection, only use the


humidification sponge when passive humidification is used. While
waiting for use by a new patient, the sponge should not be inserted.

Warning: High relative humidity concentration may cause


condensation to form on the inner walls of the hood if there is a
significant difference between temperatures inside and outside the
Infant Incubator.

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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.

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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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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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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.

6.3.2 Pieces used with the Babypuff


6.3.2.1 Gas Inlet Hose
Nontoxic PVC hose (2.10 m), with connectors on the ends for quick coupling
between the gas source (through a flow meter) and the Babypuff gas inlet.
6.3.2.2 Corrugated Tube with Ayre's T-Piece
Connection circuit between the Babypuff gas outlet and the patient,
composed of a quick coupler corrugated tube and Ayre's T-piece with a
PEEP valve.

6.3.2.3 Round Masks


In sizes 00, 0 and 1, they are made of transparent silicone, which makes
them easier to handle and enables full viewing of the patient's mouth and
nostrils.

6.3.2.4 Test Lung


Made of silicone, with a polypropylene connector for coupling to the Ayre's
T-piece.
Designed for running tests with this 1020 Infant Resuscitator and setting
individualized parameters.

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6.3.3 Installation of the pieces used with the Babypuff


When the Babypuff 1020 Infant Resuscitator is already integrated into the transport Infant Incubator,
simply proceed to set up the gas circuit which is supplied through a flow meter and the test lung that will
later be replaced by a mask or endotracheal tube for use with the patient.
Warning: The maximum pressure relief (safety pressure) valve comes
factory set to open at 40 cmH2O. This setting may change due to handling,
excessive variations of network inlet pressure or different flows.
Therefore, before using the 1020 Infant Resuscitator, all the parameters
should be re-checked and calibrated, using the test lung, according to the
network conditions and flow that will be used. This setting can be changed
by the user to up to 80 cmH2O, but take note that opening pressures
greater than 80 cmH2O should not be used.
After possible changes in this pressure setting, it is necessary to
recalibrate the pressure relief to the usual pressure of 40 cmH2O.

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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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.

6.3.4 Operation of the Babypuff


TM
After installing and setting the Babypuff 1020 Infant Resuscitator, as per the instructions from the
previous section, uncouple the Test Lung from the Ayre's T-piece, attach the appropriate sized silicone
mask or endotracheal tube and proceed as follows to conduct the mechanical ventilation process:
Using the Silicone Mask:
Fit the mask over the mouth and nose of the patient seeking to form a good seal. The PEEP
setting will be displayed on the manometer once the ideal seal has been achieved.
Using the Endotracheal Tube:
With the endotracheal tube and intermediary already attached to the patient, connect the
intermediary to the Ayre's T-piece and seek to form a good seal. The manometer will display the
PEEP setting once the ideal seal has been achieved;
Start manual ventilation:
Manually ventilate the patient by placing your thumb over the central aperture of the PEEP
valve cover and then remove it, to enable inspiration and expiration.

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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7. Preventive and Corrective Maintenance and Conservation


Preventive and corrective maintenance and conservation should be performed only by duly qualified
and trained professionals.

Warning: Before starting any maintenance or cleaning procedure,


ensure that the Infant Incubator is disconnected from the wall.

Warning: Make sure the oxygen supply to the Infant Incubator is


turned off and that the equipment is disconnected from the oxygen
cylinder whenever cleaning or maintenance procedures are
performed. There is a risk of fire or explosion in an oxygen enriched
environment.

Warning: The heating element may be hot enough to cause burns;


avoid touching or removing the heating element until the unit has
been switched off for at least 45 minutes.

7.1 Cleaning and Conservation


Full disassembly is recommended for removal and/or access to the different compartments and parts
for terminal cleaning of the equipment when first received and between times of use with different
patients.
7.1.1 Acrylic Hood
Always remove the fittings before starting to clean. The hood and its inner wall can be removed
completely. It is recommended to remove them for a more effective and thorough cleaning between
each use. When removing them, it is recommended to place them on a surface that is appropriate for
their sizes and weights.
Carefully clean with a soft pad all the inner and outer surfaces of the hood using water and mild or
enzymatic detergent that does not contain agents that could damage the acrylic, plastic or metal parts in
general, as well as the fittings.
Completely remove the product with a damp pad, and then dry and reassemble the compartments and
parts.

Warning: Do not use disinfectants that contain alcohol and/or


abrasives or sodium hypochlorite, because they will damage the
acrylic hood and other parts used in the equipment. Do not use
abrasive sponges and/or steel wool.

7.1.2 Structure of the Infant Incubator


Carefully clean with a soft pad all the surfaces of the equipment using water and mild or enzymatic
detergent that does not contain agents that could damage the plastic and polyurethane parts.
Completely remove the product with a damp pad, and then dry and reassemble the compartments and
parts.

Warning: The lower base should be cleaned every time the


equipment was used.

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Conservation

7.1.3 Disassembly for Cleaning


To clean the equipment, the hood must be separated from the base.
Before starting to clean, make sure all the accessories have been removed to prevent possible damage
to them.
Disconnect the cables and sensors from the Infant Incubator.
Check to see whether a cylinder is connected, turn off the oxygen supply and disconnect the supply
hose.
Completely remove all the access port fittings and the membranes for inserting tubes.
Using two professionals, release the rubber rings, remove the outer acrylic hood and place it on a
suitable surface. Then, remove the inner acrylic hood.
Remove the bed, moving it out through the side and tightening the inner latch.
In the case of prior use, with humidification, remove and discard the sponge.
Unlock the side clamps and remove the upper base, taking care not to damage the air temperature
sensor attached to the lower base.
The cleaning and/or disinfection must be carried out with the Infant Incubator disassembled up to this
level, including the finned heating element, blower rotor and thermostats.
7.1.4 Heating Element, Blower Rotor and Thermostats
Clean and or disinfect using a soft pad and disposable spatula to remove dirt from the blower rotor,
finned heating element and thermostats.
Make sure that the product used does not contain agents that could damage the plastic and metal parts
of these pieces.
Completely remove the product.
Warning: The heating element may be hot enough to
cause burns; avoid touching it until the equipment has
been switched off and the heating element has cooled.

Warning: Do not use products that contain alcohol and/or


abrasives, or sodium hypochlorite.

Warning: Improper cleaning of the heating element and


blower rotor can result in a buildup of lint that could
impair or affect the heating and air circulation in the Infant
Incubator.

Warning: Do not use running water (hoses or showers) to


clean and/or disinfect the parts of the Infant Incubator.

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and Conservation

7.1.5 Integrated Babypuff Parts


The cleaning and/or disinfection procedure for the 1020 Infant Resuscitator is performed together with
the one used for the control panel of the Transport Infant Incubator.
The parts and pieces listed below are single-use items. They may be sterilized beforehand using
ethylene oxide and/or gamma ray radiation.
Gas inlet hose
Corrugated tube
Ayre's T piece
Test lung
Silicone masks

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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7.2 Cleaning and/or Disinfection Procedure


The IT-158 TS Transport Infant Incubator can be cleaned and/or disinfected. It is necessary to use the
appropriate products and choose a disinfectant that dispenses with pre-cleaning, thereby helping to
reduce the steps and time needed to carry out the procedure.
7.2.1 Adoption of the cleaning procedure:
Use:
Good quality water. Suitable physical area for
disassembling and placing the
Mild or enzymatic detergent.
components.
Clean, soft and preferably disposable
Procedure gloves
pads.
7.2.1.1 When to perform a complete or terminal cleaning:
Before first use. After each transport.
7.2.1.2 How to perform the terminal cleaning procedure:
Moisten the pad with a solution of water and recommended detergent.
Wipe all the equipment with the pad to remove dirt.
Replace the pad as often as necessary.
Remove the product with another damp pad.
Dry and assemble the components.
7.2.2 Adoption of the disinfection procedure:
Choose an appropriate disinfectant for the fixed surface and components of the equipment,
such as a quaternary ammonia solution for example: Scotch-Brite Flex from 3M.
Use clean, soft and preferably disposable pads.
Use a suitable physical area for disassembling and placing the components.
Use procedure gloves.
7.2.2.1 When to perform a complete or terminal disinfection:
Before first use. After each transport.
7.2.2.2 How to perform the terminal disinfection procedure:
Utilize the disinfectant according to the dilution indicated for use on fixed surfaces.
Moisten a dry pad with the disinfectant.
Wipe all the equipment with the pad and disinfectant to remove dirt.
Wait the indicated time for the disinfectant to work and then totally remove the product with
another damp or dry pad, depending on the product used, preferably disinfectant. There is no
need for rinsing. For example, in the case of Scotch-Brite Flex, the waiting time is ten minutes
and the product can be removed with either a dry or damp pad.
Dry and assemble the components.
7.2.3 Mandatory aspects for performing cleaning and/or disinfection procedures:
It should be performed by a professional who is properly prepared to do the task.
Have an appropriate location.
Use one of the procedures and the recommended products and materials.
Unplug the equipment from the wall and the oxygen supply.
Disassemble all the recommended components in order to access all the internal spaces.
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and 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

7.3.1 Changing the Air Filter


Open the lid of the filter by releasing the clamp.
Using procedure gloves, remove the used air filter and dispose of it.
Clean and dry all the surfaces of the filter container.
Using procedure gloves, install the new air filter. Close and latch the lid.
Use a label to indicate the date the air filter was changed.

Warning: Do not use an excessively dirty air filter in order not to


affect the oxygen concentration inside the Infant Incubator. Only use
original filters and check the filter frequently to determine when it
needs to be changed.

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7.4 Oxygen - Precautions


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: Always use an oxygen analyzer to verify the


concentration being administered. It is recommended to use the
THOR 3620 Oxygen Analyzer for this purpose.

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.

Warning: There is a risk in administering oxygen at high


concentrations for extended periods of time to newborns. Strictly
follow the medical prescription and frequently monitor and
evaluate the concentrations supplied in comparison with the
clinical conditions and parameters of the patient.

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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Note: Whenever the transport Infant Incubator is stored for a long


period of time, the fuse for the batteries located in the Charging
Module (Vital Module) should be removed to prevent the batteries
from discharging.

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.

7.5.3 Air Filter:


The air filter of the Transport Infant Incubator is a required item for the safe operation of the equipment
in terms of the quality of air supplied to its internal environment. Along with the positive pressure inside
the hood, it contributes to the protective insulation of the newborn.
This filter is a disposable item that must be continuously monitored by the user, during the terminal
disinfection of the equipment, between uses with newborns, to determine when it should be replaced,
which should be done by the user or the hospital's maintenance staff.
Therefore, the air filter of the Infant Incubator Transport should always be changed whenever it is
sufficiently dirty. When this layer is completely filled with dirt, the filter should be replaced with a new
one. The compartment should be cleaned and the new unit installed correctly.

Warning: Only use original FANEM parts.

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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7.5.5 Humidifier Sponge:


The single-use, disposable sponge, when moistened with distilled water provides passive humidification
for the microclimate of the Infant Incubator. Only use original Fanem sponges and be sure to replace it
between uses with patients.
7.5.6 Oxygen Cylinders and Valves:
Use oxygen and compressed air cylinders that comply with the standards established by the ABNT or
international equivalents.
The cylinders must be connected to the supply pressure control valves. For supplying oxygen to the
Infant Incubator, a connection through a properly calibrated flow meter must be used. For connection
with a blender, a hose must be used where there is a direct connection between the relief valves of the
oxygen and compressed air cylinders and the gas inlets of the blender.
When opening the cylinder valves, be careful that it is not done abruptly, as this could affect the
diaphragm of the control valve.
When handling the cylinders and valves, look out for the presence of grease, oil, paint or kerosene on
gloves, rags or tools, since these products can instantly ignite when in contact with oxygen. Small
quantities of flammable agents left in the equipment, such as alcohol, may cause a fire when in contact
with oxygen.
Use properly calibrated valves. Never attempt to repair a damaged valve.
Note: Before handling cylinders or valves, always consult with the
internal accident prevention committee (CIPA in Brazil) for further
clarifications and information.

Note: It is recommended to use control valves with pressure set at


3.5 kgf.

7.5.7 Calibration:
The air temperature sensors, as well as the safety temperature sensors, should be calibrated regularly
every 4 to 6 months.

Note: Calibration should be performed by a qualified technician who


has been certified by FANEM Ltda.

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7.6 Spare Parts


For spare parts, check the section "Parts, Pieces and Accessories".
The functions and safety of the IT-158 TS Transport Infant Incubator are only ensured if the preventive
maintenance and repair services are performed by the technical assistance team or those properly
trained and qualified by FANEM Ltda.
FANEM assumes no responsibility for any damage that may occur with the equipment or for any
consequences to the patient or user due to improper maintenance not performed by our Technical
Assistance team, or in the event non-original spare parts / accessories were used as replacements.
The materials used in the design of parts, accessories and consumables aim to ensure the proper
operation of the equipment in accordance with its original features, as well as safety in terms of the
toxicity and flammability of the materials used.

Warning: Only use original FANEM parts.

7.6.1 Consumables

Description Frequency Performed by


200
12V Battery - - - charges / Technician
discharges
Air Filter kit with 10 units 45 days User/Technician
Oval Access port 6 months User/Technician
Access port Fittings 12 months User/Technician
Base Fittings (kit) 12 months Technician
Hood Fittings (kit) 12 months Technician
Humidifier Sponge Single-use User/Technician
Oxygen Cylinder - Size E (aluminum) 12 months Inspection
Complete Acrylic Hood (Dual Tube 6 months Inspection
Insert)
Silicone Double Air Damper (unit) 12 months Inspection
Self-Extinguishing Foam Mattress 12 months User/Technician
Mattress Cover in non-toxic PVC 12 months User/Technician
Safety Belt 6 months Inspection
NiCd 9V Battery 12 months Technician

7.7 Battery for the Power Failure Alarm


---
The control unit of the IT-158 TS Transport Infant Incubator has a rechargeable NiCd 9V battery,
designed to operate the power failure alarm when the transport batteries are low.
This battery recharges through normal equipment use and its expected lifetime is 12 months, after
which it should be replaced with a new original one.
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---
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.

Warning: The disposal of batteries must be done according to the


laws of the country.

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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7.9 Maintenance Chart

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

12V Battery (or every time the Technician


Infant Incubator is
used)
Rechargeable Battery 12 months
Technician
(replacement)
Elastic Cuff 3 months User / Technician
Auxiliary Lighting Set 6 months Technician
Routine Calibration 4 to 6 months Technician
Lock Handle of the Hood 6 months Technician
Upper Base Latches 6 months Technician
Fittings (all) 6 months User / Technician
Oxygen Cylinder and Valves 4 months User / Technician
Access Door Latches every time the Infant
User / Technician
Incubator is used

7.10 Troubleshooting

MALFUNCTION CAUSE SOLUTION


Turn on the master switch in the source
The Infant Incubator Master switch not turned on
module and press the "On" key in the front
doesn't turn on. or discharged battery.
panel.
Access door open. Close the access doors.
Air temperature does Power input is not properly Check the power supply voltage and
not increase. connected. voltage in the battery.
Blocked air passage. Unblock air circulation.
Turn on the master switch in the source
The master switch is not
module and press the "On" key in the front
turned on.
panel.
The AC mode LED
indicator does not turn Fuse from the source
Change the fuse.
on. module is burned out.
The power cable is not
Check the power cable connection.
connected.
Battery power failure Discharged or damaged Turn on the Infant Incubator for 30 hours to
alarm activated. battery. ensure that the battery is fully charged or
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else change the battery.


Master switch turned off. Turn on the switch in the lower panel.
Panel with display and
LEDs turned off. Replace the fuses with others of the same
Burnt Fuse.
rating as indicated in the lower panel.
Replace the fuses with others of the same
Burnt Fuse.
rating as indicated in the lower panel.
Power Failure Alarm
Activated. No Power. Check the mains voltage.
Cord disconnected. Connect the power cable.
Access port door open. Correctly close all the access doors.
Low Skin Temperature Skin sensor incorrectly
Alarm. positioned on the infant Correctly reattach the sensor to the infant.
(Skin Mode).
Check the blower rotor unit or whether there
Inadequate Ventilation. Inadequate Air Circulation. is an obstruction in the inlet or outlet that
provides air to the tray

Low Oxygen Access doors open. Close the doors.


Concentration O2 inlet tube with a leak. Change the tube.
Air filter not installed. Install the air filter.
High Oxygen
Saturated air filter. Change the air filter.
Concentration
Panel display with
Excess electromagnetic Turn off the unit and turn it on again. If the
incorrect and random
irradiation (EMI) in the problem continues, call Technical
indications and
hospital electricity grid. Assistance.
improper functions.

Warning: If it is not possible to correct the malfunction, contact an


authorized FANEM service technician.

7.11 Checking the Alarms

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.

7.11.1 "No Sensor" Alarm


With the "Patient Sensor" connected to the Infant Incubator panel, select "Skin Mode" on the front
panel. Disconnect the "Patient Sensor" from the side panel. The audible and visual "No Sensor" alarm
should immediately be triggered.
7.11.2 "Air Circulation" Alarm
Select "Air Mode" on the Infant Incubator panel and set the temperature at 36C in the "Temperature
Set Point" display. Let the system stabilize for approximately 30 minutes. Disconnect the motor at the
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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.

7.11.3 "High Temperature" Alarm


7.11.3.1 "Skin Mode"
Note: This alarm is triggered by a +1C difference in relation to the temperature set point.
Select Skin Mode and set the temperature at 36C on the "Temperature Set Point" display. Place the
"Patient Sensor" inside the hood and once the system has stabilized, lower the previous temperature
set point by 1C on the "Temperature Set Point" display. The audible and visual "High Temperature"
alarm should immediately be triggered.
7.11.3.2 "Air Mode"
Note: This alarm is triggered by a +1C difference in relation to the temperature set point.
Select Air Mode and set the temperature at 36C on the "Temperature Set Point" display. Once the
system has stabilized, lower the previous temperature set point by 1C on the "Temperature Set Point"
display. The audible and visual "High Temperature" alarm should immediately be triggered.
7.11.4 "Low Temperature" Alarm
7.11.4.1 "Skin Mode"
Note: This alarm is triggered by a -1C difference in relation to the temperature set point.
Select Skin Mode and set the temperature at 36C on the "Temperature Set Point" display. Place the
"Patient Sensor" inside the hood and once the system has stabilized, raise the previous temperature set
point by 1C on the "Temperature Set Point" display. The audible and visual "Low Temperature" alarm
should immediately be triggered.
7.11.4.2 "Air Mode"
Note: This alarm is triggered by a -1C difference in relation to the temperature set point.
Select Air Mode and set the temperature at 35C on the "Temperature Set Point" display. Once the
system has stabilized, raise the previous temperature set point by 1C on the "Temperature Set Point"
display. The audible and visual "Low Temperature" alarm should immediately be triggered.
7.11.5 "Power Failure" Alarm
Remove the 10 A fuse of the batteries, located on the side panel of the Infant Incubator. Plug the Infant
Incubator into a 127 V or 220 V socket, according to the specifications of the equipment. Wait for the
system to stabilize and then unplug the power cable from the socket.
The audible and visual "Power Failure" alarm should immediately be triggered.

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IT-158 TS

8. Warranty and Technical Assistance



As with all FANEM brand equipment, this one is also covered by a total one year warranty against
defects in materials and workmanship (see enclosed warranty statement).
For any type of maintenance, whether during or outside the warranty period, always contact an
authorized FANEM Service Technician. Do not allow third parties, without the appropriate technical
training, to accidentally damage or alter the original characteristics of your equipment.

Always use original FANEM parts.
ANVISA Registration No. 10.224.620.035
Technician in charge
Eng. Orlando Rossi Filho
CREA/SP 98.435/D

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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