INSTRUCTIONS OF USE

Equipment:

GRN NEONATAL INCUBATOR

Model: Millennium

Gigante Recm-Nascido I. C. R. Ltda.

Rua Amrico Reis, 604 - Parque Industrial Tanquinho

CEP: 14075-620 - Ribeiro Preto
So Paulo Brazil
Phone: + 55 16 3969-1000
Fax: +55 16 3969-1001
www.gigante.com.br
sac@gigante.com.br

INSTRUCTIONS OF USE
(EQUIPMENT MANUAL)

Congratulations !
You have just acquired an incubator developed with the highest technology available in the
market, projected to give the maximum of efficiency, quality and safety.
Thank you to choose a Gigante product.
Equipment:
Technical Name: Neonatal Incubator (newborn)
Commercial Name: GRN Neonatal Incubator
Commercial Model: Millennium
Brand:
Gigante Recm Nascido
Equipment Origin (Producer):
Gigante Recm Nascido Indstria Comrcio e Representao Ltda
Rua Amrico Reis, 604 Parque Industrial Tanquinho
CEP 14075-620 Ribeiro Preto So Paulo - Brasil
Phone: + 55 16 3969 1000 Fax + 55 16 3969 1001
CNPJ: 62.413.869/0001-15 Inscrio Estadual: 582.245.178.115
Technical Responsible: Eng. Rogrio Augusto de Oliveira CREA-SP n 0400451831
ANVISA Register n: 10228740018
ATTENTION :
For a better safety:
a) Read and understand all the instructions contained in this Instructions of Use before
installing or operating this product.
b) Be sure that all the instructions are informed in the content of this Manual.
Note: This Manual should be read by all the operators of this product.
This Manual was originally written in Portuguese.
Code : 17072II
Manual Revision: 00
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CONTENTS:

General Information
Terminology
Symbology
1 IDENTIFICATION
1.1 Equipment description
1.2 Principle physic and technology basis of the product, applied for its operation and action
1.3 Parts, accessories, optional, consume and support materials.
1.4 Specifications and Technical Characteristics
1.5 Electromagnetic Compatibility
2
SPECIAL STORAGE CONDITIONS, CONSERVATION AND/OR PRODUCT HANDLING
2.1 Storage
2.2 Conservation
2.3 - Transport
3
INSTRUCTIONS FOR THE USE OF THE PRODUCT
3.1 IDENTIFYING THE CONTROL PANEL
3.2 KEYBOARD
3.3 LIGTH EMITTING DIODE (LED)
3.4 OPERATING THE EQUIPMENT
3.4.1
Before starting the equipment
3.4.2
Starting the equipment
3.5 SELECTING THE OPERATION MODE
3.5.1
Working in AIR Mode (ATC Air Temperature Control)
3.5.2
Working in SKIN Mode (ITC Newborn Temperature Control)
3.6 PROGRAMMING THE TEMPERATURE
3.7 MESSAGES / ALARMS
3.8 SAFETY ELECTRONIC THERMOSTAT
3.9 HOOD
3.10 TRENDELENBURG, PROCLIVE, HIGHT AND LOW HORIZONTAL POSITIONS
3.11 ICE DRAWER
3.12 AIR FILTER
3.13 HUMIDIFIER (optional item)
3.14 IV POLE
3.15 SKIN SENSOR PROBE
3.16 LIST OF THE ACCESSORIES AND PARTS, ELECTRONIC SCHEME AND TECHNICAL INFORMATION
3.17 MECHANICAL STABILITY
3.18 CONCENTRATION OF CARBON DIOXIDE (CO2)
3.19 OXYGEN (O2)
4
WARNING AND/OR PRECAUTION
4.1 In the installation
4.2 In the operation
4.3 In the maintenance
4.4 In the cleaning
4.5 In the transport and storage
4.6 In the Printed equipment
5
EQUIPMENT PERFORMANCE
5.1 Indication, purpose or use destination of the product
5.2 Undesirable and secondary or collateral effects and counter indications
5.3 Safety and efficacy of the equipment
5.4 Biocompability of the materials which that get in contact to the patient skin
6
INSTALLATIONS OR CONNECTION TO OTHER PRODUCTS
7
INSTALLATION, CORRECTIVE AND PREVENTIVE MAINTENANCE
7.1 - Installation
7.2 Corrective Maintenance
7.3 - Preventive Maintenance
7.4 - Conservation
8
- ADDITIONAL PROCEDURES FOR REUTILIZATION
8.1 Cleaning
8.2 Disinfection
9
ADDITONAL PROCEDURES BEFORE UTILIZATION OF THE EQUIPMENT
10 - PRECAUTION IN CASE OF FUNCTIONING ALTERATION OF THE EQUIPMENT
11 SENSIBILITY TO PREDICTABLE ENVIRONMENTAL CONDITIONS IN THE NORMAL SITUATIONS OF USE
12 PRECAUTION IN CASE OF INUTILIZATION OF EQUIPMENTS
13 - EQUIPMENTS WARRANTY
14 RESPONSABILITY TERM

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GENERAL INFORMATION
Attention!
This Manual (Instructions of Use) should be read and understood for all the users of the
equipment, including the cleaning personnel.
If there is any doubt, please contact Client Attendance Department of Gigante through
telephone +55 16 3969-1000 or fax + 55 16 3969-1001 or e-mail suporte@gigante.com.br.
TERMINOLOGY AND DEFINITIONS
Incubator (Item 2.1.101 IEC 60601-2-19)
Compartment designated to contain one newborn (infant) that has section(s) transparent(s)
and allow(s) visualizing the newborn, provided by means that enable the control of the
environment inside the NEWBORN COMPARTMENT, mainly by heated air.
Newborn Compartment (Item 2.1.102 IEC 60601-2-19)
Part of the INCUBATOR designated to contain a newborn.
Incubator with air temperature controlled (ATC) (Item 2.1.103 IEC 60601-2-19)
INCUBATOR on which the air temperature is automatically controlled through an air
temperature sensor at a value established by the user.
Incubator with Newborn Temperature Controlled (ITC) (Item 2.1.104 IEC 60601-2-19)
INCUBATOR with air temperature controlled has an additional capacity to control
automatically the Incubator air temperature, in order to maintain the temperature according
to the measure which was done by a SKIN TEMPERATURAE SENSOR, near to a value
established be the user.
Skin Temperature Sensor (Item 2.9.101 IEC 60601-2-19)
Sensorial device designated to measure the SKIN TEMPERATURE of the Newborn.
Skin Temperature (Item 2.9.102 IEC 60601-2-19)
NEWBORN SKIN TEMPERATURE at a level on which the SKIN TEMPERATURE SENSOR
is placed.
Average Temperature (Item 2.9.103 IEC 60601-2-19)
The average of the maximum and minimum temperatures in any point specified in the
NEWBORN COMPARTMENT, obtained during the CONDITION OF CONSTANT
TEMPERATURE.
Control Temperature (Item 2.9.104 IEC 60601-2-19)
Temperature selected in the temperature control.
Incubator Temperature (Item 2.9.105 IEC 60601-2-19)
Air temperature at a point 10 cm above the geometric center of the mattress surface, at the
Newborn compartment.
Average temperature of the Incubator (Item 2.9.106 IEC 60601-2-19)
Average of the maximum and minimum INCUBATOR TEMPERATURE, obtained during the
CONDITION OF CONSTANT TEMPERATURE.
Condition of constant temperature (Item 2.10.101 IEC 60601-2-19)
Condition reached when the INCUBATOR TEMPERATURE does not vary more than 1C in
period of 1 hour.

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SYMBOLOGY

WARNING - Symbol of attention. Consult attached documents.

VOLTAGE -Symbol of alternated current. ALTERNATING CURRENT

Symbol of equipment type BF

Symbol Turn-on (with electric feeding tension)

Symbol Turn-off (without electric feeding tension)

Symbol Turn-on, only to one part of the equipment

Symbol Turn-off, only to one part of the equipment

Symbol Take Care on Transport and Storage (fragile)

Symbol Maximum Allowed Cargo under one packing (transport and storage

Symbol Maximum of identical packing which can be piled up one to another (transport
and storage)
Symbol need to be protected against humidity in the transport and storage

Symbol of Transport and Storage Position ( up direction)

Symbol Temperature Limit for transport and storage

Symbol Ground wire terminal for protection

Symbol of Functional ground wire

Symbol for protection against harmful penetration of water Common equipment

(Equipment closed and protected against water dripping).

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1 IDENTIFICATION
Technical name: Neonatal Incubator (Infant)
Commercial Name: GRN Neonatal Incubator
Commercial Model: Millennium

1.1 Equipment description

It is an equipment which controls the environmental temperature of the newborn and could be
controlled based at the AIR temperature adjustment (inside the hood) or based on the patient
temperature. These controls are digitals, with resolution of 0,1C.
It utilizes microprocessed system to control the temperatures and the protection system. The safety
circuit is electronic and independent from the principal circuit.
It utilizes duct for exclusive air passage, with total access and fan with removable propeller that
facilitates the asepsis.
Its transparent hood allows an ample foresight from any angle.
It has casters for moving and easy positioning and two of them have brakes to allow its stability at the
desirable place.
It is painted with high resistance paint (electrostatic epoxy and polyurethane aliphatic) and the
equipment is resistant to cleaning with detergents and germicides.
1.2 - Physic principle and technology elements of the product, applied to its operation and
action
Electric heater with temperatures controlled by thermo sensors, adjusted through keys and indicated
in the display.
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1.3 Parts, accessories, optional, consumption material and support material

Attention!: The use of any part, accessory or non-specified or foreseen material in these Instructions
of Use is of entire responsibility of the user.
Parts and accessories which accompany (principles):
1 IV Pole
2 Set of cabinet with air duct
3 Hood in Acrylic ( Simple Pushing Back)
4 Digital Control Panel (AIR SKIN)
5 Cart
6 4 Swivel Casters (2 with brake and 2 without brake)

Other parts and accessories which accompany:

Set of electronic plates
Skin sensor
Air Filter
Portable Mattress (Mattress)
Bed made of radius-transparent material
Ice drawer
Bed support
Electric cable
Optional:
Hood in Acrylic (Pushing Back Frontal Opening)
Hood in acrylic (Frontal Opening All Extremity)
Hood with double wall
Humidity control relative to servo-active
External removable humidifier with flux meter (that can be used in autoclave)
External removable humidifier with flux meter
Alarm signalized at distance
Cabinet with drawer(s)
Cabinet with door
Electronic microprocessed scales to incubator
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Supports for monitor

Support for cylinder/cylinder/cylinder valve
Cabinet in non-ferrous material (aluminum, plastic, stainless steel etc)
Set of auxiliary external plugs
Oval porthole with non-toxic lining
Porthole iris type
Bushing iris type
Sixth porthole
Sensor adhesive
Third and Fourth casters with brakes
Second serum stick
Auxiliary light focus
Drawer for X-Ray chassis
AIR/O2 Valve
Lateral door of hood
Extension of the AIR/O2
Consummation Materials:
Air Filter
Sleeve iris type
Portable Mattress (Mattress)
Non-toxic lining porthole
Skin sensor
Support Material:
Instructions of Use
General Note: The lists of the parts and pieces, as well as the electro-electronic scheme or any other
necessary information are available and could be furnished by Gigante Recm-Nascido, since it has
been necessary to the technical maintenance of the equipment by the user and of common
agreement of both parties.

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1.4 Specifications and Technical Characteristics

Classification of the product as per ANVISA
Fitting

Class III (high risk)

Classification of the product as per NBR IEC 60601-1 Standard

Type of Protection against Electric Discharge
Level of Protection against Electric Discharge

Class I
Equipment BF Type

Protection against Noxious Penetration of Water

IPX1 Common Equipment

(Equipment
closed
protected
against leakage of water)

Safe level of application in the presence of an anesthetic mixture inflammable with the
air, oxygen or nitrous oxide
Not adequate
Operation Mode
Continuous
Ambient conditions of operation (as per IEC 601601-2 Item 10.2.1)
Range of ambient operation temperature
Range of ambient temperature recommend by Gigante
Range of relative humidity of operation
Note: Incubators does not have the possibility to control the relative humidity
Range of atmospheric pressure of operation
Ambient conditions of transport or storage
Range of ambient temperature of transport or storage
Range of relative humidity to transport or storage
Note: Incubator does not have the possibility to control the relative humidity
Range of atmospheric pressure of transport or storage

+20C to +30C
+21C to +26C
30% to 75% (non-condensing)
700hPa to 1060 hPa
(525 mmHg to 795 mmHg)

0C to +55C
0% to 90% (non-condensing)
500hPa to 1060 hPa
(375 mmHg to 795 mmHg)

Feeding Tension Automatic reversion

110-130V ~/ 220-230 V~
Frequency
50 / 60 Hz
N of phases
Mono-phase
Fuse (fast 20 mm)
5A (127V net) / 3A (220V net)
Potency of the heating element
300 Watts
Nominal potency of entrance (Total)
400 V.A.
Working Range (control modes)
ATC (AIR) / ITC (NB)
Working Range (ATC mode)
From 28C to 37C
Extended Working Range 39C mode (ATC mode)
From 37 C to 39C
Working Range (ITC mode)
From 35C to 37,5C
Extended Working Range 39C mode (ITC mode)
From 37,5C to 39C
Reading Range (indication at temperature displays)
From 0C to 50C
Accuracy Reading Range of conformity
30C to 37,5C
Programming resolution and displays indication
0,1C
Maximum error to the indicator of the Newborn temperature
+/- 0,3C
Maximum error to the temperature control
Note 1: Condition when the incubator has been working as an incubator of the
controlled air. Error related to the average temperature of the incubator and the +/- 1,5C
temperature indicated.
Note 2: Condition to ambient temperature between 21C and 25C
Time of heating to reach 36 from an ambient temperature of 25C
Maximum of 30 minutes
Thermostat (working thermometer
Electronic microprocessed
Thermo limiter (safety thermometer)
Electronic
Equipment Dimensions (Length x Width x Height)
1,000 x 0,590 x 1,400 mm
Occupied area
0,432 m3
Mattress
Non-toxic and ant allergic
Mattress Dimensions (Length x Width x Height)
0,580 x 0,285 x 0,030 m
Total Net Weight
57 kg
Electronic system
Microprocessed

1.5 - Electromagnetic Compatibility

The equipment continues performing its demanded functions, without failures and without creating
RISK OF SECURITY, according to specification in this manual, when submitted to an
electromagnetic radiation of radiation frequency, at a level minor than or equal to 10 V/m in a range
of frequency from 26 MHz to 1 GHz.

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- SPECIAL CONDITIONS OF STORAGE, CONSERVATION AND/OR HANDLING OF THE

PRODUCT

2.1 Storage:
- Keep on a local protected from rain or direct sunlight and in its original package.
- In case of storage of several boxes of the equipment packed, the maximum piling up should
be as per indicated in the symbol of piled up (maximum 3 units) printed in the package.
2.2 Conservation:
- When in use, clean using a wet cloth and soap (humidify with water or sodium hypochlorite
in water at 0,5%).
- Keep the equipment clean and disinfected for the next use.
- Do not allow that liquids are inserted in the equipment.
- Do not use organic solvents like thinner to clean the equipment.
- Keep the equipment in a clean place, far from dust.
- Never use alcohol in the acrylic parts.
2.3 Transport:
- During the transport avoid vibrations and impact in the equipment.
- Do not let to fall in the floor.
- In case of transport of several boxes of the packed equipment, the maximum piling up
should be according to indication by the piling up symbol at the packing (maximum 3 units).
Note: The equipment is exclusive for stationary use, so when reading transport in this manual, it is
understood that this term means to installation conditions or handling of it. It is totally forbidden to
transport this equipment with a patient inside the compartment.
Environmental Conditions of Transport or Storage
Range of ambient temperature of transport and storage
Range of humidity relative to transport or storage
Note: The incubator does not has ways to control the humidity level
Range of atmospheric pressure of transport or storage

0C to +55C
0% to 90% (non-condensing)
500hPa to 1060hPa
(375 mmHg to 795 mmHg)

Environmental Conditions of Work (according IEC 60601-2-19 Item 10.2.12

Range of ambient temperature of operation
+20C to +30C
Range of ambient temperature recommend by Gigante
+21C to +26C
Range of humidity related to the operation
Note: the incubator does not has ways to control the humidity level
30% to 75% (non-condensing)
Working range of atmospheric pressure
700hPa to 1060 hPa
(525 mmHg to 795 mmHg)

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INSTRUCTIONS FOR THE USE OF PRODUCT

3.1 IDENTIFYING THE CONTROL PANEL

Caption
1 Display of occurrences
2 Real temperature of the Newborn
3 Real temperature of the incubator (inside the hood)
4 Key to select SKIN Mode
5 Key to select AIR Mode
6 Key to increase in temperature programmed
7 Key of decrease in temperature programmed
8 - Led indicator of stand-by equipment
9 Led indicator of key Release 39C activated
10 Led indicator of keyboard protected
11 Led indicator of lack of energy (without network)
12 - Led indicator of alarm situation
13 Led indicator of alarm silencer activated
14 - Key START
15 Key OFF
16 Key Function
17 Key Enter
18 Key Release for temperature up to 39C
19 Key for Keyboard protection
20 Key Audio Alarm silencer

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3.2 - KEYBOARD
Key START (14)
Start the equipment, activating automatically the Temperature Control Mode.
Key OFF (15)
Turn-off the equipment leaving it at stand-by mode.
Key FUNCTION (16)
Exhibit the following functions:
a) CHRONOMETER
The incubator is composed of one counter for hours/minutes/seconds placed at the
occurrence screen (1). This chronometer has the function to help the nursery in situations
where it is necessary to set a time for special treatment times as the exposition time at
phototherapy, time of permanence that the patient can stay inside the incubator etc.
Display time: HH:MM:SS
b) RESET CHRONOMETER
This function restarts the chronometer counting at the occurrence display (1).
c) AUTO TEST
This function executes a checking routine of the control and alarms system.
d) POTENCY FUNCTION
This function indicates the percentage of the heating element. The resolution is 1%.
KEY ENTER (17)
Select the desired function, i.e., after moving between the options of the key Function (16), by
pressing it the function will be executed or exhibited.
KEY RELEASE TEMPERATURE OF 39C (18)
The incubator has as special key to work with two range of temperature control: 28 up to 37C or 28
up to 39C when the key release 39C is activated and operating at AIR MODE and 35 up to 37,5C
or 35 up to 39C when the key release 39C is activated and operating at SKIN MODE.
The key Release 39C, rarely is used in the countries of hot weather, standing normally deactivated,
as it allows a Range of temperature which goes from 28C up to 39C.
NOTE: The key Released 39.8C should be activated only when the real temperature of the incubator
reaches and stabilizes at 37C.
IMPORTANT: This key should be only activated before medical prescription, duly oriented about the
risks and benefits of its uses to the patient.
Key for the Keyboard protection (19)
When pressed for approximately 5 seconds it locks the function of all other keys of the panel,
avoiding any undesirable activation.
To release the keyboard, press again the key of keyboard protection for approximately 5 seconds.
Key Audio Alarm Silencer (20)
The alarm silencer KEY (20) has the purpose to switch off the audio in situation of emergency which
may occur. When pressed, the audio becomes noiseless for 20 seconds, and will come back in
action in case alarm situation remains.

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Key to select SKIN Mode (4)

Select the mode of temperature control to the SKIN mode (ITC mode).
Key to select AIR Mode (5)
Select the mode of temperature control to AIR mode (ATC mode).
Key to INCREASE THE TEMPERATURE (6)
Increase 0,1C to the programmed temperature.
Key to DECREASE THE TEMPERATURE (7)
Decrease 0,1C the programmed temperature.
3.3 LED INDICATOR (LIGHT EMITTING DIODE)
STAND BY (8)
This LED indicates that the equipment is connected to the electric net.
RELEASE 39C (9)
This LED indicates that the key Release 39C is activated.
PROTECTION TO KEYBOARD (10)
This LED indicates that the Keyboard Protection is activated.
WITHOUT NET (11)
This LED indicates one of the following situations:
Lack of energy from electric net;
The feeding cable was disconnected from the net of the equipment;
Protection fuse(s) placed at the rear panel, near to the cable plug of energy is(are) burnt
ALARMS (12)
This LED indicates that the alarm was activated (except the alarm of lack of energy).
ALARMS SILENCER (13)
This LED indicates that the Alarms Silencer is activated.
3.4 OPERATING THE EQUIPMENT
This equipment can only be used or operated by a professional with defined qualification (physician)
or people who have specific training provided by the company Gigante Recm Nascido.
Note: see item 4 WARNINGS AND/OR PRECAUTIONS before starting the equipment.
3.4.1 Before turning-on the equipment
a) Make the habitual asepsis (item 8.1 and 8.2). Read carefully the printed warnings in the
equipment.
b) Verify if the outlet where the equipment is connected has the wire ground pin, indispensable
to the perfect functioning and the safety of the equipment according ABNT standard.
c) Be sure that the tension of the net is under the specified to the equipment. This equipment
has automatic reversion of tension and can be connected to 127 or 220 Volts (see Range at
item Specifications and Technical Characteristics).
d) Connect the power cord at the incubator and after at the plug to the outlet.
e) Connect the cable of the Newborn sensor to the equipment, using the appropriated plug,
placed at the superior lateral and left side of the incubator cabinet. After connect it, turn the
locking screw of the sensor at the clockwise to fix it.

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3.4.2
a)
b)
c)

Starting the equipment

Turn-on the general key of the equipment placed at rear panel of the incubator.
Turn-on the equipment through the Key START (14)
When turning-on the incubator, it will automatically start the operation, assuming as the adjust
temperature both to the AIR as the NEWBORN, the last programmed temperature, i.e., the
incubator maintains always stored the last programming, even the incubator has been turnedoff.
d) It is recommended to prepare the incubator at the AIR mode.
e) Adjust the AIR programmed temperature to increase (6) or decrease (7).
f) After the selection of the desired temperature, the message; Heating will be shown at the
occurrence display (1), until the temperature establishes inside the incubator.
g) After the accomplishment of temperature programming, the program will pass to manage the
heating system, enabling the indicator of the real temperature of the incubator (3) equalizes
the programmed temperature. When reaching this point it will be exhibited the mode of
operation at the occurrence display (1) the message AIR MODE

IMPORTANT: when turning-off the equipment through the plug, it is essential that the key at the rear
part has been disconnected. It will avoid that the alarm battery advising the lack of energy will be
totally discharged.
3.5 SELECTING THE MODE OF OPERATION
3.5.1 Working at AIR Mode (ATC Air Temperature Control)
a) Press the key AIR (5) to work at Air Mode. In this system the equipment controls
automatically the air temperature inside the hood between 28C and 39C according to the
programmed temperature through the increase (6) and decrease keys (7).
b) The real temperature of the incubator is indicated at the display (3).
c) The real temperature of the Newborn is indicated at the display (2).
d) The system will indicate at the occurrences display (1) the message AIR Mode and the
programmed temperature of the air.
e) At the AIR Mode, the equipment will always activate the alarm that the real temperature of
the incubator (3) will be at 3C below the programmed temperature Hyperthermia or
Hypothermia.
3.5.2 Working at SKIN Mode (ITC Newborn Temperature Controlled)
NOTA: Before the use of incubator at SKIN Mode, it should already be implicitly operating at
AIR Mode with a real temperature of the incubator stabilized preferably at 36C. For this reason
please execute the operations given at item 3.5.1 and continue the below instruction.
a) Make the patient comfortably at the mattress. It is only necessary to open the frontal door of
the hood and slide the bed towards you
b) Fix the skin sensor at the abdominal region through an adhesive micro pore type.
c) Press the key SKIN (4), to work at the SKIN Mode. In this system the air temperature is
controlled automatically, according to measure exercised by an accurate sensor, which
captures the skin temperature of the newborn, maintaining the predetermined program (35C
to 39C).
d) The system will indicate in the occurrences display (1) the message SKIN Mode and the
programmed temperature for the patient.
e) The real temperature of the patient is indicated at the display (2).
f) In the SKIN Mode, the equipment will activate the alarm at the moment that the temperature
captured by the skin sensor will be 1C above or below the programmed temperature to the
patient, with the messages Hyperthermia or Hypothermia.
IMPORTANT: Both at the AIR Mode and SKIN Mode, it is necessary that the skin sensor will be
fixed preferable at the abdomen of the patient.

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3.6. PROGRAMMING THE TEMPERATURE

After selecting the operation mode AIR or SKIN MODE, press the key to increase (6) or decrease (7)
temperature, following the respective numeric values, shown at the occurrences display (1).
For the temperature programming higher to 37,5C SKIN Mode or 37C AIR Mode, the key liberates
39C (18) should be activated (see more details at item 3.2).
NOTE: The last value programmed of the temperature will remain saved at the memory, even the
equipment will be turned-off.
3.7 MESSAGES/ALARMS
For protection and safety of the patient the incubator is endowed of an efficient audiovisual alarm
system as per the below description and the audio can be deactivated per 2 minutes through the
alarm silencer key (20).
HEATING This message is shown to indicate that the heating control module of the incubator is
executing the heating phase to reach the temperature of thermo comfort programmed by the
operator.
It is recommended do not put the patient inside the equipment in this stage of the process.
ALARM AUTO TEST This message is shown at the occurrences display (1) when the Function
Auto Test will be selected - key Function (16) and key Enter (17).
OPENED HOOD This message is shown at the occurrences display (1) when the incubator has
been opened. The audio can be silenced through the key alarm silencer.
AIR MODE indicates the incubator is in operation at AIR Mode controlling and monitoring the
temperature inside the hood without patient intervenes.
SKIN MODE indicates that the incubator is operating at SKIN Mode controlling and monitoring the
temperature inside the hood according to the information captured by the skin sensor of the patient
and the predetermined program to the treatment.
OVER TEMPERATURE . This message is shown and the audio alarm activated at the moment the
incubator temperature (3) exceeds the programmed temperature in 3C, as the temperature is
constantly monitored through the sensor placed at the air duct, being:
The audio can be deactivated through the alarm silencer (20) during 2 minutes.
IMPORTANT:

Keep totally unobstructed the air entry and exit of the hood, for the safety and control of
temperature.

In this alarm situation it should be checked the reasons that have taken the incubator to
reach such temperature.

In any hypothesis that this alarm occurs, both in the AIR Mode and SKIN Mode, the heating
system is automatically turned-off until the temperature will return to safe levels.
UNDER TEMPERATURE This message is shown and the audio alarm activated at the time that
the incubator temperature (3) will exceed 3C below the programmed temperature, as the
temperature is constantly monitored through the sensor placed at the air duct, being:
IMPORTANT
Keep totally unobstructed the air entry and exit of the hood, for the safety and control of
temperature.
In this alarm situation it should be checked the reasons that have taken the incubator to reach
such temperature.
The audio can be deactivated through the key alarm silencer (20) during 2 minutes.

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HYPERTHERMIA When the skin temperature, measured by the sensor of the patient, will exceed
1C above the programmed temperature, this alarm will be activated and the message shown at the
occurrences display (1) until the patient will get out the hyperthermia.
The audio can be deactivated through the key alarm silencer (20) during 2 minutes.
HYPOTHERMIA When the skin temperature, measured through the patient sensor will exceed 1C
under the programmed temperature, this alarm will be activated and the message shown at the
occurrences display (1) until the patient will get out the hypothermia condition.
The audio can de deactivated although the key alarm silencer (20) during 2 minutes.
VENTILATION FAILURE This alarm is activated when there is failure at the ventilation system of
the incubator, being the problem at the set motor/fan . In this condition the heating system is
interrupted until the situation of the alarm can be solved. The message is exhibited at the
occurrences display (1).
The audio CANNOT be deactivated through the key of the alarm silencer (20).
THERMOSTAT ACTIVATED. This alarm is activated when the temperature surpasses the limit of
38C with the key release 39C deactivated and at 40C activated. In this situation the heating
system is deactivated until the temperature will return to the safety limits. The message will be
shown in the occurrences display (1).
The audio CANNOT be deactivated through the key of alarm silencer (20).
SKIN SENSOR FAILURE This alarm is activated when problems occur at the skin sensor of the
Newborn. In this conditions the heating system is interrupted until the alarm situation has been solved
(change the sensor). The message is shown at the occurrence display (1).
The audio CANNOT be deactivated through the key of alarm silencer (20).
AIR SENSOR FAILURE This alarm is activated when it occurs problems at the AIR Sensor. In this
condition the heating system is interrupted until the alarm situation will be solved (change of the
sensor). The message is exhibited at the occurrences display (1).
The audio CANNOT be deactivated through the key of alarm silencer (20).
HEATING FAILURE This alarm is activated whenever a failure in the heating system of the
incubator occurs. The message is shown at the occurrences display (1). The audio CANNOT be
deactivated through the key alarm silencer (20).
DESCONNECTED SENSOR This alarm is activated when the equipment has been operating in the
SKIN MODE and the sensor will not be properly connected.
The message is shown at the occurrences display (1).
The audio CANNOT be deactivated through the key alarm silencer (20).
3.8 SAFETY ELECTRONIC THERMOSTAT
The GRN incubator has double system of protection against overheating. The heating element
maintains automatically ON and OFF for the controlling of the incubator temperature according to
the previous programming. Although it has been applied the more advanced techniques of
temperature control (microprocessed controllers), the GRN incubators are endowed of safety
thermostats for the overheating which are installed at the ducts of air circulation to protect the patient
against any failure which may occur with the electronic temperature control.
IMPORTANT: Keep totally unobstructed the openings for air entry and exit from the hood for safety
and temperature control.
3.9 - HOOD
The hood of the GRN incubator has smooth movements for opening and closing, impeding abrupt
actions and protecting possible accidents. It has holes for the introductions of tubes, drain pipes,
sensors wire, etc.
It comes with portholes and a system for opening with a simple elbow touch for the better handling
of the newborn without opening the hood and handling without contamination of the nurse hands.

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BED RADIO TRANSPARENT. The bed and the incubator mattress are produced in radio transparent
material which enables a simple and quick access to placement of the X-Ray chassis under the bed
avoiding the patient has to be displaced from its ambient of thermo comfort to do this procedure.
The hood of the GRN incubator has a frontal opening which provides an ample access for the
handling of the newborn without needing to open the hood. The mattress tray can slides smoothly
outside, with the limited bolt safety, making easy the urgency care as it will change into support
platform.
IMPORTANT: For a perfect sliding of the tray, observe if the frontal levers (trendelemburg) are at the
low horizontal position.
3.10 TRENDELENBURG POSITIONS, PROCLIVE, HIGH AND LOW HORIZONTAL
These positions are activated by the levers situated at the frontal part of the incubator hood, with
movements downward and upward without the need to open the hood and interfere in the ambient
and the thermo comfort of the patient.
NOTE: When it will perform the high horizontal movement, this procedure is recommended to do
initially the trendelemburg movement and then a reverse trendelemburg, as in case of effecting both
at the same time, it can generate stress to the patient.
IMPORTANT: For safety of the patient please avoid opening the hood or slid the bed outside the
hood, when it will be at trendelemburg, reverse trendelemburg or high horizontal positions.
3.11 ICE DRAWER
When the ambient temperature has been up to the desired, it is necessary to use an ice drawer,
placed at the right lateral side of the incubator cabinet. Supply the drawer with ice and turn-on the
incubator at the desired temperature. Supply the ice how many times it will be necessary until the
temperature will stabilize.
Note: The ice camera is also known as ice drawer.
Important: The ice drawer is a fundamental item for the operation. It should only be withdrawn for
asepsis.
3.12 AIR FILTER
The air filter is able to filtrate micro particles, protects the air which circulates in the incubator, from
impurities as dust and the microorganisms of the air.
It must be changed habitually when it is necessary and obligatorily after the use of a patient with
infected and contagious illness.
To substitute the filter just open the compartment located at the left lateral side of the equipment
cabinet. Take off the filter, make the asepsis of the compartment, install the NEW filter and close it.
It is recommended as a control of the filter substitution, to note the date of the filter change in an
adhesive tape and fix it the frontal part of the filter compartment.
IMPORTANT: The air filter must always be substituted by a NEW one, never should be placed at the
opposite side or cleaned with a cloth, brush, air gush, etc.
NOTE: The equipment must not be operated without the air filter.
3.13 HUMIDIFIER (Optional item)
The humidifier can be activated through the net of compressed air or oxygen (this last one if it was
prescribed by a licensed person who knows the risks and benefits).
The managing of oxygen or compressed air should be done by a pressure of entrance from 3 to 7
bar. The outflow to the interior of the equipment is controlled by a flux meter which has a register to
control the outflow.
After the use, do the asepsis, unroll the clamp which is connected to the incubator cabinet,
withdrawing it with the hose which transports the humid air into the air conduct enabling a complete
cleaning.

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1. Fix the flux meter (3) which is

already connected to the
humidifier flask (4) at the thread
(B) of the item (1).
2. Fit into the hose (2) at the hole
(C) at the inferior part of the
item (1)
3.

Next fix the hose (5) at the

thread (A) of the item (1).

3.14 SERUM SUPPORT

This device is connected to the incubator cabinet and provided of four hooks to sustain serum flasks,
endowed of a system which allows the adjustment to a desired position.
3.15 SKIN SENSOR
The incubator has a skin sensor of high sensibility to measure the temperature of the patient, so it is
necessary that to be perfectly fixed to the patient, preferably at abdominal region.
If occurs any problem with the sensor, as the internal wires breakage, it will appear at the
occurrences display (1) the pertinent information and at the same time the audio alarm will be
activated. It is necessary an immediate substitution of the sensor.
If the problem with the skin sensor occurs when the equipment in the AIR Mode it will not cause any
problem to the patient. Being so the equipment can continue in use until the change of the sensor.
If the problem will occur when the equipment is working at SKIN Mode, the protection system
immediately will emit the audio visual alarm of SKIN SENSOR FAILURE at the occurrences display
(1).
In this situation the skin should be promptly substituted by any a new one.
Important: This sensor could not be used in any hypothesis to measure the rectal temperature.

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3.16 LIST OF THE PARTS AND PECES, ELECTRONIC SCHEME AND TECHNICAL
INFORMATION
The electro electronic schemes, the list of parts or any other necessary information are available and
could be supplied by Gigante Recm-Nascido, since it has been necessary to the technical
maintenance of the equipment by the user since both agreement of both parties.
3.17 MECHANIC STABILITY
The equipment is safe of turn over, when positioned in an angle until 5.
For transportation, maintain the hood closed.
3.18 CONCENTRATION OF CARBON DIOXIDE (CO2)
The concentration if CO2 which will occur in the Newborn compartment during the described test as
per Item 105.1 of NBR IEC 60601-2-19 will be at maximum 0,5%.
3.19 OXYGEN (O2)
If it will be necessary the administration of oxygen, it should attend the parameters established by the
physician.
As a safety step, when the oxygen was being administrated it should do confirmation of routine using
an Oxygen Analyzer.
Attention: The incidence risk of RETROLENTAL FIBROPLASIA (Retinopathy of premature infant) is
developed when are applied concentrations of oxygen higher to 40% to the newborns with cardio
respiratory diseases.
Table of Concentration:
Oxygen
Liters per minute
Concentration rate

Concentration
1
22-24%

2
25-27%

3
28-30%

4
31-35%

The above mentioned values should be used only as reference, as it is obligatory the use of Oxygen
Analyzer.
4 WARNINGS AND/OR PRECAUTIONS
4.1 Warnings and/or Precaution in the installation of net tension, auxiliary plug and power
plug
Check the electric net tension if it is compatible to the limits established to this equipment (before
connecting the plug of the outlet).
The auxiliary outlet (optional item) follows the voltage of the net where the equipment is installed. The
maximum potency allowed will be identified near to it..
Verify if the plug where the equipment will be connected has a wire ground pin, indispensable to the
perfect operation and safety of the equipment as per Standard ABNT (NBR 5410).
Presence of anesthetic gas
The Incubator is not appropriated for utilization in the presence of anesthetic and inflammable gas or
other inflammable materials, such as a kind of fluid for cleaning.
Other equipments
It should take particular care to guarantee that the additional equipments connected to the Newborn
or to the Incubator itself are electrically safe.
Additional equipments as phototherapy, warmed mattress etc, can change the performance of the
incubator related to the temperatures and their controls.
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4.2 Warnings and/or Precautions for the operation

Used only for authorized staff
This equipment must be only used by personnel properly trained and under the direction of a
qualified physician team, which are well familiarized with all risks and benefits presently known for
the utilization of the Newborn Incubators.
The use of any part, accessory of non-specified or foreseen material ins these Instructions of Use is
of entire responsibility of the user.
Monitoring the Newborn
The independent monitoring of the newborn temperature by the operator is essential and it is
inadvisable leaving the newborn without attending inside de incubator.
Increase of the temperature (dangerous levels)
If the equipment is exposed to the direct sunlight or any other radiant source, it can cause an
increase of Incubator temperature at dangerous levels.
Operation Modes
In the Manual Control (AIR) mode, the Incubator does not monitories the skin temperature of the
patient and so it is of most importance that during the treatment, the newborn has its corporal
temperature monitories periodically and if it is necessary it may adjust the incubator temperature.
Note 1: the incubator indicates only the newborn temperature.
Note 2: in order to have the newborn temperature monitored by the incubator, it is necessary use the
control at SKIN (ITC) mode.
At the SKIN mode of operation the Incubator depends on the information collected through the
sensor of the skin patient. Therefore it is of the most importance that during the treatment it is being
checked if its positioning is correctly placed at the patient body.
Use of the skin sensor
Never take out the plug of the skin sensor pulling it by the wire/cable. Take if off by holding the plug.
Never remove the skin sensor of the patient pulling it by the cable. First of all remove adhesive tape
carefully.
Never use the equipment at the SKIN Mode, if the skin sensor is duly not fixed to the patient body.
The skin sensor should be used exclusively to the cutaneous control (to measure the skin
temperature) and should be placed at the abdominal region. It cannot be used to measure the rectal
temperature.
Use only original Gigante skin sensor, as the other sensors could cause errors at the temperature
reading and cause damages to the newborn.
Lack of energy
If occurs lack of energy or burnt fuse, the equipment should be turned-off through the general key
and so avoiding when the energy supply will come back to the equipment, an overload can damage
the system of control.
Turning-off the equipment
When turning-off the equipment it is necessary that the key ON/OFF have been turned-off before
turning-off the equipment from the plug. This will avoid that when turning-off again the plug to the net,
a possible overload damages the equipment.
Danger of Fire
Even small quantities of inflammable agents, like ether or alcohol which was let on or inside the
incubator can cause a fire in association with the oxygen.
The utilization of oxygen increases the danger of fire and equipments which produce sparks can not
be placed in the incubator.
Rack for equipments
The maximum permissible loads:
Serum Rod = 1 kg Newborn Bed = 10 kg

Racks = 5 kg

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Increase o Noise
The supply of oxygen can raise the level of noise to the Newborn inside the incubator.
Panel of control
Do not activate the keys of the panel with nails or either sharp objects such as pens, pencils etc.
Newborn Compartments
The hood, portholes and/or parts in acrylic as fragile parts, can not be submitted a any kind of efforts,
as well as can not act as support for other equipments even though as support for the operator.
When handling equipments or any other utensils in procedures to the Newborn, take care with the
mechanical shocks at the deflectors in the hood, as they are responsible for the homogenization of
temperature in the surface of the mattress.
When opening and closing the hood do smooth movements as it can cause a risk to the patient if it
is used an excess of power.
All the time that the bed is extended to do a procedure with the Newborn, it is totally forbidden to
open the hood. Verify at the end of procedure if the bed is at the initial operation position.
Never open the hood with the frontal door opened, as the lock of safety can beat the equipment
generating a vibration to the equipment.
When the hoses, tracheas and sensors will be applied to the patient, it is totally forbidden to open the
hood.
When closing the frontal door, be sure that the lock is totally closed.
Guarantee that the patient stay always at the center of the mattress.
Do not use any object strange to the Newborn compartment (blankets, pillows etc...)
Never remove the double hood when the patient was inside the equipment.
4.3 - Warnings and/or Precautions in the Maintenance
When substituting the fuses and to assure the electric protection, keep the same specifications (type
and capacity).
Use only Gigante original accessories and parts for a perfect operation and safety of the equipment.
4.4 Warnings and/or Precautions at the Cleaning
GRN recommends using products containing alcohols or ether at the cleaning of the acrylic parts, as
they can damage them.
The cleaning of the equipment should be done with a wet cloth and neutral soap, added with a
germicide or a disinfectant of large specter.
4.5 Warnings and/or Precautions in the Transport and Storage
The product should be stored or transported with a maximum piling up of 3 units, as well as protected
against humidity and heat. (See specifications at item 2 Special conditions of storage, conservation
and/or handling of the product).
As it is a fragile product, it is necessary to take care and do not let it fall in the floor.
Effect always the transport of the equipment with the hood closed.
The transport should be performed without the patient and with the cable of energy turned-off the
electric net.
Note The equipment is exclusive for stationary use. Therefore when it reads transport, it is
understood that this is referring for the condition of installation or handling of it. It is totally forbidden
to transport the equipment with the patient inside the compartment.
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4.6 Warnings and/or Precautions Printed in the Equipment

a) Newborn sensor / Protection against Electric Chocks
Attention n 1

Identification of the localization to connect the sensor.

Identification the Protection Against Electric Discharges Equipment BF type

b) Entrance connection of the humidification and oxygenation system

Attention n 2

- Identification of the localization to connect the humidification entrance system and oxygenation.
- Identification of the alarm about the necessity to be used an Oxygen Analyzer to apply oxygen.
See item 3.13 for installation of it.
c) Air filter and presence of ignition source in the incubator place
Attention n 3 and n 14

- Alert about the necessity to change the air filter periodically (see item 3.12 for more details).
- Alert about risk of combustion (see item 4 Warnings and/or Precautions)

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Ice drawer
Attention n 4

See item 3.11 about use of ice drawer.

d) Air duct Top
Attention n 5

alert about heated local (danger of burning).

Note: it will be necessary the use of tools to remove this top.

e) Entrance and Exit of the Air
Attention n 6

- alert about the necessity to keep the entrance and exit air areas unobstructed.

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f) Fuse specification of the electric energy or feed entrance

- The fuse should be according to the electric net voltage. Use a fuse according to the table.
Note: See item Specifications and Technical Characteristics for the fuse specification.
h) Cleaning of the Hood
Attention n 7

- Alert about the cleaning of the hood. See item 4.4 In the cleaning.
i) Serial Label

This label is placed at the cabinet, at the rear part of the incubator.
j) Internal battery of the equipment
Attention n 8

The internal battery for signaling of lack of energy is the type of reloaded and can only be
substituted by authorized technical assistance of GRN.
The Range of work of these batteries is from 10C to +60C.

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k) Protection device of the plate GRN33

Attention n 9

The plate GRN33 has a protection cover which must only be removed by the authorized
technical assistance of GRN in the case of maintenance.
When removing the protection device, the equipment must be with the general key turnedoff and the feeding cable out of the outlet. If this is not done this alert, it has a risk of electric
discharge.

l) Maximum potency of the heater element

Attention n 10

- alert about the maximum potency of the heating element (300 Watts).
m) Use of the skin sensor
Attention n 11

- alert Do not use the probe for rectal temperature checking.

n) Lock of the frontal cover of the hood

Alert to close the frontal door of the hood.

Keep always the lock at the end of the running.

o) Passage of the Newborn sensor

At left lateral of the incubator there is an adequate compartment, identified to the passage
of the Newborn sensor.
Do not use the opening of the tubes, tracheas and porthole as the passage of this sensor.

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5 PERFORMANCE OF THE EQUIPMENT

5.1 - Indication, purpose or destination use of the product.
Indication: newborn that needs warm are\ with controlled temperature, normally for newborn
of low weight and high risk.
Purpose: thermo-regulatory of newborns, attending its needs of heat.
5.2 Secondary or collateral and undesirable effects and counter indication:
Not applicable.
5.3 Safety and efficacy of the equipment:
The incubator is totally safe and efficient as it was projected attending the safety standards (NBR IEC
60601 general, collateral and particular applied) and produced following a quality system (NBR ISO
9001:2000 and Good Practices of Medical Products Production (RDC 59 ANVISA).
Since it is maintained (stored) and preserved according to the mentioned in the item 2 of this
Instructions of Use, the equipment will not lose or modify
its physical and dimensional
characteristics.
5.4 Biocompatibility of the materials which contact the patient
The parts which contact the patient and users are biocompatible as the incubator was projected and
produced with standard materials, used in the building of the electro medical equipments.
6 INSTALLATION OR CONNECTION TO OTHER PRODUCTS
The incubator does not have the purpose or use of a direct connection with other equipments.
Therefore if it is necessary the utilization together with other equipment, it should be connected to an
outlet at the electric net independent of the incubator outlet.
Attention: The use of any parte, accessory or material non-specified or foreseen in these Instructions
of Use is of entire responsibility of the user.
7 INSTALLATION, CORRECTIVE AND PREVENTIVE MAINTENANCE
7.1 - Installation:
When receiving the incubator, it will be necessary two persons to take it off the packing, in a carefully
way to avoid accidental fall.
Do the assembly of the cabinet support according the instructions below:
Assembly sequence:
Join the part 2 to the part 3 as per
indication in the picture at side.
Fix them using 4 screws 1 with a 4mm
Allen wrench .
Join the part 4 in the assembled parts
taking care not to let the silk on front
of the part 4 to the same side which
the silken stripes at part 3.
Fix with the remaining screws 1

Place the incubator on the cabinet support, observing the correct position indicated at the cabinet
surface and tied it using the lateral fixing fastening.

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Take off the packing and fix the universal support for the monitors trays (optional item) and the
serum support at the rear inferior left side of the equipment, through the screw which comes along.
Place the chromate serum support with 4 hooks.. Choose the desired position and fix it through the
screw.
It is necessary to proceeds a general inspection: painting, acrylic, portholes, humidifier, casters,
serum support, operation, positions reverse trendelemburg trendelemburg, air filter, mattress,
connecting cable, manual, etc.
IMPORTANT: Use only GRN original accessories, as they are dimensioned and projected to attend
the necessities of the equipment, without compromising the safety of the patient. The utilization of
non-original GRN parts or adoptions can compromise the stability of the equipment and
consequently offer risks to the patient and the operator.
7.2 Corrective Maintenance
When a damage in one or more parts of the equipment occurs, isolate and identify it with a label
reading in maintenance.
PROBLEM
CAUSE
1. Lack of heating a) Feeding
voltage
below the
even
with
the
specification;
equipment indicating b) Burnt of the Heating Element;
ON.
c) Lack of contact of the internal
connections of the Incubator.
2. Super heating a) Strange body (fabric or paper) under
inside the hood
the opening of the air exit in the
hood;
b) Rupture of the cable of the
thermostatic command sensor ;
c) Alteration in the internal adjusts of
temperature.
3. Equipment does a)
not start
b)
c)
4. Bad operation of
the displays which
indicates
the
temperature
5. Indication lack of
air
circulation
constantly activated

a)
b)
a)
b)

SOLUTION
a) Verify the hospital electric net voltage.
b) With the help of a multimeter, test the
heating resistances and the connections
inside the equipment (only by technician
people)
a) Withdraw all and any element placed
under the opening of air entrance and exit of
the hood;
b) Effect the change of the cable of the
thermostatic command sensor: (only by
technician people).
c) Recalibrate the adjust of the Thermostatic
Control (only by technician people).
Bad connection of the feeding cable; a) Connect the feeding cable correctly to the
Burnt fuse;
electric net;
Bad operation of the key ON/OFF
b) Check the fuse conditions and change it;
c) Test the operation of the key ON/OFF.
Rupture of
the cable of the a) Effect the change of the temperature
respective sensor;
sensor cable (only by technician people);
Bad contact
in the internal b) Readjust the defective connections (only by
connections of the control panel
technician people);
Bad operation in the micro-switch a) Check the operation of this activation
activating of the air circulation;
device (only by technician people);
Engine burnt of the air circulation.
b) Test the engine air circulation (only by
technician people).

NOTE: If these steps were performed and the problem are not solved, contact the GRN Authorized
Technical Assistance whose telephones and addresses can be got through the site
http://www.gigante.com.br sac@gigante.com.br or through the Customer Service at the plant
through the telephone
+55 16 3969-1000 or fax +55 16 3969-1001.

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7.3 - Preventive Maintenance

The Preventive Maintenance must be made periodically according to the table below, with the
objective of:
- check wastage at the casters, conditions of the air circulation motor, resistance, electronic
circuits, painting, etc.
- check the conformity to the specifications of the product.
- Perform the calibration (or gauging) of the equipment thermometer , as well as the other
essential parts for a perfect operation and safety of the equipment.
The Preventive Maintenance must be done exclusively by the Authorized Technical Assistance
whose telephones and addresses can be got through the site http://www.gigante.com.br
sac@gigante.com.br or through the Customer Service through the telephone +55 16 3969-1000 or
fax +55 16 3969-1001
Table of Maintenances
Item
Heating element (resistance)
External fuses
Reloaded batteries
Temperature sensors calibration

Period
2 years
1 year

1 year
4
to
months
Calibration in other electronic parts
1 year
Checking the conformity to the product 1 year
specifications
Disinfection and cleaning of the air duct Every
change
patient

Type
Replacement
Replacement
Replacement
6 Checking
Checking
Checking
Cleaning
of disinfection

Executor
Technical Assistance
User
or
Tech.
Assistance
Technical Assistance
Technical Assistance
Technical Assistance
Technical Assistance
/ User

The lists of parts and pieces, as well as the electro electronic schemes or any other necessary
information are available and will be supplied by Gigante Recm-Nascido, since it has been
necessary to the technical maintenance of the equipment by the user and as common agreement of
seller and buyer.
7.4 Conservation:
GRN recommends not using products containing alcohols or ether to the cleaning of the acrylic parts
as they can damage them.
The cleaning of the equipment should be done with a wet cloth with water and neutral soap.
8 ADDITIONAL PROCEDURES TO REUTILIZATION
The equipment is reusable in undetermined quantities, i.e., unlimited and needs only conservation,
preventive maintenance and eventually corrective maintenance.
Before each utilization, it is necessary to do cleaning and disinfection of the equipment.
8.1 Cleaning
Habitual or Current Asepsis: It should be done before and after receiving the newborn.
a) Remove the baby tray and the mattress. Wash them using water and neutral soap;
b) Clean the support-tray with a wet cloth and neutral soap;
c) Remove the top of the air circulation duct according to indication printed in the proper piece.
Perform the duct cleaning including the resistance and fan.
d) Hoods and other acrylic parts use only wet cloth and neutral soap;
e) Change the air filter placed at the left lateral side of the incubator cabinet. Do the substitution
always when it is necessary or obligatorily when it was used by an infected patient.
f) Clean the skin sensor, inclusively its cable using water and neutral soap.

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8.2 Disinfection
It is effected the habitual asepsis adding a germicide or large specter disinfectant, taking care of
does not leave any residue which can provoke any toxic action in contact to the patient body. It is
obligatory to change the air filter.
It is also necessary to disinfect the skin sensor and the cable using a germicide or large specter
disinfectant product.
Using disinfectant containing alcohol:
The disinfectants can be bought in the market in several concentrations.
Another disinfectants can be utilized such as:
Note: The values indicated are the maximum values and should not be surpassed!
Product
Ethanol at 96% ........................................
Propane ...................................................
Glutaric diluted at 25% ............................
Ethiltexanol ...............................................
Formaldehyde solution .............................
Glyoxalin....................................................
Sodium hypochlorite .................................

Dilution
= max. 40 g / 100 g of disinfectant
= max. 35 g / 100 g of disinfectant
= max. 75 mg / 100 g of disinfectant
= max. 10 mg / 100 g of disinfectant
= max. 10 mg / 100 g of disinfectant
= max. 165 mg / 100 g of disinfectant
= max. 50 mg / 100 g of disinfectant

Note: Do not utilize any kind of alcohol in the acrylic parts.

Gigante Recm-Nascido is not responsible for the utilization of preparation whose components are
different of our indications.
9 ADDITIONAL PROCEDURES BEFORE THE UTILIZATION OF THE EQUIPMENT
Assemble the equipment according to description at item 7.1.
Even on the first utilization, the equipment should be cleaned and disinfected and it should be
followed the same additional procedures for the reutilization according to item 8 of this Use
Instruction.
10 PRECAUTION IN CASE OF ALTERATION IN THE EQUIPMENT OPERATION
In case of the equipment presents heating or abnormal noises or any other abnormality, check if the
problem is related to any of the items mentioned on item 7.2. If it is not possible to solve the
problem, ask the authorized technical assistance. In this case, turn-off the equipment, take off the
feed cable of the energy from the outlet and ask for the services of the authorized technical
assistance through site http://www.gigante.com.br through the Customer Service in the plant by
telephone: +55 16 3969-1000 or fax +55 16 3969-1001.
11 SENSIBILITIES TO PREDICTABLE CONDITIONS AT THE NORMAL SITUATIONS OF USE
The GRN Neonatal Incubator Millennium model was projected not to be sensitive to interference with
magnetic fields, external electric influences, electrostatic discharges, pressure or pressure alteration,
since the equipment will be installed, kept clean, preserved, transported and operated according to
the Instructions of Use.
12 PRECAUTION IN CASE OF EQUIPMENTS INUTILIZATION
To avoid environment contamination or improper use the GNR Neonatal Incubator Millennium model,
when it will be unutilized , it should be isolated, packed, identified and sent (by clients own
responsibility) to the plant of Gigante Recm-Nascido to be done the duly discard with safety.

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13 - WARRANTY DO THE EQUIPMENT

Gigante Recm Nascido Indstria, Comrcio e Representao Ltda.
guarantees to its clients
originals users, that the manufactured products are produced within the most advanced technique
and with rigorous quality control, assuring inside the conditions and terms below, a perfect operation
of them.
1. EQUIPMENTS
1.1 This guaranty is valid for all equipments of GRN mark produced by GRN.
2. INSTALLATION AND USE
2.1. The installations and/or operation of the equipments, as well as the work conditions should
attend GRN Standards mentioned in the Operation Manual. Different conditions of that
indicated invalidate the guaranty clauses of this Term.
3. WARRANTY
3.1. The warranty, without any onus to the acquirer user, is limited to the substitution and/or repair
of eventual defective parts or to the correction of any production defect, through the
confirmation given by Gigante Technical Assistance Department.
3.2. The substitution and/or repair mentioned in the anterior item is not applicable to the parts
with wastage of natural use (filters, rubbers, mattress, shock absorber, parts in acrylic,
fuse, plates, resistances, bulbs) as well as by incompetence or negligence in the use of the
equipment, or also, that has been repaired or modified by non-authorized by GRN.
3.3. In any hypothesis, if it occurs the necessity of substitution of any component covered by this
Term, the original warranty period will be expanded by the increase of the eventual
supplementary of the substituted component.
4. LOCAL OF THE GUARANTY
4.1. The repair and/or substitution of parts will be executed by a GRN technician or authorized
by the same.
4.2. When it will be attested that a perfect repair of the equipment will be only possible in our
installations (plant), or in the companies authorized by us, the freight (coming and going)
will be for the buyers account.
5. TIMES
5.1 . It starts at the date of the Sales Invoice issuance from GRN or their resellers by a period
of 12 months.
RESPONSABILITY
5.2 . This warranty is only valid for equipment which has been used and in the original user
ownership posses.
5.3 . GRN responsibility is limited to the substitution and/or repairs of the components except the
warranty of eventual prejudice by ceasing profits or by indemnity or any other damages
indirect or immediate.
OBS.: The present guaranty is only valid attached to the Invoice.
14 TERM OF RESPOSNABILITY
The company GIGANTE RECM-NASCIDO IND. COM.. REPRESENTAO LTDA, represented
by its Technical Responsible Eng. Rogrio Augusto de Oliveira and by its Legal Representative
Erica Vernile Pereira Vezono, assumes the technical and legal responsibilities of the product
and for all information given, referring to the product Neonatal Incubator Millennium model,
containing in this Instructions of Use, are truthful.

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