User Manual Intensive Care Unit Heated Cradle Amplatm 2085

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7/11/2020 USER MANUAL INTENSIVE CARE UNIT HEATED CRADLE AMPLATM 2085

Page 1

USER'S MANUAL

SÃO PAULO - BRAZIL

INTENSIVE CARE UNIT


HEATED CRADLE
AMPLA TM 2085

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Technical Standard - NBR IEC 60601-1


NBR IEC 60601-1-2
Revision: 09/01
NBR IEC 60601-2-21
Edition: 09/09
NBR IEC 60601-2-49
NBR IEC 60601-2-50 Ref .: 004.107.550

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INDEX
1 - Equipment Identification ............................................. .................................................. .......... one

2 - Technical Specifications ............................................... .................................................. ................ two


2.1 - Electrical Specifications .............................................. .................................................. ....... two
2.2 - Classification and Characteristics ............................................. .................................................. .... two
2.3 - Control Characteristics ............................................. .................................................. .......... 3
2.4 - Physical Characteristics .............................................. .................................................. .............. 4
2.5 - Gas Module ............................................. .................................................. ....................... 5
2.6 - Maximum Loads .............................................. .................................................. ........................ 5
2.7 - Audiovisual Alarms .............................................. .................................................. .............. 5
2.8 - Symbology ............................................... .................................................. ................................ 7
2.9 - Environmental Conditions .............................................. .................................................. ........ 10

3 - Actions, Parts and Accessories ........................................... .................................................. ........... 10

4 - Precautions, Restrictions and Warnings ........................................... ........................................ 31


4.1 - Precautions regarding Bilitron TM Bed 4006 Phototherapy ....................................... ......... 35

4.2 - Electromagnetic Compatibility and Immunity ............................................ ........................... 37


5 - Equipment Installation ............................................. .................................................. ............ 38
5.1 - Accessories ............................................... .................................................. .............................. 42

6 - Equipment Operation ............................................. .................................................. ............ 43


6.1 - Operational Functions .............................................. .................................................. ....... 43
6.2 - Monitor ............................................... .................................................. ................................... 49
6.3 - Turning on the Monitor ............................................. .................................................. ............ 81
6.4 - Balance Operation ............................................. .................................................. ........... 82
6.5 - Table Movement ............................................ .................................................. .............. 83
6.6 - Opening of the Laterals ............................................ .................................................. .......... 84
6.7 - X-rays ............................................. .................................................. .................................... 84
Obs .: Housing for the X-ray tray only for the Intensive Care Unit ............. 84
6.8 - Gas Module ............................................. .................................................. ..................... 85
6.9 - Vacuum of Secretions ............................................. .................................................. ........ 86

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6.10 - Sensor Operation ............................................ .................................................. ......... 88
6.11 - Bilitron TM Bed 4006 Phototherapy Operation ......................................... ............................. 90
7 - Preventive, Corrective Maintenance and Conservation .......................................... ............................ 91
7.1 - Monitor ............................................... .................................................. .................................... 91
7.2 - Phototherapies ............................................... .................................................. ............................ 92
7.3 - Protection Fuses ............................................. .................................................. ............. 92
7.4 - Cleaning and Conservation ............................................. .................................................. ......... 93
7.5 - Maintenance Chart ............................................. .................................................. ........... 94
7.6 - Disposal ............................................... .................................................. ................................. 94
7.7 - Auto Check-up Operation and Alarm Tests ..................................... ......... 95
7.8 - Replacement Parts ............................................. .................................................. ............... 98
7.9 - Fault Diagnosis ............................................. .................................................. ............... 99

8 - Warranty and Technical Assistance ............................................ .................................................. ......... 102

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

1 - Equipment Identification

The AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT , as well as all its accessories, is
developed within the highest standards of technology and security, while maintaining a
excellent versatility for use in Intensive Care Units, Delivery Rooms and Neonatal Nests.

This equipment was designed to meet all the needs of a wide and safe treatment, in
the most varied forms of use. It has an irradiating heat system, designed to attend to the newly
born in the first moments of life in prolonged care, when access to the patient and
visualization are required.

The radiant heat system has a quartz-covered heating element source and a
protection for the patient. Through its routers located near the reflector, it provides heat
homogeneous in all areas of the mattress. Still, the irradiating reflector has as characteristic, aperture
retractable on both sides to access X-ray equipment and auxiliary lighting.

The microprocessor control monitor may be provided according to the following options

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different:
a) Microprocessed Colorful Graphic Display Monitor;
b) Microprocessed Monochromatic Graphic Screen Monitor;
c) Microprocessed LED Screen Monitor.

According to the monitor configuration, the following parameters are applied, among others:
two skin temperatures, monitoring room temperature, monitoring oxygen saturation
and beatings, scales integrated into the bed, monitoring of the oxygen administered to the patient, among others.

Electric table with Trendelemburg positions, reverse and horizontal automatically or optionally, from
manually operated, with 4 cable or tube loops, drawer for X-ray chassis, memory mattress and sheet
of identification. It also has the acrylic bed configuration with manual movement.
In its central column, the serum support, lateral support shelf, thread support can still be attached,
gas inlet panel, flushometer, transport handle and hook and collection bag.

It has a metal frame base reinforced with a plastic cover and 4 rotations with a 5 ”brake.

The AMPLA TM 2085 Heated Crib still has a number of other optional items that can be attached to the
equipping in a modular way, configuring and perfecting the product to the conditions
actual use, as for the case, such as; Metabolic with Scale integrated to the bed, Oximeter of
Pulse (SpO2, Phototherapy BILITRON TM 3006, Reverse Phototherapy BILITRON TM BED 4006, Mattress
Transparent for reverse phototherapy, Thermal Mattress, Transport Set with Thermal Mattress + Mattress
Transparent + Batteries, Support for Infusion Pumps, Auxiliary plugs in various configurations,
Ergometer with side pedalboards, Trays, shelves and drawer sets for accessories, Support for
Cylinders and cylinders for Air and O2. Gas front panel with configuration options,
Aspirator, Blender and BABYPUFF TM , Neonatal CPAP by water seal, etc.

With the intention of conserving its efficiency and taking into account the nature of the work of this
equipment, certain special care is necessary in its handling and operation. This Manual of the
User provides general instructions for the installation, use, maintenance of the operator and diagnosis of
failures of the AMPLA TM 2085 Heated Cradle manufactured by FANEM ® .

In accordance with the applicable legislation, FANEM ® is not responsible if the user who operates the
According to your instructions, do not follow the maintenance recommendations in this manual or do any
repair through unauthorized elements and accredited by the company with non-components
authorized. Calibration and repairs should only be carried out properly by qualified personnel.
Any additional information is done through your local distributor.

This manual must be read and absolutely understood and must be in quick access for each person
which will work with the unit. When it is not in use, the User Manual must be kept with the cradle or
guaranteed access through the hospital's competent tracking system. If there is any
information that you do not understand, please contact FANEM ® representatives to
further explanations.

one

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

2 - Technical Specifications

2.1 - Electrical Specifications

♦ Supply Voltage 127 V ~ u 220/240 V ~ ± 5%

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♦ Network frequency 50/60 Hz

♦ Input Power 800 W

♦ Nominal Current 7 A p / 127V ~


4 A p / 220 / 240V ~

♦ Exhaust Current <300 µA

♦ Ergometric Power 75 W

♦ Rechargeable Battery (Panel) 9 V ---

♦ Rechargeable Battery (Transport Set) 12 V - - - - 9 Ah

♦ Plugs and Auxiliary Network - Maximum Power per Plug 150W

Fuses

Application Fuse

♦ Red 127V ~ 10A - Type F

♦ Red 220 / 240V ~ 5A - Type F

2.2 - Classification and Characteristics

♦ Type of Electric Shock Protection Class I equipment

♦ Degree of Protection against Electric Shock Type BF Applied Part


♦ Degree of Protection against Water Penetration - Cradle 2085 IPX0
AMPLA TM
♦ Equipment not appropriate for use in the presence of anesthetics
No AP / No APG
flammable with air, oxygen or nitrous oxide
♦ Mode of Operation Continuous operation

OBS: Values and classifications according to NBR IEC 60601-1 and NBR IEC 60601-2-21 standards

2.2.1 - BILITRON BED TM 4006 Phototherapy - Classification and Characteristics

♦ Degree of Protection Against Water Penetration Irradiance


IPX4
BILITRON BED TM 4006 phototherapy Converted *
♦ Total Irradiance for Bilirubin 3.6 mW / cm 2 36 µW / cm 2 nm
♦ Average of Total Irradiance (Ebimax) 3.0 mW / cm 2 30 µW / cm 2 nm
♦ Minimum Irradiance Average (Ebimin) 1.7mW / cm 2 17μW / cm 2 nm
♦ Effective Surface Area 25 X 30 cm ---

♦ Distance between the irradiation source and the Surface ---


127 mm
Effective
♦ Maximum Noise Level (45dBA environment) 60dBA ---

(*) The irradiance declared in mW / cm2 is presented and converted into µW / cm 2 nm through the
FANEM 2620 radiometer with 500 nm spectrum band

two

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

♦ Graph of Total Spectral Irradiance - BILITRON BED TM 4006 - Interval 320 nm to 550 nm

SpectralIrradiance
Spectral Irradiance

5.00E-05

4.00E-05

ectral 3.00E-05

cia esp
(W / cm2 nm)
2.00E-05
iân (W / cm2 nm)
Spectral Irradiance

Irrad
1.00E-05

0.00E + 00
320 325 330 335 340 345 350 355 360 365 370 375 380 385 390 395 400 405 410 415 420 425 430 435 440 445 450 455 460 465 470 475 480 485 490 495 500 505 510 515 520 525 530 535 540 545 550

Wave Compression (nm)


Wavelength

♦ FANEM TM 2620 Radiometer Calibration Curve

Calibration Curve
Radiometer of the Radiometer
Calibration Curve
1,60E-02

1,40E-02

1,20E-02

] 1.00E-02

/W
m 8.00E-03
η
two

m 6.00E-03
c
4.00E-03
)λ [TO
(
R 2.00E-03

0.00E + 00
200 250 300 350 400 450 500 550 600 650

Wavelength
Wave Compression (m) η

2.2.2 - Pulse Oximeter - Features

Indication:

♦ SpO 2 measurements 1% to 100%

♦ Pulse Measurements 20 to 250 bpm

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Precision:

70% to 100% + 2
Digits
♦ Saturation (% SpO 2 + 1 SD) RN:
60% to 80% + 4
Digits

♦ Low Perfusion 70% to 100% + 2 Digits

♦ Heart Rate 20 to 250 bpm + 3 Digits

♦ Low Perfusion 20 to 250 bpm + 3 Digits

♦ Perfusion Index 0.03% to 20%

♦ Measurement Variation% SpO 2 1% to 100%

♦ Heart Rate 20 to 250 bpm

2.2.3 - Thermal Mattress - Classification and Characteristics

♦ Degree of Protection against Electric Shock Type BF Applied Part


♦ Low Heat Transfer Heating Device
♦ Power (Watts) 50 W
♦ Equipment not appropriate for use in the presence of anesthetics
No AP / No APG
flammable with air, oxygen or nitrous oxide

2.3 - Control Features

Temperatures
♦ Temperature Screen Resolution 0.1 o C

♦ Control Belt 25.0 - 38.0 o C

♦ Control Accuracy ± 0.2 o C

♦ Actuation Strip of the Temperature Display 20.0 - 45.0 o C


Weighing System - Balance

♦ Screen Resolution 2g
♦ Performance Belt - Weight 0 to 10 kg
♦ Indication Accuracy ±2g
2.4 - Physical Characteristics
Cradle in Fixed Support
♦ Width 630 mm
♦ Length 1119 mm
♦ Total height 2003 mm
♦ Height - Mattress Level 1000 mm
♦ Rotating Rotation 5 ”- Brake 4 und

Cradle on Ergometric Support


♦ Width 630 mm
♦ Length 1119 mm

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♦ Length (with resuscitation support) 2003 mm
♦ Maximum height 2100 mm
♦ Minimum height 1900 mm
♦ Height - Mattress Level 1000 mm +100 / -100
♦ Rotating Rotation 5 ”- Brake 4 und

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

2.5 - Gas Module

♦ O 2 Inlet and Outlet Nipple 9/16 ”Screw - 18UNF


♦ Compressed Air Inlet and Outlet Nipple 3/4 ”Screw - 16UNF

Vacuum Nipple for Network (Optional). Special settings, such as customer and customer requests
local legislation, under consultation.

2.6 - Maximum Loads

♦ Whey Stand 2 kg
♦ Auxiliary Shelves 10 kg
♦ Bed 7 kg
♦ Intermediate Tray 7 kg

2.7 - Audiovisual Alarms

System alarms

♦ Lack of Energy Activated when there is a power failure


or if the power cord is disconnected from the system. In
In case the transport module (optional item) is
present, the low power alarm will actuate when charging
transport batteries finish. This alarm is signaled on the
panel by red LED of lack of energy and by a high sound signal and
keep going.
♦ Heater Failure Activated when there is a fault in the radiant heater (resistor
Irradiant burned or with interrupted power). Alarm with indication
visual and intermittent sound signal.
♦ 100% permanence of Powered case the radiant heater remains, without
Heating Power interruption, at 100% power for more than 15 minutes. It happens
both in Manual Mode and Skin Mode operation
(Servo controlled). Alarm with visual indication and sound signal
intermittent.

By activating the alarm, the radiant heating is interrupted. To the


press the button to Inhibit Sound, the alarm is canceled on
radiant heating is resumed and the 15 minute count is
restarted.
♦ 15 minute alert Triggered every 15 minutes, when the system is operating
stay in mode Manual mode and with adjusted heating power for values
Handbook below 100%, contrary to what happens with the alarm
stay at 100% power, radiant heating, on
this case is not interrupted. Alarm with visual indication and signal
intermittent sound. When you press the button to Inhibit Sound, the alarm

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is canceled and the 15 minute count is reset.

♦ Low Load of Alarm associated with the transport module (optional article).
Transport Batteries Powered when the system is operating with power to
through the transport batteries (lack of power in the network
or the system disconnected from the mains) and the voltage
in batteries it is less than 11.3 V.
Alarm with visual indication and intermittent sound signal.

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Temperature Alarms and Skin Sensor

♦ High Temperature Actuated case the skin temperature T1 is 1º C or more above the
skin temperature set point. When this alarm occurs, the
( T1 Skin Sensor Only )
Radiant heating is interrupted. Alarm with visual indication and
intermittent sound signal.
♦ Low Temperature Actuated case the skin temperature T1 is 1º C or below the
skin temperature set point. Alarm with visual indication and
( T1 Skin Sensor Only )
intermittent sound signal.
♦ Lack of Skin Sensor Actuated in case the Skin Sensor T1 is disconnected or there is a failure of the
T1 sensor (broken threads, damaged pine trees, etc.). When it occurs, the system
automatically interrupts the radiant heating and goes into Mode
( T1 Skin Sensor Only )
Handbook. Alarm with visual indication and intermittent sound signal.
♦ Skin Sensor Actuated case the Skin Sensor T1 is dislodged from the skin of the
Evicted patient. Alarm with visual indication and intermittent sound signal. He
actuation is based on the detection of abrupt variation,
( T1 Skin Sensor Only )
negative or positive, of the temperature of the Skin Sensor T1.
The following points should be observed:
- When the system is turned on, there is a 10 minute inhibition of
this alarm (for the temperature in the Skin Sensor T1 to stabilize
on the patient's skin), after which sensor detection
evicted is enabled.
- Detection of the evicted sensor occurs as follows: yes
within a period of 7 seconds a positive variation is verified
greater than or equal to 0.5º C or a negative variation greater than or equal to 0.3º C
on the T1 Skin Sensor, then the alarm triggers.
- Once triggered, the alarm is canceled just if the temperature
Skin Sensor T1 return for the temperature prior to variation or
if the user presses the button to Inhibit Sound.
- When canceling the alarm through the Inhibit Sound button, there will be a
2-minute alarm inhibition period, after which the alarm
eviction sensor detection is enabled again.
- Every time the user goes from Manual Mode (or preheat)

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For Skin Mode, there will be 1 minute inhibition of the alarm, after the
which should activate the dislodged sensor detection.
- If T1 Skin Sensor failure occurs, so the sensor is reset
there will be 2-minute inhibition of the alarm, after which it is
enabled eviction sensor detection enabled.
- If after carrying out any of the actions below the
system enter Skin Mode (servo-controlled), there will be a period of 2
minutes of alarm inhibition, after which the detection of
evicted sensor is enabled again.
- Turn off the thermal mattress
- Return the radiant heater to the central position
- Switch from battery power to power supply

Operating Indications

♦ Servant Automatically activated when the T1 Skin Sensor is


connected.
♦ Manual Automatically activated when the T1 Skin Sensor is
disconnected, or when the sensor or sensor wire is damaged.
♦ Inhibit Sound Indicates that the sound of the alarm that is activated will be inhibited
for 15 minutes or the interval indicated in the function
correspondent. The sound will automatically return to normal after
This weather.
♦ Heating Indication of heating power from 0 to 100% of the
total power, via power bar in increments of 10
in 10%.

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Pulse Oximeter Alarms

♦ High SpO 2 Concentration If the patient's oxygen saturation is above the


(Adjustable 21 to 100%) high SpO2 concentration limit. In the versions with screen
LCD and colorful monochrome, the pulse oximeter features the
SpO2 alarm management SatSeconds 1 function (see the
Pulse Oximetry section in the Crib functions chapter
Heated). Alarm with visual indication in the Information and
Alarms and intermittent sound signal.
♦ Low SpO 2 Concentration Actuated case the patient's oxygen saturation is below the
( Adjustable 20 to 99%) SpO2 concentration limit. In the versions with screen
Colorful and monochrome, the pulse oximeter features the function
SpO2 alarm management SatSeconds 1 . (look at the section
Pulse Oximetry in the chapter on Functions of the Heated Cradle).
Alarm with visual indication in the Information and Alarms section and
intermittent sound signal.
♦ High level of BPM Actuated case the level of beats per minute (BPM) of the
patient is above the high BPM level limit. Alarm with
( Adjustable 11 to 250)
visual indication and intermittent sound signal.
♦ Low or BPM level Actuated case the level of beats per minute (BPM) of the
patient is below the low BPM level limit. Alarm with
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( Adjustable 10 to 249) visual indication and intermittent sound signal.
♦ Sensor in Motion Actuated during variations in the reading of the SpO2 value for
the pulse oximeter sensor. It is automatically disabled
when the SpO2 value is stable again. Alarm with indication
visual and intermittent sound signal.
♦ Evicted Sensor Actuated case the pulse oximeter sensor is dislodged from the
patient. It is automatically disabled when the sensor is
relocated. Alarm with visual indication and intermittent sound signal.
♦ Sensor Disconnected Powered case the pulse oximeter sensor is disconnected
panel or sensor failure. (broken threads, damaged pine trees, etc.)
Alarm with visual indication and intermittent sound signal.
♦ Failure of the Oximeter Occurs when there is a communication failure with the
Pulse pulse oximetry. Alarm with visual indication and sound signal
intermittent.

In this module, the alarm inhibition occurs for up to 02 minutes


1 SatSeconds is a registered trademark of Covidien AG

Oxygen Monitor Alarms

♦ High O2 Concentration Actuated case the oxygen concentration is above the limit of
high concentration. Alarm with visual indication and sound signal
(Adjustable 16 to 100% )
intermittent.
♦ Low Concentration O 2 Actuated case, the oxygen concentration is below the limit of
(Adjustable 15 to 99% ) low concentration. Alarm with visual indication and sound signal
intermittent.
♦ Lack of O 2 Sensor Actuated in case the oxygen sensor is disconnected from the system
or there is a sensor failure (broken wires, damaged pine trees, etc.). Alarm with
visual indication and intermittent sound signal.

Blender Mixer Alarm

♦ Sound alarm The Blender will trigger an internal alarm, characterized by a


Network Pressure continuous sound, in case an imbalance occurs between the pressures of
Air and Oxygen inlet greater than 20 psi. (1.4 Kgf / cm 2 ).

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

FOG® 1140 Humidifier Alarms

♦ High Temperature Shown on the humidifier FOG TM by a red LED, a beep


flashing and the indication "Ht 'on the screen. It is always powered
( "HI TEMP" - ERROR )
that the temperature of the gas captured by the Temperature Sensor
the patient circuit is greater than 36º C.
♦ Internal Sensor Failure Visual alarm indicating damage or connection failure of the
Of temperature Humidifier internal temperature control sensor. Such failure
it is indicated by the characters "SF" on the screen. When
( "Sensor Failed" - ERROR )
powered, all humidifier operations and
heating are interrupted.
The screen will remain with the indication "SF" one way
intermittent while the equipment is energized and the fault is

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correct.
♦ Lack of Water in the Audiovisual alarm activated whenever the water level of the
Deposit of humidifier tank is low. It is indicated by the characters
Humidifier "LL" on the humidifier display and with an intermittent beep.

( “Low Level” - ERROR )


♦ Lack of sensor If the humidifier is used without the circuit temperature sensor
circuit temperature of the patient, the screen will alternately indicate the Level of
of the patient Power and the characters “nS” “No Sensor”, indicating that the
equipment is with the sensor disconnected.

2.8 - Symbology

Attention: Consult documents


Type BF Applied Part
companions

OR OFF (No Electrical Voltage


Feeding) I ON (With Electric Voltage of
Feeding)

OFF (only part of the ON (only part of the


equipment) equipment)

T TARE I PRINT

Timer - APGAR Inhibit the Sound Alarm

Grounding Terminal for


Alternating current
Protection

Attention: Heat Emission


Protection for the patient's eyes
by Radiation

Top Ergometric Down Ergometric

Tilting Movement of the


Movement in both directions
Table

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

2.8.1 - Symbology - Packaging

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Fragile This sense up

Protect from Sunlight Protect from the Rain

Attention: Consult documents


Stacking Limit
companions

2.9 - Environmental Conditions

♦ Operating Temperature Strip 19 o C to 28 o C - Environment

♦ Operation Humidity Belt 15% to 95% - Non-condensing

2.9.1 - Environmental Conditions of Transport and Storage

♦ Storage Temperature Strip 0 o C to 55 o C - Environment

♦ Storage Humidity Belt 30% to 75%

Obs .: Conditions specified with packaged equipment.

3 - Actions, Parts and Accessories

Heated Cradle AMPLA TM 2085


Complete with Accessories
Color Monitor, Balance, Ergometric, ICU Table

Illustration 1 - Configuration Example

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Heated Cradle AMPLA TM 2085


Complete with Accessories
Color Monitor, Ergometric, Acrylic Bed Table

Illustration 2 - Configuration Example

Heated Cradle AMPLA TM 2085


Wall Unit with Accessories
LED Monitor, Compact table from LDR with Cj.
Aspiration.

Illustration 3 - Configuration Example

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10

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Heated Cradle AMPLA TM 2085


Mounting / Optional Configurations

Fixed without Balance - STD Fixed without Balance - STD Fixed without STD Balance
LED monitor Monocolor monitor Color Monitor
Ref .: 004.032.700 / 800/850 Ref .: 004.031.700 / 800/850 Ref .: 004.030.700 / 800/850

OBS .: REFERENCES ABOVE FOR BASIC UNITS (STD) WITH RESPECTIVE MONITORS AND WITHOUT ACCESSORIES
OPTIONAL

Microprocessed Color Graphic Monitor


Ref .: 004,111,900

Monocolor Microprocessed Graphic Monitor


Ref .: 004.120.900

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Monitor Display LED´s Microprocessed


Ref .: 004.126.900

eleven

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

LED monitor Monocolor monitor Color Monitor

ACCESSORIES STD OPTIONAL STD OPTIONAL STD OPTIONAL

Irradiant Retractable Reflector


√ √ √
REF: 004.085.700 / 800

Auxiliary lighting
√ √ √
REF: 004.123.900

Adjustable Serum Holder


√ √ √
REF: 004.335.600

Side Shelf - 10Kg


√ √ √
REF: 004.324.600

Electric Table
√ √ √
REF: 004.122.900

Manual Adjustment Table


√ √ √
REF: 004.362.600

Acrylic Bed Table


√ √ √
REF: 004.358.600

Transport handle
√ √ √
REF: 004.343.300

Rotation 5 "with Brake (4x)


√ √ √
REF: 000.232.021

Thread Support Winder


√ √ √
REF: 150.100.322

Bi-lateral ergometric pedal


√ √ √
REF: 004.110.900

Gas Inlet Panel


√ √ √
REF: 004.315.600

Extension 1.5m for O2 (1x)


√ √ √
REF: 004.058.600

Extension 1.5m for Ar (1x)


√ √ √
REF: 004.212.600

Ambient Temperature Sensor


√ √ √
REF: 004.350.600

Collection Bag Hooks and


Cable Router (3x) √ √ √
REF: 158.100.320
DOT 3AL Air Cylinder
(aluminum) with registration valve √ √ √
REF: 158.103.500

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DOT 3AL Oxygen Cylinder
(aluminum) with registration valve √ √ √
REF: 058.116.500
Cylinder Support
Right left √ √ √
REF: 004.352.600
Complete Cylinder Assembly
√ √ √
REF: 004.348.600

O2 Flushometer (0-15 bpm) (1x)


√ √ √
REF: 003.054.500

Air Flushometer (0-15 bpm)


√ √ √
REF: 004.052.500

Humidifier bottle for


Flushometer √ √ √
REF: 003.053.500

# Not Available in “Acrylic Bed” configuration

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LED monitor Monocolor monitor Color Monitor

ACCESSORIES STD OPTIONAL STD OPTIONAL STD OPTIONAL

Gas Panel - Aspiration


(Vacuum meter; Bottle; Vacuum cleaner
√ √ √
Mechanic)
REF: 004.359.600
Gas Panel with Blender
√ √ √
REF: 004.360.600
Gas Panel
Aspiration + Babypuff TM √ √ √
REF: 004.317.600
Gas Panel
Babypuff suction + TM + Blender √ √ √
REF: 004.332.600
Humidifier + Bubble Bottle +
CPAP circuit n or 0 √ √ √
REF: 004.083.700 / 800
Integrated Bed Scale
# √ √ √
REF: 004.114.900

Pulse oximeter With


Plestimographic curve NA NA √ √
REF: 004.125.900
Bilitron® 3006 phototherapy with
Articulated arm √ √ √
REF: 004.112.900
Reverse phototherapy Bilitron TM
Bed 4006 √ √ √
REF: 004.116.900
Transparent Mattress
Reverse Phototherapy / Surgery
√ √ √
REF: 004.310.321 ICU table
REF: 006.107.321 Acrylic Bed

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Thermal Mattress # √ √ √
REF: 004.118.900

Transport Game -
Batteries
Thermal Mattress + Mattress # √ √ √
Transparent
REF: 004.129.900

Infusion Pump Support


√ √ √
REF: 004.347.600

Accessories Tray
√ √ √
REF: 004.327.600

Accessories Tray
2 drawers √ √ √
REF: 004.239.600
Accessories Tray
4 drawers # √ √ √
REF: 004.330.600
Accessories Tray
2 Joints Shelves and
# √ √ √
"By Pass" drawer
REF: 004.328.600
Side Shelf with Adapter
√ √ √
REF: 004.355.600
Auxiliary Plugs –Shucko (2x)
√ √ √
REF: 004.349.600
Auxiliary Plugs - 3P
NEMA Standard 10-20R (2x) √ √ √
REF: 004.357.600
Auxiliary Plugs - 3P
SNAP FIT IEC (3x) √ √ √
REF: 004.356.600

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LED monitor Monocolor monitor Color Monitor

CABLES AND SENSORS STD OPTIONAL STD OPTIONAL STD OPTIONAL

O2 analyzer
Cable with Cell NA NA √ √
REF: 004.353.600
O2 analyzer
Cable with Connector NA NA √ √
REF: 004.361.600
O2 analyzer
Oxygen Cell NA NA √ √
REF: 090.855.020
Temperature sensors
Skin Sensor 1 √ √ √
REF: 092.059.600
Temperature sensors
Skin Sensor 2 √ √ √
REF: 092.072.600
Rectal Temperature Sensor
√ √ √
REF: 004.370.600
Pulse Oximeter - SpO2
D-YS Sensor NA NA √ √

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REF: 090.137.600
Heated Humidifier -
CPAP FOG TM
√ √ √
Temperature sensor
REF: 150.076.600
Heated Humidifier -
CPAP FOG TM
√ √ √
Water Level Sensor
REF: 140.050.600

SENSOR ADHESIVES STD OPTIONAL STD OPTIONAL STD OPTIONAL

Skin Sensor Adhesive - 100 un


√ √ √
REF: 086.068.600

SpO2 Sensor Adhesive


NA NA √ √
REF: 090.151.600

# Not Available in “Acrylic Bed” configuration NA Article Not Applicable to the model

Wall Unit Configuration

The AMPLA TM Heated Cradle Intensive Care Unit


2085, can be configured as a Wall Unit, having
the same options of monitors, that is, Graphic Monitor
Color, Monochrome Graphic Monitor and LED Screen Monitor.
You have only one basic bed option and several bed options
accessories, can be used on top of a bench, on top of
a hospital crib or together with wardrobe in rooms
humanized childbirth.

Attention: For plus explanations of


configurations optional accessories see
our technical assistance department.

Wall Unit - STD Wall Unit - STD Wall Unit - STD


LED monitor Monocolor monitor Color Monitor

REF: 004.034.700 / 800/850 REF: 004.035.700 / 800/850 REF: 004.036.700 / 800/850

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3.1 - Microprocessed Control Monitor

The Microprocessed Control Monitor can be provided in the following options and according
with the appropriate applications and usage requirements:

a) 8.4 ”Microprocessed Colorful Graphic Screen Monitor - REF: 004.111.900;


20 Functions and 19 Graphic Parameters
b) 5.5 ”Microprocessed Monochrome Graphic Screen Monitor –REF: 004,120,900;
20 Functions and 11 Graphic Parameters

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c) Microprocessed LED Screen Monitor - REF: 004.126.900.
10 Basic Functions

♦ These models monitor the patient's temperature by electronically ordering the amount of
heat radiated by the heating element, according to the patient's need. This amount of
Heat is informed to the equipment through the Patient Sensor that it must contact
with the newborn's skin on the abdomen.
♦ With the microprocessed circuit working at the control point, it keeps the patient at
desired temperature with variation of ± 0.2º C, through a sensor applied to the newborn's skin.
It has alarms for hypothermia, hypertemia, sensor disconnection and sensor displacement, with
differentiated sounds and audiovisual indicative screens.
♦ Hypothermia audible alarm inhibition key, to fasten the system to the control point and
patient care with automatic reset.
♦ The temperature setting to be controlled is indicated on the screen under TEMPERATURE OF
FIT, and the amount of radiant power can be displayed on the LED bar. Temperature
indicated on the screen in the SKIN TEMPERATURE is the skin of the newborn in the area of the
sensor.
♦ These monitors also allow the manual control way, where the proportional energy of the
heating can be adjusted by the operator. In this case, monitoring the temperature of the
The patient's body must be done manually.

According to the configuration of the monitor and its respective accessories, it is still applied, among others, the
following parameters: monitoring two skin temperatures, monitoring the temperature of the
environment, monitoring of oxygen saturation and heart beat, integrated bed scale,
monitoring of oxygen administered to the patient, monitoring of the temperature of the thermal mattress, etc.

3.1.1 - Ambient Temperature Sensor


Located at the top of the column, it measures the temperature where the
Cradle Heated and constantly reports this temperature on the monitor screen
control as additional information to the user.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.350.600

3.2 - Irradiant Reflector

REF: 004.085.700 - 127V ~ 50 / 60Hz


REF: 004.085.800 - 220 / 240V ~ 50 / 60Hz

Provides the necessary heat to the patient, through indirect infrared radiation originating from the
560W heating element made with chrome nickel wire encapsulated in the special quartz tube.
The reflector has directional fins that distribute heat evenly over the mattress area,
while just concentrating on this region.
The Irradiant Reflector has a retractable function for both sides, +90 or / -90 or , to allow fast
access to X-ray equipment. During the action of this retractable function, a device
safety switch is activated and interrupts the power supply to the heating element, returning to its condition
normal operation so that if it restores its original position.

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Attention: Estimated lifetime of the heating element 18 months. (In


normal conditions of use).

3.3 - Auxiliary Lighting

Provides illumination on the patient, for use in less illuminated environment.


Its light source is a battery of white LEDs and a diffusing lens. It is powered
by the light switch located at the bottom of the Irradiant Reflector.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.123.900

Attention: Optional Article .

3.4 - Soro Regulável Support

Made of metal pole and hook in engineering plastic, the Serum Holder is
coupled to the back of the column, being articulated for the two sides of the
Heated cradle and, providing height adjustment. Can be docked
double cross.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.335.600

Attention: Optional Article .

3.5 - Side Shelf

Side swivel shelf, fixed at half height near the column, ideal for
junctions of multi-parameter monitors and fans and other peripherals. May
fit up to 3 shelves.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.324.600

Attention: Maximum load on shelf 10 Kg.

Attention: Optional Article .

3.6 - Side Shelf with Adapter

Side swivel shelf, fixed at half height near the column, ideal for
junctions of multi-parameter monitors and fans and other peripherals.
Additional shelf provided with adapter block.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.355.600

Attention: Maximum load on shelf 10 Kg .

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Attention: Optional Article .

3.7 - Patient Bed

3.7.1 - Electric Table - REF: 004.122.900

ICU Table Bed provided with electric drive system allowing


smooth bed movement without causing noise to the patient. It has side edges on
transparent acrylic.

Operated through access keys located in the column, near the panel,
for the Trendelenburg (-12 o ), Proclive (+12 o ) and Automatic Horizontal positions. Have
transparent acrylic side edges, Identification Sheet (REF: 094.101.321),
Drawer for the X-ray chassis type 'By Pass' and (REF: 004.323.600) and 4 Pins
Tubes and Cables (REF: 090.111.322) in silicone.

Attention: Optional Article . Not available in the monitor version LED display.

Obs. In the display LED monitor version, non-executable automatic horizontal turn.

3.7.2 - Mechanical Table - REF: 004.362.600

ICU Table Bed provided with mechanical adjustment drive system


manual that allows the movement of the bed for the Trendelenburg positions (-12 o ),
Proclive (+12 o ) and Horizontal. It has transparent acrylic side edges,
Identification REF: 094.101.321, Drawer for the X-ray chassis type "By Pass" (REF:
004.323.600) and Tubing and Cable Pins (REF: 090.111.322) in silicone.

Attention: Optional Article .

3.7.3 - Acrylic Bed - REF: 004.358.600

Made on the support platform in the crib unit, it is composed of the


patient bed, completely removable, made in acrylic with round edges. In
the platform is incorporated the manual adjustment mechanical drive system
that allows the movement of the bed in the Trendelemburg (-10 o ), Proclive positions
(+ 10º), and Horizontal. It has an identification sheet (REF: 094.101.321).

Attention: Optional Article .

Attention: The Maximum Load in the patient's bed is 7 kg.

3.8 - Memory Mattress

The AMPLA TM 2085 Heated Cot comes from the factory with a PU foam mattress
with appropriate density and composition, while providing the patient with
superior softness, with "memory effect". This mattress is covered by a layer in
Non-toxic PVC and accompanies the bedding assembly. (ICU Table or Acrylic Bed).

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.103.100 - For ICU Table
REF: 004.104.100 - For Acrylic Bed

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3.8.1 - Transparent Mattress

Transparent mattress with appropriate density and gel composition, provides the
patient excellent softness. Suitable for use in procedures
reverse phototherapy or in cases of surgery where it must be used together with the mattress
thermic to maintain the patient's body temperature.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.310.321 - For ICU Table
REF: 006.107.321 - For Acrylic Bed

Attention: Optional Article .

3.8.2 - Thermal Mattress - REF: 004.118.900

Thermal mattress, used under the transparent mattress, provides heat generation
indirect to the patient. With safety thermostat, it has programming and control of
temperature through the heated crib control monitor.
Suitable for use in surgical procedures, for example in surgery
cardiac or in situations where the superior radiant heat can make the
team procedures. It must be used together with the transparent mattress for
maintenance of the patient's body temperature.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

Attention: Item available only for Heated Cradle configuration


AMPLA TM 2085 - ICU Table .

3.8.3 - Transport Set - REF: 004.124.900


02 Batteries
01 Charger
In intrahospital transport situations, such as delivery room / ICU or
01 Source

delivery room / nest, etc. where it is necessary to maintain body temperature


of the patient, the optional Transport Set consisting of 2 Batteries + Charger
Voltage + Thermal Mattress + Transparent Mattress, maintains total autonomy for
execution of this transport under appropriate thermal conditions.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

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Attention: Item available only for Heated Cradle configuration


AMPLA TM 2085 - ICU Table .

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3.9 - Accessories Tray and Drawers

3.9.1 - Accessories Tray - REF: 004.327.600

Tray installed under the patient bed assembly. This tray can be used
to accommodate clothing and / or various utensils.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: optional item.

Attention: The maximum tray load: 7 kg.

3.9.2 - Accessories Tray and 2 Drawers - REF: 004.329.600

Tray installed under the patient bed assembly. This set has 2 drawers
to accommodate clothing and / or various utensils.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: optional item.

Attention: The maximum tray load: 7 kg.

3.9.3 - Accessories Tray and 4 Drawers - REF: 004.330.600

Tray installed under the patient bed assembly. This set has 4 drawers
to accommodate clothing and / or various utensils.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: optional item.


Available only for AMPLA TM 2085 Heated Cradle configuration -
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ICU table .

Attention: The maximum tray load: 7 kg.

3.9.4 - Accessory Tray with 2 Joints Shelves and “By Pass” type Drawer
REF: 004.328.600

Tray installed under the patient bed assembly. This set has 2 shelves
with articulation for help and support in routine procedures and 1 “By” drawer
Pass ”to accommodate clothing and / or various utensils.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: optional item.


Available only for AMPLA TM 2085 Heated Cradle configuration - Table
ICU .

Attention: The maximum load in tray: 7 kg.

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3.10 - Transport Handle

Auxiliary handle located at the rear of the column, facilitates


movement and transport operations of the AMPLA TM 2085 Heated Cradle .

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.343.300

3.11 - Gas Inlet

All connections, valves, gauges and tanks can vary with customer and regulatory needs
local.

3.11.1 - Gas Inlet Panel - REF: 004.315.600

The panel located at the back of the column, has a different way
Gas Module and Aspiration Module that allows the user a series of
options for use in resuscitation, oxygenation, aspiration procedures,
CPAP, etc.
The Gas Module is made with 1 nipple for the input of O2, 1 nipple for the output of
O2, 1 air inlet nipple and 1 air outlet nipple.
The Aspiration module is made of 1 nipple for the air intake and 1 nipple for the
aspiration.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

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3.11.2 - O2 Flushometer - REF: 003.054.500

O2 flushometer - 0 to 15 LPM, to be attached to the side of the


column. Maintains flow control in the most various options of use in the
resuscitation, oxygenation, aspirational, CPAP, procedures.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Additional flushometers, optional, may be incorporated into the


system according to the need of use.

Attention: Optional Article .

3.11.3 - Humidifier Bottle for Flushometer - REF: 003.053.500

Plastic humidifier bottle, capacity 230ml, to be attached low to the base of the
flushometer with the purpose of supplying humidified oxygen in the most varied
options for use in resuscitation, oxygenation procedures, etc.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

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3.11.4 - Air Flushometer - REF: 004.052.500

Air Flushometer - 0 to 15 LPM, can be used together with the output nipple of Modulo de
Rear panel gases, maintaining flow control for the most diverse options
use in resuscitation, oxygenation, aspiration, CPAP procedures, etc.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.11.5 - Extension for O2 - REF: 004.058.600


Extension for Air - REF: 004.212.600

Extensions for O2 and Air, in high pressure braided non-toxic hose, 250 PSI,
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with female connectors for interconnection of the respective gas sources to the Panel
Gas Inlet.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.12 - Cylinder and Cylinder Support

3.12.1 - Right / Left Cylinder Support - REF: 004.352.600

Support for Air and O2 cylinders. Installed at the rear of the column
the cradle, maintains fixation and security for the gas cylinders during a possible
internal transport or in conditions where there are no power sources or networks
of medicinal gases.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.12.2 - Oxygen and Air Cylinder

Oxygen Cylinder - REF: 058.116.500


Oxygen cylinder with registration valve, type E in aluminum, according to the standard
DOT 3 AL, reference volume 4.6 L (H2O).

Air Cylinder - REF: 058.116.500

Air cylinder with registration valve, type E in aluminum, according to DOT 3 standard
AL, reference volume 4.6 L (H2O).

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article . Not included Reducing Valve.

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3.12.3 - Complete Set of Two Cylinders - REF: 004.348.600

Complete set consisting of Right / Left Cylinder Support, 1 Cylinder


Aluminum Type E Oxygen, 1 Aluminum Type E Air Cylinder, 1 Regulating Valve
for Oxygen with Flushometer ( REF: 000.601.020 ) and 1 Regulating Valve for Air
with Flushometer ( REF: 000.617.020 ).

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Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.13 - Gas Front Panel - Settings

Warmed AMPLA Cradle TM 2085 provides a number of options and configurations mounting
the Gases front panel. Its configuration options are modular and seek to assist the various
requirements of resuscitation, oxygenation, aspiration, CPAP procedures, etc. according to
wrapped applications.

3.13.1 - Gas Panel - Aspiration - REF: 004.359.600

Modular panel, contains only the aspiration mode, with vacuum gauge, bottle of
aspiration, meconium aspirator and silicone aspiration hose.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.13.2 - Gas Panel with Blender - REF: 004.360.600

Modular panel contains only the Blender type gas mixer - 21 to 100% O2.
Necessary in procedures that require control of the Air / O2 mixture with extreme
precision.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.13.3 - Aspiration Gas Panel + Babypuff TM - REF: 004.317.600

Modular panel contains aspiration module with vacuum gauge, aspiration bottle,
meconium vacuum cleaner and silicone suction hose, plus the
BabypuffTM resuscitator, consisting of pressure gauge, pressure valve
safety, PIP inspiratory pressure valve, gas inlet hose, tube
corrugated with "T de Ayre" and PEEP valve.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

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3.13.4 - Aspiration Gas Panel + Babypuff TM + Blender - REF: 004.332.600

Modular panel contains all the complete modules, that is; suction module with
vacuum gauge, aspiration bottle, meconium aspirator and aspiration hose in
silicone, plus the Babypuff TM resuscitator module , consisting of a pressure gauge,
safety pressure valve, inspiratory pressure valve PIP, hose
gas inlet, corrugated pipe with "Ayre T" and PEEP valve, plus the mixer
Blender type gases - 21 to 100% O2.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

Attention: Optional Article .

3.14 - Humidifier + Bubble Bottle + CPAP Circuit

This option is composed of FOG TM 1140 Heated Humidifier , plus bottle


bubble, plus Circuit CPAP n or 0. When used in conjunction with Input Panel
Gases and the various Gas Front Panel configurations, provides the
possibility of executing procedures using heated and humidified gases
such as CPAP, resuscitation, oxygen therapy, etc.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.083.700 (127V ~ 50 / 60Hz)
004,083,800 (220V ~ 50 / 60Hz)

Attention: Optional Article .

3.15 - Infusion Pump Support

Set of metal pole with fixing next to the side of the column. Projected to unite
infusion pumps, it has 4 upper hooks for fixing bags
and IV solutions that can be height adjustable to provide
more or less gravitational pressure.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.347.600

Attention: Optional Article .

3.16 - Hooks - Collector Bag and Cable Manager

Hooks made of engineering plastic, has the purpose of supporting the bag
collector (2 hooks located on the sides near the patient's bed), and also
the purpose of routing the control monitor sensor cables (1
hook located on the side of the column).

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 158.100.320

2. 3

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3.17 - Auxiliary Plugs

Installed on the side of the column, the set of auxiliary mains plugs is intended for the
connection of monitors and auxiliary devices.

Attention: The Maximum Power for each auxiliary plug is 150W.


Verify that the equipment connected to the auxiliary plugs
they are according to the IEC 60601-1 standard and its particular standards.

NOTE: The configuration of the plugs may vary according to local legislation.

3.17.1 - Shucko Pattern Auxiliary Plug

The auxiliary plug set consisting of 2 Shucko pattern plugs.

REF: 004.349.600

Attention: Optional Article .

3.17.2 - Auxiliary Plug Pattern 3 P NEMA standard

Auxiliary plug set consisting of 2 standard 3P plugs according to standard


NEMA 10-20R.

REF: 004.357.600

Attention: Optional Article .

3.17.3 - Auxiliary Plug Pattern 3 P SNAP FIT

The set of auxiliary plugs consisting of 3 standard 3P plugs according to the standard
SNAP FIT IEC.

REF: 004.356.600

Attention: Optional Article .

3.18 - Thread Support Winder

Made of rubber and located on the side of the spine, it provides accommodation
perfect and fixing of the network cable when used in transport or proportional removal of the
network cable avoiding excess wires in use.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 150.100.322

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3.19 - Integrated Bed Scale

Metabolic bed with integrated neonatal balance, used for weighing and monitoring
of the newborn, the weighing function is executed through internal load cells
on the table platform, thus decreasing, thus, the need greater
handling the newborn. Measuring capacity of up to 10 Kg and precision of 2g.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.114.900

Attention: Optional Article .


Available only for the configuration of the Multisystem® 2085 Heated Crib
AMPLA - ICU table.

3.20 - Pedal Ergometer

The ergometric column with pedalboards on both sides of the Heated Cradle
AMPLA TM 2085, has variable height, electrically operated with the total course of 200
mm (+100 / -100 mm).
This optional provides better ergonomic condition to team members
patient service, adjusting the bed height accordingly in a smooth way
with better posture of the assistant.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.110.900

Attention: Optional Article .

3.21 - BILITRON TM 3006 Phototherapy

Microprocessed phototherapy using 5 blue Super LEDs as the irradiation source.


With reduced dimensions, it is coupled through a flexible articulated arm
directly onto the patient bed structure, while allowing the
Adjusted irradiation intensity so that the treatment does not suffer variations in
intensity and focus, due to interference from the patient / source distance when in
Trendelenburg, Proclive and Horizontal positions.

ANVISA registration: 10,224,620,049

REF: 004.112.900

Attention: Optional Article .

3.22 - Reverse Phototherapy BILITRON TM BED 4006

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Phototherapy Reverse Bilitron TM BED 4006 consists of a group of 17 Super
Blue LEDs arranged at the base of the bed in such a way that the acrylic in the background
stay approximately 9 centimeters from the light source.
This group of Super LEDs emit light from bottom to top that crosses the bottom of the bed
in acrylic and reaches the newborn. At the bottom of the acrylic bed is a mattress
transparent so as not to interfere with the radiation to be received by the patient.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.116.900

Attention: Optional Article .

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3.23 - Pulse Oximeter

It is a Pulse Oximeter to be used as a continuous non-invasive monitor


partial arterial oxygen saturation (SpO2) and pulse rate of neonatals with
plethysmographic curve. Use in AMPLA TM 2085 Heated Cot in conjunction with
other control and monitoring instruments, such as: Skin Temperature,
oxygen concentration, etc. providing greater ease and information in the
Verification of the vital signs of the newborn.
This optional uses pulse oximetry to measure functional oxygen saturation in
the blood. Pulse oximetry with the application of a sensor to a vascular bed
arterial, such as the foot. The sensor contains a dual light source and a
photodetector.
Bones, tissues, pigmentation, and venous vessels normally absorb an amount
light constant over time. The arteriolar bed pulses and normally absorbs
variable amounts of light during pulsations. The absorbed light ratio is
converted into a measure of functional oxygen saturation (SpO2).
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

REF: 004.125.900

Attention: The Pulse Oximeter should be used only as a supplement in the


evaluation of the patient and should be considered together with the
clinical signs and symptoms.

Attention: The SpO 2 measurement depends on the sensor light, then the excess
Ambient lighting can interfere to that extent.

Attention: Optional Article .

3.24 - Cables, Sensors and Adhesives

3.24.1 - Pulse Oximeter Sensor - SpO2 - D-YS Sensor

Reusable latex-free sensor, used in children (3 - 15 kg) and in neonatal patients.


For use in children the ideal area for application is the big toe,

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with the cable attached along the sole of the foot.
For application in neonates, the ideal area for application is the anterior part of the
sole, another area alternative would be the palm of the hand, under the toes,
with the cable fixed along the palm.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle

REF: 090.137.600

Attention: Optional Article . Accompanying the optional Pulse Oximetry.

3.24.1.1 - Adhesive for SpO2 Sensor

Latex-free tether, type FOAN - P / I for WRAPS sensor - 10 units


Latex-free tether, type ADH - P / I for WRAPS sensor - 10 units

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 090.151.600

Attention: Optional Article . Accompanying the optional Pulse Oximetry.

Oximax TM - Trademark Nellcor Puritan Bennett

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3.24.2 - Skin Temperature Sensors 1

3.24.2.1 - Skin Temperature Sensor 1

Skin Temperature Control Sensor 1, totally latex free,


line provided in various configurations Cradle Cradle Warmed AMPLA TM
2085 .

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 092.059.600

3.24.2.2 - Skin Temperature Sensor 2

Skin Temperature Indication Sensor 2, totally latex-free, used


as optional for the indication of peripheral temperatures of the patient. Does not act on
the heating control of the Heated Cradle.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 092.072.600

Attention: Optional Article .

3.24.2.3 - Rectal Temperature Sensor

Rectal temperature indication sensor, encapsulated in 304 stainless steel,


completely latex-free, used as an option for temperature indication

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peripherals of the patient. It does not act in the heating control of the Heated Cradle.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.370.600

Attention: Optional Article . (On request)

3.24.2.4 - Skin Sensor Adhesive

Antiallergic adhesive, latex-free, especially developed for perfect fixation of the


Temperature sensor to the skin of the newborn. Supplied in box with 100
units.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 086.068.600

Attention: Optional Article .

3.24.3 - Oxygen Analyzer

3.24.3.1 - Cable with Cell

Complete set of cable and oxygen cell for sensing of


gases through the Oxygen Analyzer of the Heated Cradle monitor
AMPLA TM 2085.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.353.600

Attention: Optional Article .

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3.24.3.2 - Cable with Connector

Cable with connector, without cell.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.361.600

Attention: Optional Article .

3.24.3.3 - Oxygen Cell

Oxygen Cell - MAXTEC® MAX 13 or ANALYTICAL PSR –11-917-J5.

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Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 090.855.020

Attention: Optional Article .

MAXTEC TM - Registered Trademark Maxtec Inc.


3.24.4 - Heated Humidifier

3.24.4.1 - Temperature Sensor

Used next to the heated humidifier, it indicates the temperature of the gas mixture
received heated and humidified.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 150.076.600

Attention: Optional Article . Comes with the optional Heated Humidifier.

3.24.4.2 - Water Level Sensor

Used in conjunction with the heated humidifier, it monitors the water level internally to the bottle
of the humidifier.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 140.050.600

Attention: Optional Article . Comes with the optional Heated Humidifier.

3.25 - Flexible Adapter for “Goose Neck” Circuit Support

The "Goose Neck" Adapter is attached to the rear protector, helping the
fixing and directing the respirator tubing to the patient. Made with antler
Flexible metal, the Adapter makes it easy to route the respirator tubes.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 013.050.600

Attention: Optional Article .

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3.26 - Accessories Basket

Basket in a rounded structure, used to accommodate materials and various utensils.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.351.300

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Attention: Optional Article .

3.27 - Thermometer and Stethoscope Door

Attached to the column of the AMPLA TM 2085 Heated Cradle , the stethoscope door and
thermometer door provide the accommodation of the respective instruments,
while avoiding surprises and possible losses.
Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.316.321

Attention: Optional Article .

3.28 - Child Reanimator

Reanimator Model 020, made entirely of silicone, with corrugated accumulative tube
for oxygen, mask "0" and 40cmH2O safety valve.

ANVISA registration: 10,224,620,036

REF: 020.010.600

Attention: Optional Article .

3.29 - Neonatal Pillow

Neonatal pillow in antiallergic TNT, with an appropriate format for the anatomy of the
newborn. The fixation of the head of the RN helps in the procedures of
intubation, oxygen therapy, phototherapy and others. Provided as boxes with 10 units.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 094.070.600

Attention: Optional Article .

3.30 - Tents and Hoods


When high concentrations of oxygen are required, with or without humidification, in procedures
specific.

3.30.1 - Cap sizes 1/2/3

ANVISA registration: 10,224,620,003

REF: 016.000.600 - Size 1


REF: 016.001.600 - Size 2
REF: 016.002.600 - Size 3

Attention: Optional Article .

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3.30.2 - Stores Sizes 1/2

ANVISA registration: 10,224,620,003

REF: 014.000.600 - Size 1


REF: 014.001.600 - Size 2

Attention: Optional Article .

3.31 - Hydrophobic Filter

Filter for prevention of transmission of pathogenic viruses according to standards and practices
recommended by the AORN'S (Association of Operating Room Nurses Statements -
USA) located on the suction line.
It is made of 'Teflon' and PTFE micropore membranes capable of retaining aerosol and
micro organisms in the ULPA pattern, which means capturing 99.9% of all
particles from 0.1 to 0.5 microns or larger. Provided in box with 10 units.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 089.206.600

Attention: Optional Article. Consumer item.

3.32 - Babypuff TM 1020 Infant Resuscitator

The resuscitator Children BabypuffTM Model 1020 facilitates the delivery of controlled PIP
and secure, it still provides consistent PEEP to help establish and maintain the
functional residual capacity (FRC), providing an ideal respiratory index for a
Better gas change, driven by maximum safety pressure.

ANVISA registration: 10,224,620,065


REF: 089.130.600

Attention: Optional Article.

3.33 - Meconium Vacuum Cleaner

Meconium vacuum cleaner made in polycarbonate, aid in aspiration procedures


the newborn. Provided the box with 5 units.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 004.369.600

Attention: Optional Article.

3.33 - Blender Mixer

Blender for mixing Air / Oxygen, used when there is a need for a
perfect control of the concentration of the Air / O2 mixture.

Accessory for the exclusive use of the AMPLA TM 2085 Heated Cradle
REF: 150.083.600

Attention: Optional Article.

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4 - Precautions, Restrictions and Warnings

Attention: This chapter of the User Manual contains extremely important information
important to guarantee the safety and integrity of the patient,
user and equipment. Read CAREFULLY!

♦ Check if the network where the equipment must be connected has the characteristics to withstand the
electrical voltage and power conditions of the equipment indicated on the label attached to the device.
♦ The power cable connector must be plugged into grounded socket, fixed
permanently on the wall, in accordance with current regulations and standards for installations of
low voltage and electrical legislation for Healthcare Establishments.

Attention: Do not use multiple plugs or extensions. If he doesn't have a perfect ground, no
use equipment.

♦ Check if the rotation brake levers are down, keeping the unit locked.
♦ To connect the oxygen supply tube to the hospital network or oxygen cylinder, check before
if all records are closed (totally to the right).
♦ A misused crib can cause serious risks to the newborn. This unit must be operated
exclusively by specialized and qualified personnel who know the risks and benefits of their
utilization.

Explosion Hazard: Do not use the Crib in the presence of flammable anesthetics or agents
cleaning agents that can cause combustion.

♦ This unit cannot be used if any of its functions does not operate correctly. The service
Qualified technician should be requested.
♦ Constant monitoring by the operator is essential, regardless of patient temperature.

♦ Never put the Skin Sensor 1 under the newborn, or use to monitor rectal temperature.
♦ The skin temperature sensor 1 must be exclusively dedicated to monitoring the temperature
superficial of the skin, in the same region whose face turns and is exposed to the element that is
heats from the irradiator.
♦ Never use skin sensor 1 under the newborn.
♦ The skin sensor 1, should never be used under clothing, diapers, blankets or any part it
Put it into the gap between the sensor and the radiant heat source.
♦ Never place any object that if it constitutes an obstacle enters the skin sensor 1 and the source of
radiant heat.
♦ Never use the skin sensor 1 and the skin sensor 2 to sense the remnant temperature.

♦ The sensors described in this manual are not intended to measure the patient's axilla. To this end, use
the right clinical thermometer.

Attention: Rectal temperatures are not appropriate to control the power of the Crib
Heated.

♦ When in skin control, Skin Sensor 1 must be in direct contact with the skin to
provide necessary monitoring of the patient's skin temperature. In the event that the Sensor
Skin 1 is poorly positioned on the patient, it can cause overheating. Always check the
conditions of the newborn for the correct positioning of the sensor. Observe the newborn's skin
to monitor superheat signals.

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♦ It is not good to leave a patient without constant attention under the Heated Cradle.

Attention: The radiant heater can cause increased insensitive water loss (IWL).
Appropriate measures should be considered to maintain water balance
wanted.

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♦ The distance between the heating system and the mattress is standard and fixed and any alteration in it
Distance can cause serious risks to the patient.

♦ It is recommended to inspect the conditions of the bed lock protectors and to be certified
if it is correctly locked to prevent the patient from falling.
♦ When using the shelves, take the following precautions:

♦ Always put the monitor in the center of the shelf.


Check if the monitor is inside the shelf.
Avoid putting one monitor on top of another on the shelf.
Observe the maximum load limits of the shelves.

♦ The peripheral equipment that can be connected to the patient and energized through the set
of the plugs, must have perfect grounding and be in accordance with the electrical standards of
safety for electromedical equipment, IEC 60601-1 and its particular standards.

♦ Never go beyond the power range specified by the set of Auxiliary Plugs when
Peripheral equipment is powered through these plugs.

♦ Additional equipment such as phototherapy, heated mattresses, etc. in use with the Crib, they can
alter the action of the Crib in relation to the average temperatures.

Attention: When to use conventional phototherapy equipment, type 006OFL or Bilitron TM


3006, together with the Heated Cradle, certify that the phototherapy equipment does not
invades the heat area radiated by the crib

♦ For Trendelenburg and Proclive positions, where there is an inclination in relation to the heating element
of the equipment, this may alter the action of the equipment.

♦ Environmental conditions, such as air movement and flow and incidence of sunlight, can
affect the patient's thermal balance.

Attention: This equipment cannot differentiate a temperature increase condition


body internally with cold skin (fever) and a low temperature internally of
cold skin (hypothermia). We recommend constantly monitoring the
patient temperature with clinical thermometer.

♦ When using radiant heat warming, never put blankets on patients. This
interferes with the control of the warming of the Crib, and may expose the patient to serious or fatal risks
due to overheating of the system.

♦ The Cradle operating in Manual Mode continuously emits an amount of energy / heat to the patient
preset, regardless of patient temperature. Operating in Serbian Mode, the Cradle supervises
the temperature of the patient using the Skin Sensor 1, ordering the amount of energy / heat
electronically, according to the real need of the patient. Accordingly and preferentially, the
Serbian mode must be used.

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Attention: Skin Sensor 2 barely works as an indication of temperature, and no
electronically orders the amount of energy / heat provided to the patient.

♦ The AMPLA TM 2085 Heated Crib is developed for use restricted to a single patient.

♦ The AMPLA TM Heated Crib 2085 has protection filters sized to withstand the
specifications of the electromagnetic compatibility standards, but, may be adversely affected and
suffer interference from certain equipment, such as high-frequency surgical equipment,
defibrillators, short wave therapy, cardiac pacemaker, and other connected electrical stimulators
to the patient.

♦ Before starting the monitoring of a physiological parameter, observe all the information and care in
the operation and application of the accessories, because the incorrect use of these may cause damage to the
patient, such as burns and / or electric shock, in a possible defibrillator discharge.

Attention: Patient cables and sensors are not protected against the effects
defibrillation.

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♦ Despite the patient's bed being made of engineering plastic, fully electrically insulated, it
the use of high-frequency surgical equipment in conjunction with the Crib is recommended
Heated AMPLA TM 2085;

♦ The AMPLA TM 2085 Heated Cradle has in its constructive form all its parameter modules
physiological equalized to the same potential, not having an external potential equalization conductor.

♦ To prevent slipping of the Heated Crib, when it is standing on a ramp, check that
the rotations are locked and do not present movement.

♦ For added safety, do not carry the Heated Crib with its shelves loaded.

♦ When using the optional ergometric column, always transport the Heated Cradle at its lowest height
for better stability of the set.

♦ Do not operate command keys with your fingernail and also do not use sharp objects to operate them.

♦ Only use original FANEM TM accessories and parts to ensure good performance and safety of the
equipment.

Explosion Hazard: Caution

♦ Never use the Heated Crib in the presence of flammable anesthetics;

♦ Verify that the oxygen supply provided by the Heated Crib is turned off and that the Crib is
Disconnected from oxygen supply when performing cleaning or maintenance procedures. Exists
a fire and explosion hazard when performing cleaning and / or maintenance procedures in an environment
enriched with oxygen.

♦ Keep matches, cigarettes, and all other sources of ignition out of the place where the Crib is
located. Fabrics, oils, and other fuels easily enter the ignition and burn when the air is
with oxygen.

♦ Small amounts of flammable, such as ethyl and alcohol, can cause fire in contact with the
oxygen.
Oxygen: Precautions

♦ Improper use of supplemental oxygen can be associated with serious side effects, including blindness and

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brain damage and death. The risks vary for each newborn. The method, concentration and duration
of oxygen administration should be prescribed by a qualified physician.

♦ Oxygen concentrations should always be measured to verify the correctness of the


independently prescribed oxygen concentration.

♦ If it is necessary to administer Oxygen in an emergency, notify the responsible physician immediately.

♦ If the patient's arterial oxygen levels cannot be maintained even when the oxygen control
is adjusted for maximum, alteration in procedures must be prescribed by the doctor
responsable.

♦ The concentration of oxygen inspired by the newborn does not determine the partial pressure of oxygen
(pO 2 ) precisely in the blood. When judged correct by the physician, the pO 2 of the blood should be
measured with appropriate clinical techniques.

♦ Oxygen Concentrations Oxygen concentrations must be measured with an oxygen analyzer


calibrated, at regular intervals defined by the responsible physician.

Attention: The risk of incidence of RETROLENTAL FIBROPLASIA (Retinopathy of


Prematurity) is increased when oxygen concentrations are applied
greater than 40% in newborns with cardiorespiratory diseases.
♦ Gas cylinders compressed as oxygen, can become dangerous if gas is released quickly
due to damage or other causes. The cylinder must be securely locked and constantly verified how much
to integrity.

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Precautions - Integrated Pulse Oximetry Kit (optional)

♦ The Biocompatibility test was conducted with NELLCORTM sensors in accordance with ISO 10993-1,
E valuation
biological medical devices, Part 1 : Evaluation and testing. The sensors passed the tests
recommended biocompatibility and are therefore in accordance with ISO 10993-1.

Attention: Pulse oximetry and pulse rate readings may be affected by


certain environmental conditions, errors in the application of the sensor and
specific patient conditions.

♦ Inaccurate measurements can be caused by:

- Incorrect application of the sensor.


- Positioning the sensor on one end with a pressure gauge sleeve,
arterial catheter or intravascular access.
- Ambient lighting.
- Prolonged movement of the patient.

♦ Loss of pulse rate can be caused by the following reasons:

- The sensor is very firm.

- The pressure gauge cuff is blowing at the same extremity as the

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sensor connected.

- There is arterial occlusion close to the sensor.

◆ Clean and remove any substance, such as adhesive, from the application area. Periodically check if the
sensor continues to be positioned appropriately on the patient.

◆ A strong lighting environment, such as surgical lamps, phototherapy as Bilitron TM , or lighting


from the sun, can interfere with the action of a SpO 2 sensor , check that the sensor is correctly applied
and cover the sensor area with the opaque material, without covering the skin temperature sensor.

◆ Do not use damaged sensor or sensor cable. Do not use exposed optical components.

Attention: Only use NELLCOR TM sensor and sensor cables with this monitor. Other
sensor and cables can produce an unsatisfactory result in the Set
for Integrated Pulse Oximetry.

◆ Do not use a sensor cable to increase the length of the sensor. Any questions consult FANEM. Use if
necessary, for the “Mãe Canguru” procedure, the Nellcor TM extender .

Attention: The use of more than one sensor cable may have an adverse effect on the action. Not
connect any proprietary cable to the sensor input port for use in
computer. Do not connect any device to the sensor connector that does not
has been approved by FANEM.

Attention: Incorrect application or prolonged use of a SpO 2 sensor can damage the
tissues. Observe the sensor area regularly as indicated on your
instructions.

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4.1 - Precautions according to BILITRON BED TM 4006 Phototherapy

♦ Check if the network where the equipment will be connected has characteristics to withstand the
electrical voltage and power conditions of the equipment indicated on the label attached to the device.

Attention: Do not use phototherapy equipment in the presence of anesthetics


flammable, oxidizing gases or cleaning agents that can cause
combustion.

♦ The power cable connector should be connected in a grounded and fixed place
permanently on the wall, in accordance with current regulations and standards for installations
low voltage electrical and electrical legislation for Healthcare Establishments.

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Attention: If you do not have a perfect grounding, do not use the equipment.

♦ BILITRON BED TM 4006 Phototherapy must be used according to the ideal environmental standards for the crib,
being 23 to 27º C.

♦ Maximum noise level next to the patient bed 60dBA for 45dBA environment.

♦ Constantly monitor the patient's temperature through a clinical thermometer.

♦ Thermotherapy Apparatus (Heated Cribs) coupled with phototherapy, can raise the temperature in
the patient's body at dangerous levels. Always monitor the patient's temperature through a
clinical thermometer.

♦ Protective devices intended to protect the patient from leaving the Effective Surface of the
light source, must be inspected regularly to ensure its safety function.

♦ Normally, the life expectancy of Super Leds is over 20,000 hours of use. Without
However, to confirm the perfect radiation conditions of the sources, it is recommended to use
Periodically the FANEM Model Radiation Monitor. 2620 for a better evaluation of the real effectiveness of
Super Leds. Thus, radiation sources should be replaced whenever they achieve a loss of
25% of its total irradiance for bilirubin-Ebi which is of the order of 36 µW / cm 2 ηm.
♦ Still, it is always recommended to check if the Siper Leds are not darkened and oscillating, for
Consequently in that case, they should be changed to allow proper treatment.
♦ Always use original parts. The use of different types of radiation sources can alter the
irradiance conditions (riation intensity) and the temperature within the levels specified for the
equipment.
♦ When used in conjunction with thermotherapy devices, (Heated Cradle) it is recommended that these
materials operate in the skin-controlled (servo-controlled) mode, or then manually, and must
reduce the heat output of the radiant heater according to constant measurements of the temperature of the
patient's body.
♦ Do not use reflection plates or sheets in phototherapy equipment, as they can cause temperatures
are dangerous to the patient and, together with the radiant heat unit, can cause serious injury to the
patient.

4.1.1 - Suggestion to Improve the Efficacy of Phototherapy

♦ To improve the effectiveness of treatment, the newborn should be naked , only with protection
ocular. The larger the area of skin exposed to light, the better the result.
♦ However, in case you choose to use diapers, this should be as few as possible , so
simply cover a small part of the newborn's perineum.
♦ Large diapers, by preventing the action of light on the skin of the newborn, considerably reduce
the efficacy of phototherapy.
♦ The irradiance combined with the largest body surface will allow achieving the best clinical efficacy. It will return
It is possible to reduce the phototherapy treatment time significantly and, consequently, allow the
hospital and reduction of hospital costs.

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4.1.2 - Special care with the Mattress

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♦ The transparent gel mattress is a very important and sensitive part of Phototherapy. Treat it on
everything with extreme care.
♦ To clean it, use a soft cloth with warm water and neutral soap . Do not use chemicals or
alcohol for cleaning it.
♦ The use of iodine solutions used in routine procedures near the patient, may
yellow / or leave the mattress amber or even the prolonged use of the equipment itself may
cause a photo-reaction in the mattress and yet produce significant loss of radiance.
♦ Do not bend or roll up the mattress, because it may suffer a break in its protective film, thus running the
risk of gel emptying.
♦ Do not use sharp or pointed objects in contact with the mattress. Beware of nails, rings and
bracelets while handling the mattress, because it can be easily pierced. To extend the service life, the
The use of special polyfilm- type transparent film is recommended for use with phototherapy with the
mattress (Protection Plastic for Silicone Mattress Code 000.106.022 - Roll with 50 meters).
Polyfilms of the conventional and domestic type can adhere to the mattress or even to the patient's skin
causing a risk situation to the patient.
♦ In case the mattress is accidentally punctured, do not attempt to reuse , because the gel may be
contaminated or even ingested by the patient. Contact our Technical Assistance for
replacing the mattress with a new piece.

4.1.3 - Physiological Effects

Phototherapy is normally used in the treatment of neonatal hyperbilirubinemia, while subjecting


the patient to a radiation exposure concentrated in the blue spectrum of visible light, for a time,
depending on the case, medical hair.
BILITRON BED TM 4006 Phototherapy allows rapid reduction in serious bilirubin levels,
thus decreasing the need for transfusion and reducing the duration of treatment.
♦ Although transient, side effects of phototherapy can be observed. Among them, the
increased blood flow with vasodilation, erythema, and increased callous water loss and alteration
of the intestine.
♦ Patientsclose to phototherapy equipment may need protection, such as safety glasses.
protection etc.
♦ The patient's water balance can be altered with the use of phototherapy.
♦ Consequently, newborns undergoing phototherapy, as well as in the use of any other type of
phototherapy, need appropriate technical support and eye protection during treatment, in addition to
routine nursing and medical care.
♦ The eyes of the "operator" can be damaged in cases of long visual permanence near the area of the
patient. During patient care, the operator can turn off phototherapy, if desired.
♦ During treatment, Bilirubin photoisomers can cause toxic effects.
♦ The patient's serum Bilirubin levels should be measured regularly.
♦ Liquid infusions and drugs in general should be kept within the radiation area.

4.2 - Thermal Mattress Precautions

♦ The AMPLA TM 2085 Heated Cradle thermal mattress must be used separately from the PATIENT for a
intermediate layer, the Patient Mattress, in transparent gel or in memory PU foam.
♦ Beware of possible pointed objects, such as needles, scalpel, etc. that can penetrate the mattress
Thermal and cause Security Risks.

Attention: Before each use of the thermal mattress, check the integrity of the
mattress to verify any mechanical damage to its surface. If the mattress
thermal is not in perfect condition, do not use the equipment.

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♦ When not in use, the thermal mattress should be stored in a rolled up way to avoid possible
Security risks caused by bending or compression.

♦ When fully or partially covering the thermal mattress by pillows, positioning cushions of the
patient or other items with thermal insulation, they can cause Safety Risks.

♦ The thermal mattress of the AMPLA TM 2085 Heated Crib is an accessory for exclusive use and can be used
only coupled to the AMPLA TM 2085 Heated Cradle - FANEM.

♦ The temperature sensors available by the AMPLA TM 2085 Heated Cradle perform monitoring and
control of the patient's temperature through the radiant heat system. The module of the thermal mattress does not
It has any sensor that, coupled to the patient, will control the temperature of the mattress. Is
temperature is selected by the operator near the AMPLA TM Heated Cradle control monitor
2085, in a manual way.

♦ Materials with good thermal conduction, such as water, gel and other similar substances, with the mattress
Thermal shutdown , can reduce the patient's body temperature.

♦ The time necessary to heat a Heating Device, from 20º C to 37º C, when operated
according to the Adequate Thermal Discharge Conditions, it is approximately 9 minutes, as
specified in the tests of the NBR IEC 60601-2-35 standard.

♦ The thermal mattress is calibrated at the factory, and does not require supplemental calibration. Possible
Routine maintenance and calibrations must be carried out by technicians accredited by FANEM.

♦ The thermal mattress internally a safety thermostat that interrupts heating in case of
isolated imperfection, hindering the temperature in the patient of the joint surface with the
Transparent gel mattress exceeds 42ºC, in accordance with NBR standard IEC 60601-2-35. He
operation of the safety thermostat can be verified by means of the analysis described in point
52.5.102 of the related standard.

4.3 - Electromagnetic Compatibility and Immunity

It is the ability of an equipment and / or system to work in an electromagnetic environment, without introducing
electromagnetic disturbances for anything in this environment and on the other hand working without
degradation in the presence of an electromagnetic disturbance.

This equipment was designed, tested and made according to the following compatibility standards
electromagnetic.
♦ 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

Being within the parameters for RF emissions; Immunity; Electrostatic discharge; Fields
Radiated Radiofrequency Electromagnetics; and Transients (Striped and Irruption of Tensions).

Attention: Mobile and portable RF communication equipment can affect


Electromedical equipment.

Attention: The use of accessories, transducers, sensor and network cables


Originals can produce an increase in emissions or decrease in
Equipment immunity.

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Manufacturer's Guidelines and Statement - Electromagnetic Emissions


The AMPLA TM 2085 Heated Cradle is intended for use in an electromagnetic environment of
specified below.
It is recommended that the customer or user of the heated Crib ensure that it is used in such an environment.

Emission tests Accordance Electromagnetic Environment - Guidelines

The Heated Crib uses RF energy only for its


RF emissions internal functions. However, its RF emissions
Group 1
CISPR 11 they are very low and you are not likely to do any
interference in nearby electronic equipment.

RF emissions The Heated Cradle is suitable for use in


A class
CISPR 11 all establishments other than domestic and
Harmonic emissions can be used in residential establishments and
A class those directly connected to the public network of
IEC 61000-3-2
low voltage electrical power distribution that
feeds buildings for domestic use, from
follow the following warning:
Warning: This equipment is intended for
Emissions due to floating
use only by professionals in the area of
tension / waviness
According health.
IEC 61000-3-3
This equipment may cause radio interference or
interrupt equipment operations in
proximities. It may be necessary to adopt
mitigation procedures, such as reorientation or
relocation of the Heated Cradle or local armor.

Guidelines and manufacturer's declaration - Electromagnetic Immunity

The AMPLA TM 2085 Heated Cradle is intended for use in an electromagnetic environment of
specified below.
It is recommended that the customer or user of the heated Crib ensure that it is used in such an environment.
Test Essay Level Level of Electromagnetic Environment - Guidelines
Immunity ABNT Accordance
NBR IEC 60601
Portable and mobile RF communication equipment no
must be used next to any part of the Crib
Heated AMPLA TM 2085, including cables, with
less than the recommended separation, calculated from
of the equation applicable to the transmitter frequency.
Recommended Separation Distance

d = 0.35.P 1/2 80MHz up to 800 MHz

RF Driven 3 V ms 10 V d = 0.7.P 1/2 800MHz up to 2.5 MHz


IEC 61000-4-6 150 KHz up to
where P is the maximum nominal output power of the
80 MHz
transmitter in watts (W), according to the manufacturer of the
RF Driven 10 V / m
transmitter, and d is the recommended separation distance
IEC 61000-4-3 3 V ms
in meters (m).
80 MHz up to 2.5
It is recommended that the established field strength
GHz
by the RF transmitter, as determined through a
electromagnetic on-site inspection, be less than

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level of conformity in each frequency band. b
Interference may occur around the equipment
marked with the following symbol:

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NOTE 1: At 80 MHZ and 800 MHZ, the highest frequency band is applied.
NOTE 2: These guidelines may not be applicable in all situations. Electromagnetic propagation is
affected by the absorption and reflection of structures, objects and people.
a The field strengths established by the fixed transmitters, such as the base radio, telephone (mobile / wireless) and

land mobile radios, amateur radio, AM and FM radio transmission and Television transmission theoretically not
They can be accurately planned. To assess the electromagnetic environment due to RF transmitters
fixed, an electromagnetic site survey is recommended. If the measurement of the field intensity in place
Where the AMPLA TM 2085 Heated Cradle is used exceeds the compliance level used previously, the Cradle
Heated AMPLA TM 2085 should be observed to verify if operation is normal. If an abnormal action is
observed, additional procedures may be necessary, such as reorienting or relocating the Crib
Heated AMPLA TM 2085.
b Above the frequency band 150 kHz to 80 MHz, the field strength must be less than 10 V / m.

Recommended separation distances between portable and mobile RF communication equipment


Heated Cradle AMPLA TM 2085
The AMPLA TM Heated Cradle 2085 is intended for use in an electromagnetic environment where
Radiated RF disturbances are controlled. User can help prevent electromagnetic interference
maintaining a minimum distance between portable and mobile RF communication equipment (transmitters) and
the AMPLA TM 2085 Heated Cradle as recommended below, according to the maximum output power of the
communication equipment.
Nominal maximum power Separation distance according to the frequency of the transmitter
transmitter output W M

150 kHz up to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
d = 0.35 P 1/2 d = 0.35 P 1/2 d = 0.7 P 1/2

0.01 0.04 0.04 0.07

0.1 0.11 0.11 0.22

one 0.35 0.35 0.7


10 1.11 1.11 2.21

100 3.50 3.50 7.00


For transmitters with maximum rated power not listed above, the recommended separation distance d in
meters (m) can be determined through the applicable equation for the transmitter frequency where P is the
maximum nominal output power of the transmitter.
NOTE 1: At 80 MHZ and 800 MHZ, the highest frequency band is applied.
NOTE 2: These guidelines may not be applicable in all situations. Electromagnetic propagation is
affected by the absorption and reflection of structures, objects and people.

5 - Equipment Installation

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Unpack the AMPLA TM 2085 Heated Crib , checking if all Using a "Philips" key,
the parts are in perfect condition. Also check if all connect the 4 screws (M6 x 16
your requested accessories are complete. mm), 4 locknuts (6.4
Basically, the equipment is divided into 3 parts, the pole, the mm) and 4 plain nuts (6.4 mm) in
main structure and accessories. Follow the exploited drawing of the the sides of the post.
unit for mounting.
To assemble the equipment, position the base structure in the
ground, in its normal use condition, locking rotations and
using the brakes.
With the help of 2 people, tilt the pole close to its socket
located in the part of the base structure. Internally to
column of the pole, there are the 2 cables with their respective connectors.
Connect these cables to their respective cables positioned on the
structure of the base, note that the connectors of the cables of the
column and base have male / female of the respective
connectors, not allowing wrong connection.

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Attention: The connectors of the base (frame) must be connected to the connectors that leave
the column (pole). Observe that the connectors of the cables of the column and the
base have the respective male / female connectors, not allowing connection
incorrect.
For devices that have the configuration of the electric table, and / or balance, and / or
humidifier, and / or phototherapy, and / or heated mattress, connect the respective cables
connection in its proper connector located next to the column, at the bottom of the
patient bed.

Attention: The column of the Heated Cradle must be perfectly fixed to the base
(structure), failures in this fixation can produce separation and fall of the column,
while involving risks to the patient and operators.

For the transport and internal movement of the Heated Cradle, it must be handled by the
rear. Hold the pole near the Transport Handle.

Attention: Do not transport the Crib with load on the shelves. Do not transport the Ergometric Crib
(optional) in high position.

Attention: Before using the Heated Cot, the cleaning procedure must be done,
followed by initial disinfection of the equipment, according to the instructions of the
Chapter 7 of this manual and with the protocols adopted by the Control Commission
of Hospital Infection - CCIH of the service.

Wall Unit Configuration

To install the equipment, position the main structure, pole and radiating reflector next to the wall,

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at a minimum distance between the heating element and the mattress surface of 835mm , level the
set and mark the fixing points on the wall. Drill holes in the wall, position the plugs in the respective
holes, to attach the structure and fix it through the screws and nuts provided.

Attention: It is certified that the wall has a solid, alvenarian constitution. Dry-type installations
Wall ”should not be used for fixing the heated cradle. Check yourself
structure found firmly fixed. Use buchas e parafuso S-10.

Wall (Masonry)
The Heated Cradle Wall Unit
AMPLA TM 2085 can be used on top of a
bench, in a hospital crib or together with
wardrobe in the humanized delivery rooms. For
each and every application, the
minimum distance of 835 mm between the element
heater and mattress surface itself
under the danger of exposing the patient to risks
serious.

Attention : Do not use additional heaters or other


thermotherapy materials in use with the
Cradle Heated. Risk of
overheating.

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5.1 - Installation of Accessories

This article provides basic instructions for the installation of parts, pieces, accessories and
options provided with the AMPLA TM 2085 Heated Cradle and which, due to its
packaging, they are presented separately from the equipment.

Other parts, accessories and options are determined in the order and properly installed at the factory.
and they are still assembled in the Crib, according to the configuration defined in the order.
♦ Whey Stand
Locate the fixing base for the Serum Support and to install on the back of the column
the bottom tip, checking its perfect fit and tighten it down.
♦ Auxiliary Shelves
Shelves are attached to the shelf adaptation blocks located on the side of the
column. To fix it, position the shelf screw in the adaptation block, frame the
Guide screw in its respective hole and fit into the assembly, pressing down.

Attention: The maximum load allowed for each shelf is 10Kg. Never exceed this
limit. Do not transport the Heated Crib with cargo on the shelves.
The maximum allowed height of peripherals is 30cm.

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♦ Bumpers and Plastic Foot Protector


Verify the correct positioning of the bumpers and plastic foot protectors, according to their
internal cuts, according to their mounting positions next to the right and left feet of the
Heated Cradle base.
Once this positioning is defined, fit the protector in a parallel way to the foot, pressing
slightly down

Attention: When the Heated Cradle configuration is with the optional


Ergometric, check the perfect fit and coupling of the pedals
located in the foot protector, next to the actuation keys
located on their upper faces. Be certified of the perfect coupling
Between the parts.

♦ BILITRON TM 3006 phototherapy

To locate the face of the patient bed structure and the hole intended for coupling
BILITRON TM 3006 phototherapy. Position the articulated arm screw in the adaptation hole,
align the guide screw and fit the assembly, pressing down directly on the frame of the
patient bed.
♦ FOG TM 1140 Heated Humidifier and Bubble Bottle

Through the fitting guide, connect the Bubble Bottle next to the side of the humidifier and connect this
assembly to the side of the column, at its bottom, together with the existing column guide.

6 - Equipment Operation

6.1 - Operational Functions of the Heated Cradle


This User Manual article describes the operational functions of the AMPLA TM Heated Crib.
2085 in a general way.

➢ Two different modes of treatment with irradiation heating:

Attention: While using radiant heat heating, never put blankets on


the patient. Such action interferes in the control of the warming of the crib,
exposing the patient to serious or even fatal risks from overheating
of the system.

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- Skin Mode : Servo controlled. The desired temperature (set point) is set and the system controls
heating by irradiation so that the patient's skin temperature (T1) equals the point of
adjustment.

The skin temperature is monitored through the Skin Sensor T1 and, therefore, this sensor
participate in the heating process in Skin Mode.

Attention : The auxiliary Skin T2 sensor only provides a temperature reading, not having
influence on heating by radiant heat or on the alarm performance of

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security.

The difference between the T1 Skin Set Point and the temperature determines the heat power level
irradiant applied to the patient, so that:

- in case the skin temperature T1 is below the Skin Set Point, a radiant heat power
greater than 0% is applied to the patient. The further from the Set Point is the temperature T1,
the higher the power level of the applied radiant heat.

- if the skin temperature T1 is above the Skin Set Point, then heating by
radiant heat is interrupted.

Manual mode : In this way, the user adjusts the radiant heat power level (from 0 to 100%)
for patient heating. The power level of the radiant heat will remain constant,
regardless of the patient's skin temperature.

Attention : When operating in manual mode, always check the skin temperature of the
patient. Risk of overheating.

When operating in Manual Mode, in case the radiant heat power level remains at 100% during the 15
Subsequent minutes, the warm-up will be interrupted and an audiovisual security alarm will act.

When operating with the power level adjusted for a value below 100%, in every 15 minutes after a
audiovisual alarm will act to check the patient's temperature. Warming up, in
this case is not interrupted.
During Manual Mode operation, Skin Temperature, Skin Set Point T1 and
Auxiliary Skin T2 temperature will not be displayed. These parameters are not displayed to avoid possible
false interpretation that the patient's temperature is being controlled by the system.

➢ Preheating of the bed by radiant heat.

The AMPLA TM 2085 Heated Crib features the function of preheating by radiant heat, to
warm the bed before placing the patient in the Heated Crib.
When entering preheat mode, the radiant heat power level acquires a value between
10% and 30%, depending on the ambient temperature. The higher the ambient temperature,
the lower the radiant heat power level, according to the table below.

Preheat power Temp. ambient


30% <23ºC
twenty % 23 ≤ T amb <26ºC
10% T amb ≥ 26ºC

In Preheat mode the user can adjust the power level from 0 to 30%. While the
user do not select another operating mode and exit preheat mode, the level of
Power will remain constant for undetermined time.

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Attention : Preheat mode should not be used to warm the patient,


but only to heat the bed before its arrival, because at
Contrary to what happens in Manual Mode, there are no alarms for
verification of the patient's temperature every 15 minutes.

➢ Monitoring the patient's skin temperature (T1)

➢ Indication of auxiliary skin temperature (T2)


➢ Indication of the Ambient Temperature.

➢ APGAR Clock Function


Minute and second counter, with audible beep in each minute and prolonged in the fifth and tenths
minutes.

➢ Alarm Clock Function


To indicate medication application times and procedures.

➢ Displays the current date and time


Available only in versions with a colorful or monochrome LCD monitor.

➢ Trend line graph


Available only in versions with a colorful or monochrome LCD monitor. the 11 parameters
(monochrome) and 19 parameters (color), monitored in graphical form: skin temperature
(T1), the temperature of the auxiliary skin (T2), difference between T1 and T2 the ambient temperature SpO 2 (%),
BPM, Power (%), Relative weight, temperature of the thermal mattress, Bilirubin (mg / dl), Concentration
oxygen (%). In the colorful monitor, in addition to these mentioned parameters, increase, high and low
SpO 2 , high and low BPM, thermal mattress set point, skin set point, high and low
% O 2 . You have 5 days of memory trendline storage.

➢ Electronic patient file


Name, gestational age (weeks), initial weight, current weight, start of treatment, use or not of
phototherapy, phototherapy time, bilirubin level (mg / dl). Available only in monitor versions
Colorful or monochrome LCD.

➢ Preventive Maintenance
Record of the dates of preventive maintenance of the most critical parts that make up the appliance.
Available only in versions with a colorful or monochrome LCD monitor.

➢ Oxygen concentration monitor for general use (optional item)


Available only in versions with a colorful or monochrome LCD monitor

➢ Metabolic Bed with Balance (optional item)


➢ Data Communication
The AMPLA TM 2085 Heated Crib , in versions with a colorful or monochrome LCD monitor, has a
door for data communication with the computer, allowing the transfer of parameters
supervised for recording, analysis or printing.

Attention : Optional Article. Available on request.

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➢ Servo-Controlled Thermal Mattress (optional item)

Optional item, available in versions with colorful or monochrome LCD monitor. Used for
warming up the patient during surgical procedures or transporting the Heated Crib. He
Thermal mattress is positioned under the patient's mattress. Warming happens one way
indirect, that is, the thermal mattress heats the other mattress in which the patient is, and the patient does not
It comes into direct contact with the thermal mattress.

Attention : Never put the patient directly on the thermal mattress, because
there is a risk of burns.

Attention : During the use of the thermal mattress, the patient's temperature
it must always be accompanied by trained personnel.

- The working temperature of the mattress can be adjusted, from 31 to 38ºC on the monitor of the Crib
Heated.

- The mattress temperature indicated on the monitor screen refers to the temperature within the
thermal mattress. The temperature of the mattress where the patient rests tends to be the same
temperature of the thermal mattress in the area of contact with the body of the newborn, because, there, the
Heat loss from the patient's mattress to the environment is less.

- When activating the thermal mattress, the heating by radiant heat is interrupted, in other words,
Skin Mode, Manual Mode and Warm-up operations are not activated.

- If there is a failure of the internal temperature sensor of the thermal mattress, a visual message is
will indicate on the control panel. Available only in versions with a colorful LCD monitor or
monochromatic

- When turning off the thermal mattress, the system returns to the previous operating mode (Mode
Skin, Manual or Preheating).

- If at the time of activating the thermal mattress, the system was operating in manual mode or
preheating, when deactivating the thermal mattress, the heating level of the power by
Irradiation will return to the adjusted value before the thermal mattress turns on. That is valid even if
during the period when the mattress was on the system has turned off.

- If, when activating the thermal mattress, the BILITRON TM BED 4006 reverse phototherapy (optional item) is
On, it will automatically turn off.

-While the thermal mattress is on, Skin Temperature T1 and Set Point will not be displayed
Skin Tightening. The patient's temperature can be observed with the use of the Temperature Sensor
T2 auxiliary leather.

Two types of patient mattress are available to be used in the thermal mattress:

- Memory foam mattress - REF: 004.310.321

- Transparent gel mattress - REF: 004.103.100

Attention : Use only mattresses specified by Fanem for heating by


thermal mattress.

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➢ Transport module with batteries to supply the Heated Cradle during the
transportation (optional item)

The transport module (optional item) contains two 12 V batteries that maintain the Cradle
Heated on during transportation or during periods of power outage.
The duration of the battery charge can vary from 2 to 3 hours, while
depending on the functions of the Heated Cradle used. The battery charge level is
indicated on the control panel of the Crib.

- The Heated Cradle automatically enters the power mode for the batteries when the
mains power cable is disconnected or when there is a power outage.

- The power condition for the batteries is visually indicated on the control panel.

- In case it is operating by batteries and the batteries charge is low, an audiovisual alarm will act.

- When entering battery power mode, radiant heat heating is


interrupted, in other words, the operations in Skin Mode, Manual Mode and Warm-up
will be disabled.

- During battery operation, the thermal mattress works normally.

- When exiting the battery power mode, the system returns to the operating mode in which it was
before. (Skin Mode, Manual or Preheating).

- If before entering battery power mode the system was operating in Mode
Manual or Preheating, when returning to the mains supply, the power level for the
Irradiation will return to the value it had before the system started operating by batteries. That's
Valid same if during the operation period the system batteries have turned off.

- During operation in battery powered mode, the


T1 Skin and the Skin Fit Point. The patient's temperature can be observed with the use of the
Auxiliary Skin Temperature Sensor T2.

➢ Displacement of the Irradiant Reflector


To facilitate the access of X-ray equipment to the patient, if necessary, the Irradiant Reflector
containing the heating element can be displaced up to 90º for both sides.
- The displaced reflector condition is visually indicated on the control panel.

- By moving the reflector from the central position, heating by radiant heat is interrupted, in
In other words, the operations in Skin Mode, Manual Mode and Warm-up are disabled.
When the reflector is returned to the center position, the system returns to the operating mode of
before (Skin Mode, Manual or Warm-up).

- The Mãe Canguru function of irradiation heating can be used while the Reflector
Irradiant is displaced (see the description of the Mãe Canguru function in section 6.1).
- If, before moving the reflector, the system was operating in Manual Mode or Preheat,
When the reflector is returned to the center position, the radiant heat power level will return to the value
that had before the reflector to be displaced. This is valid even if during the period in which the

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reflector moved the system was turned off.
- While the Irradiant Reflector is moving, the Skin Temperature T1 and the Skin Set Point do not
will be exhibited. The patient's temperature can be observed with the use of the
Auxiliary skin T2.

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➢ Pulse Oximetry (optional item)


Optional item, available only in version with colorful or monochrome LCD monitor allows
monitor the oxygen saturation (SpO 2 ) and beat per minute (BPM) levels of the newborn
born.
In configurations Cradle Warmed AMPLA TM 2085 with monochrome LCD monitor, the
SpO 2 monitoring is provided from the SatSeconds 1 alarm management function which
reduces the occurrence of SpO 2 alarms without clinical value, that is, false alarms that simply
disrupt the treatment environment.
SatSeconds 1 is an adjustable parameter that can take one of the following values: 0 (off),
10,25.50 or 100.
The alarm of high or low concentration of SpO 2 will only act just in case if the number of points of the
SpO 2 percentile that exceeded the alarm limit, multiplied by the time, in seconds, that the
limit was exceeded, is greater than or equal to the value of SatSeconds 1 .
As an example, suppose that the low SpO 2 concentration limit is set to 90% and that the
SpO 2 value has dropped from 92% to 88%, while remaining so for 15 s, according to
illustration below:

SpO 2
92%
15 s

90%

88%
The number of percentile points that have violated the limit is 90% - 88% = 2%. Case the value of
SatSeconds is set to 10, then the SpO 2 low concentration alarm will act 5
seconds after the limit violation, because 2% x 5 s = 10. If the SatSeconds is adjusted for
25, then the alarm will act 12.5 seconds after the limit violation, because 2% x 12.5 s =
25. If, on the other hand, the SatSeconds is set to 50, the alarm will not act, therefore 2% x
15 s = 30 is the total value observed in the period of violation of the limit.
When SatSeconds is off, all violations of high and low concentration limits
of SpO2 produce the alarm performance.

Attention: The decision of the use of alarm management and SatSeconds appropriate adjustment
of its value of this parameter is the responsibility of the doctor, based on the
patient's clinical condition.
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1 SatSeconds is a registered trademark of Covidien AG.

➢ Reverse phototherapy BILITRON BED TM 4006

If, when turning on the Bilitron Bed TM 4006 phototherapy , the thermal mattress is on, it will turn off
automatically. A phototherapy using reverse Bilitron Bed TM 4006, mattress transparent gel
(REF: 004.310.321) must be used because it has high transparency for the radiation emitted by the
phototherapy.
The Bilitron Bed TM 4006 internally has 2 safety thermostats that act by interrupting the
radiation, if its internal temperature exceeds the safety limit.

Attention : Optional Article .

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USER'S MANUAL
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➢ BILITRON TM 3006 phototherapy


SuperLed´s microprocessed phototherapy is directly coupled through an arm
articulated in the patient's bed frame, while allowing the intensity of
Adjusted irradiation for the treatment does not suffer variations of intensity and focus, due to the
interference from the patient / source distance when in the Trendelenburg positions,
Proclive and Horizontal.

Attention : Optional Article .

Attention: When using the Bilitron TM 3006 phototherapy equipment , together with the Cradle,
check that the phototherapy equipment works in the peripheral area,
while not invading the heat area radiated by the crib.

➢ Adjustable bed height

Attention : Optional Article .

➢ Inclination of the bed


Trendelenburg and Proclive, with automatic rotation to the horizontal position.

Attention : Optional Article .

➢ Use in the “Mãe Canguru” procedure


The AMPLA TM 2085 Heated Cradle Intensive Care Unit , in version with LCS Monitor
Colorful or Monochromatic, allows its use according to the "Mãe Canguru" technique and procedure. In
In this condition, the “Mãe Canguru” function must be activated together with the monitor, releasing the

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irradiating reflector assembly to provide heating in use condition
displaced. The irradiating reflector assembly should be directed where the RN will be accommodated
in the lap of his mother, or his father, being (e) sitting (or) in the appropriate chair.
NOTE: Do not use this function with the RN in the standing lap. The Skin Temperature Sensor
Auxiliary T2 must be fixed to the RN itself for a check and monitoring of the
RN temperature, while the power of the heating element is controlled
automatically and limited in the adjusted levels seeking maximum comfort.
The Mãe Canguru function becomes available only when the Irradiant Reflector is displaced.
When turning on the Mãe Canguru function, the power of the radiant heat takes on a value
depending on the temperature that adapts, according to the table below:

Power in the Mãe Canguru function Temp. ambient


30% <23ºC
twenty % 23 ≤ T amb <26ºC
10% T amb ≥ 26ºC

By operating in the Mãe Canguru function, the user can adjust the power level from 0 to
30% As long as the user does not change to another operating mode and comes out of the function
Mãe Canguru, the power level will remain constant for an indefinite time.
During operation in Mãe Canguru mode, the Skin Temperature T1 is not displayed and the
Leather Adjustment Point. The patient's temperature can be observed with the use of the
Auxiliary skin temperature T2.

Attention : Line item for graphic and monochrome monitors. Not available for
LED display monitor.

Attention : During use in the Mãe Canguru function, constantly check the temperature
of the patient because, unlike what happens in Manual Mode, in Mãe mode
Canguru there are no alarms to verify the patient's temperature in every 15
minutes.
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6.2 - Monitors

6.2.1 - Colorful LCD Monitor

The control panel of the AMPLA TM 2085 Heated Crib is organized according to the illustration below.

Colorful LCD screen

Buttons
access to

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bar of
tool
s
LED
indicator of
alarm

LED indicator
lack of energy

Buttons
inclination
of the bed

Sensor
T2 Skin Sensor Oximetry Sensor Rotary knob com
Skin T1
Pulse Enter function

Colorful LCD screen : screen in which all the parameters, graphics and functions controlled by
the control panel.

Access buttons to the toolbar: access buttons to the functions of the cradle ordered by the
control Panel.

Rotary knob with Enter function: rotary knob with Enter function: button used to change values of
parameters through rotary movement and to confirm the alteration through pressing.

Bed tilt buttons: adjust the tilt of the patient bed. The upper and lower buttons
cause the bed to tilt (Trendelenburg or Proclive) and the central button causes the automatic return to the
horizontal position.

Alarm Indicator LED: Red LED stays on whenever there is an active alarm associated with
functions controlled by the control panel.

Low power indicator LED: Red LED stays on when there is low power
power in the system (power failure or disconnected power cable). When the module
transport is present (optional item), the LED will light up if, in the absence of power from the mains, the load
of the transport batteries are over.

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Skin Sensor T1: Main sensor for monitoring and controlling the temperature of the skin of the newborn. That
through the T1 skin sensor that controls the patient's temperature through the radiant heater
(Skin Mode). Temperature monitoring by this sensor determines the occurrence of Skin Mode alarms
(See the Alarms section of the AMPLA 2085 Heated Cradle).

T2 Skin Sensor : Auxiliary surface temperature sensor, which can be used to visualize the
temperature of peripheral areas of the newborn's body (limbs). Optionally the Sensor can be used
Rectal Temperature - REF: 004.370.600

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Attention : The auxiliary skin sensor T2 only allows a temperature reading, not having
influence on heating by radiant heat or on the alarm performance of
security.

Pulse Oximetry Sensor: the sensor is used to obtain measurements of oxygen saturation and beatings
of the heart (optional item).

Organization of colorful LCD monitor screen

Bar value
heating power (0
up to 100 %)
Rotating rosette

Temperature of
Temperature of T2 Skin Sensor
Skin Sensor
T1
Concentration
n
Point of
adjustment of the Oxygen
Skin

Position
Mattress
Thermal and
Bilitron batteries
Bed
Bar of
Tools

C urva de
trend

Date and Time


Curve
Name of current
plethysmographic
patient

Information and Alarms: The information and alarms section displays informational messages about the
system operation and operating alarms.

Rotating rosette: symbol that keeps rotating during the entire operation of the system, while
indicating that the control panel processing unit is working. When the rosette
is stopped, it means that the processing unit is locked, being necessary
restart the
system.

Bar and value of heating power: indicates the proportional heating level of the radiant heater
(0 to 100%).

Toolbar: gives access to the functions and menus of the heated cradle.

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Navigating on-screen features

Navigation is done by the toolbar. A toolbar icon can lead


directly to a parameter setting or a menu with more options.

Main toolbar: Contains the icons in the illustration on the right. Whenever the
screen is in another toolbar or on a menu screen, if no button
triggered, the screen will automatically return to the main toolbar after 2
ADJUSTMENT
minutes.
SKIN

Use the Menu icon to toggle between the various toolbars. PRE

Use the Enter icon or press the rotary knob to alter a parameter.
ENTER

Use the return icon to return to the previous menu or main toolbar.

Use the right arrow icon to move the cursor to the right.

Use the left arrow icon to move the cursor to the left.

Heating mode setting

Press the Menu icon to go to the second toolbar.

MODE If the system is in Skin Mode, the Manual Mode icon will appear. Select to go
HANDBOOK
for Manual Mode. In Manual Mode, the Skin Set Point and T1 and T2
they disappear, indicating that there is no control of skin temperature.

If the system is in Manual Mode, the Skin Mode icon will appear. Select to go to Skin Mode.
MODE
SKIN

Manual mode Skin mode

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USER'S MANUAL
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Leather Set Point Adjustment

ADJUSTMENT
With the system in Skin Mode, select the Skin Adjustment icon in the toolbar
SKIN principal. Alter the Skin Set Point (from 20 to 38ºC) through the rotary knob.
Select the Skin Adjustment icon or press the rotary knob to exit adjustment mode.

INTENSIVE CARE UNIT AMPLA 2085

INFORMATION AND ALARMS


TEMPERATURE ºC
SERVIO SENSOR SKIN SENSOR (T1)
LEATHER (T1) SKIN: NORMAL OPERATION
NORMAL BPM
SPO 2 NORMAL
ADJUSTMENT
SKIN

Heating power adjustment

With the system in Manual Mode, select the Power Adjustment icon on the toolbar
ADJUSTMENT
POWER principal. Alter the power level (from 0 to 100%) via the rotary knob. Select icon
Adjust Power or press the rotary knob to exit adjustment mode.

INTENSIVE CARE UNIT AMPLA 2085

INFORMATION AND ALARMS


TEMPERATURE ºC
MANUAL MODE AND ALARMS
INFORMATION
LEATHER (T1)
NORMAL BPM
MANUAL MODE
SPO 2NORMAL
NORMALBPM
SpO 2 NORMAL
ADJUSTMENT
POWER

Preheat adjustment

Select the Preheat icon on the main toolbar. The power level of the
PRE Radiant heat will adjust according to the ambient temperature, as explained in article 6.1, or it may
adjust in the range from 0 to 30%.

INTENSIVE CARE UNIT AMPLA 2085


INFORMATION AND ALARMS
TEMPERATURE ºC MANUAL MODE:
LEATHER (T1) PREHEATING
NORMAL BPM
SPO 2 NORMAL

ADJUSTMENT
POWER

THERMAL MATTRESS OFF

BATTERIES 12.1 V PRE

Mãe Canguru function

To activate the “Mãe Canguru” function, move the Irradiant Reflector from the central position, setting
the desired position. It will be indicated in the Information and Alarms section of the monitor that the heater
Irradiant is displaced and heating by radiant heat, if it occurs, will be discontinued. In the bar

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From the main toolbox, the Warm Up icon will be replaced by the Kangaroo icon. To the
Select this icon, the radiant heat heating will be activated, with the power set as the
ambient temperature (see explanation in article 6.1). The power level can be adjusted from 0
up to 30%.

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The patient's temperature can be verified and can be monitored through the Skin Temperature
T2 assistant.

Attention : While using the “Mãe Canguru” function, check the patient's temperature
because, contrary to what happens in the Manual Mode, in the "Mãe Canguru" mode there is no
alarms to verify the patient's temperature every 15 minutes.

INFORMATION AND ALARMS


TEMPERATURE ºC
MÃE CANGURU MODE
LEATHER (T1)
NORMAL BPM
SPO 2 NORMAL

ADJUSTMENT
POWER

THERMAL MATTRESS OFF


BATTERIES 12.1V
BILITRON BED OFF

Suspension of audible alarms

To temporarily suspend the legitimate signal of an alarm, select the Inhibit Sound icon on the
main toolbar. The icon will become a cut bell and the time will appear
remaining, in minutes, for the alarm to sound again.

fifteen

The audible alarm inhibit time can be adjusted for a range value of 1 to 15 minutes.
Therefore, in the menu Configuration, (Configuration icon) set the password to 121 and alter
the sound inhibition time for the desired value.

SETTING

CLOCK. CALENDAR

OFF / CLOCK
SOUND INHIBITED (MIN.)
fifteen
OXIMETER BEEP VOLUME
PASSWORD 000

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Blocking alteration of parameters

To block the alteration of the most important parameter values, select the icon
Padlock on the main toolbar, adjusting it for the closed padlock shape.

Selecting the APGAR Clock or Clock Alarm function

In the Configuration menu, select the desired function.

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APGAR Clock

With the APGAR Clock function selected, press the Clock icon button on the toolbar
to start counting the APGAR clock. The APGAR watch plays a beep every minute and a beep
prolonged in the fifth and tenth minutes.
To stop the count, press the Clock icon button again and to restart the count, press
this same button once again.

Clock Alarm Setting

With the Alarm Clock function selected, press the Clock icon button on the
main tools to open the Alarm Programming menu. Adjust the hours of the
next alarm, the time interval between each alarm and turning on the Alarm Clock. It will be exhibited
on the main screen the time of the next alarm. The alarm will emit an intermittent sound and, if not
is interrupted, it will last approximately 40 seconds. To inhibit the sound of the alarm, press the button
Inhibit Sound. As soon as the sound is inhibited or within 40 seconds, the next time will be displayed.
alarm.

ALARM PROGRAMMING

WEIGHT (Kg) AL.LOCK


NEXT ALARM
15:03
PERFORM ALL
00:30 MIN
AT CLOCK ............ ON

Adjustment of Pulse Oximetry parameters


SpO 2
Select the Heart icon. The following parameters can be adjusted:
- High concentration limit of SpO 2, from 21 to 100%
- Low SpO 2 concentration limit , from 20 to 99%
- BPM high level limit, from 11 to 250,
- Low BPM level limit, from 10 to 249
- SatSeconds: Off, 10,25,50 or 100 (See section "Pulse Oximetry", article 6.1)
- Audible beep synchronized with the beatings: On / Off
- Pulse Oximeter On / Off
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Attention Deciding to use SatSeconds alarm management and adjusting the value
appropriate for this parameter is the responsibility of the doctor, based on the
clinical conditions of the patient.

On the main screen, the SpO2 and BPM values are displayed, in a vertical bar synchronized with BPM and the
plethysmographic curve. If the SatSeconds is on, its value will be displayed below the plethysmographic curve,
along with a bar that accompanies the evolution of an event of violation of limits of high or low saturation.
When this bar is completely full, it means that the event reached the value of SatSeconds (see the
Pulse Oximetry section), and the corresponding high or low saturation alarms are activated.
Synchronized bar
with the paddles

PULSE OXIMETER
Curve
plethysmographic
HIGH% SPO2 .. ………… .. …… ..84
LOW% SPO2…. ………. ……… 73
HIGH BPM ……… .. …… .. …… ..193
LOW BPM ………… .. ……. …… ..50 Bar
SatSeconds .... ……… ... ………. 10 SatSeconds
BEEP ………………… ... ON
OXIMETER ……… .... ON

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To adjust the volume of the beep synchronized with the beatings select the function "Beep volume
oximeter "in the Settings menu.

Balance functions

Select the Balance menu. The following functions are available:

- Tara: I will tare the balance

- Automatic tare: when selected, starts a time count synchronized with a bar
horizontal. When the bar is completely full, an audible beep is emitted and the tare is done.

- Initial weight: when selected, registers the weight that the balance is currently reading. Register the
weight of the newborn at the beginning of the treatment, to monitor the evolution of the
weight gains and losses through the "Relative Weight" trend line.

- Current weight: when selected, registers the weight that the balance is currently reading. Register
the weight of the newborn during treatment, to monitor the evolution of the
weight gains and losses through the "Relative Weight" trend line. It's recommended that
each time a newborn weight measurement is made, the current Weight is updated, for the
consequent update of the trend line "Relative weight".

- Turn off Records: turn off the Initial Weight and Current Weight records.

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BALANCE

TARE
AUTOM. TARE
INITIAL WEIGHT = 3400g
CURRENT WEIGHT = 3450 g
TURN OFF RECORDS

Adjustment of trend lines

Select the Graphics menu. The following functions are available:

- Selection of trend line

- Display of previous period

- Turn off graphics


Trend lines are displayed in 8-hour periods (except the Relative Weight trend line
of which the period prior to the present period is displayed in blocks of 24 hours) and is stored in the memory of the
control panel a total of 5 days (120 hours) of each trend line.

Graphics related to optional accessories (pulse oximeter, balance and oxygen monitor) will have
your selection disabled if the optional does not exist in the device.

The following parameters are monitored in the form of trend lines:

- SKIN (T1): the temperature of the skin T1 (ºC). Whenever the SKIN (T1) chart is selected, it is also
The line of the Skin Adjustment Point (ºC) will be displayed on the same graph. SKIN trend lines
(T1), SKIN (T2) and Environment can be displayed on the same graph, in any combination, making
simultaneous monitoring of the evolution of these parameters is possible.

- SKIN (T2): auxiliary skin temperature T2 (ºC)

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- Difference T1 - T2: difference between temperatures T1 and T2 (ºC)

- Environment: ambient temperature (ºC)

- SpO 2 (%): oxygen saturation measured by the pulse oximeter. In the SpO 2 graph the lines of the
High limit and low oxygen saturation are also displayed, allowing visualization of the
occurrence of violation of the limits in the previous periods.

- Heart beat: moderate BPM for the pulse oximeter. BPM is displayed on the chart
also the low and high BPM level limit lines, allowing the occurrence visualization
violation of the limits in the previous periods.

- Heating Power. (%): level of the proportional power of the radiant heat.

- Relative weight (g): difference between the current Weight and the initial Weight, registered in the Balance menu.
Represents the weight gains or losses of the newborn in the period. Differently from the others

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trend lines, the previous periods of this graph are presented in 24-hour periods.

- Thermal mattress (ºC): temperature of the internal sensor of the thermal mattress.

- Bilirubin (mg / dl): bilirubin concentration as recorded in the patient's record.

- Oxygen (%): oxygen concentration measured by the Oxygen Monitor. In the graph of the
O 2 concentration the high and low concentration limit lines are also displayed, allowing
the visualization of the occurrence of violation of the limits in the previous periods.

GRAPHICS GRAPHICS

SKIN (T1) - PERIOD OF ...... 8 HOURS


SKIN (T2)
- RESET GRAPHICS
Ambient
Difference T1 - T2
SpO2 (%)
Beatings / minute
Power of Aq. (%)
Relative Weight (g)
Thermal Mattress (C)
Bilirubin (mg / dll)
Oxygen (%)
Plus…

To view trend lines from previous periods, select View Periods from the Charts menu.
The charts are presented in the 8 hour periods. In a period to be selected, under the horizontal axis of the
The times and dates of the beginning and end of the period will be displayed on the chart.

SKIN ENVIRONMENT - Adj

Hs
Start of End of
period period

To turn off 5 days of saved graphics from memory, select Reset Graphics from the
Graphics. A confirmation will be asked. Once confirmed, the user must wait for the deletion process to end
of the graphics that last approximately 35 s.

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Patient file

Select the icon Prontuario. The following data about the patient are recorded in the
record:

- Nome: nome do patient. Name: the name of the patient. To insert the name, position

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the cursor on the Name and press the Enter button. A virtual keyboard will appear, where can
select the letters of the name.

- Gestational age of the patient. Adjustable parameter in the girdle from 12 to 42 weeks.

- Initial weight: Weight of the patient at the beginning of the treatment, registered in the balance menu. In the
prompt screen, this parameter is displayed and cannot be altered.

- Current weight: Most recent weight of the patient, registered in the Balance menu. This parameter
it is exhibited and cannot be altered.

- Start: date the patient started treatment in the Heated Cradle.

- Phototherapy: (Yes or No) indicates whether the patient is under phototherapy treatment.

-Photo time: time of phototherapy treatment already provided to the patient. Cradle case
It has heated module phototherapy Bilitron Bed TM 4006 (optional item), will be the
indication "(Bilitron Bed)" next to the photo time and this field will have the treatment time
made with Bilitron Bed TM 4006, automatically made by the system during the use of the
phototherapy. If there is no Bilitron Bed TM 4006, there will be no indication and treatment time
they must be inserted by the user.

- Bilirubin (mg / dl): level of bilirubin concentration, inserted by the user (adjustable from 0
up to 50 mg / dl). After the recorded value the bilirubin trend line is constructed.

PRONTUARIO

NAME BABY AMPLA

GESTATIONAL AGE ................ 36 WEEKS


INITIAL WEIGHT = 3400G
CURRENT WEIGHT = 3450G
HOME .................. 10 | 02 | 09
PHOTOTHERAPY ....................... YES
PHOTO TIME. 03h 20m (Bilitron Bed)
BILIRRUBINE (mg | dll)… ...... 09

Setting the current time and date

In the settings menu, select Clock / Calendar. In the Clock Setting menu, adjust the date and
hour.

CLOCK ADJUSTMENT

Language selection

In the Language menu, select the desired language

LANGUAGE

PORTUGUESE
ENGLISH
SPANISH

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Preventive maintenance

Open the Maintenance menu. The dates of the last and next preventive maintenance of the
Parts of the system will be displayed and the general review of the Heated Cradle. After the
maintenance done, the cursor must be positioned on the revised article and press the Enter button,
so that the date of the last support shows the present date and the date of the next
support is automatically calculated.

MAINUTENTION
LATEST NEXT

IRRAD HEATER.
BATTERIES 12V TRANSP .
9V ALARM BATTERY
BLENDER
BILITRON BED
OXYGEN CELL
GENERAL REVIEW

Display of optional items

Select the "Optional" icon. A list of available optional items will be displayed for the
OPTIONAL
Multisystem 2085 Ampla, and the optional items present in the device will be with the
corresponding marked selection box.

OPTIONAL

PULSE OXIMETRY
BALANCE
THERMAL MATTRESS
TRANSPORTATION MODULE
BILITRON BED
OXYGEN MONITOR
PPCVR | BLENDER

Adjusting the parameters of the thermal mattress

Open the Thermal Mattress menu. The following parameters can be adjusted:
MATTRESS
THERMAL

- Set point of the thermal mattress: the temperature at which the


thermal mattress. Adjustable in the band from 31 to 38 o C

- Turn on / off the thermal mattress


In the On condition, the display will indicate "Thermal Mattress - ON", accompany the
operation of the mattress, visualizing the gradual increase in its temperature on the screen.

Attention : Never put the patient on the thermal mattress, with the risk of having
Burns

Thermal mattress conditions are displayed on the main screen.


Temperature
Thermal Mattress

THERMAL MATTRESS
ADJ THERMAL MATTRESS WEIGHT

BATTERIES :
ADJUST…….……. BILITRON BED OFF
THERMAL MATTRESS …… ON

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Parameter setting BILITRON TM BED 4006

Select the Bilitron Bed menu. The treatment time is displayed at the top of the menu
BILITRON
BED phototherapy up to now and the total use time of the lamps (SuperLeds). To complete
10000 hours of use of SuperLeds, there will be a message "Check SuperLeds", indicating that the need
The change of the radiation module must be verified (contact Authorized Technical Assistance).
The following functions are available:

- Restart treatment time

- On / Off Bilitron Bed TM 4006

Conditions B shown Bilitron TM 4006 on the home screen. While it is on, the
Account of treatment time will be displayed.

WEIGHT
BATTERIES 12.1V
PHOTO TIME .. . PHOTO TIME
TOTAL TIME ............

PROCESSING TIME

SWITCHED ON

Adjusting the parameters of the Oxygen Monitor

MONITOR
Select the Oxygen Monitor menu. The following functions are available:
OXYGEN

- High O 2 concentration limit adjustment : adjustable in the range from 16 to 100%

- Low O 2 concentration limit adjustment : adjustable in the range of 15 to 99%

- Calibration of the oxygen cell

- Turn On / Off Oxygen Monitor

To calibrate the oxygen cell, select the Calibrate Sensor option. The menu for calibration of the
Oxygen cell can only be accessed if the Oxygen Monitor is on. Once on the menu
Calibration, to calibrate the cell, leave it exposed to the open air (concentration of 21% O 2 ) and press
the Enter button. After calibration is complete, the convenient O2 concentration value on the display
main must be 21% (+/- 1%).

Attention : Cell calibration at 21% must be done every time the


oxygen is used.

When an oxygen cell is used for the first time, calibration at 100% O2 concentration
It must also be done (contact Authorized Technical Assistance).
The oxygen concentration is displayed on the main screen, below the Information and Alarms section.
Concentration of
oxygen

INFORMATION AND ALARMS

OXYGEN MONITOR CALIBRATION OF THE O2 CELL SERVIO MODE - SKIN SENSOR (T1)

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SKIN: NORMAL OPERATION
NORMAL BPM

NORMAL SPO2
HIGH 02% ........................ 41 APPLY 100% O2 IN THE ADJUSTMENT

CELL AND PRESS ENTER. SKIN


LOW 02% ..................... 20%
CALIBRATE THE SENSOR APPLY 21% O2 IN THE
CELL AND PRESS ENTER.
MONITOR 02 ... ON
WEIGHT (kg) AL. CLOCK
PRE

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6.2.2 Monochromatic Panel

The control panel of the AMPLA TM 2085 Heated Cradle with Monochrome LCD Monitor is organized
according to the illustration below.

Monochrome LCD Monitor

Buttons
access to
bar of
tools

LED indicator
alarm

LED indicator
lack of energy

Buttons
inclination
of the bed

Skin Sensor
T2 Skin Sensor Oximetry sensor Rotary knob with
T1 pulse
with Enter function

Monochrome LCD Monitor: screen that shows all the parameters, graphics and functions
controlled by the control panel.

Access buttons to the toolbar: access buttons to the functions of the crib

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heated, sorted by control panel.

Rotary button with Enter function: button used to alter parameter values through the
rotary movement and to confirm the alteration through pressing, Enter function.

Bed tilt buttons: adjusts the tilt of the patient's bed. The upper buttons e
lower make the bed tilt (Trendelenburg or Proclive) and the central button makes the return
automatic to horizontal position.

Alarm indicator LED: The red LED stays on whenever an alarm occurs
associated with the functions controlled by the control panel.

Low power indicator LED: Red LED stays on when there is power failure
energy in the system (power failure or disconnected power cable). When the module
transport is present (optional item), the LED will light up, in the lack of network power
electric, charging the transport batteries.

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Skin Sensor T1: Main sensor for monitoring and controlling the temperature of the skin of the newborn.
It is through the T1 skin sensor that the temperature of the patient is controlled through the
radiant heater (Skin Mode). Temperature monitoring for this sensor only determines the
occurrence of Skin Mode alarms (see the Alarms section of the AMPLA TM 2085 Heated Cradle ).

T2 skin sensor: The auxiliary skin temperature sensor can be used to display the
temperature of peripheral areas of the newborn's body (limbs). Optionally the Sensor
Rectal temperature can be used - REF: 004.370.600.

Attention: O The T2 Auxiliary Skin Sensor only does a temperature reading, not
influencing heating by radiant heat or on the
actuation of security alarms.

Pulse Oximetry Sensor : Sensor used to obtain measurements of oxygen saturation and
beats per minute (optional item).

Organizing the Monochrome LCD Monitor Screen

Temperature Temperature Temperature


T1 Skin Sensor Skin Sensor Mattress
(ºC) T2 (ºC) Thermal (ºC)
Concentration
oxygen
Point of
adjustment of the
Skin

Bar and Value


of power

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of
Bar of
heating tools
(0 to 100%)

Line of
trend

Date and Time Loading of


current batteries for him
transport
Information and Alarms: The information and alarms section displays the informative messages of the mode
of system operation and alarms in action.

Bar and heating power value: Indicates the proportional heating level of the heater
irradiating (0 to 100%).

Toolbar: gives access to the functions and menus of the heated cradle.

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Navigating the functions on the screen

Navigation is done by the toolbar. A toolbar icon can take


to a parameter setting or directly to a menu with more options.

Main Toolbar - Contains the icons in the illustration on the right. Always
the screen is in another toolbar or on a menu screen, case
no button is lit, the screen will automatically return to the toolbar
main after 2 minutes.
ADJUSTMENT
SKIN

Use the Menu icon to toggle between the various toolbars.


PRE
Use the Enter icon or press the rotary knob to alter a parameter.
ENTER

Use the return icon to return to the previous menu or main toolbar.

Use the Right Arrow icon to move the cursor to the right.
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Use the Left Arrow icon to move the cursor to the left.

Heating mode setting

Press the Menu icon to get to the toolbar.

If the system is in Skin Mode, the Manual mode icon will appear. Select to get to
MODE
HANDBOOK Manual mode. In Manual Mode, the Skin Set Point, T1 and T2 disappear,
while stating that there is no control of skin temperature.

MODE If the system is in Manual Mode, select the Skin Mode icon to reach Mode
SKIN
Skin.

Go for Go for
Mode Skin mode
Skin Mode System
Handbook System in Manual Mode

6
6

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Leather Set Point Adjustment

ADJUSTMENT With the system in Skin Mode, select the Skin Adjustment icon on the main toolbar. He
SKIN Adjustment Point and the Skin Adjustment icon will enter the blink mode. Alter the Skin Set Point (
from 20 to 38 ° C) through the rotary knob. Select the Skin Adjustment icon or press the rotary knob to
exit setting mode.

TEMPERATURE T1 INFO AND ALARMS


SKIN MODE (T1)
SKIN: NORMAL

ADJUSTMENT

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SKIN

Heating power adjustment

ADJUSTMENT
With the system in Manual Mode, select the Power Adjustment icon on the toolbar
POWER
principal. The power level and the Power Adjustment icon will go into blink mode. Alter the level of the
power (from 0 to 100%) through the rotary knob. Select the Power Adjustment icon or press the
rotary knob to exit setting mode.

TEMPERATURE T1 INFO AND ALARMS


MANUAL MODE

ADJUSTMENT
POWER

POWER

Preheat Adjustment

Select the Preheat icon on the main toolbar. The Preheat icon
PRE
it will go into yaw mode. The radiant heat power level acquires a value between 10% and 30%,
while depending on the ambient temperature, according to the table below.

Preheat power Temp. ambient

30% <23ºC

twenty % 23 ≤ T amb <26ºC

10% T amb ≥ 26ºC

Temperature INFO AND ALARMS

PREHEATING
ADJUSTMENT
POWER

Power
Mattress

Ambient Temp Alarm Clock


Temperature
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Mãe Canguru function

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To activate the “Mãe Canguru” function, move the Irradiant Reflector from the central position, setting
in the desired position. It will be indicated in the Information and Alarms section of the monitor that the heater
Irradiant is displaced and heating by radiant heat, if it occurs, will be discontinued. In the bar
From the main toolbox, the Warm Up icon will be replaced by the Kangaroo icon. To the
Select this icon, the radiant heat heating will be activated, with the power set as the
ambient temperature (see explanation in article 6.1) The power level can be adjusted from 0 to
30%
The patient's temperature can be verified and can be monitored through the Skin Temperature
T2 assistant.

Attention : When using the Mãe Canguru function, always check the patient's temperature
because, contrary to what happens in the Manual Mode, in the “Mãe Canguru” mode,
There are alarms to verify the patient's temperature every 15 minutes.

TEMPERATURE T1 INFO AND ALARMS

PREHEATING

ADJUSTMENT

POWER

POWER
Mattress

Ambient Temp Clock

Suspension of audible alarms

To temporarily suspend the sound signal of an alarm, select the Inhibit Sound icon in the
main toolbar. The icon will become a cut bell and the time will appear
remaining, in minutes, for the alarm to sound again.

fifteen

The audible alarm inhibit time can be adjusted for a value from 1 to 15 minutes. For
Therefore, in the Configuration menu (Configuration icon), set the password to 121 and alter the
sound inhibition time by the desired value.

SETTING

Date and time setting


Clock function ........ AL. CLOCK
Inhibited Sound .... 15 min.
Password .......... 000

Blocking of parameter alteration

To Block the alteration of the parameter values, select the Padlock icon in the bar
Main toolbox, adjusting for closed padlock shape. Release the adjustment of the
parameters, select the Padlock icon in the main toolbar, leaving in the form of
open lock.

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USER'S MANUAL
AMPLA TM 2085 HEATED CRADLE INTENSIVE CARE UNIT

Selecting the APGAR Clock or Clock Alarm function

In the Configuration menu, select the desired function.

APGAR Clock

With the APGAR clock function selected, press the Clock icon button on the toolbar
main to start the APGAR clock count. The APGAR watch plays a beep on each
last minute and a long beep in the fifth and tenth minutes. To stop the account, press
the Clock icon button again and to restart the account, press this same button one
one more time.
INFO AND ALARMS
SKIN MODE (T1)
SKIN: NORMAL ADJUSTMENT
SKIN CLOCK

Turn off

Setting the Clock Alarm

With the Alarm Clock function selected, press the Clock icon button on the
main tools to open the Alarm Programming menu. Adjust the hours of the
next alarm, the time interval between each alarm and press the Alarm Clock. It will be exhibited at the
main screen the time of the next alarm. When discharged, the alarm will emit a sound
flashing and, if not interrupted, will last approximately 40 seconds. To inhibit the sound of the
alarm, press the Inhibit Sound button. When the sound is inhibited or if 40 seconds have passed,
will display the next alarm schedule.
INFO ALARMS

PROGRAMMING
OF THE ALARM SKIN MODE (T1)

SKIN: NORMAL Skin


Next Alarm ............... 10:20 Ajust

Play all : 00 h 15m.

Alarm Clock ................ On

AL Clock.

Adjustment of Pulse Oximetry parameters

Select or icon SpO 2 . The following parameters can be adjusted:


SpO 2
- High concentration limit of SpO 2 , from 21 to 100%
- Low SpO 2 concentration limit , from 20 to 99%
- High BPM level limit, from 11 to 250
- Low BPM level limit, from 10 to 249
- SatSeconds: Off, 10, 25, 50 or 100 (see section “Pulse Oximeter”, article 6.1)
- Visualize the plethysmographic curve
- Legitimate beep synchronized with the paddles: On / Off
- Pulse Oximeter On / Off.
Attention: Deciding to use SatSeconds alarm management and adjusting the value
appropriate for this parameter is the responsibility of the doctor, based on the

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SpO 2 and BPM values and a vertical bar synchronized with BPM are displayed on the main screen . Case the
SatSeconds is turned on, its setting value will also be displayed.

Synchronized bar
with the paddles
SpO 2

PULSE OXIMETER
Paddles
High Spo2% .......................... 90 Mattress
per minute
Low% of SpO2 ................. 70
AL Clock .
High BPM ........................... 200
SatSeconds ......................... 25
Beep ...................... ON
Value
See plethysmographic SatSeconds
........... oximeter . SWITCHED ON
Weight

The plethysmographic curve can be displayed when the "Look Plethysmographic" function is selected on the screen
of the pulse oximeter. The curve will be displayed at the bottom of the pulse oximeter screen, along with the
skin temperature T1 and SpO 2 and BPM values .

PULSE OXIMETER
High% of SpO 2 ................ 89
Low% SpO 2 ................ 70
High BPM ......................... 202
Low BPM .......................... 54

Plethysmography

Balance functions

Select the balance menu. The following functions are available:

- Tara: Tares the balance

- Automatic tare: when selected, a synchronized time count starts with a horizontal bar
growing. During this period, the operator lifts the newborn from the bed. When the bar is complete, a beep
sonorous is emitted and the tare is done, being able, then, to do the weighing of the newborn soon after. The
Automatic tare is ideal for performing the patient weighing procedure by a single operator.

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- Initial weight: when selected, registers the weight that the balance is currently reading. Record the weight of the
newborn at the beginning of the treatment, to follow the evolution of the gains and losses of
weight through the trend line "Relative weight".

- Current weight: when selected, registers the weight that the balance is currently reading. Record the weight of the
newborn at the beginning of the treatment, to follow the evolution of the gains and losses of
weight through the trend line "Relative weight". It is recommended that each time a measurement of
newborn weight, the current Weight is updated, for the consequent update of the trend line
"Relative weight".

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- Turn off Records: turns off the Initial Weight and Current Weight records.

BALANCE

Tare
Automatic tare
Initial weight .................. 3562 g
Current weight .................. 3565 g
Turn off records
Weight:

Adjusting trend lines

Select the "Graphics" menu. The following functions are available:

- Selection of trend line


- Visualization of previous periods
- Turn off graphics

Trend lines are displayed in 4-hour periods (except the Relative Weight trend line
of which the periods prior to the current period are displayed in 24-hour blocks) and are stored in the
control panel memory in a total of 5 days (120 hours) of each trend line.

The following parameters are monitored in the form of trend lines:

- SKIN (T1): the skin temperature T1 (ºC).


- SKIN (T2): the auxiliary skin temperature T2 (ºC)
- T1-T2 difference: difference between T1 and T2 temperatures (ºC)
- Environment: ambient temperature (ºC)
- SpO 2 (%): oxygen saturation measured by the pulse oximeter.
- Beat / minute: BPM measured by the pulse oximeter.
- Heating Power (%): level gives radiant heat power.
- Relative weight (g): difference between the current weight and the initial weight, registered in the menu
Balance. Represents the weight gains or losses of the newborn over time.
- Thermal mattress (ºC): temperature of the internal sensor of the thermal mattress.

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-- Bilirubin (mgoxygen
Oxygen (%): / dl): theconcentration
concentrationmeasured
of bilirubin as recorded
by the in the patient's record.
Oxygen Monitor.

Graphics related to optional accessories (pulse oximeter, balance and oxygen monitor) will have
your selection disabled if the corresponding option does not exist in the device.

SKIN (T1) ..................... Thermal Colchão (ºC) .....



SKIN (T2) ..................... Bilirubin

Difference T1-T2 (ºC) ... (MG / dl) ............


Environment (ºC) .............. Period ......... Present period

Beatings / minute .... Reset graphics

Power of Aq. (%) ....

Relative weight (g) ..........

More ............................

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To view trend lines of previous period, select the desired period through the function
"Period" in the Graphics menu. When a period is selected, the horizontal axis of the graph will display
the times and date of the beginning and end of the period.

Start
of the Period End of
Period

To turn off all 5 days of saved graphics from memory, select Restart Graphics from the Graphics menu.
A confirmation will be asked. Once confirmed, the user must wait for the end of the deletion process of the
graphics lasting approximately 35 s.

Patient file

Select the icon Prontuario. The following data about the patient are recorded in the medical record:

- Name: the name of the patient. to insert the name, position the cursor on Name and
press the Enter button or the rotary button. A virtual keyboard will appear, where you can select the
letters of the name.

- Gestational age of the patient. adjustable parameter in the girdle from 12 to 42 weeks.

- Start: date when the patient started treatment in the heated crib.

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- Phototherapy (Yes / No): indicates if the patient's phototherapy treatment is being done.
-Photo time: time of phototherapy treatment already provided to the patient. La Cuna case
Warmed have phototherapy module Bilitron Bed TM 4006 (optional item), the display will
"(Bilitron Bed)" next to the photo time and this field will show the treatment time done with
Bilitron, automatically counting by the system during the use of phototherapy. Case the
Bilitron Bed TM 4006 is not installed, there will be no indication and treatment time must be inserted
by the user.

- Bilirubin (mg / dl): level of bilirubin concentration, inserted by the user (adjustable from 0 to 50
mg / dl). From the registered value the bilirubin trend line is constructed.
This graphic can be used in the local service protocol agreement for the definition of this
parameter
- Initial weight: weight of the patient at the beginning of the treatment, registered in the Balance menu. On the screen
This parameter is displayed and cannot be altered.

- Current weight: most recent weight of the patient, registered in the Balance menu. On the docket screen,
This parameter is displayed and cannot be altered.

PRONTUARIO

Name: BABY AMPLA


Gestational age ... 36 weeks
Start ...................... 02/19/09
Phototherapy .............. YES
Photo time ...... 01 h 15 m
Bilirubin mg \ dl ... 005
Initial Weight ………… 3,400 g
Current weight ............. 3,450 g

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Setting the current time and date

In the Settings menu, select Clock / Calendar. In the Clock Setting menu, set the date
and hour.

ADJUSTMENT OF
CLOCK

Day = ...................... 20
Month = ...................... 02
Year = ..................... 09
Time = ................. 08
Minute = .................. 51

Language selection

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In the Language menu, select the desired language.

Preventive maintenance

Open the Maintenance menu. The dates of the last and next preventive maintenance of the parts of the
system will be exhibited and the general review of the Heated Cradle. After doing the
maintenance, the cursor must be positioned on the revised article and press the Enter button or the
rotary knob, so that the date of the last support receives the present date and the date of the
next support is automatically calculated.

MAINTENANCE

Radiant heater
12v transport batteries
9V-alarm batteries
Blender
Bilitron Bed
Oxygen cell
General Review

Latest Next

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Display of optional items

Select the "Optional" icon. A list of available optional items will be displayed for
OPTIONAL the AMPLA TM 2085 Heated Cradle whose functionality is related to the control panel, and for each
article there is an indication (YES or NO) of the existence of the optional on the device.

OPTIONAL

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Pulse oximetry ............... YES
Balance ................................... YES
Thermal Mattress .................. YES
Mode of transport .............. Yes
Bilitron Bed 4006 ................. YES
Oxygen Monitor ............. YES
CPAP / Blender ..................... YES

Adjusting the parameters of the thermal mattress

MATTRESS
Open the Thermal Mattress menu. The following parameters can be adjusted:
THERMAL

- Set point of the thermal mattress: the temperature must remain the thermal mattress.

Adjustable in the band from 31 to 38ºC.

- Turn on / off thermal mattress

In the on condition, the display will indicate "Thermal Mattress - ON", accompany the
operation of the mattress, visualizing the gradual increase in its temperature on the screen.

Attention: Never put the patient directly on the thermal mattress, with the risk
of having burns.
At the temperature of the thermal mattress is shown on the main fabric.

Temperature do
Mattress
Thermal (ºC)

INFO AND ALARMS


THERMAL MATTRESS MATTRESS THERM. ACTIVE

MANUAL / SKIN APA GADO

BPM: NORMAL
SpO2: NORMAL OPTIONS
Setting .................. 34.0 (° C)
Mattress
Thermal ON
Mattress
CLOCK ALARM

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Bilitron parameter setting Bed TM 4006

Select the Bilitron Bed menu. Treatment time is displayed at the top of the menu
BILITRON
BED phototherapy done so far and the total time of use of the lamps
(SuperLeds). When you complete 10000 hours of use of the SuperLeds, there will be a message
"Check SuperLeds", indicating that the need to change the radiation module must be
verified (Contact Authorized Technical Assistance).

The following functions are available

- Restart treatment time

- Turn On / Off Bilitron Bed

Total usage time


Treatment time
from SuperLEDs

BILITRON BED

Photo time ............... 00 h 02 min.


Total time .............. 0000 h

Reset Treatment Time


Bilitron Bed ................. ON

Oxygen Monitor Parameter Adjustment

Select the Oxygen Monitor menu. The following functions are available:
O2
- High O 2 concentration limit adjustment : adjustable in the range from 16 to 100%

- Low O 2 concentration limit adjustment : adjustable in the range of 15 to 99%

- Calibration of the oxygen cell

-Turn On / Off Oxygen Monitor

To calibrate the oxygen cell, select the Calibrate Sensor option. The menu of the calibration of the cell
Oxygen can only be accessed if the Oxygen Monitor is on. Once in the calibration menu, to
calibrate the cell, leave it exposed to the open air (concentration of 21% O 2 ) and press the Enter button. Concluded the
calibration, the convenient O 2 concentration value on the main screen should be 21% (+/- 1%).

Attention: Cell calibration at 21% must be done every time the monitor
oxygen is used.

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When an oxygen cell is used for the first time, calibration at 100% O 2 concentration
It must also be done (contact Authorized Technical Assistance).
The oxygen concentration is displayed on the main screen, below the Information and Alarms section.

OXYGEN MONITOR CELL CALIBRATION O 2

High% of O2. .................... 65 Apply 100% O 2 in

Low% of O 2 ................. 20 cell and press ENTER ✓


Apply 21% O 2 in
Calibrate sensor
cell and press ENTER.
O 2 Monitor ... On

O 2 concentration :

INFO AND ALARMS


ACTIVE THERMAL MATTRESS

MANUAL / SKIN / OFF


Option
BPM: NORMAL
Concentration
SpO2: NORMAL
oxygen
Mattress

Weight

Indication of charge of transport batteries

When the optional Transport Module is present in the AMPLA TM 2085 Heated Cradle , the voltage of the
batteries for transport and a bar that indicates the charge shown in the lower right corner of the
pantella. The batteries are complete when the voltage value is above 12 V and is considered low
when the voltage value is below 11.3 V.

Weight

Bar that
Voltage of the
indicates the load
batteries
of batteries

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6.2.3 LED Display Panel

The control panel of the AMPLA TM 2085 Heated Cradle Intensive Care Unit with monitor
7-segment LED display is organized as shown in the figure below.

LEDS monitor

Buttons
access to
bar of
Lack of energy tools

Sensor missing

High temperature

Low temperature

Connector
Skin sensor Buttons
T1 inclination
of the bed

Skin Connector Rotary knob with


T2 sensor Enter function

7 Segment LED Display Monitor: Monitor showing all the parameters, graphics and
functions controlled by the control panel.

Access buttons to the toolbar: Access buttons to the functions of the Crib
Heated, ordered by the control panel.

Rotary knob with Enter function: Button used to alter parameter values through the
rotary movement and to confirm the alteration through pressing, Enter function.

Bed Tilt Buttons: Adjust patient bed tilt. The upper buttons e
lower make the bed tilt (Trendelenburg or Proclive) and the central button makes the return
automatic to horizontal position.

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Skin Sensor T1: Main sensor for monitoring and controlling the temperature of the skin of the newborn.
It is through the T1 skin sensor that the temperature of the patient is controlled through the
radiant heater (Skin Mode - Servo-controlled). Temperature monitoring for this sensor only
determines the occurrence of Skin Mode alarms (see the Warmed Crib Alarms section
AMPLA TM 2085).

T2 Skin Sensor: The auxiliary skin temperature sensor can be used to display the
temperature of peripheral areas of the newborn's body (limbs). The temperature value for the
T2 sensor is displayed only if the T1 temperature sensor is also present and the system is operating
in Skin Mode

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Attention: The T2 auxiliary skin sensor only makes a temperature reading, not having
influence on heating by radiant heat or on the performance of
Security alarms.

Organization of the 7-segment LED monitor fabric


Skin Set Point (Skin Mode)
at the Power level of
Heating (Manual Mode or
Sensor temperature
Level bar Preheating)
Leather T1
power
Clock Function
of
OFF TIME
heating current
(0 to 100%)

Sensor temperature
Skin T2 (ºC)

LED indicator
Bar of
lack of energy
tools

LED indicator of lack of


Pele Sensor T1
LACK OF ENERGY

LED high indicator Weight


stripping temperature (T1) MISSING SENSOR

Low indicator LED


HIGH TEMPERATURE
Temperature
stripping temperature (T1)
ambient

LOW TEMPERATURE

LED indicator 15
LED indicator
minutes in 100% of Warning LED for
radiant heater
power verification of
displaced
patient temperature

Navigating the monitor functions

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Heating Mode Setting

Attention: During the use of radiant heat heating, never put blankets on
the patient. Such action interferes in the control of the warming of the crib,
exposing the patient to serious or fatal risks from overheating of the
system.

Skin Mode (Serbian): Press the button on the toolbar that corresponds to the
SERVIO
HANDBOOK heating modes, until the LED for the Serbian option (Skin Mode) lights up. He
Preheat system will only enter Skin Mode if the Skin Sensor T1 is connected to the panel, on the other
In addition, the system will only allow the selection of the Manual or Preheat Modes.

If the Cradle is operating in Manual or Preheat Mode and the T1 Skin Sensor connects to the panel,
then the system will automatically switch to Skin Mode (Serbian).

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When operating in Skin Mode (Serbian), the monitor displays the Skin temperature T1 and the Skin Set Point, depending on the
illustration below.
SKIN MODE (Serbian)
Temperature of Set Point
SKIN T1 (° C) Skin (º C)

SERVIO Manual Mode: Press the button on the toolbar that corresponds to the modes of
HANDBOOK
Preheat
heating, until the Manual Mode option LED turns on.

If the system is operating in Skin Mode (Servo) and the Skin Sensor T1 is disconnected from the panel, the
system will automatically switch to Manual Mode, adjusting heating power to 0%
) (heating off).

When operating in Manual Mode, the monitor does not display the Skin Temperatures, T1 and T2 display the value of the level of
power (from 0 to 100%) according to the illustration below.

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Manual mode Power level
heating
(0 to 100%)

Preheating: Press the button on the toolbar that corresponds to the


SERVIO
heating modes, until the LED for the Preheating option lights up. He
HANDBOOK
Preheat radiant heat power level acquires a value between 10% and 30%, while
depending on the ambient temperature, according to the table below.

Preheat Power Temp. Ambient

30% <23ºC

twenty % 23 ≤ T amb <26ºC

10% T amb ≥ 26ºC

Attention: Preheat mode should not be used to warm the patient, but
only to heat the bed before the arrival of the patient, because on the contrary
than what happens in manual mode, preheat mode has no
alarms to check the patient's temperature in every 15
minutes.

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When operating in Preheat, the monitor does not display Skin Temperatures T1 and T2, and displays the value
of the power level (from 0 to 100%). according to the table below.

Level of
power of
Preheating
heating
(0 to 30%)

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Skin Tight Adjustment

With the system in Skin Mode (Serbian), press the Rotary Knob. Digits of the Skin Set Point
they will enter the yaw mode. Alter the Skin Set Point (from 20 to 38ºC) through the Button
rotary. Press the Skin Adjust icon press the Rotary Button to exit adjustment mode

Heating power adjustment

With the system in Manual Mode, press the Rotary Knob. The digits of the power will enter the
wink mode. Alter the power level (from 0 to 100%) through the rotary knob. Tighten the
Rotary knob again to exit setting mode.

Power setting in Preheat mode

When entering Preheat mode, the system adjusts the power level as the temperature
(as explained in section Heating mode setting). The operator can, without
However, adjust the level of the heating power, from 0 to 30%. With the system in mode
Preheat, press the Rotary Knob. The digits of the power will go into blink mode. Alter
the power level (from 0 to 30%) through the rotary knob. Tighten the rotary knob again
to exit setting mode.

Suspension of audible alarms

To suspend for 15 minutes the sound signal of an alarm, press the Inhibit Sound button
in the toolbar. The LED will light up, indicating that the alarm sound is
inhibits.

Blocking of parameter alteration

To block alteration of monitor parameter values (Power Level or Set Point)


Leather Adjustment), press the Padlock button on the toolbar. The LED will light, while
indicating that the alteration of parameters is blocked.

To release the parameter setting again, press the Padlock button so the LED stays
off.

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APGAR counter

CLOCK To select the Counter OFF function, press the "Clock / OFF" button to leave
Turn off the corresponding LED on.

To start the count, press the Account / To button on the toolbar. The Apgar Accountant
he plays a beep in every last minute and a long beep in the fifth and tenth minutes. To stop the

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count, press the Account / Stop button again, and to restart the count press this same button
once again.

APGAR counter
Minutes
Seconds

Clock (Current time)

TO THE. CLOCK
The Alarm Clock function plays an alarm each time a time interval programmed by the
user pass. This function is ideal for counting the intervals between applying
Turn off
medications or procedures. To select the Alarm Clock function, press the button
"Clock / OFF" to leave the LED corresponding to CLOCK ON.

In the corresponding field, the time interval will be displayed between the alarms (in hours and minutes).
time count for the occurrence of the first alarm will start whenever one of the
conditions below:
➢ When there is the transition from the APGAR Clock function to Alarm Clock

➢ The user alter the time interval between alarms

To adjust the time interval between alarms, keep the Count / Stop button pressed for
some moments. The digits corresponding to the time will go into blink mode, set the time to
via the Rotary Knob.

To adjust the minutes, press the Rotary Knob. The minute digits will enter blink mode.
After adjusting the minutes, press the Rotary Button or the Count / Stop button to exit the
adjustment.

From then on, the time count will start for the first alarm. The alarm is characterized by
same time for an intermittent sound in which the interval between the alarms is winking in the
monitor. To inhibit sound, press the Inhibit Sound button. Inhibit Sound case do not press, the alarm
will play for 40 s. To turn off the Clock Alarm function, set the interval between alarms to 00:00.
CLOCK Hours
Minutes

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Balance

To tare the balance, press the Tara button. It will be started, in the field that corresponds to
TARE
Weight, a count from 0 to 10, at the end where the tares of the balance will be made. This period of
the account gives the user time to raise the patient on the bed.

If you want to advance the tare, press the Tara button once more before the end of the count. The tare is
then immediately done.

After the end of the tare, the 0.000kg will be displayed and the patient can then be put on the bed to
weighing.
Weight

6.3 - Turning on the Monitor

Attention : Check that the mains voltage where the power cable joins
corresponds to the same equipment voltage, indicated on the label on the
Heated Cradle power cable, 127V ~ or 220 / 240V ~.
Never turn on the Heated Crib if the hospital plug does not have a
reliable grounding.
Never disconnect the power cord with the monitor on.

Plug the power cord into a 3-pin hospital socket.

Check if the hospital plug corresponds to the voltage and the power of the equipment is indicated in the
identification plate next to the power cable.

Attention: Never switch on the appliance if the plug does not have a reliable ground.

Connect all sensors and accessories to their respective appropriate plugs.

To connect the skin sensor plug, check that the plug and the plug match. After the
connection, thread the lock nut clockwise.

Attention: Never remove the plug through the thread.

Turn on the general equipment key located on the side, the network indication LED on the
front panel will turn on.

Adjust the control parameters according to the need and instructions in article 6.2.

Position the metal surface of the T1 Skin Sensor in contact with the skin of the newborn,
preferably in the abdominal area and fix it with Fanem TM Sensor Adhesive .

Note: If the sensor is not in proper thermal contact with the newborn's skin, a reading
Incorrect skin temperature can occur as a consequence of false temperature.
The use of an appropriate, non-allergenic adhesive can preferably avoid these false readings.
Regularly checking the sensor is a recommended attitude.

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Ref .: 086.068.600

Ref .: 092.059.600

Metallic Surface
METALLIC SURFACE

Attention: This sensor must be used exclusively for skin control.


used for rectal temperature measurement.

Attention: Only use FANEM TM sensors . Using another type of sensor can cause
temperature error causing damage to the patient.
The sensors FANEM TM are tested and are individually controlled.

The current surface patient temperature will be displayed on the SKIN TEMPERATURE display.

The power provided for the heating resistor will be indicated on the
HEATING.

The HIGH and LOW TEMPERATURE alarms will act when the skin temperature is higher or
equal to 10 ° C, or less than or equal to 0 ° C, respectively, with respect to the set temperature.

Attention: the audible alarm can be inhibited for 10 minutes, while being
rather press the INHIBIT SOUND button. The opposite will feel
automatically after this time has passed. When the alarm
HIGH TEMPERATURE is powered for the resistance
heating is interrupted through a protection relay.

Attention: Never remove the sensor through the wire. Remove the adhesive first and then
the sensor.
Before installing the patient sensor, check that the sensor body
it is clean and contains no adhesive residue.

Attention: The setting values will be memorized when the appliance has turned off.

Attention: If the temperature monitored by the sensor oscillate rapidly, it will indicate that
a displacement of the sensor with respect to the newborn's body passed.
In this situation the FAULT SENSOR alarm is activated in a way
flashing and you can stop the sensor to return to its original condition,
If this does not happen, check the correct positioning of the sensor when

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patient and then press the INHIBIT SOUND key to cancel the alarm
of LACK OF SENSOR.

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6.4 - Balance Operation (only available in ICU Table model)

Place the RN on the bed and wait for stabilization of the wood.
To do the Tara of the Scale System, before the Heated Cradle receive the RN, set the table in
horizontal position, and do the following steps:
Select the Tare function in the Balance menu. The Automatic Tare function when selected starts
a time count synchronized with a horizontal bar. When the bar is completely full,
an audible beep is emitted and the tare is done.
Put the RN in the bed and wait for the stabilization of the reading.

Attention: The RN must always be weighed in the center of the mattress. Maximum load
on the bed / scale 7kg

Attention: Movements in the Crib during weighing can cause


oscillations in the weight indication on the display.

Attention: Toys or other objects on the mattress must not rest on


the acrylic sides. Inaccurate readings can occur.
In addition, the bed assembly must not be together with the sides.

Attention: The bed must always be horizontal.

6.5 - Table Movement

For the procedures and treatments that need to position the patient in Trendelenburg or Proclive,
it is enough:
For the configuration of the electric table:

♦ Press the respective bed tilt buttons (Trendelenburg or Proclive) near the panel
front, until you are in the desired position;

♦ Return to the horizontal position, it is enough to operate with a touch the "horizontal" button of the
table near the front panel, the table will automatically return to the horizontal position.

To configure the manual adjustment table:

♦ Position yourself in front of the Intensive Care Unit.

♦ With the left hand, holding the support lap at the lower front of the table, with the
right hand pull the actuation lever located at the bottom right front of the
table. Move the bed up or down until it is in the desired position.

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♦ Release the actuation lever and certify that the bed will be locked in position
desired.

In the case of the ladder installed in the current bed, because of the execution of the vice and the
pesagem will be necessary places it in the horizontal position (Vide 6.4).

For the configuration of the Acrylic Bed:

♦ Position yourself in front of the Intensive Care Unit.

♦ With the left hand, containing the lower front part of the table, with the right hand pull the
actuation button located on the right side of the table. Make the bed move
up or down until you are in the desired position.

♦ Release the actuation button and certify that the bed will be locked in the desired position.

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BUTTON
10 o

DRIVE

10 o

6.6 - Opening of the Laterals


Only for the Intensive Care Unit - ICU Table

Grasp the protective side with one hand,


tighten the side in the direction indicated by the
arrows - (side illustration) to the
unlocking. Tilt the lateral in the direction of
inside out until it stays in the
rest position down.

The protective side located at the rear of the


bed can be removed by pulling up.

It is recommended that castors are


unemployed.

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6.7 - X-ray

The reflector assembly can be moved to


both sides to give way to the Rayo apparatus
X.

For movement, it is enough to move the whole


of the reflector turning to the right or to the
left.

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The bed and mattress are made of materials


that allow transparency to X-rays. A
accommodation exists under the bed, to be
inserted and positioned the film plate to
X-rays.

Obs .: Housing for X-ray tray


only for the Intensive Care Unit -
ICU table

6.8 - Gas Module

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6.8.1 - Oxygen

Oxygen feeding is supported through two different ways; through the cylinders of
oxygen or from the oxygen line of the hospital network.

The administration of oxygen through the Gas Module is carried out by connecting a
pressure of nylon twisted 250Psi Ø3 / 16 ”(Ref .: 004.058.600) to the oxygen inlet nipple of the
Gases.

In this way, we will be supplying the gas module and also the outlet nipple of
oxygen in the Gas Module. This oxygen output in the Gas Module is used for the
supply respirators, Blender, Babypap TM and other peripherals.

Oxygen Administration - Precautions:

♦ In the event of oxygen administration being necessary, this should be established for
parameters established by the doctor.

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♦ Whenever administering oxygen it is necessary, as a normal procedure, to do the tests


routine, with an Oxygen Analyzer.
♦ The manufacturer's instruction must be followed carefully for the use of the Monitors /
Oxygen Controllers.
♦ Oxygen Monitors / Controllers must be demonstrated periodically, taking
samples of pure ambient air following the manufacturer's instructions. If the indications of the
instruments are correct at both ends, the intermediate readings will be reliable, within
of the required limits of accuracy.
♦ Concentrations above 40% oxygen are likely to be dangerous for certain newborn
born. There are still cases where, to raise oxygen pressure to normal levels,
it is necessary to increase the concentration for values above 60%. For this reason, it is extremely
It is important to analyze arterial blood gases to regulate blood concentrations.
inspired oxygen.

Attention: Maximum inlet pressure of 3.5 kgf / cm 2 .

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O 2 Nipple - 9/16 ”Screw –18UNF

6.8.2 - Compressed Air and Vacuum-Vacuum

Compressed air supply can be supported in two different ways; through the
compressed air cylinders or the compressed air line of the hospital network.

Compressed air management through the Gas Module is performed by connecting a hose
of 1250Psi ∅3 / 16 ”stranded nylon pressure (Ref .: 004.212.600) to the air inlet nipple
Compressed from the Gas Module, and another hose connected through the Aspiration Module.

In this way, we will be feeding the compressed air outlet, for the use of
respirators, Blender, Babypap®, etc. and in the Aspiration Module, the secretion aspirator, type
Venturi where the vacuum can be adjusted through the button located on the vacuum gauge at the front
and can be adjusted in the range from 0 to 200 mm Hg of vacuum. Also comes with the bottle for
secretions, with level limiter, cover and vacuum hose.

Attention: Maximum Compressed Air inlet Pressure = 3.5 kgf / cm 2 .


Compressed Air Nipple - 3/4 "Screw - 18UNF

Attention: After the usual medical procedures the bottle may contain
contaminated waste, check that your waste is in accordance with the
current national legislation, and the Infection Control Commission
Hospital of your unit.

OBS: Optionally, a connection for direct connection can be installed in the hospital's vacuum network. In
In this case, request this factory condition.

6.9 - Vacuum of Secretions

Venturi type, is powered by the flow of compressed air.

The vacuum can be adjusted through the front button - vacuum strip from 0 to 200 mm Hg.

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Connection Diagrams - Gas Module and Accessory Configurations

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6.10 - Sensor Operation

The AMPLA TM 2085 Heated Cradle sensor was developed by FANEM for use in its
equipments.

The sensors, due to their characteristics of use, are delicate parts and must be handled
carefully, especially its decoupling should not be pulled by its connecting thread.

The FANEM also produces patterned stickers attaching the sensor to the skin of the RN, these stickers
They are made of non-toxic and antiallergic material, facilitating the removal of the sensor without damaging them. The box is
it provides with 100 units (Ref. 086.068.600).

The Peel Sensor T1 (Ref. 092.059.600) must be positioned with its metallic surface in contact
direct with the skin of the RN, and fado through the adhesives for FANEM sensor, avoiding mistakes
positioning which results in reading failures and various operational alarms.

Attention: Position the metal surface in


contact with the patient's skin
on the most suitable surface,
normally abdominal area.

Patient Sensor
Ref .: 092.059.600

Attention: Never remove the RN sensors by the wire. Remove the adhesive first and then
the sensor.

Before installing the sensor to the patient, check if the sensor body is
clean and contains no adhesive residue.

Attention: Never put the T1 Skin Sensor for rectal, oral temperature measurement
or auxiliary.

The Pel T1 Sensor must be in direct contact with the skin for the
necessary temperature monitoring. Failures maintaining contact
direct with the skin can produce excellent heating and possible risks
to the RN. Check the condition of the RN at least every 15 minutes for the
correct sensor fixation and observe the patient in relation to the
possible signs of overheating.

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6.11 - Bilitron Bed TM 4006 Phototherapy Operation

Select the Bilitron Bed TM 4006 menu. At the top of the menu, the time is displayed.
BILITRON of the phototherapy treatment done so far and total time of use of the lamps
BED
(SuperLeds).
The following functions are available:

- Restart treatment time

- On / Off Bilitron Bed TM 4006

♦ Turn the Bilitron Bed TM 4006. The conditions are displayed Bilitron TM on the main screen.
While when on, the treatment time count will be displayed.

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♦ Position the newborn in phototherapy, centralized in the mattress.

♦ Keep the air intake and exhaust fins unobstructed to improve the efficiency of the system.

Attention: To avoid eye injuries, the RN will need protection


ocular.

Attention: Do not attach the Reflective arch in this type


phototherapy.

Attention: In case LED's wilt, it means that the temperature exceeded


the preset. To check if there was no lock or stop
of the fans.

7 - Preventive, Corrective and Conservation Maintenance

This section provides cleaning and maintenance instructions. Where necessary, the
disassembly instructions. Support that is not provided in that section should only be performed by
qualified technical service.

Rotineiramente, inspect the patient compartment, put back the accessories that connect to your
respective electrical outlet before putting the Heated Cradle into service.

Attention : To start a maintenance or cleaning procedure, check that the Crib


Heated it is disconnected from the electrical network.

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Attention : Be sure that the oxygen supply for the crib has turned off and that the crib
is disconnected from the oxygen supply when performing
cleaning and maintenance; the risk of fire or explosion exists when executing
cleaning and maintenance procedures or in an oxygen environment.

Attention : The heating element may be hot enough to cause


∫∫∫ Burns; avoid removing or playing the heating element until the
unit is turned off for at least 45 minutes.

7.1 - Monitor

♦ Batteries
This Monitor contains a rechargeable 9Vdc - NiCd battery for LOW POWER alarm.
This battery should be changed every 12 months of use. To change the battery, you need to turn off the
GENERAL KEY located on the side of the pole and remove the monitor from the pole. To remove the monitor,
you must loosen the six screws on the panel at the back of the column where you will have access to the panel
of the monitor and its fixing clips. Drop the monitor at the front of the column next to these
fixing clips.

The battery housing is at the rear of the monitor on a platform above the screen. Remove the
battery from your door and make the substitution. The battery connector is polarized, eliminating the risk
of inadvertent connections.

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Attention: Danger of explosion. Do not use ordinary or alkaline battery. Use only rechargeable
FANEM TM - Ref .: 092.100.026.

Attention: The disposal of batteries must be done according to the legislation in force in the country.

♦ Calibration
Temperature calibration should be verified every 6 months of use.
This procedure must be done by technicians accredited by FANEM TM . The procedure should be
made in accordance with internal standards.

7.2 - Substitution of Super LED for BILITRON TM 3006 and BILITRON BED TM 4006 Phototherapies

Attention: Contact our ATN or FANEM TM authorized service , to


have a trained technician.

Attention: Never replace parts or parts with the appliance switched on at the plug.

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Attention: Total irradiance for Bilirubin-Ebi = 36 µW / cm 2 .


Radiation sources should be replaced whenever they achieve a loss
25% of its total irradiance for bilirubin-Ebi. The typical value of the
irradiation for Phototherapy BILITRON BED TM 4006 is on the order of
36µW / cm2nm.

Attention: It is recommended to use the FANEM Radiation Monitor Mod. 2620 to confirm the
Perfect radiation conditions from phototherapy sources periodically.
It is still recommended, always check if the Super Leds are dark or
oscillating, therefore in that case they should be changed immediately,
to always allow proper treatment.
Use only original FANEM TM parts , as they guarantee proper radiance
and temperatures within specified levels.

7.3 - Protection Fuses

To replace the equipment protection fuses, it must be entered as follows:


♦ Remove the plug from the mains power cable.
♦ Certify that the equipment and its accessories are without power.
♦ With the help of a screwdriver, tighten and turn the door-fuse face to the left.
♦ The door-fuse cover will be disconnected and the fuse will be attached to this cover.
♦ Proceed to replace the defective fuse with a new fuse, according to its specification
electric and to lift the set.

Application Fuse
Network 127V ~ 10A - Type F (3 cm)

220 / 240V ~ network 5A - Type F (3 cm)

7.4 - Cleaning and Conservation

It is recommended when the initial reception of the equipment and whenever the crib is out of use,
or when a newborn is removed from the unit, medical discharge or still, according to certain procedures
of the Hospital Infection Control Commission - CCIH. Do the cleaning procedure followed
by the crib disinfection protocol. Clean carefully, using soft cloth and
moistened with water and neutral soap or, only, disinfectant that does not contain agents that damage the parts

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acrylic, general metal parts and paint.

Attention: Do not use disinfectants containing alcohol and / or abrasive, or hypochlorite of


sodium, in the acrylic parts (bed protectors) and in the parts of
polyurethane (ICU bed and intermediate shelf), because these products
these materials can deteriorate. It is recommended that users do not use
decontamination or cleaning methods different from those recommended
by the manufacturer without prior consultation regarding possible damage
caused by the proposed methods.

Shelves and BILITRON TM 3006 Phototherapy can be removed for cleaning and asepsis, being quite
for this move them up, see chapter 3 of this manual.

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7.4.1 - Cleaning of Phototherapy BILITRON BED TM 4006
Always keep the mattress, patient bed and acrylic sheet clean. For cleaning
use a soft cloth with warm water.

Do not use chemicals or alcohol to do this cleaning.

Constantly check the condition of the mattress, and that it does not present perforations
undesirable.

7.4.2 - Bottle for Secretions - Sterilization

The bottle of secretions can be sterilized by the disinfection process with peracetic acid, or
through autoclave process , or still by Ethylene Oxide and low temperature steam
for formaldehyde (low temperature sterilization process), and health institutions
who use the STERRAD ® Plasma of Peroxide must validate the referred process.

1- Autoclave Sterilization Procedure:

Firstly for the sterilization of the bottle, a manual cleaning of the bottle should be done to
secretions with the enzymatic detergent, with subsequent rinsing in running water . For
wrap the bottle, use surgical grade paper or crepe or SMS paper. The bottle for secretions
must be sterilized with the following parameters:

Temperature 121 o C for 20 minutes - Clothes Cycle

Attention: Never exceed the maximum temperature of 121º C to proceed the


sterilization. Validate your autoclave for the desired temperatures.

Using surgical grade paper packaging and plastic film, it will be checked internally on the
correct positioning of the bottle to the packaging. This should be with the nozzle for the paper side
permeable, not of the plastic film, avoiding the obstruction of the nozzle and the internal pressure in the
jar.

Remove the autoclave package and store for 30 days.

Attention: Do not sterilize the secretion bottle with the cap attached.

2- Disinfection Procedure in Peracetic Acid:


- Receive the bottle for secretions from the Neonatal Intensive Treatment Unit, disassemble and
wash with enzymatic detergent.
- Remove excess product with water.
- Make a new rinse with water and dry.
- Dive the bottle into the container containing the peracetic acid – STERILIFETM, and leave it
for 10 minutes.
- Remove the bottle from the solution and rinse in sterile distilled water.
- Condition appropriately.

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For your comfort and safety, we recommend having at least 2 spare units.
In this way you can have one unit at work, another in sterilization and another stored.

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STERRAD TM - Johnson & Johnson Trademark
STERILIFE TM - Registered Trademark Lifemed

7.4.3 - Cleaning the Patient Sensor

Being considered that the Sensor Patient comes into direct contact with the RN, it is necessary
disinfection at each patient change. For this an Alcohol 70% should be used together with a
surgical pad or cotton pad, proceeding scrubbing the whole in a way
careful not to damage the sensor.

Attention: Do not immerse the sensor in the disinfection solution.

7.5 - Maintenance Chart

Piece Term Performer


Quartz Resistance 12 months (substitution) Technical

Rechargeable battery 12 months (substitution) Technical

Auxiliary Lighting Lamp 12 months (verification) User / Technician

Trendelenburg Performance Ensemble 12 months (verification) Technical

Routine Calibration 4 to 6 months Technical

Ducts and Hoses 5 years (substitution) Technical

Cleaning and Disinfection of the Vacuum Assembly The patient's every troca User

7.6 - Disposal
If the need for disposal of the equipment exists, or parts, and they do not have a defined destination
by the customer, the item must be sent to the manufacturer or its legal representative, with paid freight, for
disposition provisions due, according to the national legislation in force.

Attention: The disposal of batteries must be done according to the legislation in force in the country.

Obs: The equipment and / or its parts must be sent in clean and aseptic conditions.
Failure to comply with these conditions exempts the provider from responsibilities regarding possible
impacts to the environment and / or people.

7.7 - Auto Check-Up Operation and Alarm Tests

When we turn on the monitor we have visual and sound indications of the LED LACK OF
ENERGY. This check-up is automatically done so that you can be aware of any
damaged screen or LED, as well as the audible alarm.

Attention: When you turn on the monitor, the LOW TEMPERATURE audible alarm
it will be inhibited for 15 minutes.

Attention: When pressing the INHIBIT SOUND button, the respective audible alarm (s) will be
they will be inhibited for 15 minutes.

The procedures below describe verification tests of alarms that can be performed by
the user.

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System alarms

♦ Lack of Energy

For systems that do not have the transport module (optional item), disconnect the
Mains power supply with the system switched on. The alarm will be immediately signaled in
the panel by red LED of lack of energy and by a high and continuous sound signal.

For systems with the transport module, disconnect the transport module from the system.
(See Technical Assistance authorized by Fanem to do this). With the system turned on,
disconnect the power cable from the mains. The alarm will be immediately signaled in
the panel by LED of lack of energy and by a high and continuous sound signal.

♦ Alarm of Permanence in 100% of Heating Power

Skin Mode Operation: With the T1 skin sensor held at a constant temperature, adjust the
skin set point at least for a temperature 1.1 ° C above temperature T1, of
so that the heating power stays at 100%. After 15 minutes the alarm should
act, with the interruption of the radiant heat (power bar at 0%), visual indication on the
Information and Alarms section and intermittent sound signal.

Operation in Manual Mode: set the heating power to 100%. After 15 minutes,
the alarm must act, with interruption of the radiant heat power bar (power bar
at 0%), visual indication in the Information and Alarms section and intermittent sound signal.

♦ Alarm of 15 minutes of permanence in Manual Mode

With the system set for Manual mode, adjust the heating power to a value below
100%. After 15 minutes the alarm must act, with visual indication in the section
Information and Alarms and intermittent sound signal.

♦ Low Load Alarm Transport Batteries

With the system switched on and disconnected from the electricity grid, wait for the transport batteries to
discharge until their voltage drops to 11.3 V. The alarm will act, with the visual indication on the
Information and Alarms section and intermittent sound signal.

Attention: after the test, leave the system connected to the electrical network to recharge the
batteries.

Skin Mode Alarms

♦ High Skin Temperature

With the system in Skin Mode, to adjust the skin set point for at least 1ºC
below the temperature of the skin sensor T1. The alarm should act immediately, with indication
visual in the Information and Alarms section and intermittent sound signal.

♦ Low Skin Temperature

With the system in Skin Mode, adjust the skin set point to at least 1C above
temperature sensor of skin T1. The alarm should act immediately, with visual indication
in the Information and Alarms section and intermittent sound signal.

♦ Lack of T1 Skin Sensor

With the system set for Skin Mode, disconnect the skin sensor T1 from the panel. The alarm should
act immediately, with visual indication in the Information and Alarms section and audible signal
intermittent.

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♦ Evicted Skin Sensor

With the system operating in Skin Mode, keep the T1 skin sensor pressed against the
behind your hand until the temperature stabilizes. Soon after, remove the sensor from the skin,
keeping at room temperature. When the temperature variation is detected, the alarm
will act, with the visual indication in the Information and Alarms section and intermittent sound signal.

Pulse Oximeter Alarms *

♦ High SpO2 Concentration

A Nellcor SRC-MAX pulse oximeter simulator is required to test this alarm. Adjust the
high SpO 2 concentration limit for a value below the SpO 2 concentration indicated in the
screen. The alarm should act after a time determined by the setting of SatSeconds 1
(see the Pulse Oximetry section in the Ampla TM 2085 Heated Cradle functions chapter )
the versions with colorful or monochrome LCD screen, or immediately, in the case of the version
with LED screen.

♦ Low SpO2 Concentration

A Nellcor SRC-MAX pulse oximeter simulator is required to test this alarm. Adjust the
low SpO 2 concentration limit for a value above the SpO 2 concentration on the display.
The alarm should act after a time determined by the SatSeconds 1 setting (see the
Pulse Oximetry section in the Ampla TM 2085 Heated Cradle functions chapter ) in the
versions with colorful or monochrome LCD screen, or immediately, in the case of the version
with the LED display.

♦ High BPM Level

A Nellcor SCR-MAX pulse oximeter simulator is required to test this alarm. Adjust the
High BPM level limit for a level value below BPM indicated on the screen. The alarm should
act immediately.

♦ Low BPM Level

A Nellcor SRC-MAX pulse oximeter simulator is required to test this alarm. Adjust
the low BPM level limit for a level value above BPM indicated on the display. The alarm
you must act immediately

♦ Evicted Sensor

With the pulse oximeter turned on, keep the sensor out of contact with the skin. The alarm should
act for a few seconds.

♦ Sensor Disconnected

With the pulse oximeter turned on, disconnect your sensor from the panel. The alarm must act by
few seconds.

1 SatSeconds is a registered trademark of Covidien AG.


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* Existing alarms only when there is the corresponding optional item.

Oxygen Monitor Alarms *

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♦ High O 2 Concentration

Adjust the high O 2 concentration limit to a value below the O 2 concentration indicated in
the screen. The alarm should act immediately.

♦ Low O 2 Concentration

Adjust the low O 2 concentration limit to a value above the indicated O 2 concentration
on the screen. The alarm should act immediately.

♦ Lack of Oxygen Sensor

With the oxygen monitor on, disconnect its sensor from the side panel. The alarm must act
immediately.

* Existing alarm only when there is corresponding optional item

CPAP alarms

♦ Blender alarm

With the air and oxygen flow sources from the power supply connected to the inlet of the
blender, open the flow of gases and, through the manometer of the pressure regulating valves of
Air and O 2 , regulate the inlet pressure for the 3.5 Kgf / cm2 belt.
With the connecting end of the respiratory circuit to the patient free, open the flow of the
gas (5 to 12 LPM) near the CPAP Module flushometer and see if there is an outlet in it
tip.
Disconnect one of the flow sources (Air and Oxygen) from the Blender inlet. The alarm of the
Blender should sound

FOG TM 1140 Humidifier Alarms

♦ High Temperature - “HI TEMP” (ERROR)

With water placed in the tank at the ideal level and with the Power Level of the humidifier adjusted
for 10, rest the head of the patient circuit temperature sensor on the metal part
external of the tank (since this part can reach a temperature higher than 36ºC). check
on the humidifier display the increase in the temperature of the sensor according to which the
tank is heated. When the temperature of 36ºC is reached, the alarm will act.

♦ Lack of Water in the humidifier reservoir - “ Low Level ” (ERROR)

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With the humidifier tank empty, verify the occurrence of the alarm.

♦ Lack of patient circuit temperature sensor

Disconnect the temperature sensor from the patient circuit from the humidifier. The alarm will act
immediately.

Thermal Mattress

Safety thermostat performance

The operation of the safety thermostat can be verified by means of the analysis described in
point 52.5.102 of IEC 60601-2-35 of the NBR standard.

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7.8 - Replacement Parts

For possible replacement parts, see section 3 of this manual: Parts, Parts and Accessories,
with their respective references.

To obtain diagrams, parts, components or other additional references, go directly to


Contact with FANEM LTDA. or their commercial representatives.

The function and safety of this equipment are only guaranteed if the verification services of
maintenance and repair are done by Fanem Technical Assistance or by people themselves
rated by FANEM LTDA.

FANEM LTDA does not take responsibility for future damage to the device, and the
consequences to the patient based on improper maintenance, not made by our Assistance
Technique, or when used in a change, non-original replacement parts / accessories.

The materials used in the design of parts and accessories and consumer and wear items,
seek to guarantee the perfect operation of the equipment according to its characteristics
originals, as well as safety with regard to the toxicity, flammability and biocompatibility of the
Materials employed.

Attention: Use only original FANEM TM parts .

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7.9 - Fault Diagnosis of the Heated Cradle AMPLA TM 2085 with LCD Screen Monitor

Symptom Possible cause Solution

The monitor does not turn on (system without


the optional Transport Module),
with the lack of power alarm.

The monitor always turns on Blown fuse. Check the fuses on the panel
battery powered mode side.
(system with the optional Module
Transportation), even being the
system connected to the electrical network.

1. Reboot the system.


Freeze frame monitor, 2. If the problem persists, do
Microprocessor failure
while not answering any contact service
principal.
order. Rotating rosette stopped. Authorized Technical Assistance
Fanem.

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Excess EMI from the electricity grid Turn unit off and on
Panel monitor with prompts hospitable. new. If the problem persists,
wrong, random and functions make contact with the service
improper Excess EMI from radiation Authorized Technical Assistance
electromagnetic. FANEM.
Does not heat by radiant heat,
Mains supply voltage
even with the indication of Check the network voltage
electrical below
normal operation in the electric 127 V or 220 V ± 10%:
specs.
monitor.

Continuous radiant heater


heating (power bar Reflector sensor failure Contact or Assistance service
other than 0%), even with the displaced. Authorized FANEM technique.
displaced reflector.
System does not accept change for
T1 skin temperature sensor Connect the temperature sensor
Skin mode, while staying
disconnected. leather T1.
in Manual Mode.
Connect the temperature sensor
Auxiliary temperature value T2 T2 skin temperature sensor Auxiliary T2.
does not appear on the monitor. disconnected or defective. If the problem persists, replace the
sensor.

The charge of the batteries


transport last little, long Contact the Assistance service
Batteries consumed.
less than 2 hours. Batteries are not Authorized Fanem technique
reload.

1. Check if the cell


oxygen connects to the side panel
of the Heated Cradle.

Calibration in 21% of the cell Disconnected oxygen cell. 2. Replace the cell
oxygen results in different value 3.If the problem persists, contact
of 21% ± 1% Saturated oxygen cell. with the Assistance service
Authorized Fanem technique for
change and full calibration of
the cell.

Bed Bilitron connector TM Check if the connector


Bilitron Bed TM not emit radiation,
disconnected or poorly connected to Bilitron Bed TM is connected to the
even with the indication of
system. Column of the Heated Cradle.
switched on.

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Some SuperLeds of Bilitron Bed TM Contact the Assistance service


Burned out SuperLeds lamps.
do not light. Authorized Fanem technique

Adjust the radiation level to


tall.
Radiation level set to "low."
SuperLeds of the Bilitron Bed TM , If the problem persists, contact
They ignite but are weak. SuperLeds lifetime
the Technical Assistance service
exceeds 10,000 hours
authorized FANEM.

The thermal mattress does not heat. Thermal mattress connector Check if the mattress connector

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Message “Thermal mattress without
sensor" disconnected or poorly connected to thermal connects in the column
the Heated Cradle.
system.

Pulse oximeter with reading Check the positioning of the


Poorly positioned sensor.
unstable. sensor

1. Reboot the system.


Pulse oximeter does not work.
Failure to communicate with the
Message "Failure in the oximeter of 2. If the problem persists, contact
oximeter module.
pulse" the Technical Assistance service
authorized Fanem

Check if the connector of the


balance connects in the column
the Heated Cradle.

Balance connection failure. Check if the weight in the bed does not
Balance weight with indication
is greater than 10 kg.
8,888 kg.
Excess weight on the bed.
If the problem persists, contact
the Technical Assistance service
authorized FANEM.

1. Check the inlet pressures


Air / O 2 in the CPAP, must be
equalized in 3,5Kgf / cm 2

Sound alarm in the Blender 2. Check pressure difference


Gas inlet line with
input must be less than
unbalanced pressure.
(CPAP module) 1.4Kgf / cm 2

3. If the problem persists, contact


with the Technical Assistance service
authorized FANEM.

1. Check the parameters of


flow adjustment.

2. Check the connections of the


circuit, close the outlet with your fingers
of the cannula and check the
Lack of Bubble in the CPAP Bottle. Pressure casting.
bubble generation.

3. Check the output for


nostrils of the RN or for the
mouth, if necessary alter the
cannula size.

Low water level signal in the


Poor contact between the bottle of Clean or dry the housing of the
Fog 1140 humidifier, same
humidifier and base. humidifier bottle.
having water in the tank.

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Fault Diagnosis of the AMPLA TM 2085 Heated Cradle with LED Display Monitor

Symptom Possible cause Solution


Check fuses on panel
Monitor does not turn on, with alarm Blown fuse.
side.
of lack of energy.

Monitor with frozen image, Microprocessor failure 1. Reboot the system.


while not answering any principal.
2. If the problem persists,
order.
contact the service
Authorized Technical Assistance
FANEM.
Panel monitor with Excess IEM (Interference Turn unit off and on
wrong, random indications and Electromagnetic) network new. If the problem persists,
improper functions. hospital electrical. contact the service
Excess of EMI due to radiation Authorized Technical Assistance
electromagnetic FANEM.

Does not heat by radiant heat, Mains supply voltage Check network voltage
even with the indication of electrical below Electric: 127V or 220V ± 10%
normal operation in the specs.
monitor.

The radiant heater continues Reflector sensor failure Contact the Assistance service
heating (power bar displaced Authorized FANEM technique.
other than 0%), even with the
displaced reflector.
System does not accept change for T1 Skin Temperature Sensor Connect the temperature sensor
Skin mode, while staying disconnected or defective. of skin. If the problem persists,
in Manual Mode. replace the sensor.

Auxiliary temperature value T2 T1 Temperature Sensor Check sensor T1.


does not appear on the monitor. disconnected or defective.
Connect the Sensor
T2 Temperature Sensor Auxiliary temperature T2.
disconnected or defective.
If the problem persists, replace the
sensor.

Check if the connector of the


Balance connection failure.
balance connects properly
in the Cradle column
Heated
Balance weight with indication
8,888kg.

Excess weight on the bed. Check if the weight in the bed


is not greater than 10 kg.

If the problem persists, contact


with the Assistance service
Authorized FANEM technique.

Obs: if the problem persists, contact the nearest FANEM Authorized Technical Assistance in your city.

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8 - Warranty and Technical Assistance

♦ Like all FANEM TM brand equipment , this also receives a full 01 (um) year warranty
against possible defects in production parts (see attached warranty term).

♦ For all types of maintenance, within or outside the guarantee, always seek Technical Assistance
authorized FANEM, do not let third parties, without appropriate technical qualification, come to damage or mark the
original characteristics of its equipment.

♦ Use only original FANEM TM parts .

♦ Registration at the Ministry of Health No. 10,224,620,067

♦ Technical support
Eng. Orlando Rossi Filho
CREA / SP 98.435 / D

♦ EC REP
Cinterqual LTDA
Av. Ressano Garcia, 39
1070-234
Lisbon Portugal

Telephone –351-21-386 90 78

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