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ORIGINAL

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Atom Transcapsule

Operation Manual

TO THE OPERATOR AND THE PERSON IN CHARGE OF


MAINTENANCE AND CARE OF THE UNIT:

• Read this Manual carefully before operating the unit.


• Keep this Manual where it is readily accessible for reference in case of
need.
EU OFFICE
Via F. Croce, 65 - 20081 Abbiategrasso (MI) - Italy
Tel: +39 02 99763101 Fax: +39 02 99763110
INTRODUCTION
This Operation Manual deals with the specifications, operation and maintenance of the V-808 Atom Transcapsule.
Atom is by no means responsible for any malfunction arising from a user ignoring the instructions for operation
and maintenance described in this Manual, as well as, for any accident attributable to repair by someone other
than technical personnel certified by Atom.
Read this Manual carefully and familiarize yourself thoroughly with its contents before operating the unit. Keep
this Manual where it is readily accessible for reference in case of need. If any technical problem should arise,
please contact your local Atom representative.

CAUTION
This product is shipped without being disinfected. Be sure to clean and disinfect the unit before
using it for the first time after purchase.

INTENDED USE

The V-808 Atom Transcapsule is a closed-type transport incubator for neonatal and premature infants and is
intended to transport low birth weight infants and seriously ill neonates.

SAFETY INFORMATION
Instructions to ensure the safe operation of the unit are found throughout this Manual. Please read the Manual
carefully before operating the unit. Please follow the instructions in operating it.

[1] Basic Instructions


1. Follow the instructions for the safe use of the unit.
Follow the operating instructions described in this Manual for the safe use of the unit.

2. Inspect the unit on a periodical basis.


Periodical inspection is needed to operate the unit under optimum conditions (See “⁄1 Maintenance Inspec-
tion” of this Manual.)

3. Never use the unit when faulty.


If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your local
Atom representative.

4. EMC
Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in this Manual.
✽ EMC stands for electromagnetic compatibility. EMC requirements specify measures against emitting and
receiving unwanted electronic interference.

−1−
[2] Definition of Warning Indication
Three levels of warning indication are used throughout this Manual and on the unit. They are defined as
follows.
A DANGER notice indicates an immediately hazardous situation which, if not
DANGER: avoided, will result in death or serious injury, serious damage to property such
as total loss of use of equipment, and a fire.

A WARNING notice indicates an indirectly (potentially) hazardous situation


WARNING: which, if not avoided, will result in death or serious injury, serious damage to
property such as total loss of use of equipment, and a fire.

A CAUTION notice indicates a hazardous situation which, if not avoided, can


CAUTION: result in minor or moderate injury, partial damage to property, and loss of data
stored in computers.

[3] Definition of Marks


1. Marks indicating caution or warning

Mark Title and Indication

General attention
Indicates unspecified general caution or warning.

Caution: Hot surface


Indicates that the surface can be dangerously hot.

2. Marks to prohibit action

Mark Title and Indication

General prohibition
Indicates unspecified general prohibition.

Prohibition of disassembly
Indicates prohibition of disassembly of the unit where it may cause an electric shock or other
hazards.
Prohibition of use of fire
Indicates prohibition of use of fire where an external use of fire may cause the unit to ignite
under certain conditions.

3. Marks indicating actions to be taken

Mark Title and Indication

General Instruction
Indicates unspecified general action on the part of the user.

Remove the power plug from the power outlet


Instructs the user to remove the power plug from the power outlet in the case of malfunction or
where lightning may occur
Connect a ground wire
Instructs the user to connect the ground wire without fail where the unit is provided with a
ground terminal.
−2−
4. Marks of international standards (IEC)

Mark Title and Indication

Equipment partially on
Indicates that a part of the device is “ON”.

Equipment partially off


Indicates that a part of the device is “OFF”.

Type BF applied part


Indicates that in terms of the degree of protection against an electric shock the device is classi-
fied as Type BF.

Alarm
Indicates a switch for setting the alarm function.

Audible alarm silenced


Indicates that an audible alarm is silenced.

Caution
Indicates that the user needs to review accompanying document before operating the unit.

Fan
Indicates a control switch that controls the fan.

Lighting
Indicates a switch that controls lighting.

Recycle mark (battery)


Indicates that recycling is recommended.

Date of manufacture
Indicates the date when the unit was manufactured in the factory.

WEEE symbol
In the EC area, an electrical and electronic product falling in one of the categories specified by
“DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27
January 2003 on Waste Electrical and Electronic Equipment (WEEE)” should be disposed of in a
manner consistent with relevant laws and regulations.
This symbol indicates that the above-mentioned requirement applies to this product.

Fuse
Indicates the fuse.

Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manufac-
turer.
Authorized representative in the European Community
This symbol indicates the name and the address shown adjacent to the symbol is of the autho-
rized representative in the European Community.

−3−
5. Other marks

Mark Title and Indication

Setting
Indicates that a setting is increased.

Setting
Indicates that a setting is decreased.

Alarm
Indicates a power failure alarm.

AC power
Indicates that the device is connected to AC power.

Battery
Indicates that the device is being powered by a battery or batteries.

Alarm
Indicates an alarm related to temperature.

External DC power source


Indicates that the unit is operating on an external DC power source.

Alarm
Indicates that an audible alarm is silenced.

Alarm
Indicates that a system of the unit is in an abnormal condition.

Alarm
Indicates that the rotation of the fan is abnormal or the fan has not been attached.

Alarm
Indicates a high temperature condition with the incubator air temperature exceeding 39˚C.

Alarm
Indicates an alarm related to a skin temperature probe or an oxygen sensor.

Battery 1
Indicates the state of Battery 1.

Battery 2
Indicates the state of Battery 2.

Oxygen
O2 Indicates a switch that controls a function related to oxygen, or the state of oxygen.

−4−
Mark Title and Indication

Increased %SpO2, pulse rate, or oxygen concentration


Indicates that %SpO2, pulse rate or oxygen concentration has risen above the upper limit.

Decreased %SpO2, pulse rate, or oxygen concentration


Indicates that %SpO2, pulse rate or oxygen concentration has dropped below the lower limit.

SpO2
Indicates a detected current SpO2 value.

Pulse rate
Indicates a detected pulse rate.

Setting
Indicates a setting value of the incubator air temperature.

Incubator air temperature


Indicates a present incubator air temperature and the connecting port of the incubator air tem-
perature sensor cable.

Heater
Indicates a heater output.

Skin temperature
Indicates the infant’s skin temperature, the connecting port of the skin temperature probe and
the connecting port of the skin temperature monitor cable.

Power switch
POWER
Indicates the power switch of the main body.

Breaker
BREAKER
Indicates the breaker of the main body.

DC power connecting port


24V12V
Indicates the DC power connecting port of the main body.

Oxygen monitor switch


Indicates the switch to turn on/off the oxygen monitor function.

Pulse synchronous beep switch


Indicates the switch to enable/disable the pulse synchronous beep.

Lock
Indicates that the locking function becomes released.

Lock
Indicates that the locking function becomes effective.

−5−
Mark Title and Indication

Lock
Indicates that the locking function becomes effective or released alternately.

Test switch
Indicates the test switch.

Button
Indicates that the button should be kept pressed for the specified period of time.

Reset indicator
Indicates the reset indicator.

Reset switch
Indicates the switch to reset.

Battery replacement
Indicates that the battery should be replaced.

Battery
Indicates the battery type, capacity and quantity.
(Lead-acid battery, 6V48Ah, 2 pieces)
Battery
Indicates the battery type, capacity and quantity.
(Lead-acid battery, 12V7.4Ah, 1 piece)

−6−
[1] Precautions on Jamming

WARNING
Electric surgical knives, portable and mobile communication equipment, and other devices which
generate high-frequency noise can cause jamming to various electric equipment for medical use
and thus result in malfunction.
Since portable and mobile communication equipment, etc. are often used in medical facilities,
some measures should be taken to prevent jamming due to such devices.
Portable and mobile communication equipment and other devices which generate high frequency
should not be used near the unit during its operation to prevent malfunction of the unit due to
jamming.

[2] Responsibility for Care of Equipment

CAUTION
It is the user (a hospital, a doctor’s office, a clinic) that is responsible for the operation, mainte-
nance and care of the electric equipment for medical use. The equipment should be used only by
medical personnel.

[3] Prohibition of Modification

WARNING

Do not disassemble or modify the unit. Otherwise a fire, an electric shock or injury may result.

[4] Periodical Inspection

CAUTION

Proper periodical inspection is needed to use the unit under optimum conditions.

[5] In Case of Trouble

CAUTION
If any abnormal condition or trouble should occur to the unit, indicate on the unit that it is out of
order and immediately contact your local Atom representative or service engineer. See this Opera-
tion Manual for where to make contact.

If any abnormal condition or trouble should occur, do not use the unit until it has been repaired
completely by a service engineer so as to prevent possible danger.

−7−
C O N T E N T S

INTRODUCTION ............................................................................................. 1
[1] Operating Precautions
1-1. DANGER .......................................................................................... 10
1-2. WARNING ........................................................................................ 12
1-3. CAUTION ........................................................................................ 14
[2] Parts Identification
2-1. Main Body .............................................................................................. 15
2-2. Main Body - Sides .................................................................................. 16
2-3. Main Body - Rear ................................................................................... 17
2-4. Main Body - Inside ................................................................................ 18
2-5. Mount ...................................................................................................... 19
2-6. Control Panel ......................................................................................... 19
[3] Setting Up the Incubator
3-1. Assembling ............................................................................................. 21
3-2. Locking the Caster ................................................................................ 22
3-3. Adjusting the Height of the Stand ........................................................ 22
3-4. Detaching/Attaching the Main Body from/to the Mount ................ 23
3-5. Where to Place the Incubator .............................................................. 24
3-6. Storing the Cylinders ............................................................................ 24
3-7. Fixing of the Incubator to a transport vehicle .................................... 25
3-8. Power Outlet and Grounding ............................................................... 25
3-9. Power Cord and Power Switch ............................................................. 26
3-10. Inspection before Use ........................................................................... 27
[4] Power Sources
4-1. AC Power ................................................................................................ 28
4-2. Internal Battery Power ......................................................................... 29
4-3. External DC Power (DC 12V/24V) ..................................................... 31
[5] Incubator Air Temperature Control and Placing the Infant in the Incubator
5-1. Setting the Incubator Air Temperature ............................................... 32
5-2. Placing the Infant in the Incubator ...................................................... 33
5-3. Skin Temperature Monitoring ............................................................. 35
[6] Pulse Oximeter
6-1. Attaching the Sensor ............................................................................. 37
6-2. Setting the Upper/Lower Alarm Limits .............................................. 39
6-3. Setting the Heartbeat Synchronous Sound ........................................ 40
[7] Oxygen Monitor
7-1. Calibration .............................................................................................. 41
7-2. Setting the Upper/Lower Alarm Limits .............................................. 42
[8] Oxygen Supply ............................................................................................. 43
[9] Other Operating Procedures
9-1. Drawing Out the Mattress Platform .................................................... 46
9-2. Arranging the cords and Tubes ........................................................... 46
9-3. Lighting Lamp ........................................................................................ 47
9-4. I.V. Pole ................................................................................................... 47
9-5. Test Switch ............................................................................................. 48
9-6. Reset Indicator/Reset Switch ............................................................... 48
[10] Cleaning, Disinfection and Maintenance ............................................... 49
[11] Maintenance Inspection ............................................................................. 54
[12] Alarms ............................................................................................................. 63
[13] Troubleshooting ........................................................................................... 67
[14] Technical Data .............................................................................................. 68
[1] Operating Precautions
Please follow the operating instructions described in this Manual for the safe use of the unit. The unit should
be operated only by those who have been trained and instructed properly in its operation. The unit should be
operated only for its intended use.

1-1. DANGER
Death or serious injury, damage to equipment or a fire will result if the instructions given below are not fol-
lowed.

Turn the lighting switch off before replacing the fluorescent lamp.
The fluorescent lamp becomes hot immediately after use. Before replacing the fluorescent lamp,
make sure that it has cooled down sufficiently.

Do not replace the fluorescent lamp with wet hands.

Be sure to keep the admittance panels and the access ports closed when
using the unit.
If an admittance panel or an access port is left open when the unit is in use, the infant may fall out of
the baby compartment. Be sure to keep the admittance panels and the access ports closed during
phototherapy when an infant is in the incubator.

Do not leave the unit unattended when an admittance panel or an access


port is open.
If an admittance panel or an access port is left open, the infant may fall out of the baby compartment and
sustain life threatening injury. Never leave the unit unattended when an admittance panel or an access
port is open.

If an admittance panel, a snap-open access port or a hook slider should be


found loose or faulty, stop using the unit immediately and ask for repair.
The infant may fall out of the unit.

Always check the admittance panel operating knobs and the hook sliders of
the snap-open access ports for proper operation. If the front admittance
panel or a snap-open access port should not close securely, do not place
any infant in the unit and ask for the problem to be corrected.

Do not open an admittance panel or an access port in order to lower the


incubator air temperature.
Because the incubator air temperature is controlled automatically at a set temperature, the heater
output will increase dangerously to make up for any temperature drop.

Open and close the snap-open access ports gently.


If you open or close them with to much force, they may not open or close properly, which is dangerous.

After the infant is placed in the incubator, check again that the admittance
panels and the access ports are all closed securely.

For the infant’s safety, never leave the incubator unattended when an admit-
tance panel or an access port is open.

− 10 −
Do not fasten the infant fixing bands too tightly.
If they are fastened too tightly, they could injure the infant.

Never place a body warmer or other possible ignition sources in or near the
unit.
Use of oxygen will increase a risk of explosion or a fire. A body warmer or other devices in which fire
is used, or which may generate a spark, may cause an explosion or a fire if used near the unit.

Do not use the unit in the presence of a flammable anesthetic gas.


The unit may experience an explosion or a fire if used in the presence of such a gas.

Do not use ether, alcohol or other ignitable substances.


Even a small amount of ether, alcohol or other ignitable substances may cause a fire when mixed
with the oxygen in the incubator.

Ground the unit securely.


Otherwise, a leakage current may cause an electric shock. In order to complete the ground connec-
tion, connect the power cord only to a 3P power outlet including a ground terminal which is grounded
properly. Do not operate the unit if you have any doubt about its ground connection.

Do not use a device generating high frequency near the unit.


To prevent malfunction of the unit due to jamming, do not use electric surgical knives, portable and
mobile communication equipment and other devices which generate high frequency near the unit
during its operation.

Analyze arterial gas levels repeatedly when a high oxygen environment is


required.
It is reported to be extremely important and essential to repeatedly analyze arterial gas levels, when
the infant’s conditions call for a high oxygen environment, in order to maintain the oxygen concen-
tration in the incubator at a desired level. Follow the doctor’s instructions in measuring the oxygen
concentration because ignoring essential requirements may increase a risk of retinopaths of prema-
turity and other adverse effects.

Do not jolt or drop the unit or allow it to be struck by other objects.


The screws or fixed parts may become loose.

Be sure to insert the power plug fully into a power outlet.


Incomplete insertion of the plug may cause heat to generate and a fire may result.

Check the power outlet regularly to make sure that it presents no abnormal-
ity.
A loose or damaged outlet can cause a poor electrical connection, which may generate heat and
result in a fire.

Keep the area around the power plug and power outlet free of dust.
Accumulated dust on the plug can cause heat to generate and may lead to a fire.

− 11 −
1-2. WARNING
Death or serious injury due to a fire or an electric shock will result if the instructions given below are not
followed.

Always keep the unit warm to maintain the incubator air temperature at a
fixed level during the standby mode.

Place the infant in the incubator only when the incubator air temperature
has stabilized.

Be sure to follow the doctor’s instructions in setting the incubator air tem-
perature.

Be sure to follow the doctor’s instructions in setting the oxygen concentra-


tion in the incubator.

Use only oxygen certified for medical use.

Be sure to bear in mind the following precautions during oxygen supply.


쎲 Do not place a body warmer, a flashlight, oils and fats, or flammable vaporizable matters in the
incubator.
쎲 Use pure cotton for the infant’s clothing and bed sheets, etc. Do not use any material that is easily
charged with static electricity.
쎲 Use pure cotton or fire-proof materials for the clothing of doctors, nurses and those ambulance
staff who handle this unit.

Bear in mind the following precautions while using oxygen supply equip-
ment.
쎲 If oil, grease or a grease-like substance should get in contact with pressurized oxygen, a violent
spontaneous ignition may occur. Do not let such substances stick to the oxygen pressure regula-
tor, the oxygen cylinder valve, pipings, connections and other oxygen supply equipment.
쎲 On a high-pressure oxygen cylinder, use only a tested pressure reducing valve or pressure regu-
lating valve indicated specifically for oxygen supply. Do not use such a valve for any gas other than
air or oxygen. It is dangerous to use a valve to supply a gas other than air or oxygen first and then
to supply oxygen again.

The electrolyte may leak out if the oxygen sensor should be damaged. If
you should come in contact with the electrolyte, wash the site immediately
and thoroughly with copious amounts of water.

Smoking is prohibited in the room where the unit is installed. Do not place
any possible ignition sources in the room.

Avoid damaging the power cord.


A damaged power cord may cause a fire or an electric shock.
쎲Do not pinch the power cord between the unit and the wall, a shelf or the floor.
쎲Do not place the power cord near a heating apparatus or heat it.
쎲Do not put anything heavy on the power cord.
쎲Always grasp the power plug with your hand to remove the power cord from the power outlet.
A damaged power cord should be replaced immediately with a new one.

− 12 −
Use only the power cord supplied with the unit.
Otherwise a fire or an electric shock may result.

Before sanitizing the unit, be sure to turn off the unit, remove the power
plug and check that the unit and the heater have sufficiently cooled down.

Do not touch the power plug with a wet hand.


Touching the power plug with a wet hand may cause an electric shock.

Do not disassemble or modify the unit.


Disassembling or modifying the unit may cause a fire, an electric shock or injury.

Do not install the unit where it will be exposed to excessive humidity, dust
or steam.
Installing the unit in such a place may cause a fire or an electric shock.

The power outlet should be located near the unit to prevent accidental con-
tact with a trailing power cord. Use a separate power outlet for each unit.

Do not put many loads on one power outlet.

In order to complete the ground connection, connect the power cord only to
a 3P power outlet including a ground terminal which is properly grounded.

Do not operate the unit if you have any doubt about its ground connection.

Ground peripheral electric equipment securely.

Never connect the unit to a power source other than that specified.

The unit should be serviced only by qualified personnel.

Be sure to inspect the unit before starting a day’s work.


Operating the unit without inspecting it before starting a day’s work may let a defect pass unnoticed
and cause a serious accident.

− 13 −
1-3. CAUTION
Injury or damage to nearby objects may result if the instructions given below are not followed.

If the unit has been kept disconnected from the electrical outlet for a long
period of time (for about 3 months), the internal battery will be left in a dis-
charged condition. Turn the power switch to the ON position. If the charge
level indicator of battery 1 or 2 does not come on, plug the power cord in the
electical outlet to charge the battery.

Be sure to clean and disinfect the unit before using it for the first time after
purchase.
The unit is shipped without being disinfected.

When inserting a cord or a tube into the unit, be careful not to let it wind
around or squeeze the infant inside.

Do not twist or pull the cords by force.


If any defect should be found, ask an expert for repair without attempting to repair it yourself.

Remove the power plug from the power outlet before moving the unit to
another place or when the unit is not going to be used for a long time.
Moving the unit to another place with the power plug connected to the power outlet will damage the
power cord and may cause a fire or an electric shock.

Remove the power plug from the power outlet before cleaning or disinfect-
ing the unit.
Cleaning or disinfecting the unit with the power plug connected to the power outlet may cause an
electric shock.

Place the unit on a stable surface.


Placing the unit on an unstable platform or a tilted surface will cause it to fall or drop and may hurt
someone. Check the strength and stability of the place where the unit is to be placed or installed.

Install the unit out of reach of small children.

Do not install the unit in direct sunshine or near a heating apparatus.

Do not place anything heavy on the unit.

Check the operation of the peripheral devices.


If a device transmitting of receiving weak signals is installed near the unit, it may be affected by the
electromagnetic waves generated by the latter. Check the operation of peripheral devices for any
effect before using the unit in clinical settings. Stop using the unit immediately if any trouble is
detected.

− 14 −
[2] Parts Identification
2-1. Main Body

y
w

u
i
e

r
o

!0 !2

!1

!3

!4

쎲 Main body 쎲 Mount

No. Name No. Name


q Lighting lamp !0 Main body locking device
w Front admittance panel !1 Mount
e Snap-open access port
쎲 Stand
r Control panel
t I.V. pole No. Name
y Head-end admittance panel !2 Operating lever
u Iris access port !3 Gas spring
i Tube introduction slit packing !4 Caster
o Hood fixing device

− 15 −
2-2. Main Body - Sides

쐽 Right side

y
u

q w e

쐽 Left side

i o !0 !1

No. Name No. Name


q Power switch u DC power breaker (for 12V)
w AC power input i Test switch
e External power input (24V/12V) o Oxygen sensor connecting port
r Oxygen supply port !0 Connector for SpO2
t AC power breaker !1 Skin temperature probe connecting port
y DC power breaker (for 24V)

− 16 −
2-3. Main Body - Rear

w e r t y

No. Name
q Oxygen sensor module
w Main board box
e Fuse (for Battery 1)
r Reset indicator
t Reset switch
y Battery 1

− 17 −
2-4. Main Body - Inside

y
u i

!0 o

!1

!2

!3

No. Name No. Name


q Mattress i Incubator air temperature sensor
w Mattress platform o Conditioning chamber
e Middle deck !0 Heater
r Middle deck packing !1 Connector (on the main body)
t Fan cover !2 Connector (on the mount)
y Fan fixing screw !3 Mount
u Fan

− 18 −
2-5. Mount

r q w e r t y u

No. Name
q Battery cover
w Connector (on the mount)
e Mount switch
r Main body locking device
t Fuse (for Battery 2)
y Reset indicator
u Reset switch

2-6. Control Panel


@1 @2 @3 @4 @5 !4 !5 !7 !6 q w e r t y u i @9 @8 #1 #2 #3

@6 @7 !8 !9 @0 o !0 !1 !2 !3 #0 #4

No. Name No. Name


q High temperature alarm indicator t Set point alarm indicator
Comes on when a detected incubator air tempera- Comes on when a detected incubator air tempera-
ture is too high. ture deviates from the set point by at least 앐3˚C.
w Alarm silence indicator y Power failure alarm indicator
Comes on when an audible alarm is silenced. Comes on when power supply has stopped.
e Skin temperature probe alarm indicator u System failure alarm indicator
Comes on when a skin temperature probe is faulty. 앫 Comes on when an incubator air temperature
r Fan alarm indicator sensor is faulty.
앫 Comes on when the rotation of the fan is faulty. 앫 Comes on when power supply to the heater can-
앫 Comes on when the fan or the fan cover is not not be controlled.
attached properly.
− 19 −
No. Name No. Name
i Incubator air temperature display @4 %SpO2 display
앫 Displays a detected incubator air temperature digitally. 앫 Displays a detected %SpO2 digitally.
앫 Flashes during a set point alarm. 앫 Remains blank when an SpO2 sensor has not
o Skin temperature display been connected yet or when the SpO2 function
앫 Displays a detected skin temperature digitally. is not provided.
앫 Flashes when a skin temperature probe is faulty. 앫 Displays a flashing “ ” when an SpO2 sen-
앫 Remains blank when a skin temperature probe sor has become disconnected.
has not been connected yet. Displays “ ” with “ ” flashing when an SpO2
!0 Set temperature display sensor has become detached.
Displays a set temperature digitally. 앫 Displays an alarm setting when an SpO2 alarm
!1 Incubator air temperature selector switch limit is being set.
Used to set an incubator air temperature. @5 Pulse rate display
!2 Heater output indicator 앫 Displays a detected pulse rate digitally.
Displays a heat output level of the main heater in 앫 Remains blank when an SpO2 sensor has not
ten grades. been connected yet or when the SpO2 function
!3 Setting switch / is not provided.
Used to set a desired incubator temperature. Also 앫 Displays a flashing “ ” when an SpO2 sen-
used to set SpO2/pulse rate/oxygen concentration sor has become disconnected.
alarm limits to a desired level. Displays “ ” with “ ” flashing when an SpO2
!4 Oxygen concentration alarm indicator sensor has become detached.
앫 Flashes when a detected oxygen concentration 앫 Displays an alarm setting when a pulse rate alarm
violates the upper or lower alarm limit. limit is being set.
앫 Comes on when an upper or lower alarm limit 앫 Displays a setting when a heartbeat synchronous
for oxygen concentration is being set. sound is being set.
!5 Oxygen sensor indicator 0: Synchronous sound OFF
앫 Comes on when an oxygen sensor could not be 1: Synchronous sound ON
calibrated. @6 Heartbeat synchronous sound switch
앫 Comes on when an oxygen sensor has come off Switches on/off the heartbeat synchronous sound.
during oxygen monitoring. @7 Alarm limit selector switch
!6 Oxygen concentration display Used to set SpO2 pulse rate alarm limits.
앫 Displays a detected oxygen concentration digitally. @8 Battery 1 charge level indicator
앫 Remains blank when the oxygen monitor mode is OFF. 앫 Displays a charge level of Battery 1 in ten grades.
앫 Displays an alarm setting when an oxygen alarm 앫 Flashes when charging is faulty.
limit is being set. @9 Battery 2 charge level indicator
!7 Oxygen concentration alarm indicator 앫 Displays a charge level of Battery 2 in ten grades.
Comes on when a detected oxygen concentration 앫 Flashes when charging is faulty.
violates the alarm settings. 앫 Remains blank when the unit is in use with the
!8 O2 switch mount removed.
Used to set oxygen concentration alarm limits. #0 Alarm silence/reset switch
!9 Calibration indicator Silences an audible alarm or resets an alarm con-
Flashes when an oxygen sensor is being calibrated. dition.
@0 Oxygen monitor switch #1 AC power indicator
Switches on/off the oxygen monitor function. Comes on when the unit is connected to AC power.
@1 Plethysmograph indicator #2 Battery power indicator
Indicates changes in an arterial flow on a bar graph. Comes on when the unit is powered by its internal
@2 SpO2 alarm indicator batteries (Battery 1 and/or Battery 2)
앫 Flashes when a detected SpO2 violates the up- #3 External power indicator
per or lower alarm limit. Comes on when the unit is powered by its exter-
앫 Comes on when an upper or lower alarm limit nal power source.
for SpO2 is being set. #4 Lighting switch
@3 Pulse rate alarm indicator Switches on /off the lighting lamp.
앫 Flashes when a detected pulse rate violates the
upper or lower alarm limit.
앫 Comes on when an upper or lower alarm limit
for pulse rate is being set.

− 20 −
[3] Setting Up the Incubator
3-1. Assembling
The main body of the incubator with the mount attached and the stand are separately packed and shipped from
the factory. Assemble the separate components correctly as instructed below.

CAUTION

The incubator is heavy. At least two able people are required to assemble or move the incubator.

The main body is shipped with the mount attached.

(1) Hang the hook of the mount fixing lever on the right Frame
side of the stand on the frame of the stand by pulling
it slightly toward you. This unlocks the connection
between the stand and the mount.
(2) Place the main body on the stand in such a way that
the front side of the main body and the front side of
Mount fixing lever
stand may face in the same direction.
The two pins on the top surface of the stand (near
To unlock
left and far right) should fit into the corresponding
holes in the bottom of the mount. This allows the
Frame
mount and the stand to be assembled without any
gap between them or tilting.
(3) Remove the hook of the mount fixing lever from the
frame of the stand and let it hang down. Now the
mount with the main body on it and the stand are
locked together. Mount fixing lever

To lock
WARNING
Be sure to lock the incubator with the mount
attached to the stand by removing the mount
fixing lever from the frame of the stand. Oth-
erwise the incubator may tip over when force
is applied to open the hood, or it may fall
down if jolted or dropped during transport.
Never operate the incubator before the in-
cubator is locked securely to the stand.

− 21 −
3-2. Locking the Caster

(1) When the incubator is installed in a desired place,


step on the stoppers on two casters of the stand to To lock
lock them in place.
(2) To move the incubator to another place, unlock the
casters.

CAUTION
Install the incubator on a horizontal and
steady surface. Step-on the stoppers to lock
the casters securely.
To move the incubator to another place, be To unlock
sure to unlock the casters.

3-3. Adjusting the Height of the Stand


The height of the stand is adjustable. Follow the instructions below to adjust the height.
(1) Check that the incubator is locked securely to the
stand by the mount fixing lever.
(2) While holding the upper frame with your hands, Upper frame
grasp the operating lever and move the frame up or
down. Release the lever when a desired height is
achieved, and the stand will be locked at that height.

Operating lever
CAUTION
The stand is provided with a spring for eleva-
tion. Therefore, be sure to adjust the height
of the stand with the incubator fixed to the
stand. For safety’s sake, two people should
cooperate in performing this procedure. Be
very careful in using the operating lever with-
out the incubator on the stand because the
stand may rise up suddenly.

− 22 −
3-4. Detaching/Attaching the Main Body from/to the Mount
The main body of the incubator is delivered to the customer with the mount attached. However, the main body
can be detached from the mount and used separately.
(1) To unlock, pull up the lever of the main body locking
device on each side of the incubator.

Lever

(2) To detach, hold the handles of the main body with


an associate and join forces to pull up the main body
simultaneously.

(3) To attach the main body to the mount again, hold


the main body over the mount in such a way that the
front side of the main body and the front side of the
mount face in the same direction. Put down the main
body onto the main body locking devices. Connector

FR
ON
T

“FRONT” mark

(4) To lock, push down the lever of the main body lock-
ing device on either side of the incubator.

Lever
WARNING
When the main body is placed on the mount,
be sure to lock them together. Otherwise
the main body may tip over when force is
applied to open the hood, or it may fall down
when a shock is given during transport.

− 23 −
3-5. Where to Place the Incubator
Except during transport, place the incubator on a horizontal surface convenient for work. Avoid placing it near
a heating apparatus, by the window or where fire is used.

CAUTION
Avoid placing the incubator in direct sunshine, near a stove or a radiator, in the current of an air-
conditioner, or by a cold window so that it may not be affected directly by such external thermal
conditions.

3-6. Storing the Cylinders


Two oxygen or air cylinders can be stored in the stand.
(1) Slide the cylinders through the cylinder holder for
storage. The cylinders can be stored from either side.

Cylinder

Cylinder holder

(2) Attach the cylinders with the cylinder fixing screw.

CAUTION
After storing the cylinders, be sure to attach
them securely with the cylinder fixing screw.
Cylinder holder

Cylinder fixing screw

− 24 −
3-7. Fixing of the Incubator to a transport vehicle
Fixation of the unit to a transport vehicle such as an ambulance, varies with the type of transportation means.
Consult with the manufacturer and the institutions concerned or refer national norms about this.
(1) The unit should be fixed securely to the transport vehicle.
(2) The peripheral devices associated with the unit should be removed from the unit and individually fixed to
the transport vehicle.
(3) To securely fix the unit to the transport vehicle, use the handles of the main body.

WARNING
Lock the main body of the incubator and the mount together securely with the main body locking
device on the left and right sides of the unit.

For secure fixation of the unit, any external parts of the unit should not be used as connection
points between the unit and the transport vehicle other than the handles of the main body.

Make sure that the unit is securely fixed to the transport vehicle, or personal injury and/or equip-
ment damage may result.

Note : The main body and the mount conform to IEC 13976-1 : 2003, IEC 13976-2 : 2003, CS-27(CS-27,561) :
2003 and EN 1789(6.3.5, 6.4.1) : 2003, however the stand(manufactured by Atom Medical Corp.) is not in
conformity with those standards.

3-8. Power Outlet and Grounding

WARNING
The power outlet should be located near the unit to prevent accidental contact with a trailing
power cord. Use a separate power outlet for each unit.

Do not put many loads on one power outlet.

In order to complete the ground connection, connect the power cord only to a 3P power outlet
including a ground terminal which is properly grounded.

Do not operate the unit if you have any doubt about its ground connection.

Ground peripheral electric equipment securely.

The unit should be serviced only by qualified personnel.

− 25 −
3-9. Power Cord and Power Switch

(1) Connect the power cord to the connector of the power


Power switch
source on the side panel of the main body. Then con-
nect the power plug on the other end of the power
cord to the power outlet.
(2) Turn on the power switch.

쐽 Memory function
If power supply should be interrupted, the preselected
settings and the items to be displayed will be retained in
the memory, so that it is not necessary to set them anew
when power returns. When the power switch is turned
on, the last selected settings and display items will be dis-
played.

쐽 How to reset the circuit breaker (for AC power and DC power)


If an overcurrent condition should occur during the operation of the unit, the circuit breaker of the unit will be
tripped to prevent possible accidents. To reset the breaker, take the following steps:
(1) Turn off the power switch. Normal position

(2) Allow at least one minute after the breaker was


tripped, and then depress the breaker pushbutton to
reset it to the “Normal” position. Tripped
position
(3) Turn on the power switch.
If the circuit breaker should be tripped again, con-
tact your local Atom representative.

CAUTION
To prevent a malfunction, allow at least one minute or so after the activation of the circuit breaker
before pressing the breaker pushbutton.

− 26 −
쐽 How to replace the fuse (for Battery 1 and Battery 2)
If any faulty condition should occur to the circuit, the fuse will burn out to shut off the battery power in order
to prevent possible accidents. To replace the fuse, take the following steps:
(1) Turn off the power switch. [For Battery 1 (Main body-Rear)]
(2) Remove the power cord from the AC power source.
Fuse✽
(3) Turn the fuse holder counterclockwise while press- (for Battery 1)
ing it and remove the fuse holder. Reset indicator

(4) Replace the burnt fuse with a new one from the spare Reset switch
fuse holder.
(5) After replacing the fuse, turn the fuse holder clock-
[For Battery 2 (Mount-right side)]
wise while pressing it and attach the fuse holder as
before. Fuse✽
(6) Press the reset switch to make sure that the reset (for Battery 2)
indicator goes off. Reset indicator
(7) Connect the power cord to the AC power source to Reset switch
charge the batteries.
✽) Fuse type: 312025

3-10.Inspection before Use


Before using the unit, inspect it carefully for any trouble, dirt, missing parts or defective parts to make sure
that it can be operated safely.

WARNING
Be sure to inspect the unit before using it. Operating the unit without inspecting it before use
may let a defect pass unnoticed and cause a serious accident.

DANGER
Always check the admittance panel operating knobs and the hook sliders of the snap-open
access ports for proper operation. If the front admittance panel or a snap-open access port do
not close securely, do not place any infant in the unit, and ask for repair.

− 27 −
[4] Power Sources
This incubator is powered by the AC power source, the internal batteries (DC 12V) or the external DC power
source (DC 12V/24V).

CAUTION
If the power cord is not connected to the power outlet or if the AC power source and the external
DC power source (DC 12V/24V) is shut off, the unit will automatically switch to its internal battery
power.

4-1. AC Power

(1) Connect the power cord to the connector of the power Power cord
source on the right side panel of the main body.
Connect the power plug on the other end of the power
cord to the power outlet. The AC power indicator
adjacent to “ ” will come on and the internal bat-
tery will be charged automatically.

AC power indicator

(2) Turn the power switch on ( side). Power will be Power switch
supplied to the unit and the unit will start operation.

CAUTION
At least five seconds must elapse before
power is applied again.

− 28 −
4-2. Internal Battery Power

CAUTION
The internal batteries will be worn out gradually while the incubator is powered by them. Use the
internal battery or batteries only when the AC power source or the external DC power source (DC
24V/12V) cannot be used. Use the AC power source whenever possible.

If the unit has been kept disconnected from the electrical outlet for a long period of time (for about
3 months), the internal battery will be left in a discharged condition. Turn the power switch to the
ON position. If the charge level indicator of battery 1 or 2 does not come on, plug the power cord in
the electical outlet to charge the battery.

The main body of this incubator can be detached from the mount and used independently. The main body and
the mount each have a built-in battery of different capacity.
앫 Battery 1 : in the main body
앫 Battery 2 : in the mount

쎲 When the main body is detached from the mount and used independently
Battery 1 in the main body supplies power. A fully charged battery (over 6 hours’ charging) enables approx.
15 minutes’ continuous operation with the ambient air temperature at 15˚C and the incubator air tempera-
ture stable at 36˚C.

쎲 When the main body is attached to the mount


Battery 2 in the mount supplies power first. When the battery 2 charge level has decreased so much that
only three of ten divisions on the indicator remain on, Battery 1 also begins to supply power. Fully charged
batteries (over 8 hours’ charging) enable approx. 90 minutes continuous operation with the ambient air
temperature at 15˚C and the incubator air temperature stable at 36˚C.
(1) Make sure that the unit is connected neither to the
AC power source nor to the external DC power
source (DC12V/24V).
(2) Turn the power switch on ( side). The batter y
Power switch
power indicator adjacent to “ ” will come on, power
will be supplied to the unit and the unit will start op-
eration.

Battery power indicator

− 29 −
쐽 Checking the battery charge level
Battery 1 charge level indicator and Battery 2 charge level indicator show the charge level of Battery1 and
Batter y 2 respectively on a bar consisting of ten divisions “ ” (charge level indicator). As a
battery discharges, the number of turned-on divisions decreases.

Charge level indicator Operation

All divisions are on. Fully charged

Only 3 divisions Connect to the AC power


(in the red zone) are on. source and start charging.

쐽 Precautions in using a battery


General precautions in using an internal battery are given below. They may not apply to all cases because
the condition of a battery depends on how it is used and stored.

WARNING
Do not throw a used battery into a fire or apply heat to a battery. The battery may generate heat,
explode or catch fire.

Do not immerse a battery in a fluid or get it wet. The battery may generate heat, explode or catch
fire.

Do not step on a battery or give a strong jolt to a battery by dropping it, etc.

Do not disassemble or modify a battery. Its safety mechanism or protective device may break
and the battery may generate heat, explode or catch fire.

Do not leave or charge the battery near a fire or under a hot sun.

A battery contains dilute sulfuric acid. If it should leak out of the battery and come in contact with
skin or clothes, wash it away immediately with copious amounts of water. If it should get in the
eye, flush the eye with copious of amounts of tap water or other clean water and contact a
physician immediately. If dilute sulfuric acid comes in contact with your skin or eyes, burns may
occur, as well as, loss of eyesight.

The charge level of an internal battery will decrease due to spontaneous discharge during trans-
port or storage. Be sure to fully charge the battery before using it for the first time.

In order to keep an internal battery ready for use, connect the power cord to the AC power
source whenever possible and charge the battery.

The charge level of an internal battery will decrease due to spontaneous discharge when it is
only kept in storage for a long time. Charge the battery periodically (once a month or so) even
during storage.

Be sure to charge an internal battery after use regardless of the length of operation on the
battery. Leaving the battery uncharged will affect its performance adversely and shorten its life.

− 30 −
4-3. External DC Power (DC 12V/24V)

CAUTION
Use only an external DC power source which meets the requirements of the international stan-
dards IEC60601-1 and IEC60601-1-2 or which is its equivalent in performance and safety.

Make sure that the external DC power source can supply the rated voltage and current.

Before connecting the unit to the external DC power source, remove the AC power cord from the
power outlet.

쐽 Requirements of the external DC power source


Use only the external DC power source that meets the requirements shown below. Otherwise the unit may
not operate.

DC12V DC24V
DC voltage range 11.0 ~ 14.5V 22.0 ~ 26.0V
Max. DC 20A 10A
Transient voltage fluctuation 앧5% 앧3%

쐽 Connecting the connecting cord to the external DC power source


(1) Connect the connecting cord (option) to the exter-
nal power input on the right side of the main body. External power input

Turn the ring on the connecting cord for secure con-


nection. Connecting cord

Ring

(2) Turn the power switch on ( side). The external Power switch
power indicator will come one, power will be sup-
plied to the unit and the unit will start operation.
(3) To stop the operation on external DC power, turn
the power switch off and remove the connecting cord
from the external power input.
(4) When external DC power is not used, keep a cap on
the external power input.

Even if the unit is connected to the external DC power


External power indicator
source, neither Battery1 nor Battery 2 will be charged.
✽ If the unit is connected to the external DC power source
and the AC power source at the same time, AC power
will take precedence.

− 31 −
[5] Incubator Air Temperature Control and Placing the Infant in the Incubator
5-1. Setting the Incubator Air Temperature
Practice and master the operation procedure before placing the infant in the incubator. Conduct temperature
tests with the unit empty in order to make sure that it operates normally.

WARNING

Be sure to follow the doctor’s instructions in setting the incubator air temperature.

CAUTION
Practice and master the operation procedure before placing the infant in the incubator. Conduct
temperature tests with the unit empty in order to make sure that the incubator operates normally.

While the infant is in the incubator, check the heater output, the incubator air temperature, and the
oxygen concentration continuously to make sure that nothing is the matter with the infant.

Check that the air outlets are not blocked with a diaper or a gauze. If they are blocked, the tem-
perature in the incubator cannot be controlled correctly.

(1) Turn on the unit and check that the incubator air
temperature and the set temperature are displayed.
The incubator air temperature is displayed in the
range of 20.0~42.0˚C in 0.1˚C increments. “ ” will
be displayed if it is 19.9˚C or lower; “ ” will be
displayed if it is 42.1˚Cor higher.
The set temperature can be selected in the range of
23.0~38.0˚C in 0.1˚C increments.

(2) To set or change the incubator air temperature, press


the switch for about one second.
While the set temperature is flashing, press an ap-
propriate setting switch ( or )to set the
incubator air temperature to a desired level.

WARNING
Be sure to follow the doctor’s instructions in
setting the incubator air temperature.

− 32 −
(3) Allow about 30-40 minutes for the incubator air tem-
perature to stabilize (depending on the ambient tem-
perature).
The incubator air temperature is regarded as stabi-
lized when the incubator air temperature reading is
equal or close to the set temperature.

쐽 Heater output indicator


The heater output indicator indicates the amount of
heat supply required to maintain the incubator air tem-
perature at the preselected level. As the incubator air
temperature rises toward the set temperature, the heat
supply decreases, and with it the output level shown
on the heater output indicator also decreases gradu-
ally from 100. When the incubator air temperature has
reached the set temperature, the reading on the indi-
cator remains within the balanced heat supply range.
Thus the heater output indicator helps grasp the
changes in incubator air temperature control.

5-2. Placing the Infant in the Incubator

WARNING

Place the infant in the incubator only when the incubator air temperature has stabilized.

(1) Turn the front admittance panel operating knobs and To close
fold down the front admittance panel gently toward
To close
you.
To open

Left side To open

Front admittance Right side


panel operating knob

(2) Place the infant on the center of the mattress with


the head to the left and the legs to the right. Fix the Infant fixing band
infant securely with the infant fixing bands attached
to the mattress platform.
(3) After placing the infant, close the front admittance
panel and turn the front admittance panel operating
knobs to close the panel securely.

− 33 −
(4) A gentle touch by the elbow on a hook slider will
Hook slider
open a corresponding snap-open access port. To
close the port, push the port door until it closes com-
pletely.

DANGER
Always check the admittance panel operating knobs and the hook sliders of the snap-open
access ports for proper operation. If the front admittance panel or a snap-open access port
should not close securely, don’t place any infant in the unit, and ask for repair.

Do not open an admittance panel or an access port in order to lower the incubator air tempera-
ture. Because the incubator air temperature is controlled automatically at a set temperature, the
heater output will increase dangerously to make up for any temperature drop.

Open and close the snap-open access ports gently. If you open or close them forcefully, they
may not open or close properly, which is dangerous.

After the infant is placed in the incubator, check again that the admittance panels and the access
ports are all closed securely.

Do not leave the incubator until you have made sure that the snap-open access ports and the
front admittance panel operating knobs are locked reliably.

For the infant’s safety, never leave the incubator unattended when an admittance panel or an
access port is open.

Do not fasten the infant fixing bands too tightly. If they are fastened too tightly, they could injure
the infant.

CAUTION

Place the infant in the incubator only after the incubator air temperature has stabilized.

Opening the admittance panels or the access ports, using a sheet to cover the infant, or using an
oxygen headbox, etc. will change the air circulation pattern inside the incubator. This may affect
the thermal uniformity, the detection and control of the incubator air temperature, and the infant's
skin temperature.

Avoid opening the entire hood to place the infant in the incubator. It may cause the incubator air
temperature to fluctuate widely.

Never open the entire hood when the infant is in the incubator. Cords and tubes may damage the
infant. All procedures should be performed through the admittance panels or the access ports.

− 34 −
5-3. Skin Temperature Monitoring
To monitor the skin temperature of the infant placed in the incubator, it is necessary to attach a skin tempera-
ture probe to the infant. The skin temperature probe is to be connected to the skin temperature probe connect-
ing port on the left side panel of the main body.
The temperature detected by the skin temperature probe will be displayed on the skin temperature display.
(1) Insert the cable plug of the skin temperature probe
Skin temperature probe connecting port
firmly in the skin temperature probe connecting port
on the left side of the main body.

Skin temperatre probe

(2) Pass the skin temperature probe cable through the


tube inlet on the side of the hood into the incubator.
Tube inlet
(3) Before attaching the skin temperature probe to the
infant, clean the site of attachment with alcohol or
lukewarm water to get rid of any fetal fat or dirt.
Skin temperature
probe cable
WARNING
Do not place the skin temperature probe
under the infant. Do not use it as a rectal
probe.

CAUTION “Cover baby”

Follow the doctor’s instructions as to where


to attach the skin temperature probe to an
infant in a prone position.

(4) Attach a yellow skin temperature probe to a site be- Temperature probe
tween the navel and the xiphoid process on the Tape
infant’s abdominal median line with the “cover baby”.
The heat-sensing surface should touch the skin. Af- “Cover baby”
fix a piece of tape at short distance from the tip of Heat-sensing srface Resin

the probe and fix the probe securely to the skin. Metal
(5) The temperature detected by the skin temperature Skin
probe will be displayed on the skin temperature dis-
play. If a disposable skin temperature probe is used, Disposable Skin Temperature Probe (Yellow)

insert the plug of the connecting cable firmly into Sensor module
[Skin temperature probe
the skin temperature probe connecting port, and connecting port 1]
connect the connector on the other end of the con- Disposable Skin Temperature Disposable skin temperature
Probe (Yellow) probe connecting cable (Yellow)
necting cable to the disposable skin temperature
probe as shown in the figure on the right.
To the patient

− 35 −
(6) Allow 45 minutes after connecting the skin tempera-
ture probe for the skin temperature reading to stabi-
lize before starting skin temperature monitoring .
The skin temperature is displayed in the range of
30.0~42.0˚C in 0.1˚C increments. “ ” will be dis-
played if it is below 30.0˚C; “ ” will be displayed if
it is above 42.0˚C.

CAUTION
If the heat-sensing surface of the skin tem-
perature probe is attached inproperly to the
infant, or if it comes off, you cannot measure
the infant’s skin temperature accurately. Be
very careful in attaching the skin temperature
probe.

− 36 −
[6] Pulse Oximeter
6-1. Attaching the Sensor
The patient cable is necessary when the pulse oximeter sensor is connected to the unit. The procedure for
attaching the sensor to the patient varies with the sensor to be used. For information on how to attach the
sensor to the patient, see the instructions for use supplied with each sensor.

WARNING
Failure to handle the pulse oximeter sensor properly may result in inaccurate measurements. Moreover, it
may cause tissue necrosis due to pressure at the sensor site, skin irritation due to the adhesive, or burns.
Attach the sensor properly as instructed in this Operation Manual. Pay special attention to the following
points.

Wrap the adhesive tape for fixing the sensor in place only lightly so that the sensor may just stay
on the skin. Wrapping it too tightly will hinder the circulation of the blood and may result in no
measurements.

The sensor is for single patient use only.

The sensor is not sterile when shipped from the factory.

The sensor is intended for pulse oximetry specified by Atom.

Failure to attach the sensor properly to the patient may result in inaccurate measurements.

Leaving the sensor attached for a long time may result in inaccurate measurements. Moreover,
you may not notice tissue necrosis due to pressure, skin irritations due to the adhesive, and/or
burns. Change the sensor site at least every eight hours.

Check continuously the circulation of the blood distal to the sensor site.

Make sure that the emitter and the detector face each other across the tissue.

Do not use a damaged sensor.

Do not immerse the sensor in any liquid.

Elevated levels of carboxyhemoglobin (COHb) or methemoglobin (MetHb) or the presence of


intravascular dyes may result in inaccurate measurements.

Do not use the sensor during MRI scanning.

Do not attach the sensor to the arm to which a blood pressure cuff or an arterial catheter is
attached.

− 37 −
WARNING
Premature infants tend to develop retinopathy of prematurity in a high oxygen environment.
Therefore, be especially cautious in setting the SpO2 upper alarm limit.

Do not expose the sensor to xenon light, phototherapy light, fluorescent light, infrared light, or
direct sunlight. Otherwise, the performance of the sensor may be affected.

The plethysmograph on the display is not proportional to the size of the pulse.

CAUTION
Use only the sensors and the patient cables specified by Atom to connect to the pulse oximeter in
this unit. Using any other sensor or patient cable may injure the patient.

The above sensors and patient cables are not waterproof.

6-1-1.

Pass the plug of the patient cable through the tube inlet
out of the incubator and insert it into the connector for Connector for SpO2
SpO2 on the left side of the main body. After a while,
SpO2 will be displayed on the %SpO2 display, and pulse
rate will be displayed on the pulse rate display.
Patient cable plug

CAUTION
The %SpO2 display will blink when the reliability of measurements is spoiled by turbulence and low
flow back. Please confirm the presence of turbulence and the state of the installation part when
blinking continues.

If a SpO2 sensor is already connected to the unit before the unit is powered up or it is connected for
the first time after power up, zeroes (“0”) will appear and flash in the %SpO2 and pulse rate displays.
During this period, the pulse oximeter will search for a pulse.
If the pulse oximeter fails to detect a pulse rate after it has been taking measurements during
normal monitoring operation, it will start searching for one again. If this happens, the last detected
reading will appear and flash in the %SpO2 display as well as in the pulse rate display while search-
ing. Wait for a reading to be displayed.

− 38 −
6-2. Setting the Upper/Lower Alarm Limits
You can set upper/lower limits respectively for SpO2 and the pulse rate monitored with the pulse oximeter.
Audible and visible alarms will be given if any of the alarm limits is violated.
(1) Press the alarm selector switch for about one
second. The SpO2 upper alarm limit is now ready to
be set and the SpO2 upper alarm indicator ( ) will
come on. While it is on, press an appropriate setting
switch ( or ) to set the SpO2 upper alarm
limit to a desired level. The alarm limit can be set in
the range of 50-100% in 1% increments. If is
pressed when the alarm limit is 100%, the setting will
be “ ” and the upper alarm cannot be set.
(2) In the SpO2 upper alarm limit setting mode, press
the alarm limit selector switch . The SpO2 lower
alarm limit is now ready to be set and the SpO2 lower
alarm indicator ( ) will come on. While it is on,
press an appropriate setting switch ( or )
to set the SpO2 lower alarm limit to a desired level.
The alarm limit can be set in the range of 45-95% in
1% increments. If is pressed when the alarm
limit is 45%, the setting will be “ ” and the lower
alarm cannot be set.
(3) In the SpO2 lower alarm limit setting mode, press
the alarm limit selector switch . The pulse rate
upper alarm limit is now ready to be set and the pulse
rate upper alarm indicator ( ) will come on. While
it is on, press an appropriate setting switch ( or
) to set the pulse rate upper alarm limit to a
desired level. The alarm limit can be set in the range
of 80-240bpm in 5bpm increments. If is pressed
when the alarm limit is 240bpm, the setting will be
“ ” and the upper alarm can not be set.
(4) In the pulse rate upper alarm limit setting mode, press
the alarm limit selector switch . The pulse rate
lower alarm limit is now ready to be set and the pulse
rate lower alarm indicator ( ) will come on. While
it is on, press an appropriate setting switch ( or
) to set the pulse rate lower alarm limit to a
desired level. The alarm limit can be set in the range
of 35-180bpm in 5bpm increments. If is pressed
when the alarm limit is 35bpm, the setting will be
“ ” and the lower alarm cannot be set.

WARNING
Premature infants tend to develop retinopathy of prematurity in a high oxygen environment.
Therefore, be very cautious in setting the SpO2 upper alarm limit in particular.

− 39 −
CAUTION

The SpO2 lower alarm limit is set to 85% automatically when the power is turned on again.

6-3. Setting the Heartbeat Synchronous Sound


You can turn on/off the heartbeat synchronous sound.
(1) Press the heartbeat synchronous sound switch
for about one second. The heartbeat synchronous
sound is now ready to be set, and whether the heart-
beat synchronous sound is on or off will be shown
on the pulse rate display.
(2) In this mode, press an appropriate setting switch
( or ) to turn on/off the heartbeat syn-
chronous sound.

When the setting switch is pressed to turn on the heartbeat synchronous sound, the pulse rate display will
show “ ”. When the setting switch is pressed to turn off the heartbeat synchronous sound, the pulse rate
display will show “ ”.

− 40 −
[7] Oxygen Monitor

WARNING
Be sure to follow the doctor’s instructions in making decisions on oxygen supply. Pay utmost
attention to the oxygen concentration in the incubator during oxygen supply.

7-1. Calibration

(1) Insert the plug of the oxygen sensor module in the Oxygen sensor cable plug
oxygen sensor connecting port on the left side of the
Oxygen sensor
main body.
connecting port

(2) Press the oxygen monitor switch for about one


second, and the oxygen concentration will be dis-
played.

(3) Press and hold the calibration switch with the sen-
sor module directed downward. A click is heard and Calibration switch
the calibration indicator begins to flash when cali-
bration gets started. In about thirty seconds another
click is heard and the calibration indicator goes off Oxygen sensor
module
when calibration is complete.
At this point, release the calibration switch.
(4) Insert the oxygen sensor module in the oxygen sen-
sor attaching port on the rear of the hood.
Oxygen sensor
CAUTION Oxygen sensor module attaching port

Be sure to calibrate the oxygen sensor before


using the unit.

Be sure to place the oxygen sensor in the


open air (oxygen concentration 21%) in cali-
brating it.
Keep the oxygen sensor module directed
downward when calibrating it.
If the oxygen sensor indicator “ ” comes on,
calibration has failed. Perform the calibration
procedure again.
− 41 −
7-2. Setting the Upper/Lower Alarm Limits
You can set upper/lower alarm limits for oxygen concentration. Audible and visible alarms will be given if
either alarm limit is violated.
(1) Press the O2 switch for about one second. The
oxygen concentration upper alarm limit is now ready
to be set and the oxygen concentration upper alarm
indicator ( ) will come on. While it is on, press
anappropriate setting switch ( or ) to set
the oxygen concentration upper alarm limit to a de-
sired level. The alarm limit can be set in the range of
22-99% in 1% increments.

(2) In the oxygen concentration upper alarm limit set-


ting mode, press the O2 switch . The oxygen
concentration lower alarm limit is now ready to be
set, and the oxygen concentration lower alarm indi-
cator ( ) will come on.
While it is on, press an appropriate setting switch
( or ) to set the oxygen concentration
lower alarm limit to a desired level. The alarm limit
can be set in the range of 19-96% in 1% increments.

− 42 −
[8] Oxygen Supply
(1) Be sure to connect an oxygen flowmeter between the
oxygen supply source and the oxygen supply port of Oxygen flow
Oxygen supply port meter
the incubator. Turn the knob on the oxygen flow-
meter, adjust the flowmeter and then adjust the flow
rate to a desired level.
(2) The oxygen concentration in the incubator will sta-
bilize in about 30 minutes. Increase the supply flow
rate if the detected oxygen concentration in the in-
cubator is lower than a desired level; decrease the
supply flow rate if the detected oxygen concentra-
tion in the incubator is higher than a desired level.
Pay utmost attention to the changes in the oxygen
concentration in the incubator by monitoring it with
an oxygen monitor until it stabilizes.

쐽 Connecting the oxygen cylinder


To connect the oxygen cylinder, use the optional high pressure oxygen hose (for V-505/pressure reducing
regulator) and the optional OX-231 pressure reducing regulator (for oxygen).

WARNING

Be sure to use an oxygen cylinder intended for medical use.

Be sure to connect an oxygen flowmeter between the oxygen supply source and the oxygen
supply port of the incubator.

Be sure to follow the doctor’s instructions in making decisions on oxygen supply.

Pay utmost attention to the oxygen concentration in the incubator during oxygen supply.

Be sure to use oxygen specified for medical use.

Pay utmost attention to the changes in the oxygen concentration in the incubator by monitoring
it continuously with an oxygen monitor. If the oxygen concentration in the incubator deviates
from a desired level, make necessary adjustment by increasing or decreasing the oxygen flow
rate.

Improper use of supplementary oxygen may cause serious side effects including loss of sight,
damage to the brain and death. The risks of side effects vary with infants. Follow the doctor’s
instructions in selecting a desired method of oxygen administration, a desired oxygen concen-
tration, and a desired duration of administration.

− 43 −
WARNING
A risk of a fire hazard increases when oxygen is used. Do not place such auxiliary equipment as
will generate sparks at the place where the incubator is installed.

If oil, grease or a grease-like substance should get in contact with pressurized oxygen, a violent
spontaneous ignition may occur. Do not let such substances stick to the oxygen pressure regu-
lator, the oxygen cylinder valve, pipings, connections, and other oxygen supply equipment.

On a high pressure oxygen cylinder, use only a tested pressure reducing valve or pressure
regulating valve indicated specifically for oxygen supply.

Replace the old filter with a new one every three months in general. The contamination of the
filter varies with the degree of air pollution and the frequency of operation. Check the contami-
nation of the filter through the window of the filter cover. If the filter should be found discolored,
replace it with a new one even if the three month interval is not over yet.

The oxygen flowmeter cannot be used as an accurate indicator of the oxygen concentration in
the incubator. The oxygen concentration should be checked with a calibrated oxygen monitor or
oxygen controller by following the doctor’s instructions.

The oxygen concentration in the incubator varies with the contamination of the filter, the operat-
ing conditions of the incubator, the accuracy of the oxygen flowmeter, etc. To maintain the
oxygen concentration in the incubator accurately at a desired level, measure it repeatedly with
an accurate oxygen monitor.

Every time you use the oxygen monitor, calibrate it with the oxygen in the atmosphere (20.9%).

Be sure to follow the doctor’s instructions in deciding an optimum oxygen concentration based
on PaO2 (a measured arterial oxygen partial pressure level). It is reported to be extremely
important and essential, when a high oxygen environment is required, to measure the oxygen
concentration in the incubator and analyze arterial gas levels repeatedly in order to provide an
optimum oxygen concentration.

Cleaning or maintaining the incubator in an environment where the oxygen concentration is high
may lead to a fire or an explosion. Before cleaning or maintaining the incubator, check that
oxygen supply has been stopped and that the oxygen hose has been removed from it. Oxygen
supply should be stopped, or the oxygen hose should be removed from the incubator, when the
unit is not in operation.

The oxygen cell is a sealed device containing an electrolyte of potassium hydroxide. The
electrolyte may leak out if the sensor should be damaged when dropped, etc. If the electrolyte
should touch the skin or clothes, wash it away with a lot of water. If it should get in the eye, wash
the eye immediately with a lot of water and consult a doctor.

Check the sensor for any sign of deterioration or leaking fluid as a part of routine inspection. if a
crack or any other defect should be detected in its appearance, replace it immediately with a
new one.

Check the oxygen concentration with another monitor to make sure that oxygen is being sup-
plied at a prescribed level.

− 44 −
WARNING
The oxygen concentration inside the incubator hood may be affected when an access port or the
front admittance panel is opened. Check that the access port packings and the tube inlet are
securely attached. Any gap in the hood assembly may cause the oxygen concentration in the
incubator to drop.

Oxygen administration may increase the noise level to the infant in the incubator.

− 45 −
[9] Other Operating Procedures
9-1. Drawing Out the Mattress Platform
Open the head-end admittance panel on the left side of
the hood and draw out the mattress platform toward you. Mattress platform
The stopper will function and the mattress platform will
be locked in place halfway. You can draw it out completely
by pressing the stopper to unlock.

WARNING
Head-end
Before drawing out the mattress platform, admittance panel
check that the mattress platform is fitted in
the rail grooves. Otherwise, the mattress plat-
form will come off and cause a hazard.

Do not open the hood with the mattress plat- Mattress platform
form drawn out. The mattress platform will
come off and cause a hazard.

Do not release the stopper and draw out the Stopper


mattress platform completely except for
cleaning. It may cause an infant to fall and/
or cause a hazard.

9-2. Arranging the cords and Tubes


A number of cords and tubes may be connected to the
infant in the incubator. Insert them through a tube inlet
into the incubator so that they do not get in the way of
procedures. Tube inlets are provided on either side of
the front admittance panel and on the left side of the hood.
Tube inlet

Cord

− 46 −
9-3. Lighting Lamp

WARNING
Do not touch the lighting lamp when it is on because it will have become very hot and you may
burn yourself.

(1) Press the lighting switch , and the lighting lamp


will come on. Press it again, and the lighting lamp
will go off.

(2) To fix the lighting lamp, align the projection under


the fixing knob on either side with a mating recep-
tacle on the top surface of the hood, and press the
knob.
To release, press the knob again. Fixing knob

9-4. I.V. Pole

WARNING

The maximum permissible load attachable to the I.V. pole is 3kg.

(1) To adjust the height of the I.V. pole, loosen the twist
Twist lock
lock. Adjust the height to a desired level and tighten
the twist lock to fix securely.

To To
tighten loosen

− 47 −
9-5. Test Switch
Press the test switch on the left side of the unit and all the
Test switch
LEDs will turn on and the audible alarm will sound. This
will ensure that the alarms operate normally.

9-6. Reset Indicator/Reset Switch


When Battery 1 or Battery 2 is replaced, a correspond- [For Battery 1 (Main body-Rear)]
ing reset indicator comes on. After replacing the battery,
Fuse✽
press the reset switch to turn off the reset indicator. If (for Battery 1)
your fail to do so, the battery may not be changed prop- Reset indicator
erly.
Reset switch

✽ For the replacement of the batteries, see the separate


[For Battery 2 (Mount-right side)]
service manual.

Fuse✽
(for Battery 2)

Reset indicator
Reset switch

✽) Fuse type: 312025

− 48 −
[10] Cleaning, Disinfection and Maintenance

CAUTION
Before cleaning or disinfecting the unit, be sure to turn the power off, remove the power plug and
allow the incubator and the heater to cool down sufficiently.

This product is shipped without being disinfected. Be sure to clean and disinfect the unit before
using it for the first time after purchase.

Before cleaning or servicing the unit, make sure that oxygen supply to the incubator has been
stopped and that the incubator has been disconnected from the oxygen supply source. Cleaning or
servicing the incubator in an environment where the oxygen concentration is high may lead to a
fire or an explosion.

Clean and disinfect the unit whenever you use it for a new infant .

Clean and disinfect the unit whenever you notice dirt or stains which might cause infection.

After cleaning and disinfection, assemble the removed parts correctly and perform an inspection
before use to ensure that the unit operates normally.

Obtain a soft clean cloth and a disinfectant detergent solution for cleaning and disinfection.

쐽 Recommended disinfectant detergents include:


앫 0.2—0.5% benzalkonium chloride aqueous solution (e.g. Osvan)
앫 0.2—0.5% benzethonium chloride aqueous solution (e.g. Hyamine)
앫 0.1—0.5% chlorhexidine aqueous solution (e.g. Hibitane)
Never use the above agents undiluted. Do not use any abrasive cloth, cleaner, alcohol, acetone or other
solvent for cleaning and disinfection. Do not autoclave.

10-1.Hood
쎲 Access port cover
Remove all the access port covers (iris access port
covers, semi-iris access port covers). Immerse and
clean them in a disinfectant detergent.

CAUTION
The semi-iris access port cover is very im-
portant to maintain the performance of the
incubator when the access port is open. It’s
specially effective in oxygen therapy, so be
sure to attach it.

Spare access port covers should always be


on hand. A dirty cover should be replaced
immediately with a new one.

− 49 −
쎲 Snap-open access port packing Snap-open access port packing
Remove the rubber packings from the snap-open ac-
cess ports. Immerse and clean them in a disinfectant
detergent.

쎲 Admittance panel packing


Remove the rubber packings from the admittance pan-
els. Immerse and clean them in a disinfectant deter-
gent.

쎲 Tube inlet Tube inlet packing


Remove the packings from the tube inlets. Immerse
and clean them in a disinfectant detergent.

쎲 Inside panel (front, rear, top, right)


Fixing screw
(1) Open the front admittance panel. Loosen the fixing
screws for each inside panel(i.e. front, rear, top and
right) and remove the inside panels.
(2) Clean both sides of each inside panel with a soft cloth
moistened with a disinfectant detergent. Inside panel

쎲 Hood
After all the parts have been removed from the hood,
wipe clean the inside and the outside of the hood with
a soft cloth moistened with a disinfectant detergent.

쐽 Assemble all the removed parts as before and check


that they are attached correctly.

− 50 −
10-2.Mattress Platform and Parts Beneath
Unlock the hood fixing devices. Hold up the hinges on
the front admittance panel with both hands, and then push
the hood stopper on the right side of the hood all the way
until it locks in place.
Stopper
WARNING Lever

Clean and disinfect the heater and its sur-


rounding only after the heater has cooled
down sufficiently or you may get burned.

To raise the hood, be sure to hold the hinges


on the front admittance panel with both hands. Hood stopper
If you hold the hood by any other part, the
hood will slip and become a hazard.

Be sure to make sure that the hood stopper


has fallen backward completely. If it has fallen
down only insufficiently, the hood will fall for-
ward and become a hazard.

Before opening the hood, remove the lighting


lamp from the hood. If the hood is opened
with the lighting lamp on it, the lamp may get
broken.

쎲 Middle deck and middle deck packing


Hold the middle deck by both sides, lift it together with Mattress platform
the mattress platform and take them out. Remove the Infant fixing bands
middle deck packing from the middle deck.
Clean them with a soft cloth moistened with a disinfec-
tant detergent. The middle deck packing has an up-
side and a downside, therefor, be careful not to attach
it upside down to the middle deck.
Middle deck
Middle deck packing

쎲 Mattress platform and infant fixing bands


(1) Slide the mattress platform out of the middle deck
until the stopper is engaged. To take the mattress
platform out, press the stopper down to disengage
lock. Clean it with a soft cloth moistened with a dis- Mattress platform
infectant detergent.
(2) Remove the infant fixing bands from the mattress
platform and immerse it in a disinfectant detergent. Stopper
After disinfection, let it dry completely.

− 51 −
쎲 Fan cover
Remove the fan cover and clean it with a soft cloth
moistened with a disinfectant detergent. Fan cover

쎲 Fan
Turn the fixing screw clockwise to loosen and then
pull up the fan to remove. Immerse and clean it in a Fixing screw

disinfectant detergent.

Fan

쎲 Conditioning chamber
The conditioning chamber will appear when all the com- Conditioning chamber
ponents mentioned above have been removed. Clean
it thoroughly with a soft cloth moistened with a disin-
fectant detergent.
쐽 Assemble all the removed parts as before in the re-
verse order of disassembly. Check that they are at-
tached correctly and then close the hood.

− 52 −
10-3.Others
쎲 Skin temperature probe
Wipe a used probe lightly with a soft dry cloth. Wipe
the thermistor with a soft cloth moistened with a disin-
fectant detergent to disinfect.
Be sure to keep the skin temperature probe in its case.

CAUTION
Never wipe the skin temperature probe with
any alcohol or the material will harden.

쎲 Mattress
Remove the mattress before placing a new infant in
the incubator. Disinfect it by immersing the entire
Mattress
mattress in a disinfectant detergent.
Since the mattress consists of a special sponge com-
pletely sealed up in a vinyl cover, the sponge inside
cannot be contaminated unless the cover gets damaged.

− 53 −
[11] Maintenance Inspection
To use the unit safely for a longer period, perform the maintenance inspection procedures as instructed below.

앫 Inspection before use


Check the basic functional operation of each part every time you are going to use the unit.

앫 Three-month inspection
Check the operation of each function every three months or so.

앫 Periodical inspection
Contact your local Atom representative for periodical inspection at least once a year.

앫 Parts requiring periodical replacement


Some parts need periodical replacement based on their usage.

CAUTION
Medical institutions are responsible for performing maintenance inspection. They are allowed to
ask an appropriate, certified dealer to perform the maintenance inspection of the unit.

Before maintenance inspection, repair or disposal, clean and disinfect the unit and its accessories.

11-1. Inspection before Use


Check the following before each use.

Item to check Description


Appearance The hood, the main body and the stand should not be broken or deformed.
(Otherwise, the infant and the user may be injured.)
Hood fixing device The hood and the main body should be locked securely with the two hood
fixing devices. (Otherwise, the infant and the user may be injured.)
Stand fixing lever There should be no gap between the bottom of the main body and the top of
the stand. The hook of the fixing lever should be off the frame of the stand,
hanging down, and the incubator should be fixed securely to the stand. (Oth-
erwise, the main body may fall down.)
Caster The casters should not be loose, shaky or broken. The casters provided with
a stopper can be locked securely. (Otherwise, the main body may fall down.)
Main body locking device The main body and the mount should be locked securely with the fixing de-
vices. (Otherwise, the main body may fall down.)
Access port cover Each access port cover should be attached securely to its access port packing
and should not be broken or deformed. (Otherwise, airtightness may be de-
creased.)
Access port packing Each packing should be attached correctly to the hood. (Otherwise, airtight-
ness may be decreased.)
Admittance panel packing Each packing should be attached correctly to a corresponding admittance
panel and should not be broken. (Otherwise, airtightness may be decreased.)
Tube inlet packing The packing should be attached correctly to the head-end admittance panel
and should not be broken. (Otherwise, airtightness may be decreased.)
Incubator air temperature It should not be broken or deformed. (Otherwise, the incubator air tempera-
sensor ture may not be detected correctly and thus it may not be controlled correctly.)

− 54 −
Item to check Description
Oxygen sensor module It should not be broken or deformed. (Otherwise, the oxygen concentration
may not be detected correctly.)
Front admittance panel op- The knobs should not be loose. They can be locked securely. They can open
erating knob and close the front admittance panel reliably. (If they cannot be locked se-
curely, the infant may fall.)
Hook slider for the snap- The sliders should not be loose. They can be locked securely. They can open
open access port and close the snap-open access ports reliably. (If they cannot be locked se-
curely, the infant may fall.)
Middle deck, Mattress plat- The middle deck and the mattress platform should be installed securely. The
form, Infant fixing band infant fixing bands should be attached reliably. (Otherwise, the temperature
cannot be controlled and the infant cannot be fixed reliably in place during
transport.)
Middle deck packing The packing should be attached correctly to the middle deck. (Otherwise,
airtightness may be decreased.)
AC power indicator The AC power indicator should come on when the power cord is connected to
the power outlet. (Otherwise, the batteries may not be charged.)
Test switch When the test switch is pressed, the LED displays should come on fully and
the audible alarm should sound. (LED displays may be faulty.)
Battery charge level When the power switch is turned on, the battery 1 charge level indicator and
indicator the battery 2 charge level indicator should come on. (Otherwise, the internal
battery power may not be available.)
Filter The filter should be clean. (Otherwise, air circulation may not be controlled
correctly.)

11-2. Three-month Inspection


Check the following points every three months.

Item to check Procedure Description


Incubator air tempera- Set the incubator air temperature to The displayed temperature should be
ture control 36.0˚C. stable at 36.0앐0.1˚C.
Oxygen concentration Supply oxygen at 10L/min from the The displayed oxygen concentration
oxygen supply port. should be 60% or higher.
Pulse oximeter Connect a Masimo sensor to the sen- 95~100%should be displayed on the SpO2
sor panel on the left side of the main display. Pulse rate should also be dis-
body and attach it to the inspector. played.
Fan Check the appearance of the fan by The fan should make no strange sound.
visual inspection. It should not be loosely attached, broken
or deformed.
Lighting lamp Check the lamp by visual inspection When the lamp switch is turned on, the
both on AC power and on the battery lamp should come on.
power.
Battery Charge the battery for a least eight The unit should operate for at least 90
hours and make the incubator air tem- minutes on the battery power at the am-
perature stable at 36˚C. bient air temperature of 15˚C.

− 55 −
11-3. Parts requiring periodical replacement
Parts which gradually deteriorate and become worn down with use need periodical replacement to keep the
accuracy and performance of the unit at a proper level. The timing of replacement varies with the frequency
and conditions of use. Consult your local Atom representative for replacement.
Part name Period of use Reason for replacement
Access port cover 3-6 months Decreased airtightness due to breakage or deformation.
Access port packing 1-2 years Decreased airtightness due to breakage or deformation.
Front admittance
1-2 years Decreased airtightness due to breakage or deformation.
panel packing
Tube inlet packing 1-2 years Decreased airtightness due to breakage or deformation.
Middle deck packing 1-2 years Decreased airtightness due to breakage or deformation.
Mattress 1-2 years Decreased elasticity due to breakage or deformation.
Poor air circulation control due to dirtiness or clogging
Filter Less than 3 months
with dust.
Circulating fan motor 3 years Decreased air circulation
Fan 3 years Decreased air circulation
Hook slider 2 years Poor locking
Middle deck, Fan cover 3 years Poor temperature control due to breakage or deformation
Depending on
Oxygen sensor Poor calibration due to sensor life.
conditions of use✽
Depending on
Battery Poor operation on battery power due to battery life.
conditions of use
Fluorescent lamp
3,000 hours Decreased illuminance due to lamp life
(FL8EX-N-H)

✽ The life of the oxygen sensor used with this unit is expected to be about 24 months when used at the ambient
temperature of 25˚C and in the atmosphere containing 21% O2. However, this sensor is greatly affected by
the overall conditions under which it is used (i.e. ambient temperature, oxygen concentration). For ex-
ample, its life will be reduced by half if the oxygen concentration or the ambient temperature should be
doubled.
Therefore, be aware that the actual product life of the oxygen sensor may be reduced even further.

− 56 −
11-4. Replacing the Filter

CAUTION
Replace the old filter with a new one every three months in general. The dirtiness of the filter
varies with the degree of air pollution and the frequency of operation. Check the condition of the
filter through the window of the filter cover. If the filter should be found discolored, replace it with
a new one eve if the three-month interval is not over yet.

(1) Loosen the right and left screws on the filter cover
Filter cover
and remove the cover.
(2) Remove the dirty filter, taking care that the contami-
nations are not dislodged, and dispose of it properly.
(3) Clean the filter cover and the section to which the
filter is attached with a soft cloth moistened with a
disinfectant detergent.
(4) Replace the dirty filter with a new one, attach the
cover to its former position, and tighten the screws.

CAUTION
Do not attempt to reuse the dirty filter by
washing it or attaching it inside out.

Open the filter cover only to replace the old


filter with a new one.

− 57 −
11-5. Replacing the Oxygen Sensor

WARNING
Check the sensor for any sign of deterioration or leaking fluid as a part of routine inspection. If
a crack or any other defect should be detected in its appearance, replace it immediately with a
new one.

The oxygen cell is a sealed device containing an electrolyte of potassium hydroxide. The elec-
trolyte may leak out if the sensor should be dropped or damaged in any way. If the electrolyte
should touch the skin or clothes, wash it away with copious amounts of water. If it should get in
the eye, flush the eye with copious amounts of water and consult a physician immediately.

Discard a used oxygen sensor according to an appropriate disposal procedure.

CAUTION
If the oxygen sensor alarm indicator should come on during 21% calibration, the oxygen sensor
may be defective. Replace the old oxygen sensor with a new one.

Avoid jolting or hitting the sensor when replacing it.

(1) Remove the plug of the cable of the oxygen sensor Oxygen sensor cable plug
module from the connecting port on the left side of
Oxygen sensor
the main body. Pull out the oxygen sensor module connecting port
from the hood.

(2) Turn the holder fixing ring counterclockwise and re- Oxygen sensor
move it.

Holder fixing ring

(3) Remove the connector from the old oxygen sensor.

Connector

− 58 −
(4) Turn the old oxygen sensor counterclockwise and
remove it from the sensor holder. Attach a new oxy- Oxygen sensor
gen sensor to the sensor holder.
Connect the connector to the new oxygen sensor,
and then turn it counterclockwise to attach it as be-
fore.

Sensor holder

(5) Insert the oxygen sensor module in the hood and


connect the connector of the cable to the connecting Oxygen sensor module
port on the left side of the main body.

11-6. Replacing the Fluorescent Lamp

DANGER
Turn the lighting switch off before replacing the fluorescent lamp. The fluorescent lamp has
become hot immediately after use. Before replacing the fluorescent lamp, make sure that it has
cooled down sufficiently.

Do not replace the fluorescent lamp with wet hands.

(1) Press the fixing knobs on the right and left of the
lighting lamp, and remove the lamp from the hood.

Fixing knob

(2) Remove the screw on the left side cover of the light- Lighting lamp
ing lamp. Screw

Left side cover

− 59 −
(3) Remove the left side cover of lighting lamp.
Left side cover

(4) Slide out the lighting lamp cover.

Lighting lamp cover

(5) Turn and remove the old fluorescent lamp, and re-
place it with a new one.

Fluorescent lamp

(6) Install the all detached parts as before and fix the
lighting lamp to the hood again. Lighting lamp cover

− 60 −
11-7. Inspection Checklist
Serial No. ( ) Date of inspection ( . . ) Inspector:

No. Item to check


Inspection before use (every time)
1 Are the main body, the hood and the stand free from any breakage? OK/NG
2 Are the main body and the hood locked together securely? OK/NG
3 Are the stand and the incubator mount attached to each other and locked securely? OK/NG
4 Are the casters attached securely and tightly? Can the stoppers be locked securely? OK/NG
5 Are the main body and the mount locked together securely? OK/NG
6 Are the access port covers free from any breakage and attached securely? OK/NG
7 Are the access port packings attached securely to the hood? OK/NG
Is a packing which is not broken attached to the head-end admittance panel and the front
8 OK/NG
admittance panel respectively?
9 Is a packing which is not broken attached securely to the tube inlet? OK/NG
10 Is the incubator air temperature sensor free from any breakage or deformation and attached securely? OK/NG
11 Is the oxygen sensor free from any breakage, deformation or sign of leaking fluid? OK/NG
Are the front admittance panel operating knobs not loose?
12 OK/NG
Can the admittance panel be opened and closed reliably?
Are the hook sliders for the snap-open access ports firm to the touch and not loose? Can the
13 OK/NG
snap-open access ports be opened and closed reliably?
14 Are the infant fixing bands free from any flaws and damage? OK/NG
15 Are the middle deck and the mattress platform installed securely? OK/NG
16 Is the middle deck packing attached correctly without being upside down? OK/NG
17 Does the AC power indicator come on when the power cord is connected to the power outlet? OK/NG
Do the LED displays come on fully and does the audible alarm sound when the test switch
18 OK/NG
is pressed?
Do the battery 1 charge level indicator and the battery 2 charge level indicator come on as far
19 OK/NG
as the green zone when the power switch is turned on?
20 Does the filter look clean and uncontaminated? OK/NG
Three-month Inspection
1 Is the incubator air temperature stable at the set point of 36.0앐1˚C? OK/NG
2 Is the oxygen concentration 60% or higher at the supply rate of 10L/min? OK/NG
3 Are SpO2 and pulse rate displayed when the SpO2 sensor is attached? OK/NG
4 Is the fan properly attached-not loose, deformed or broken? OK/NG
5 Does the lighting lamp come on both on AC power and on the battery power? OK/NG
6 Does the unit operate for at least 90 minutes on a fully-charged internal battery? OK/NG

WARNING
If any trouble should be detected in any of the above inspections, indicate on the unit that it is out
of order and have it repaired without fail.

Contact your local Atom representative for further information on repair.

− 61 −
11-8.Disposal
The main body, packing materials, parts beyond their lives and disposables should be disposed of properly
according to an applicable waste disposal law by the medical institution concerned.
In addition to a rechargeable lead-acid battery, a rechargeable Ni-Cd battery and an oxygen sensor are used for
this unit. Dispose of the batteries and the oxygen sensor properly.

11-9. Replacing batery


Please contact the local distributor of Atom for the replace of battery.

− 62 −
[12] Alarms

WARNING
This incubator is provided with the following alarms. If an alarm condition should occur, check
for a possible cause of the alarm. If the incubator seems to be defective, it may be in need of
repairs. Indicate on the incubator that it is out of order and contact your local Atom representa-
tive.

12-1.High Temperature Alarm HIGH TEMP


The indicator will flash and a continuous audible alarm will sound before the incubator air temperature
exceeds 39.0˚C.
Action to take : If the middle deck is not placed properly, the high temperature alarm may occur even when
the alarm limit has not been exceeded. If no trouble is found with the middle deck, the incuba-
tor should be regarded as out of order.
Alarm reset : The audible alarm cannot be silenced and the alarm cannot be reset unless the normal condi-
tion has returned.

12-2.Set Point Alarm

CAUTION
The unit is so designed that the set point alarm does not activate for 30 minutes after power is
applied to the unit or after the set temperature is changed to another level. However, the set point
alarm will begin to activate even within 30 minutes of the above-mentioned events if the incubator
air temperature reaches the range of the set temperature 앐3˚C.

If the incubator air temperature exceeds or falls below the set temperature by 3˚C or more, the indicator
will come on, the incubator air temperature display will flash, and a continuous audible alarm will sound. Power
supply to the heater will be shut off if the incubator air temperature exceeds the set temperature by 3˚C or
more; it will not be shut off if the incubator air temperature falls below the set temperature by 3˚C or more.
Action to take : Is the middle deck placed properly? Is an air outlet, an air inlet or the incubator air tempera-
ture sensor covered with diapers, etc? If no trouble is found with the above items, the incuba-
tor should be regarded as out of order.
Alarm reset : Press the alarm silence/reset switch and the alarm silence indicator will come on and the
audible alarm will be silenced for fifteen minutes. If another alarm should occur while the
audible alarm is silenced, the audible alarm will be reset automatically and begin to sound.
The alarm will be reset automatically and stop if the normal condition has returned.

12-3.Fan alarm
If the fan provided for air circulation in the incubator has stopped or isn’t attached properly, or if the fan cover
isn’t attached properly, the indicator will come on and a continuous audible alarm will sound. At the same
time, the power supply to the heater will be shut off.
Action to take : Turn the power switch off and check that the fan and the fan cover are attached properly. If
the fan operates normally when the power switch is turned on again, the alarm will be reset.
Alarm reset : The audible alarm cannot be silenced.

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12-4.System Failure Alarm SYSTEM
If any trouble should occur to the high temperature sensor or the incubator air temperature sensor, the
indicator will come on and a continuous audible alarm will sound. At the same time, power supply to the heater
will be shut off.
Action to take : Turn the power switch off and check the attachment of the temperature sensors. If no trouble
is found with their attachment, the incubator should be regarded as out of order.
Alarm reset : The alarm cannot be reset during the alarm condition.

12-5.Skin Temperature Probe Alarm


If any trouble should occur to the skin temperature probe, the indicator will come on and a continuous
audible alarm will sound.
Action to take : The skin temperature probe may be faulty. Replace it with a new one.
Alarm reset : Press the alarm silence/reset switch, and the alarm silence indicator will come on and the
audible alarm will be silenced. If another alarm should occur while the audible alarm is si-
lenced, the audible alarm will be reset automatically and begin to sound again.

12-6.Power Failure Alarm


If the internal battery charge level should decrease while the unit is being powered by the battery or batteries,
the indicator will come on and a continuous audible alarm will sound.
Action to take : Connect the unit to the AC power source to charge the internal batteries.
Alarm reset : The audible alarm cannot be silenced.

12-7. SpO2 Upper/Lower Limit Alarm


If the SpO2 upper/lower alarm limit is violated, an appropriate SpO2 alarm indicator (“ ” “ ”) will flash and
an audible alarm (“pip pip pip silent pause pip pip”) will sound.
Action to take : Check that the patient’s respiratory condition has not deteriorated.
Alarm reset : The audible alarm can be silenced for two minutes.
The alarm will stop if the detected SpO2 has returned to a normal value within the period.

12-8.Pulse Rate Upper/Lower Limit Alarm


If the pulse rate upper/lower alarm limit is violated, an appropriate pulse rate alarm indicator (“ ” “ ”) will
flash and an audible alarm (“pip pip pip silent pause pip pip”) will sound.
Action to take : Check that the patient’s respiratory condition has not deteriorated.
Alarm reset : The audible alarm can be silenced for two minutes.
The alarm will stop if the detected pulse rate has returned to a normal value within the period.

12-9.SpO2 Sensor Alarm


If a wire of the SpO2 sensor or the patient cable has broken, the connector is faulty, or the sensor has been
removed intentionally from the connector, the SpO2 display and the pulse rate display will indicate “ ” and
flash. At the same time, an audible alarm (“pip pip pip silent pause pip pip”) will sound to notify the alarm
condition.
Action to take : Check the SpO2 sensor, the patient cable and the connector for any fault.
Alarm reset : The alarm will stop if the SpO2 sensor is connected properly as it should.
If the alarm silence/alarm switch is pressed, the alarm will be cancelled and the SpO2 function
will be stopped.

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12-10. SpO2 Sensor OFF Alarm
If a pulse cannot be detected due to patient low perfusion or disconnection of a SpO2 sensor from the patient,
the following will occur to alert the operator: an audible alarm (a bursting sound, “pip pip pip”) will sound, the
SpO2 lower alarm indicator and the pulse rate lower alarm indicator will light up, and flashing zeroes (“0”) will
appear in the % SpO2 and pulse rate displays.
Action to take : Check that the SpO2 sensor is properly connected and the surfaces of emitter and detector
windows are clean. Also check that the patient’s condition has not deteriorated.
Alarm reset : The audible alarm cannot be silenced until the pulse oximeter starts taking measurements.

12-11. Oxygen Sensor Alarm


If the 21% calibration has not been performed properly, or if the oxygen sensor should come off the connector
during oxygen monitoring, the indicator will come on and a continuous audible alarm and an audible alarm
(“pip pip pip silent pause pip pip”) will sound.
Action to take : Recalibrate the sensor. If recalibration should fail, the oxygen sensor may be faulty. Check
that the oxygen sensor module is connected securely.
Alarm reset : If recalibration is successful, the alarm will stop.
If the oxygen monitor switch is pressed, the alarm will be cancelled and the oxygen monitor
function will be stopped.

12-12. Oxygen Concentration Alarm


If the oxygen concentration upper/lower alarm limit is violated, the indicator will come on, an appropriate
oxygen concentration alarm indicator (“ ” “ ”) will flash, and an audible alarm (“pip pip pip silent pause pip
pip”) will sound.
Action to take : Check that the access ports and the admittance panels are closed and that oxygen is supplied
sufficiently.
Alarm reset : If the alarm silence/reset switch is pressed, the audible alarm will be silence for two minutes.
The alarm will sound again in two minutes unless the normal condition has returned.

12-13. Low Battery Alarm


If both Battery 1 and Battery 2 have fallen into a low battery condition (i.e. only two or less divisions of the
battery charge level indicators are on) while the unit is being powered by the internal batteries, an audible
alarm (“pip pip”) will sound every 15 seconds.
Action to take : Connect the unit to the AC power source.
Alarm reset : The alarm will be reset if the unit is connected to the AC power source.

12-14. Charging Circuit Alarm


If a charging voltage and a charging current should exceed a specified level while the batteries are being
charged, or if no charging current should flow for two minutes after charging is started, the entire battery
charge level indicators and the reset indicator will flash.
Action to take : The charging circuit is faulty or a battery fuse (F1 or F2) has burnt out. Check the battery
fuses and replace a blown fuse as necessary.
Alarm reset : Press the reset switch. The reset indicator will stop flashing and remain on. Then press the
reset switch again. (The batteries will begin to be charged. If the alarm should occur again,
the charging circuit may be faulty.)

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12-15. Faulty Battery Alarm
If a charging current keeps on flowing even after a specified time has elapsed while the batteries are being
charged, or if a battery charge level falls below a specified level after charging a battery, about half the corre-
sponding battery charge level indicator and the reset indicator will flash.
Action to take : The batter may have deteriorated in quality.
Alarm reset : Press the reset switch. The reset indicator will stop flashing and remain on. Then press the
reset switch again. (The batteries will begin to be charged. If the alarm should occur again,
the battery may be faulty.)

− 66 −
[13] Troubleshooting

CAUTION

Check the following points before requesting repair service.

Trouble Check

It is impossible to charge the 앫 Is the incubator connected to the AC power source?


batteries. 앫 Has the AC power breaker opened the circuit?

The incubator doesn’t operate 앫 Is the incubator connected to the AC power source? When it is con-
when connected to the external DC nected to the AC power source and the external DC power source
power. simultaneously, the AC power source takes precedence.
앫 Is the voltage low?
앫 Has the DC power breaker opened the circuit?

The incubator air temperature does 앫 Is the incubator air temperature set too low?
not rise. 앫 Is the supply voltage low?
(The incubator should not share a power outlet with another device.)
앫 Is the incubator exposed directly to a strong wind or a low ambient
temperature?
앫 Is the air circulating fan attached correctly?

The incubator air temperature rises 앫 Is the incubator air temperature set too high?
too high. 앫 Is the incubator exposed to direct sunshine or affected by a heating
apparatus nearby?
앫 Is an air inlet in the incubator covered with diapers, gauze, or ob-
structed in any way?

The oxygen concentration does not 앫 Check the flow rate on the oxygen flowmeter.
rise. 앫 Is the oxygen cylinder empty?
앫 Are the access ports closed securely?
앫 Is the filter cover attached secrurely?

WARNING
If the unit seems to be defective, indicate on the unit that it is our of order, stop using it at once,
and contact your local Atom representative.

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[14] Technical Data
Power requirements AC power source AC220-240V 앐10% 50/60Hz
Power consumption 800VA
External DC power source DC12V, 20A
DC24V, 10A
Operating voltage range: DC12V: DC11.0V~DC14.5V
DC24V: DC22.0V~DC26.0V
Internal battery Main body: Battery 1 DC12V/7.2Ah
(one lead-acid battery) 12V/7.2Ah҂1
Mount: Battery 2 DC12V/50Ah
(one lead-acid battery) 12V/50Ah҂1
Continuous operation (ambient temperature 15˚C, incubator
air temperature stable at 36˚C)
Main body: Approx. 15 minutes (after charging for at least 6
hours)
Main body and mount: Approx 90 minutes (after charging
for at least 8 hours)

Classification Type of protection: Class I equipment


Degree of protection: Type BF applied part
Protection against ingress of water: not protected
Not for use in air and flammable anesthetic gas or oxygen/nitrous oxide and flammable
anesthetic gas
Mode of operation: Continuous operation

Operating condition Ambient temperature: 10~30˚C


Relative humidity: 30~75%
Atmospheric pressure: 70~106kPa
Airflow velocity: 0.3~1.0m/s

Storage condition Ambient temperature: 0~50˚C


Relative humidity: 30~75%
Atmospheric pressure: 70~106kPa

Transport condition To be transported with the stand at the lowest level.

Dimensions Main body: 98(W)҂49(D)҂76(H)cm


Stand: 120(W)҂52(D)҂32~61(H)cm
Mattress: 62(W)҂33(D)҂3(T) cm

Weight Main body: Approx. 34kg


Mount: Approx. 26kg
Stand: Approx. 26kg

Maximum load I.V. pole: Approx. 3kg

− 68 −
Accessories Skin Temp Probe, O.D.(Yellow) .............................................. 1
Access port cover ..................................................................... 1
Semi-iris access port cover ...................................................... 4
Patient cable .............................................................................. 1
Infant fixing band ...................................................................... 3
Oxygen sensor .......................................................................... 1
Dust cover ................................................................................. 1
Filter Element E ........................................................................ 1
Operation manual ..................................................................... 1
쐽 Temperature
Incubator air temperature control Time proportional control
Incubator air temperature setting range 23.0~38.0˚C (in 0.1˚C increments)
Incubator air temperature display range 20.0~42.0˚C (accuracy: 앐1.0˚C)
Skin temperature display range 30.0~42.0˚C (accuracy: 앐0.3˚C)
Heater output 0~100 (in 10 levels)
Warming time 40 minutes (ambient temperature: 20˚C)
Alarms High temperature, set point, fan, system failure, skin temperature
probe, power failure

쐽 Oxygen concentration
Oxygen sensor Galvanic cell
Oxygen concentration display range 15~105%
Accuracy: 앐2% O2 in 15~25%
앐3% O2 in 25~100%
Oxygen concentration alarm setting range Upper limit: 22~99%O2 (in 1% increments)
Lower limit: 19~96%O2 (in 1% increments)
Response time of oxygen concentration display 30 seconds (90% response)
Stability of oxygen concentration
measurements and calibration cycle 24 hours
Calibration 21%
Oxygen sensor life Approx. 24 months (ambient temperature: 25˚C, oxygen concen-
tration in the air: 21%)
Alarms Oxygen sensor, oxygen concentration

쐽 Oxygen supply
Max. oxygen concentration 60% (oxygen flow: 10L/min)
Achieving time 30 minutes (from 21% to 55%, oxygen flow: 10L/min)

쐽 Environment
CO2 concentration in the hood: CO2 concentration when stabilized after administering air mixed
with 4% CO2 to a point 10cm above the center of the mattress at
750mL/min doesn’t exceed 0.5%)

− 69 −
쐽 Pulse oximeter *1,5,6,7,9 (Masimo)
SpO2
• Measurement
Display range: 1~100%
Accuracy (in 70~100%): 앐3 digits (during no motion conditions)*2
앐3 digits (during motion conditions)*3
앐3 digits (during low perfusion conditions)*4
Update cycle: 1 second
• Alarm function
Setting range: Upper limit: 50~100%, OFF (in 1% increments)*8
Lower limit: 45~95%, OFF (in 1% increments)*8
Pulse
• Measurement
Display range: 25~240bpm
Accuracy (in 25~240bpm): 앐3 digits (during no motion conditions)*2
앐5 digits (during motion conditions)*3
앐3 digits (during low perfusion conditions)*4
Update cycle: 1 second
• Alarm function
Setting range: Upper limit: 80~240bpm, OFF (in 5bpm increments)*8
Lower limit: 35~180bpm, OFF (in 5bpm increments)*8
Sensor
Wavelength: 660nm (rd) 905nm (ir)
Brightness: 울15mW
Non-sterile, latex-free

✽ This unit meets the EMC (electromagnetic compatibility) requirements (IEC60601-1-2: 2001). It is in confor-
mity to IEC60601-2-20:1996, ISO9919:2005, IEC13976-1:2003, IEC13976-2:2003, ISO7767:1997 and IEC60601-
1:1995.

*1 This device is calibrated to display functional oxygen saturation.


*2 SpO2 70~100% hypoxia was induced in healthy adult volunteers with light skin and dark skin. Accuracy was
checked in no motion conditions against a laboratory CO-oximeter and an ECG monitor. Variability distri-
bution at this accuracy was 앐1SD. 앐1SD covers 68% of all data.
*3 SpO2 70~100% hypoxia was induced in healthy adult volunteers with light skin and dark skin. Accuracy was
checked by 1~2cm tapping 2~4 times per second and by 2~3cm irregular tapping 1~5 times per second
against a laboratory CO-oximeter and an ECG monitor. Variability distribution at this accuracy was 앐1SD.
앐1SD covers 68% of all data.
*4 In a laboratory test, in the range of 70~100% SpO2, accuracy in low perfusion conditions was checked
against the Biotec Index2 Simulator and the Masimo Simulator, both of whose signal strength is 0.02% or
more and permeability 5% or more. Variability distribution at this accuracy was 앐1SD. 앐1SD covers 68% of
all data.
*5 The materials accessible to the patient and the user comply with ISO 10993-1.
*6 All the sensors and patient cables that can be used with this device have been tested and verified by using
the Masimo SET technology (MS series boards).
*7 Since the measurements taken by the pulse oximetry equipment are statistically distributed, only about
two-thirds of them fall in the accuracy (Arms) range of values obtained with a CO-oximeter.

− 70 −
*8 Even if the power supply is interrupted due to power failure, disconnection of the power plug, or some other
cause, the preselected settings will be retained in the memory. When the power supply is resumed, the unit
will start operation with the last selected settings.
*9 The above specifications apply when the sensor and the patient cable specified by ATOM are used. For
information on the sensor and the patient cable specified by ATOM, contact your local Atom representative.

− 71 −
The unit for use in 100V regions doesn’t meet the requirements for CE marking.
For further information or questions, please contact the following representative if you are in an EU member
state. If you are not in an EU member state, please contact your local Atom representative.
C59M430

3-18-15, Hongo, Bunkyo-ku, Tokyo, Japan


Tel: +81 3 38152311 Fax: +81 3 38123144

201108

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