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PARKER

H e a l t h c a r e
0123

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.
Distributed by:

PARKER
H e a l t h c a r e

w w w . p a r k e r h e a l t h . c o m . a u

Parker Healthcare Pty Ltd


Head Office & International Department:
16 Redland Drive, Mitcham VIC 3132 Australia
Ph: +61 3 9872 0222 Fax: +61 3 9873 5911
Email: sales@parkerhealth.com.au
INTRODUCTION
This Operation Manual deals with the specifications, operation and maintenance of the V-808 Atom Trascapsule.
Atom is by no means held responsible for any malfunction arising from a user ignoring the instructions for opera-
tion and maintenance described in this Manual as well as for any accident attributable to repair by someone other
than technical personnel belonging to 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.

Used parts and products past their lives should be disinfected and/or sterilized and then disposed
of as medical waste.

INTENDED USE

The V-808 Atom Transcapsule is a closed-type transport incubator for neonatal and premature infants in-
tended 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 use the unit under optimum conditions (See “⁄1 Maintenance Inspection” 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 electric waves.

−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 to indicate 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. Mark to give instructions for action

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 a thunderbolt may fall.
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 see a relevant accompanying document before operating the
unit.

Fan
Indicates a control switch that controls the fan.

Lighting
Indicates a switch that controls lighting.

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.

−3−
Mark Title and Indication

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.

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.

−4−
WARRANTIES
This equipment is guaranteed by Atom Medical Corporation for a period of one year from the date of delivery to be
free of any defects in both materials and workmanship when used normally for its intended purpose. Any parts of
this equipment proving to be so defective will be repaired or replaced at no charge during the warranty period. In
the following cases, however, actual expenses need to be paid even during the warranty period.
(1) Wear and tear of expendable.
(2) Trouble and damage due to improper handling, such as dropping the unit during transport or transfer.
(3) Trouble and damage due to a fire, salt, gas, extraordinary voltage, earthquake, thunder, storm and
flood, or other natural calamities.
(4) Travel expenses in the case of a trip to an isolated island, a remote place, etc. for the purpose of repair.
Damage in shipment should be reported promptly to Atom accompanied by the certificate of the carrier con-
cerned.
All correspondence concerning the equipment should specify the model name and the serial number.

WARNING
Atom is by no means held responsible for compensation for death, injury or damage to property if such loss
should occur due to any of the following causes.
1. Probleme und Beschädigungen während der Installation, Wartung oder Reparatur durch Personal, das
nicht zu Atom gehört oder entsprechend von Atom autorisiert ist.Atom is by no means held responsible
for compensation for death, injury or damage to property if such loss should occur due to any of the
following causes.
2. Trouble or damage of Atom products caused by a product of another company other than that supplied
by Atom.
3. Trouble or damage due to modification, maintenance or repair using a part other than that specified by
Atom.
4. Trouble or damage due to neglecting the operating precautions or operating instructions described in
the Operation Manual of the unit.
5. Trouble of damage due to operation under ambient conditions, including electrical requirements and
installation requirements, other than those described in the Operation Manual.
6. Trouble due to carelessness or improper modification.
7. Trouble or damage due to using secondhand equipment.
8. Trouble or damage due to using the unit connected to a peripheral device which is not specified by
Atom, which does not meet the applicable requirements of the international standards IEC60601-1 and
IEC60601-1-2, or which is not equipped with equivalent safety features.

−5−
[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 contact immediately 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.

−6−
C O N T E N T S

INTRODUCTION ............................................................................................. 1
[1] Operating Precautions
1-1. DANGER ............................................................................................ 8
1-2. WARNING .......................................................................................... 9
1-3. CAUTION ........................................................................................ 11
[2] Parts Identification
2-1. Main Body .............................................................................................. 12
2-2. Main Body - Sides .................................................................................. 13
2-3. Main Body - Rear ................................................................................... 14
2-4. Main Body - Inside ................................................................................ 15
2-5. Mount ...................................................................................................... 16
2-6. Control Panel ......................................................................................... 16
[3] Setting Up the Incubator
3-1. Assembling ............................................................................................. 18
3-2. Locking the Caster ................................................................................ 19
3-3. Adjusting the Height of the Stand ........................................................ 19
3-4. Detaching/Attaching the Main Body from/to the Mount ................ 20
3-5. Where to Place the Incubator .............................................................. 21
3-6. Storing the Cylinders (500L) ................................................................ 21
3-7. Fixing the Incubator to an Ambulance ................................................ 21
3-8. Power Outlet and Grounding ............................................................... 22
3-9. Power Cord and Power Switch ............................................................. 22
3-10. Inspection before Use ........................................................................... 23
[4] Power Sources
4-1. AC Power ................................................................................................ 24
4-2. Internal Battery Power ......................................................................... 25
4-3. External DC Power (DC 12V/24V) ..................................................... 27
[5] Incubator Air Temperature Control and Placing the Infant in the Incubator
5-1. Setting the Incubator Air Temperature ............................................... 28
5-2. Placing the Infant in the Incubator ...................................................... 29
5-3. Skin Temperature Monitoring ............................................................. 31
[6] Pulse Oximeter
6-1. Attaching the Sensor ............................................................................. 33
6-2. Setting the Upper/Lower Alarm Limits .............................................. 37
6-3. Setting the Heartbeat Synchronous Sound ........................................ 38
[7] Oxygen Monitor
7-1. Calibration .............................................................................................. 39
7-2. Setting the Upper/Lower Alarm Limits .............................................. 40
[8] Oxygen Supply ............................................................................................. 41
[9] Other Operating Procedures
9-1. Drawing Out the Mattress Platform .................................................... 44
9-2. Arranging the cords and Tubes ........................................................... 44
9-3. Lighting Lamp ........................................................................................ 45
9-4. I.V. Pole ................................................................................................... 45
9-5. Test Switch ............................................................................................. 46
9-6. Reset Indicator/Reset Switch ............................................................... 46
[10] Cleaning, Disinfection and Maintenance ............................................... 47
[11] Maintenance Inspection ............................................................................. 52
[12] Alarms ............................................................................................................. 61
[13] Troubleshooting ........................................................................................... 64
[14] Technical Data .............................................................................................. 65
[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 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.

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 also when it is performed on an infant placed 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
even lose its life. 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 faulty, stop using the unit immediately and ask for repair.
The infant may fall.

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 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 rudely, 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.
Do not fasten the infant fixing band too tightly.
If they are fastened too tightly, they will press the infant dangerously.

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.
−8−
Do not use the unit in the presence of a flammable anesthetic gas.
The unit may cause 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 and 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 give a shock to the unit or allow it to be struck by other objects.


The screws or fixed parts may become loose.

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 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
men who handle this unit.

−9−
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
touch the electrolyte, wash it away immediately with a lot 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.
쎲 Do not pinch the power cord between the unit and the wall, a shelf or the floor.
쎲 Do not place the power cord near a heating apparatus or heat it.
쎲 Do not put anything heavy on the power cord.
쎲 Always 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.

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 and 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.

− 10 −
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.

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

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 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 expose the unit to extraordinarily high temperature or excessive


humidity.
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.

− 11 −
[2] Parts Identification
2-1. Main Body

t
w
y

i !0

!1

!2

쎲 Main body 쎲 Mount

No. Name No. Name


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

− 12 −
2-2. Main Body - Sides

쐽 Right side

t
i
y
u

q w e

쐽 Left side

o !0 !1 !2

No. Name No. Name


q Power switch u DC power breaker (for 12V)
w AC power input i Hood fixing knob
e External power input (24V/12V) o Test switch
r Oxygen supply port !0 Oxygen sensor connecting port
t AC power breaker !1 SpO2 sensor connecting port
y DC power breaker (for 24V) !2 Skin temperature probe connecting port

− 13 −
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

− 14 −
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

− 15 −
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.
− 16 −
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.

− 17 −
[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
Because the incubator is heavy, at least two powerful people should join forces in assembling the
unit.

The main body is shipped with the mount attached.

(1) Hang the hook of the mount fixing lever on the right Mount fixing lever
side of the stand on the frame of the stand by pulling
it slightly toward you to unlock the connection be-
tween 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
Frame
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 in the corresponding
holes in the bottom of the mount so that the mount Mount fixing lever
and the stand may 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 and the stand are Frame
locked together.
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 when a shock is given during trans-
port. Never operate the incubator before the
incubator is locked securely to the stand.

− 18 −
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.
(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 in three levels. 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 up or down the
frame. 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 come up suddenly.

− 19 −
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) Pull up the lever of the main body locking device on
each side of the incubator to unlock.

Lever

(2) Hold the handles of the main body with your partner
and join forces to pull up the main body simulta-
neously to detach.

(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 may face in the same direction, and put down
the main body onto the main body locking devices. Connector

“Front” mark

(4) Push down the lever of the main body locking de-
vice on either side of the incubator to lock.

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.

− 20 −
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 (500L)


Two 500L oxygen or air cylinders can be stored in the stand.
(1) Lay the cylinders through the cylinder holder for stor-
age. The cylinders can be stored from either side.

Cylinder

Cylinder holder

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

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

Cylinder fixing screw

3-7. Fixing the Incubator to an Ambulance


How to fix the incubator to an ambulance varies with the type of ambulance. Consult with the institutions
concerned (hospitals, the fire station) about this.

WARNING
Lock the main body of the incubator and the mount together securely with the main body locking
device on either side of the unit.

Lock the incubator and the stand together securely with the fixing lever.

CAUTION
To place the incubator in an ambulance, at least two powerful people should join forces. With the
sand lowered, two people should hold the stand and lift up the incubator.

− 21 −
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 and 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.

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.

− 22 −
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 pushbutton.

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 in 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.

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
should not close securely, don’t place any infant in the unit, and ask for repair.
− 23 −
[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.

− 24 −
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.

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 battery
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

− 25 −
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 depend on how it is used and stored.

WARNING
Do not throw a used battery into a fire or heat such 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 shock to a battery by dropping it, etc.

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

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

A battery contains dilute sulfuric acid. If it should leak out of the battery and touch the skin or
clothes, wash it away immediately with a lot of water. If it should get in the eye, wash it away with
a lot of tap water or other clean water and go to see a doctor. If dilute sulfuric acid should get in
your eye or touch your skin or clothes, you may lose your eyesight or get burned.

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 AC100V 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.

− 26 −
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 equivalent in 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.

− 27 −
[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, and conduct tempera-
ture 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, and con-
duct temperature tests with the unit empty in order to make sure that the incubator operates nor-
mally.

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.

− 28 −
(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 To open To open
fold down the front admittance panel gently toward
you.

To close
Front admittance panel
operating knob
Left side Right side

(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.

− 29 −
(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 rudely, 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 will press the
infant dangerously.

CAUTION

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

Opening the admittance panels or the access ports or using sheet with which to cover the infant, an
oxygen headbox, etc. in the incubator will change the air circulation pattern inside and may affect
thermal uniformity, thermal change, 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 greatly.

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.

− 30 −
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 a little 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 tempera-ture 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

− 31 −
(6) Allow 45 minutes after connecting the skin tempera-
ture probe for the skin temperature reading to stabi-
lize before starting skin temperature monitoring with
the skin temperature probe.
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 incompletely 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.

− 32 −
[6] Pulse Oximeter
6-1. Attaching the Sensor

CAUTION
Use only Masimo sensors to connect to the pulse oximeter of the unit. No other sensors can be
used.

6-1-1. Preparation before attachment

(1) Use either the neonatal sensor or the premie sensor


depending on the size of the infant and the site of Adhesive side of the ensor
attachment.
s For infants with fragile skin, such as very small
premature infants, it is recommended to diminish
the stickiness of the adhesive by rubbing the ad-
hesive areas with a swab to have cotton fibers stick
Swab
to them.

6-1-2. Attaching the sensor to the patient

Four kinds of sensors can be used for the pulse oximeter incorporated in this incubator: the neonatal dispos-
able sensor (L type) and the premie disposable sensor (L type) supplied with the incubator, and the optional
neonatal disposable sensor and the optional premie disposable sensor. Follow the steps below in attaching
each sensor.
쐽 Neonatal disposable sensor (L type)
q Open the pouch and take out the sensor.
Fig. A
Holding the sensor along the length of the “L”, remove
the backing from the sensor and bandage. Position
the detector onto the sole of the foot aligned with the
fourth toe (Fig. A).

Sole
Detector

Emitter

w Orient the emitter window on top of the foot directly


Fig. B Fig. C
opposite the detector. Wrap the bandage around the
foot to maintain proper alignment of the detector and
emitter windows (Fig. B).
Fix the bandage properly without applying excessive
tension (Fig. C).

− 33 −
쐽 Premie disposable sensor
q Open the pouch and take out the sensor.
Fig. A
Holding the sensor along the length of the “L”, remove
the backing from the sensor.
Position the detector onto the sole of the foot aligned
with the fourth toe (Fig. A).

Sole
Detector

Emitter

w Orient the emitter window on top of the foot directly


Fig. B Fig. C
opposite the detector. Wrap the bandage around the
foot to maintain proper alignment of the detector and
emitter windows (Fig. B).
Fix the bandage properly with a Velcro fastener with-
out applying excessive tension (Fig. C).

Velcro fastener

쐽 Neonatal disposable sensor


q Open the pouch and take out the sensor.
Fig. A
Holding the sensor along the length of the “Y”, remove
the backing from the sensor and bandage. Position
the detector onto the sole of the foot aligned with the
fourth toe (Fig. A).

Detector
Sole
Emitter

w Orient the emitter window on top of the foot directly


Fig. B Fig. C
opposite the detector. Wrap the bandage around the
foot to maintain proper alignment of the detector and
emitter windows (Fig. B).
Fix the bandage properly without applying excessive
tension (Fig. C).
Sensor properly applied

− 34 −
쐽 Premie disposable sensor
q Open the pouch and take out the sensor.
Fig. A
Holding the sensor along the length of the “Y”, remove
the backing from the sensor and bandage.
Position the detector onto the sole of the foot aligned
with the fourth toe (Fig. A).

Detector
Sole
Emitter

w Orient the emitter window on top of the foot directly


Fig. B Fig. C
opposite the detector. Wrap the bandage around the
foot to maintain proper alignment of the detector and Velcro fastener
emitter windows (Fig. B).
Fix the bandage properly with a Velcro fastener with-
out applying excessive tension (Fig. C).

6-1-3. Connecting to the patient cable and the main body

(1) Mate the logo on the sensor tab the logo on the pa- Patient cable
tient cable connector. Insert the sensor tab into the
patient cable connector.
Match logos

Sensor
Push the sensor tab into
the patient cable

Shiny contact

(2) Pass the plug of the patient cable through the tube
inlet out of the incubator, and insert it into the SpO2 SpO2 Connecting port
connecting port 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
Patient cable plug
rate display.

− 35 −
WARNING
If the pulse oximeter sensor is not handled properly, accurate measurements may not be ob-
tained. Moreover, it may cause tissue necrosis due to pressure at the sensor site, skin irritation
due to the adhesive or burns due to the light emitter.

Attach the sensor properly as instructed in this Operation Manual. Pay special attention to the
following points.
앫 Wrap the adhesive tape for fixing the sensor in place only lightly so that the sensor may just
stay on the skin. If it is wrapped too tightly, the circulation of the blood will be hindered and
measurements may not be obtained.
앫 The sensor is for single patient use only.
앫 The sensor is not sterile when shipped from the factory.
앫 The sensor should be a Masimo Sensor specially intended for pulse oximetry.

If the sensor is attached improperly to the patient, correct measurements may not be obtained.

If a sensor is left placed on the patient for an extended period of time, accurate measurements
may not be obtained. Moreover, you may miss tissue necrosis due to pressure, skin irritations
due to the adhesive or burns. The sensor site should be changed at least every eight hours.

Change the sensor site at least every two hours if the patient has poor circulation at the site;
otherwise the patient may get burned.

Check the circulation of the blood distal to the sensor site at all times.

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 intravascular dyes


may lead to inaccurate measurements.

Do not use the sensor during MRI scanning. Iron etc. will be attracted with its strong magnetism.

Do not attach the sensor to the arm to which a blood pressure cuff or an arterial catheter is
attached. It will reduce the circulation of the blood and make a pulse difficult to feel, so that
measurements may not be obtained.

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.

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

− 36 −
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.

− 37 −
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 “ ”.

− 38 −
[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 in calibrating it.
If the oxygen sensor indicator “ ” comes on,
calibration has failed. perform the calibration
procedure again.
− 39 −
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.

− 40 −
[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 and adjust the flowmeter and 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 till 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 intended for medical use.

Never supply humidified oxygen to the oxygen supply port.


Supplying humidified oxygen by means of a humidifier jar or other devices may damage the
oxygen supply port of the incubator.

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.

− 41 −
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 dirtiness of the filter
varies with the degree of air pollution and the frequency of operation. Check the dirtiness 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 dirtiness of the filter, the operating
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 accu-
rate 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.

− 42 −
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.

− 43 −
[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 on the
rails. If not on the rails, 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 let an infant fall down and
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 may 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

Cord

Tube inlet

− 44 −
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

Lighting lamp

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 then
tighten the twist lock to fix securely.

To To
tighten loosen

− 45 −
9-5. Test Switch
Press the test switch on the left side of the unit, and all
Test switch
the LEDs will turn on and the audible alarm will sound.
Thus you can make sure 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


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

Fuse
(for Battery 2)

Reset indicator
Reset switch

− 46 −
[10] Cleaning, Disinfection and Maintenance

CAUTION
Before cleaning or disinfecting the unit, be sure to turn 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 stain which might cause infection.

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

Obtain a soft clean cloth and a disinfectant detergent solution needed 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.

− 47 −
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
Remove the packings from the tube inlets. Immerse
Tube inlet packing
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.

− 48 −
10-2.Mattress Platform and Parts Beneath
Press the hood fixing knob and unlock the hood. Hold
up the hinges on the front admittance panel with both
hands. The hood stopper on the right side of the hood
will fall backward completely and the hood will be locked
in place.

WARNING
Clean and disinfect the heater and its sur- Hood fixing knob
rounding only when the heater has cooled
down sufficiently or you may get burned.

To raise the hood, be sure to hold the hinges


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

Before opening the hood, remove the light-


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

쎲 Mattress platform and infant fixing bands


(1) Hold the mattress platform by both sides.
Mattress platform
When it has come off the rails, lift it up and take to
out. Clean it with a soft cloth moistened with a disin-
fectant detergent.
(1) Remove the infant fixing bands from the mattress
platform and immerse it in a disinfectant detergent.
After disinfection, let it dry completely.

쎲 Middle deck and middle deck packing


Hold the middle deck by both sides, lift it and take it
out. Remove the middle deck packing from the middle Middle deck
deck.
Clean them with a soft cloth moistened with a disinfec-
tant detergent. The middle deck packing has the up-
side and the downside. Be careful not to attach it up-
side down to the middle deck.

Middle deck packing

− 49 −
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.

− 50 −
10-3.Others
쎲 Skin temperature probe
Wipe lightly a used probe 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.

− 51 −
[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 once a year or so.

앫 Parts requiring periodical replacement


Some parts need periodical replacement based on their period of use.

CAUTION
Medical institutions are responsible for performing maintenance inspection. They are allowed to
ask an appropriate external 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.)
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 it should not be broken or deformed. (Otherwise, airtightness may be
decreased.)
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 it 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 it 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.)
Oxygen sensor module It should not be broken or deformed. (Otherwise, the oxygen concentration
may not be detected correctly.)

− 52 −
Item to check Description
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.) (Otherwise, 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 36.00.1˚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 attached loosely, 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.

− 53 −
11-3. Parts requiring periodical replacement
Parts which become gradually deteriorated and 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 oxygen sensor is an expendable, whose life is greatly affected by the ambient conditions under which it
is used (i.e. ambient temperature, oxygen concentration). 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, its life will be reduced by half if the oxygen concentration or the ambient
temperature should be doubled. Therefore, when attached inside the incubator and exposed to the incuba-
tor air temperature of 36˚C and the oxygen concentration of 40%, its life will be reduced to 2/5 of its expected
life. Considering the fact that the oxygen sensor is exposed to the oxygen in the ambient air even when the
incubator is not in operation, its actual life will be about one year.

− 54 −
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 dirtiness 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 not to let the dirt
fly about.
(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.

− 55 −
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 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.

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 giving a mechanical shock to 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

− 56 −
(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

Lighting lamp

(2) Remove the screw on the left side of the lighting lamp. Lighting lamp
Screw

− 57 −
(3) Hold the lamp by the left side and slide it out.
Left side

(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.

Lighting lamp

(6) Slide on the lighting lamp cover and attach it as be-


fore. Lighting lamp cover

− 58 −
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?
2 Are the stand and the incubator mount attached to each other and locked securely? OK/NG
3 Are the casters attached securely and tightly? Can the stoppers be locked securely? OK/NG
4 Are the main body and the mount locked together securely? OK/NG
5 Are the access port covers free from any breakage and attached securely? OK/NG
6 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
7 OK/NG
admittance panel respectively?
8 Is a packing which is not broken attached securely to the tube inlet? OK/NG
9 Is the incubator air temperature sensor free from any breakage or deformation and attached securely? OK/NG
10 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?
11 OK/NG
Can the admittance panel be opened and closed reliably?
Are the hook sliders for the snap-open access ports not loose? Can the snap-open access ports
12 OK/NG
be opened and closed reliably?
13 Are the infant fixing bands free from any flaws and damage? OK/NG
14 Are the middle deck and the mattress platform installed securely? OK/NG
15 Is the middle deck packing attached correctly without being upside down? OK/NG
16 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
17 OK/NG
is pressed?
Do the battery 1 charge level indicator and the battery 2 charge level indicator come on as far
18 OK/NG
as the green zone when the power switch is turned on?
19 Does the filter not look blackish with dirt? OK/NG
Three-month Inspection
1 Is the incubator air temperature stable at the set point of 36.01˚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 not attached loosely, 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.

− 59 −
11-8. Life
The life of the unit is four years. Beyond this period overall maintenance including the replacement of parts
must be carried out.

11-9. 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.

− 60 −
[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 is in need of repairs.
Indicate on the incubator that it is out of order and contact your local Atom representative.

12-1.High Temperature Alarm HIGH TEMP HIGH TEMP


The HIGH TEMP indicator will flash and a continuous audible alarm will sound before the incubator air tem-
perature 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 3˚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? Isn’t 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. If another alarm should occur while the audible alarm is si-
lenced, 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, 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 SYSTEM
If any trouble should occur to the high temperature sensor or the incubator air temperature sensor, the SYS-
TEM 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
a bursting audible alarm (“pip pip peep 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 a bursting audible alarm (“pip pip peep 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 flash, and a bursting
audible alarm (“pip pip peep pip pip”) will sound.
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. 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 a bursting
audible alarm (“pip pip peep 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.

12-11. 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 a bursting audible alarm (“pip pip peep 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.

12-12. 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.

12-13. 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.)

12-14. 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.)

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[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 Hasn’t the AC power breaker opened the circuit?

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

The incubator air temperature does 앫 Isn’t the incubator air temperature set too low?
not rise. 앫 Isn’t the supply voltage low?
(The incubator should not share a power outlet with another device.)
앫 Isn’t 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 Isn’t the incubator air temperature set too high?
too high. 앫 Isn’t the incubator exposed to direct sunshine or affected by a heat-
ing apparatus nearby?
앫 Isn’t an air inlet in the incubator covered with diapers, gauze, etc?

The oxygen concentration does not 앫 Check the flow rate on the oxygen flowmeter.
rise. 앫 Isn’t 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 Rating: AC230V; power consumption 800VA; frequency 50Hz
Operating voltage range: AC230V10%
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
Mount: Battery 2 DC12V/48Ah
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
Ingress of water: With an enclosure not protected against the ingress of water
Not for use in air and flammable anesthetic gas or oxygen/nitrous oxide and flam-
mable 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)x49(D)x72(H)cm
Stand: 120(W)x52(D)x32~61(H)cm
Mattress: 62(W)x33(D)x3(T) cm
Weight Main body: Approx. 34kg
Mount: Approx. 27kg
Stand: Approx. 26kg
Maximum load I.V. pole: Approx. 3kg
Accessories I.V. pole ..................................................................... 1
Dust cover ................................................................ 1
Access port cover (for semi-iris access port) ....... 4
Access port cover .................................................... 1
Infant restraing strap ............................................... 3
Filter element E ....................................................... 1
Skin temperature probe .......................................... 1
Spare fuse ................................................................. 2
Neonatal disposable sensor (L type) ..................... 1
Premie disposable sensor (L type) ........................ 1
Patient cable (1.6m) ................................................ 1
Oxygen sensor ......................................................... 1

− 65 −
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: 1.0˚C)
Skin temperature display range 30.0~42.0˚C (accuracy: 0.3˚C)
Heater output 0~100 (in 10 levels)
Warming time 40 minutes (ambient temperature: 20˚C)
Alarms High temperature, set point, power failure, fan, skin temperature
probe, system failure

쐽 Oxygen concentration
Oxygen sensor Galvanic cell
Oxygen concentration display range 15~105%
Accuracy: 2% O2 in 15~25%
3% 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%)

쐽 Pulse oximeter
Display calibration Functional saturation
Display update cycle 1 second
SpO2 display range 1~100% SpO2, Accuracy: 3% SpO2 (in 70~100% SpO2)
SpO2 alarm setting range Upper limit: 50~100%SpO2,
OFF (in 1%SpO2 increments)
Lower limit: 45~95%SpO2,
OFF (in 1%SpO2 increments)
Pulse rate display range 25~240bpm, Accuracy: 3bpm
Pulse rate alarm setting range Upper limit: 80~240bpm,
OFF (in 5bpm increments)
Lower limit: 35~180bpm
OFF (in 5bpm increments)
Sensor Neonatal disposable sensor, premie disposable sensor
Wavelength: 660nm(rd) 905nm (ir)

− 66 −
✽ This unit meets the EMC (electromagnetic compatibility) requirements (IEC60601-1-2: 2001). It is in confor-
mity to IEC60601-2-20:1996, EN865:1997, ISO7767:1997 and IEC60601-1:1995.

− 67 −
C59M030

Distributed by:

PARKER
H e a l t h c a r e

w w w . p a r k e r h e a l t h . c o m . a u

Parker Healthcare Pty Ltd


Head Office & International Department:
16 Redland Drive, Mitcham VIC 3132 Australia
Ph: +61 3 9872 0222 Fax: +61 3 9873 5911
Email: sales@parkerhealth.com.au

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


Phone: +81-3-3815-2311
Fax: +81-3-3812-3144

8. 2004. PRINTED in Japan

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