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Atom Incu-I Operation Manual
Atom Incu-I Operation Manual
ORIGINAL
0123
Operation Manual
The unit is shipped without being disinfected. Be sure to clean and disinfect the unit before using
it for the first time after purchase.
The product and its parts that are past their service lives should be disinfected before being dis-
posed of in accordance with the applicable waste management laws.
This product maintains the ambient temperature around an infant by drawing in the air outside
and warming it. It does not have the capability to cool the air drawn from outside. Be sure to set
the incubator air temperature at least 3°C higher than the ambient temperature. In particular, if a
phototherapy unit, a heated humidifier, or some other heat-generating device is used with the in-
cubator, set the incubator air temperature at least 5°C higher than the ambient temperature. If a
lower setting is selected, the incubator may not be controlled correctly.
INTENDED USE
The Air Incu i is an incubator for newborns and premature neonates. It is mainly intended for temperature con-
trol in neonatal hypothermia, observation and examination in newborn nurseries, prevention of body tempera-
ture drop shortly after delivery, and pre-operative and post-operative intensive care in neonatal surgery. This in-
cubator has the capability to control the infant’s skin temperature.
1
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 when operating the
unit.
Basic Instructions
1. Follow the instructions for the safe use of the unit.
Please follow the operating instructions described in this Manual to help ensure safe use of the unit.
Three levels of warning indication are used throughout this Manual and on the unit. They are defined as
follows.
2
Definition of Symbols
1. Symbols to indicate danger, warning or caution
Symbol 《Title》and indication
General attention
Indicates unspecified general danger, warning or caution.
Caution:Withstand load
Indicates that the use exceeding the indicated maximum load capacity (withstand load) may
cause falling or damage of the unit.
No humidified oxygen
Indicates that humidified oxygen must not be supplied.
Do not immerse
Indicates that the humidity chamber must not be immersed in water.
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 contact
Indicates that touching a certain part of the unit where it may cause injury is prohibited under
certain conditions.
General instruction
Indicates unspecified general action on the part of the user.
3
4. Symbols of international standards (IEC)
Symbol 《Title》and indication
Type BF applied part
Indicates that the device is classified as Type BF in terms of the degree of protection against
electric shock.
Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manu-
facturer.
Date of manufacture
Indicates the date when the unit was manufactured in the factory.
WEEE symbol
In the EC area, an electrical and electronic product falling in one of the categories specified by
“DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27
January 2003 on Waste Electrical and Electronic Equipment (WEEE)” should be disposed of in
a manner consistent with relevant laws and regulations.
This symbol indicates that the above-mentioned requirement applies to this product.
Locked
Indicates a locked condition.
Unlocked
Indicates an unlocked condition.
Power on
Indicates the device is “ON”.
Stand-by
Indicates the device is “STAND-BY”.
Bell silenced
Indicates either a control switch to silence the bell permanently or temporarily, or that the bell is
silenced.
4
Symbol 《Title》and indication
Equipotentiality
Indicates the terminals which, when connected together, bring the various parts of an equip-
ment or of a system to the same potential.
5. Other symbols
Symbol 《Title》and indication
Setting
Indicates that a setting is increased.
Setting
Indicates that a setting is decreased.
Setting
Indicates set values or the setting procedure.
Skin temperature
Indicates the function related to the infant’s skin temperature or that the incubator is in servo
control.
Temperature
Indicates, with this symbol alone or with other symbols, a detected temperature or a set temper-
ature alarm.
Peripheral temperature
Indicates the function related to the infant’s peripheral temperature (skin temperature 2).
5
Symbol 《Title》and indication
Humidity
Indicates the function related to humidity.
O2
Oxygen
Indicates the function related to oxygen.
Gross weight
Indicates that the gross weight when peripheral devices of maximum loading capacity are at-
tached to the product is as inscripted.
AC power indicator
The indicator lamp comes on in green when the unit is connected to the AC power source. It
comes on in red when no power is supplied to the unit.
Interference
(Nellcor) Indicates that interference exists.
Pulse search
Indicates that no pulse is detected.
(Nellcor)
Press
Indicates that the lock function will be released when the key with this symbol is pressed.
6
Precautions on Jamming
The user (a hospital, a doctor’s office, a clinic) is responsible for the operation, maintenance and
care of the electrical equipment for medical use.
The equipment should be used only by medical personnel.
Prohibition of Modification
Periodical Inspection
Proper periodical inspection is needed to use the unit in the optimum condition.
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 your local Atom representative or service engineer immediately.
If any abnormal condition or trouble should occur, do not use the unit until it has been repaired
completely by a service engineer so as to prevent possible danger.
7
Contents
PREPARATION
Brightness ............................................ 79 15-1-2. Principle of Measurement ................ 115
10-1-7. Setting the Light Sensor Level .......... 79 15-2. Technical Data ............................................. 116
10-1-8. Setting the Alarm Volume ................... 80 15-3. EMC Level and Classification ................... 123
10-1-9. Setting the Clock ................................. 80
10-1-10. Checking and Resetting the
Operating Time of the Filter ............... 81
10-1-11. Checking and Resetting the Number
of Days the Oxygen Sensors Have
Been Used............................................ 81
10-1-12. Setting the Pulse Synchronization
Beep Volume ........................................ 81
OPERATION
10-1-13. Setting the Sensitivity Mode ............. 82
10-1-14. Setting the Averaging Time ............... 82
10-1-15. Setting the FastSat ............................. 83
10-1-16. Setting the SatSeconds ..................... 83
10-1-17. Setting the Response Mode ............. 84
10-2. Drawing out the Mattress Platform ............. 85
10-3. Tilting the Mattress Platform ....................... 86
10-4. X-ray Cassette Tray....................................... 86
10-5. Feeding Cables and Tubes into or out of
the Incubator.................................................. 87
MAINTENANCE
10-6. I/O port (External communication
connector) ...................................................... 88
10-7. Handle (option).............................................. 89
MAINTENANCE
[11] Cleaning and Disinfection .......................... 90
11-1. Hood Assembly ............................................. 91
11-2. Mattress Platform and Inside of
Incubator ........................................................ 93
11-3. Humidity Chamber ........................................ 96
11-4. Others ............................................................. 98
APPENDIX
Please follow the operating instructions described in this Manual to help ensure safe use of the unit. The unit
should be operated only by those who have received relevant training and instruction regarding its opera-
tion. 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.
Be sure to keep the admittance panels and snap-open access ports closed while the unit
is in use.
Using the unit with the admittance panel or snap-open access port left open may cause the infant to fall out of
the baby compar tment. Be sure to close the admittance panels and the access por ts when providing
phototherapy to an infant.
Do not leave the unit unattended when the admittance panel or snap-open access port is
open.
Otherwise, the infant may fall out of the baby compartment.
Stop using the unit immediately and request repairs if you find any abnormalities, such as
a misaligned admittance panel or snap-open access port, or a loose press lever.
The admittance panel or snap-open access port may unexpectedly open, causing the infant to fall out of the
baby compartment.
When providing phototherapy to an infant in the incubator, watch for a rise in the incubator
air temperature.
Since a mature infant emits a lot of heat, the incubator air temperature may rise if you place the infant in the
incubator and per form phototherapy. The incubator air temperature may also rise if you use multiple
phototherapy units at the same time, or if the room temperature is high. In such a case, proceed with the
phototherapy after placing the infant in a cot or an open-type incubator, as directed by the doctor.
Any type of ignition source, such as a hand warmer, must be kept away from the incubator.
Hand warmers or other items that may catch fire or devices that generate sparks may cause an explosion or a
fire if used near the unit when oxygen is being supplied.
10
Operating Precautions
Analyze arterial gas levels repeatedly when a high oxygen environment is required.
1-2. WARNING
Death or serious injury, damage to equipment or a fire will result if the instructions given below are not fol-
lowed.
Be sure to follow the doctor’s instructions when setting the incubator air temperature or
the infant’s skin temperature.
Be sure to follow the doctor’s instructions when setting the relative humidity in the incuba-
tor.
The doctor is responsible for making a decision regarding transporting a premature infant.
Be sure to observe the infant continuously during transport.
Transporting a premature infant is associated with a risk of intracerebral hemorrhage due to vibration during
transport.
Smoking is prohibited in the room where the unit is installed. Do not place any potential ig-
nition sources in the room.
Follow the doctor’s instructions when selecting an appropriate method of oxygen adminis-
tration, an appropriate oxygen concentration, and an appropriate duration of administra-
tion.
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. Be sure to follow the doctor’s instructions when
deciding the oxygen concentration on the basis of PaO2 (a measured arterial oxygen partial pressure level).
Bear in mind the following precautions while using oxygen supply equipment.
z A spontaneous and violent ignition may occur if oil, grease, or greasy substances come in contact with
pressurized oxygen. These substances must be kept away from oxygen regulators, cylinder valves, tubing
and connections, and all other oxygen supply equipment.
z On a high-pressure oxygen cylinder, only use tested pressure reducing or regulating valves marked for
oxygen service. Do not use these valves for air or gases other than oxygen. It is dangerous to use a valve to
supply a gas other than air or oxygen and then to supply oxygen again.
11
Operating Precautions
Do not use any devices that generate high frequencies near the unit.
Using electric surgical knives, mobile phones, or other devices that generate high frequencies near the unit
may cause malfunctions due to jamming.
Avoid connecting the unit to a power supply that uses a different voltage level than the rat-
ed one.
The electrical rating of this unit is as follows:
Power voltage AC230V; frequency 50/60Hz; power consumption 600VA; operating voltage range AC230V±10%
Do not connect the unit to any other power source.
12
Operating Precautions
The unit should only be serviced by qualified personnel in accordance with the appropriate
service manual.
Check for conformity to the applicable standard if the unit is going to be connected to an-
other medical device for use as a system.
Accessory equipment connected to the analogue and digital interfaces must comply with the relevant IEC
standards (e.g. IEC 60950-1 for data processing equipment). Furthermore all configurations should comply
with IEC 60601-1. However, the items that are not specified as part of the system should not be connected.
Anybody who connects additional equipment to the signal input or signal output configures a medical system,
and therefore is responsible for ensuring the medical system complies with the requirements of IEC 60601-1. If
in doubt, consult your local Atom representative.
1-3. CAUTION
Injury or damage to surrounding objects may result if the instructions given below are not followed.
Place the infant in the incubator only after the incubator air temperature has stabilized.
Be sure to always preheat the unit in order to keep the incubator air temperature stable.
When feeding the cords and tubes into the unit, be very careful not to let them wind or
tighten around the infant.
13
Operating Precautions
Unplug the power plug before moving the unit to another location or when the unit is not
used for an extended period of time.
Moving the unit to another location with the power plug connected to a power outlet will damage the power cord
and may cause a fire or electric shock.
Do not install the unit in excessively hot or humid places, excessively dusty environments,
or where it will be exposed to steam.
Installing the unit in such a place may cause a fire or electric shock.
Be sure to clean and disinfect the unit before using it for the first time after purchase.
The unit is shipped without being disinfected.
Remove the power plug from the power outlet before cleaning and disinfecting the unit.
Cleaning and disinfecting the unit with the power plug connected to the power outlet may cause electric shock.
When moving the unit, watch your step to ensure your feet do not get caught in the casters.
When moving the unit, do not put your hand on an admittance panel.
If you push or pull an admittance panel hard, the unit may be damaged. Be sure to assign at least two people to
hold the main body by hand when moving the unit.
When taking radiographs with the supplied X-ray cassette tray, read the instruction manual
for the X-ray equipment, and make sure that necessary protection measures are taken.
14
Operating Precautions
The user must operate the unit at a position facing the operation panel.
The incubator cannot differentiate between an increase in core temperature with a cold
skin (fever) and a low core and skin temperature (hypothermia). Monitor the temperature of
the infant.
15
Parts Identification
① ⑫ ⑱ ⑲⑳
②
⑬
③
④
⑤ ⑭
⑥
⑦ ⑮
⑯
⑧ u
Front Rear
JJ Mattress platform/Inside
②
③
④ ③
①
②
⑫
⑤
⑦
(for the unit provided with
a weight monitor)
⑨
No. Name
Tube introduction slit packing
Baby guard
Mattress
⑧ Mattress platform
⑩
X-ray cassette tray
Mattress platform tray
Middle board
Heater
Fan cover
Fan
Weight monitor unit
Tray for weight monitor
Weight monitor module
2-2. Display
① ② ③ No. Name
Alarm lamp
Operation panel
Power failure alarm indicator
Connector for the main body
I/O port
(external communication connector)
JJ Rear
17
Preparation before Use
3-1. Assembly
Do not perform the following operation while the infant is in the incubator.
(1) Attach the side hoods (head side/foot side) by Side hood (Head side)
placing the side hood fixing knobs to the attach-
ment position. Place the side hood fixing knobs to
the fixing position. Fixing Attachment
position position
(2) Move the left and right canopy securing sliders in-
Canopy securing sliders
wards and place the canopy on the side hood while
the unlocked symbols appear.
Secure the canopy by moving the left and right
canopy securing sliders outwards. The labels of the
canopy securing sliders are locked symbols .
18
Preparation before Use
(3) Attach the front and rear admittance panels by slid- Admittance panel axis slider
ing the admittance panel axis slider in the direction
of the arrow.
Attach the hinge caps to the admittance panel axis
sliders.
Admittance panel
PREPARATION
Hinge cap
(1) Insert the display pole into the pole hook on the
Display pole
main body. Tighten the thumbscrew to secure the
pole.
(2) Insert the display into the pole and secure it by Display
tightening the thumbscrew.
Thumbscrew
19
Preparation before Use
JJ Assembling the Weight Monitor Unit (for a unit equipped with a weight monitor)
(1) Run the weight monitor module cable through a Boss (reverse
hole in the mattress platform. Place the weight side)
monitor module on the mattress platform, aligning Holes for
two bosses on the back side of the module with attaching Boss
the boss (reverse side)
holes in the mattress platform.
Cable
20
Preparation before Use
Cutout
Cable
PREPARATION
(3) Insert the cable into the connector for the weight
monitor on the main body of the incubator. Weight monitor module cable
Avoid installing the incubator in direct sunlight, near a stove or a radiator, in the direct airflow of
an air conditioner, or by a cold window in order to prevent it from being directly affected by
such external thermal conditions.
Install the incubator on a level surface in a location where it is easy to operate. Avoid installing it near a heating
apparatus, beside a window, or where fire is used. Do not place it where chemicals may splash onto the display.
JJ To lock
Lower the stopper on the caster to the LOCKED position.
JJ To unlock
Raise the stopper on the caster to the FREE position.
To unlock
21
Preparation before Use
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.
In order to complete the ground connection, only connect the power cord to a correctly ground-
ed 3P power outlet.
Do not operate the unit if you have any doubts about its ground connection.
Power switch
22
Preparation before Use
JJ Memory function
Even if the power is turned off or the power supply should be interrupted due to power failure, disconnec-
tion of the power plug or some other cause, the preselected settings and the items to be displayed will be re-
tained in the memory. When the power supply is resumed, the last selected settings and display items will be
displayed and become functional.
PREPARATION
JJ To raise
Step on the right side ( ) of the foot switch con-
tinuously until the desired height is reached.
JJ To lower
Step on the left side ( ) of the foot switch continu-
ously until the desired height is reached.
23
Preparation before Use
If a power failure alarm does not go off when the power switch is turned on with the power
cord disconnected after recharging, contact your local Atom representative.
The unit contains a rechargeable battery for generating an alarm when the power supply has stopped. The
battery needs charging in any of the following cases:
z immediately after purchasing the unit
z after the activation of a power failure alarm
z when the unit has not been in use for a long time
z if no alarm or only a feeble alarm is heard when a power failure alarm is activated by turning the power
switch on with the power cord disconnected
The battery is charged automatically when the unit is connected to the supply mains.
It takes about 50 hours for a completely discharged battery to be fully recharged.
Always check that the admittance panel operating knobs and the snap-open access ports op-
erate correctly. If an admittance panel or a snap-open access port does not close securely,
stop using the unit and request repairs.
Be sure to inspect the unit at the start of each day. Operating the unit without inspecting it at
the start of each day may let a defect pass unnoticed and cause a potentially unfavorable out-
come.
Before using the unit, check it carefully for any faults, contamination, missing parts or defective parts to
make sure that it can be operated safely.
24
Display Screens
JJ Main screen
This screen appears first.
If any other screen is being displayed, touch ,
and the main screen will be displayed.
This screen displays the set temperature, the incuba-
OPERATION
tor air temperature, the skin temperature 1, the skin
temperature 2, the relative humidity, the oxygen
concentration, SpO2, the pulse rate, etc.
25
Display Screens
JJ Trend screen
Touch on any other screen, and the trend
screen will be displayed.
This screen displays trend graphs.
In addition, the set temperature, the incubator air
temperature, the skin temperature 1, the skin tem-
perature 2, the relative humidity, the oxygen concen-
tration, SpO2, the pulse rate, etc. are displayed.
JJ Menu screen
Touch on any other screen, and the menu
screen for advanced settings will be displayed.
Use this screen to select advanced settings. In addi-
tion, the set temperature, the incubator air tempera-
ture, the skin temperature 1, the skin temperature 2,
the relative humidity, the oxygen concentration,
SpO2, the pulse rate, etc. are displayed.
When this screen is displayed, you can only select
advanced settings of each menu item, or switch the
screen to another.
26
Display Screens
Menu screen
Trend screen
OPERATION
[Main screen] display switch
[Pulse oximeter screen] display switch
[Weight screen] display switch
[Trend screen] display switch
27
Display Screens
Pulse
Setting (measuring) Weight
Main screen oximeter Trend screen Menu screen
Operation screen✽4
screen✽3
Temperature-related
operation (manual/servo)
Setting humidity✽1
28
Display Screens
JJ Temperature area
Touch this area to start the temperature-related setting operation.
No. Name Description
Skin tempera- Displays a detected skin temperature 1
ture 1 display digitally.
Manual Control: Displays a set incubator air
Set tempera- temperature.
ture display Servo Control: Displays a set skin temperature
1.
Incubator air
Displays a detected incubator air temperature
temperature
digitally.
display
Heater output
Indicates the heat supply in 10 levels.
indicator
comes on in manual control and
Mode indicator
comes on in servo control.
Override (in manual control) or (in servo
indicator control) comes on in the override mode.
Displays a detected skin temperature 2 or T
Skin tempera-
(detected skin temperature 1–detected skin
ture 2 display
temperature 2) digitally.
OPERATION
No. Name Description
Relative
Displays a detected relative humidity in the
humidity
incubator digitally.
display
Set relative
humidity Displays a set relative humidity digitally.
display
Displays a symbol of the condition when the
Water level the level of water in the humidity chamber is
indicator lowered or when the humidity chamber is in
an abnormal condition.
JJ Oxygen area
Touch this area to start the oxygen-related setting operation.
No. Name Description
Oxygen
Displays a detected oxygen concentration in
concentration
the incubator digitally.
display
Set oxygen
concentration Displays a set oxygen concentration digitally.
display
Oxygen flow Indicates a detected oxygen flow rate in 6
rate indicator levels.
29
Display Screens
JJ Pulse area
Touch this area to start the pulse oximeter-related setting operation.
No. Name Description
Plethysmograph
Indicates changes in the arterial flow.
bar
%SpO2 display Displays a detected SpO2 value digitally.
Pulse rate
Displays a detected pulse rate digitally.
display
Pulse rate Displays a pulse rate upper alarm limit above
alarm limits and a pulse rate lower alarm limit below
display digitally.
SpO2 alarm Displays an SpO2 upper alarm limit above and
limits display an SpO2 lower alarm limit below digitally.
Interference
indicator Comes on when interference is detected.
(Nellcor only)
Pulse search
indicator Comes on when no pulse is detected.
(Nellcor only)
JJ Message area
Messages other than those related to operations are displayed in this area.
Message area
30
Display Screens
OPERATION
31
Display Screens
32
Display Screens
JJ Pulse area
Touch this area to start the pulse oximeter-related setting operation.
No. Name Description
%SpO2 display Displays a detected SpO2 value digitally.
SpO2 alarm Displays an SpO2 upper alarm limit above and
limits display an SpO2 lower alarm limit below digitally.
Pulse rate
Displays a detected pulse rate digitally.
display
Displays a pulse rate upper alarm limit above
Pulse rate alarm
and a pulse rate lower alarm limit below
limits display
digitally.
PI display
Displays the perfusion index.
(Masimo only)
Set sensitivity
Indicates the currently selected sensitivity
For the unit equipped with the Masimo indicator
pulse oximeter (Max, Normal, APOD).
(Masimo only)
FastSat
indicator Comes on when the FastSat mode is ON.
(Masimo only)
The numerical value on the left is the SatSec-
onds setting. The circular indicator on the
right changes color little by little clockwise
For the unit equipped with the Nellcor each time a detected SpO2 is found to be above
pulse oximeter the SpO2 upper alarm limit or below the SpO2
SatSeconds
lower alarm limit. When the whole indicator
display
has changed color, either the SpO2 upper limit
(Nellcor only)
OPERATION
alarm or the SpO2 lower limit alarm will occur
appropriately. The discolored area will
decrease little by little counterclockwise each
time a detected SpO2 is found to be within the
acceptable range.✽1
Fast Response Indicates that the response mode is set to
Mode “Fast.” This indicator will disappear when the
(Nellcor only) response mode is switched to “Normal.”
Interference
indicator Comes on when interference is detected.
(Nellcor only)
Pulse search
indicator Comes on when no pulse is detected.
(Nellcor only)
Pulse waves
Displays pulse waves.
display
Displays the Signal IQ (SIQ) bar graph.
The height of each bar is in proportion to the
SIQ display quality of the input signal concerned. The
(Masimo only) more reliable a measured value is, the higher
the bar becomes. The less reliable a measured
value is, the lower the bar becomes.
✽1 The higher the SatSeconds limit is set, the longer it takes for the upper or lower limit alarm to occur. Set
the SatSeconds limit appropriately by taking into consideration the patient’s condition. For example,
select a higher setting for monitoring an active patient whose %SpO2 values tend to fluctuate greatly.
The upper or lower limit alarm will occur even when the whole indicator has not changed color if a
detected %SpO2 value deviates from the acceptable range three or more times within 60 seconds.
33
Display Screens
Message area✽
(See p.30)
Clock and other indicators
area✽ (See p.30)
✽ The display of the screen display switch area, clock and other indicators area, and the message area is
the same as that described in “4-3. Main screen”. (Therefore, the explanation is omitted.)
Pulse area
✽ The display of the temperature, relative humidity, and oxygen areas is the same as that described in “4-4.
Pulse Oximeter Screen”. (Therefore, the explanation is omitted.)
34
Display Screens
JJ Weight area
OPERATION
35
Display Screens
JJ Trend area
36
Display Screens
✽1
Numerical valuesarea
Numerical values area
✽1
(See p.34)
(See p.32)
Message area✽✽2
Message area 2 (See p.30)
(See p.28)
Clock andother
Clock and otherindicators
indicators
area✽✽22 (See
area (Seep.28)
p.30)
✽2
Screen displayswitch
Screen display switch area
area ✽2
(See p.30)
(See p.27)
✽1 The display of the numerical values area is the same as that described in “4-5. Weight Screen”. (Therefore,
the explanation is omitted.)
✽2 The display of the screen display switch area, clock and other indicators area, and the message area is
the same as that described in “4-3. Main screen”. (Therefore, the explanation is omitted.)
OPERATION
JJ Menu area 1
This screen appears first when the menu screen is selected.
No. Name Description
Delete Trend Touch this switch to delete the trend data
Data switch displayed on the trend screen.
Delete Weight Touch this switch to delete the weight data
Data switch displayed on the weight screen.
Touch this switch to have the menu area 4
Pulse Oximeter
displayed for the pulse oximeter-related setting
switch
operation.
This switch is used for advanced settings of
Service Menu
the unit. For details of the operation of this
switch
switch, see the Service Manual.
Trend Period Touch this switch to select a trend period to be
selector switch displayed on the trend screen.
Touch this switch to have either a detected
Skin TEMP. 2 skin temperature 2 or ∆T (detected skin
Display switch temperature 1–detected skin temperature 2)
displayed in the temperature area.
°C/°F selector Touch this switch to switch the unit of tem-
switch perature from °C to °F, and vice versa.
Touch this switch to have the menu area 2
Next switch
displayed.
37
Display Screens
JJ Menu area 2
Select [Next] in the menu area 1 to enter this screen.
No. Name Description
LCD Screen
Touch this switch to set the brightness of the
Brightness
display screen to a desired level.
selector switch
Light Sensor Touch this switch to set the light sensor level
Level selector to a desired level in switching to the night
switch mode.
Go Back switch Touch this switch to return to the menu area 1.
Alarm Volume Touch this switch to set an alarm volume to a
selector switch desired level.
Clock setting Touch this switch to set the year, the month,
switch the date, the hour and the minute.
Touch this switch to have the menu area 3
Next switch
displayed.
JJ Menu area 3
Select [Next] in the menu area 2 to enter this screen.
No. Name Description
Touch this switch to check the number of
Filter used time
hours the filter has been used and reset the
RESET switch
elapsed time.
O2 Sensor days Touch this switch to check the number of days
of use RESET the oxygen sensors have been used and reset
switch the elapsed days.
Go Back switch Touch this switch to return to the menu area 2.
38
Display Screens
JJ Menu area 4
Select [Pulse Oximeter] in the menu area 1 to enter this screen.
<For the unit equipped with the optional Masimo pulse oximeter>
① ④ ⑤ No. Name Description
Synchronizing
Touch this switch to set the volume of the
Pulse Beep vol-
synchronizing pulse beep of the pulse oxim-
ume selector
eter to a desired level.
switch
Sensitivity Touch this switch to set the sensitivity of the
selector switch pulse oximeter to a desired level.
Go Back switch Touch this switch to return to the menu area 1.
Averaging Time Touch this switch to set the averaging time of
selector switch the pulse oximeter.
FastSat Touch this switch to enable or disable the
② ③ selector switch FastSat mode of the pulse oximeter.
<For the unit equipped with the optional Nellcor pulse oximeter>
① ④ No. Name Description
Synchronizing
Touch this switch to set the volume of the
Pulse Beep
synchronizing pulse beep of the pulse oxim-
volume selector
eter to a desired level.
switch
SatSeconds
Touch this switch to set SatSeconds as desired.
OPERATION
selector switch
Go Back switch Touch this switch to return to the menu area 1.
Response Mode Touch this switch to set the response mode of
selector switch the pulse oximeter as desired.
② ③
39
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
Two modes of incubator air temperature control are available in using the unit: the manual control mode and
the servo control mode. In the manual control mode, the heater output is controlled to achieve a preselected
incubator air temperature; in the servo control mode, a skin temperature probe is attached to the infant and
the heater output is controlled to maintain the infant’s skin temperature at a preselected level.
Be sure to follow the doctor’s instructions in setting the incubator air temperature.
Practice and master the operation procedure before placing the infant in the incubator, and
conduct temperature tests with the unit empty to check that it operates normally.
Check that the air inlets and outlets are not blocked with obstacles such as a diaper, gauze,
etc. If they are blocked, the temperature and the relative humidity in the incubator cannot be
controlled correctly.
Ensure that the sensor module is not covered with a cloth or other object. Otherwise, accurate
temperature and relative humidity readings will not be obtained.
40
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
5-1-1. Displaying and Setting the Incubator Air Temperature (Manual Control)
(1) When the power switch is turned on, an appropri- Mode Set Incubator air
ate mode indicator ( in manual control or indicator temperature temperature
OPERATION
(2) To change the set temperature, touch the tempera-
ture area. A message window used to select a tem-
perature control mode will appear.
41
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
42
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
The incubator air temperature can be set to above 37.0°C in the range of 37.1-39.0°C in 0.1°C increments by
using the override function.
(1) Touch the temperature area. A message window
used to select a temperature control mode will ap-
pear.
OPERATION
(4) When the incubator air temperature is set to
37.0°C or above, will be displayed in the tem-
perature area.
43
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
Always check the admittance panel operating knobs and the press levers of the snap-open ac-
cess ports for proper operation. If an admittance panel or a snap-open access port should not
close securely, do not place the infant in the incubator and seek repair.
NEVER open an admittance panel or an access port in order to lower the incubator air tem-
perature. This can be dangerous because the heater output will increase automatically to
maintain the incubator air temperature. This may also cause the infant to fall out of the baby
compartment.
After the infant has been placed in the incubator, check to ensure that the admittance panels
are closed securely.
For the infant’s safety, never leave the incubator unattended when an admittance panel or an
access port is open.
When opening or closing an admittance panel, be careful not to get the infant caught.
Do not place a load weighing 7kg or more (including the infant) on the mattress platform.
Place the infant in the incubator only after the incubator air temperature has stabilized.
While the infant is in the incubator, check the heater output, the incubator air temperature, the
relative humidity, the oxygen concentration, etc. continuously to make sure that the infant is not
disturbed.
Be sure to cover the mattress with an appropriate bed sheet. Since the mattress is not air-per-
meable, it may cause bedsores.
Opening an admittance panel or an access port, using a sheet to cover the infant or using an
oxygen head box, etc. in the incubator will change the air circulation pattern in the incubator.
This may affect the thermal uniformity and change, the detection and control of the incubator
air temperature, and the infant’s skin temperature.
Make sure there are no cords and/or tubes within the range of the motion of the admittance
panels.
44
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
Admittance panel
Close
operating knob
Open
Admittance panel
operating lever
Push
OPERATION
the “close” side in order to close the panel secure- Open Admittance panel
ly. operating knob
Admittance panel
operating knob Close
Open
(6) To close the port, push the port door until it closes
Red marking
completely. Make sure that the red marking on the
snap-open access por t is not visible after it is
closed. If the red marking is visible, close the ac-
cess port completely again.
45
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
46
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
Metal
Skin
z If the heat-sensing surface of the skin tempera-
ture probe is not correctly attached to the infant,
or if it accidentally comes off the infant, the skin
temperature will not be able to be detected accu-
rately. In servo control operation, in particular, im-
proper attachment of the skin temperature probe
OPERATION
may cause excessive heating. Be very careful
when attaching the skin temperature probe to the
infant.
z Follow the doctor’s instructions as to the site of at-
tachment of the skin temperature probe when the
infant is in a prone position.
47
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
The white skin temperature probe is mainly used to monitor the infant’s peripheral skin temperature.
(1) Follow the procedure described in “5-3-1. Skin
Skin temperature probe
Temperature Monitoring” to attach the yellow skin
connecting port 1
temperature probe to the infant. Skin temperature probe
connecting port 2
(2) Insert the cable plug of the white skin temperature
probe firmly into the skin temperature probe con-
necting port 2. Pull the cable into the incubator
through the tube introduction slit packing.
(3) Attach the white skin temperature probe to the in- White skin temperature probe
fant.
48
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
Be sure to follow the doctor’s instructions in setting the skin temperature. The “skin tempera-
ture” is defined as the infant’s “abdominal skin temperature” detected by the skin temperature
probe.
In the servo control mode, if the infant should produce heat spontaneously or should have de-
veloped a fever, the incubator air temperature may drop and/or some other adverse effects to
the infant may result.
Practice and master the operation procedure before placing the infant in the incubator, and
conduct temperature tests while the unit is empty to check that it operates normally.
Before starting servo control operation, have the incubator air temperature stabilized in manual
control first, and then switch the control mode to servo control.
While the infant is in the incubator, check the heater output, the incubator air temperature, the
relative humidity, the oxygen concentration, etc. continuously to make sure that the infant is not
OPERATION
disturbed.
In servo control, bear in mind that the skin temperature probe may cool down due to the in-
fant’s perspiration, which may cause the heater to start heating.
Monitor the infant’s core temperature separately during servo control operation.
In the servo control mode, the incubator air temperature is controlled by giving priority to the maintenance
of the infant’s skin temperature. It detects the infant’s skin temperature with a skin temperature probe at-
tached to the infant’s abdomen and maintains the optimum thermal environment through feedback control.
In the servo control mode, the incubator air temperature is controlled automatically to maintain the infant’s
skin temperature at a constant level (i.e. the set temperature); if the infant’s skin temperature is lower than
the set temperature, the incubator air temperature will rise, while if the infant’s skin temperature is higher
than the set temperature, the incubator air temperature will fall.
49
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
5-4-1. Preparation
(1) After turning the power switch on, check that is Mode indicator
displayed on the mode indicator.
Allow about 50~60 minutes for the incubator air temperature to stabilize in the manual control mode. After it
has stabilized, place the infant in the incubator by following the procedure described in “5-2. Placing the In-
fant in the Incubator.”
50
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
OPERATION
51
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
52
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
OPERATION
(2) Touch to select servo control. A message win-
dow used to set the skin temperature will appear.
53
Setting Incubator Air Temperature/Skin Temperature and Placing the Infant in the Incubator
The skin temperature can be set to above 37.5°C in the range of 37.6-38.0°C in 0.1°C increments by using
the override function.
(1) Touch the temperature area. A message window
used to select a temperature control mode will ap-
pear.
54
Humidity Control
Skip this section if your unit is not equipped with a humidification function.
Humidity should be controlled after the incubator air temperature has stabilized. Be sure to fol-
low the doctor’s instructions in humidity control.
Do not put water directly into the humidity chamber. Be sure to fill the cartridge tank with sterile
distilled water.
Allow the humidity chamber and the water in it to cool down sufficiently before removing the
humidity chamber. The temperature of the water in the humidity chamber can be high enough
to cause burns. The temperature of the water in the chamber will exceed 70°C.
Do not leave water inside the humidity chamber except when humidifying the incubator air.
OPERATION
To prevent the multiplication of microorganisms and the contamination of the humidity cham-
ber, empty the humidity chamber and the cartridge tank every 24 hours and refill the cartridge
tank with fresh, sterile distilled water.
The temperature of the sterile distilled water to pour in the cartridge tank should not exceed
40°C.
55
Humidity Control
(3) Take out the car tridge tank from the humidity
chamber. Humidity chamber
Cartridge
tank
(4) Open the cartridge tank cap and fill up the tank
with sterile distilled water.
Close the tank cap securely and place the tank Cartridge tank
56
Humidity Control
OPERATION
midity chamber because the chamber itself may
have become very hot.
57
Humidity Control
Indicates that there is no water in the humidity chamber when the humidity is
not controlled.
<Humidity chamber off>
Indicates that the humidity chamber is disengaged from the main body when
the humidity is not controlled.
<Defective humidity chamber>
Indicates that a fault has occurred in the humidity chamber when the humidity
is not controlled.
<Low water level alert>
Indicates that the water level in the humidity chamber is low while the humid-
ity is being controlled.
Humidity control is active
58
Oxygen Supply
The unit is capable of delivering oxygen to the inside of the incubator. If your unit is equipped with the oxy-
gen controller, the oxygen concentration in the incubator can be controlled.
The risk of fire hazards increases while oxygen is being supplied. Do not use body warmers or
other devices that may produce sparks around the unit.
When raising the oxygen concentration in the incubator, it is extremely important and essential
to periodically analyze arterial gas levels in order to maintain the desired oxygen concentration
in the incubator. Follow the doctor’s instructions for measuring the oxygen concentration be-
cause ignoring essential requirements may increase the risk of retinopathy of prematurity and
other adverse effects.
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. Be sure to follow the
OPERATION
doctor’s instructions regarding the concentration of oxygen delivered to the inside of the incu-
bator.
While oxygen is being supplied, continuously measure the oxygen concentrations in the incu-
bator using an oxygen monitor. Pay particular attention to changes in oxygen concentration. If
the oxygen concentration in the incubator deviates from a desired level, make necessary ad-
justments by increasing or reducing the oxygen flow rate.
A spontaneous and violent ignition may occur if oil, grease, or greasy substances come in
contact with pressurized oxygen. These substances must be kept away from oxygen regula-
tors, cylinder valves, tubing and connections, and all other oxygen supply equipment.
On a high-pressure oxygen cylinder, only use tested pressure reducing or regulating valves
marked for oxygen service.
Never supply humidified oxygen from the oxygen supply port. Humidified oxygen may damage
the internal oxygen supply valve.
The oxygen flowmeter cannot be expected to provide an accurate index of the oxygen concen-
tration in the incubator. Check the oxygen concentration using a calibrated oxygen monitor by
following the doctor’s instructions.
59
Oxygen Supply
The oxygen concentration in the incubator varies with the operating conditions of the incuba-
tor, the accuracy of the oxygen flowmeter, etc. To accurately maintain the oxygen concentration
inside the incubator at a desired level, measure it repeatedly using an accurate oxygen moni-
tor.
Before using the incubator, check the oxygen sensors for any sign of deterioration or leakage,
and replace them immediately if any cracks should be found on the outside.
The oxygen sensor is a sealed unit that contains potassium hydroxide electrolyte. The electro-
lyte may leak out if the sensor is damaged when dropped, etc. If contact with the skin or cloth-
ing occurs, wash the area using large amounts of water. In case of eye contact, flush eyes im-
mediately using large amounts of water and consult a doctor.
Be sure to perform the 21% calibration (calibration of the oxygen sensor to the air) when oxy-
gen is not in use before using the unit for a new patient (before disinfection). If the 21% calibra-
tion is performed while oxygen is being supplied to the incubator or after it is supplied to it, oxy-
gen inside the hood will leak and may affect the calibration.
The oxygen concentration in the incubator may be affected when the snap-open access ports
or admittance panels are opened. Any open gaps in the incubator hood may reduce the incu-
bator’s internal oxygen level. Make sure that the tube introduction slit packing is correctly at-
tached.
A dirty filter will affect the oxygen concentration. Check the filter. If it is dirty, replace it.
When you use the oxygen flowmeter to supply oxygen, the supply flow rate must not exceed
10L/min. If it exceeds 10L/min, the oxygen supply hose may come off.
Supplementing oxygen may increase the noise level for the infant inside the incubator.
60
Oxygen Supply
OPERATION
oxygen concentration in the incubator has stabi-
lized. Pay particular attention to changes in oxy-
gen concentration.
z Be sure to supply oxygen to the oxygen supply
port 1 through the oxygen flowmeter (option).
61
Oxygen Supply
Be sure to calibrate the oxygen controller with the oxygen in the atmosphere (21%O2) before
using it.
Check the oxygen concentration as appropriate to make sure that oxygen is being supplied at
a prescribed level.
If any abnormal condition or trouble should occur to the oxygen sensors or the oxygen control-
ler while oxygen is supplied, turn the oxygen controller off immediately and then switch the ox-
ygen supply source to the oxygen flowmeter. Measure the oxygen concentrations in the incu-
bator continuously using another oxygen monitor while paying particular attention to any
changes in oxygen concentration. However, this should only be a temporary measure. After
use, indicate on the unit that it is out of order, and do not use the oxygen controller until it has
been repaired.
62
Oxygen Supply
OPERATION
7-2-3. Calibrating the Oxygen Sensor
Sensor module
63
Oxygen Supply
64
Oxygen Supply
OPERATION
65
Pulse Oximeter
Wrap the adhesive tape for securing the sensor, but not too tightly. Wrapping it too tightly will
hinder the circulation of the blood and may result in no measurements.
Failure to correctly attach the sensor to the infant may result in inaccurate measurements.
Leaving the sensor attached to the infant for a long time may result in inaccurate measure-
ments. Moreover, it may cause necrosis due to compression, and skin irritation due to applica-
tion of adhesive tape. Change the sensor site at least every eight hours.
Make sure that the emitter and the detector face each other across the tissue.
Do not attach the sensor to the hand or foot to which a blood pressure cuff or an arterial cath-
eter is at-tached.
Do not expose the sensor to xenon light, phototherapy light, fluorescent light, infrared light or
direct sunlight. Otherwise, the performance of the sensor may be affected.
The plethysmograph on the display is not proportional to the size of the detected pulse. (For
the unit equipped with Masimo pulse oximeter)
66
Pulse Oximeter
The plethysmograph on the display is proportional to the size of the detected pulse.
(For the unit equipped with Nellcor pulse oximeter)
Before attaching the sensor to the infant, connect the patient cable to the unit to confirm that
an alarm occurs.
Only use sensors and patient cables specified by Atom to connect to the pulse oximeter in this
unit. Do not use any other sensors or patient cables.
Do not set alarm limits to extreme values that render the monitoring system useless. Please
check the upper/lower alarm limit settings and confirm that it is appropriate for the patient be-
ing monitored.
OPERATION
(1) Connect the patient cable to the SpO2 sensor.
(2) Guide the patient cable out of the incubator
through the tube introduction slit and plug the ca-
ble into the connector for SpO2 on the back of the Plug of the patient cable
main body.
After a short time, a detected SpO2 value appear in
the SpO2 display and a detected pulse rate appears
Connector for SpO2
in the pulse rate display.
67
Pulse Oximeter
68
Pulse Oximeter
OPERATION
80~240bpm in 5bpm increments. To set the upper
limit alarm to OFF, touch when 240bpm is dis-
played. The pulse rate upper alarm limit will be dis-
played as “— —”.
The lower alarm limit can be set in the range of
35~180bpm in 5bpm increments. To set the lower
limit alarm to OFF, touch when 35bpm is dis-
played. The pulse rate lower alarm limit will be dis-
played as “— —”.
(4) When the setting procedure is completed, touch
to close the message window.
69
Weight Monitor
This chapter contains instructions for operating the weight monitor. Skip this chapter if your unit is not
equipped with a weight monitor.
Ensure that the mattress platform is level before weighing the infant. If the mattress platform is
not level, the user may not be able to obtain accurate readings.
Be sure to place the infant in the center of the mattress in order obtain accurate readings.
Routing of the infusion tubing, the cables of the heart rate monitor, the respiration monitor or
other devices may affect the weight measurement. During the weighing procedure, ensure that
no forces are applied to the tubing and cables.
Do not put any unnecessary objects on the mattress, and be sure to secure a large area on
the mattress when weighing the infant.
Before weighing the infant, make sure that the bed sheet and the instruments on the mattress,
etc. are within the boundary of the mattress. Failure to do so can result in inaccurate readings.
Do not lean on the incubator while weighing the infant. Otherwise, inaccurate readings can oc-
cur.
To ensure accurate readings, calibrate the weight monitor periodically. Please contact your lo-
cal Atom representative for calibration.
9-1. Preparation
Level
70
Weight Monitor
2016
OPERATION
(3) Lift up the infant, and the tare deduction process
will be started automatically. A message “Tare in
progress.” will appear.
✽ If the “Failed to deduct tare” message appears,
see “ If deduction of tare weight or measure-
ment does not work correctly:” on page 73.
71
Weight Monitor
72
Weight Monitor
OPERATION
(4) Make sure that the weight reading is “0”, and then gently place the infant on the mattress.
(5) Once the reading has stabilized, touch . The reading will stay constant.
✽ If the “Reading unstable.” message appears, see “ If deduction of tare weight or measurement
does not work correctly:” described above.
73
Weight Monitor
74
Weight Monitor
OPERATION
1 connected properly.
unconnected
Check the weight measuring section for proper connection.
Weighning scale abnormal An abnormal condition of the weight monitor has been detected.
2
(E-F0) The weight monitor is considered faulty.
75
Other Operation Procedures
Menu area 2
Menu area 4
<For the unit equipped with the optional
Nellcor pulse oximeter>
Menu area 3
76
Other Operation Procedures
OPERATION
(2) Touch to delete the weight data.
Touch to cancel this procedure.
Note that if the trend period is changed, past trend data will be erased. Erased data cannot be
recovered.
The trend period that is displayed in a single trend screen can be set to 1, 3, 6, 12 or 24 hours.
77
Other Operation Procedures
78
Other Operation Procedures
OPERATION
10-1-7. Setting the Light Sensor Level
The unit is provided with a night mode in which the screen background turns black depending on the light
level of its surroundings. The light sensor level at which the screen automatically switches to the night mode
can be set.
(1) Touch [Light Sensor Level] in the menu area 2,
and a message window for setting the light sensor
level will appear.
79
Other Operation Procedures
80
Other Operation Procedures
10-1-11. Checking and Resetting the Number of Days the Oxygen Sensors Have Been
Used
OPERATION
oxygen sensors have been used. The display shows
the number of days for which the sensors have
been used.
81
Other Operation Procedures
82
Other Operation Procedures
When the FastSat is enabled, it becomes possible to detect rapid changes in %SpO2.
(1) Touch [FastSat] in the menu area 4, and a message
to confirm whether to enable/disable the FastSat
will appear.
When FastSat is currently disabled:
“Enables FastSat”
When FastSat is currently enabled:
OPERATION
“Disables FastSat”
(2) Touch [OFF], [10], [25], [50] or [100] to set the de-
sired SatSeconds alarm limit.
When the setting procedure is completed, touch
to close the message window.
83
Other Operation Procedures
OxiMax™ Algorithm
The advanced signal processing of the OxiMax al-
gorithm automatically extends the amount of data
required for measuring SpO2 and pulse rate de-
pending on the measurement conditions. During
normal measurement conditions in the Normal
Mode, the SpO2 averaging time is six (6) to seven
(7) seconds or approximately three (3) seconds in
Fast Mode. Equivalently, the typical pulse rate av-
eraging time is approximately five seconds, inde-
pendent of response mode.
84
Other Operation Procedures
Before drawing out the mattress platform, check that the mattress platform stopper has en-
OPERATION
gaged the rail. If it has not engaged, the mattress platform will come off, posing a risk of injury.
When the weight monitor unit is being used, do not forcefully pull the cable when sliding the
mattress platform out of the incubator. Do not get the cable caught in the mattress platform
and do not push it into a gap when placing the mattress back into place.
When drawing out the mattress platform with the infant on it, be careful not to get the patient
circuit pulled out or pulled by force.
85
Other Operation Procedures
When the mattress platform is tilted, there will only be a little difference in the level between
the mattress and a snap-open access port. If a snap-open access port is left open, the infant
may fall out through it. Be sure to close the snap-open access ports securely.
When the weight monitor unit is being used, do not forcefully pull the cable when tilting the
mattress platform. Do not get the cable caught in the mattress platform and do not push it into
a gap when placing the mattress back into place.
When tilting the mattress platform, be careful not to get any probes or tubes caught.
Mattress platform
tilting knob
When taking radiographs with the supplied X-ray cassette tray, read the instruction manuals for
the radiation device, and make sure that necessary protection measures are taken.
Open
86
Other Operation Procedures
Admittance panel
operating lever
Push
(3) Draw out the X-ray cassette tray from under the
mattress platform. X-ray cassette tray
OPERATION
10-5. Feeding Cables and Tubes into or out of the Incubator
Always guide the cords and tubes into the incubator in such a way that they will not get
wrapped around the infant.
Always watch the infant to prevent cords or tubes from being wrapped around the infant.
87
Other Operation Procedures
To prevent a risk of an electric shock, only connect equipment that provides a level of safety
equivalent to medical electric equipment that complies with the requirements of IEC 60601-1:
2005. Connect these devices to a common protective grounding system.
Install any piece of equipment that is connected to the unit to a patient environment defined in
IEC60601-1:2005.
The I/O port is intended to display and log the operations status of the unit on an external com-
puter or other devices. The unit cannot be controlled from the external computer.
Be sure to follow the “External communication specifications” when using the communication
function. For information about the “External communication specifications”, please contact
your local Atom representative.
I/O port
(external communication
connector) Display
88
Other Operation Procedures
OPERATION
89
Cleaning and Disinfection
Before cleaning and disinfecting the unit, be sure to turn the power off, remove the power plug
from the power outlet, and allow the incubator and the heaters to cool down sufficiently.
The heaters remain very hot after use. Allow the heaters to cool down sufficiently before clean-
ing and disinfecting them in order to avoid burns.
A fire and explosion hazard exists when performing cleaning in an oxygen-enriched environ-
ment. Turn off the oxygen supply and disconnect the oxygen supply hose from the incubator
before cleaning the incubator.
The unit is shipped without being disinfected. Be sure to clean and disinfect the unit before us-
ing it for the first time after purchase.
To prevent infections, disinfect the unit at regular intervals. The intervals to disinfect and disinfec-
tion methods vary depending on the usage frequency and the environment in which the unit is
used. Medical institutions that use the unit should determine appropriate disinfection intervals
and methods.
For the concentration, duration of effectiveness and handling of the disinfectants you use, fol-
low the directions for use and dosage and precautions provided by the manufacturers.
Be sure to dilute disinfectants, such as Osvan, Hyamine, and Hibitane. NEVER use undiluted
solution.
Do not use any abrasive cloth, cleaner, alcohol, acetone or other types of solvent for cleaning
or disinfecting.
Turn the power switch off and unplug the power plug before cleaning and disinfecting the unit.
Clean and disinfect the unit whenever it is used for a different infant.
Clean and disinfect the unit whenever you notice any dirt or contamination which may intro-
duce an infection.
After cleaning and disinfecting, reassemble the removed parts correctly and check that the unit
operates normally.
After cleaning and disinfecting, remove the disinfectant solution thoroughly from the incubator
before using it.
Provide a soft clean cloth and a disinfectant solution suitable for cleaning and disinfection.
90
Cleaning and Disinfection
Tube
introduction
slit packing
z When putting the hood assembly back into place,
ensure that it is seated all the way in each pack-
ing on the hood.
MAINTENANCE
Lever
(4) Open the admittance panel, gently lift the boss Admittance panel
shown in the right figure with a dotted line and re-
move the inner panel by sliding it in the direction
of the arrow.
Inner panel
91
Cleaning and Disinfection
Admittance panel
(6) Move the left and right canopy securing sliders in-
Canopy securing sliders
wards and lift the canopy to remove while the un-
locked symbols appear.
(7) Turn each of the four hood panel fixing knobs to Side hood (Head side)
unlock the position and remove the side hoods
(head side/foot side).
Lock Unlock
position position
92
Cleaning and Disinfection
MAINTENANCE
z When placing the mattress platform back into
place, put it in the center of the mattress platform
tray and make sure that the legs of the mattress
platform are in the groove of the rail.
93
Cleaning and Disinfection
JJ When the unit is equipped with a weight monitor unit (If your unit is not equipped with it, go to step (4))
(3) Remove the tray for weight monitor and weight
Tray for weight
monitor module from the mattress platform. monitor
Weight monitor
z Do not immerse the weight monitor module in liq- module
uids. Doing so may cause it to malfunction.
Mattress
platform
(4) Pull the hook on the mattress platform tray in the Mattress platform tray
direction of the arrow and remove the platform by
lifting it up.
Tilting arm
(5) Hold one end of the middle board with one hand Middle board
and hold a slot in the fan cover with the other
hand, and then remove the middle board.
Fan cover
94
Cleaning and Disinfection
Fan
z When placing the fan back into place, be sure to
push the fan onto the shaft as far as it will go.
MAINTENANCE
z When putting the heater back down, push it down
gently.
z When propping the heater against the condition-
ing chamber, be sure to do so gently.
95
Cleaning and Disinfection
96
Cleaning and Disinfection
(2) Remove the cartridge tank, the tank cap and the Boiler cap Humidity
boiler cap from the humidity chamber and disinfect chamber
them.
Parts that are to
be cleaned by Cartridge tank
immersing them Tank cap
in a disinfectant Boiler cap Tank cap
solution
Cartridge tank
Parts that are to
be cleaned us-
ing a soft cloth
that has been Humidity chamber
soaked in a dis-
infectant solution
and wrung out
Boiler
z The humidity chamber contains electric parts.
Never immerse it in a disinfectant solution. Do not
rub the water level sensor of the humidity cham-
ber or the surface of the boiler with a metal brush
Water level
or any other hard material. Otherwise, it may sensor
cause a malfunction.
MAINTENANCE
z Be sure to attach the boiler cap and the cartridge
tank without fail.
97
Cleaning and Disinfection
11-4. Others
JJ Display
Body: Clean it using a soft cloth that has been soaked
in a disinfectant solution and wrung out.
LCD panel: Clean the surface of the liquid crystal pan-
el lightly with a dry cloth. Use a specified
disinfectant solution when necessary.
JJ Mattress
Take out the mattress before placing another infant in
Mattress
the incubator. Clean the mattress with a soft cloth
dampened with a disinfectant solution. Since the mat-
tress consists of a special sponge sealed up in a vinyl
cover, the sponge inside cannot be contaminated unless
the cover gets damaged.
98
Maintenance Inspection
In order to use the unit safely for a longer period, perform the maintenance inspections described below.
Clean and disinfect the unit and its accessories before maintenance inspections, repairs, or
disposal
z Periodical inspection
Inspections should be carried out approximately once a year. Contact your local Atom representative for
periodical inspection.
Keep this Manual in a location that is readily accessible should any problems occur on the
MAINTENANCE
unit.
If any problems are detected during any inspection, indicate on the unit that it is out of order,
arrange repairs without fail, and do not use the unit until it has been repaired. Contact your lo-
cal Atom representative for further information on repairs.
The inspection checklist before use is used to carry out an operation check before using the
unit. In order to maintain the cleanliness of the interior of the incubator, it does not contain any
items involving checking of temperature, humidity, or oxygen concentration control functions. If
any problems are detected in relation to any of the control functions during use, indicate on the
unit that it is out of order and do not use the unit until it has been repaired.
99
Maintenance Inspection
Date of
Device Name Air Incu i
Inspection
Serial No. Inspector
1 Main body (3) When the admittance panels and snap-open access ports are fully
closed, do they stay locked in place when they are pushed from
the inside?
Operation
Before (1) Does the power failure alarm activate when the power switch is
connecting the turned on?
power cord
(2) When the power switch is turned on, does the alarm lamp come on
and is the startup sound emitted?
2
Operation (3) Is it possible to successfully configure the settings for temperature,
After humidity and oxygen concentration?
connecting the * The oxygen concentration can be set when the unit is equipped
power cord with an oxygen controller.
* The humidity can be set when the unit is equipped with a humid-
ification function.
100
Maintenance Inspection
Date of
Device Name Air Incu i
Inspection
Serial No. Inspector
(4) Are the admittance panels and snap-open access ports securely
locked?
1 Main body
(5) Are the air inlets and outlets free of obstacles that may block air
circulation?
* Check that no objects are placed in any spaces other than the
mattress in the incubator.
MAINTENANCE
equipped with a humidification function)
* Check the ambient humidity. It is not possible to reduce the incu-
bator humidity below the ambient humidity.
101
Maintenance Inspection
Date of
Device Name Air Incu i
Inspection
Serial No. Inspector
(2) Are all casters firmly mounted, and able to turn smoothly and be
locked securely?
(3) Are the access port covers free of damage and deformation, and at-
tached securely to the access ports?
(6) Are the press levers of the snap-open access ports secured tightly
and able to work correctly to open and close the snap-open access
ports?
When the snap-open access ports are fully closed, do they stay
locked in place when they are pushed from the inside?
(1) Does the power switch turn the power on and off reliably?
(2) Does the mattress platform tilting knob turn smoothly? Does the
mattress platform smoothly tilt as the knob is turned?
* Check that the mattress platform is correctly set.
(4) Is a sound alarm activated when the power switch is turned on and
the power plug is removed from the power outlet?
Overall judg- Are any abnormalities discovered after performing the above inspec-
3
ment tions?
102
Maintenance Inspection
✽ The oxygen sensor is a consumable item and its life is affected greatly by the ambient conditions under which it is
used (i.e. ambient temperature, oxygen concentration). It is recommended to replace an oxygen sensor when more
than one year has passed since it was taken out of its package.
MAINTENANCE
103
Maintenance Inspection
Replace the old filter with a new one every three months as a general rule. The degree of filter
contamination varies with the level of air pollution or frequency of use. Check the filter for con-
tamination through the window of the filter cover. If the filter is discolored, replace it with a new
one even if it has not been used for three months.
Dispose used filters in accordance with the designated disposal procedure of each hospital.
(1) Loosen the screw of the filter cover and open the
cover.
Filter cover
✽ The unit counts the hours for which the filter is used. When the time comes to replace it, a message
appears on the screen to remind the user to do so. The message remains unless you reset the counter
after the filter is replaced.
To reset the counter, see “10-1-10. Checking and Resetting the Operating Time of the Filter.”
104
Maintenance Inspection
As part of a daily inspection routine, check the oxygen sensor for any signs of deterioration or
leaking liquid. If any cracks are found on the external surface, replace it immediately with a
new one.
The oxygen sensor is a sealed device containing a potassium hydroxide electrolyte. The elec-
trolyte may leak out if the sensor should be damaged when dropped, etc. If the electrolyte
should touch your skin or clothes, wash it away with copious amounts of water. If it should get
in your eye, wash your eye immediately with copious amounts of water and consult the doctor.
Dispose of a used oxygen sensor in accordance with the appropriate disposal procedure.
There are small holes in the bag containing the oxygen sensor. They are intended to prevent a
voltage defect which can occur during initial use if the oxygen sensor is contained in airtight
packaging. Thus there is no effect on the replacement period which Atom recommends for the
oxygen sensor.
If an oxygen sensor alarm remains on, the oxygen sensors may be defective. Replace them.
Wait at least one hour after attaching the oxygen sensor to the incubator before using it. The
electrolytes contained in the oxygen sensor are not equalized immediately after installation, so
MAINTENANCE
sensor output is therefore unstable and an oxygen sensor alarm may occur.
Avoid direct sunlight and high temperature when storing the oxygen sensor.
The life span of the oxygen sensor varies depending on the ambient conditions under which it
is used. It is recommended that an oxygen sensor be replaced when more than one year has
passed since it was first used.
105
Maintenance Inspection
Lever
Sensor module
(2) Remove the oxygen sensor cap and remove the Oxygen sensor cap
two oxygen sensors from the sensor module.
(3) Attach two new sensors to the module by fitting
each sensor head correctly in the corresponding Cable
holder in the module. Replace the oxygen sensor
cap.
(4) Put the sensor module back into place. After con-
necting the sensor module connector to the main Oxygen sensor
body, calibrate the sensors. (For information on
how to calibrate an oxygen sensor, see “7-2-3. Cali-
brating the Oxygen Sensor”.)
✽ The unit counts the hours for which each oxygen sensor is used. When the time comes to replace it, a
message appears on the screen to remind the user to do so. The counter must be reset after the oxygen
sensors are replaced. Otherwise, the message will remain on.
To reset the counter, see “10-1-10. Checking and Resetting the Operating Time of the Filter.”
12-5. Disposal
The medical institution concerned is responsible for proper disposal of the main body, old parts past their
expected life span and disposables in accordance with applicable waste management laws and regulations.
Rechargeable NiMH batteries, a button type lithium battery and oxygen sensors are used in this unit.
Dispose of the batteries and the oxygen sensors in accordance with local regulations.
106
Alarms
[13] Alarms
This incubator is provided with the following alarms. If an alarm condition should occur, check
for a possible cause of the alarm and take the correct measures. If the alarm is caused most
likely by a failure, the unit needs to be repaired. Indicate on the incubator that it is out of order
and contact your local Atom representative.
MAINTENANCE
ture probe will
not function.
This alarm will occur
Skin Abnormality in (The skin
if a wire of the skin Remove the skin
temperature yellow skin temperature is 15
temperature 1 probe temperature probe Low
probe alarm temperature not displayed.) min.
has snapped or from the infant.
(MC) probe. The incubator
shortcircuited.✽2
heater will be
turned off (in the
SC mode).
Check the This alarm will occur The incubator The alarm will be
Skin
connection of if the skin tempera- heater will be reset automatically
temperature 10
the yellow skin ture 1 probe is not turned off. when the skin Medium
probe alarm min.
temperature connected in the SC (SC will not temperature probe is
(SC)
probe. mode.✽2 function.) connected.
107
Alarms
control)
detected by the other
functional ones
sensor by 7% or more.
(calibration required).
Oxygen This alarm will occur if the The alarm will be
Oxygen concentration in oxygen concentration in the reset automatically
Oxygen control
concentration incubator incubator deviates from the when the deviation Medium 2 min.
will be continued.
alarm (±3%) deviates from set oxygen concentration by decreases to less
the set value. 3% or more.✽8 than 3%.
This alarm will occur if The alarm will be
the oxygen supply is reset automatically
Oxygen flow No oxygen Oxygen control
interrupted or if oxygen when a normal Medium 2 min.
rate alarm delivered. will be continued.
has stopped flowing supply of oxygen is
during oxygen control. detected.
108
Alarms
✽1 When the incubator air temperature deviates continuously from the set temperature alarm threshold range for 10 seconds
during manual control, the alarm will be activated.
However, the alarm will not work for up to 30 minutes after changing the setting value. (When the incubator air temperature
reaches the set temperature warning threshold range or the speed at which the incubator air temperature approaches the
set value is 0.1°C/3 minutes or less, the alarm resumes.)
✽2 If any disruption should occur to the skin temperature 2 probe, warning information will be given to the user.
✽3 Check that all the ports and admittance panels are securely closed and that the packings are securely attached.
✽4 When the skin temperature 1 deviates continuously from the set temperature alarm threshold range for 10 seconds during
servo control, the alarm will be activated.
However, the alarm will not work for up to 30 minutes after changing the setting value.(When the skin temperature 1 reaches
the set temperature warning threshold range or the speed at which the skin temperature 1 approaches the set value is
0.1°C/3 minutes or less, the alarm resumes.)
✽5 Check the unit is set correctly. If the alarm is repeatedly generated despite the fact that the condition of the unit is correct, it
is conceivable that the incubator air temperature sensor is defective. Stop using the unit and perform inspection.
✽6 Check the unit is set correctly. If the alarm is repeatedly generated despite the fact that the condition of the unit is correct, it
is conceivable that the skin temperature probe is defective. Stop using the unit and perform inspection.
✽7 When the incubator humidity deviates continuously from the set humidity alarm threshold range for 15 minutes, the alarm
will be activated.
However, no alarm will occur during 30 minutes after changing the setting value, until the incubator humidity reaches the
set humidity warning threshold range.
✽8 When the oxygen concentration in the incubator deviates continuously from the set oxygen concentration alarm threshold
range for 30 seconds, the alarm will be activated.
However, the alarm will not work for up to 40 minutes after changing the setting value. (When the oxygen concentration in
the incubator reaches the set oxygen concentration warning threshold range or the speed at which the oxygen concentra-
tion in incubator approaches the set value is 0.1%/2 minutes or less, the alarm resumes.)
MAINTENANCE
109
Alarms
exceeded.
limit. alarm limit.
Pulse Oximeter The alarm will be
This alarm will occur
SpO2 reading reset automatically
SpO2 lower limit if the SpO2 lower Measurement
has exceeded when the reading Medium 2 min.
alarm alarm limit is will be continued.
lower alarm exceeds the lower
deviated.
limit. alarm limit.
Pulse Oximeter The alarm will be
This alarm will occur
Pulse rate Pulse rate reset automatically
if the pulse rate upper Measurement
upper limit reading has when the reading Medium 2 min.
alar m limit is exceed- will be continued.
alarm exceeded upper falls below the upper
ed.
alarm limit. alarm limit.
Pulse Oximeter The alarm will be
This alarm will occur
Pulse rate reset automatically
Pulse rate lower if the pulse rate lower Measurement
reading has when the reading Medium 2 min.
limit alarm alarm limit is will be continued.
exceeded lower exceeds the lower
deviated.
alarm limit. alarm limit.
The unit will automatically
This alarm will return to the normal state
Pulse Oximeter activate if the SpO2 when it is reset by the
No sensor Check the sensor is discon- “– – –” will be Alarm silence switch
High Reset
connected patient cable nected from the displayed. (function disabled) or
Pulse Oximeter
correctly connected.
The unit will automati-
Pulse Oximeter This alarm will occur
“– – –” will be cally return to the
Pulse search No pulse when it is difficult to High 2 min.
displayed. normal state when
detected. detect a pulse.
pulses are detected.
This alarm will activate
Pulse Oximeter Replace the
Defective if the SpO2 sensor has “– – –” will be
Sensor abnor- defective sensor with Low 2 min.
sensor become defective and displayed.
mal. a functional one.
cannot be recognized.
This alarm will occur Replace the
Pulse Oximeter
if the patient cable has “– – –” will be defective patient
Defective cable Patient cable Low 2 min.
become defective and displayed. cable with a
abnormal.
cannot be recognized. functional one.
Pulse Oximeter This alarm will activate
This alarm will occur
Internal system if the SpO2 sensor is
if the unit has “– – –” will be
Internal error abnormal. not connected (or the Low 2 min.
encountered a displayed.
Power cycle the connector is discon-
problem.
incubator. nected).
110
Alarms
Replace the
Nellcor
MAINTENANCE
problem.
incubator.
This alarm will activate
if the sensor module is This alarm will be
placed at a position automatically reset
Sensor Place the sensor The fan will
other than the when the sensor
moduleposition module back in continue normal Medium 2 min.
calibration position or module is placed
alarm its proper place. operation.
the normal position for back in its correct
Others
111
Alarms
min.
mal. (E7) heater has snapped. turned off.
No message
(The power Impos-
failure alarm sible
Replace the
indicator This alarm will occur if to
Defective Incubator control defective display
remains lighted the display has encoun- High si-
display will be continued. with a functional
green, and the tered a problem. lence
one.
response on the the
display screen alarm
disappears.)
Impos-
This alarm will occur if The unit will
sible
Display a display connecting automatically return
to
connecting Display screen cable is disconnected, Incubator control to the normal state
High si-
cable has no display. or a wire of the display will be continued. when the display
lence
disconnection connecting cable has connecting cable is
the
snapped. correctly connected.
alarm
This alarm will occur if
the power supply is
inter rupted due to
power failure, a Impos-
No message
disconnected power sible
Power failure/ (The power No control
plug, a broken power Impossible to reset to
internal error failure alarm All the heaters High
cord, a tripped breaker the alarm. silence
alarm indicator will will be turned off.
or some other cause, the
flashes in red.)
or if some internal alarm
error (a defective CPU
or a defective control
board) has occurred.
112
Troubleshooting
[14] Troubleshooting
If the unit seems to be defective, stop using it immediately, indicate on the unit that it is out of
order, and contact your local Atom representative.
Nothing is displayed on the display, z Check that the display connection cable is correctly connected to the
and an audible alarm is given. main body and the display.
z Check that the incubator air temperature is not set too low.
z Check that the supply voltage is not low. (The incubator should not share
a power outlet with another device.)
The incubator air temperature does
z Check that the fan is neither damaged nor deformed.
not rise.
z Check that the snap-open access ports are closed.
z Check that the admittance panels are closed.
z Check that the tube introduction slit packing is correctly attached.
z Check that the incubator air temperature is not set too high.
z Check that the incubator is not exposed to direct sunlight or affected by a
MAINTENANCE
heating apparatus nearby.
The incubator air temperature rises z Check that the air inlet in the incubator is not blocked by obstacles such
too high. as a diaper, gauze, etc.
z Check that the incubator air temperature is not set too low relative to the
room temperature.
z Check that a phototherapy unit is not in use.
z Check that the air outlets in the incubator are not blocked by obstacles
such as a diaper, gauze, etc.
z Check that the cartridge tank is filled with distilled water.
z Check that the humidity chamber cover is closed properly.
Humidity does not rise.
z Check that the boiler cap is fitted properly.
z Check that the snap-open access ports are closed.
z Check that the admittance panels are closed.
z Check that the tube introduction slit packing is correctly attached.
z Check that the relative humidity is not extremely high due to the rainy
Humidity rises too high.
season or some other cause.
113
Troubleshooting
114
Technical Information
1. Temperature control
The air warmed by the heater is sent by the fan into the hood containing the baby.
Temperature control has the following two modes.
z Manual control mode
In this mode, the heater output will be increased or decreased automatically depending on the difference
between the set temperature selected by the user and the incubator air temperature in order to maintain
the incubator air temperature at the set temperature.
z Servo control mode
In this mode, the heater output will be increased or decreased automatically depending on the difference
between the set temperature selected by the user and the skin temperature detected by the skin tempera-
ture probe attached to the infant’s skin in order to maintain the infant’s skin temperature at the set temper-
ature.
2. Humidity control
The water in the humidity chamber is evaporated with a heater and is sent by the air supply fan into the hood
containing the infant.
The humidity inside the hood is measured to control the heater output so that it matches the set humidity.
3. Oxygen control
Oxygen supplied from the oxygen supply port with the outside air is sent by the air supply fan into the hood
containing the infant.
The oxygen concentration in the hood is measured to control the oxygen supply amount so that it matches
the set oxygen concentration.
1. Temperature
The temperature sensor include an incubator air temperature sensor and a skin temperature probe. The tem-
perature sensor uses a thermistor whose resistance varies according to the temperature. Therefore, the tem-
perature can be determined by measuring the impedance of the thermistor.
2. Humidity
A capacitance type humidity sensor whose capacitance changes according to the relative humidity of the am-
bient air is used for the humidity sensor. A voltage corresponding to the relative humidity is output from the
APPENDIX
sensor.
Therefore, the humidity can be determined by measuring of the voltage.
3. Oxygen
This equipment uses a galvanic type oxygen sensor that is composed of two electrodes (noble metal and
base metal), a membrane through which oxygen permeates, and an electrolyte, which provides an output
voltage proportional to the amount of oxygen being permeated through the membrane.
Therefore, the oxygen concentration can be determined by measuring of the voltage.
115
Technical Information
116
Technical Information
Weight High-Low stand type: approx. 82kg (86kg if the unit includes the weight
monitor)
Cabinet stand type: approx. 76.5kg (80.5kg if the unit includes the weight
monitor)
Operating conditions Ambient temperature: 20~30°C
Ambient humidity: 30~75% (no condensation)
Atmospheric pressure: 70~106kPa
Wind velocity: <0.3m/s
Storage conditions Ambient temperature: 0~50°C
Ambient humidity: 30~75% (no condensation)
Atmospheric pressure: 70~106kPa
Transportation conditions Ambient temperature: 0~50°C
Ambient humidity: 30~75% (no condensation)
Atmospheric pressure: 70~106kPa
Accessories Skin Temp Probe 5mm O.D.(Y) , 1.65m................................1
Pneumoclean (Electrostatic air filter) ....................................1
Access port cover .....................................................................2
Sensor module ..........................................................................1
Operation Manual ....................................................................1
Skin Temp probe, 5mm O.D.(W) ..........................................✽
Skin Temp probe, 10mm O.D.(Y) .........................................✽
Skin Temp probe, 10mm O.D.(W) ........................................✽
Connecting Cable (Y) .............................................................✽
Connecting Cable (W) ............................................................✽
Dispo Skin Temp Probe (Y) ...................................................✽
Dispo Skin Temp Probe (W)..................................................✽
SpO2 Unit (Masimo) ...............................................................✽
SpO2 Unit (Nellcor) ................................................................✽
HL Stand for Air (AC230V) ....................................................✽
Cabinet Stand for Air ..............................................................✽
O2 Controller Unit for Air .......................................................✽
Weight Monitor Unit for Air...................................................✽
I.V Pole for Cabinet Stand for Air ..........................................✽
I.V Pole for HL Stand for Air ..................................................✽
Handle for Air (Head or Foot Side).......................................✽
Snap-Open Access Port for Air (Head or Foot Side) ...........✽
Cabinet Board for Cabinet Stand for Air...............................✽
Monitor Tray for HL Stand for Air ........................................✽
Drawer w/mounting bracket, for HL Stand for Air .............✽
APPENDIX
✽ Optional Accessories
117
Technical Information
JJ Temperature
Control mode Manual control/servo control (selectable)
Setting range Skin temperature (ser vo control): 34.0~37.5°C (over ride mode:
37.6~38.0°C)
Incubator air temperature (manual control): 23.0~37.0°C (override
mode: 37.1~39.0°C)
Display range Skin temperature: 30.0~42.0°C (Accuracy ±0.3°C)
Incubator air temperature: 20.0~42.0°C (Accuracy ±0.3°C)
Heater output 0~100% (indicated in 10 levels)
Warm-up time Maximum 60 min at an ambient temperature of 25°C
Alarms High temperature, set temperature, skin temperature probe
118
Technical Information
JJ Oxygen supply
Maximum oxygen concentration 65%O2 (at O2 flow rate 10L/min)
JJ Environment
CO2 concentration in the hood When a gaseous mixture comprising 4% CO2 is delivered at 750mL/
min at a point 10 cm above the center of a mattress and a steady state
is achieved, the CO2 concentration in the hood should not exceed
0.4%.
119
Technical Information
✽3 SpO2 70~100% hypoxia was induced in healthy male and female adult volunteers with light skin and
dark skin. Accuracy was checked by 1~2cm tapping 2~4 times per second and by 2~3cm irregular tap-
ping 1~5 times per second against a laboratory CO-oximeter and an ECG monitor. Variability distribu-
tion at this accuracy was ±1SD. ±1SD covers 68% of all data.
✽4 In a laboratory test, in the range of 70~100% SpO2, accuracy in low perfusion conditions was checked
against the Biotec Index2 Simulator and the Masimo Simulator, both of whose signal strength is 0.02%
or more and permeability 5% or more. Variability distribution at this accuracy was ±1SD. ±1SD covers
68% of all data.
✽5 The materials accessible to the patient and the user comply with ISO 10993-1.
✽6 All the sensors and patient cables that can be used with this device have been tested and verified by us-
ing the Masimo/MX series pulse oximeter technology.
✽7 Since the measurements taken by the pulse oximetry equipment are statistically distributed, only about
two-thirds of them fall in the accuracy (Arms) range of values obtained with a CO-oximeter.
✽8 Even if the power supply is interrupted due to power failure, disconnection of the power plug, or some
other cause, the preselected settings will be retained in the memory. When the power supply is re-
sumed, the unit will start operation with the last selected settings.
✽9 Alarm delays should not exceed 30 seconds other than as specified in this manual.
120
Technical Information
✽1 Subjects used to validate SpO2 measurement accuracies were healthy and recruited from the local pop-
ulation. Comprised of both men and women, subjects spanned a range of skin pigmentations and
ranged in age from 18-50 years old. Accuracy specifications are based on controlled hypoxia studies
with healthy non-smoking adult volunteers over the specified SpO2 range(s). Pulse oximeter SpO2 read-
ings were compared with SaO2 values of drawn blood samples measured by hemoximetry. All accura-
cies are expressed as ±1SD. Pulse oximeter equipment measurements are statistically distributed;
about two-thirds of pulse oximeter measurements are expected to fall in this accuracy (Arms) range.
Because scatter and bias of pulse oximter SpO2 and blood SaO2 comparison commonly increase as the
saturation decreases, and accuracy specifications are calculated from data spanning the stated range,
different accuracy values may result when describing partially overlapping ranges.
Pulse rate from SpO2 was compared to ECG heart rate.
✽2 Reading accuracy in low perfusion conditions (detected IR pulse modulation amplitude 0.03~1.5%) was
verified by using signals supplied by a patient simulator. SpO2 and pulse rate values were varied across
the monitoring range over a range of weak signal conditions and compared with the known true SpO2
and pulse rate values of the input signals.
✽3 The materials accessible to the patient and the user comply with ISO 10993-1.
✽4 All the sensors and patient cables that can be used with this device have been tested and verified by us-
ing the Nellcor/NELL-1 module pulse oximeter technology.
✽5 Even if the power supply should be interrupted due to power failure, disconnection of the power plug
or some other cause, the preselected settings will be retained in the memory. When the power supply
is resumed, the unit will start operation with the last selected settings.
✽6 This device is calibrated to display functional oxygen saturation.
✽7 Alarm delays should not exceed 10 seconds other than as specified in this manual.
Oxygen sensor life span The life span of the oxygen sensor varies depending on the ambient conditions
under which it is used. It is recommended to replace the oxygen sensor when
more than one year has passed since it was taken out of its package.
121
Technical Information
JJ Weight monitor (the unit equipped with the weight monitor unit)
Weighing range 7000g
Scale interval 1g (weight monitor without official verification)
5g (weight monitor with official verification)
122
Technical Information
APPENDIX
123
Technical Information
124
Technical Information
APPENDIX
125
• Reproduction of all or part of this Manual without permission from Atom Medical Corporation is strictly
prohibited.
• The contents of this Manual are subject to change without notice due to technical improvement.
• All possible measures have been taken to ensure the accuracy of the contents of this Manual. However, if any
errors should be noticed, Atom would greatly appreciate being informed of them.
C75MC010
201904