Atom IncuArch User manual

TO THE OPERATOR AND THE PERSON IN CHARGE OF
MAINTENANCE AND CARE OF THE UNIT:
zRead this Manual carefully before operating the unit.
zKeep this Manual where it is readily accessible for reference when needed.
zThis Manual describes operations of this unit and instructions on how to
operate the pulse oximeter and oxygen monitor. You may skip any section(s)
describing functions that are not included in your specific unit.
Operation Manual
Equipment for neonatal and premature infants: Incubator
0123
ORIGINAL
Lithium-ion battery type

Via Libia, 54 - 20081 Abbiategrasso (MI) - Italy
Tel: [phone] Fax: [phone]
EU OFFICE

1
INTRODUCTION
Thank you for purchasing IncuArch.
This Operation Manual deals with the specifications, operation and maintenance of the IncuArch. Atom is by no
means responsible for any malfunction arising from a user ignoring the instructions for operation and mainte-
nance described in this Manual as well as any accident attributable to repair by someone other than technical
personnel belonging to or authorized by Atom.
Read this Manual carefully and familiarize yourself with its contents before operating the unit. Keep this Manual
where it is readily accessible for reference when needed. If any technical problems should arise, please contact
your local Atom representative.
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.
This product is categorized as a portable medical device. It is intended for installation in an ambu-
lance or rotorcraft. Make sure to perform test operation when installing it to confirm that there is
no problem with the operation of the product or the vehicle where it is installed. For the device
characteristics, see "[15] Device Characteristics - EMC Level and Classification."
INTENDED USE
The IncuArch is a closed-care transport incubator for neonatal and premature infants and is intended to transport
low birth weight infants and seriously ill neonates.

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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.
2. Inspect the unit on a periodical basis.
It is necessary to carry out appropriate periodical inspections in order to maintain the unit in optimum
condition.
3. Never use the unit if it is found to be defective.
If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your local
Atom representative.
4. Follow the EMC information given in this Manual.
Electrical equipment for medical use needs special precautions regarding EMC. It needs to be installed and
put into service according to the EMC information provided in this Manual.
Definitions 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 immediate hazardous situation which, if
not avoided, will result in death or serious injury, serious damage to property
such as total loss of use of equipment or fire.
A WARNING notice indicates an indirect (potentially) hazardous situation
which, if not avoided, will result in death or serious injury, serious damage to
property such as total loss of use of equipment or fire.
A CAUTION notice indicates a hazardous situation which, if not avoided, can
result in minor or moderate injuries, partial damage to equipment, and
loss of data stored in computers.

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Definition of Symbols
1. Symbols to indicate danger, warning or caution
Symbol Title and indication
Caution:Withstand load
Indicates that the use exceeding the indicated maximum load capacity (withstand load) may
cause falling or damage of the unit.
General attention
Indicates unspecified general danger, warning or caution.
Caution: Hot surface
Indicates that the surface can be dangerously hot under certain conditions.
2. Symbols to prohibit action
Symbol 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 un-
der certain conditions.
Prohibition of contact
Indicates that touching a certain part of the unit where it may cause injury is prohibited under
certain conditions.
3. Symbols to give instructions for action
Symbol Title and indication
General instruction
Indicates unspecified general action on the part of the user.
Connect a ground wire
Instructs the user to connect the ground wire without fail where the unit is provided with a
ground terminal.
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
when there is a threat of lightning.

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4. Symbols of international standards (IEC)
Symbols Title and indication
Type B applied part
Indicates that the device is classified as Type B in terms of the degree of protection against elec-
tric shock.
See Operation Manual
Follow Operation Manual.
Type BF applied part
Indicates that the device is classified as Type BF in terms of the degree of protection against
electric shock.
See Operation Manual
Follow operation manual.
Date of manufacture
Indicates the date when the unit was manufactured in the factory.
Lighting
Indicates a switch that controls lighting.
Power
Indicates a switch to turn the power on or off.
Electrostatic discharge
Indicates a caution regarding electrostatic discharges.
Recycle mark
Indicates that recycling is recommended.
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.
Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manufacturer.
Authorised representative in the european community
This symbol indicates the name and the address shown adjacent to the symbol is of the authorised
representative in the European Community.

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5. Other symbols
Symbol Title and indication
Setting
Indicates that a setting is increased.
Setting
Indicates that a setting is decreased.
AC Power
Indicates that the AC power is being supplied if an adjacent indicator is on.
Indicates that the AC power is not being supplied if an adjacent indicator is off.
Alarm
Indicates that an audible alarm is silenced.
Alarm
Indicates that a system of the unit is in an abnormal condition.
Alarm
Indicates that the rotation of the fan is abnormal or the fan has not been attached.
Alarm
Indicates an alarm related to temperature.
Alarm
Indicates an alarm related to a skin temperature probe.
Battery
Indicates the power level of battery 1 and 2.
24V12V
DC power connecting port
Indicates the DC power connecting port of the main body.
Alarm
Indicates excessive temperature condition.
Alarm
Indicates a low battery level.
Alarm
Indicates an alarm related to the SpO2patient cable. (For Masimo pulse oximeter)
Alarm
Indicates an alarm related to a failure of the SpO2patient cable. (For Masimo pulse oximeter)
Alarm
Indicates an alarm related to the SpO2sensor.
Alarm
Indicates an alarm related to a failure of the SpO2sensor.
Alarm
Indicates an alarm related to a failure of the SpO2sensor function.

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Symbol Title and indication
(Red marking)
Alarm
Indicates the inability to detect pulse during measurement. (For Nellcor pulse oximeter)
Alarm
Indicates an alarm related to an oxygen sensor.
Sensitivity setting indicator
Indicates that the sensitivity mode is set to “Max”. (For Masimo pulse oximeter)
Sensitivity setting indicator
Indicates that the sensitivity mode is set to “APOD”. (For Masimo pulse oximeter)
Pulse search indicator
Indicates that a pulse is being detected. (For Masimo pulse oximeter)
Interference indicator
Indicates that interference is detected. (For Masimo pulse oximeter)
Fast response mode indicator
Indicates that the response mode of the pulse oximeter is set to “Fast.” (For Nellcor pulse oxim-
eter)
Pulse search indicator
Indicates that a pulse is being detected. (For Nellcor pulse oximeter)
Interference indicator
Indicates that interference is detected. (For Nellcor pulse oximeter)
10kg MAX. Load capacity
Indicates the maximum load capacity.
Gross weight
Indicates that the gross weight when peripheral devices of maximum loading capacity are at-
tached to the product is as inscripted.
Precautions on Jamming
The unit is intended for use in hospitals.
Portable and mobile communication equipment and other devices which generate high frequency
should be used at least 30cm away from the unit, including cables specified by the manufacturer.
Failure to do so may cause malfunction.
Note: The emission characteristics of this unit make it suitable for use in industrial areas or hospi-
tals (CISPR11 Class A). Take care when using the unit in residential environments (normally CIS-
PR11 Class B), as it may not provide adequate protection from wireless frequency communication
services. The user may also need to relocate or realign the unit to alleviate the problem.

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Responsibility for Care of Equipment
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
Do not disassemble or modify the unit.
Otherwise, a fire, electric shock or injury may result.
Periodical Inspection
Proper periodical inspection is needed to use the unit in the optimum condition.
In Case of Trouble
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.

Table of Contents
INTRODUCTION........................................................... 1
PLEASE READ WITHOUT FAIL
[1] Safety Instructions.........................................10
1- 1. DANGER ................................................. 10
1-2. WARNING ............................................... 11
1-3. CAUTION ................................................ 14
[2] Parts Identification.........................................16
2-1. Main body ...................................................... 16
2-2. Operation panel ............................................ 18
2-3. Stands ............................................................ 19
PREPARATION
[3] Preparation before Use................................20
3-1. Assembly........................................................ 20
3-1-1. For HL Stand (Option) ........................ 20
3-1-2. For Cabinet Stand (Option)................ 20
3-2. Adjusting the HL Stand ................................ 21
3-3. Where to Install the Incubator..................... 21
3-4. Locking the Casters...................................... 22
3-4-1. For HL Stand (Option) ........................ 22
3-4-2. For Cabinet Stand (Option)................ 22
3-5. Securing the Unit to an Ambulance ........... 23
3-6. Inspections Before Start .............................. 23
[4] Power requirements ......................................24
4-1. Power Outlet and Grounding....................... 24
4-2. Using an AC Power Source
(AC100-240V)................................................ 25
4-3. Using the Built-in Battery Power Supply.... 27
4-4. Using an External DC Power Source
(DC12V/24V) ................................................. 31
4-4-1. Requirements for External
DC Power Source................................ 31
4-4-2. Connecting External DC Power
Source and Connection Cable .......... 31
OPERATION
[5] Display Screens ..............................................34
5-1. Overview of Display Screens...................... 34
5-2. Main screen ................................................... 35
5-3. Menu Screen ................................................. 39
[6] Setting the Incubator Temperature and
Placing the Infant in the Incubator.........41
6-1. Setting the Incubator Temperature............. 41
6-2. Placing the Infant in the Incubator ............. 43
6-3. Drawing out the Mattress Platform............. 46
6-4. Skin Temperature Monitoring ...................... 46
[7] Oxygen Supply ................................................49
7-1. Supplying Oxygen......................................... 50
7-2. Using the Oxygen Monitor........................... 51
7-2-1. Calibrating the Oxygen Monitor......... 51
7-2-2. Setting the Upper and Lower Alarm
Limits for Oxygen Level ...................... 53
[8] Pulse Oximeter ................................................55
8-1. Attaching the SpO2Sensor ......................... 55
8-2. Connecting the Patient Cable ..................... 56
8-3. Setting Alarm Limits...................................... 56
8-3-1. Setting SpO2Upper/Lower Alarm
Limits..................................................... 57
8-3-2. Setting Pulse Rate Upper/Lower
Alarm Limits ......................................... 58
[9] Other Operation Procedures .....................59
9-1. Working with the Menu Screen................... 59
9-1-1. Setting the Alarm Volume................... 60
9-1-2. Setting the LCD Screen Brightness.. 61
9-1-3. Setting the Display Size...................... 62
9-1-4. Setting the Language.......................... 63
9-1-5. Setting the Synchronizing Pulse
Beep Volume........................................ 64
9-1-6. Setting the Sensitivity Mode ............. 65
9-1-7. Setting the Averaging Time ................ 66
9-1-8. Setting the Pulse Oximeter Power
Frequency............................................. 67
9-1-9. Setting the Response Mode .............. 68
9-2. Feeding Cords and Tubes into or out of
the Incubator.................................................. 69
9-3. Lighting lamp ................................................. 69
9-4. Multi-purpose pole (option) ......................... 70
MAINTENANCE
[10] Cleaning and Disinfection..........................71
10-1. Hood Assembly ............................................. 72
10-2. Mattress Platform and Inside of
Incubator ........................................................ 74
10-3. Others............................................................. 76
[11] Maintenance and Inspection.....................77
11-1. Inspection Checklist ..................................... 77
11-1-1. Inspection Checklist - Before Use..... 78
11-1-2. Inspection Checklist - During Use .... 79
11-1-3. Inspection Checklist - After Use ........ 80
11-2. Periodic Replacement of Parts ................... 81
11-3. Replacing the Filter....................................... 82
11-4. Replacing the Oxygen Sensor.................... 83
11-5. Replacing the Batteries................................ 85
11-6. Expected Life................................................. 85
11-7. Disposal.......................................................... 85