Atom Infa Warmer i User manual

From the delivery room to the NICU. The new generation Infa Warmer i meets wide needs with substantial
functions and features
Mo el:
Infa Warmer i
Description:
From the delivery room to the NICU. The new generation Infa Warmer i meets wide needs with substantial functions and
features. Through the add-on unit, two kinds of resuscitation units are available depending on the user’s demand.
Medical care in the emergency stag
Surgical operations can be performed safely in the NICU
Medical care in the chronic stag
Long-term management is possible with less stress on the infant
Resuscitation Functio
Makes prompt and safe resuscitation possible
Heat Supply Functio
The falling skin temperature can be prevented.
Ato
Infa Warmer i
RT2 Catalogue 2021
Consistent Committed Service
Michelle Grobler (Fisher&Paykel Divisional Manager) Respiratory Care Africa
[e-mail] CONTACT USContact
D etails

Equipment for neonatal and premature infants: Infant Warmer
Atom Infant Warmer 103
Operation Manual
TO THE OPERATOR AND THE PERSON IN CHARGE OF
MAINTENANCE AND CARE OF THE UNIT:
Read this●Manual carefully before operating the unit.
Keep this●Manual where it is readily accessible for reference when needed.
This Manual contains description of all the functions available, including the●
pulse oximeter. Please skip any section unrelated to your unit.

1
INTRODUCTION
This Operation Manual deals with the specifications, operation and maintenance of the Infa Warmer i. 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 for any accident attributable to repair by someone other than technical
personnel belonging to or authorized by Atom.
This Manual contains description of all the functions available, including the pulse oximeter and the CPR timer.
Please skip any section unrelated to your unit.
Read this Manual carefully and familiarize yourself thoroughly with its contents before operating the unit. Keep
this Manual where it is readily accessible for reference when needed. If any technical problem should arise, please
contact your local Atom representative.
This product is shipped without being disinfected. Be sure to clean and disinfect the unit before
using it for the first time after purchase.
CAUTION
INTENDED USE
The Infa Warmer iis a radiant-warming open-type incubator for newborns and premature neonates. It is intended
for pre-operative and post-operative intensive care in neonatal surgery, temperature control in neonatal hypothermia,
observation and examination in newborn nurseries, prevention of body temperature drop shortly after delivery,
etc. The Infa Warmer ihas the capability to control the infant’s skin temperature as well as the pulse oximeter to
measure SpO2and the pulse rate and the CPR timer.

2
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.
Follow the operating instructions described in this Manual for the safe use of the unit.
2. Inspect the unit on a periodical basis.
Periodical inspection is needed to use the unit in the 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.
Electric 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.
Definition of Warning Indication
Three levels of warning indication are used throughout this Manual and on the unit. They are defined as
follows.
A DANGER notice indicates an immediately hazardous situation which, if not 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 indirectly (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 injury, partial damage to equipment, and loss of data stored
in computers.
DANGER:
WARNING :
CAUTION:

3
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: 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 under
certain conditions.
Prohibition of contact
Indicates prohibition of contact.
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.
4. Symbols of international standards (IEC)
Symbol Title and indication
Equipment partially on
Indicates that a part of the device is "ON."
Equipment partially off
Indicates that a part of the device is "OFF."
Type BF applied part
Indicates that the device is classified as Type BF in terms of the degree of protection against an
electric shock.

4
Symbol Title and indication
Bell silenced
Indicates either a control switch to silence the bell permanently or temporarily or that the bell is
silenced.
Caution
Indicates that the user needs to see a relevant accompanying document before operating the unit.
Caution against electrostatic discharge
Indicates that appropriate precautions must be taken against electrostatic discharge.
Lighting
Indicates a switch that controls lighting.
Recycle mark (battery)
Indicates that recycling is recommended.
Manufacturer
This symbol indicates the name and the address shown adjacent to the symbol is of the manufac-
turer.
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.
5. Other symbols
Symbol Title and indication
Setting
Indicates that a setting is increased.
Setting
Indicates that a setting is decreased.
Alarm
Indicates a power failure alarm.
AC power
Indicates that the device is connected to AC power.
Battery
Indicates that the unit is being powered by the Power Pack i(UPS).

5
Symbol Title and indication
Alarm
Indicates that a system of the unit is in an abnormal condition.
Alarm
1. In manual control (when monitoring the skin temperature): Indicates that the skin temperature
has become 40°C or higher.
2. In servo control: Indicates that the skin temperature deviates from the set temperature by 1.0°C
or by 0.5°C.
Alarm
Indicates that a wire of the skin temperature probe has snapped or short-circuited.
Alarm
Indicates that 15 minutes have elapsed since the heater was turned on.
Alarm
Indicates that the canopy is tilted.
Setting
Indicates a setting of the skin temperature.
Skin temperature
Indicates a detected current skin temperature of the infant.
Heater
Indicates the manual control mode, the manual control mode switch and the heater output.
Skin temperature
Indicates the servo control mode, the servo control mode switch and the skin temperature probe
connecting port.
Preheat
Indicates the preheat mode and the preheat mode switch.
Peripheral temperature
Indicates the function related to the infant's peripheral temperature (skin temperature 2).
Temperature unit
Indicates the switch to select either °C or °F as the unit of the temperature to be displayed.
Timer
Indicates the timer.
Timer
Indicates the timer switch.
SpO2
Indicates the alarm limit selector switch.

6
Symbol Title and indication
(Masimo)
SpO2
Indicates the sensitivity selector switch.
SpO2
Indicates the patient cable connecting port.
SpO2
Indicates that the SpO2lower alarm limit is set to lower than 85%.
(Masimo)
SpO2
Indicates that the current sensitivity is "APOD."
(Masimo)
SpO2
Indicates that the current sensitivity is "NORM."
(Masimo)
SpO2
Indicates that the current sensitivity is "MAX."
SpO2
Indicates a detected current SpO2value.
(Nellcor)
SpO2
Indicates that the SatSeconds limit is set. Also indicates that the SatSeconds point is increasing or
decreasing.
(Nellcor)
SpO2Alarm
Indicates an interference alarm.
(Nellcor)
SpO2Alarm
Indicates a pulse search alarm or a pulse timeout alarm.
(Nellcor)
SpO2Alarm
Indicates a sensor off alarm.
Pulse rate
Indicates a detected pulse rate.
Load capacity
Indicates the maximum load capacity.
Prohibition of lubrication
Indicates that lubrication is prohibited.
Avoid getting caught
Indicates that the user must avoid getting caught in the gap in the device.
Locking of the baby guard
Indicates that the user must check whether the baby guard is securely locked.

7
WARRANTIES
This equipment is guaranteed by Atom Medical Corporation to be free of any defects in both materials and work-
manship for a period of one year from the date of delivery when used normally for its intended purpose. Any part
of this equipment proving to be defective will be repaired or replaced at no charge during the warranty period. In
the following cases, however, actual expenses need to be paid even during the warranty period.
Wear and tear of expendables(1)
Trouble and damage due to improper handling, such as dropping the unit during transport or transfer(2)
Trouble and damage due to a fire, salt, gas, extraordinary voltage, earthquake, lightning, storm and flood,(3)
or other natural calamities.
Travel expenses in the case of a trip to an isolated island, a remote place, etc. for the purpose of repair(4)
Any damage incurred in transit should be reported promptly to Atom accompanied by the certificate of the car-
rier concerned.
All correspondence concerning the equipment should specify the model name and the serial number.
Atom is by no means held responsible for compensation for death, injury or damage to property if such loss
should occur due to any of the following causes.
1. Trouble or damage due to installation, relocation, maintenance or repair by someone other than:
technical personnel employed by Atom•
a sales representative of Atom•
an installation company authorized by Atom.•
2. Trouble or damage to Atom products caused by a product of another company that is not supplied by
Atom.
3. Trouble or damage due to modification, maintenance or repair using a part other than that specified by
Atom.
4. Trouble or damage due to neglecting the operating precautions or operating instructions described in
the Operation Manual of the unit.
5. Trouble or damage due to operation under ambient conditions, including electrical requirements and
installation requirements, other than those described in the Operation Manual.
6. Trouble due to carelessness or improper modification.
7. Trouble or damage due to using a device sold or repaired by a secondhand goods dealer or a repair shop
without notifying Atom. Trouble or damage due to using a device sold or repaired by the above dealer or
shop without following the instructions specified by Atom.
8. Trouble or damage due to using the unit connected to a peripheral device which is not specified by Atom,
which does not meet the applicable requirements of IEC-60601-1 and IEC-60601-1-1, or which is not
equipped with equivalent safety features.
WARNING

8
Precautions on Jamming
WARNING
Electric surgical knives, portable and mobile communication equipment, and other devices which
generate high-frequency noise can cause jamming to various kinds of electric equipment for medi-
cal use and thus result in malfunction.
Since portable and mobile communication equipment, etc. are often used in medical facilities, some
measures should be taken to prevent jamming due to such devices.
Portable and mobile communication equipment and other devices which generate high frequency
should not be used near the unit during its operation to prevent malfunction of the unit due to jam-
ming.
Responsibility for Care of Equipment
It is the user (a hospital, a doctor's office, a clinic) that is responsible for the operation, maintenance
and care of the electric equipment for medical use. The equipment should be used only by medical
personnel.
CAUTION
Prohibition of Modification
WARNING
Do not disassemble or modify the unit.
Otherwise, a fire, an electric shock or injury may result.
Periodical Inspection
Proper periodical inspection is needed to use the unit in the optimum condition.
CAUTION
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. See the end of
this Operation Manual for whom to contact.
If any abnormal condition or trouble should occur, do not use the unit until it has been repaired
completely by a service engineer so as to prevent possible danger.
CAUTION

PREPARATION OPERATION MAINTENANCE APPENDIX
PLEASE READ WITHOUT FAIL
CONTENTS
INTRODUCTION .................................................... 1
PLEASE READ WITHOUT FAIL
[1] Operating Precautions ............................ 10
1-1. DANGER........................................... 10
1-2. WARNING......................................... 11
1-3. CAUTION .......................................... 13
[2] Parts Identification................................... 15
2-1. Main Body................................................. 15
2-2. Support Column....................................... 16
2-3. Operation Panel ....................................... 17
PREPARATION
[3] Preparation before Use ........................... 20
3-1. Where to install the Unit.......................... 20
3-2. Locking the Casters................................. 20
3-3. Adjusting the Hi-Low Stand.................... 21
3-4. Power Outlet and Grounding.................. 22
3-5. Power Cord and Power Switch .............. 22
3-6. Power Failure Alarm ................................ 23
3-7. Daily Inspection........................................ 24
OPERATION
[4] Heat Control............................................... 25
4-1. Setting the Heater Output
(Manual Control) ...................................... 25
4-1-1. Setting Preheating
(Manual Control) ....................... 26
4-1-2. Skin Temperature
Monitoring (Skin
Temperature Probe:
Yellow and White) ..................... 27
4-1-3. Heater Output Indicator ........... 29
4-2. Setting the Skin Temperature
(Servo Control)......................................... 29
[5] Pulse Oximeter.......................................... 32
5-1. Attaching the Sensor............................... 32
5-1-1. Connecting the Patient
Cable to the Main Body ........... 33
5-2. Setting the Upper/Lower Alarm Limits .. 33
5-3. Setting the Sensitivity (Masimo)............ 34
5-4. Setting the Synchronizing Pulse
Beep Volume and the Averaging Time.. 35
5-5. SatSeconds (Nellcor) .............................. 35
5-6. Setting the Fast Response (Nellcor)..... 36
5-7. Turning on/off the Pulse
Oximetry Function ................................... 37
[6] Tilting the Mattress Platform ................. 38
6-1. Operating the Mattress Platform ........... 38
[7] Other Operation Procedures ................. 39
7-1. Timer.......................................................... 39
7-1-1. Operating the Timer ................. 39
7-1-2. Setting the Timer Mode............ 39
7-2. I/O Port (Communication Connector) ... 40
7-3. Lighting...................................................... 41
7-4. Rotating/Tilting the Canopy.................... 41
7-5. Baby Guard............................................... 42
7-6. Support Column Rail............................... 42
7-7. X-ray Cassette Tray.................................. 43
7-8. Setting the Alarm Volume ....................... 44
7-9. Changing the Temperature
Deviation Limit of the Set
Temperature Alarm .................................. 44
7-10. Enabling/Disabling the Key Click........... 45
MAINTENANCE
[8] Cleaning and Disinfection...................... 46
8-1. Main Body................................................. 46
8-2. Others........................................................ 47
[9] Maintenance Inspection.......................... 48
9-1. Inspection before Use ............................. 49
9-2. Quarterly Inspection................................ 51
9-3. Periodical Replacement Parts ............... 51
9-4. Inspection Checklist ................................ 52
9-5. Disposal .................................................... 53
[10] Alarms ......................................................... 54
[11] Troubleshooting........................................ 58
APPENDIX
[12] Technical Data........................................... 59

10
Operating Precautions
Operating Precautions[1]
Please follow the operating instructions described in this Manual for the safe use of the unit. The unit should
be operated only by those who have been trained and instructed properly in its operation under the supervision
of qualified medical personnel familiar with the currently known risks and benefits associated with the use of
a radiant warmer. 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.
Monitor the infant’s skin temperature when operating the unit.
The operator must monitor the infant’s skin temperature when operating the unit. Avoid unattended
use of the unit.
Do not leave the unit unattended with the baby guards folded down.
If the baby guards are left folded down, the infant may fall out and get fatally injured. Never leave the
unit unattended with the baby guards folded down.
Do not tilt the mattress platform with the baby guards folded down.
If the mattress platform is tilted with the baby guards folded down, the infant may fall out.
When you pull up and lock the baby guards in position, be sure to check that no mattress
sheet or linen is caught between any of the baby guards and the mattress platform. Make
sure that the baby guards are locked securely.
If linen or other object is caught between any of the baby guards and the mattress platform, remove
it. Otherwise, the baby guards will not be locked completely. The baby guards may swing down and
the infant may fall out of the unit and suffer serious or fatal injury.
Stop using the unit immediately and seek repair if the locking mechanism of the baby guards
or other related parts should be found faulty in any way.
The infant may fall out.
Never place a body warmer or any other possible ignition source in or near the unit.
Use of oxygen will increase the risk of explosion or fire. Body warmers or other devices in which fire
is used or which will generate a spark may cause an explosion or a fire if used near the unit.
Do not use the unit in the presence of a flammable anesthetic gas.
The unit may cause an explosion or a fire if used in the presence of such a gas.
Do not use ether, alcohol or any other ignitable substance.
Even a small amount of ether, alcohol or any other ignitable substance may cause a fire when mixed
with the oxygen supplied to the unit.
Do not hang any flammable materials on the canopy.
It may cause a fire.

11
PLEASE READ WITHOUT FAIL
Operating Precautions
Ground the unit securely.
Otherwise, a leakage current may cause an electric shock. In order to complete the ground connection,
connect the power cord only to a properly grounded 3P power outlet including a ground terminal. Do
not operate the unit if you have any doubt about its ground connection.
Do not use a device generating high frequency near the unit.
To prevent malfunction of the unit due to jamming, do not use electric surgical knives, portable and
mobile communication equipment and other devices which generate high frequency near the unit
during its operation.
Analyze arterial gas levels repeatedly when a high oxygen environment is required.
When the infant requires a high oxygen environment, it is extremely important and essential to periodi-
cally analyze arterial gas levels. Follow the doctor’s instructions in measuring the oxygen concentra-
tion because ignoring essential requirements may increase the risk of retinopathy of prematurity and
other adverse effects.
Do not give a shock to the unit or let it hit anything.
The screws or fixed parts may become loose.
1-2. WARNING
Death or serious injury due to a fire or an electric shock will result if the instructions given below are not fol-
lowed.
Be sure to follow the doctor’s instructions in setting the infant’s skin temperature.
Be sure to follow the doctor’s instructions in supplying oxygen.
Use only oxygen for medical use.
Be sure to bear in mind the following precautions during oxygen supply.
Do not place a body warmer, a flashlight, oils and fats, or flammable vaporizable matters near the•
unit.
Use pure cotton for the infant’s clothing, bed sheets, etc. Do not use any material that is easily•
charged with static electricity.
Use pure cotton or fire-proof materials for the clothing of doctors, nurses and ambulance staff who•
handle this unit.
Bear in mind the following precautions while using oxygen supply equipment.
If oil, grease or a grease-like substance should get in contact with pressurized oxygen, a violent•
spontaneous ignition may occur. Do not let such substances stick to the oxygen pressure regulator,
the oxygen cylinder valve, piping, connections and other parts of oxygen supply equipment.
On a high-pressure oxygen cylinder, use only a tested pressure reducing valve or pressure regulat-•
ing valve indicated specifically for oxygen supply. Do not use such a valve for any gas other than
air or oxygen. It is dangerous to use a valve to supply a gas other than air or oxygen and then to
supply oxygen again.
Smoking is prohibited in the room where the unit is installed.
Do not place any possible ignition sources in the room.

12
Operating Precautions
Avoid damaging the power cord.
A damaged power cord may cause a fire or an electric shock.
Do not get the power cord caught between the unit and the wall, a shelf or the floor.•
Do not place the power cord near a heating apparatus or heat it.•
Do not put anything heavy on the power cord.•
Always grasp the power plug with your hand to remove the power cord from the power outlet. A•
damaged power cord should be replaced immediately with a new one.
Use only the power cord supplied with the unit.
Otherwise, a fire or an electric shock may result.
Do not touch the heater with your hand when the heater is on.
You may burn yourself.
Do not touch the power plug with a wet hand.
Touching the power plug with a wet hand may cause an electric shock.
Do not disassemble or modify the unit.
Disassembling or modifying the unit may cause a fire, an electric shock or injury.
Do not install the unit where it will be exposed to excessive humidity, dust or steam.
Installing the unit in such a place may cause a fire or an electric shock.
Before cleaning and disinfecting the unit, be sure to turn the power switch off, remove the
power plug, and allow the heater temperature to drop sufficiently.
The power outlet should be located near the unit to prevent accidental contact with a trailing
power cord. Use a separate power outlet for each unit.
Do not put many loads on one power outlet.
In order to complete the ground connection, connect the power cord only to a properly
grounded 3P power outlet including a ground terminal.
Do not operate the unit if you have any doubt about its ground connection.
Ground peripheral electric equipment securely.
The electrical rating of this unit is as follows:
AC120V; power consumption 700VA; frequency 60Hz; operating voltage range AC120V±10%
Do not connect the unit to any other power source.
The unit should be serviced only by qualified personnel.
Be sure to inspect the unit at the start of each day.
Operating the unit without inspecting it before at the start of each day may let a defect pass unnoticed
and cause a potentially unfavorable outcome.

13
PLEASE READ WITHOUT FAIL
Operating Precautions
Check for conformity to the applicable standard if the unit is going to be connected to another
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 for data processing equipment). Furthermore all configurations should
comply with IEC 60601-1-1. But 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 should make the medical system comply with the requirements of
60601-1-1 on his or her own responsibility. 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.
Be sure to clean and disinfect the unit before using it for the first time after purchase.
The unit is shipped without being disinfected.
During the standby mode, be sure to preheat the unit in order to keep the mattress surface
temperature stable.
Place the infant on the mattress only after the mattress surface temperature has stabilized.
Do not twist or pull the cords by force.
If any defect should be found, ask an expert for repair without attempting to repair it yourself.
When feeding the cords and tubes into the unit, be very careful not to let them wind or tighten
around the patient.
Remove the power plug from the power outlet before moving the unit to another place or
when the unit is not going to be used for a long time.
Moving the unit to another place with the power plug connected to the power outlet will damage the
power cord and may cause a fire or an electric shock.
Remove the power plug from the power outlet before cleaning and disinfecting the unit.
Cleaning and disinfecting the unit with the power plug connected to the power outlet may cause an
electric shock.
Install the unit on a stable surface.
Installing the unit on an unstable platform or a tilted surface will cause it to fall or drop and may injure
someone. Therefore, before installing the unit, make sure that the place where the unit is to be installed
is stable and strong enough to support the weight of the unit.
Install the unit out of reach of small children.
Do not operate the unit with the canopy covered with a cloth, etc.
Operating the unit covered with a cloth or pressed tightly against the wall may cause a fire or an
electric shock due to overheating.
Do not install the unit in direct sunlight or near a heating apparatus.