V-2100G A Type Service Manual and Replacement Parts List April 2004

Introduction This Service Manual describes procedures for inspecting, repairing and changing the settings of the Atom Infant Incubator series. It also describes precautions and troubleshooting in alarm conditions. The procedures described in this Service Manual should be carried out only by personnel trained in electricity and the operation of the unit. Neither Atom Medical Corporation nor its distributor will be responsible for the quality and performance of the unit if the unit should not be handled as instructed or if unauthorized parts should be used in repairs. It should be noted that any responsibility arising from inspecting, repairing or changing the settings of the unit lies with the person who carried it out. Read this Service Manual and the Operation Manual carefully and familiarize yourself thoroughly with its contents before inspecting, repairing or changing the settings of the unit. Keep this Manual where it is readily accessible for reference in case of need. For more detailed information on inspecting, repairing and changing the settings of the unit, contact your Atom distributor.

[1] Basic Instructions 1. Medical institutions should be responsible for the maintenance, inspection and care of the unit. 2. When you choose to have the unit maintained and inspected or when the unit is found in need of repairs from the results of inspection, consult your Atom distributor and 1) have the work carried out by a person with adequate technical knowledge and skills who has taken a course specified by Atom, 2) ask Atom to send its service engineer if a person with adequate technical knowledge and skills who has taken a course specified by Atom is not available, or 3) ask Atom for its approval of returning the unit for repair service. 3. Follow the instructions for safety. Read the operating precautions thoroughly before operating the unit. 4. Inspect the unit on a periodical basis. Periodical inspection is needed to use the unit under optimum conditions. 5. Ensure that the unit should not be used when faulty. Take proper measures to ensure that a faulty unit will not be used by mistake before it is properly inspected, repaired and has its settings changed for normal operation. Such measures include indicating on the unit that it is under inspection/repair, and keeping it away from other devices that function correctly.

[2] Definition of Warning Indication Three levels of warning indication are used throughout this Manual and on the unit. They are defined as follows. A DANGER notice indicates an immediately hazardous situation which, if not DANGER： avoided, will result in death or serious injury, serious damage to property such as total loss of use of equipment, and a fire. A WARNING notice indicates an indirectly (potentially) hazardous situation WARNING： which, if not avoided, will result in death or serious injury, serious damage to property such as total loss of use of equipment, and a fire. A CAUTION notice indicates a hazardous situation which, if not avoided, can reCAUTION： sult in minor or moderate injury, partial damage to property, and loss of data stored in computers.

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[3] Definition of Marks 1. Marks to arouse attention Mark

《Title 》and Indication 《General attention 》 Indicates unspecified general caution, warning or danger. 《Beware of ignition》 Indicates possible ignition under certain conditions. 《Beware of electric shock》 Indicates possible electric shock under certain conditions. 《Beware of high temperature》 Indicates possible injury due to high temperature under certain conditions. 《Beware of a pinched finger or hand》 Indicates possible injury by having a finger or a hand pinched in a door or a port.

2. Marks to prohibit action Mark

《Title 》and Indication 《General prohibition 》 Indicates unspecified general prohibition. 《Prohibition of disassembly》 Indicates prohibition of disassembly of the unit where it may cause an electric shock or other hazards. 《Prohibition of contact》 Indicates prohibition of touching a certain part of the unit where it may cause injury under certain conditions. 《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.

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3. Marks to give instructions for action Mark

《Title》and Indication 《General instruction》 Indicates unspecified general action on the part of the user. 《Remove the power plug from the power outlet》 Instructs the user to remove the power plug from the power outlet in the case of malfunction or where a thunderbolt may fall. 《Connect a ground wire》 Instructs the user to connect the ground wire without fail where the unit is provided with a ground terminal.

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[4] General Precautions

DANGER To prevent hazardous explosion, the unit should not be handled where oxygen, nitrous oxide or flammable anesthetic gas is used.

WARNING The unit should not be touched with wet hands. The power cord of the unit should be connected to that power outlet including a ground terminal which meets the rated electrical requirements of the unit. If a fingertip or a tool should touch a harness or a terminal in the unit, an electric shock or a short circuit may result. Be sure to turn the unit off before handling it.

CAUTION Only qualified personnel belonging to Atom or a repair shop with proper training in the handling of the unit should inspect, repair, change the settings of, or disassemble and assemble the unit. In replacing a part, make sure that the new part you intend to use is the one specified by Atom. Replacing a part with one other than specified by Atom may compromise the safety feature or the unit. The unit should not be handled in electromagnetic environments where electrocautery or imaging devices such as MRI and CT equipment are used, or near equipment provided with an electromotor that consumes a lot of currents. The electronics of the unit may be affected by the radiation of various electromagnetic waves in the hospital and be led to malfunction. The unit cannot be disinfected by immersing in a medical fluid; it cannot be sterilized by autoclaving or with EOG. Follow the instructions of the Operation Manual in cleaning and disinfecting the unit. The unit should not be immersed in a medical fluid. A portion of the medical fluid may enter the unit and short the electronic circuits inside. After repairing, disassembling and assembling, changing the settings of, or cleaning and disinfecting the unit, check that the unit operates properly.

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Ｃ Ｏ Ｎ Ｔ Ｅ Ｎ Ｔ Ｓ Introduction ... 1 [1] Technical Data ... 6 [2] Parts Identification 2-1. Main Body ... 8 2-2. Control Panel ... 10 [3] Troubleshooting 3-1. Troubleshooting in cintrol failure ... 12 3-2. Troubleshooting in system malfunction ... 14 [4] Cleaning, Disinfection and Maintenance 4-1. Hood ... 18 4-2. Mattress Platform and Part Beneath ... 20 4-3. Others ... 22 4-4. Humidity Chamber ... 22 4-5. Replacing the filter ... 24 [5] Inspection ... 25 [6] Replacing the fuse and the battery ... 30 [7] Setting the DIP switch ... 31 [8] Periodical replacement parts ... 32 [9] Block Diagram and wiring Diagram ... 33 Replacing Parts List ... 35

[1] Technical Data Power requirements

Main body : AC230V ± 10% 50Hz 500VA (Maximum) HL stand : AC230V ± 10% 50Hz 630VA (When actuated)

Classification

Type of protection: Class1. Degree of protection: Type BF Not for use in air and flammable anesthetic gas or oxygen/nitrous oxide and flammable anesthetic gas. Mode of operation: Continuous operation. The HL stand is for intermittent operation (3 minutes per hour).

Operating condition

Ambient temperature: 20-30℃ (68-86 °F) Relative humidity: 30-75% Atmospheric pressure: 76-106kPa

Storing condition

Ambient temperature: 0-50℃ (32-122°F) Relative humidity: 30-75% Atmospheric pressure: 70-106kPa

Dimensions

With HL stand: 100(W)쎹58.5(D)쎹126.5-146.5(H)cm (Mattress surface 89.5-109.5cm) With cabinet: 100(W)쎹58.5(D)쎹134.5(H)cm (Mattress surface 97.5cm) Mattress : 74(W)쎹36(D)쎹2(T)cm

Weight

With HL stand: Approx. 88kg (Main body:Approx 54.5kg, HL stand:Approx.33.5kg) With cabinet: Approx. 83kg (Main body:Approx 54.5kg, Cabinet:Approx.28.5kg)

Maximum load capacity

MF rail: 10kg HL Stand drawer: 5kg/each IV pole (option): 5kg

Accessories

Access port cover ... 2 Skin temperature probe ... 1 F-6E electrostatic filter ... 1 Cap (rubber plug) ... 1 Dust cover ... 1

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■ Temperature control Temperature control mode

Servo Control/Manual Control also available

Temperature setting range

Skin temperature(Servo Control): 35.0-37.5 ℃(Override mode:37.6-39.0 ℃) Incubator air temperature (Manual Control): 23.0-37.0℃ (Override mode:37.1-39.0 ℃) In 0.1 ℃ increments

Temperature display range

Skin temperature: 30.0-42.0℃ (86-107.6°F) Precision: ± 0.3℃ Incubator air temperature: 20.0-42.0 ℃ (68-107.6°F) Precision: ± 0.3℃

Heater output indication:

0-100 (in 10 levels)

Warming time:

≦ 60min at ambient temperature 25℃

Alarm

High temperature, set point, power failure, fan, skin temperature probe, system failure

■ Humidity control Humidity control mode

Servo Control

Humidity setting range

40-90% RH ( in 1% increments)

Humidity display range

15-99% RH（器内温 36℃以上の場合） Precision: ± 5%

Maximum humidity

A type : ≧85% (at ambient humidity 50% RH, ambient temperature 25 ℃, incubator air temperature setting 37℃)

Alarm

Humidity chamber off, low water level

■ Oxygen Maximum oxygen concentration

≧ 65% (at O2 flow rate 10L/min)

Achieving time

≦ 30min (from 21% to 60% at O2 flow rate 10L/min)

■ Environment CO2 concentration in the hood

CO2 concentration when stability has been achieved after administering air mixed with 4% CO2 to a point 10cm above the center of the mattress at 750mL/min doesn't exceed 0.4%.

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[2] Parts Identification 2-1. Main body

y w

u o

i

!0

q

t !1

e

!2

r

!4 !3

No. q w e r t y u i o

Name Sensor module Iris access port MF rail Mattress platform tilting knob Humidity chamber cover Front admittance panel operating knob Front admittance panel Tube introduction slit assembly Snap-open access port

No. !0 !1 !2 !3 !4

Name Mattress Control panel Drawer Caster Elevating pedal

Note: !2Drawer (one-layer type and two-layer type) is optionally available.

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■ Rear

■ Right side

!5

!6 !7

■ Inside

!9 @0 @1 @2 @3 @4

@5

No.

Name

No.

!5 !6 !7 !8 !9 @0 @1

Filter cover Oxygen connecting port 1 Power switch Hood stopper Mattress platform X-ray cassette tray Top board packing

@2 @3 @4 @5

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Name Top board Fan cover Fan Conditioning chamber

!8

2-2. Control Panel q

o !0 @4 !1 !2 !3

i

˚C ˚F

%

SKIN

%

˚C ˚F

t ew r

w

e

r

t

i o

!0

＞37℃ 100

AIR

!6

@6

Temperature !1

Relative humidity display Displays a detected relative humidity in the incubator digitally. Relative humidity selector switch Press this switch to set a relative humidity. When this switch is pressed, the relative humidity display will flash, and a relative humidity can be set. Select a desired setting by pressing an appropriate setting switch. Humidity chamber off alarm indicator Illuminates when the humidity chamber is not positioned properly. Low water level alarm indicator Flashes and illuminates when there is little water in the humidity chamber. Set relative humidity display Displays a set relative humidity digitally.

!2

!3

!4 !5

Temperature

u

＞37.5℃ 0

˚C ˚F

!7 y u @0 !9 !8 @1 @3 @2 !5 @5

!6

y

˚C ˚F

>37.5℃ .>37℃

Humidity q

!4

High temperature alarm indicator ・Servo Control: Illuminates when the incubator air temperature exceeds 40 ℃. ・Manual control: Illuminates when the incubator air temperature exceeds 38 ℃ (or 40℃ in the override mode). Silence indicator Illuminates when an audible alarm is disabled. Skin temperature display Displays a detected skin temperature digitally. Servo Control indicator Illuminates when the incubator is operating in the Servo Control mode. ">37.5℃" indicator Illuminates when the incubator is operating in the Servo Control override mode.

!7

!8

!9

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Set temperature display ・Servo Control: Displays a set skin temperature digitally. ・Manual Control: Displays a set incubator air temperature digitally. ">37℃" indicator Illuminates when the incubator is operating in the Manual Control override mode. Manual Control indicator Illuminates when the incubator is operating in the Manual Control mode. Incubator air temperature display Displays a detected incubator air temperature digitally. Power failure alarm indicator Illuminates when power supply is interrupted due to power failure, disconnected power plug or other causes. System failure alarm indicator Illuminates wehn an abnormal condition is detected in self-diagnosis. ℃/ ° F selector switch Press this switch to change the temperature display unit from ℃ to ° F and vice versa. Servo Control switch Press this switch to operate the incubator in the Servo Control mode. Skin temperature probe alarm indicator Servo Control: Illuminates when the skin temperature probe is faulty or not connected. Manual Control: Illuminates when the skin temperature probe is faulty.

Temperature @0

@1

@2

@3

@4

Others @5

Override switch Press this switch while the SKIN indicator is flashing to select the override mode; the ">37.5℃" indicator will flash, and the high skin temperature range of 37.639.0℃ will be available. Press this switch while the AIR indicator is flashing to select the override mode; the ">37.0 ℃" indicator will flash, and the high incubator air temperature range of 37.1-39.0℃ will be available. Fan alarm indicator Illuminates when the fan is not operating or when the fan, the fan cover and the top board are not attached properly. Set point alarm indicator Servo Control: Illuminates when a detected infant's skin temperature deviates from the preselected temperature by more than ± 1 ℃. Manual Control: Illuminates when a detected incubator air temperature deviates from the preselected temperature by more than ± 3 ℃. Manual Control switch Press this switch to operate the incubator in the Manual Control mode. Heater output indicator Illuminates to indicate heater output in ten levels.

@6

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Setting switch Press this switch to set temperature, relative humidity, SpO2/pulse rate alarm limits, etc. to a desired level. Every time switch is pressed, a setting increases. Every time switch is pressed, a setting decreases. Alarm silence/reset switch Press this switch to silence an audible alarm or to reset an alarm condition.

[3] Troubleshooting 3-1. Troubleshooting in control failure Trouble

Check

The incubator air temperature does not rise.

1. Is the incubator air temperature set too low? 2. Is the incubator installed in the current of an air-conditioner, or by a cold window? Avoid installing the incubator in such a place in order not to cause a heat loss to the environment. 3. A temporary temperature drop might have been caused by opening and closing the front admittance panel. Wait for a while and check the unit again. 4. Is the supply voltage low? The incubator should not share a power outlet with another device. 5. Is the fan alarm indicator on? …… See 3-2 (3) 6. The incubator air temperature does not exceed 38℃ in the Servo Control mode. The incubator air temperature does not exceed 39℃ in the Servo Control override mode.

The incubator air temperature rises too high.

1. Is the incubator air temperature set too high? 2. Is the incubator installed in direct sunshine or near a heating apparatus? Avoid installing the incubator in such a place so that it may not be affected by external thermal conditions. 3. Is the air inlet in the incubator free from diapers, gauze, etc.? 4. A temporary temperature rise might have been caused by opening and closing the front admittance panel. Wait for a while and check the unit again. 5. Is the incubator air temperature set too low relative to the room temperature? The set temperature should be at least +3℃ higher than the room temperature. 6. Is a phototherapy unit or a heating humidifier in use? The set temperature should be at least +5℃ higher than the room temperature when these units are used. 7. The incubator air temperature may rise due to the heat generated by the infant itself.

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Trouble

Check

Humidity does not rise.

1. Is the relative humidity set too low? 2. Is the air outlet in the incubator free from diapers, gauze, etc.? 3. Is the humidity chamber off alarm indicator on? ……See 3-2(4) 4. Is the low water level alarm indicator on? ……See 3-2(5)

Humidity rises too high.

1. Is the relative humidity set too high? 2. Is the relative humidity extremely high due to the rainy season or some other cause?

The oxygen concentration does not rise.

1. Is the flow rate set too low on the oxygen flowmeter? 2. Are the access ports closed securely? 3. Are all the packings attached securely? 4. Is the filter cover attached securely?

The oxygen concentration rises too high.

1. Is the flow rate set too high on the oxygen flowmeter?

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3-2. Troubleshooting in system malfunction （1）The skin temperature probe alarm indicator illuminates. (Skin temperature probe alarm)

Is the skin temperature probe connected to the "skin temperature" port of the power unit?

NO

Connect the skin temperature probe to the "skin temperature" port of the power unit, and press the "alarm silence/reset" switch.

YES Replace the skin temperature probe with a new one, and press the "alarm silence/reset" switch.

Does the skin temperature probe alarm indicator go out?

NO

Ask for inspection/service.

YES Checking is completed.

（2）The system failure alarm indicator illuminates. (System failure alarm)

Turn power off.

Is the cable from the sensor module connected to the "J 1" port of the power unit?

NO

Connect the cable from the sensor module to the "J1" port of the power unit.

YES The performance of the system might have been affected by the noise. Turn power on again.

Does the system failure alarm indicator go out?

NO

YES Checking is completed.

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Ask for inspection/service.

（3）The fan alarm indicator illuminates.(fan alarm)

Turn power off.

NO

Is the middle deck installed?

Install the middle deck.

YES NO

Is the fan cover attached

Attach the fan cover.

YES NO

Is the fan attached?

Attach the fan.

YES Is the fan inserted securely up to the bottom of the motor axis?

NO

Insert the fan securely up to the bottom of the motor axis.

YES Is the fan for V2100G attached?

NO

Attach the fan for V2100G.

YES Turn power on.

Does the fan alarm indicator go out?

NO

YES Checking is completed.

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Ask for inspection/service.

（4）The Humidity chamber off alarm indicator illuminates. (Humidity chamber off alarm) NO

Is the humidity chamber cover closed?

Close the humidity chamber cover.

YES NO

Is the humidity chamber attached?

Attach the humidity chamber.

YES NO

Is the humidity chamber fully inserted?

Insert the humidity chamber fully.

YES NO

Is the boiler cap attached?

Attach the boiler cap.

YES If a replacement humidity chamber is available, replace the used humidity chamber with it.

Does the humidity chamber off alarm indicator go out ?

NO

YES Checking is completed.

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Ask for inspection/service.

（5）The low water level alarm indicator illuminates. (Low water level alarm)

Is the humidity chamber filled with sterile distilled water properly?

NO

If humidification is necessary, supply additional sterile distilled water to the humidity chamber.

YES If a replacement humidity chamber is available, replace the used humidity chamber with it.

Does the low water level alarm indicator go out?

NO

Ask for inspection/service.

YES Checking is completed.

（6）The power failure alarm indicator illuminates. (Power failure alarm)

Is power supply interrupted currently?

YES

Checking is completed.

NO Is the power cord connected?

NO

Connect the power cord.

YES Is the circuit breaker positioned On?

NO

Reset the circuit breaker.

YES Replace the power cord with a new one.

Does the power failure alarm indicator go out?

NO

YES Checking is completed.

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Ask for inspection/service.

[4] Cleaning, Disinfection and Maintenance

CAUTION Be sure to turn power off, remove the power plug and allow the incubator and the heater to cool down sufficiently before cleaning or disinfecting the unit. This product is shipped without being disinfected. Be sure to clean and disinfect the unit before using it for the first time after purchase. Before cleaning or disinfecting the unit, check that oxygen supply to the incubator has been stopped and that the incubator has been disconnected from the oxygen supply source. Cleaning or maintaining the incubator in an environment where the oxygen concentration is at a high level may lead to a fire or an explosion. Clean and disinfect the unit whenever you use it to a new infant.

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

Obtain a soft clean cloth and a disinfectant solution needed for cleaning and disinfection. ■ Recommended disinfectant solution include: 앫 0.2-0.5% benzalkonium chloride aqueous solution (e.g. Osvan) 앫 0.2-0.5% benzethonium chloride aqueous solution (e.g. Hyamine) 앫 0.1-0.5% chlorhexidine aqueous solution (e.g. Hibitane) Never use the above agents undiluted. Do not use any abrasive cloth, cleaner, alcohol, acetone or other solvent for cleaning and disinfection. Do not autoclave.

4-1. Hood ● Access port cover Remove all the access port covers. Immerse and clean them in a disinfectant solution.

CAUTION Spare access port covers should always be on hand. A dirty cover should be replaced immediately with a new one.

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● Snap-open access port packing Remove the rubber packing from the snap-open access port. Immerse and clean it in a disinfectant solution.

Snap-open access port packing

● Front admittance panel packing Remove the rubber packing from the front admittance panel. Immerse and clean it in a disinfectant solution.

● Tube introduction slit assembly Remove the packing from the tube introduction slit assembly. Immerse and clean it in a disinfectant solution.

● Inner wall panel Open the front admittance panel. Push down the lever for the inner wall panel and open the inner wall panel. Wring tightly a soft cloth dampened with a disinfectant solution and clean the inner wall panel.

CAUTION Do not remove the inner wall panel.

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Tube introduction slit assembly packing