V-808 Service Manual Nov 2014

Introduction This Service Manual describes procedures for inspecting, repairing and changing the settings of the Atom Transcapsule V-808. 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 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] Parts Identification 1-1. Main Body ... 6 1-2. Main Body - Sides ... 7 1-3. Main Body - Rear ... 8 1-4. Main Body - Inside ... 9 1-5. Mount ... 10 1-6. Control Panel ... 10 [2] Maintenance Inspection 2-1. Inspection before use ... 12 2-2. Three-month Inspection ... 13 2-3. Cleaning, Disinfection and Maintenance ... 14 2-4. Periodical replacing parts and Procedure ... 19 2-5. Inspection Checklist ... 22 [3] Settings 3-1. Special features ... 23 3-2. Setting the DIP switches ... 24 [4] Troubleshooting ... 27 [5] How to repair 5-1. Disassembling procedure ... 31 5-2. Inspection procedure ... 35 5-3. Replacement procedure... 38 [6] Electric Block Diagram ... 47 [7] Wiring Diagram ... 48 [8] Technical Information ... 50

[1] Parts Identification 1-1. Main Body q

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쎲 Main body No. q w e r t y u

쎲 Mount Name

Lighting lamp Front admittance panel Snap-open access port Control panel I.V. pole Head-end admittance panel Iris access port

No.

Name

i o

Main body locking device Mount

쎲 Stand No. !0 !1 !2

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Name Operating lever Gas spring Caster

1-2. Main Body - Sides 쐽 Right side

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q

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쐽 Left side

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No. q w e r t y

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Name Power switch AC power input External power input (24V/12V) Oxygen supply port AC power breaker DC power breaker (for 24V)

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!1

!2

No.

Name

u i o !0 !1 !2

DC power breaker (for 12V) Hood fixing knob Test switch Oxygen sensor connecting port SpO2 sensor connecting port Skin temperature probe connecting port

1-3. Main Body - Rear

q

w

e r t

No.

Name

q w e r t y

Oxygen sensor module Main board box Fuse (for Battery 1) Reset indicator 1 Reset switch 1 Battery 1

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y

1-4. Main Body - Inside

q

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r

t y u

i

!0

o

!1 !2 !3

No. q w e r t y u

Name

No. i o !0 !1 !2 !3

Mattress Mattress platform Middle deck Middle deck packing Fan cover Fan fixing screw Fan

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Name Incubator air temperature sensor Conditioning chamber Heater Connector (on the main body) Connector (on the mount) Mount

1-5. Mount

r

q

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t

No. q w e r t y u

y

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Name Battery cover Connector (on the mount) Mount switch Main body locking device Fuse (for Battery 2) Reset indicator 2 Reset switch 2

1-6. Control Panel @1 @2 @3

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@4 @5 !4 !5

@7

!7 !6 q

!8 !9 @0

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!0

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!1

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@9 @8

#1

#0

#2 #3

#4

No.

Name

No.

Name

q

High temperature alarm indicator Comes on when a detected incubator air temperature is too high. Alarm silence indicator Comes on when an audible alarm is silenced. Skin temperature probe alarm indicator Comes on when a skin temperature probe is faulty. Fan alarm indicator 앫 Comes on when the rotation of the fan is faulty. 앫 Comes on when the fan or the fan cover is not attached properly.

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Set point alarm indicator Comes on when a detected incubator air temperature deviates from the set point by at least 앐3˚C. Power failure alarm indicator Comes on when power supply has stopped. System failure alarm indicator 앫 Comes on when an incubator air temperature sensor is faulty. 앫 Comes on when power supply to the heater cannot be controlled.

w e r

y u

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No.

Name

No.

Name

i

Incubator air temperature display 앫 Displays a detected incubator air temperature digitally. 앫 Flashes during a set point alarm. Skin temperature display 앫 Displays a detected skin temperature digitally. 앫 Flashes when a skin temperature probe is faulty. 앫 Remains blank when a skin temperature probe has not been connected yet. Set temperature display Displays a set temperature digitally. Incubator air temperature selector switch Used to set an incubator air temperature. Heater output indicator Displays a heat output level of the main heater in ten grades. Setting switch / Used to set a desired incubator temperature. Also used to set SpO2/pulse rate/oxygen concentration alarm limits to a desired level. Oxygen concentration alarm indicator 앫 Flashes when a detected oxygen concentration violates the upper or lower alarm limit. 앫 Comes on when an upper or lower alarm limit for oxygen concentration is being set. Oxygen sensor indicator 앫 Comes on when an oxygen sensor could not be calibrated. 앫 Comes on when an oxygen sensor has come off during oxygen monitoring. Oxygen concentration display 앫 Displays a detected oxygen concentration digitally. 앫 Remains blank when the oxygen monitor mode is OFF. 앫 Displays an alarm setting when an oxygen alarm limit is being set. Oxygen concentration alarm indicator Comes on when a detected oxygen concentration violates the alarm settings. O2 switch Used to set oxygen concentration alarm limits. Calibration indicator Flashes when an oxygen sensor is being calibrated. Oxygen monitor switch Switches on/off the oxygen monitor function. Plethysmograph indicator Indicates changes in an arterial flow on a bar graph. SpO2 alarm indicator 앫 Flashes when a detected SpO2 violates the upper or lower alarm limit. 앫 Comes on when an upper or lower alarm limit for SpO2 is being set. Pulse rate alarm indicator 앫 Flashes when a detected pulse rate violates the upper or lower alarm limit. 앫 Comes on when an upper or lower alarm limit for pulse rate is being set.

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%SpO2 display 앫 Displays a detected %SpO2 digitally. 앫 Remains blank when an SpO2 sensor has not been connected yet or when the SpO2 function is not provided. 앫 Displays a flashing “ ” when an SpO2 sensor has become disconnected. Displays “ ” with “ ” flashing when an SpO2 sensor has become detached. 앫 Displays an alarm setting when an SpO2 alarm limit is being set. Pulse rate display 앫 Displays a detected pulse rate digitally. 앫 Remains blank when an SpO2 sensor has not been connected yet or when the SpO2 function is not provided. 앫 Displays a flashing “ ” when an SpO2 sensor has become disconnected. Displays “ ” with “ ” flashing when an SpO2 sensor has become detached. 앫 Displays an alarm setting when a pulse rate alarm limit is being set. 앫 Displays a setting when a heartbeat synchronous sound is being set. 0: Synchronous sound OFF 1: Synchronous sound ON Heartbeat synchronous sound switch Switches on/off the heartbeat synchronous sound. Alarm limit selector switch Used to set SpO2 pulse rate alarm limits. Battery 1 charge level indicator 앫 Displays a charge level of Battery 1 in ten grades. 앫 Flashes when charging is faulty. Battery 2 charge level indicator 앫 Displays a charge level of Battery 2 in ten grades. 앫 Flashes when charging is faulty. 앫 Remains blank when the unit is in use with the mount removed. Alarm silence/reset switch Silences an audible alarm or resets an alarm condition. AC power indicator Comes on when the unit is connected to AC power. Battery power indicator Comes on when the unit is powered by its internal batteries (Battery 1 and/or battery 2) External power indicator Comes on when the unit is powered by its external power source. Lighting switch Switches on /off the lighting lamp.

o

!0 !1 !2

!3

!4

!5

!6

!7

!8 !9 @0 @1 @2

@3

@5

@6 @7 @8

@9

#0

#1 #2

#3

#4

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[2] Maintenance Inspection 2-1. Inspection before use Check the following before each use. Item to check 1) Appearance

2) Stand fixing lever

3) Caster 4) Main body locking device 5) Access port cover 6) Access port packing 7) Admittance panel packing 8) Tube inlet packing 9) Incubator air temperature sensor 10) Oxygen sensor module 11) Front admittance panel operating knob 12) Hook slider for snap-open access port 13) Infant fixing band 14) Middle deck, Mattress platform 15) Middle deck packing 16) AC power indicator 17) Test switch 18) Battery charge level indicator 19) Filter

Description The hood, the main body and the stand should not be broken or deformed. (Otherwise, the infant and the user may be injured.) There should be no gap between the bottom of the main body and the top of stand. The hook of the fixing lever should be off the frame of the stand, hanging down, and the incubator should be fixed securely to the stand. (Otherwise, the main body may fall down.) The casters should not be loose, shaky or broken. The casters provided with a stopper can be locked securely. (Otherwise, the main body may fall down.) The main body and mount should be locked securely with the fixing devices. (Otherwise, the main body may fall down.) Each access port cover should be attached securely to its access port packing, and it should not be broken or deformed. (Otherwise, air tightness may be decreased.) Each packing should be attached correctly to the hood. (Otherwise, air tightness may be decreased.) Each packing should be attached correctly to a corresponding admittance panel and it should be not be broken. (Otherwise, air tightness may be decreased.) The packing should be attached correctly to the head-end admittance panel, and it should not be broken. (Otherwise, air tightness may be decreased.) It should not be broken or deformed. (Otherwise, the incubator air temperature may not be detected correctly and thus it may not be controlled correctly.) It should not be broken or deformed. (Otherwise, the oxygen concentration may not be detected correctly.) The knobs should not be loose. They can be locked securely. They can open and close the front admittance panel reliably. (If they cannot be locked securely, the infant may fall.) The knobs should not be loose. They can be locked securely. They can open and close the snap-open access port reliably. (If they cannot be locked securely, the infant may fall.) The infant fixing band should be attached to the middle deck securely. (Otherwise, infant can not be fixed reliably in place during transport.) Middle deck and Mattress platform should be installed securely. (Otherwise, the temperature cannot be controlled.) The packing should be attached correctly to the middle deck. (Otherwise, air tightness may be decreased.) The AC power indicator should come on when the power cord is connected to the power outlet. (Otherwise, the batteries may not be charged.) When test switch is pressed, the LED displays should come on fully and the audible alarm should sound. (LED displays may be faulty.) When power switch is turned on, the battery 1 charge level indicator and battery 2 charge level indicator should come on. (Otherwise, the internal battery power may not be available.) The filter should be clean. (Otherwise, air circulation may not be controlled correctly.) − 12 −

2-2. Three-month Inspection Check the following points every three months. Item to check 1) Incubator air temperature control 2) Oxygen concentration

3) Pulse oximeter

4) Fan

5) Lighting lamp

6) Battery

Procedure Set the incubator air temperature to 36.0℃. Supply oxygen at 10L/min from the oxygen supply port. Connect a Masimo sensor to the sensor panel on the left side of the main body and attach it to the inspector. Check the appearance of the fan by visual inspection. Check the lamp by visual inspection both on AC power and on the battery power. Charge the battery for at least eight hours and make the incubator air temperature stable at 36℃.

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Description The displayed temperature should be stable at 36.0 ± 1℃. The displayed oxygen concentration should be 60% or higher. 95-100% should be displayed on the SpO2 display. Pulse rate should also be displayed. The fan should make no strange sound. It should not be attached loosely, broken or deformed. When the lamp switch is turned on, the lamp should come on. The unit should operate for at least 90 minutes on the battery power at the ambient air temperature of 15℃.

2-3. Cleaning, Disinfection and Maintenance

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

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

After cleaning and disinfection, assemble the removed parts correctly and perform the inspection before use to make sure that the unit operates normally. Obtain a soft clean cloth and a disinfectant detergent solution needed for cleaning and disinfection. 쐽 Recommended disinfectant detergents include: 앫 0.2 − 0.5% benzalkonium chloride aqueous solution (e.g. Osvan) 앫 0.2 − 0.5% benzethonium chloride aqueous solution (e.g. Hyamine) 앫 0.1 − 0.5% chlorhexidine aqueous solution (e.g. Hibitane) Never use the above agents undiluted. Do not use any abrasive cloth, cleaner, alcohol, acetone or other solvent for cleaning and disinfection. Do not autoclave. 2-3-1. Hood 쎲 Access port cover Remove all the access port covers (iris access port covers, semi-iris access port covers). Immerse and clean them in a disinfectant detergent.

CAUTION The semi-iris access port cover is very important to maintain the performance of the incubator when the access port is open. Itﾕs specially effective in oxygen therapy, so be sure to attach it. Spare access port covers should always be on hand. A dirty cover should be replaced immediately with a new one.

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쎲 Snap-open access port packing Remove the rubber packings from the snap-open access ports. Immerse and clean them in a disinfectant detergent.

Snap-open access port packing

쎲 Admittance panel packing Remove the rubber packings from the admittance panels. Immerse and clean them in a disinfectant detergent. 쎲 Tube inlet Remove the packings from the tube inlets. Immerse and clean them in a disinfectant detergent.

쎲 Inside panel (front, rear, top, right) (1) Open the front admittance panel. Loosen the fixing screws for each inside panel(i.e. front, rear, top and right) and remove the inside panels. (2) Clean both sides of each inside panel with a soft cloth moistened with a disinfectant detergent.

쎲 Hood After all the parts have been removed from the hood, wipe clean the inside and the outside of the hood with a soft cloth moistened with a disinfectant detergent. 쐽 Assemble all the removed parts as before and check that they are attached correctly.

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Tube inlet packing

Fixing screw

Inside panel

2-3-2. Mattress Platform and Parts Beneath Press the hood fixing knob and unlock the hood. Hold up the hinges on the front admittance panel with both hands. The hood stopper on the right side of the hood will fall backward completely and the hood will be locked in place.

WARNING Clean and disinfect the heater and its surrounding only when the heater has cooled down sufficiently or you may get burned.

Hood fixing knob

To raise the hood, be sure to hold the hinges on the front admittance panel with both hands. If you hold the hood by any other part, the hood will slip and cause a hazard.

Hood stopper

Be sure to make sure that the hood stopper has fallen backward completely. If it has fallen down only insufficiently, the hood will fall forward and causes a hazard. Before opening the hood, remove the lighting lamp from the hood. If the hood is opened with the lighting lamp on it, the lamp may get broken. 쎲 Mattress platform and infant fixing bands (1) Hold the mattress platform by both sides. When it has come off the rails, lift it up and take to out. Clean it with a soft cloth moistened with a disinfectant detergent.

Mattress platform

(2) Remove the infant fixing bands from the mattress platform and immerse it in a disinfectant detergent. After disinfection, let it dry completely.

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

Middle deck

Middle deck packing

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쎲 Fan cover Remove the fan cover and clean it with a soft cloth moistened with a disinfectant detergent.

Fan cover

쎲 Fan Turn the fixing screw clockwise to loosen and then pull up the fan to remove. Immerse and clean it in a disinfectant detergent.

Fixing screw

Fan

쎲 Conditioning chamber The conditioning chamber will appear when all the components mentioned above have been removed. Clean it thoroughly with a soft cloth moistened with a disinfectant detergent. 쐽 Assemble all the removed parts as before in the reverse order of disassembly. Check that they are attached correctly and then close the hood.

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Conditioning chamber

2-3-3. Others 쎲 Skin temperature probe Wipe lightly a used probe with a soft dry cloth. Wipe the thermistor with a soft cloth moistened with a disinfectant detergent to disinfect. Be sure to keep the skin temperature probe in its case.

CAUTION Never wipe the skin temperature probe with any alcohol, or the material will harden. 쎲 Mattress Remove the mattress before placing a new infant in the incubator. Disinfect it by immersing the entire mattress in a disinfectant detergent. Since the mattress consists of a special sponge completely sealed up in a vinyl cover, the sponge inside cannot be contaminated unless the cover gets damaged.

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Mattress

2-4. Periodical replacing parts and Procedure

CAUTION Be sure to turn power off, remove the power plug and allow the incubator and the heater to cool down sufficiently before replacing parts. Before replacing parts, check that oxygen supply to the unit has been stopped and that the unit has been disconnected from the oxygen supply source. Never use the parts other than that specified. Otherwise it may cause a failure to the unit.

2-4-1. Replacing the Filter

CAUTION Replace the old filter with a new one every three months in general. The dirtiness of the filter varies with the degree of air pollution and the frequency of operation. Check the dirtiness of the filter through the window of the filter cover. If the filter should be found discolored, replace it with a new one even if the three-month interval is not over yet. Do not attempt to reuse the dirty filter by washing it or inserting it inside out.

Open the filter cover only to replace the old filter with a new one.

(1) Loosen the right and left screws on the filter cover and remove the cover. (2) Remove the dirty filter, taking care not to let the dirt fly about. (3) Clean the filter cover and the section to which the filter is attached with a soft cloth moistened with a disinfectant detergent. (4) Replace the dirty filter with a new one, attach the cover to its former position, and tighten the screws. ■ Filter Parts No. C092422

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Filter cover