V-80TR Transcapsule Operation Manual July 2004

INTRODUCTION This Operation Manual deals with the specifications, operation and maintenance of the V-80TR Atom Transcapsule (Transport Incubator). Atom is by no means responsible for any malfunction arising from a user ignoring the instructions for operation and maintenance described in this Manual as well as for any accident attributable to repair by someone other than technical personnel belonging to Atom or a qualified repairman. 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 in case of need. If any technical problem should arise, please contact your Atom distributor.

CAUTION This product is shipped without being disinfected. Be sure to clean and disinfect the unit before using it for the first time after purchase.

SAFETY INFORMATION Instructions to ensure safe operation of the unit are found throughout this Manual. Please read the Manual carefully before operating the unit. Please follow the instructions in operating it.

[1] Basic Instructions 1. Follow the instructions for safe use of the unit. Follow the operating instructions described in this Manual for safe use of the unit. 2. Inspect the unit on a periodical basis. Periodical inspection is needed to use the unit under optimum conditions. 3. Never use the unit when faulty. If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your ATOM distributor.

[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 which, WARNING：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 CAUTION：which, if not avoided, can result 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 indicate caution or warning Mark

<Title> and Indication <General attention> Indicates unspecified general caution, warning or danger.

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 use of fire> Indicates prohibition of use of fire where an external use of fire may cause the unit to ignite under certain conditions.

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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WARRANTIES This equipment is guaranteed by Atom Medical Corporation for a period of one year from the date of delivery to be free of any defects in both materials and workmanship when used normally for its intended purpose. Any parts of this equipment proving to be so 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. (1) Wear and tear of expendables. (2) Trouble and damage due to improper handling, such as dropping the unit during transport or transfer. (3) Trouble and damage due to a fire, salt, gas, extraordinary voltage, earthquake, thunder, storm and flood, or other natural calamities. (4) Travel expenses in the case of a trip to an isolated island, a remote place, etc. for the purpose of repair. Damage in shipment should be reported promptly to Atom accompanied by the certificate of the carrier concerned. All correspondence concerning the equipment should specify the model name and the serial number.

WARNING Atom is by no means 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 belonging to Atom or a qualified repairman. 2. Trouble or damage of Atom products caused by a product of another company other than that 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 secondhand equipment.

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[1] Precautions on Jamming

WARNING Medical radio knives, portable phones and other devices which generate high-frequency noise can cause jamming to various electric equipment for medical use and thus result in malfunction. Since portable phones and other devices are often used in medical facilities, some measures should be taken to prevent jamming due to such devices. Portable phones 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 jamming.

[2] Responsibility for Care of Equipment

CAUTION 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.

[3] Prohibition of Modification

WARNING Do not disassemble or modify the unit. Otherwise, a fire, an electric shock or injury may result.

[4] Periodical Inspection

CAUTION Proper periodical inspection is needed in order to maintain and use the unit under optimum conditions.

[5] In Case of Trouble

CAUTION If any abnormal condition or trouble should occur to the unit, indicate on the unit that it is out of order and contact immediately your Atom distributor or service engineer. See the end of this Operation Manual for where to make 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.

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INTRODUCTION ... 1 [1] Operating Precautions 1-1.

DANGER ... 7

1-2.

WARNING ... 7

1-3.

CAUTION ... 9

[2] Parts Identification 2-1. Main Body ... 11 2-2. Power Unit ... 12 2-3. Power Pack ... 12 2-4. Air Circulation System ... 13 [3] Installation of the Incubator 3-1. Assembly ... 14 3-2. Where to Install the Incubator ... 15 3-3. Locking the Casters ... 15 3-4. Adjusting the Height of the Stand ... 15 3-5. Power Outlet and Grounding ... 16 [4] Operation 4-1. Power Sources ... 17 4-2. How to use the Power Pack ... 18 4-3. How to Operate the Incubator ... 20 [5] Cleaning, Disinfection and Maintenance ... 28 [6] Troubleshooting ... 33 [7] How to Reset the Circuit Breaker and How to Replace the Fuse ... 34 [8] High Temperature Test and Adjustment of the Activation Temperature of the High Temperature Alarm Mechanism ... 36 [9] Technical Data 9-1. Incubator Main Body ... 37 9-2. Power Pack ... 37

[1] Operating Precautions Please follow the operating instructions described in this Manual for safe use of the unit. The unit should be operated only by those who have been trained and instructed properly in its operation. The unit should be operated only for its intended use.

1-1.

DANGER

Death or serious injury due to a fire or an electric shock will result if the instructions given below are not followed.

Do not leave the unit unattended when the front door or an access port is open. If the front door or an access port is left open, the infant may fall out of the baby compartment and get seriously injured. Never leave the unit unattended when the front door or an access port is open.

Do not bring fire near the unit while oxygen is used. If a lighted cigarette, a flame of a cigarette lighter or a burning gas is brought near the unit while oxygen is used, it may cause an explosion or a fire.

Do not place a possible ignition source in or near the unit. If a body warmer or an electric or gas heating apparatus is used or a device which may generate a spark is used in or near the unit, or if oil, a match or a volatile flammable substance is placed in or near the unit, it may cause an explosion or a fire.

Do not use the unit in the presence of a flammable anesthetic gas. The unit may cause explosion or a fire if used in the presence of such a gas.

Do not use ether, alcohol or other ignitable substances. Even a small amount of ether, alcohol or other ignitable substances may cause a fire when mixed with the oxygen in the incubator.

1-2.

WARNING

Death or serious injury due to a fire or an electric shock will result if the instructions given below are not followed.

Be sure to follow the doctor’s instructions in setting the oxygen concentration. Oxygen for medical use should be used. Be sure to use the oxygen flowmeter or the oxygen controller in supplying oxygen. To maintain the oxygen concentration in the incubator accurately at a desired level, check it immediately after starting oxygen supply and also repeatedly at a fixed interval with an oxygen monitor. If the oxygen concentration in the incubator deviates from a desired level, make necessary adjustments by increasing or decreasing the oxygen flow rate. −7−

Analyze arterial gas levels repeatedly when a high oxygen environment is required. It is reported to be extremely important and essential, when the infantﾕs conditions call for a high oxygen environment, to repeatedly analyze arterial gas levels in order to check for the oxygen concentration in the incubator and to prescribe a desired oxygen concentration. Follow the doctorﾕs instructions in measuring the oxygen concentration because ignoring essential requirements may increase risks of retinopathy of prematurity and other adverse effects.

Be sure to bear in mind the following points during oxygen supply. ●Use pure cotton for the infantﾕs clothing and bed sheets, etc. Do not use any material that is easily charged with static electricity. ●Use pure cotton or fire-proofed materials for the clothing of doctors, nurses and those ambulance men who handle this unit.

Bear in mind the following points 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, pipings, connections and other oxygen supply equipment. ● On an oxygen cylinder, use only a tested pressure reducing valve or pressure regulating 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.

Place the infant in the incubator only after the incubator temperature has stabilized. Do not use near the unit a device generating high frequency. Medical radio knives, portable phones 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 jamming.

Avoid damaging the power cord. A damaged power cord may cause a fire or an electric shock. ● Do not pinch the power cord 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 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.

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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.

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. Connect the power cord only to a 3P power outlet including a ground terminal and properly grounded in order to complete the ground connection. Do not operate the unit if you have any doubt about its ground connection.

Ground peripheral electric equipment securely. The rated voltage of the incubator main body is DC 12V. Never connect the incubator main body to a power source other than that specified. To use AC power, be sure to convert it to DC 12V via the Power Pack. Do not connect the incubator directly to the AC power outlet.

The unit should be serviced only by qualified personnel.

1-3.

CAUTION

Injury or damage to ambient 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. 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 or disinfecting the unit. Cleaning or disinfecting the unit with the power plug connected to the power outlet may cause an electric shock.

Place the unit on a stable surface. Placing the unit on an unstable platform or a tilted surface will cause it to fall or drop and may hurt someone. Check the strength of the place where the unit is to be placed or installed.

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Install the unit out of reach of small children.

Do not operate the unit covered with acloth. Do not operate the unit covered with a cloth or pressed tightly against a wall. Occluded air vents may result in heating the unit and cause a fire or an electric shock.

Do not install the unit in direct sunshine or near a heating apparatus. Do not expose the unit to extraordinarily high temperature or excessive humidity. Do not place anything heavy on the unit. Do not cause the unit to bump against anything, fall or drop.

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[2] Parts Identification 2-1. Main Body

I.V. Pole (detachable) Front door Incubator thermometer Hood (with Observation Light) Oxygen supply port Snap-open access port Semi-iris port cover

Power unit

Power Pack

Grip

Mattress platform

Mattress

Front door fastener

Snap lock

High temperature adjustment hole

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Connecting cable

2-2. Incubator Power Unit

Low voltage alarm lamp (red) Operation indicator lamp (green)

Standby heating indicator lamp (green)

High temperature alarm lamp (red)

Observation light switch (ON-OFF)

Heater indicator lamp (orange)

Power switch (OFF-STANDBY HEATING OPERATION)

Alarm buzzer

Filter cover

Temperature control dial

Power input connector

High temperature test terminal Circuit breaker (6A)

2-3. Power Pack Battery check button Battery condition indicator Power switch (lighted) Power cord

Shoulder strap Power output connector Shoulder strap fastening metal Power output fuse holder (blue, 8A) Power input fuse holder (white, 4A)

Auxiliary power source (12V DC)

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2-4. Air Circulation System The air circulation system of this incubator is designed to provide an infant with an optimum air environment through precisely controlled temperature, humidification and oxygen supply. External air is filtered in to provide a flow of clean air free of dust and dirt circulating inside the incubator. The air is humidified as it passes over the humidity sponge, and is fed into the hood through holes surrounding the mattress platform to ensure a uniform temperature distribution over the mattress.

Hood

Front door

Mattress platform Oxygen inlet

Mattress

Filter element Fan

Humidity sponge Conditioning chamber

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[3] Installation of the Incubator 3-1. Assembly The incubator is packed up when shipped from the factory. Assemble the separate components correctly. If the HL stand (option) is going to be used with the incubator, assemble the unit as instructed below.

CAUTION Because the incubator is heavy, at least two powerful people should join forces in assembling the unit.

(1) Place the incubator on the HL stand in such a way that the front of the incubator and the front of the HL stand may be positioned in the same direction. The rubber feet on the four corners of the incubator should be positioned reliably on the mounting sufface of the stand with out tilting or unstability. (2) Pass the incubator strap on either side of the unit securely round the grip of the incubator and the frame on the upper part of the stand.

Incubator fixing straps

(3) Place the Power Pack on the mounting table in the lower part of the stand. Two 500L oxygen cylinders can be placed in the lower part of the stand if necessary.

Oxygen cylinder rack Power Pack

WARNING Be sure to use the incubator straps to reliably fix the incubator to the HL stand. Otherwise the incubator might tip over when force is applied in opening the hood, or it might fall down when a shock is given during transport. Never move or operate the incubator before the main body is fixed securely to the stand.

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3-2. Where to Install the Incubator Unless during transport, install the incubator in a horizontal plce convenient for work. Avoid installing it near a heating apparatus, by the window or where fire is used.

CAUTION Avoid installing the incubator in direct sunshine, near a stove or a radiator, in the current of an airconditioner, or by a cold window so that it may not be affected directly by such external thermal conditions.

3-3. Locking the Casters Two of the casters of the HL stand (option) have a stopper. Follow the instructions below if the incubator is going to be used on the HL stand. (1) When the incubator is installed in a desired place, step on each of the two stoppers to lock the casters of the HL stand. (2) To move the incubator to another place, unlock the casters.

To lock

Stopper

CAUTION Install the HL stand on a horizontal and steady floor. Step on the two stoppers to lock the casters securely. To move the incubator to another place, be sure to unlock the casters.

3-4. Adjusting the Height of the Stand The height of the HL stand (option) can be adjusted freely within the range of 48-80cm. Follow the instructions below to adjust the height. (1) Check that the incubator is fixed securely to the stand with the incubator fixing straps. (2) Hold the frame on the upper part of the stand with both hands and pull up the operation lever toward the frame. The lever will be unlocked and the height of the stand can be adjusted. (3) When the height of the stand reached a desired level, release the operation lever. The stand will retain the level reliably.

To unlock

Operation lever

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CAUTION The stand is provided with a spring for elevation. Therefore, for safety's sake, two people should cooperate in adjusting the height of the stand with the incubator fixed to the stand.

3-5. Power Outlet and Grounding

CAUTION 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.

Connect the power cord only to a 3P power outlet including a ground terminal and properly grounded in order to complete the ground connection. Do not operate the unit if you have any doubt about its ground connection.

Ground peripheral electric equipment securely.

The unit should be serviced only by qualified personnel.

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[4] Operation 4-1. Power Sources This incubator is designed to operate on one of the three power sources: AC power (converted to DC 12V via the Power Pack), the transport incubator battery (Power Pack, DC 12V) or a vehicle battery (DC 12V). 4-1-1 Operation on AC power (1) Connect the power input connector of the incubator to the power output connector of the Power Pack securely with the con-necting cable supplied with the unit. (2) Connect the power cord of the Power Pack to the power outlet. (3) Turn the Power Pack on (the power switch should come on). Power will be supplied and the battery will be charged automatically. Overcharging cannot occur.

AC outlet

Power Pack Connecting cable

CAUTION To use AC power, be sure to supply power to the incubator via the Power Pack. Do not connect the incubator directly to the AC power outlet. When the power switch of the Power Pack is set to the OFF position, the power cord is not connected to the power outlet, AC power is shut off, power will automatically supplied from the Power Pack. 4-1-2 Operation on the Power Pack

CAUTION Supply power from the Power Pack only when AC power is not available. Use AC power whenever possible.

(1) Connect the power input connector of the incubator to the power output connector of the Power Pack securely with the connecting cable supplied with the unit. (2) Check the battery condition by following the procedure described in 4-2. How to Use the Power Pack. ●It is difficult to generalize on the hours of continuous incubator operation available on a battery, but it is estimated that a fully charged battery can provide approximately 3.5 hours of continuous operation.

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Power Pack Connecting cable

4-1-3. Operation on a vehicle battery

WARNING Before actually placing an infant in a vehicle, check the vehicle battery and the cigar lighter outlet. Perform a temperature test without placing an infant in the incubator and make sure that the incubator operates normally on the vehicle battery.

(1) Set the slider position depending on the classification by country. (2) Start the engine of the vehicle. (3) Connect the power input connector of the incubator to the cigar lighter outlet (DC 12V) of the vehicle securely with the car plug (option).

쮿 Car plug

CAUTION Be sure to start the engine before supplying power from the vehicle battery. If the incubator is used with the engine stopped, the vehicle battery may become completely discharged after a period of time.

Slider

WN-

Position of slider N W

Turn off the headlights when the vehicle is parked or stopped during nighttime transport. Do not keep the foot brake on but use the side brake to minimize the consumption of the battery power.

Classification by country Japanese cars, American cars European cars

※The slider is in “N” position when the unit is shipped from the factory.

Cigar lighter outlet

Car plug

4-2. How to Use the Power Pack The Power Pack is specifically designed to supply DC 12V power to the V-80TR Atom Transcapsule. The Power Pack is capable of supplying stable power when AC power is not available. The maintenance-free battery does not require troublesome maintenance including periodical replenishment of distilled water. Another feature of this battery is that it will not be damaged by overcharging.

4-2-1. Checking the battery capacity When power is supplied to the incubator from the Power Pack, periodically check the battery capacity before and during use.

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(1) Connect the power input connector of the incubator to the power output connector of the Power Pack securely with the connecting cable supplied with the unit. (2) Set the power switch of the incubator to the STANDBY HEATING position. (3) While pressing the battery check button of the Power Pack, check the pointer of the battery condition indicator.

Battery check button Battery condition inicator

● If the pointer of the battery condition indicator is in the green zone, the battery is ready for use (fully charged).

BEING CHARGED

ING RG D A CH EEDE N

● If the pointer of the battery condition indicator is in the yellow zone, the battery needs approx. 10-15 hours of charging.

READY FOR USE BATTERY CONDITION INDICATER

BEING CHARGED

ING RG D A CH EEDE N

● If the pointer of the battery condition indicator is in the brown zone, the battery needs approx. 15-20 hours of charging.

READY FOR USE BATTERY CONDITION INDICATER

BEING CHARGED

ING RG D A CH EEDE N

READY FOR USE BATTERY CONDITION INDICATER

* Actual charging time depends on the condition of the battery. The above figures are given for reference. 4-2-2. Low voltage alarm When the battery voltage falls below 10.7V, the alarm buzzer on the incubator will sound and the low voltage alarm lamp will come on. In such a case start charging the battery immediately. 4-2-3. Charging the battery (1) Connect the power cord of the Power Pack to the power outlet. (2) Set the power switch of the Power Pack to the ON position (the power switch lamp will come on). The battery begins to be charged. At this time, power can also be supplied to the incubator if necessary.

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4-2-4. Precautions in using the battery General precautions in using the battery are as given below. They may not necessarily apply because the condition of the battery depends on how it is used and stored.

CAUTION Be sure to charge the battery before using it because the battery capacity decreases due to spontaneous discharge during transportation or storage. Charge the battery in a dry thermal environment of 0-40℃.

Charge the battery periodically even during storage because the battery capacity decreases due to spontaneous discharge when it is kept in storage for a long time. Be sure to charge the battery after use whether or not the incubator was operated on the battery for a long time. If the battery is left uncharged, its performance and its life will be affected adversely. The battery will generate some heat during charging due to a chemical reaction. Also a very small quantity of gas will generate. Avoid charging in a closed environment.

4-3. How to Operate the Incubator

WARNING The operator should master the operating procedures completely before placing an infant in the incubator. Perform a temperature test without placing an infant in the incubator and make sure that the incubator operates normally. While an infant is in the incubator, check the incubator temperature and the oxygen concentration. Monitor the infant continuously for any abnormal condition.

4-3-1. Standby heating In the standby heating mode, power is supplied only to the heater. The fan motor does not rotate. This is intended to prevent the filter element from contamination. It has no effect on temperature control. The incubator should always be in the standby heating mode, ready for use any time. (1) Connect the power input connector of the incubator to the power output connector of the Power Pack securely with the connecting cable supplied with the unit. (2) Connect the power cord of the Power Pack to the power outlet.

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Power switch