V-707 Transcapsule Operation Manual Feb 2009

The unit for 100V region doesn’t suit the CE mark. For further information or questions, please contact the following representative if you are in an EU member state. In other countries, please contact your distributor or Atom Medical International, Inc.

Atom Medical International Inc. EU Office Via Francesco Croce, 65 20081 Abbiategrasso (MI) ITALY Tel: +39-02-9976-3101, Fax: +39-02-9976-3110

INTRODUCTION This Operation Manual deals with the specifications, operation and maintenance of the Atom Transcapsule V-707. 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. 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 local Atom representative.

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. Used parts and products past their lives should be disinfected and/or sterilized and then disposed of as medical waste.

INTENDED USE The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and seriously ill neonates.

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 in operating it.

[1] 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 under optimum conditions. (See “[9] Maintenance Inspection” of this Manual.) 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 local Atom representative. 4. EMC Medical electric equipment needs special precautions regarding EMC. It needs to be installed and put into service according to the EMC information provided in this Manual. ❉ EMC stands for electromagnetic compatibility. EMC requirements specify measures against emitting and receiving unwanted electric waves.

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[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 avoided, will result in death or serious injury, serious damage to property such as DANGER： 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.

[3] Definition of Marks 1. Marks to indicate caution or warning Mark

Title

and Indication

General attention Indicates unspecified general caution or warning. Caution: Hot surface Indicates that the surface can be dangerously hot.

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.

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3. Symbols 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 lighting may occur. Connect a ground wire Instructs the user to connect the ground wire without fail where the unit is provided with a ground terminal. 4. Symbols of international standards (IEC) Mark

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. Alarm setting Indicates a switch for setting the alarm function. Audible alarm silenced Indicates that an audible alarm is silenced. Caution Indicates that the user needs to see a relevant accompanying document before operating the unit. Fan Indicates a control switch that controls the fan. Lighting Indicates a switch that controls lighting. Recycle mark (battery) Indicates that recycling is recommended.

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5. Other symbols Mark

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 device is being powered by a battery or batteries. External DC power source Indicates that the unit is operating on an external DC power source. Alarm Indicates that an audible alarm is silenced. Alarm Indicates that a system of the unit is in an abnormal condition. Alarm Indicates that the incubator air temperature has exceeded or fallen below the set temperature by 3˚C or more. Alarm Indicates that the rotation of the fan is abnormal or the fan has not been attached. Alarm Indicates a high temperature condition with the incubator air temperature exceeding 39˚C, and the high temperature adjusting volume. Setting Indicates a setting value of the incubator air temperature. Incubator air temperature Indicates a present incubator air temperature and the connecting port of the incubator air temperature sensor cable. Heater Indicates a heater output. Skin temperature Indicates the infant’s skin temperature, the connecting port of the skin temperature probe and the connecting port of the skin temperature monitor cable.

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Mark

Title

and Indication

POWER

Power switch Indicates the power switch of the main body.

BREAKER

Breaker Indicates the breaker of the main body.

12V

DC power connecting port Indicates the DC power connecting port of the main body. Lighting lamp Indicates the lighting lamp cable connecting port. Test switch Indicates the test switch.

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WARRANTIES This equipment is guaranteed by Atom Medical Corporation to be free of any defects in both materials and workmanship for a period of one year from the date of delivery 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, extraordinar y 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 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 personnel belonging to Atom or a sales representative or an installation company authorized by Atom. 2. Trouble or damage to Atom products caused by a product of another company other than that delivered 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 careless or improper modification. 7. Trouble or damage due to using equipment sold or repaired by a secondhand goods dealer or a repair shop without notifying Atom. Trouble or damage due to using equipment 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 the international standards IEC-60601-1, IEC-60601-1-1 and IEC-60601-1-2, or which is not equipped with equivalent safety features.

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[1] 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 electric equipment for medical 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 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 to 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 local Atom representative or service engineer. See this Operation Manual for whom 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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C

O

N

T

E

N

T

S

INTRODUCTION ... 1 [1] Operating Precautions 1-1. DANGER ... 10 1-2. WARNING ... 12 CAUTION ... 14 1-3. [2] Parts Identification ... 15 [3] Setting up the Incubator 3-1. Assembling ... 21 3-2. Locking the Casters ... 23 3-3. Adjusting the Height of the HL Stand ... 23 3-4. Connecting the Power Pack to the Main Body ... 24 3-5. Where to Place the Incubator. ... 24 3-6. Fixing the Incubator to transport vehicle ... 24 3-7. Power Outlet and Grounding ... 25 3-8. Power Cord and Power Switch ... 26 3-9. Inspection before Use ... 27 [4] Power Source 4-1. Using the AC Power (AC220-240V) ... 28 4-2. Using the Battery Power ... 29 4-3. Using the External DC Power (DC12V) ... 30 [5] Incubator Air Temperature Control and Placing the Infant in the Incubator 5-1. Setting the Incubator Air Temperature ... 31 5-2. Placing the Infant in the Incubator ... 33 5-3. Skin Temperature Monitoring ... 35 [6] Oxygen Supply ... 37 [7] Other Operating Procedures 7-1. Inserting the Cords and Tubes ... 39 7-2. Lighting Lamp ... 39 7-3. I.V. Pole (Option) ... 39 7-4. Test Switch ... 40 7-5. Check Switch ... 40 7-6. Unlocking the Hood Lock (for opening the rear hood) ... 40 [8] Cleaning and Disinfection 8-1. Skin Temperature Probe ... 41 8-2. Hood ... 42 8-3. Mattress Platform ... 43 8-4. Replacing the Filter ... 44 [9] Maintenance Inspection 9-1. Daily Inspection ... 45 9-2. Three-month Inspection ... 46 9-3. Periodical Replacement Parts ... 46 9-4. Inspection Checklist ... 47 9-5. Life ... 48 9-6. Disposal ... 48 [10] Alarms and Alerts ... 49 [11] Troubleshooting ... 51 [12] Technical Data ... 52

[1] Operating Precautions 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. 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 followed.

Be sure to keep the front admittance panel and the access ports closed when using the unit. If the front admittance panel or an access port is left open when the unit is in use, the infant may fall out of the baby compartment. Be sure to keep the front admittance panel and the access ports closed during phototherapy also when it is performed on an infant placed in the incubator.

Do not leave the unit unattended when the front admittance panel or an access port is open. If the front admittance panel or an access port is left open, the infant may fall out of the baby compartment and even lose its life. Never leave the unit unattended when the front admittance panel or an access port is open.

If the front admittance panel, a snap-open access port or a hook slider should be found loose or faulty, stop using the unit immediately and ask for repair. The infant may fall.

Always check the front admittance panel operating retainer and the hook sliders of the snap-open access ports for proper operation. If the front admittance panel or a snap-open port should not close securely, don’t place an infant in the unit, and ask for repair. Do not open the front admittance panel or an access port in order to lower the incubator air temperature. Because the incubator air temperature is controlled automatically at a set temperature, the heater output will increase dangerously to make up for any temperature drop.

Open and close the snap-open access ports gently. If you open or close them roughly, they may not open or close properly, which is dangerous.

After the infant is placed in the incubator, check again that the front admittance panel and the access ports are all closed securely. Do not fasten the infant fixing bands too tightly. If they are fastened too tightly, they will press the infant dangerously.

Never place a body warmer or other possible ignition sources in or near the unit. Use of oxygen will increase a risk of explosion or a fire. A body warmer 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.

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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 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.

If water or any liquid should get into the unit, stop using the unit and request a repair service. If the power supply should be short-circuited, it may cause the incubator to ignite or burn out. Chemical fluids, having entered the unit, may stick to the incubator parts and cause abnormal operation of the incubator.

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

Do not give a shock to the unit or allow it to be struck by other objects. The screws or fixed parts may become loose.

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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.

Always maintain the incubator air temperature at a fixed level during the standby. Place the infant in the incubator only when the incubator air temperature has stabilized. Be sure to follow the doctor’s instructions in setting the incubator air temperature. Be sure to follow the doctor’s instructions in setting the oxygen concentration in the incubator. Be sure to use oxygen intended for medical use. Be sure to bear in mind the following precautions during oxygen supply. 쎲 Do not place a body warmer, a flashlight, oils and fats, or flammable vaporizable matters in the incubator. 쎲 Use pure cotton for the infant’s clothing, bed sheets, etc. Do not use any material that is easily charged with static electricity. 쎲 Use pure cotton or fire-proof materials for the clothing of doctors, nurses and those ambulance men who handle this unit.

Bear in mind the following precautions while using oxygen supply equipment. 쎲 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. 쎲 On a high-pressure 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 first 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. Avoid damaging the power cord. A damaged power cord may cause a fire or an electric shock. 쎲 Do not pinch the power cord between the unit and the wall, a shelf or the floor. 쎲 Do not place the power cord near a heating apparatus or heat it. 쎲 Do not put anything heavy on the power cord. 쎲 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.

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Use only the power cord supplied with the unit. Otherwise a fire or an electric shock may result.

Before cleaning or disinfecting the unit, be sure to turn off the unit, remove the power plug and make sure that the incubator air temperature and the heater temperature have sufficiently fallen. 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.

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. Electrical ratings of this unit are as follows: q AC220-240V; power consumption 220VA; frequency 50/60Hz; operating voltage range AC198264V w DC12V; 10A; operating voltage range 11.0-14.0V The unit should not be connected to any other power source.

The unit should be serviced only by qualified personnel. Be sure to inspect the unit before starting a day’s work. Operating the unit without inspecting it before starting a day’s work may let a defect pass unnoticed and cause a serious accident.

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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. The unit is shipped without being disinfected.

When inserting a cord or a tube into the unit, be careful not to let it wind around or squeeze the infant inside. 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.

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.

Install the unit out of reach of small children. Do not install the unit in direct sunshine or near a heating apparatus. Do not expose the unit to an extraordinarily high temperature or an excessive humidity. Do not place anything heavy on the unit. The unit uses rechargeable batteries (a lead-acid battery and a nickel metal hydride battery). To dispose of the unit, remove the lead-acid battery and the nickel metal hydride battery from the unit and send them to authorized recycling facilities for recycling. Check the operation of the peripheral devices. If a device transmitting or receiving weak signals is installed near the unit, it may be affected by the electromagnetic waves generated by the latter. Check the operation of peripheral devices for any effect before using the unit in clinical settings. Stop using the unit immediately if any trouble is detected.

When you transfer the incubator by holding the handles, make sure you do so with the help of another person. The power pack weighs about 13kg. Please use caution when handling it. − 14 −

[2] Parts Identification 2-1. Main body e

r

t

q y

w

u i o

!0

!1

!2

!3

!4 ❉ The I.V pole (option) can be attached to either side of the incubator.

No.

Name

No.

q w e r t y u

Front admittance panel Mattress platform (placed in the unit) Front admittance panel packing Lighting lamp Front admittance panel retainer I.V. pole (option) Skin temperature probe connecting port

i o !0

Oxygen supply port Handle Mattress (placed in the unit)

!1 !2 !3 !4

Snap-open access port Control panel Power panel Hood fixing device

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Name

2-2. Right side of the main body (the power supply)

POWER

q

BREAKER 15A

w

No. q w e

12V

e

Name Power switch Breaker DC power connecting port

2-3. Rear side of the main body w

q

e

No.

Name

q w e

Filter High temperature adjusting volume Test switch

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2-4. Inside of the main body

q

w e

r

t

y

u

No. q w e r t y u

Name Mattress Hood packing Mattress platform Fan cover Fan Fan cover catch Heater

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2-5. Stand 쎲 HL stand

q w

e No. q w e

Name Main body HL stand Power pack for V-707

쎲 Cabinet stand for internal hospital use

q w

e

No. q w e ❉ The HL stand, Cabinet stand for internal hospital use and Oxygen gas cylinder in the figure are not accessories.

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Name Main body Cabinet stand for internal hospital use Power pack for V-707

2-6. Operation panel

u q i o !0

w

!1 !2

e

!3

r

!4 !5

t

!6

y

!7

No.

Name

No.

q w e r t y u i o

Skin temperature display Incubator air temperature display Set temperature display Heater output indicator Incubator air temperature selector switch Setting switch 왓•왕

!0 !1 !2 !3 !4 !5 !6 !7

Alarm silence/reset switch Alarm silence indicator System failure alarm indicator

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Name Power failure alarm indicator Set point alarm indicator Fan alarm indicator High temperature alarm indicator AC power indicator Battery power indicator External DC power indicator Lighting switch