ATOM Medical Corporation
Transport Incubators
V-850TR Transcapsule Incubator Operation Manual June 2006
Operation Manual
46 Pages
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Transport Incubator
V-850TR Atom Transcapsule Incubator
Operation Manual
TO THE OPERATOR AND THE PERSON IN CHARGE OF MAINTENANCE AND CARE OF THE UNIT: 앫 Read this Manual carefully before operating the unit. 앫 After reading this Manual, keep it where it is readily accessible for reference in case of need.
The name and address of our authorized representative within the community are as stated below.
PHARMASERVE-LILLY S.A.C.I.
15th klm National Road Athens-Lamia, 145 64 Kifissia, Greece Post Address : P.O.Box 51288, 145 10 Kifissia, Greece Tel. : 3016294600, Fax. : 3016294610
INTRODUCTION This Operation Manual deals with the specifications, operation and maintenance of the Atom V-850TR Transcapsule 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, or authorized by, 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 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. Used parts and other products past their useful lives should be disinfected or sterilized and pose of as medical wastes.
dis-
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 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.
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 when thunder storm conditions threaten and lightning might occur. 《Connect a ground wire 》 Instructs the user to connect the ground wire without fail where the unit is provided with a ground terminal.
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, electrical storm and flooding, 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, maintenance or repair by someone other than technical personnel belonging to, or authorized by, Atom. 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. 8. If an accessory device which does not meet the safety requirements of this unit is used in combination with the unit, the safety level of the resulting system may be compromised. When selecting an accessory device, the following point should be taken into consideration. Evidence that the safety of the accessory device was certified in accordance with a national standard conforming to IEC60601-1 and/or IEC60601-1-1.
[1] Precautions on Jamming
WARNING Electrosurgical apparatus, 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.
C O N T E N T S [1] Operating Precautions 1-1. DANGER ... 1 1-2. WARNING ... 2 1-3. CAUTION ... 4 [2] Parts Identification 2-1. Main Body ... 5 2-2. Control Unit ... 6 [3] Install the Infant Incubator 3-1. Assembly ... 7 3-2. Where to Install the Infant Incubator ... 8 3-3. Locking the Casters ... 8 3-4. Adjusting the Stand ... 8 3-5. Installation procedure of oxygen/air cylinders (500L) ... 9 3-6. Power Outlet and Grounding ... 10 [4] How to Use 4-1. Power source ... 11 4-2. Operating the Battery ... 14 4-3. Operating the Incubator Unit. ... 15 [5] Alarms ... 22 [6] Cleaning, Disinfection and Maintenance 6-1. Front Admittance Panel ... 24 6-2. Head Admittance Panel ... 24 6-3. Inner Hood Panel (Top, Rear and Right-Side) ... 24 6-4. Hood ... 24 6-5. Front Access Door Packing ... 24 6-6. Snap-Open Access Port Packing ... 25 6-7. Semi-Iris Port Covers... 25 6-8. Full-Iris Port Covers ... 25 6-9. Mattress ... 26 6-10. Mattress Platform and Infant Restraining Straps ... 26 6-11. Mid-Floor Plate ... 26 6-12. Casing ... 26 6-13. Fan ... 27 6-14. Humidity Sponge ... 27 6-15. Replacing the Filter ... 27 6-16. Assembly ... 28 6-17. Verifying ... 28 [7] Maintenance Inspection 7-1. Inspection before use ... 30 7-2. Three-month Inspection ... 31 7-3. Periodical Replacement Parts ... 31 7-4. Inspection Check List ... 32 7-5. Life ... 33 7-6. Disposal ... 33 [8] Troubleshooting ... 34 [9] Technical Data ... 35
[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, damage to equipment or a fire will result if the instructions given below are not followed.
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 suffer serious or fatal injury. Never leave the unit unattended when the front admittance panel or an access port is open.
Keep fire away from the unit during oxygen supply. Do not place ignition sources in or near the unit. 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−
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 in the incubator. Oxygen for medical use should be used. Be sure to connect an oxygen flowmeter or an oxygen controller to the oxygen source. To maintain the desired oxygen concentration in the incubator, use an oxygen flow meter to measure the oxygen concentration immediately after the incubator starts being used and at regular intervals thereafter. If the oxygen concentration inside the incubator is not at the desired level, increase or decrease the oxygen flow rate until the desired level is reached.
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.
Be sure to bear in mind the following points during oxygen supply. ● Use pure cotton for the infant'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 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 and then to supply oxygen again.
Place the infant in the incubator only after the incubator air temperature has stabilized. Do not used near the unit a device generating high frequency. Electrosurgical apparatus, celular 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−
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. ● 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.
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 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 input voltage of this unit is AC230V, 50Hz. Never connect the unit to the power source other than that specified. The unit should be serviced only by qualified personnel.
−3−
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. 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 operate the unit covered with cloth. Operating the unit covered with a cloth or pressed tightly against the wall may cause a fire or electric shock from overheating
Do not install the unit in direct sunshine or near any heating apparatus. Do not expose the unit to extraordinarily high temperature or excessive humidity. Do not place anything heavy on the unit. Do not let the unit bump against anything, fall or drop inadvertently. Check the operation of the peripheral devices. If a devices 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.
−4−
[2] Parts Identification 2-1. Main body
Illuminating lamp Front admittance panel
Snap-open access port
I.V Pole Front admittance panel operating knob
Head access door
Tubing inlet port (right and left)
Iris access port
Control Unit
Mattress platform Oxygen inlet port
M.F. rail (right and left) Oxygen cylinder rack (front and rear)
Release lever Gas spring
Caster
−5−
2-2. Control Unit Operating Instruction
ALARMS
Alarm indicator lamp
HIGH TEMP HEATER FAN MOTOR SENSOR LOW VOLT
POWER FAILURE
AIR TEMPERATURE ℃
Incubator air temperature display Internal Battery operation indicator lamp External power operation indicator lamp Battery status indicator
HEATER
Heater output indicator EXT PWR
INT PWR CHARGING
Battery-on-charge indicator lamp
CHARGE ENABLE REQUIRED
BATTERY CHECK
Battery check button
TEMPERATURE CONTROL
LAMP
Incubator temperature control
Illuminating lamp on/off switch
Part name Alarm indicator lamp
Function Flashes and illuminates to indicate over-temperature, heater, fan motor, sensor malfunction, low power voltage, and power failure.
Incubator temperature display panel
Digitally displays air temperature within the incubator.
Heater output display panel
Indicates heater's thermal output levels in 6 steps from 0 to Full.
Battery-on-charge indicator lamp
Comes on to indicate the battery is being charged when the unit is connected to an AC outlet.
Battery operation indicator lamp
Comes on when the unit is switched to the battery operation mode.
Line power operation indicator lamp
Stays on when the unit is being operated from AC line power.
Battery status indicator
Comes on or flashes when the battery check button is pressed.
Incubator temperature control
Sets incubator air temperature.
Illuminating lamp on/off switch
Switches the illuminating lamp on/off.
Battery check button
Battery status indicator will be lit or flash when this button is pressed.
−6−
[3] Install the Infant Incubator 3-1. Assembly The main body of the incubator and the stand are separately packed when shipped from the factory. Assemble the components correctly.
CAUTION At least two people should join forces in assembling the unit for safety's sake.
(1) Secure the hook of the fixing lever at the right side of the stand over the stand frame. This releases the lock. (2) Place the main incubator body on the stand in such a way that front of the main body and the front surface of the stand may be positioned in the same direction. The metal fittings on the two corners of the upper surface of the stand should fit in the sockets in the bottom surface of the main body without leaving any space between them or without tilting.
Frame To unlock : Secure the hook of the fixing lever over the stand frame.
(3) Release the hook of the fixing lever from the stand frame and leave the hook hanging down. The incubator body and the stand are now locked together.
WARNING Fix the main incubator body reliably to the stand by fitting in the interlocking hooks securely with the metallic parts. Otherwise the main incubator body might tip over and fall down when force is applied in opening the hood. Never move or operate the incubator before the main incubator body is fixed securely to the stand. Check that the interlocking hooks are locked in routine inspection.
−7−
Frame To lock : Release the hook of the fixing lever from the stand frame.
3-2. Where to Install the Infant Incubator Except for transporting, install the incubator in a horizontal place convenient for work. Avoid installing it near any 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 air-conditioner, or by a cold window so that it may not be affected directly by such external thermal conditions.
3-3. Locking the Casters (1) When the incubator is installed in a desired place, lock the two casters on the stand. (2) To move the incubator to another place, be sure to unlock the casters.
To lock
CAUTION Install the incubator on a horizontal and steady floor. Step on the caster stoppers to lock securely. To move the incubator to another place, be sure to unlock the casters.
To unlock
3-4. Adjusting the Stand The height of the stand is adjustable in three steps. The adjustment procedures are as follows. (1) Check the incubator body and the stand are locked together. (2) Grasp the upper frame with your right hand and hold both the release lever and frame in your left hand with the palm upward. (3) Release the lock by pulling the release lever leftward while slightly lifting the upper frame, and adjust the incubator height to the desired level. (4) Then, let the lever go. This will click it into the lock position again.
−8−
Frame
Release Lever
CAUTION The stand is loaded with push-up springs. To ensure greater safety, the above procedures should always be taken with the incubator unit mounted, using two persons.
3-5. Installation procedure of oxygen/air cylinders (500L) The stand has two racks for oxygen/air gas cylinders. (1) Install the gas cylinder through the cylinder rack and push until the bottom of the gas cylinder reaches the stopper.
(2)Fix the cylinders with fixing screw securely.
Cylinder rack
Fixing screw
CAUTION Be sure to fix the cylinders with the fixing screw after installation. When using oxygen or air cylinders, always connect an oxygen pressure reducing valve and pressure gauge to indicate the remaining capacity of the cylinder.
−9−
Stopper
3-6. Power Outlet and Grounding
WARNING 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 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 input voltage of this unit is AC230V, 50Hz. Never connect the unit to a power source other than that specified. The unit should be serviced only by qualified personnel.
■ How to reset the circuit breaker If an over current condition should occur during the operation of the unit, the circuit breaker of the unit will be tripped to prevent possible accidents. To reset the breaker, take the following steps: (1)Press the power switch to turn the power off. (2)Allow at least one minute after the breaker was tripped, and then depress the breaker pushbutton to reset it to the "Normal" position. (3)Press the power switch to turn power on. If the circuit breaker should be tripped again, contact your Atom distributor.
CAUTION To prevent a malfunction, allow at least one minute or so after the activation of the circuit breaker before pressing the pushbutton.
− 10 −
Normal position
Tripped position
[4] How to use 4-1. Power source This unit operates either on AC power or on internal battery power.
CAUTION When the power cord is not connected to the power outlet or the AC power is interrupted, the internal battery will supply the power to the unit automatically. When the unit is operated on AC power in an ambulance or other emergency vehicle, ensure that the vehicle provides the power required.
4-1-1. Operation on AC power (1) Check to ensure that the power cord and other connecting cables are securely connected to the respective sockets on the unit. Then, securely connect the unit to an appropriate AC power. The "Battery-on-charge" indicator lamp will be lit to indicate the internal battery is being charged.
EXT PWR
(2) Press the power ON/OFF switch to ON. The "exteral power" indicator lamp will come on and indicates the unit has been energized. When the unit is connected to AC power, the internal battery is being charged automatically but will not overcharge.
INT PWR
TEMP.
POWER
I
CHARGING
ADJUST HI TEMP.
O BREAKER HI TEMP.TEST 〜230V
EXT PWR
− 11 −
INT PWR
CHARGING
4-1-2. Operation on internal battery power
CAUTION Whenever possible, the unit should be operated from AC power. In other words, the internal battery should be used only when an appropriate AC power source is not available for the unit. (1) By referring to Sec.4-2, check for status of the internal battery. (2) Check to ensure that the connecting cables are securely connected to the respective socket, then press the power on/off switch to ON. The " internal battery " indicator lamp will light up to indicate the unit has been energized. ● The table to the right shows the approximate maximum hours of continuous incubator operation possible with the internal battery fully charged. The maximum operation time depends on the charged level of the battery.
TEMP.
POWER
I
ADJUST HI TEMP.
O BREAKER HI TEMP.TEST 〜230V
EXT PWR
INT PWR
CHARGING
Ambient temp. Hours of operation possible 20℃
Approx. 5 hours
0℃
Approx. 2 hours Incubator temp set at 34℃
4-1-3. When using external DC power
CAUTION Use external DC power only when use of the internal battery is not possible. Whenever possible, use AC power or the internal battery. Confirm that the connected DC power supplies the correct voltage and current. Before you connect the external DC power supply, first turn off this appliance and remove the AC plug from the power socket.
(1) Conditions for use of external DC power ● Connect an external DC power supply that provides stable power within the range of 22.0 V DC to 27.5 V DC. ● Connect an external DC power supply that provides the stable 12 A DC required. ● Connect the external DC power supply using a cable with a cross-section area of 2.0 mm2 or more. ● Connect the positive and negative terminals correctly. If there is a danger that the terminals can be connected incorrectly, take steps to prevent incorrect connection. − 12 −