IncuArch Operation Manual Oct 2016

INTRODUCTION Thank you for purchasing IncuArch. This Operation Manual deals with the specifications, operation and maintenance of the IncuArch. 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 any accident attributable to repair by someone other than technical personnel belonging to or authorized by Atom. Read this Manual carefully and familiarize yourself with its contents before operating the unit. Keep this Manual where it is readily accessible for reference when needed. If any technical problems should arise, please contact your local Atom representative.

The unit is shipped without being disinfected. Be sure to clean and disinfect the unit before using it for the first time after purchase. The product and its parts that are past their service lives should be disinfected before being disposed of in accordance with the applicable waste management laws. This product maintains the ambient temperature around an infant by drawing in the air outside and warming it. It does not have the capability to cool the air drawn from outside. Be sure to set the incubator air temperature at least 3°C higher than the ambient temperature. In particular, if a phototherapy unit, a heated humidifier, or some other heat-generating device is used with the incubator, set the incubator air temperature at least 5°C higher than the ambient temperature. If a lower setting is selected, the incubator may not be controlled correctly.

INTENDED USE The IncuArch is a closed-care transport incubator for neonatal and premature infants and is intended to transport low birth weight infants and seriously ill neonates.

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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 when operating the unit.

Basic Instructions 1. Follow the instructions for the safe use of the unit. Please follow the operating instructions described in this Manual to help ensure safe use of the unit. 2. Inspect the unit on a periodical basis. It is necessary to carry out appropriate periodical inspections in order to maintain the unit in optimum condition. 3. Never use the unit if it is found to be defective. If any damage or malfunction of the unit should be noticed, stop using it immediately and contact your local Atom representative. 4. Follow the EMC information given in this Manual. Electrical equipment for medical use needs special precautions regarding EMC. It needs to be installed and put into service according to the EMC information provided in this Manual.

Definitions 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 immediate hazardous situation which, if not avoided, will result in death or serious injury, serious damage to property such as total loss of use of equipment or fire. A WARNING notice indicates an indirect (potentially) hazardous situation which, if not avoided, will result in death or serious injury, serious damage to property such as total loss of use of equipment or fire. A CAUTION notice indicates a hazardous situation which, if not avoided, can result in minor or moderate injuries, partial damage to equipment, and loss of data stored in computers.

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Definition of Symbols 1. Symbols to indicate danger, warning or caution Symbol

Title and indication General attention Indicates unspecified general danger, warning or caution. Caution: Hot surface Indicates that the surface can be dangerously hot under certain conditions.

2. Symbols to prohibit action Symbol

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. Prohibition of contact Indicates that touching a certain part of the unit where it may cause injury is prohibited under certain conditions.

3. Symbols to give instructions for action Symbol

Title and indication General instruction Indicates unspecified general action on the part of the user. Connect a ground wire Instructs the user to connect the ground wire without fail where the unit is provided with a ground terminal. 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 there is a threat of lightning.

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4. Symbols of international standards (IEC) Symbols

Title and indication Type BF applied part Indicates that the device is classified as Type BF in terms of the degree of protection against electric shock. See Operation Manual Follow operation manual. Attention Indicates that the user needs to consult accompanying documents. Date of manufacture Indicates the date when the unit was manufactured in the factory. Lighting Indicates a switch that controls lighting. Power Indicates a switch to turn the power on or off. Electrostatic discharge Indicates a caution regarding electrostatic discharges. Recycle mark Indicates that recycling is recommended. WEEE symbol In the EC area, an electrical and electronic product falling in one of the categories specified by “DIRECTIVE 2002/96/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 2003 on Waste Electrical and Electronic Equipment (WEEE)” should be disposed of in a manner consistent with relevant laws and regulations. This symbol indicates that the above-mentioned requirement applies to this product. Manufacturer This symbol indicates the name and the address shown adjacent to the symbol is of the manufacturer. Authorised representative in the european community This symbol indicates the name and the address shown adjacent to the symbol is of the authorised representative in the European Community.

5. Other symbols Symbol

Title and indication Setting Indicates that a setting is increased. Setting Indicates that a setting is decreased.

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Symbol

Title and indication AC Power Indicates that the AC power is being supplied if an adjacent indicator is on. Indicates that the AC power is not being supplied if an adjacent indicator is off. 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 rotation of the fan is abnormal or the fan has not been attached. Alarm Indicates an alarm related to temperature. Alarm Indicates an alarm related to a skin temperature probe. Battery Indicates the power level of battery 1 and 2.

24V12V

DC power connecting port Indicates the DC power connecting port of the main body. Alarm Indicates excessive temperature condition. Alarm Indicates a low battery level. Alarm Indicates an alarm related to the SpO2 patient cable. (For Masimo pulse oximeter) Alarm Indicates an alarm related to a failure of the SpO2 patient cable. (For Masimo pulse oximeter) Alarm Indicates an alarm related to the SpO2 sensor. Alarm Indicates an alarm related to a failure of the SpO2 sensor. Alarm Indicates an alarm related to a failure of the SpO2 sensor function.

(Red marking)

Alarm Indicates the inability to detect pulse during measurement. (For Nellcor pulse oximeter) Alarm Indicates an alarm related to an oxygen sensor.

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Symbol

Title and indication Sensitivity setting indicator Indicates that the sensitivity mode is set to “Max”. (For Masimo pulse oximeter) Sensitivity setting indicator Indicates that the sensitivity mode is set to “APOD”. (For Masimo pulse oximeter) Pulse search indicator Indicates that a pulse is being detected. (For Masimo pulse oximeter) Interference indicator Indicates that interference is detected. (For Masimo pulse oximeter) Fast response mode indicator Indicates that the response mode of the pulse oximeter is set to “Fast.” (For Nellcor pulse oximeter) Pulse search indicator Indicates that a pulse is being detected. (For Nellcor pulse oximeter) Interference indicator Indicates that interference is detected. (For Nellcor pulse oximeter) Rotating parts Indicates there is a risk of injury if you touch rotating fan blades.

Precautions on Jamming

Electric surgical knives, portable and mobile wireless communication devices (e.g., cellular phones) that generate high frequency noise may jam various types of electrical 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 that generate high frequencies should not be used near the unit when it is operating in order to prevent the unit malfunctioning due to jamming. The unit should not be used adjacent to or stacked with other equipment. If the unit needs to be adjacent to or stacked with other equipment, the unit should be observed to verify that it operates normally in the configuration it is in.

Responsibility for Care of Equipment

The user (a hospital, a doctor’s office, a clinic) is responsible for the operation, maintenance and care of the electrical equipment for medical use. The equipment should be used only by medical personnel.

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Prohibition of Modification

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

Periodical Inspection

Proper periodical inspection is needed to use the unit in the optimum condition.

In Case of Trouble

If any abnormal condition or trouble should occur to the unit, indicate on the unit that it is out of order and contact your local Atom representative or service engineer immediately. 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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Table of Contents INTRODUCTION... 1

[7]

7-1. Supplying Oxygen... 47 7-2. Using the Oxygen Monitor ... 48 7-2-1. Calibrating the Oxygen Monitor... 48 7-2-2. Setting the Upper and Lower Alarm Limits for Oxygen Level ... 50

PLEASE READ WITHOUT FAIL [1]

Safety Instructions... 10 DANGER ... 10 WARNING ... 11 CAUTION ... 13

1-1. 1-2. 1-3.

[2]

[8]

PREPARATION Preparation before Use ... 19 3-1. Assembly ... 19 3-1-1. For HL Stand (Option) ... 19 3-1-2. For Cabinet Stand (Option)... 19 3-2. Adjusting the HL Stand ... 20 3-3. Where to Install the Incubator ... 20 3-4. Locking the Casters ... 21 3-4-1. For HL Stand (Option) ... 21 3-4-2. For Cabinet Stand (Option)... 21 3-5. Securing the Unit to an Ambulance ... 22 3-6. Inspections Before Start ... 22

[4]

Power requirements ... 23 4-1. Power Outlet and Grounding... 23 4-2. Using an AC Power Source (AC100-240V)... 24 4-3. Using the Built-in Battery Power Supply... 26 4-4. Using an External DC Power Source (DC12V/24V) ... 29 4-4-1. Requirements for External DC Power Source ... 29 4-4-2. Connecting External DC Power Source and Connection Cable ... 29

OPERATION [5]

Display Screens ... 32 5-1. Overview of Display Screens ... 32 5-2. Main screen ... 33 5-3. Menu Screen ... 37

[6]

Setting the Incubator Temperature and Placing the Infant in the Incubator ... 39 6-1. 6-2. 6-3. 6-4.

Setting the Incubator Temperature ... 39 Placing the Infant in the Incubator ... 41 Drawing out the Mattress Platform ... 44 Skin Temperature Monitoring ... 44

Pulse Oximeter ... 52 8-1. Attaching the SpO2 Sensor ... 52 8-2. Connecting the Patient Cable ... 53 8-3. Setting Alarm Limits... 53 8-3-1. Setting SpO2 Upper/Lower Alarm Limits ... 53 8-3-2. Setting Pulse Rate Upper/Lower Alarm Limits ... 55

Parts Identification... 15 2-1. Main body ... 15 2-2. Operation panel ... 17 2-3. Stands ... 18

[3]

Oxygen Supply ... 46

[9]

Other Operation Procedures ... 56 9-1. Working with the Menu Screen... 56 9-1-1. Setting the Alarm Volume ... 57 9-1-2. Setting the LCD Screen Brightness.. 58 9-1-3. Setting the Display Size... 59 9-1-4. Setting the Language... 60 9-1-5. Setting the Synchronizing Pulse Beep Volume ... 61 9-1-6. Setting the Sensitivity Mode ... 62 9-1-7. Setting the Averaging Time ... 63 9-1-8. Setting the Pulse Oximeter Power Frequency ... 64 9-1-9. Setting the Response Mode ... 65 9-2. Feeding Cords and Tubes into or out of the Incubator ... 66 9-3. Lighting lamp ... 66 9-4. Multi-purpose pole (option) ... 67

MAINTENANCE [10] Cleaning and Disinfection ... 68 10-1. Hood Assembly ... 69 10-2. Mattress Platform and Inside of Incubator ... 71 10-3. Others ... 73

[11] Maintenance and Inspection ... 74 11-1. Inspection Checklist ... 74 11-1-1. Inspection Checklist - Before Use... 75 11-1-2. Inspection Checklist - During Use ... 76 11-1-3. Inspection Checklist - After Use ... 77 11-2. Periodic Replacement of Parts ... 78 11-3. Replacing the Filter ... 79 11-4. Replacing the Oxygen Sensor ... 80 11-5. Replacing the Batteries ... 82 11-6. Disposal... 82

[13] Troubleshooting ... 86 APPENDIX [14] Technical Data ... 88

PLEASE READ WITHOUT FAIL

[12] Alarms ... 83

[15] Device Characteristics - EMC Level and Classification... 93

PREPARATION OPERATION MAINTENANCE APPENDIX

Safety Instructions

[1]

Safety Instructions

Please follow the operating instructions described in this Manual to help ensure safe use of the unit. The unit should be operated only by those who have received relevant training and instruction regarding its operation. The unit should only be operated according to 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. Monitor the infant’s skin temperature when operating the unit. Be sure to keep the admittance panels and snap-open access ports closed while the unit is in use. Using the unit with the admittance panel or snap-open access port left open may cause the infant to fall out of the baby compartment. Be sure to close the admittance panels and the snap-open access ports when administering phototherapy to an infant.

Do not leave the unit unattended when any of the admittance panels or snap-open access ports are open. The infant may be in danger of falling.

Stop using the unit immediately and request repairs if you find any abnormalities, such as a misaligned admittance panel or snap-open access port, or a loose press bar. The admittance panel or snap-open access port may unexpectedly open, causing the infant to fall out of the baby compartment.

When providing phototherapy to an infant in the incubator, watch for any increase in the incubator air temperature. Since a mature infant emits a lot of heat, the incubator air temperature may rise if you place the infant in the incubator and perform phototherapy. The incubator air temperature may also rise if you use multiple phototherapy units at the same time, or if the room temperature is high. In such a case, proceed with the phototherapy after placing the infant in a cot or an open-type incubator, as directed by the doctor.

Do not overtighten the dispo safety bands. Doing so may harm the infant.

Any type of ignition source, such as a hand warmer, must be kept away from the incubator. Hand warmers or other items that may catch fire, or devices that generate sparks may cause an explosion or a fire if used near the unit when oxygen is being supplied.

Do not use the unit in the presence of a flammable anesthetic gas. Otherwise, a fire or an explosion may result.

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Safety Instructions

Even a small amount of ether, alcohol or other flammable substances may cause a fire when mixed with the oxygen in the incubator.

Analyze arterial gas levels repeatedly when a high oxygen environment is required. It has been reported that when setting the concentration of oxygen in the incubator to a high level, it is extremely important and essential to repeatedly measure the oxygen concentrations inside the incubator and analyze arterial blood gas in order to correctly maintain oxygen concentrations. Follow the doctor’s instructions for measuring the oxygen concentration because ignoring essential requirements may increase the risk of retinopathy of prematurity and other adverse effects.

1-2.

PLEASE READ WITHOUT FAIL

Do not use ether, alcohol or any other flammable substances.

WARNING

Death or serious injury, damage to equipment or a fire will result if the instructions given below are not followed. Be sure to follow the doctor’s instructions in setting the incubator air temperature. The doctor is responsible for making a decision on transporting a premature infant. Watch the infant continuously during transport. Transporting a premature infant is associated with a risk of intracerebral hemorrhage due to vibration during transport.

Smoking is prohibited in the room where the unit is installed. Do not place any potential ignition sources in the room. Follow the doctor’s instructions when selecting an appropriate method of oxygen administration, an appropriate oxygen concentration, and an appropriate duration of administration. Incorrect use of supplementary oxygen may cause serious side effects including loss of sight, damage to the brain, and death. The risks of side effects vary with infants. The concentration of oxygen delivered to an incubator must be followed by the doctor’s instructions.

Use oxygen for medical use only. Be sure to bear in mind the following precautions when supplying oxygen. z A hand warmer, flashlight, oils and fats, or combustible vaporized gases should not be placed in or near the incubator. z Use pure cotton for the infant’s clothing, bed sheets, etc. Do not use any material that is easily charged with static electricity. z Be sure that the clothing of doctors, nurses and ambulance attendants who handle this unit is made from pure cotton or fire-proof materials.

Observe the following precautions when oxygen supply equipment is in use. z A spontaneous and violent ignition may occur if oil, grease, or greasy substances come in contact with pressurized oxygen. These substances must be kept away from oxygen regulators, cylinder valves, tubing and connections, and all other oxygen supply equipment. z On a high-pressure oxygen cylinder, only use tested pressure reducing or regulating valves marked for oxygen service. Do not use these valves for air or gases other than oxygen. It is dangerous to use a valve to supply a gas other than air or oxygen and then to supply oxygen again.

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Safety Instructions

Do not use any devices that generate high frequencies near the unit. Using electric surgical knives, mobile phones, or other devices that generate high frequencies near the unit may cause malfunctions due to jamming.

Ensure the unit is securely grounded when connecting the unit to a power source. This can prevent electric shock due to current leakage. In order to complete the ground connection, be sure to connect the power plug to a three-prong, correctly grounded outlet. Do not operate the unit if you have any doubts about its ground connection.

Ensure the peripheral electrical equipment is securely grounded when connecting the unit to a power source. Avoid damaging the power cord. A damaged power cord may cause a fire or electric shock. If a power cord is damaged, it should be immediately replaced with a new one. z Do not allow the power cord to get caught between the unit and wall, shelf or floor. z Do not place the power cord near a heating apparatus or heat it. z Do not place any heavy objects on the power cord. z Always grasp the power plug with your hand to remove the power cord from the power outlet.

Only use the power cord supplied with the unit. Otherwise, a fire or electric shock may result.

Do not put multiple loads on one power outlet. The power outlet should be located near the unit in order to prevent accidental contact with a trailing power cord. Use a separate power outlet for each unit.

Avoid connecting the unit to a power source other than a appropriately rated power source. The electrical rating of this unit is as follows: Power voltage - AC100-240V; frequency - 50/60Hz; power consumption - 220VA; operating voltage range -AC100-240V±10%. Do not connect the unit to any other power source.

Do not touch the power plug with wet hands. Touching the power plug with wet hands may cause electric shock.

Charge the battery as instructed. Failure to do so may cause the battery to leak, generate heat or smoke, rupture, or ignite.

If the battery is not fully charged after the specified charging time period has elapsed, stop charging it. Failure to do so may cause the battery to leak, generate heat or smoke, rupture, or ignite.

Do not charge the battery in locations such as gas stations where flammable gases (propane gas, gasoline, etc.) or fine particulates are produced. Otherwise, gases may ignite. Doing so may cause an explosion or fire.

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Safety Instructions

Failure to do so may cause the battery to leak, generate heat or smoke, rupture, or ignite.

Do not directly touch electrolyte that has leaked from the battery cover. If any electrolyte comes in contact with your eyes, you may lose your sight. If it comes in contact with your skin or clothing, it may cause irritation. Flush it immediately with plenty of water and consult a physician.

Install the unit on a stable surface. Installing it on an unstable surface or a slope may cause it to topple, fall, or move, resulting in injury or damage. Therefore, before installing the unit, make sure that the place where the unit is to be installed is stable and strong enough to support the weight of the unit.

PLEASE READ WITHOUT FAIL

If a leakage is suspected or you detect a strange odor, keep the battery away from fire.

Do not subject the oxygen sensor to impact. If the oxygen sensor is damaged, the electrolyte inside may leak out of the sensor. If contact with the skin or clothing occurs, rinse the area immediately with running water.

Do not touch the heaters during use or shortly after use. The heaters are very hot during use and shortly after use. Allow the heaters to cool down sufficiently before cleaning and disinfecting them in order to avoid injury.

Do not attempt to disassemble or modify the unit. A fire, electric shock or injury may result.

The unit should only be serviced by qualified personnel in accordance with the appropriate service manual. Be sure to inspect the unit at the start of each day. Operating the unit without inspecting it at the start of each day may result in a defect passing unnoticed and cause a potentially unfavorable outcome.

If the unit fails to operate correctly, stop using it immediately. Indicate on the incubator that it is out of order and contact your local Atom representative.

Do not reuse the dispo safety bands. Change the dispo safety bands for every infant. Reusing them could lead to infection.

Do not stare into the lighting lamp or expose your eyes to the light. Doing so may cause retinal damage.

1-3.

CAUTION

Injury or damage to surrounding objects may result if the instructions given below are not followed. Place the infant in the incubator only after the incubator air temperature has stabilized. Prior to placing the infant in the incubator, pre-warm the incubator to keep the incubator air temperature stable.

Do not forcefully pull on or twist cords.

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Safety Instructions

When feeding the cords and tubes into the unit, be very careful not to let them wind or tighten around the infant. Do not press strongly or rub on the LCD screen. Doing so may result in damage or malfunction.

Do not allow any chemicals to adhere to the display. If any chemicals do adhere to the display, wipe them off immediately.

Check that the peripheral devices operate correctly. A device that transmits or receives faint signals may be affected by the electromagnetic waves generated by the unit. If such a device is used in the vicinity of the unit, check the operation of that device for any detrimental effects before using the unit in clinical environments. Stop using the unit immediately if any problems occur.

Unplug the power plug before moving the unit to another location or when the unit is not used for an extended period of time. Moving the unit to another location with the power plug connected to a power outlet will damage the power cord and may cause a fire or electric shock.

Do not apply impact to the unit or hit it on something. Doing so may result in damage or malfunction.

Do not install the unit in excessively hot or humid places, excessively dusty environments, or where it will be exposed to steam. Installing the unit in such a place may cause a fire or electric shock.

Do not install the unit in direct sunlight or near a heating apparatus. Keep the unit out of reach of small children. Do not place any heavy objects on the unit. Do not pour liquids directly onto the unit. A fire or electric shock may result, or the unit may malfunction. If a large amount of liquid has spilled on the unit, immediately wipe it up and call your local Atom representative to request checking of the internal electronic circuit.

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 cleaning and disinfecting the unit. Cleaning and disinfecting the unit with the power plug connected to the power outlet may cause electric shock.

Do not connect any equipment items other than those we specify.

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Parts Identification

Parts Identification

2-1.

Main body

JJ Left side

PLEASE READ WITHOUT FAIL

[2]

JJ Right side

No.

Name

JJ Rear of the main body

No.

Name

Admittance panel

Snap-open access port

Hood

Oxygen sensor connection port

Lighting lamp Admittance panel latch

Skin temperature probe connection port

Tube introduction slit

Connector for SpO2 sensor

Oxygen sensor module

AC inlet

Handle

DC power breaker (for 24V)

Operation panel

DC power breaker (for 12V)

Multi-purpose pole (option)

External DC power inlet

Oxygen supply port

Filter cover

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Parts Identification

JJ Mattress Platform and Inside of Incubator

No.

Name Mattress

No.

Name

Dispo safety band

Fan (common to both V-707 and V-808)

Mattress platform

Heater

Packing for main body

Battery 1

Middle board

Battery 2 (option) Battery cover

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Parts Identification

No.

PLEASE READ WITHOUT FAIL

Operation panel

2-2.

Name

Description

Display area

Displays skin temperature, set temperature, SpO2, pulse rate, oxygen concentration, etc.

Control switches

Used to switch display screens or to specify various settings.

Light switch

Used to turn the light ON or OFF or to change brightness.

Alarm silence switch

Used to silence alarms.

Power switch

Used to turn the power ON or OFF.

AC power indicator

Lights up when the power cord is connected to an AC outlet.

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Parts Identification

2-3.

Stands

JJ HL stand (option)

No.

Name HL stand Caster

JJ Cabinet stand (option)

No.

Name Cabinet stand Caster

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Preparation before Use

[3]

Preparation before Use

3-1.

Assembly

The incubator is heavy and should be assembled and moved by at least two people.

PREPARATION

Be sure to secure the incubator and a stand using the incubator retainer. Failure to do so may cause the incubator to tip over if a force is applied while the hood is open, or to fall due to shock received during transportation. Never operate the incubator until it has been firmly secured.

The incubator is packed when shipped. When using the incubator placed on the HL or cabinet stand, follow the procedure below to assemble the stand.

3-1-1.

For HL Stand (Option)

(1) Mount the incubator on the high-low stand. (2) Be sure that the rubber feet of the incubator are placed on the incubator retainer before tightening the lever of the retainer to secure the incubator.

Incubator retainer

Lever

3-1-2.

For Cabinet Stand (Option)

(1) Mount the incubator on the cabinet stand.

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