aquatherm III International Operating Manual April 2007

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Contents Features...2 Introduction...3 Warnings and Cautions...4 Symbols...7 Operating Environment...8 Specifications...14 Controls and Indicators...16 Directions for Use...19 Service...25 Maintenance...26 Troubleshooting Guide...27 Warranty...28

AQUATHERM®, AQUAPAK® and Hudson RCI® are registered trademarks of Teleflex Medical Incorporated. in the USA and in selected other countries.

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Features Illuminated power switch Temperature control knob Adjustable temperature range Corrosion-resistant metal components

Figure 1: AQUATHERM III Heater

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Features Intended Use The Hudson RCI AQUATHERM® III External Adjustable Electronic Heater is designed for use with the Hudson RCI Nebulizer Adaptor and the AQUAPAK® system to provide continuous heated aerosol for respiratory applications. Heater Operation The Hudson RCI AQUATHERM III Heater is placed between a nebulizer adaptor and a reservoir of sterile solution. When gas flow is initiated to the nebulizer, sterile solution is drawn up from the reservoir and through the stainless steel puncture pin in the center of the AQUATHERM III Heater. The solution is heated as it flows through the pin. The heated solution is then drawn into the nebulizer adaptor where it is aerosolized into the patient gas stream. Rainout within the nebulizer adaptor returns to the reservoir bottle via a rainout return tube. The warmed rainout gradually raises the temperature of the reservoir contents, increasing the overall heat output of the device. An electronic temperature control circuit provides consistent heating across a wide range of adjustments. A non-reversing thermal fuse prevents overheating in the event the control circuit fails.

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Warnings and Cautions This manual uses special indicators to convey information of a specific nature. A warning is indicated by this special character. It indicates a condition that can endanger an operator, patient or a service person. A caution is indicated by this special character. condition that can damage equipment.

It indicates a

These are the warnings and cautions for the AQUATHERM III Nebulizer Heater. Warning: Fire Hazard. Do not use the heater in the presence of flammable anesthetic gases. Warning: Burn Hazard. Internal components are hot, up to 135 °C and may contain liquid heated to temperatures of up to 100 °C. Allow the heater to cool before handling. Warning: Electrical Shock. Refer all servicing to qualified, trained personnel only. Warning: Always measure and verify the aerosol temperature before connecting the heater to the patient. Warning: The use of accessories, transducers, and cables other than those specified may result in increased emissions or decreased immunity of the AQUATHERM III Nebulizer Heater. 4

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Warning: The AQUATHERM III Nebulizer Heater should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, the AQUATHERM III Nebulizer Heater should be observed to verify normal operation in the configuration in which it will be used. Warning: This unit requires 220–240 AC, 50 Hz sine wave input. When used in ambulances, helicopters and other mobile life support vehicles requiring an invertor, do not use square wave or pulse-width modulated sine wave output. Overheating could result. Warning: Do not operate the heater without oxygen or air flow to the nebulizer adaptor. Warning: Always measure and verify the oxygen concentration before connecting the heater to the patient. Warning: Gas temperature, room temperature, flow rate, entrainment collar setting, and aerosol delivery tube length all affect the output temperature, and depending on conditions may result in aerosol delivery exceeding 41 °C at the patient. Caution: Do not autoclave, gas sterilize, pasteurize or immerse this device in liquid. Severe equipment damage will result. Caution: Do not operate the heater with a dry reservoir bottle.

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Caution: Do not leave the power ON while changing a reservoir bottle. Caution: Do not overtighten the reservoir bottle. Caution: Always ensure the heater is aligned in a vertical position for best performance. Caution: Not for use with any type of ventilator. Caution: Do not operate heater without monitoring aerosol temperature at the patient interface.

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Symbols The following symbols are used in this manual and on the heater label. Symbol

Definition

I

Power ON

O

Power OFF

A

Ampere

~

Alternating Current

V

Volt

Hz

Hertz Type B Applied Part Protective Earth (ground) Attention, consult accompanying documents as applicable.

IPX0

Ordinary Equipment

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Operating Environment Ignition Sources All sources of ignition must be kept away from the AQUATHERM III Nebulizer Heater, and preferably out of the room in which the heater is being used. In a hospital environment, an incubator is an example of an ignition source. “NO SMOKING” signs should be prominently displayed. Electromagnetic or Other Interference Caution Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided in this manual. Portable and mobile RF communications equipment can affect Medical Electrical Equipment. This equipment has been tested to EN60601-1-2 and found to comply with the electromagnetic compatibility requirements for medical devices. It is important to install and use this AQUATHERM III Nebulizer Heater in accordance with the instructions, to prevent harmful interference to other devices in the vicinity. To determine if this equipment does cause harmful interference to other devices, turn the heater OFF and then back ON. If interference is observed when the heater is operating, try to correct the interference by one or more of the following measures:

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Reorient or relocate other device(s) in the surrounding area. Increase the separation between other device(s). Connect this device into an outlet that is on a circuit different from the other connected device(s). Consult the manufacturer or field service technician for help.

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Guidance and manufacturer's declaration - electromagnetic immunity The AQUATHERM III Heater is intended for use in the electromagnetic environment specified below. The customer or the user of the AQUATHERM III Heater should assure that it is used in such an environment. Immunity test Electrostatic discharge (ESD)

IEC 60601 test level

Compliance

±6 kV contact

±6 kV contact

±8 kV air

±8 kV air

Electromagnetic environment - guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%

IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field transient/burst

±2 kV for power supply lines ±1 kV for input/output lines ±1 kV differential mode

±2 kV for power supply lines

Mains power quality should be that of a typical commercial or hospital environment.

±1 kV for input/output lines ±1 kV differential mode

±2 kV common mode <5%UT (>95% dip in UT) for 0.5 cycle

<5%UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (> 95% dip in UT) for 5 sec

<5% UT (> 95% dip in UT) for 5 sec

Mains power quality should be that of a typical commercial or hospital environment.

±2 kV common mode Mains power quality should be that of a typical commercial or hospital environment. If the user of the AQUATHERM III Heater requires continued operation during power mains interruptions, it is recommended that the AQUATHERM III Heater be powered from an uninterruptible power supply or a battery.

Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. 3 A/m

3 A/m

IEC 61000-4-6 NOTE UT is the a.c. mains voltage prior to application of the test level.

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Specifications Electrical Characteristics Voltage and Power: 220–240 AC at 50 Hz, 0.8 A Warning: This unit requires 220–240 AC, 50 Hz sine wave input. When used in ambulances, helicopters and other mobile life support vehicles requiring an invertor, do not use square wave or pulse-width modulated sine wave output. Overheating could result. Current: Power Fuses: Thermal Fuse: Leakage Current: Dielectric Withstand: Classification: Protection Against Electrical Shock: Protection Against Water Ingress: Mode of Operation:

0.8 A, maximum 3.15 A, 250V quick-acting, two (2) required 152 ºC nonreversing < 100 μA 1,500 V minimum for one (1) minute 1 Type B IPX0 Continuous

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Physical Characteristics Weight: 860 g Dimensions: 119 mm (H) x 81 mm (W) x 82 mm (D) Power Cord: Three-conductor cable, unshielded Size: 3 x 1.00mm2 Power Cord Length: 2.5m Solution: Use only Hudson RCI AQUAPAK Reservoir Nebulizer: Use only Hudson RCI Series 031 Nebulizer Adaptors Transportation and Storage Temperature: -40° C to 70 °C Relative Humidity: 10% to 95% (non-condensing, transportation) 10% to 85% (non-condensing, storage) Pressure: 500 to 1060 hPa Operating Environment Temperature: 10 °C to 40 °C Relative Humidity: 30% to 75% (non-condensing) Pressure: 700 to 1060 hPa

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Controls and Indicators Main Power Switch This switch is illuminated when the heater is turned ON. Temperature Control Knob Adjusts the temperature of the heater, within a range of 1 to 7. Flow Chart Label A chart for Total Oxygen Flow is printed on the side of each heater. The label is shown in the graphic below.

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The flow chart shows the oxygen flow rate from the O2 or air source in the left hand column, in liters per minute (LPM). The numbers across the top show the Fractional Concentration of Inspired Oxygen, (FIO2) in percent, as printed on the entrainment collar. The numbers given at the intersection of the flow and FIO2 values represent the total flow emitting from the nebulizer adaptor outlet, for delivery to the patient. A recommended range for this number is highlighted on the label. Locate the point where these two numbers intersect to determine the Total Flow in LPM.

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Figure 2: The AQUATHERM system using a nebulizer and AQUAPAK reservoir.

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Directions for Use Installing the Heater Performance of this procedure requires compressed gas source, a clean, unused nebulizer adaptor and a Hudson RCI AQUAPAK, reservoir bottle. Thoroughly clean and test the heater before installing and placing it in service. When this assembly is complete, the reservoir bottle is suspended from the bottom of the heater and does not rest on a surface. Temperature is measured at the output end of the sixty inch hose, closest to the patient. Caution: Always ensure the heater is aligned in a vertical position for best performance. 1.

2. 3.

Check the heater to be sure all surfaces are clean and intact. Wipe the heater with a damp cloth and mild detergent if necessary. Turn the power switch to OFF. Turn the temperature control knob to the number “1”, fully to the left.

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