aquatherm III Plus Operating Manual 2019

INSIDE FRONT COVER

Contents Features... 5 Introduction... 6 Warnings and Cautions... 7 Symbols... 8 Operating Environment... 9 Specifications... 10 Controls and Indicators... 11 Directions for Use... 13 Service... 17 Maintenance... 17 Troubleshooting Guide... 18 Warranty... 19

Aquatherm, Aquapak and Hudson RCI are registered trademarks of Teleflex Incorporated or its affiliates.

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

Figure 1: Aquatherm III Plus Heater

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Introduction Intended Use

The Hudson RCI® Aquatherm® III Plus 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 Plus 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 Plus 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 indicates a condition that can endanger an operator, patient or a service person. A caution indicates a condition that can damage equipment. These are the warnings and cautions for the Aquatherm III Plus 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 (275ºF) and may contain liquid heated to temperatures of up to 100 °C (212ºF). 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: This unit requires 115 VAC, 60 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 (105°F) at the patient. Warning: No modification of this equipment is allowed. 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. 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. 7

Symbols

O

The following symbols are used in this manual and on the heater label:

I

Symbol

A

~ V

HZ IPX0

Power ON

Follow Instructions for Use

A p i d

Power OFF

Rx Only

E

Ampere

Caution

Alternating Current

Product is not sterile

Volt

Warning: Hot Surface

Hertz

Catalogue Number

Protective Earth (ground)

Manufacturer

Ordinary Equipment

Date of Manufacture

Humidity Limitation

Batch Code

Temperature Limitation

Serial Number

Definition

Symbol

Consult Instructions for Use

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Definition

T c P d

T O i

• • • •

Operating Environment Ignition Sources

All sources of ignition must be kept away from the Aquatherm III Plus 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

This equipment has been tested to UL60601-1-2 and found to comply with the electromagnetic compatibility requirements for medical devices. It is important to install and use this Aquatherm III Plus 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: • • • •

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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Specifications

C

Electrical Characteristics

M

Warning: This unit requires 115 VAC, 60 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.

T

Voltage and Power:

115 VAC at 60 Hz, 1.5 A

Current: 1.5 A, maximum Power Fuses: 3.15 A, 250V quick-acting, two (2) required Thermal Fuse: 152 ºC (305.6ºF) non-reversing Leakage Current: < 100 mA Dielectric Withstand: 1,500 V minimum for one (1) minute Classification: 1 Mode of Operation: Continuous Protection Against Water Ingress: IPX0

T

A

F

A

Physical Characteristics Weight: Dimensions: Power Cord: Power Cord Length: Solution: Nebulizer:

800 g 119 mm (H) x 81 mm (W) x 82 mm (D) Three-conductor cable 3m Use only Hudson RCI Aquapak Reservoir Use only Hudson RCI Aquapak Nebulizer Adaptors

Storage and Transportation Environment Temperature: Relative Humidity:

-20 °C to 50 °C (-4ºF to 122ºF) 0% to 94% (non-condensing)

Operating Environment Temperature: Relative Humidity: Pressure:

18 °C to 26 °C (64ºF to 79ºF) 30% to 75% (non-condensing) 700 to 1060 hPa 10

T l O

T f

A t

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 9.

Flow Chart Label

A chart for Total Oxygen Flow is printed on the side of each heater.

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. 12

Directions for Use Installing the Heater

Performance of this procedure requires a compressed gas source, a clean, unused nebulizer adaptor and a Hudson RCI Aquapak, reservoir bottle. The Aquatherm is to be installed and monitored by trained medical professionals. 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. To connect the Aquatherm to main power, plug the device in. To cut power to the Aquatherm, unplug the device. Ensure that the device is positioned in such a way that disconnection from main power is not impeded. Caution: Always ensure the heater is aligned in a vertical position for best performance. 1. Check the heater to be sure all surfaces are clean and intact. Wipe the heater with a damp cloth and mild detergent if necessary. 2. Turn the power switch to OFF. 3. Turn the temperature control knob to the number “1,” fully to the left. 4. Attach a clean, unused nebulizer adaptor to the threaded nebulizer connection on top of the heater. 5. Connect the Hudson RCI Aquapak reservoir to the threaded reservoir connection at the bottom of the Aquatherm III Plus Heater. Insert the flange on top of the bottle into the fitting underneath the heater. Turn the bottle to the right until it is secured to the bottom of the heater and stops. Do not overtighten. 6. Remove the plastic cap from the end of the nebulizer rainout return tube, to expose the connector pin. 7. Insert the pin into the round, ¼ inch diameter raised surface above the label. Use a slight twisting motion to pierce the plastic bottle and seat the pin. A brief “whoosh” sound may be heard as the pin pierces the bottle. 8. Screw the threaded wing nut on top of the nebulizer adaptor onto the flow meter bottom flange on the oxygen source. Rotate the nut in a counterclockwise direction (as viewed from above) to attach it to the nebulizer adaptor. Ensure the nut is hand tight, do not overtighten. 9. Inspect all connections and ensure they are secure. 13

Placing the Heater in Service Warning: Always measure and verify aerosol temperature before connecting the heater to the patient. Warning: Always measure and verify 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 (105°F) at the patient. Warning: Do not operate the heater without oxygen or air flow to the nebulizer adaptor. 1. Connect the nebulizer to an oxygen or air source. 2. Plug the power cord into a grounded electrical outlet. Ensure there is power at the outlet and that the outlet meets the voltage requirements stated in this manual. 3. If using oxygen, adjust the nebulizer entrainment collar and select the desired oxygen concentration. If using an air source, adjust the nebulizer entrainment collar to achieve the desired total flow. 4. Adjust the oxygen or air flow to the recommended flow rate. For use with compressors, adjust the outlet pressure to a level that achieves the desired total flow. 5. Connect aerosol tubing to the nebulizer outlet. Tubing specifications are not less than 152 cm in length and 22 mm in diameter of standard aerosol delivery tubing. 6. Connect open end of aerosol tubing to a thermometer or other device for monitoring aerosol temperature (i.e., Hudson RCI 1647 not included). 7. Connect to patient interface, such as a face mask, tracheostomy mask, or trach tee. 8. Turn the heater power switch ON. 9. Turn the temperature control knob to the right, to the desired setting. For all flow entrainment settings, it is recommended to set the heater temperature at the number 5 to start. 10. Allow 25 minutes for the outlet temperature to stabilize. 11. Adjust the temperature in small increments and allow about 20 minutes after each adjustment for the temperature to change and stabilize.

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Changing the Reservoir This procedure is performed to replenish the supply of water in the nebulizer system after a reservoir bottle has been emptied. 1. Turn the heater OFF and shut off the oxygen or air supply. It is not necessary to alter the setting on the temperature adjustment knob. 2. Remove the rainout return puncture pin from the reservoir. 3. Carefully remove the empty reservoir from the heater by turning it to the left, in a counterclockwise direction, until it separates from the heater. 4. Connect a new Aquapak reservoir to the bottom of the Aquatherm III Plus Heater. Insert the flange on top of the bottle into the fitting underneath the heater. Turn the bottle to the right, in a clock-wise direction, until it is secured to the bottom of the heater and stops. Do not overtighten. 5. Connect the nebulizer rainout return tube to the return port on the reservoir. 6. Turn the heater power ON. 7. Turn the oxygen or air supply ON and adjust the oxygen flow to the desired setting. Warning: Burn Hazard. Internal components are hot, 135 °C (275ºF), and may contain liquid at temperatures to 100 °C (212ºF). Allow the heater to cool before handling. Caution: Do not operate the heater with a dry reservoir bottle. Caution: Do not leave the power ON while changing the reservoir. Caution: Do not overtighten the reservoir bottle. Caution: Do not operate heater without monitoring aerosol temperature at the patient interface.

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Removing the Heater from Service This procedure is performed to remove the heater from service and properly store it after each use. Warning: Burn Hazard. Internal components are hot, up to 135 °C (275ºF), and may contain liquid at temperatures up to 100 °C (212ºF). Allow the heater to cool before handling. Caution: Do not autoclave, gas sterilize, pasteurize or immerse this device in liquid. Severe equipment damage will result. 1. Turn the heater OFF. 2. Turn the oxygen or air supply OFF. 3. Unplug the heater. Allow the heater to cool. 4. Turn the wingnut in a counter-clockwise direction, as viewed from the top, to disconnect the nebulizer adaptor and heater from the flowmeter. Hold onto the heater as you do this so it doesn’t drop away from the connection. 5. Remove the reservoir from the bottom of the heater and discard. 6. Rotate the nebulizer / adapter on top of the heater in a counter-clockwise direction until the heater separates from the nebulizer / adapter. 7. Discard the nebulizer. 8. Wipe the heater exterior with a mild detergent and a damp cloth.

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Service User-performed repairs during the warranty period will void the Aquatherm III Plus warranty. Should your heater require service, contact Customer Service by telephone at 866-246-6990 or 919-544-8000, or by fax at 800-498-2604 for return authorization and shipping instructions. You may authorize replacing your heater with a remanufactured or replacement heater. This authorization permits Teleflex Medical to ship you a replacement heater promptly after receiving your old heater. If you choose to have your serial-numbered heater serviced and returned, repairs and turnaround time may be longer than with the replacement program. When returning a heater for service, please provide the following information in writing: 1. Your Returned Good Authorization (RGA) number, obtained from Teleflex Medical Customer Service. 2. Written approval to replace your heater OR written approval to service and return your original, serial-numbered heater. 3. Description of the nature of the malfunction. Please give specific details and describe the application.

Contents No special maintenance is required for the Aquatherm III Plus Heater.

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Troubleshooting Troubleshooting for the Aquatherm III Plus Heater encompasses problems with electrical power, controlling the temperature of the aerosol gas stream to the patient and an interrupted flow of aerosol to the patient. The troubleshooting table identifies some of these conditions and makes recommendations to correct the condition.

Possible Cause(s)

Recommended Action

Problem: POWER switch does not illuminate. 1. Unit is not connected to power. 2. POWER switch is in OFF position. 3. Fuse is blown.

1. Plug the power cord into a grounded electrical outlet. Ensure there is power at the outlet. 2. Turn POWER switch to the ON position. 3. Return the unit for service.

Problem: Heater temperature is too low. TEMP CONTROL knob set too low.

Turn the temperature knob to the right, in small increments, toward the red zone. Wait 20 minutes and readjust as necessary.

Problem: Heater temperature is too high. TEMP CONTROL knob set high.

Turn the temperature knob to the left, in small increments, to the blue zone. Wait 20 minutes and readjust as necessary.

Problem: Interrupted flow of mist to patient. 1. Inadequate seal between heater and nebulizer adaptor. 2. Inadequate seal between heater and reservoir. 3. Dry or punctured reservoir, deformed threads. 4. Vapor lock; heater element too hot.

1. Check connection; if loose, tighten firmly. If a seal can’t be made, attach a new Hudson RCI nebulizer adaptor. 2. Check connection; if loose, tighten gently; avoid overtightening. If a seal can’t be made, attach a new Aquapak reservoir. 3. Attach a new Aquapak reservoir. 4. Adjust the TEMP CONTROL knob one number down into the blue zone. Wait 10 minutes, then take a temperature reading. If the temperature is too low, turn the temperature knob in small increments, to the red zone. Wait 20 minutes and readjust as necessary. 18

Warranty The Aquatherm III Plus Heater is warranted by Teleflex Medical Inc., hereafter called Teleflex Medical, against defects in materials and workmanship for a period of one year from the date of original purchase to the end user. During the warranty period, we will repair or, at our option, replace at no charge, any heater that proves to be defective, provided you return the heater, shipping prepaid, to the distributor from whom you purchased the heater. This warranty does not apply if the device has been damaged by accident, misuse, or as a result of service or modification by someone other than Teleflex Medical. No other express warranty is given. The repair or replacement of the device is your exclusive remedy. ANY OTHER IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS IS LIMITED TO THE ONE-YEAR DURATION OF THE WRITTEN WARRANTY. Some states, provinces or countries do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. IN NO EVENT SHALL TELEFLEX MEDICAL BE LIABLE FOR CONSEQUENTIAL DAMAGES. Some states, provinces or countries do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you. This warranty gives you specific legal rights, and you may have other rights which vary from state to state, province to province or country to country. This device is sold on the basis of specifications applicable at the time of manufacture. Teleflex Medical shall have no obligation to modify or update this device once sold. For more information about the Aquatherm III Plus warranty, contact an authorized Teleflex Medical distributor or Teleflex Medical.

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Shipping Address: Teleflex Medical Incorporated 11245 North Distribution Cove Olive Branch, MS 38654 © Copyright 2009, 2013, 2016, 2017, 2019 Teleflex

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