ConchaTherm III Operating Manual Oct 1998

Contents Introduction ... 3

Applications ... 15

Intended Use ... 3

Anesthesia ... 15

Features ... 3

Incubators and Warmers ... 15

Symbols ... 4

Oxygen Hood and Nebulizer Use .. 15

General Warnings and Cautions ... 4

Transport Vehicles ... 15

Principles of Operation ... 5 Specifications ... 7

Warm or Cool Environments ... 15

Performance Characteristics ... 7

Troubleshooting and Maintenance ... 16

Electrical Characteristics ... 7

Alarm Conditions ... 16

Operating Environment Temperature ... 8

Routine Checks and Operating Maintenance ... 17

Physical Characteristics ... 8

Routine Maintenance ... 17

Transportation and Storage ... 8

Diagnostic Test ... 17

Controls and Indicators ... 8

Cleaning ... 18

Control Panel ... 8

Service and Repairs ... 18

Bottom Panel ... 9

Warranty ... 19

Alarm Indications ... 10 Directions for Use ... 10 System Setup ... 10 Operating the CONCHATHERM III ... 12 Warnings and Cautions ... 14

CONCHA, CONCHATHERM, CONCHATHERM III, CONCHA-COLUMN, Hudson RCI, and the Hudson RCI logo are registered trademarks of Hudson RCI in the United States of America and in selected other countries.

Introduction humidifier cartridges, and CONCHATHERM single temperature probes.

Intended Use The CONCHATHERM III® heated humidifier is part of a complete system, designed to heat and humidify respiratory gases delivered to adult, pediatric, and neonatal patients. The CONCHATHERM III can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adaptors for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature.

Features

The CONCHATHERM III is intended for use with the following Hudson RCI humidification system components: CONCHA® water reservoirs, CONCHA-COLUMN®

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•

Heater continuously monitors patient airway temperature

•

Digital patient airway temperature display

•

Adjustable temperature settings

•

Audio-visual alarms permit rapid detection and correction of problems

•

Preset high/low temperature alarms

•

Disconnected/damaged probe alarm indication

•

Self-contained water system

Symbols The following symbols are used in this manual and/or on the device itself:

Symbol

Description WARNING: Indicates an instruction which, if not followed exactly, may cause harm to the patient or user CAUTION: Indicates an instruction which, if not followed exactly, may cause harm to the equipment A provides additional information to clarify procedures or conditions which may otherwise be misinterpreted or overlooked.

General Warnings and Cautions Warning: Fire Hazard. Do not use the CONCHATHERM III in the presence of flammable anesthetic gases.

Warning: Always maintain adequate gas flow rates through the tubing to prevent overheating the circuit.

Warning: Burn Hazard. Internal components are hot (as high as 140°C) and may contain liquid at temperatures up to 80°C. Allow the CONCHATHERM III to cool before handling.

Warning: Be sure the ventilator's pressure and/or tidal volume alarm is functioning before connecting any circuit to the patient. If the ventilator is not equipped with these alarms, use an auxiliary pressure monitor.

Warning: Electrical Shock Hazard. Refer all servicing to qualified, trained personnel only.

Caution: Do not autoclave, gas sterilize, pasteurize, or immerse this device in any liquid. Severe equipment damage will result.

Warning: The temperature probe must be properly placed and secure before operating the CONCHATHERM III.

Caution: Do not operate the CONCHATHERM III with a dry reservoir. Caution: Do not operate the CONCHATHERM III without a CONCHA-COLUMN humidifier cartridge.

Warning: Always verify that gas is flowing and that the appropriate airway temperature has been selected before connecting the CONCHATHERM III to the patient.

Caution: Always operate the CONCHATHERM III in a vertical position with the water reservoir properly mounted.

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Principles of Operation The CONCHATHERM III system of heated humidification consists of the CONCHATHERM III heated humidifier, a CONCHA water reservoir, a CONCHA-COLUMN humidifier cartridge, a CONCHATHERM single temperature probe, and a breathing circuit. The heated humidifier continuously monitors the patient airway temperature and regulates the heat supplied to the column from the heating element.

the patient through a breathing circuit attached to the top of the CONCHACOLUMN. CONCHA-COLUMNS are available in standard and low-compliance configurations and are labeled for easy identification. Both operate on a reliable, gravity-feed system for uninterrupted water flow. The standard CONCHACOLUMN (see Figure 1) is designed for use with ventilatory parameters most commonly associated with adults. The water in the column will be at the same level as that in the reservoir. The water level in both the reservoir and the CONCHA-COLUMN decreases as water is consumed. As the water level in the CONCHA-COLUMN decreases, the compressible volume of the system increases and the system compliance changes.

The CONCHA-COLUMN cartridge is inserted into the CONCHATHERM III where it is surrounded by a heating element. Sterile water flows via a gravity-feed system from the reservoir into the CONCHA-COLUMN, wetting an internal absorbent wick. Heat is conducted through the column’s wall, thereby heating the wick and vaporizing the sterile water. Ventilatory gas passes through the CONCHACOLUMN where it picks up the moisture in molecular form. The heated, humidified gas is delivered to

Figure 1: Standard CONCHA-COLUMN Flow Diagram

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For applications requiring a more constant compressible volume and compliance, a Low-Compliance CONCHA-COLUMN (see Figure 2) is recommended. The low-compliance CONCHA-COLUMN maintains a constant water level in the column which results in a more stable compressible volume. The system’s compliance equals the CONCHACOLUMN’s compliance plus the amount of fluid transferred to the reservoir during each inspiratory phase. Some fluid, in the form of either air or water, always transfers during each cycle1. In addition, because of the smaller mass of water contained inside the column, the lowcompliance column will heat up and cool down faster as compared to the standard CONCHA-COLUMN.

Warning: Do not use a LowCompliance column in continuous flow CPAP applications with gas flows greater than 50 LPM. There is a potential for flooding the breathing circuit and airway. The CONCHATHERM III has been designed and tested to be used with Hudson RCI conventional (non-heated wire) circuits. The CONCHATHERM III requires the use of a single temperature probe at all times.

Figure 2: Low-Compliance CONCHA-COLUMN Flow Diagram

1 The amount of fluid transferred to the reservoir varies slightly depending on ventilator settings. Several factors increase the amount of fluid transfer: high peak pressure, lower breath rates, reduced water volume in reservoir, I/E ratios approaching 1:1.4, and square pressure waveforms.

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Specifications Performance Characteristics2 CONCHATHERM III Heated Humidifier Temperature Display:

Two-digit, seven-segment LED

High Temperature Alarm Limit:

40.1°C ± 0.5°C

Low Temperature Alarm:

27.0°C ± 1°C

Warm-up Cycle:

Approximately 25 minutes 3

Minimum Required Flow Rate :

5 LPM

CONCHA-COLUMN Humidifier Cartridge Water Capacity: Standard 4 Low-compliance

193mL ± 10mL with full reservoir 52mL ± 10mL with full reservoir

Compliance: Standard 4 Low-compliance

1.12mL/cmH2O with full reservoir 2.51mL/cmH2O with reservoir at “replace” mark 0.25mL/cmH2O

Compressible Volume: Standard 4 Low-compliance

103mL with full reservoir 268mL with reservoir at “replace” mark 248mL ± 12mL

Electrical Characteristics Input Voltage and Power:

103-127 VAC, 60 Hz

Power Consumption:

185W

Leakage Current:

Less than 100 microamps

Dielectric Withstand:

1,000 volts minimum for one (1) minute

Temperature Control:

Single thermistor

Power Fuse:

One (1) 4 amp, 125 VAC 5 x 20mm time delayed

Thermal Fuse:

140°C nonresettable

2

An accumulation of extreme conditions will affect the stated performance of the device. Using a continuous flow gas source. 4 Amount of water in CONCHA-COLUMN decreases as water is used, increasing the compressible volume. 3

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Operating Environment Temperature Operating Temperature:

20 to 29°C (68 to 85°F)5

Physical Characteristics Size:

16.5cm (H*) x 11.4cm (W) x 16.5cm (D) *NOTE: Allow 33 cm when circuit is installed

Weight:

2.7 kg (approximate)

Transportation and Storage Temperature:

-20 to +50°C (-4 to +122°F)

Relative Humidity:

10-100%

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Operating the CONCHATHERM III at the extremes of the operating temperature may affect the temperature output of the device and/or cause nuisance alarms. The CONCHATHERM III works ideally at a room temperature of 22 to 26°C (72 to 78°F).

Controls and Indicators After warm-up, the LO TEMP DISABLE LED will extinguish and the low temperature alarm system will activate. If output temperature surpasses the low temperature alarm threshold of 27°C ± 1°C during the warm-up cycle, the alarm remains disabled with the yellow indicator light illuminated. The operator may activate the low temperature alarm system by moving the toggle switch to ENABLE temporarily.

Control Panel (see Figure 3) 1.

POWER ON/OFF – This switch activates all systems. Initiate gas flow before turning the power “ON”. Turn power “OFF” before terminating gas flow.

2.

TEMP °C – This digital LED readout displays temperature at the proximal airway. This LED will also display error codes related to a system malfunction. (Refer to “Troubleshooting and Maintenance” for error code descriptions.)

3.

4.

LO TEMP DISABLE – This yellow indicator light illuminates during the warm-up cycle upon initiation of power. During the warm-up cycle, the low temperature alarm is automatically disabled to allow the heater to reach operating temperature.

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LO TEMP ENABLE/RESET – This toggle switch allows the operator to silence the low temperature alarm and activate a warm-up cycle. If an airway temperature of 27°C ± 1°C has not been achieved within the warmup cycle, the low temperature alarm will activate.

➁

➂ ➄ ➃

➀

➅ ➆

Figure 3: CONCHATHERM III Top Panel Controls and Indicators When an alarm condition occurs, the heater shuts off and the green light extinguishes.

Moving the toggle switch to RESET will not correct a low airway temperature condition. It only disables the low temperature alarm and initiates a new warm-up cycle.

Bottom Panel (See Figure 4)

The toggle switch returns to its center position automatically upon release. 5.

TEMP ALARM – This red alarm indicator light will illuminate during all alarm conditions. The humidifier is disabled when this light is illuminated. (Refer to "Alarm Indications" for descriptions of alarm conditions.)

6.

TEMP SET – Adjusts gas temperature to the patient. The digital LED on the panel displays the temperature in °C.

7.

HEATER FUNCTION – This green indicator light illuminates only when the heater is supplying heat to the CONCHACOLUMN. The light's intensity varies directly with the amount of power applied to the heater.

8.

TEMPERATURE PROBE JACK – Connects the temperature probe to the CONCHATHERM III.

9.

POWER CORD – Three connector cable including ground and hospital grade plug.

➈

➇ Figure 4: CONCHATHERM III Bottom Panel

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Alarm Indications The red audio-visual alarm on the control panel is activated during any alarm condition. The power to the heating element shuts off automatically for patient safety. Check the digital display when an alarm condition has occurred. After correcting the problem, move the toggle switch towards RESET to deactivate the alarm and to initiate a new warm-up cycle.

Operator must turn the unit off to deactivate a high temperature alarm. (Refer to “Troubleshooting” for display readings and warning signals.)

Directions for Use Read this entire section, including all warnings and cautions, before operating the CONCHATHERM III. Also, refer to the “Applications” section in this manual for use of the CONCHATHERM III in particular clinical situations.

3.

Insert the CONCHA-COLUMN into the CONCHATHERM III, passing the bottom puncture pin and tubing through the cylindrical heating element. Be sure that the tubing clamp(s) are in place.

System Setup 1.

2.

Install the CONCHA-COLUMN.

Warning: Do not use a LowCompliance column in continuous flow CPAP applications with gas flows greater than 50 LPM. There is a potential for flooding the breathing circuit and airway.

Mount the CONCHATHERM III. Mount the CONCHATHERM III heated humidifier to a pole, ventilator, cart, or rail system using an appropriate Hudson RCI mounting bracket. Mounting instructions are supplied with the bracket.

4.

Connect the CONCHATHERM III to power.

5.

Install the water reservoir. Place the CONCHA sterile water reservoir into the reservoir holder on the mounting bracket. Connect the breathing circuit. •

Plug the CONCHATHERM III into a grounded electrical outlet that meets the voltage requirements stated in this manual. Be sure there is power at the outlet.

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Remove all protective caps from the ports at the top of the CONCHA-COLUMN.

•

6.

Connect the tubing from the ventilator or gas source to the vertical port on the column.

•

Connect the inspiratory circuit tubing to the remaining column port.

•

Connect the expiratory circuit tubing to the expiratory port on the ventilator.

Warning: The temperature probe must be properly placed and secure before operating the heater. Caution: Placing a temperature probe in an environment which is warmer than the temperature of the gas, such as an incubator or radiant warmer, may cause the heater to shut off, thereby reducing humidity and temperature to the patient.

Connect the water reservoir to the CONCHA-COLUMN. •

•

8.

Remove the protective sheath from the bottom puncture pin on the CONCHA-COLUMN tubing. Using a twisting motion, completely push the pin through the puncture site at the bottom of the reservoir. Repeat this procedure for the top puncture pin and puncture site.

Refer to the ventilator manufacturer's instructions for ventilator operation and monitoring requirements. When removing the CONCHATHERM III from service, turn the heater off and allow the unit to cool before terminating gas flow. Leaving the heater “ON” without gas flow may result in heat buildup which could cause circuit tubing to melt.

Open all of the tubing clamps on the CONCHACOLUMN. Gently squeeze the reservoir to initiate water flow into the column.

Caution: The heater will overheat if an insufficient water level is present. Erratic temperature fluctuations may also result. 7.

Set the ventilator or gas source as required.

Install the temperature probe. Insert the temperature probe plug into the jack at the bottom of the heater. Be certain that the plug is fully installed. Place the probe into the desired temperature monitoring port on the inspiratory side of the patient circuit.

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2.

Operating the CONCHATHERM III

To increase temperature output, gradually adjust the knob in a clockwise direction as flow requirements necessitate. With each adjustment, allow adequate time for temperature stabilization.

(see Figure 5) Warning: Do not turn the CONCHATHERM III power switch to “ON” until the gas flow has been initiated and regulated. Powering the CONCHATHERM III, or leaving it “ON”, without gas flow may result in heat buildup, causing a bolus of hot air to be delivered to the patient. Circuit tubing may melt under these conditions. Turn the CONCHATHERM III power switch to “OFF”, and allow the unit to cool, before stopping gas flow. 1.

Adjust the “TEMP SET” knob.

Temperature stabilization will vary depending on a variety of factors which include: flow rate, type and length of tubing, ventilating volume, and breath rate. The Low-Compliance CONCHA-COLUMN exhibits greater thermal efficiency, and therefore requires less warm-up time than the Standard CONCHA-COLUMN. Use care when increasing temperature output.

Initiate gas flow. When using the CONCHATHERM III, a flow rate of 5 LPM or greater is required. Warning: Always maintain adequate flow rates through the tubing to help prevent overheating the circuit.

Warning: Setting the temperature output too high may overheat the circuit, which could create a rain-out condition during the cool down period.

Figure 5: The System Using an CONCHATHERM III Humidifier and a Conventional Circuit

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3.

Turn the power switch to “ON”.

warm-up cycle and enable the low temperature alarm indicators.

Turning the heater “ON” will initiate the unit's warm-up cycle. Once on, the HEATER FUNCTION LED (item ➆ , Figure 3) will illuminate and pulse as power is supplied to the column. Once the desired temperature is reached, the HEATER FUNCTION LED will only illuminate when power is being supplied to the column. 4.

Observe airway temperature readings. Monitor the patient airway temperature using the digital display. If additional warm-up time is required, RESET the alarm toggle switch (item ➃ , Figure 3). During the warm-up cycle, the LO TEMP DISABLE LED (item ➂ , Figure 3) illuminates but the low temperature alarm indicators are disabled. Upon termination of the warm-up cycle, the LED will extinguish and the low temperature alarm indicator will be enabled. If the desired temperature is reached before the warm-up cycle expires, the operator may move the toggle switch to the LO TEMP ENABLE position momentarily in order to terminate the

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5.

The CONCHATHERM III is now ready for use.

6.

When removing the CONCHATHERM III from service, turn the heater off and allow the unit to cool before terminating gas flow. Allowing the unit to operate without gas flow may result in heat buildup, which could cause the circuit tubing to melt.

standard CONCHA-COLUMN to rise temporarily and affect compressible volume.

Warnings and Cautions Warning: Do not turn the CONCHATHERM III power switch to “ON” until gas flow has been initiated and regulated. Powering the CONCHATHERM III or leaving it “ON” without gas flow may result in heat buildup, causing a bolus of hot air to be delivered to the patient. Circuit tubing may melt under these conditions. Turn the CONCHATHERM III power switch to “OFF”, and allow the unit to cool before stopping gas flow.

Warning: Anhydrous air delivered to the patient does not activate an alarm. Caution: Always operate the CONCHATHERM III in a vertical position with the water reservoir properly mounted. Caution: Proper operation of the heated humidifier system requires proper installation of the water reservoir. Follow reservoir instructions exactly. Caution: Temperature patterns within the system associated with normal operation will be disrupted if there is an insufficient water level to pass through the system, causing the unit to alarm. Be sure the reservoir is properly installed. Caution: The heater will overheat if an insufficient water level is present. Erratic temperature fluctuations may also result. Caution: Placing a temperature probe in an environment which is warmer than the temperature of the gas, such as an incubator or radiant warmer, may cause the heater to shut off, thereby reducing humidity and temperature to the patient. Caution: Do not operate the CONCHATHERM III with a dry reservoir. Caution: Do not operate the CONCHATHERM III without a CONCHA-COLUMN humidification cartridge.

Warning: Always maintain adequate flow rates through the tubing to help prevent overheating the circuit. Warning: Always verify that gas is flowing and that airway temperature is monitored before connecting the CONCHATHERM III to a patient. Warning: Setting the temperature output too high may overheat the circuit, which could create a rain-out condition during the cool down period. Warning: The temperature probe must be properly placed and secure before operating the heater. Warning: Do not use a LowCompliance column in continuous flow CPAP applications with gas flows greater than 50 LPM. There is potential for flooding the breathing circuit and airway. Warning: A change in pressure will cause the water in the

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Applications The CONCHATHERM III humidifier, in conjunction with the CONCHA humidification system, is designed to heat and humidify respiratory gases delivered to adult, pediatric, and neonatal patients. The following information is offered regarding the use of the CONCHATHERM III in specific applications.

lar humidity to oxygen hood environments, as well as to deliver heated aerosol therapy.

Transport Vehicles Electromagnetic fields generated by communications and emergency equipment found on most medical transport vehicles may affect the performance of the CONCHATHERM III. Furthermore, extreme environmental conditions may result in nuisance alarms or extended warm-up times. The interior temperature of the vehicle should be within the recommended operating environment temperature range. The user should confirm the performance of the CONCHATHERM III in the particular transport vehicle prior to installation and use.

Anesthesia The CONCHATHERM III may be used with nonflammable anesthetic gases and conventional breathing circuits at a flow rate of 5 LPM or greater, as specified in the "Directions for Use". The use of a LowCompliance CONCHA-COLUMN is recommended in order to help maintain circuit temperature.

Incubators and Warmers When installing the CONCHATHERM III for use with a radiant warmer or incubator, place the patient temperature probe away from lamps and other heat sources to help avoid inadvertent effects on the patient temperature reading.

Warning: This unit requires 115 VAC (nominal) 60 Hz sine wave output. If used in a transport vehicle requiring an inverter, do not use square wave or pulse width modulated sine wave output. Overheating could result.

Warm or Cool Environments

Warning: Placing the temperature probe in an environment which is at or near the temperature of the gas, such as an incubator or radiant warmer, may mask a dislodged probe or cause the heater to shut off, thus reducing the humidity and temperature to the patient.

Operating the CONCHATHERM III near the extremes of its operating environment temperature range may result in alarms, as the unit attempts to control the airway temperature that is affected by system path heat transfers. The CONCHATHERM III works best at a room temperature of 22 to 26°C (72 to 78°F). Evaluate the circuit, circuit length, room temperature and other factors before placing the CONCHATHERM III into service.

Oxygen Hood and Nebulizer Use The availability of dedicated adaptors enables the CONCHATHERM III to provide heated molecu-

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Troubleshooting and Maintenance Alarm Conditions Any alarm condition activates the red audio-visual alarm indicator on the control panel. The power to the heater and the green heater function LED extinguish automatically for patient safety. Check the digital display to determine which alarm condition has occurred. After correcting the problem, move the toggle switch to RESET in order to deactivate the audible low temperature alarm during the new warm-up cycle. If the temperature exceeds the low limit, move toggle switch to ENABLE to reactivate the low temperature alarm. This will bypass the remaining warm-up time.

Digital LED Display

Alarm Condition

Possible Cause

Recommended Action

00 to 03°C

Unit alarms immediately, RESET 1. Temperature cable jack not 1. Secure cable connection at does not clear alarm. Heater properly connected or unit shuts off disconnected at unit 2. Wire in cable broken 2. Replace probe cable 3. Heater sensor fails 3. Remove CONCHATHERM III from use for repair

70 to 90°C

Unit alarms. Heater shuts off

No electrical current going to the probe

1. Secure probe connection 2. Replace probe

< 28°C Low Temperature Alarm

Audible and visual low temperature alarm. Heater shuts off

1. Temperature output <28°C in warm-up cycle. 2. Temperature drops <28°C 3. Dislodged proximal airway probe.

1. Reset to initiate warm-up cycle

> 39.6°C High Temperature Alarm

Unit alarms. Heater shuts off

1. Temperature output 39-49°C

1. (a) Allow temperature to decrease (b) Reset low temperature switch 2. Replace probe. 3. Secure probe connection

2. Probe may have shorted 3. Dislodged probe

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2. Reset to initiate warm-up cycle 3. Secure probe connection

Routine Checks and Operating Maintenance 1.

2.

Observe the condensation levels in the tubing with every ventilator circuit check. Drain as necessary.

e.

It is recommended that the CONCHA-COLUMN be replaced with each ventilator circuit change. a. b.

4.

Avoid skin contact with HOT metal surfaces. Columns designated for “single patient use” should never be reprocessed.

Periodically perform a diagnostic test as described below. Check the power cord regularly for damage. Immediately remove from service any heater which shows signs of overheating, smoking, or electrical malfunction.

Check the reservoir bottle for adequate sterile water supply. A water supply at, or below, the replacement line on the bottle may cause erratic temperature fluctuations. The reservoir can be replaced at any time without interrupting the gas flow.

Diagnostic Test

To change the reservoir bottle: a.

b.

c.

d.

Check the digital temperature display on the CONCHATHERM III heater whenever an alarm condition occurs and when making any adjustment to the setup.

Routine Maintenance

Warning: The metal surfaces of the column or heater may be HOT. 3.

the bottom of the reservoir. Repeat this procedure for the top puncture pin and puncture site. Open all clamps on the CONCHA-COLUMN and squeeze the bottle to initiate flow into the column. (These instructions are also provided with each column.)

Close all tubing clamps before removing the reservoir bottle. Carefully remove the bottle from its holder and lower the bottle to a position below the column. Orient the bottle so that the puncture ports face upwards. Remove the puncture pins from the bottle. Discard the used reservoir bottle and place a new CONCHA sterile water reservoir bottle in the reservoir bracket. Using a twisting motion, completely push the pin through the puncture site at

1.

Set up the unit with a full reservoir bottle ready for normal operation. Insert a new, standard CONCHA-COLUMN into the heater. Connect the column tubing to the reservoir bottle.

2.

Provide continuous 20-26°C dry air to vertical port at the top of the column. Use the settings described below. LPM 10

3.

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Temp. Setting 7

Install the inspiratory limb of a 1.8m (72") circuit onto the remaining port of the column. Connect the temperature probe to the ported wye at the patient end.

4.

Attach a digital thermometer with a minimum accuracy of ± 1°C between the end of the tubing and a ported adaptor attached to the wye.

5.

Apply power to the heater. Allow 35 to 45 minutes for the temperature to stabilize.

in obtaining a Hudson RCI remanufactured or replacement heater for your CONCHATHERM III. User-performed repairs of leased heater should not be attempted. Such repairs shall be considered “usercaused” damage and may result in the cancellation of the lease. Repair of user-owned heaters: Hudson RCI Customer Service shall provide instructions for the return of your heater. Upon receipt, the heater will be evaluated and an estimate of repair costs will be made and provided to you. You may elect to receive a Hudson RCI remanufactured or replacement heater for your CONCHATHERM III. This option provides a substantial savings on repair costs and greatly reduces the turnaround time for the repair. User-performed repairs during the warranty period will void the CONCHATHERM III warranty. Outside the United States and Canada: If the CONCHATHERM III requires service or repair, contact the Hudson RCI International Customer Service Department by telephone at 909-676-5611, or by fax at 909-676-1578 for return authorization and shipping instructions. Upon receipt, the heater will be evaluated and an estimate of repair costs will be made and provided to you. You may elect to receive a Hudson RCI remanufactured or replacement heater for your CONCHATHERM III. This option provides a substantial savings on repair costs and greatly reduces the turnaround time for the repair. User-performed repairs during the warranty period will void the CONCHATHERM III warranty.

TEST RESULTS SHOULD BE: When room temperature is 20-25°C and the digital display is 33-37°C, the thermometer reading should be 33-37°C. 7.

If the patient airway temperature is not between 33 and 37°C, return the unit for calibration. (Refer to “Service and Repairs” in this manual.)

Cleaning HEATER: Use a 3% hydrogen peroxide solution or sodium hypochlorite to disinfect the outer surfaces. Do Not use alcohol or solvent on the unit. Caution: Never autoclave, gas sterilize (EtO), irradiate, pasteurize, or submerge in solution.

TEMPERATURE PROBE: Refer to instructions supplied with probe.

Service and Repairs In the United States and Canada: If the CONCHATHERM III requires service and repairs, contact the Hudson RCI Customer Service Department by telephone at 800-848-3766, or at 909-676-5611. Repair of leased heaters: Your Hudson RCI customer service representative will assist you

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Warranty The CONCHATHERM III heated molecular humidifier is warranted by Hudson Respiratory Care Inc. 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 Hudson Respiratory Care Inc. 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 Hudson Respiratory Care Inc.

may not apply to you. IN NO EVENT SHALL HUDSON RESPIRATORY CARE INC. BE LIABLE FOR CONSEQUENTIAL DAMAGES. Some states, provinces, or countries do not allow the exclusion or limitation of incidental or consequential damages, 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. Hudson Respiratory Care Inc. shall have no obligation to modify or update this device once sold.

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 ONEYEAR 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

For more information about the CONCHATHERM III warranty, refer to “Service and Repairs” in this manual, or contact an authorized Hudson Respiratory Care Inc. representative or Hudson Respiratory Care Inc.

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