AIRcon Respiratory Gas Conditioner BY AHMAD YOUNES PROFESSOR OF THORACIC MEDICINE Mansoura faculty of medicine

Intended use AIRcon respiratory gas humidifier is a device for heating and humidifying respiratory gases, such as medical oxygen and/or compressed air or else room air during mechanical ventilation or respiratory therapy in both the clinical and home care environments. AIRcon can be used for invasive as well as noninvasive ventilation/respiratory therapy for adults, children and newborn babies.

Intended use AIRcon is always positioned between therapy device and patient. A tubing system and humidifier chamber are always necessary for this connection. This tubing system must be matched beforehand to the therapy device being used, to the medical indication and to the respective patient group. Connect AIRcon with approved therapy devices (such as ventilators, bilevel devices, CPAP devices, etc.). Respiratory gas is passed from the therapy device or oxygen source to the humidifier chamber, where it is heated, humidified with water vapor and then passed via the inspiratory tube to the patient.

Intended use Three different basic modes, in conjunction with the fact that temperatures can be freely adjusted at any time at the humidifier chamber outlet and also close to the patient, ensure that humidification capacity can be adjusted or controlled optimally for every application. AIRcon respiratory gas humidifier is not suitable or intended for atomization of medications. AIRcon respiratory gas humidifier is suitable for reuse. When changing patient and before reusing, it is necessary to observe cleaning and disinfection instructions .

Warnings (potentially serious consequences, such as death, injury for patient or user) Position the respiratory gas humidifier below patient level, to ensure that any condensate formed will not flow into the patient’s respiratory passages, but instead will be returned to the chamber. The respiratory gas humidifier generates moist air having a relative humidity of approximately 100 %. This high relative humidity is medically desired , but also allows water to condense easily from the moist air. Condensation may occur at any time as a result of changes in the climatic conditions in the hospital room (for example, heating, air circulation) or of changes in respiration or ventilation of the patient. Do not operate AIRcon with heated breathing tubes or accessories that have not been released by WILAmed.

Warnings Insert the temperature sensor in such a way that the temperature of the respiratory gas in the respiratory tube is measured. Otherwise the temperature of the supplied respiratory gas may rise above 41 °C. When AIRcon is started or restarted, the maximum permissible temperature of the water in the humidifier chamber is 30 °C . Respiratory gas must be flowing through the breathing tube system before AIRcon is turned on and patient is connected to the patient tubing system . AIRcon measures the respiratory gas temperature flowing past the chamber outlet and close to the patient , and uses these measured values to control both of the temperatures. In absence of respiratory gas, AIRcon is unable to determine temperatures correctly.

Warnings Risk of burns! Heater plate and bottom of humidifier chamber can reach temperatures higher than 85 °C. Moist air from the humidifier chamber is heated in the breathing tube via a heater wire . Danger of overheating exists if the breathing tube were covered with sheets or blankets, potentially causing deformation or melting of the breathing tube. Ensure the breathing tube system does not get in contact with the patient skin as it may cause reddening or burning.

Precautions (ensure safe and effective use of the humidifier AIRcon ) Check basic unit, its parts and accessories for damage before each use.Do not use AIRcon and its accessories in case of defects or damage. Do not use and dismiss damaged system components. Humidity output may be impaired if the device is operated outside specified environmental temperatures. Humidity output is reduced when ventilation device supplies respiratory gas at higher temperature!

Precautions Temperature of the respiratory gas flowing into the humidifier chamber should be at least 5 °C cooler than set water chamber temperature. To prevent overheating, a continuous respiratory-gas flow of at least 1 L/min is required in the tubing system. If respiratory-gas flow is interrupted , the device is to be turned off. Water to manually fill the water chamber must not exceed 30 °C. Please pull power plug before any cleaning, maintenance, inspection or repair.

Precautions Do not sterilize basic device or accessories and do not dip them in liquids! Only a physicians are permitted to set or change patient settings. A change of room climate (for example, heating, air circulation) or input of new ventilation parameters may lead to condensation in the respiratory-tubing system. Condensation is always to be monitored and kept to a minimum.

Precautions When lifting the breathing circuit, a water level detection alarm due to recirculation of condensation may occur. In this case, deactivate water level detection temporarily and be aware that alarm is turned off when water level is too low. Respiratory gas humidifier and humidifier chamber are not inhalation devices and are not approved for administration of medications. Portable and mobile radiofrequency communication devices (such as mobile telephones) may influence the respiratory gas humidifier. Do not exceed maximum fill level when manually refilling the water chamber . An alarm is triggered if water level is too high and water from humidifier chamber may spill over into breathing tube circuit.

Basic equipment Basic AIRcon device Temperature sensor cable Heater wire distributor cable Power cord

Setup and startup Connect components AIRcon is fitted with silicone feet and can be mounted on a flat, firm and horizontal surface or fastened in an appropriate claw by means of the rear retaining strap. The socket for the power cord is located at the bottom of the AIRcon respiratory gas humidifier. Insert the two-prong power plug into power socket provided and place the power cord in the guide channel in such a way that it is clamped securely and firmly. Connect power plug to a suitable outlet or multiple outlet strip with a permissible voltage.

Setup and startup Sockets for heater wire distributor cable and temperature sensor cable are mounted on the side of the device. Both sockets are color marked , mechanically coded and identified with symbols. Connecting plugs of both heater wires (inspiratory and expiratory) are also identified by colors and are also mechanically coded to prevent misconnection. Connect temperature sensor cable (blue) to blue socket (symbol ). Connect heater wire distributor cable (yellow) to yellow socket (symbol ).

Insert humidifier chamber AIRcon respiratory gas humidifier can be used with common commercial humidification chambers. Those can be disposable or reusable chambers as well auto-filling chambers. Unpack humidifier chamber and inspect for possible damage before use. Important: Use only flawless humidifier chambers! Pull off colored seal caps and dispose of properly. Correct alignment of humidifier chamber is determined by the position of the basic device (right or left ) relative to the patient’s bed. Viewed from the front, the two tubing ports of the humidifier chamber should point toward the right and left of the basic device.

Insert humidifier chamber Push bottom edge of the humidifier first under the strap of the front structure and then under the fastening stirrup, until stirrup snaps audibly into place. Only when humidifier chamber is correctly plugged in can the sensory monitor signal to the microprocessor that device is ready to operate. In case of using auto-filling chambers , steril water reservoir needs to be attached to the supply tree . Remove seal plate and insert perforater at the connection kit. If correctly installed, water fills the humidifier chamber gradually. In case of using chambers without auto-filling mechanism, chambers must be filled with sterile water manually. Ensure that the recommended water level is reached. During operation correct water level must be checked regularly. Refill water if necessary.

Connect tubing system Using the shorter connecting tube , connect ventilation device to the tubing port of the air supply (with insert). Attach angle connector of heated inspiratory tube, which is identified by a green plug, to the other tubing port (without insert). Insert first measuring head of temperature sensor cable into the inlet of the angle connector and second measuring head at the end of temperature sensor cable into the inlet close to the patient. Both measuring heads must be inserted firmly and securely into their respective bores.

Connect tubing system Conductor of temperature sensor cable can be fixed in the corresponding hooks of the tubing clamps, so that it does not dangle loosely. Green coupling of heater wire supply must always be connected to green heater wire plug of inspiratory tube. AIRcon humidifier is ready to operate only when inspiratory heater wire has been connected. Once the tubing system being used has been fitted with a heated expiratory tube, the white coupling of the heater wire supply must always be connected to the white heater wire plug of expiratory tube.

Connect tubing system Before connecting patient to patient tubing system, make certain that the therapy device is functioning perfectly , therapy values are correctly set and respiratory gas is flowing without hindrance through the tubing system. Heater wire distributor cable (yellow device plug) can be used both for respiratory tubing systems having a heater wire in the inspiratory tube (green coupling) and for tubing systems having dual heater wires (green coupling for inspiratory tube and white coupling for expiratory tube). For connecting breathing tube systems with only inspiratory heater wire , there is an equivalent heater wire adapter available (P/N 100.942).

Any condensation in the breathing circuit, resulting from application and environmental temperatures, shall be avoided. Incorrect arrangement of breathing circuit Correct arrangement of breathing circuit

Connect tubing system An alarm signal may occur in case of recirculation of condensation into the humidifier chamber. Bear in mind, that connected breathing circuit is assembled with a slight decline towards the humidifier chamber. Correct direction of breathing circuit can be achieved by using a circuit support arm and circuit gears.

Switch-on device Turn on respiratory gas humidifier with the side-mounted main switch only when humidifier chamber and water reservoir have been correctly connected. AIRcon respiratory gas humidifier saves the last setting and uses it for a restart (for example, after a power failure). The device can be restored to factory setting as described in “Operator control in normal mode”. After it has been turned on, the device first displays product model and version and executes a self-test. No inputs are possible during this initialization.

Switch-on device The startup display is only an example for illustration. Displayed software version can differ.

Switch-on device After initialization, the operating display appears. As an example, factory setting IV (invasive) is shown below. In its factory setting IV, the device assumes the following fixed parameters: target temperature close to the patient = 39 °C, chamber temperature = 37 °C. After device has been turned on, heating phase lasts 30 minutes at most (typically 15 minutes) and symbol is displayed.

Function keys There are four different display modes and sometimes keys have different functions. HD = Hold down PB = Press briefly

Operation in normal mode

Restoring to factory settings Device is delivered with factory setting “IV”, i.e. target value of near-patient respiratory gas temperature (upper measurement point): 39 °C ,target value of chamber temperature (lower measurement point): 37 °C During operation, device can be restored to factory setting by holding down the and keys simultaneously for 3 s. While factory setting is loading, a black screen displays a yellow text, reading “FACTORY RESET…” in the left lower corner.

Therapy pause Hold down the key for 3 s in normal mode to initiate a therapy pause. While therapy pause is active, status symbol STOP is displayed in the right lower corner of the screen. After 180 s, therapy pause is automatically canceled and device resumes operating in last mode of operation. During therapy pause , heater power of the tubing heater is reduced. This reduces the risk of an increased temperature at the patient outlet once respiratory gas flow restarts after therapy pause.

Operation in modification mode Activate modification mode to adjust target temperatures or heater power in the expiratory tube by holding down for approximately 3 seconds during normal mode. Target value for near-patient temperature can be adjusted in the top row and target value for chamber temperature can be adjusted in the row below. In the bottom row, the heater power of the heater wire in the expiratory tube can be incremented or decremented in 5 stages. Select appropriate row with the and cursor keys in order to make changes.

Operation in modification mode At first, the selected element is shaded in white. When pressing ,the element is highlighted in yellow. Highlighted values can be increased or decreased by pressing and . Each adjustment must be confirmed by pressing the key . Press the key to exit modification mode.

Reducing condensation in the inspiratory tube To reduce condensate in the inspiratory tube, it is recommended to increase temperature difference between near-patient and humidifier chamber target temperature . Changing humidity Humidity for the patient can be increased by raising the humidifier chamber target temperature. The humidity for the patient can be decreased by lowering the chamber target temperature. Reducing condensation in the expiratory tube To reduce condensate in the expiratory tube, it is recommended to raise heat output of the expiratory heater wire.

Operation in configuration mode In normal mode, hold down the key for 3 s to open configuration menu . Configuration menu allows you to make individual adjustments as shown below:

Operation in configuration mode Select desired function with and . Selection is highlighted in yellow and must be confirmed with . Press to open the next menu page up to operating mode.

Operation in configuration mode

Mode of operation Factory setting “NIV” (noninvasive) works with fixed operating parameters as follows: respiratory gas temperature (upper measurement point): 34 °C chamber temperature (lower measurement point): 31 °C Factory setting “IV” (invasive) works with fixed operating parameters as follows: respiratory gas temperature (upper measurement point): 39 °C chamber temperature (lower measurement point): 37 °C

Option “FREE” allows individual operating parameters adjustments for respiratory gas and chamber temperature. Set temperatures This menu page is displayed only if user has selected operating mode “FREE”. In contrast to factory setting for invasive and noninvasive ventilation, user must set desired patient and chamber temperatures manually. Regardless of mode of operation (including IV and NIV),temperature can be adapted to patients needs (for example , respiratory gas too humid / too dry) by holding down the key for approximately 3 s. During any change of temperature parameters, the device automatically switches to “FREE” mode of operation, even from factory setting (IV or NIV).

Set humidification In non-invasive ventilation (NIV) and invasive ventilation (IV) mode, the humidity output can be individually adjusted in three levels. A single drop indicates humidification minimum, three drops indicate humidification maximum. Depending on the selected breathing tube system and applied form of therapy, the user is allowed to adapt patients’ humidification in a more flexible way; potential condensation in the breathing tube system can be reduced.

Set chamber AIRcon active humidifier automatically detects water level in the humidifier chamber. Acoustic and optical alarms are triggered if water level in humidifier chamber rises above the maximum value or drops below the minimum value. The following selectable options are available for automatic water level detection: ON= function activated OFF= function deactivated. A prerequisite for correct functioning of automatic water level detection is the use of transparent unlabeled humidifier chambers (example: WILAmed AF200). If outside wall of humidifier chamber is labeled or if a humidifier chamber with a high-flow insert is used, water level detection must be deactivated

Operation in alarm mode

Alarm muting Press briefly to suppress acoustic alarm signal for 120 s. The background illumination of the key in question will continue to flash as an optical alarm. After muting time has elapsed, the acoustic alarm sounds once again, but may be muted again if necessary. If fault is not corrected during repeated muting period, the device turns off the heaters after 10 minutes. Status is displayed with letters “OFF” under flashing symbol .

Alarm delay Alarm delay suppresses an alarm for 3 minutes and is automatically activated if a target temperature is changed. This function prevents the alarm from being triggered by unusual parameter corrections, such as a change of more than 2 °C in the target temperature close to the patient. Alarm delay is also active at the end of a therapy pause.

Alarm delay is activated when: Patient temperature too high (does not apply when exceeding 43 °C threshold) Patient temperature too low Chamber temperature too high Chamber temperature too low Heater plate sensor system defective

Heating time After device has been turned on ,“temperature alarms” and also alarm delay are disregarded for a certain time. This heating time may last for 30 minutes at most and is shortened to 5 minutes if both actual temperatures have exceeded their target limits for the first time.

Inspiratory heater missing/defect

Expiratory heater missing/defect

Respiratory gas temperature too high

Respiratory gas temperature too low

Humidifier chamber temperature too high

Humidifier chamber temperature too low

Temperature sensor cable missing/defective

Heater plate defective

Humidifier chamber missing

Water level too low

Water level too high

VT_ALM

Forced disconnection of heater wire and heater plate

Heater plate too hot

Service due

Format eeprom

Measurement in progress