Dräger Aquapor H300 Instructions For Use Manual
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Dräger Aquapor H300 Instructions For Use Manual

Dräger Aquapor H300 Instructions For Use Manual

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Instructions for use
Aquapor H300
WA RNI NG
To properly use this medical device,
read and comply with these
instructions for use.

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Summary of Contents for Dräger Aquapor H300

  • Page 1 Instructions for use Aquapor H300 WA RNI NG To properly use this medical device, read and comply with these instructions for use.

  • Page 2: Table Of Contents

    Table of contents Intended use � ��� ��� ��� ����������������������������� ��� ��� ��� ��� ��� ��� �� � � � � � � � � � � � � � � � � � � �� � � � � � � � � � � � � � � � � � � � � � � � � � � � � 4 Warnings, precautions, and notes ������������...
  • Page 3 Alarms � �� �� � �� � �� �� ���� ��� ������������������������������ ��� ��� ��� ��� ��� ��� ��� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 28 8�1 Inspiratory heater missing/faulty �����������������...

  • Page 4: Intended Use

    1. Intended use Intended use The therapy device or oxygen source conducts Aquapor H300 respiratory gas humidifier is a device the breathing gas to the breathing gas humidifier's for heating and humidifying respiratory gases, such humidifier chamber where it is heated, enriched with...

  • Page 5: Warnings, Precautions, And Notes

    WARNING WARNING Before connecting the patient to the breathing circuit, Aquapor H300 breathing gas humidifier can be check whether the breathing gas is flowing freely connected to all conventional ventilators/therapy through the breathing circuit�...
  • Page 6 26 °C for 30 minutes before operation� distance of less than 30 cm (or 12 inches) from the Aquapor H300 parts and cables stipulated by WARNING the manufacturer� Non-compliance may lead to a Small parts may be swallowed�...

  • Page 7: 2�2 Precautions

    2.2 Precautions Precautions are identified by the term CAUTION� Precautions inform the user that particular caution is required to ensure the safe and effective use of Aquapor H300 breathing gas humidifier� CAUTION CAUTION To avoid overheating, a constant breathing gas flow Do not sterilize the main device and accessories and of at least 2 L/min is required in the breathing circuit�...

  • Page 8: 2�3 Notes

    Portable and mobile high-frequency communication NOTE equipment (such as cellular phones) can influence Aquapor H300 breathing gas humidifier must be set Aquapor H300 breathing gas humidifier� Further up and operated as described in the instructions for information is provided in the manufacturer's EMC use�...

  • Page 9: Basic Equipment And Required Equipment

    4. Basic equipment and required equipment 4.1 Scope of delivery ● ● Aquapor H300 main device Temperature probe (160 cm MP07108) ● (230 V MP07101, 115 V MP07102) Power cable (country-specific) ● ● Heating wire distribution cable Instructions for use (country-specific)

  • Page 10: 4�2 Consumables

    Examples of accessory parts and consumables are listed in the following table� Main devices Item number Description MP07101 Aquapor H300 main device 230 V MP07102 Aquapor H300 main device 115 V Hose heater adapter Item number Description MP07106 H300 hose heater adapter, insp�...

  • Page 11: Setup And Operation

    Connect the power plug to an appropriate power socket or power socket strip with an approved voltage� Aquapor H300 is equipped with housing feet and The connections for the heating wire distributor cable can be placed on a flat, solid, and horizontal surface�...

  • Page 12: 5�3 Inserting The Humidifier Chamber

    5.3 Inserting the humidifier chamber Unpack the humidifier chamber with automatic refilling device and check whether any damage can be identified before use� Sealing caps First slide the humidifier chamber's lower edge under the front tab on the main device Front tab Connecting instrument Caution:...

  • Page 13: 5�4 Connecting The Breathing Circuit

    The blue coupling for the heating wire supply is always connected to the blue heating wire connector of the inspiratory hose� The Aquapor H300 main device is only ready for operation when the inspiratory heating wire is connected� T-sensor in the opening of the elbow...
  • Page 14 If the breathing circuit used is equipped with a heated Sealing plate expiratory hose, the white coupling for the heating hose supply is always connected with the white heating wire connector of the expiratory hose� Cables must be installed so that no one can become entangled�...
  • Page 15 Perforator Before the patient is connected to the breathing For water bottles, the venting cap on the perforator circuit, ensure the flawless operation of the therapy must be opened� device, the correct setting of the therapy parameters, and that the breathing gas flows smoothly out of the Venting cap breathing circuit�...

  • Page 16: 5�5 Switching On The Main Device

    5.5 Switching on the main device NOTE Only switch on the breathing gas humidifier with Aquapor H300 breathing gas humidifier saves the last the main switch mounted on the side once the setting and uses this in case of a restart (e�g� after a breathing circuit, the humidifier chamber, and the power failure)�...

  • Page 17: 5�6 Switching The Main Device Off

    39.0 °C 37.0 °C EXP . 5.6 Switching the main device off After initialization, the operating display appears� The breathing gas humidifier can be switched off at the main switch after therapy is complete� After it is switched off, the device should be allowed to cool for 30 minutes before it is dismantled, packed, or transported, as the heating plate is still hot!

  • Page 18: Operation

    6. Operation 6.1 Display in normal mode The symbol indicates This symbol indicates that the service inter- that the therapy has been val has expired� paused for the device� 39.0 Target temperature at the patient outlet and the cham- °C ber�...

  • Page 19: Function Keys

    Reset to factory settings� LP: Therapy pause 39.0 °C 37.0 38.8 °C °C EXP . Aquapor H300 Operation in normal mode LP: Access configuration mode LP: Access modification mode Ambient light sensor: Chang- ing of the background lighting depending on the ambient light�...

  • Page 20: 7�1�1 Resetting To Factory Settings

    7.2 Operation in modification 7.1.1 Resetting to factory settings mode The device is supplied with the "IV" factory setting, i�e� ● target value of the breathing gas temperature Pressing the key for approx� 3 s during normal near the patient (top measuring point): 39 °C mode accesses the modification mode and the target ●...

  • Page 21: 7�2�1 Reducing Condensation In The Inspiratory Hose

    39.0 °C 36.0 °C EXP . Aquapor H300 Operating in modification mode (free) SP: Select the modification (yellow), SP: Exit modification mode modify and confirm with the plus and minus key� 7.2.1 Reducing condensation in the 7.2.3...

  • Page 22: 7�3 Operation In Configuration Mode

    7.3 Operation in configuration mode Pressing the key during normal mode for 3 s opens the configuration menu� Individual settings can be made in the configuration menu� The following illustration explains the sequence of the menu pages: 39.0 °C 36.0 °C FREE Water Level Detection...

  • Page 23: 7�3�1 Operating Mode

    SP: Select the next or the previous menu item FREE Aquapor H300 Operation in setup mode SP: Select parameter SP: Access the next setup screen changes with the + or – key; confirm with check mark� 7.3.1 Operating mode Chamber temperature...

  • Page 24: 7�3�2 Respiratory Flow Ranges

    7.3.2 Respiratory flow ranges Operation mode Hose diameter (mm) Respiratory flow range (L/min) 2 - 15 3 - 30 4 - 80 2 - 15 3 - 30 4 - 60 2 - 15 FREE 3 - 30 4 - 80 7.3.3 Setting temperatures This menu page is only displayed if the user has selected the "FREE"...

  • Page 25: 7�3�4 Setting The Humidification Performance

    7.3.5 Adjusting the water fill level detection Aquapor H300 active humidifier automatically detects the water fill level in the humidifier chamber� An acoustic and optical alarm message is triggered if the water level in the humidifier chamber exceeds or falls below the maximum or minimum Water Level Detection filling level�...

  • Page 26: 7�4 Operation In Alarm Mode

    7.4 Operation in alarm mode SP: Silence the alarm LP: Access setup LP: Change parameters Aquapor H300 (target temperatures and expiratory heating output) Operation in alarm mode 7.4.1 Alarm silence 7.4.2 Alarm delay The acoustic alarm can be silenced for 120 s with the...

  • Page 27: 7�4�3 Warm-Up Time

    7.4.4 Effects on power No adverse effects on the power of Aquapor H300 are known from the influences of electrocauterization, electrosurgery, defibrillation, X-rays, infrared rays, transmitted switching pulses, magnetic fields, and...

  • Page 28: Alarms

    8. Alarms An acoustic signal sounds when switching on the device and a visual signal appears in the form of yellow LEDs on this display , which are used to check the functionality of the alarm system� All alarms are assigned the middle priority�...

  • Page 29: 8�3 Breathing Gas Temperature Too High

    8.3 Breathing gas temperature too high Cause Measure Sudden change in the flow rate of Silence the alarm and monitor whether the 39.4°C the breathing gas� temperature falls to the permissible value� Temperature probe faulty� Remove the hose system and switch off the temperature probe�...

  • Page 30: 8�6 Humidifier Chamber Temperature Too Low

    8.6 Humidifier chamber temperature too low Cause Measure Sudden change in the flow rate of Silence the alarm and monitor whether the the breathing gas� temperature increases to the permissible value� Temperature probe faulty� Remove the hose system and switch off the temperature probe�...

  • Page 31: 8�9 Patient Temperature Probe Missing/Faulty

    8.9 Patient temperature probe missing/faulty Possible cause Measure Temperature probe near the device Switch the device off and leave it to cool� not inserted in the hose� Insert the temperature probe near the patient in the opening of the hose and restart�...

  • Page 32: 8�12 Humidifier Chamber Missing

    8.12 Humidifier chamber missing Possible cause Measure No humidifier chamber inserted� Insert the humidifier chamber� Breathing gas humidifier faulty� Remove the hose system and notify customer service� 8.13 Water fill level too low Possible cause Measure Water reservoir empty� Replace the water reservoir and fill the humidifier chamber with water�...

  • Page 33: 8�15 Hw Alarm

    8.15 HW alarm Possible cause Measure Remove the hose system and notify customer service� 8.16 Forced shut-off of the heating wire and heating plate Forced shut-off of all heaters� This is also shown with an illustration depending on the error� Possible cause Measure An error was not rectified within...

  • Page 34: Reprocessing

    9. Reprocessing Safety information WARNING Risk due to incorrectly reprocessed products Reusable products must be reprocessed, otherwise Trademarks owned by third-party there is an increased risk of infection� manufacturers ● Follow the infection prevention policies and Trademark Trademark owner reprocessing regulations of the health-care facility� Selectatec Datex-Ohmeda ●...
  • Page 35 Classifications for reprocessing Before reprocessing Classification of medical devices Observe before disassembly The classification depends on the intended use of the medical device� The risk of infection transmission 1� Switch off the device and all devices connected through the application of the product to the patient to it�...
  • Page 36 Validated reprocessing procedures Cleaning 1� Wipe off obvious soiling with a disposable cloth Overview of the reprocessing soaked in surface disinfectant� Dispose of the procedures of the components cloth� 2� Wipe all surfaces with a new cloth� After that, Category Surface disinfection there must no longer be any soiling visible�...
  • Page 37 Other products Class of Surface Manu- Listing active disinfectant facturer ingredient Disinfectants Oxygen- Descogen Anti- releasing Liquid septica Use nationally approved disinfectants agents Descogen suitable for the respective reprocessing operation and Liquid r�f�u� the intended application� Oxygenon Liquid r�f�u� Surface disinfectant Dismozon BODE The manufacturers of the surface disinfectants have...

  • Page 38: Maintenance

    Color changes do not impair the functional integrity of the product� Aquapor H300 breathing gas humidifier does not Other surface disinfectants are used at one's own risk� need to be calibrated�...

  • Page 39: Legend

    11. Legend Type BF applied part (B= Body; F= Floating applied part) Symbol for order number Manufacturer's serial number� The first four digits indicate the date of manufacture� Lot number For USA: Caution: Federal law restricts this device to sale by or the order of a physician RX only Date of manufacture Storage temperature...
  • Page 40 Warning! Strictly follow these Instructions for Use Warning of hot surface� Can lead to burns� Connection for heating wire distribution cable (symbol printed on the housing) Connection for temperature sensor cable (symbol printed on the housing) 22 0– 24 0 V~ Operating voltage of the 230 V version 11 0–...

  • Page 41: Technical Data

    Dimensions Height: 170 mm Width: 145 mm Depth: 200 mm Weight Aquapor H300 humidifier: Approx� 2�3 kg Approx� 2�5 kg incl� supplied accessories Classification ● Device (protection class according to IEC 60601) class II ● Type BF applied parts:...
  • Page 42 Environment ● Temperature - in operation: +18 °C to +26 °C - during storage and transport: –25 °C to +70 °C ● Gas inlet temperature: +18 °C to +26 °C ● Humidity - in operation: 0 to 93 % non-condensing - during storage and transport: 0 to 93 % non-condensing...

  • Page 43: Storage And Disposal

    13. Storage and disposal ● Clean the device before storage At the end of its service life: and store it in a PE bag� ● ● Loosely coil the temperature probe Contact the relevant waste disposal and the heating wire adapter� company for appropriate disposal�...

  • Page 44: Technical Documentation

    15. EMC verification Guidelines and manufacturer declaration – electromagnetic emissions Aquapor H300 is intended for use in an electromagnetic environment as specified below� The customer or user of Aquapor H300 should ensure that it is operated in this type of environment�...
  • Page 45 Guidelines and manufacturer declaration – electromagnetic immunity Aquapor H300 is intended for use in an electromagnetic environment as specified below� The customer or user of Aquapor H300 should ensure that it is operated in this type of environment� Immunity tests IEC 60601 –...
  • Page 46 Immunity tests IEC 60601 – Test level Compliance level Electromagnetic envi- ronment – guidelines Voltage dips, short 0 % U ; ½ period 0 % U ; ½ period Mains voltage quality interruptions, and At 0, 45, 90, 135, 225, at 0, 45, 90, 135, 225, should be that of a typical fluctuations of the supply...
  • Page 47 If the measured field strengths at the location at which Aquapor H300 is used exceed the above compliance level, Aquapor H300 should be monitored in order to verify the correct function� If unusual performance characteristics are observed, additional measures may be necessary, such as a different alignment or a different location of Aquapor H300�...
  • Page 48 Test Frequency Maximum Interference Radio Distance frequency band Modulation power immunity service in MHz in MHz in W level 380 to 390 TETRA 400 Pulse 1�8 0�3 modulation 18 Hz 430 to 470 GMRS 460, FM c ±5 kHz 0�3 FRS 460 stroke 1 kHz sine...
  • Page 49 The customer or the user of Aquapor H300 can help prevent electromagnetic disturbances by complying with the minimum distance between portable and mobile HF telecommunication devices (transmitters) and Aquapor H300 – depending on the output power of the communication device, as indicated below�...
  • Page 50 Notices...
  • Page 52 Directive 93/42/EEC on medical devices Manufacturer: Drägerwerk AG & Co. KGaA Moislinger Allee 53 – 55 D-23542 Lübeck Germany +49 451 8 82-0 +49 451 8 82-20 80 http://www�draeger�com 9056342 – GA 5697�001 © Drägerwerk AG & Co� KGaA Edition: 2 – 2020-03 Dräger reserves the right to make modifications to the medical device without prior notice�...

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