Maquet HU 35 Instructions For Use Manual
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Maquet HU 35 Instructions For Use Manual

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REVISED INSTRUCTIONS FOR USE
CLEANING, DESCALING, DISINFECTION
HEATER UNIT
HU 35

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  • Page 1 REVISED INSTRUCTIONS FOR USE CLEANING, DESCALING, DISINFECTION HEATER UNIT HU 35...
  • Page 2 All rights reserved. No part of this publication may be duplicated, adapted or translated without prior written permission, except under the terms of the copyright laws. © Copyright Maquet Cardiopulmonary GmbH Subject to technical changes Owing to our policy of continuous product development, the illustrations and technical data contained in this document may differ slightly from the current version of the device.
  • Page 3 Descalcificação e desinfeção do circuito de | 115 água Polski Informacje ogólne | 132 Czyszczenie powierzchni i dezynfekcja | 134 urządzenia po każdorazowym użyciu Odkamienianie i dezynfekcja obiegu wodnego | 136 Čeština Všeobecné informace | 153 Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 4 | 279 ve dezenfeksiyonu Su devresinin kirecinin giderilmesi ve | 281 dezenfekte edilmesi Suomi Yleistä tietoa | 298 Laitteen pintapuhdistus ja desinfiointi jokaisen | 300 käyttökerran jälkeen Vedenkierron kalkinpoisto ja desinfiointi | 302 Chinese (simplified) 概述 | 319 Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 5 | HU 35 | Table of Contents | 5 | 每次使用设备后进行表面清洁和消毒 | 321 水路的除垢和消毒 | 323 Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 6 | 6 | 1 General | HU 35 | HU 35 1 General 1.1 Information on these revised Instructions for Use These revised instructions for cleaning, sterilization and disinfection replace chapter 6 "Cleaning and disinfection" of the previous Instructions for Use for the hyperthermia device HU 35. 1.1.1 Validity of these revised Instructions for Use These revised Instructions for Use for Cleaning, Descaling and Disinfection shall apply until further notice for all instructions for the Heater Unit HU 35.
  • Page 7 Identifies a possible risk to property which can result in equipment damage and/ or data loss. Structure of the other information Information concerning events without personal injury or equipment damage is indicated as follows: NOTE Additional support and other helpful information. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 8 Foram (isoflurane). They can damage the HU 35. WARNING! Do not allow liquid to penetrate the HU 35. WARNING! If the Hansen connectors at the tubes are not connected to any heat exchanger the couplings shall be connected using the cleaning connector. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 9 Disinfect the surfaces after each use. You can use the following disinfectants: Tosylchloramide sodium (Chloramine T) Alcohol (ethanol, isopropyl, 70% by vol.) Bacillol (Bode Chemie) Buraton 10F (Schülke & Mayr) Buraton rapid (Schülke & Mayr) Mikrobac forte (Bode Chemie) PeraSafe (DuPont) Pursept (Merz) Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 10 WARNING! Disinfection and descaling are two separate processes. The processes are no substitute for each other. Do not perform them at the same time. WARNING! When descaling and disinfection have to be performed, perform the descaling before disinfection. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 11 Use personal protection equipment (e.g. gloves resistant to chemicals made of Nitrile rubber or Butyl caoutchouc (butyl rubber), dust mask for respiratory protection P2, goggles and a protective lab coat) according to the Safety Data Sheet for the disinfectant/descaling agent. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 12 2% Chloramine-T in the water system of the HU 35. WARNING! If the HU 35 is out of use, empty it, remove the cap of the water filler neck and store the HU 35 in a dry place. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 13 ). Do not use deionized water. WARNING! De-air the system to achieve an even distribution of the disinfectant/descaling agent in the water system. WARNING! After the descaling/disinfection procedure, rinse the device 3 times to remove residual descaling agent/disinfectant. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 14 | 14 | 3 Descaling and disinfection of the water circuit | HU 35 | WARNING! If the Hansen connectors at the tubes are not connected to any heat exchanger the couplings shall be connected using the cleaning connector. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 15 Tip the HU 35 backwards to an angle of 45°. Do not lose the sealing rings of the two caps. 10 Tip the HU 35 further back to an angle of 90° to completely empty the HU 35 unit. 11 Close the outflow point ([1]).
  • Page 16 | 16 | 3 Descaling and disinfection of the water circuit | HU 35 | 3.1.2 Descaling of the HU 35 WARNING! Use personal protection equipment (e.g. gloves resistant to chemicals made of Nitrile rubber or Butyl caoutchouc (butyl rubber), dust mask for respiratory protection P2, goggles and a protective lab coat) according to the Safety Data Sheet for the disinfectant/descaling agent.
  • Page 17 Descaling of the HU 35 is now complete. ▶ The HU 35 is now empty. 3.1.3 Rinsing the HU 35 Disconnect the cleaning connector and disinfect it and the Hansen couplings. Connect the open hose ends to the cleaning connector supplied. Fill the HU 35 with sterile filtered water up to the maximum mark on the water level indicator.
  • Page 18 | 18 | 3 Descaling and disinfection of the water circuit | HU 35 | 14 Close the cap on the filler neck (e.g., using a coin). ▶ The HU 35 has now been rinsed. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 19 Disconnect the water tubes from the HU 35. Empty the water tubes through the Hansen couplings over an outflow. Put a container under the HU 35 or place the HU 35 over an outflow or other means of drainage. Unscrew the filler neck cap ([3]) (e.g., using a coin).
  • Page 20 | 20 | 3 Descaling and disinfection of the water circuit | HU 35 | 10 Tip the HU 35 further back to an angle of 90° to completely empty the HU 35 unit. 11 Close the outflow point ([1]). 12 Connect the water tubes to the HU 35. ▶ HU 35 is emptied.
  • Page 21 Disinfection of the HU 35 is now complete. ▶ The HU 35 is now empty. 3.2.3 Rinsing the HU 35 Disconnect the cleaning connector and disinfect it and the Hansen couplings. Connect the open hose ends to the cleaning connector supplied. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01...
  • Page 22 13 Fill the HU 35 with sterile filtered water up to the maximum mark on the water level indicator. 14 Close the cap on the filler neck (e.g., using a coin). ▶ The HU 35 has now been rinsed. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 23 Tip the HU 35 backwards to an angle of 45°. Do not lose the sealing rings of the two caps. 10 Tip the HU 35 further back to an angle of 90° to completely empty the HU 35 unit. 11 Close the outflow point ([1]).
  • Page 24 | 24 | 3 Descaling and disinfection of the water circuit | HU 35 | ▶ HU 35 is emptied. 3.3.2 High Level Disinfection of the HU 35 WARNING! Use personal protection equipment (e.g. gloves resistant to chemicals made of Nitrile rubber or Butyl caoutchouc (butyl rubber), dust mask for respiratory protection P2, goggles and a protective lab coat) according to the Safety Data Sheet for the disinfectant/descaling agent.
  • Page 25 Highly effective disinfection of the HU 35 is now complete. ▶ The HU 35 is now empty. 3.3.3 Rinsing the HU 35 Disconnect the cleaning connector and disinfect it and the Hansen couplings. Connect the open hose ends to the cleaning connector supplied.
  • Page 26 13 Fill the HU 35 with sterile filtered water up to the maximum mark on the water level indicator. 14 Close the cap on the filler neck (e.g., using a coin). ▶ The HU 35 has now been rinsed. Revised Instructions for Use ­ Cleaning, Descaling, Disinfection | 1.0 | XX | 01 Copyright Maquet Cardiopulmonary GmbH...
  • Page 27 We operate under the three Phone: +49 7222 932-0 brands of ArjoHuntleigh, GETINGE and MAQUET. ArjoHuntleigh focuses on patient mobility and wound management solutions. Fax: +49 7222 932-1888 GETINGE provides solutions for infection control within healthcare info.cp@maquet.com...

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