Maquet HU 35 User manual

REVISED INSTRUCTIONS FOR USE
CLEANING, DESCALING, DISINFECTION
HEATER UNIT
HU 35
11/11/2016

Copyright
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.
Manufacturer
Maquet Cardiopulmonary GmbH
Kehler Straße 31
76437 Rastatt
GERMANY
Phone: [phone]
Fax: [phone]
[email protected]
www.maquet.com

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Table of Contents
English 1 General | 6
2 Surface Cleaning and Disinfecting the Device
after Each Use | 8
3 Descaling and disinfection of the water circuit | 10
Deutsch 1 Allgemeines | 27
2 Oberflächenreinigung und Desinfektion des
Geräts nach jedem Gebrauch | 29
3 Entkalkung und Desinfektion des
Wasserkreislaufs | 31
Français 1 Généralités | 48
2 Nettoyage des surfaces et désinfection de
l'appareil après chaque emploi | 50
3 Détartrage et désinfection du circuit d'eau | 52
Italiano 1 Informazioni generali | 69
2 Pulizia e disinfezione delle superfici
dell’apparecchio dopo ogni uso | 71
3 Decalcificazione e disinfezione del circuito
dell'acqua | 73
Español 1 Aspectos generales | 90
2 Limpieza de superficies y desinfección del
aparato después de cada uso | 92
3 Descalcificación y desinfección del circuito de
agua | 94
Português 1 Generalidades | 111
2 Limpeza de superfícies e desinfeção do
aparelho após cada utilização | 113
3 Descalcificação e desinfeção do circuito de
água | 115
Polski 1 Informacje ogólne | 132
2 Czyszczenie powierzchni i dezynfekcja
urządzenia po każdorazowym użyciu | 134
3 Odkamienianie i dezynfekcja obiegu wodnego | 136
Čeština 1 Všeobecné informace | 153

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2 Čištění povrchů a dezinfekce jednotky po
každém použití | 155
3 Odvápňování a dezinfekce oběhu vody | 157
Nederlands 1 Algemeen | 174
2 Oppervlaktereiniging en desinfectie van het
apparaat na elk gebruik | 176
3 Ontkalking en desinfectie van de
watercirculatie | 178
Dansk 1 Generelt | 195
2 Overfladerengøring og desinfektion af
apparatet efter hver brug | 197
3 Afkalkning og desinfektion af vandkredsløbet | 199
Svenska 1 Allmänt | 216
2 Ytrengöring och desinficering av apparaten
efter varje användning | 218
3 Avkalkning och desinficering av
vattencirkulationen | 220
Norsk 1 Generelt | 237
2 Overflaterengjøring og desinfeksjon av
apparatet etter hver gangs bruk | 239
3 Avkalkning og desinfeksjon av vannkretsløpet | 241
Pусский 1 Общие сведения | 256
2 Очистка поверхностей и дезинфекция
аппарата после каждого применения | 258
3 Удаление накипи из водяного контура и его
дезинфекция | 260
Türkçe 1 Genel | 277
2 Her kullanımdan sonra cihazın yüzey temizliği
ve dezenfeksiyonu | 279
3 Su devresinin kirecinin giderilmesi ve
dezenfekte edilmesi | 281
Suomi 1 Yleistä tietoa | 298
2 Laitteen pintapuhdistus ja desinfiointi jokaisen
käyttökerran jälkeen | 300
3 Vedenkierron kalkinpoisto ja desinfiointi | 302
Chinese (simplified) 1 概述 | 319

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2 每次使用设备后进行表面清洁和消毒 | 321
3 水路的除垢和消毒 | 323

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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.
1.1.2 Symbols
References
References to other pages in these Instructions for Use begin with the arrow sign
"⇨".
Action and reaction
The operator's actions are identified with numbered paragraphs "1", while the "▶"
symbol identifies the reaction triggered in the system.
Example:
1 Switch the light switch on.
▶The lamp lights up.
2 Switch the light switch off.
Buttons and menus
The buttons and menus are shown in square brackets.
Example:
nPress the [DOWN] button in the [Operation] menu.
1.1.3 Definitions
DANGER!
Identifies an immediate, serious risk to people which will result in death or
serious injury.
EN

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WARNING!
Identifies a general, serious risk to people which can result in death or serious
injury.
CAUTION!
Identifies a possible risk which can result in injury.
NOTICE!
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.
EN

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2 Surface Cleaning and Disinfecting the Device after Each
Use
WARNING!
Only use specified liquids and substances with the HU35.
WARNING!
When cleaning the surfaces of the HU35 the safety instructions from the
cleaning agent manufacturer must be observed.
WARNING!
Pay attention to hand hygiene and protective barriers by routine hand washing
and using disposable gloves.
WARNING!
For surface cleaning of the HU35 housing use a damp cloth.
WARNING!
For surface cleaning of the HU35 use disinfectants based on aldehydes,
amonium components or alcohol only. Avoid the use of phenol derivates.
WARNING!
Switch the HU35 off and unplug the HU35 from the external power supply
before surface cleaning.
WARNING!
Do not use chemical solvents such as ether or acetone and do not spill
anesthetics such as 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.
EN

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Surface cleaning
1 Use a cloth moistened with an aqueous alcohol solution (70% ethanol/30%
water) or a suitable cleaning solution for sensitive medical devices.
2 Clean the device and cables after each use to remove soiling and residual
blood.
Surface disinfection
Disinfect the surfaces after each use. You can use the following disinfectants:
nTosylchloramide sodium (Chloramine T)
nAlcohol (ethanol, isopropyl, 70% by vol.)
nBacillol (Bode Chemie)
nBuraton 10F (Schülke & Mayr)
nBuraton rapid (Schülke & Mayr)
nMikrobac forte (Bode Chemie)
nPeraSafe (DuPont)
nPursept (Merz)
EN

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3 Descaling and disinfection of the water circuit
The water circuit of the HU35 comprises a pump, water tank, couplings and all
tubing for the HU35.
The quick reference guide for routine disinfection does not replace hygiene
monitoring. It may be necessary to shorten the interval.
Depending on how contaminated the HU35 is and the hygienic situation in the
hospital, the necessary water quality may not be achieved after routine
disinfection, and disinfection must therefore be repeated. If there are atypical
mycobacteria in the water system, highly effective disinfection must be performed.
Equipment for descaling/disinfection
The following equipment is required for descaling/disinfection:
nSterile inline filter with a pore size of 0.2µm
nPersonal protective clothing (as specified on the safety data sheet for the
descaling/disinfection agent)
– Chemical-resistant gloves made of nitrile or butyl rubber
– Dust mask for P2 respiratory protection
– Protective goggles
– Laboratory coat
The following equipment is additionally required:
nCanister (chemical-resistant, for example made of polypropylene) with a
capacity of at least 10l.
nMeasuring spoon (chemical-resistant)
nPowder funnel (chemical-resistant) for approx. 100ml
nScales for weighing the descaling/disinfection agent
nBeaker (chemical-resistant) for approx. 3l
nSmall flat tray (chemical-resistant) for the disinfection of cleaning connectors,
approx 190x 120x 40mm (LxWxH) in size
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.
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WARNING!
Only use specified agents for descaling/disinfection.
WARNING!
In order to disinfect the HU35 water circuit use the approved disinfectant Clorina
(active agent: tosylchloramide sodium, known as Chloramine-T) or another
chemically identical disinfectant.
WARNING!
The disinfectant Clorina has been tested for use with the HU35. Other
disinfectants may influence the material compatibility. Use of any other, not
chemically identical disinfectants is explicitly not allowed.
WARNING!
Thoroughly follow the manufacturer's safety instructions for the disinfectant/
descaling agent during the disinfection/descaling of the HU35.
WARNING!
Check the water level in the HU35 water tank. If the water level is too low, fill up
the tank to the maximum mark of the water level display.
WARNING!
Provide adequate ventilation for the disinfection process. Avoid generation of
dust from the disinfectant. Do not breathe in dust from the disinfectant. Avoid
contact of the disinfectant with skin, eyes and clothes.
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.
EN
*
*

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WARNING!
The system must be checked before descaling/disinfection starts:
ndevice self test ok
nno leakage in water line or leakage of the device
nwater flow ok
nwater level in tank ok.
WARNING!
All connected parts, devices, and modules must be firmly and correctly
connected. Check the mechanical stability.
WARNING!
Do not kink the tubes. Do not touch the tubes with pointed or sharp objects.
WARNING!
The disinfectant/descaling agent must only be used pre- and postoperatively,
never intraoperatively.
WARNING!
During the disinfection/descaling procedure of the HU35 the heat exchanger
must be replaced by a cleaning connector. The disinfectant/descaling agent
could damage or contaminate the heat exchanger.
WARNING!
Perform the descaling process every 6 months with a concentration of 2% citric
acid in the water system of the HU35.
WARNING!
If the HU35 is used regularly, disinfection must be performed every 7days as
well as after each use with 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.
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WARNING!
If atypical
Mycobacteria are present in the water system, perform the high level
disinfection process with a concentration of 5% Chloramine-T in the water
system of the HU35.
WARNING!
For an effective descaling/disinfection, the required amount of descaling agent/
disinfectant has to be determined depending on the tubing lengths connected to
the HU35.
WARNING!
The results of hygienic vigilance microbiological monitoring shall be used to
determine the appropriate disinfection concentration required for each HU35.
WARNING!
The re-commissioning of the device shall only be performed by accompanied
regular hygienic monitoring.
WARNING!
Use a sterile inline-filter with 0.2 μm porosity for filling the HU35 with water.
WARNING!
The HU35 tank shall be filled with soft sterile filtered water. Do not use
deionized water.
WARNING!
The HU35 tank shall be filled with sterile filtered water with a water hardness of
≤ 14 °dH (2.5 mmol/l CaCO3). 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.
EN

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WARNING!
If the Hansen connectors at the tubes are not connected to any heat exchanger
the couplings shall be connected using the cleaning connector.
EN

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3.1 Descaling Process for HU 35
The descaling process is performed every 6 months with a concentration of 2%
citric acid in the complete water volume of the HU35.
Perform the following steps for descaling the system:
nEmptying the HU35.
nDescaling of the HU35.
nRinsing the HU35.
3.1.1 Emptying the HU 35
1 Switch the device off.
2 Disconnect the device from the power supply.
3 Disconnect the heat exchanger connected to the water circuit.
4 Disconnect the water tubes from the HU 35.
5 Empty the water tubes through the Hansen couplings over an outflow.
6 Put a container under the HU 35 or place the HU 35 over an outflow or other
means of drainage.
7 Unscrew the filler neck cap ([3]) (e.g.,
using a coin).
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5
6
8
8 Unscrew the cap of the outflow point ([1]) to drain the water.
9 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]).
12 Connect the water tubes to the HU 35.
▶HU 35 is emptied.
EN

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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.
1 Connect the open hose ends to the cleaning connector supplied.
2 Produce a citric acid solution:
When connecting hoses measuring 2x 1.5m to the HU35: Use a powder
funnel to put 30g of citric acid into a chemical-resistant 10liter canister with
watertight lid. Add 1.5liters of sterile, filtered, warm water (approx. +35°C).
Close the canister, check that it is leak-tight and dissolve the citric acid by
shaking.
Or
When connecting hoses measuring 2x 3m to the HU35: Use a powder
funnel to put 34g of citric acid into a chemical-resistant 10liter canister with
watertight lid. Add 1.7liters of sterile, filtered, warm water (approx. +35°C).
Close the canister, check that it is leak-tight and dissolve the citric acid by
shaking.
3 Fill the citric acid solution up to the maximum mark on the tank's water level
indicator.
4 Close the cap on the filler neck ([3])
(e.g., using a coin).
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5
6
8
5 Connect the device to the power supply.
6 Switch on the device.
7 Run the HU35 for approx. 20minutes.
EN

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▶The hoses are filled with citric acid solution.
8 When connecting hoses measuring 2x 3m to the HU35:
Switch off the device.
Unscrew the cap on the filler neck ([3]) (e.g., using a coin).
Fill the device with the remaining citric acid solution up to the maximum mark
on the water level indicator.
Close the cap on the filler neck ([3]) (e.g., using a coin).
Switch on the device.
9 Set the setpoint temperature to +38°C.
10 Run the HU35 for 60minutes.
11 Switch off the device.
12 Disconnect the device from the mains.
13 Empty the HU35.
NOTE
Use a suitable drain for disposing of the disinfection/descaling agent solutions.
▶Descaling of the HU35 is now complete.
▶The HU35 is now empty.
3.1.3 Rinsing the HU 35
1 Disconnect the cleaning connector and disinfect it and the Hansen couplings.
2 Connect the open hose ends to the cleaning connector supplied.
3 Fill the HU35 with sterile filtered water up to the maximum mark on the water
level indicator.
4 Connect the device to the power supply.
5 Close the cap on the filler neck (e.g., using a coin).
6 Switch on the device.
7 Set the setpoint temperature to +37°C.
8 Run the HU35 for 3minutes.
9 Switch off the device.
10 Disconnect the device from the mains.
11 Empty the HU35.
NOTE
Use a suitable drain for disposing of the disinfection/descaling agent solutions.
12 Repeat the rinsed steps outlined above twice so that the HU35 is rinsed a
total of three times.
13 Fill the HU35 with sterile filtered water up to the maximum mark on the water
level indicator.
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14 Close the cap on the filler neck (e.g., using a coin).
▶The HU35 has now been rinsed.
EN

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3.2 Disinfection Process for HU 35
If the HU35 is used regularly, disinfection must be performed every 7days as
well as after each use with 2% Chloramine-T in the water system of the HU35.
Perform the following steps for disinfection:
nEmpty the HU35.
nDisinfect the HU35.
nRinse of the HU35
If there are atypical
mycobacteria in the water system, a 5% Chloramine-T
concentration must be used in the entire water volume of the HU35. Special,
highly effective disinfection and biofilm removal with 5% Chloramine-T are
described under ⇨ "High Level Disinfection and Biofilm Removal Process for HU
35", page 23.
3.2.1 Emptying the HU 35
1 Switch the device off.
2 Disconnect the device from the power supply.
3 Disconnect the heat exchanger connected to the water circuit.
4 Disconnect the water tubes from the HU 35.
5 Empty the water tubes through the Hansen couplings over an outflow.
6 Put a container under the HU 35 or place the HU 35 over an outflow or other
means of drainage.
7 Unscrew the filler neck cap ([3]) (e.g.,
using a coin).
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5
6
8
8 Unscrew the cap of the outflow point ([1]) to drain the water.
9 Tip the HU 35 backwards to an angle of 45°. Do not lose the sealing rings of
the two caps.
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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.
3.2.2 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.
1 Connect the open hose ends to the cleaning connector supplied.
2 Create a Chloramine-T solution.
When connecting hoses measuring 2x 1.5m to the HU35: Use a powder
funnel to put 30g of Chloramine-T into a chemical-resistant 10liter canister
with watertight lid. Add 1.5liters of sterile, filtered, warm water (approx.
+35°C). Close the canister, check that it is leak-tight and dissolve the
Chloramine-T by shaking.
Or
When connecting hoses measuring 2x 3m to the HU35: Use a powder
funnel to put 34g of Chloramine-T into a chemical-resistant 10liter canister
with watertight lid. Add 1.7liters of sterile, filtered, warm water (approx.
+35°C). Close the canister, check that it is leak-tight and dissolve the
Chloramine-T by shaking.
3 Fill the Chloramine-T solution up to the maximum mark on the tank's water
level indicator.
EN