Maquet HCU 40 Manuel utilisateur

INSTRUCTIONS FOR USE

HEATERCOOLER UNIT

HCU 40

11/4/2016

Validity of this document

Revision 1.0, issue date 2016-11

This document applies to the device HCU40 with software

release 1.2.1.0 or higher.

Documents for lower software releases do not apply to the

device HCU40 with software release 1.2.1.0 or higher.

duplicated, adapted or translated without prior written

permission, except under the terms of the copyright laws.

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: +49 7222 932-0

Fax: +49 7222 932-1888

[email protected]

www.maquet.com

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Contents

1 General .......................................................................................................................8

1.1 Information on these Instructions for Use .........................................................8

1.1.1 Symbols................................................................................................8

1.1.2 Definitions.............................................................................................8

1.2 Environmental Protection..................................................................................9

1.2.1 Packaging.............................................................................................9

1.2.2 Batteries ...............................................................................................9

1.2.3 Disposal................................................................................................9

1.3 Abbreviations ....................................................................................................9

2 Safety ..........................................................................................................................11

2.1 Intended Use.....................................................................................................11

2.1.1 Indications ............................................................................................11

2.1.2 Intended Use ........................................................................................11

2.1.3 Intended User .......................................................................................11

2.1.4 Intended Patient ...................................................................................12

2.1.5 Intended Environment ..........................................................................12

2.1.6 Contraindications..................................................................................12

2.2 General Safety Instructions...............................................................................12

2.2.1 Precautionary Measures.......................................................................12

2.2.2 Position of Use and Operation and Positioning of the HCU 40 ............13

2.2.3 Handling the HCU40............................................................................14

2.2.4 Water Circuits and Heat Exchangers ...................................................14

2.2.5 Monitoring and Sensors........................................................................16

2.2.6 Extended Applications ..........................................................................16

2.2.7 Electromagnetic Compatibility ..............................................................17

2.3 Symbols ............................................................................................................17

2.4 Rating Plates.....................................................................................................20

3 System Description .....................................................................................................21

3.1 How the HCU 40 Functions ..............................................................................21

3.2 System Overview ..............................................................................................22

3.3 Water Circuit Controls.......................................................................................23

3.4 Controls for Electrical Connections...................................................................23

3.4.1 Status of the On/Off switch...................................................................23

3.5 Control Unit CU.................................................................................................24

3.5.1 Rotary Knob with Button Function ........................................................24

3.5.2 Touchscreen.........................................................................................24

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3.6 Touchscreen, Display Areas.............................................................................24

3.6.1 Status Bar.............................................................................................25

3.6.2 Toolbar .................................................................................................26

3.6.3 "Warming" and "Cooling" Hotkeys ........................................................26

3.6.4 Parameter Display ................................................................................27

3.6.5 Pump Control........................................................................................28

3.7 Main Screen......................................................................................................28

3.8 Functions ..........................................................................................................29

3.8.1 De-airing the Circuits ............................................................................30

3.8.2 Emptying Tubes....................................................................................31

3.8.3 Compressor Control .............................................................................31

3.9 Settings.............................................................................................................32

3.9.1 System Settings....................................................................................33

3.10 Pausing the Current Alarm................................................................................34

3.11 Basic Handling Information for Software...........................................................34

3.11.1 Confirming or Rejecting Inputs/Changes..............................................34

3.11.2 Switching Functions On and Off ...........................................................35

3.11.3 Changing Numerical Settings ...............................................................35

3.11.4 Using a Selection List ...........................................................................36

3.11.5 Using a Wizard .....................................................................................36

3.11.6 Locked Controls....................................................................................36

4 Operation ....................................................................................................................38

4.1 Positioning and Connecting the Device ............................................................38

4.1.1 Setting up and Connecting the HCU 40 ...............................................38

4.1.2 Connecting a Control Unit ....................................................................39

4.1.3 Connecting External Devices (Optional)...............................................39

4.1.4 Connecting External Temperature Sensors (Optional).........................39

4.1.5 Securing Set of Slide Rails for Tubing Holder (Optional) .....................40

4.1.6 Opening/Closing Stopcocks .................................................................40

4.1.7 Filling/Topping Up Water ......................................................................41

4.1.8 Connecting/Removing Water Tubes.....................................................42

4.2 Using the System..............................................................................................43

4.2.1 Switching On the HCU 40, Self-Test ....................................................43

4.2.2 Setting and Changing Setpoint Temperatures .....................................45

4.2.3 Starting/Stopping Circulation ................................................................46

4.2.4 Using Hotkeys ......................................................................................47

4.2.5 Setting the Warning Limits for the External Temperature.....................48

4.2.6 Gradient Mode......................................................................................49

4.3 Water Circuits ...................................................................................................52

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4.3.1 Creating a Water Circuit .......................................................................52

4.3.2 Connecting a Heat Exchanger..............................................................52

4.3.3 De-airing the Circuits ............................................................................56

4.3.4 Emptying Water Circuits .......................................................................58

4.4 System Configuration........................................................................................59

4.4.1 Changing the Hotkey Settings ..............................................................59

4.4.2 Changing the Setpoint Ice Block Size ..................................................61

4.4.3 Changing the Water Flow .....................................................................62

4.4.4 Changing the Settings for Locking the Controls ...................................62

4.4.5 Changing the Brightness/Volume .........................................................63

4.4.6 Changing the Time, Date and Formats ................................................63

4.4.7 Changing the Display Language ..........................................................65

4.5 System Information...........................................................................................66

4.5.1 Displaying the Tank Status...................................................................66

4.5.2 Displaying the Ice Block Size ...............................................................67

4.5.3 Displaying the Pressure Limits .............................................................68

4.5.4 Testing the Functioning of the Speaker and Warning Buzzer ..............68

4.5.5 Testing Alarm Functions.......................................................................69

4.5.6 Cleaning/Emptying System Status .......................................................69

4.5.7 Displaying the Power Supply Status.....................................................70

4.5.8 Displaying System Information .............................................................70

4.6 Putting into Operation .......................................................................................71

4.6.1 Before First Use....................................................................................71

4.6.2 Check Before Every Application ...........................................................72

4.6.3 During the Application ..........................................................................73

4.6.4 On Completion of the Application .........................................................73

4.7 Emergency Procedures ....................................................................................74

4.7.1 De-airing in an Emergency During Perfusion .......................................74

4.8 Key User Functions...........................................................................................75

4.8.1 Calling Up the "Service" Screen ...........................................................76

5 Troubleshooting ..........................................................................................................78

5.1 Causes of Faults and Measures to Take ..........................................................78

6 Messages....................................................................................................................81

6.1 Alarms...............................................................................................................81

6.1.1 Duration and Intervals for Acoustic Alarms ..........................................81

6.2 Alarm List ..........................................................................................................81

6.3 Physiological Alarms.........................................................................................82

6.3.1 Medium Priority.....................................................................................82

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6.4 Technical Alarms ..............................................................................................82

6.4.1 High Priority ..........................................................................................83

6.4.2 Medium Priority.....................................................................................84

6.4.3 Low Priority...........................................................................................87

6.5 Messages..........................................................................................................90

7 Cleaning, descaling and disinfection...........................................................................91

7.1 Surface Cleaning and Disinfecting the Device after Each Use.........................91

7.2 Descaling and disinfection of the water circuits ................................................92

7.2.1 Performing Descaling ...........................................................................95

7.2.2 Performing weekly routine disinfection .................................................105

7.2.3 Performing highly effective disinfection and biofilm removal ................115

7.2.4 Emptying the Tank................................................................................125

7.3 Cleaning the Air Filter .......................................................................................127

8 Maintenance................................................................................................................128

8.1 Maintenance by the Operator ...........................................................................128

8.1.1 Daily Inspection by the Operator ..........................................................128

8.1.2 Perform Diagnosis ................................................................................129

8.2 Inspection and Maintenance by Authorized Service Personnel........................130

8.2.1 Inspection .............................................................................................131

8.2.2 Maintenance .........................................................................................131

8.3 Repair ...............................................................................................................131

8.3.1 Send Device to Authorized Service Point.............................................131

8.4 Authorized Service............................................................................................131

9 Initial Installation..........................................................................................................132

10 Accessories.................................................................................................................133

11 Technical Data ............................................................................................................135

11.1 HCU 40 Device .................................................................................................135

11.2 Control Unit CU.................................................................................................136

11.3 Permissible Heat Exchangers...........................................................................136

11.3.1 Oxygenator and Cardioplegia Heat Exchangers ..................................136

11.3.2 Blanket Connection Kit (incl. Pressure Reducer) .................................137

11.4 Components Supplied.......................................................................................137

11.5 Ambient Conditions...........................................................................................137

11.6 Measured Data and Displayed Data.................................................................138

11.7 Possible Settings and Factory Settings ............................................................138

11.7.1 Temperatures and Water Flows ...........................................................138

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11.7.2 Accuracy of the Temperature Control...................................................139

11.7.3 Hotkeys.................................................................................................139

11.8 Availability of Physiological Alarms for External Devices..................................140

11.9 Essential Performance Characteristics.............................................................140

11.10 Solution Concentration with Different Tube Lengths.........................................141

11.10.12 per cent citric acid concentration for descaling various tube lengths

141

11.10.22 per cent Chloramine-T concentration for weekly routine disinfection

of various tube lengths .........................................................................141

11.10.35 per cent Chloramine-T concentration for highly effective

disinfection and biofilm removal of various tube lengths ......................142

12 Applied Standards.......................................................................................................143

12.1 Electromagnetic Compatibility (EMC) ...............................................................143

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1 General

1.1 Information on these Instructions for Use

These Instructions for Use will familiarize you with the features of the Maquet

device.

1.1.1 Symbols

References

References to other pages in these Instructions for Use begin with the arrow sign

"⇨".

Action and reaction

The user's actions are identified with numbered paragraphs "1", while the "▶"

symbol identifies the reaction triggered in the system.

Example:

nSwitch the light switch on.

Buttons and menus

The buttons and menus are shown in square brackets.

Example:

nPress the [DOWN] button in the [Operation] menu.

1.1.2 Definitions

DANGER!

Identifies an immediate, serious risk to people which will result in death or

serious injury.

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.

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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.

1.2 Environmental Protection

1.2.1 Packaging

All packaging materials are made of environmentally safe materials. On request,

Maquet will be happy to dispose of the packaging materials.

1.2.2 Batteries

Batteries can be disposed of via the local recycling center.

1.2.3 Disposal

To ensure optimal utilization of the raw materials, the device as well as the

components and accessories must not be disposed of with normal domestic

waste. Keep separate from domestic waste and dispose of in an environmentally

safe way in compliance with local regulations.

nBefore disposal, decontaminate all parts in accordance with the procedures

applicable in clinical practice.

nIn order to prevent risks during disposal, contact the authorized service

personnel.

1.3 Abbreviations

Abbreviation Meaning

CAN ControllerAreaNetwork

CPLG Cardioplegia

CU Controlunit

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InstructionsforUse|1.0|EN|01

HCU Heatercoolerunit

Text Temperaturemeasuredattheexternalsensor

Tout Temperaturemeasuredatthewateroutlet

Tset Setpointtemperature

Ttank Temperaturemeasuredinthetank

USB Universalserialbus

ΔT Setpointgradient

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