TIM SmartVap D Manuale utente

Instructions for use

SmartVapTM D

SmartVapTM S

SW 1.n

SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 3

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4 SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

Typographic conventions

●

Bullet points indicate lists of options, objects or data.

In safety information and warnings, this arrow indicates ways to avoid the hazard.

►

The triangle indicates the result of an action.

Sequential capital letters (bold) designate a sequence of steps to be taken by the

operator. When a new sequence begins, the lettering starts at A once again.

Lower case letters (bold print) designate illustrations.

(b)

Lower case letters in parentheses in the text refer to illustrations.

Additional information is available.

Numerals (bold print) in illustrations designate elements to which reference is made

in the text.

(1)

Numerals in parentheses in the text refer to elements in a related image.

Text

Text in bold print designates important instructions or information.

Word

Words in bold print within running text describing the graphical user interface are

the names of buttons, menu items, or individual dialogs.

Trademarks

Brand name

Trademark owner

TIMTM

SmartVapTM

Technologie Institut Medizin GmbH (TIM)

Piramal FillTM

Piramal Critical Care

SelectatecTM

General Electric Healthcare

Dräger®

Drägerwerk AG & Co. KGaA

Contents 
SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 5 
Contents 
1Introduction ......................................................................................9
1 Intended purpose ............................................................................................9 
2 Product description .........................................................................................9 
3 Operator and user qualification.......................................................................9 
3.1 Medical personnel..............................................................................9 
3.2 Processing personnel.........................................................................9 
3.3 Maintenance personnel....................................................................10 
4 Contraindications ..........................................................................................10 
5 Place of use ..................................................................................................10 
2Safety ..............................................................................................12 
1 Basic safety information................................................................................12 
1.1 Safe operation..................................................................................12 
1.2 Symbols and product labels.............................................................12 
1.3 Electrical supply ...............................................................................12 
1.4 Integrated emergency power supply................................................13 
1.5 Use of volatile anaesthetics .............................................................14 
1.6 Transportation ..................................................................................14 
1.7 Devices required for using the vaporizer..........................................14 
1.8 Before every use..............................................................................15 
1.9 Device malfunctions during use .......................................................16 
1.10 Monitoring the patient.......................................................................16 
1.11 Alarms ..............................................................................................16 
1.12 Mechanical lock................................................................................17 
1.13 Modifications ....................................................................................17 
1.14 Accessories......................................................................................17 
1.15 Electromagnetic compatibility (EMC) ...............................................17 
1.16 USB interface ...................................................................................18 
1.17 Infection risk .....................................................................................19 
1.18 Maintenance.....................................................................................19 
3 Safety functions.............................................................................................20 
4 Warnings in these instructions for use..........................................................21 
3Description......................................................................................22 
1 General information.......................................................................................22 
2 Front view......................................................................................................23 
3 SmartVap D - Connection and interlock system...........................................24 

Contents 
SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 
4 SmartVap S - Connection and interlock system...........................................25 
5 Screen layout................................................................................................26 
5.1 Screen during the device test ..........................................................26 
5.2 Operating screen..............................................................................27 
5.3 Screen in Menu mode......................................................................28 
6 Symbols and labels.......................................................................................29 
6.1 Equipment and packaging ...............................................................29 
6.2Symbols on the screen ....................................................................33 
7 Functional description...................................................................................39 
4Operating concept.........................................................................41 
1 Controls.........................................................................................................41 
2 Setting the dispensing quantity.....................................................................42 
2.1 Changing the value..........................................................................42 
2.2 Confirming the changed value.........................................................43 
3 Changing parameters ...................................................................................44 
3.1 Changing a value or an entry...........................................................44 
3.2 Confirming a value or entry..............................................................45 
4 Starting a function.........................................................................................46 
5Operation........................................................................................47 
1 Before first use..............................................................................................47 
2 Connecting to the mains power supply.........................................................47 
3 Connecting to an anaesthesia workstation...................................................48 
4 Switch-on and device test.............................................................................50 
5 Filling.............................................................................................................52 
6 Starting dispensing .......................................................................................55 
7 Dispensing quantity greater than 12 Vol % ..................................................56 
8 Endingdispensing..........................................................................................58 
9 Standby mode...............................................................................................59 
9.1 Opening Standby dialog...................................................................59 
9.2 Switching to Standby mode .............................................................60 
9.3 Ending Standby mode......................................................................61 
10 Removing the vaporizer from an anaesthesia workstation...........................61 
6Alarms ............................................................................................ 62 
1 General information ......................................................................................62 

Contents 
SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 7 
2 Pausing the acoustic alarm...........................................................................64 
3 Technical fault...............................................................................................65 
7Menu mode .....................................................................................67 
1 Overview .......................................................................................................67 
2 Starting and ending Menu mode...................................................................68 
3 Resetting and downloading use case data ...................................................70 
4 Device information and settings menu..........................................................72 
4.1 Opening the menu............................................................................72 
4.2 Overview of options..........................................................................72 
4.3 Viewing device information ..............................................................73 
4.4 Changing the screen language ........................................................74 
4.5 Changing the alarm volume .............................................................75 
4.6 Changing the brightness ..................................................................76 
4.7Displaying additional information .....................................................77 
4.8 Downloading the event log data.......................................................78 
5 Expanded device information and settings menu.........................................80 
5.1 Opening the menu............................................................................80 
5.2 Overview of options..........................................................................81 
5.3 Setting the minimum alarm volume..................................................82 
5.4 Setting the date................................................................................83 
5.5 Setting the time ................................................................................84 
5.6 Perform a software update...............................................................85 
5.7 Viewing battery information..............................................................87 
5.8 Viewing operating hours...................................................................88 
5.9 Resetting and downloading consumption data ................................89 
5.10 Resetting the safety check interval ..................................................91 
8Alarm messages, notifications and malfunctions.......................92 
1 Alarm messages ...........................................................................................92 
2 Status and error messages during the device test .......................................97 
3 Messages on the operating screen.............................................................100 
4 Messages in dialogs....................................................................................101 
5 Malfunctions................................................................................................102 
9Cleaning........................................................................................103 
Emptying the vaporizer................................................................106 

Contents 
SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 
Service.......................................................................................... 109 
1 Definition of terms.......................................................................................109 
2 Maintenance ...............................................................................................109 
2.1 Safety information..........................................................................109 
2.2 Schedule........................................................................................110 
2.3 Safety check...................................................................................111 
2.4 Software update.............................................................................112 
2.5 Replacing the emergency battery..................................................113 
2.6 Further maintenance work .............................................................114 
3 Repairs........................................................................................................114 
Shipping a vaporizer ...................................................................115 
Disposal........................................................................................ 116 
1 Disposing of the vaporizer ..........................................................................116 
2 Disposing of the emergency battery...........................................................116 
Accessories and spare parts...................................................... 117 
Technical data..............................................................................118 
1 General specifications ................................................................................118 
2 Values and value ranges ............................................................................121 
3 Device settings............................................................................................123 
4 Outer materials used ..................................................................................123 
Terms and abbreviations ............................................................124 
PIN information............................................................................ 125 
 
 
 
 
 

1 Introduction

SmartVap Vaporizer SW 1.n, Instructions for use (en-US) 9

1 Introduction

1.1 Intended purpose

SmartVap is a heated, calibrated anaesthetic vaporizer for the enrichment of dry, medicinal

fresh gases from an anaesthesia workstation with the vapor of the anaesthetic agent Des-

flurane, in a concentration range of 2 to 18 Vol %.

1.2 Product description

SmartVap is an electronic vaporizer for Desflurane for integration in an anaesthesia work-

station in accordance with ISO 80601-2-13. The vaporizer is equipped with integrated flow-

rate measurement of the fresh gas flow, and a dosing unit for enriching the fresh gas with

Desflurane vapor according to the set concentration.

The fresh gas from the anaesthesia workstation can be enriched with gaseous Desflurane

in concentrations of 2 to 18 Vol %, at gas flows of 0.2 to 15 liters/minute.

1.3 Operator and user qualification

1.3.1 Medical personnel

The vaporizer may only be operated by trained medical personnel under the supervision of

a physician.

Training is conducted by a medical device consultant contracted by the manufacturer.

For later use, instruction videos can be viewed on the manufacturer’s website.

1.3.2 Processing personnel

Hygienic processing of the vaporizer must always be performed by personnel with exper-

tise in the processing of medical devices.

1 Introduction

10 SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

1.3.3 Maintenance personnel

Basic maintenance work must always be performed by personnel with electrical/electronic

and mechanical expertise, as well as experience in the maintenance of medical devices.

1.4 Contraindications

Do not use the vaporizer on patients for whom volatile anaesthetics are contraindicated.

For contraindications of Desflurane, follow the medication’s accompanying documents.

1.5 Place of use

The vaporizer is intended for stationary use in hospitals and rooms used for medical pur-

poses.

WARNING Risk of fire

Only operate the vaporizer in areas with an oxygen concentra-

tion of < 25 Vol %.

Do not operate the vaporizer in areas where combustible or

explosive gas mixtures could arise.

Do not operate the vaporizer in the presence of flammable an-

aesthetics.

WARNING Risk to patient from device malfunctions caused by interference

with other electronic medical devices

Do not use the vaporizer in the physical vicinity of an MRI unit.

Do not use the vaporizer in hyperbaric chambers.

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