1. Manuals
  2. Brands
  3. TIM Manuals
  4. Vaporizers
  5. SmartVap D
  6. Instructions for use manual

TIM SmartVap D Instructions For Use Manual

Hide thumbs
Table of Contents

Advertisement

Quick Links

Download this manual
Instructions for use
TM
SmartVap
D
TM
SmartVap
S
SW 1.n

Advertisement

Table of Contents
loading
Need help?

Need help?

Do you have a question about the SmartVap D and is the answer not in the manual?

Questions and answers

Subscribe to Our Youtube Channel

Summary of Contents for TIM SmartVap D

  • Page 1 Instructions for use SmartVap SmartVap SW 1.n...
  • Page 3 Page intentionally left blank. SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 4 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 Technologie Institut Medizin GmbH (TIM) SmartVap Piramal Fill Piramal Critical Care Selectatec General Electric Healthcare Dräger®...

  • Page 5: Table Of Contents

    Safety functions ..................... 20 Warnings in these instructions for use ............21 Description ..................22 General information ..................22 Front view ...................... 23 SmartVap D - Connection and interlock system ........... 24 SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 6 0 Contents SmartVap S - Connection and interlock system ........... 25 Screen layout ....................26 3.5.1 Screen during the device test ............26 3.5.2 Operating screen................27 3.5.3 Screen in Menu mode ..............28 Symbols and labels ..................29 3.6.1 Equipment and packaging ...............
  • Page 7 0 Contents Pausing the acoustic alarm ................64 Technical fault ....................65 Menu mode ..................67 Overview ....................... 67 Starting and ending Menu mode ..............68 Resetting and downloading use case data ........... 70 Device information and settings menu ............72 7.4.1 Opening the menu ................
  • Page 8 0 Contents Service ..................109 11.1 Definition of terms ..................109 11.2 Maintenance ....................109 11.2.1 Safety information ................109 11.2.2 Schedule ..................110 11.2.3 Safety check ................... 111 11.2.4 Software update ................112 11.2.5 Replacing the emergency battery ..........113 11.2.6 Further maintenance work .............

  • Page 9: Introduction

    1 Introduction Introduction 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 %. Product description SmartVap is an electronic vaporizer for Desflurane for integration in an anaesthesia work- station in accordance with ISO 80601-2-13.

  • Page 10: Maintenance Personnel

    1 Introduction 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. Contraindications Do not use the vaporizer on patients for whom volatile anaesthetics are contraindicated. For contraindications of Desflurane, follow the medication’s accompanying documents.
  • Page 11 1 Introduction WARNING Risk to patient from device malfunctions resulting from incor- rect ambient conditions Only operate the vaporizer in accordance with the tempera- ture, humidity, and pressure specifications provided (see chapter 15.1). SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 12: Safety

    2 Safety Safety Basic safety information 2.1.1 Safe operation If the vaporizer is not used as described in the instructions for use, this may put the patient and other persons at risk, or may damage the device. The user should become familiarized with these instructions for use before putting the vaporizer into service, and should adhere to the instructions when using the va- porizer.

  • Page 13: Integrated Emergency Power Supply

    2 Safety If the vaporizer is used with a power supply unit that is not specified for operation with the vaporizer, this may pose a risk to the patient due to vaporizer malfunctions. Only use the vaporizer with the power supply unit specified in chapter 14 (Accesso- ries and spare parts).

  • Page 14: Use Of Volatile Anaesthetics

    2 Safety 2.1.5 Use of volatile anaesthetics The handling and use of volatile anaesthetics can pose a risk to the patient and other per- sons. Pay attention to the indications and contraindications specified by the manufacturer of the volatile anaesthetic. Only use the volatile anaesthetic that is intended for the vaporizer.

  • Page 15: Before Every Use

    Please note: The current declaration of compatibility can be downloaded from the web- site of the manufacturer Technologie Institut Medizin GmbH (TIM). If the vaporizer is used together with an anaesthesia workstation that is not connected to an anaesthesia gas scavenging system in accordance with EN ISO 80601-2-13, this may pose a risk to persons.

  • Page 16: Device Malfunctions During Use

    2 Safety 2.1.9 Device malfunctions during use A device malfunction during use may result in an underdosing of volatile anaesthetic and thus pose a risk to the patient. Keep an alternative means of sedation available in case of such a malfunction. 2.1.10 Monitoring the patient Overdosing or underdosing of volatile anaesthetic may result in risk to the patient.

  • Page 17: Mechanical Lock

    2 Safety 2.1.12 Mechanical lock If the mechanical lock of the installed vaporizer is opened and the vaporizer is not removed from the anaesthesia device while the anaesthesia workstation is being used for ventilation of a patient, leakages could result in an oxygen deficiency in the patient and thus place the patient at risk.

  • Page 18: Usb Interface

    2 Safety Electrostatic discharges If protective measures against electrostatic discharges are not used in the following situa- tions, malfunctions may occur, posing a risk to the patient:  When establishing electrical connections with the vaporizer. To avoid malfunctions, observe the following measures and train the personnel involved: Observe the ESD protective measures.

  • Page 19: Infection Risk

    2 Safety 2.1.17 Infection risk To avoid an increased risk of infection for patients and users from a contaminated vapor- izer, the vaporizer must be cleaned. Observe the hygiene regulations of the place of use, including the cleaning intervals and cleaning procedures. Perform cleaning as described in chapter 9.

  • Page 20: Safety Functions

    2 Safety Safety functions The vaporizer is equipped with safety functions that are used to monitor the device status and thus to detect any changes in the parameters. Changes in the parameters may be caused by:  operating errors  device malfunctions ...

  • Page 21: Warnings In These Instructions For Use

    2 Safety Warnings in these instructions for use Warning words highlight safety-relevant information. In the Instructions for use, warning words are used for actions that could lead to the endan- germent of people or damage to the device. A warning contains information about a possible hazard and instructions on how to avoid the hazard.

  • Page 22: Description

    The vaporizer is available in two models. These models differ in how they are connected to an anaesthesia workstation:  SmartVap D Mechanical lock and interlock system, compatible with Dräger anaesthesia work- stations with the Interlock 2 system and the Dräger Plug-in adapter system.

  • Page 23: Front View

    3 Description Front view Cover flap for the fill opening with color coding for the intended volatile anaesthetic Color code for Desflurane Touchscreen with graphical user interface, divided into top bar, main section, and bottom bar Turning knob with illuminated ring for selection, setting and confirmation: ...

  • Page 24: Smartvap D - Connection And Interlock System

    Fig.: Right vaporizer (2) in operation, left vaporizer (3) blocked SmartVap D (3) is blocked from dispensing Desflurane if the interlock slider has been in- serted into the opening on the side of the SmartVap D (3) at the anaesthesia workstation. SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 25: Smartvap S - Connection And Interlock System

    3 Description SmartVap S - Connection and interlock system Locking knob for mechanical locking Interlock pins (Selectatec) Lock pin for mechanical locking USB interface to export consumption data and event log files, and to conduct SW updates Mains power supply connection with cable protection Interlock system function Fig.: Right vaporizer (2) in operation, left vaporizer (3) blocked.

  • Page 26: Screen Layout

    3 Description Screen layout 3.5.1 Screen during the device test Top bar Indicates the section of the device test, or the status during the device test. Main screen Information about the respective section of the device test or the status during the device test, e.g.

  • Page 27: Operating Screen

    3 Description 3.5.2 Operating screen Top bar Combined display area/button: In normal operating status  Display of the currently set dispensing quantity (middle of the scale) and set- ting of the desired dispensing quantity In the event of alarm  Alarm notification and button for pausing the alarm Main screen Combined display area/buttons:...

  • Page 28: Screen In Menu Mode

    3 Description 3.5.3 Screen in Menu mode Examples Top bar Display area or combined display area/button In normal operating status:  Display area with the object of the dialog In the event of alarm:  Alarm notification and button for pausing the alarm Main screen Dialog area with display areas and buttons Depending on the topic of the dialog:...

  • Page 29: Symbols And Labels

    RWTÜV e.V. Authorization Agency for Device Safety, Elevators, and Medical Technology) Medical device Serial number Catalog number Logo of the manufacturer Technologie Institut Medizin GmbH (TIM) Not safe when used in the proximity of magnetic resonance imaging (MRI) SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 30 3 Description Latex-free IP protection class Weight of the mobile medical electrical device WEEE labeling, Directive 2012/19/EC Information about disposal: The device must not be disposed of in regu- lar household waste. USB port (back panel of the vaporizer) Power supply input (back panel of the vaporizer) Lock symbol for the mechanical locking knob Direction of the fresh gas flow in the vaporizer (top of the vaporizer) This side up...
  • Page 31 3 Description Air pressure limit Relative air humidity limit Temperature limit (storage, transportation) Protect from sunlight Protect from moisture Fragile, handle with care Limit value for stacking (2) Transportation label UN 3481. Contains a telephone number to obtain additional information. SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 32 3 Description UDI label A unique device code for identification of medical devices. Example: (01)04260665920754(21)460N00101(11)202008(91)SV-S-P Application identifier (AI) Every UDI number can be divided into multiple parts, and each part is identified by its AI number. (01) Global Trade Item Number (GTIN) (11) Date of manufacture (YYYYMM) (21)

  • Page 33: Symbols On The Screen

    3 Description 3.6.2 Symbols on the screen Top bar Screen during device test The device test is active or a software update is performed. An error has occurred. Something has failed or malfunctioned. Device test successfully completed. In the event of alarm Pausing the acoustic alarm SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 34 3 Description Bottom bar Operating screen Menu mode can be activated Menu mode blocked Fill level (here: full) Fill level (almost empty) Fill level (empty) Battery, charge level 70 to 100% Battery, charge level 40 to 70% Battery, charge level less than 10 to 40% Battery, charge level 1 to 10% Battery defective SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 35 3 Description Mains power supply active Mains power supply disconnected Standby mode Screen in Menu mode Use case data Device information and settings Expanded device information and settings Standby mode Back arrow Next arrow SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 36 3 Description Main screen Operating screen The vaporizer is blocked from use by the interlock The mechanical lock of the vaporizer is open. Screen in Menu mode Device information Language Alarm volume Downloading of data (case data, event log files, consumption data) Additional information about the device Brightness Date...
  • Page 37 3 Description Time Software update Battery information Operating hours Consumption data Safety check USB drive: Suitable USB drive found (data export) Suitable file found (SW update) USB drive: No suitable file found (SW update) USB drive: No suitable USB drive found USB drive: File search (SW update) SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 38 3 Description USB drive: Data export USB drive: Insufficient memory No mains power supply QR code (links to additional information about the device) SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 39: Functional Description

    3 Description Functional description Functional diagram Carrier gas (fresh gas) Desflurane vapor Carrier gas enriched with Desflurane vapor Control signals of the central control unit Signals from the different components to the central control unit, i.e. for- warding of the signals to the display (1) Carrier gas (fresh gas) (10) Concentration selector...
  • Page 40 3 Description Carrier gas (fresh gas) (1) enters the vaporizer through the vaporizer inlet (2), passes through the carrier gas flow resistance (3), is mixed with Desflurane vapor in the mixing chamber (4), and exits the vaporizer as a mixed gas (6) through the vaporizer outlet (5). The carrier gas flow sensor (7) measures the amount of carrier gas that flows through the carrier gas flow resistance (3) and notifies the result to the central control unit (9).

  • Page 41: Operating Concept

    4 Operating concept Operating concept Controls Touchscreen Graphical user interface with  Display areas  Buttons Turning knob  By turning the knob, settings are selected.  By pressing the turning knob briefly, messages and settings are confirmed and functions are started. ...

  • Page 42: Setting The Dispensing Quantity

    4 Operating concept Setting the dispensing quantity 4.2.1 Changing the value When making changes, the value scale in the top bar and the display area for the dispens- ing quantity in the main section of the screen will show identical values. Please note: The value can be changed without having to first select it by tapping on the combined display area/button in the main section of the operating screen.

  • Page 43: Confirming The Changed Value

    4 Operating concept 4.2.2 Confirming the changed value If you tap the combined display area/button, which shows the currently set dispensing quantity, or if you change the dispensing quantity as described in chapter 4.2.1., the ring around the turning knob (2) flashes blue. The dispensing quantity value must be confirmed within 5 seconds by pressing the turning knob (2) briefly.

  • Page 44: Changing Parameters

    4 Operating concept Changing parameters 4.3.1 Changing a value or an entry a: Example dialog Language b: Example dialog Date To change a parameter in a dialog, its button must be selected. When selected, the button will be surrounded by a blue frame (1). If the dialog has only one parameter that can be changed, the button will be automatically selected when the dialog is opened (a).

  • Page 45: Confirming A Value Or Entry

    4 Operating concept Option 2: Using the turning knob c: Turning clockwise d: Turning counterclockwise Turning the knob (3).  Turning in a clockwise direction (c) increases the value or moves to the entry above (e.g. when changing the screen language). ...

  • Page 46: Starting A Function

    4 Operating concept Starting a function a: Example dialog Case data b: Example dialog File export To start a function in a dialog, the corresponding button must be active. In the active state, the button will be surrounded by a blue frame (1). If existing conditions (e.g.

  • Page 47: Operation

    5 Operation Operation Before first use The vaporizer and accessories are delivered in non-sterile condition. Before first use in a clinical setting, clean the vaporizer and accessories as described in chapter 9. Check the charge level of the emergency battery before the first use. To do this, connect the vaporizer to the power supply and turn it on.

  • Page 48: Connecting To An Anaesthesia Workstation

    Before connecting the vaporizer, make sure that the vaporizer model and the connector system of the anaesthesia workstation are compatible (see chapter 3.1). The illustrations show the connecting of a SmartVap S. The SmartVap D is connected in the same way. SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 49 5 Operation A Check that the locking knob (1) is unlocked. ► The locking knob is in horizontal position. B Check that each plug connector on the connector panel has an intact sealing ring, and that there are no foreign bodies on the plug connectors. C Hold the vaporizer in an upright position with both hands.

  • Page 50: Switch-On And Device Test

    5 Operation Switch-on and device test A Press the turning knob (1) briefly to switch on the vaporizer. ► The device test starts. During the device test, the functioning of the components is checked. The status LED flashes on and a brief acoustic signal is emitted. If required, the vaporizer is heated up. On the screen, the user is informed of the progress of the device test and any errors.
  • Page 51 5 Operation C After the device test finishes successfully, the illuminated ring around the turning knob flashes blue. Briefly press the turning knob (1). ► The vaporizer changes to the operating screen. Additional information about status and error messages during the device test can be found in chapter 8.2.

  • Page 52: Filling

    5 Operation Filling The vaporizer is filled through the Piramal Fill filling system, using Piramal DESFLURANE bottles:  when disconnected from the mains,  in Standby mode (screen is turned off),  with the vaporizer turned on. When the vaporizer is on, the fill level is displayed on the screen by the fill level indicator. Please note: The vaporizer may also be filled while dispensing Desflurane.
  • Page 53 5 Operation A Unscrew the cap of the anaesthetic bottle (Piramal Fill filling system) and ensure that the O-ring is intact. B Manually open the cover flap (1) of the fill opening on the vaporizer. C Screw the open anaesthetic bottle (2) onto the fill opening in a clockwise direction until the end of the thread is reached.
  • Page 54 5 Operation G Close the cover flap (1) of the fill opening. CAUTION Close the cover flap of the fill opening immediately after filling to avoid contaminating the fill opening with dirt particles and thus causing the valve to leak. H Close the anaesthetic bottle (2).

  • Page 55: Starting Dispensing

    5 Operation Starting dispensing WARNING Risk to patient due to underdosing or overdosing of volatile an- aesthetic Too high delivery quantities could result in an overdose. Too low delivery quantities could result in an underdose. Always set the correct delivery quantity for the individual pa- tient.

  • Page 56: Dispensing Quantity Greater Than 12 Vol

    5 Operation A Set the dispensing quantity by swiping left on the indicated screen area (1) or by turning the knob (2) in a clockwise direction. ► The illuminated ring around the turning knob flashes blue. Setting range for Desflurane dispensing quantity: 0, then 2 to 12, 12 to 18 Vol % in increments of 0.5 Vol % B Confirm the set dispensing quantity of Desflurane by briefly pressing the turning knob (2).
  • Page 57 5 Operation A Increase the dispensing quantity by swiping left on the indicated screen area (1) or by turning the knob (2) in a clockwise direction. ► If the dispensing quantity is increased above the value of 12.0 Vol %, a warning sign will appear on the value scale.

  • Page 58: Endingdispensing

    5 Operation D Confirm the set dispensing quantity of Desflurane by briefly pressing the turning knob (2). ► The illuminated ring around the turning knob shows a circling green point of light. ► The quantity of Desflurane dispensed into the fresh gas flow of the anaesthesia workstation is changed.

  • Page 59: Standby Mode

    5 Operation Standby mode If the vaporizer is not being used, it can be put into Standby mode. In Standby mode, the vaporizer continues to be heated and the emergency battery continues to be charged. 5.9.1 Opening Standby dialog Prerequisite: The vaporizer is in the operating screen and dispensing of Desflurane has ended.

  • Page 60: Switching To Standby Mode

    5 Operation Option 2: Using the turning knob A Press the turning knob (1) for longer (at least 2 seconds). ► The Standby dialog is displayed. 5.9.2 Switching to Standby mode A In the Standby dialog, set “Standby” in the Standby/Cancel button (4) by tapping the Up arrow (5) or rotating the turning knob (3) in a clockwise direction.

  • Page 61: Ending Standby Mode

    5 Operation 5.9.3 Ending Standby mode To end Standby mode, briefly press the turning knob. The vaporizer conducts a device test and is then ready for use. Additional information about the device test can be found in chapter 5.4. 5.10 Removing the vaporizer from an anaesthesia workstation Prerequisite: The vaporizer is in Standby mode.

  • Page 62: Alarms

    6 Alarms Alarms General information Example: Fill level low If an alarm is triggered, an alarm message will appear in the screen’s top bar (1) and an acoustic alarm will be emitted. The status LED (4) shows the alarm color depending on alarm priority.
  • Page 63 6 Alarms If multiple alarms are triggered at the same time, the alarm with the highest priority is dis- played. If subsequently triggered alarms have the same priority level, the alarm message of highest relevance will be shown. When the cause of an alarm is rectified, the alarm message will be disappear and the acoustic signal for this particular alarm will be silenced.

  • Page 64: Pausing The Acoustic Alarm

    6 Alarms Pausing the acoustic alarm WARNING Risk to patient due to unattended alarm Use of the Pause acoustic alarm button could result in the alarm not being noticed. Check the screen regularly for alarm messages. A Tap the Pause acoustic alarm (1) button or briefly press the turning knob (2) ►...

  • Page 65: Technical Fault

    6 Alarms Technical error If a defect on the vaporizer makes it unsafe to use, this will be indicated by an alarm. Dis- pensing of Desflurane will not be possible in this case. If the vaporizer is in the operating screen, further information will be provided, in addition to the alarm message, in an addi- tional window on the main section of the screen.
  • Page 66 6 Alarms If the vaporizer malfunctions due to a severe technical fault, it will switch to a patient-safe state that looks as follows:  dark screen  no dispensing of volatile anaesthetic agent  status LED flashes red  acoustic alarm A Turn off the acoustic alarm by pressing the turning knob for at least 5 seconds.

  • Page 67: Menu Mode

    7 Menu mode Menu mode Overview The vaporizer provides the following menus with dialogs:  User menu The menu contains the following dialogs: Case data dialog Standby dialog  Device information and settings menu Device information dialog Screen language dialog Alarm volume dialog Brightness dialog Additional information dialog...

  • Page 68: Starting And Ending Menu Mode

    7 Menu mode Starting and ending Menu mode Prerequisite: The vaporizer conducts the device test or is in operating screen, and there is no dispensing of Desflurane. a: Example: Device test b: Example: Operating screen A Tap on the Menu (1) button in the screen’s bottom bar. ►...
  • Page 69 7 Menu mode Expanded button Opens a dialog for entry of a PIN. After entering the PIN, a dialog opens up with an overview of the menu options unlocked with the PIN:  Expanded settings  Service Standby button Opens a dialog for powering down the vaporizer (Standby mode). B End Menu mode by tapping on the Back (2) button or by pressing and holding the turn- ing knob (7).

  • Page 70: Resetting And Downloading Use Case Data

    7 Menu mode Resetting and downloading use case data The vaporizer shows the following information in the Use case data dialog:  Consumption of Desflurane in mL  Duration of dispensing in h  Average consumption in mL/h The data can be reset in the Use case data dialog. If the vaporizer is put into Standby mode, or in the event of a complete power failure (no mains power supply and no power supply from the emergency battery), the data is automatically reset.
  • Page 71 7 Menu mode If the memory on the USB drive is insufficient or if no USB drive is recognized, this will be indicated by a corresponding USB symbol (3). D Confirm the resetting of the data by briefly pressing the turning knob (5). ►...

  • Page 72: Device Information And Settings Menu

    7 Menu mode Device information and settings menu 7.4.1 Opening the menu A After starting Menu mode, tap the Settings (1) button. ► The Settings (1) button in the Menu bar will change color to blue. ► The dialog with an overview of the options is displayed. 7.4.2 Overview of options Device information button...

  • Page 73: Viewing Device Information

    7 Menu mode 7.4.3 Viewing device information In the Device information dialog, the following information about the vaporizer is shown:  Vaporizer type  SW version  Serial number A In the Options dialog of the Settings menu, tap the Device information (1) button. ►...

  • Page 74: Changing The Screen Language

    7 Menu mode 7.4.4 Changing the screen language A In the Options dialog of the Settings menu, tap the Language (1) button. ► The Language dialog is displayed. B Select the desired language from the choices available by tapping on the arrow buttons (3) or by turning the knob (4).

  • Page 75: Changing The Alarm Volume

    7 Menu mode 7.4.5 Changing the alarm volume A In the Options dialog of the Settings menu, tap the Alarm volume (1) button. ► The Alarm volume dialog is displayed. B Set the desired alarm volume by tapping on the arrow buttons (3) or by turning the knob (4).

  • Page 76: Changing The Brightness

    7 Menu mode 7.4.6 Changing the brightness A In the Options dialog of the Settings menu, tap the Brightness (1) button. ► The Brightness dialog is displayed. B Set the desired brightness by tapping on the arrow buttons (3) or by turning the knob (4).

  • Page 77: Displaying Additional Information

    7 Menu mode 7.4.7 Displaying additional information In the Additional information dialog, a scannable QR code will be shown. By scanning the QR code, the manufacturer’s website containing additional information about the vaporizer will open up on the device used for scanning. A In the Options dialog of the Settings menu, tap the Info (1) button.

  • Page 78: Downloading The Event Log Data

    7 Menu mode 7.4.8 Downloading the event log data The vaporizer stores the following data, for example, in an event log file:  Set dispensing quantity and changes  Start and end of dispensing  Alarms  Device test results (test values, status messages, error messages) ...
  • Page 79 7 Menu mode If the memory on the USB drive is insufficient or if no USB drive is recognized, this will be displayed by the corresponding USB symbol (2) and a message (3) will also be shown. The Export (4) button cannot be activated in this case. C Start downloading the data by briefly pressing the turning knob (5).

  • Page 80: Expanded Device Information And Settings Menu

    7 Menu mode Expanded device information and settings menu 7.5.1 Opening the menu In order to open the menu for further device information and settings, a four-digit PIN is re- quired. This PIN is made available by the manufacturer. An additional PIN, provided by service organizations authorized by the manufacturer, can be used to start a Service mode.

  • Page 81: Overview Of Options

    7 Menu mode 7.5.2 Overview of options Alarm volume button Opens a dialog to set the minimum alarm volume. Date button Opens a dialog to set the date. Time button Opens a dialog to set the time. Software update button Opens a dialog to perform a software update.

  • Page 82: Setting The Minimum Alarm Volume

    7 Menu mode 7.5.3 Setting the minimum alarm volume A In the Options dialog of the Expanded menu, tap the Alarm volume button. ► The Minimum alarm volume dialog is displayed. B Set the desired alarm volume by tapping on the arrow buttons (3) on the screen or by turning the knob (4).

  • Page 83: Setting The Date

    7 Menu mode 7.5.4 Setting the date A In the Options dialog of the Expanded menu, tap the Date button. ► The Date dialog is displayed. The Year (2) button is selected. The date is displayed in Coordinated Universal Time (UTC) in a year-month-day format.

  • Page 84: Setting The Time

    7 Menu mode 7.5.5 Setting the time A In the Options dialog of the Expanded menu, tap the Time button. ► The Time dialog is displayed. The hour (2) button is selected. The time is shown in Coordinated Universal Time (UTC) in a 24-hour format. B Set the hour by tapping on the arrow buttons (3) on the screen or by turning the knob (4).

  • Page 85: Perform A Software Update

    7 Menu mode 7.5.6 Perform a software update Prerequisite: A USB drive (FAT32 formatted) containing the software update file made available by the vaporizer manufacturer must be connected to the vapo- rizer. Additional information about connecting the USB drive can be found in chapter 7.3. IMPORTANT Damage to the device may be caused by a failure of the power supply during the software update...
  • Page 86 7 Menu mode If a USB drive is not recognized or no suitable software update file is found on the USB drive, this will be indicated by a corresponding USB symbol (2) and a message (3) will also be shown. The Update (4) button cannot be activated in this case. The dialog can be closed by tapping on the Back (6) button.

  • Page 87: Viewing Battery Information

    7 Menu mode 7.5.7 Viewing battery information In the Battery information dialog, the following information about the emergency battery is shown:  Battery charge level  Number of charging cycles  Type  Serial number A In the Options dialog of the Expanded menu, tap the Battery information button. ►...

  • Page 88: Viewing Operating Hours

    7 Menu mode 7.5.8 Viewing operating hours In the Operating hours dialog, the following information is shown:  Operating hours in Standby mode  Operating hours with therapy  Total operating hours In the event of a complete power failure (no mains power supply and no power supply by the emergency battery), the data will be saved.

  • Page 89: Resetting And Downloading Consumption Data

    7 Menu mode 7.5.9 Resetting and downloading consumption data In the Consumption data dialog, the value for the quantity of Desflurane dispensed since the last time the data was reset, is displayed. The data can be reset in the Consumption data dialog. In the event of a complete power failure (no mains power supply and no power supply by the emergency battery), the con- sumption data will be saved.
  • Page 90 7 Menu mode C Confirm the resetting by briefly pressing the turning knob (4). ► The data is reset. ► If a USB drive with sufficient memory is recognized, the data will be automatically downloaded. D Close the dialog by tapping on the Back (5) button. ►...

  • Page 91: Resetting The Safety Check Interval

    7 Menu mode 7.5.10 Resetting the safety check interval The Safety check dialog displays the number of days until the next scheduled safety check. Once a safety check has been performed, the interval can be reset in this dialog. A In the Options dialog of the Expanded menu, tap the Safety check button. ►...

  • Page 92: Alarm Messages, Notifications And Malfunctions

    8 Alarm messages, notifications and malfunctions Alarm messages, notifications and malfunctions Alarm messages In the following tables, the alarm message priorities are indicated by exclamation points.  Low priority  Medium priority  High priority ! ! ! Some alarm messages appear in the table multiple times with different alarm priorities and different identification numbers (ID).
  • Page 93 8 Alarm messages, notifications and malfunctions Alarm Pri- Cause Remedial action ority  Check the position of Dispensing ! ! ! The vaporizer cannot de- DES paused tect any fresh gas flow. the vaporizer on the (no FGF) connector panel. ...
  • Page 94 DES stopped blocked by another vapor- anaesthetic agent, un- (interlock) izer (interlock). block the vaporizer (in- (Only with SmartVap D) terlock) and restart the dispensing of anaes- thetic agent.  Or press the turning knob to confirm the stopping of dispensing of anaesthetic agent.
  • Page 95 8 Alarm messages, notifications and malfunctions Alarm Pri- Cause Remedial action ority Loss of mains The vaporizer was discon- Connect the vaporizer to power nected from the mains the mains power supply. power supply while dis- pensing anaesthetic agent. The charge level of the emergency battery is higher than 70%.
  • Page 96 8 Alarm messages, notifications and malfunctions Alarm Pri- Cause Remedial action ority Technical >100 A technical fault has oc- Put the vaporizer into error curred. The dispensing of Standby mode and restart. anaesthetic agent is not Additional information can possible. be found in chapter 6.3.

  • Page 97: Status And Error Messages During The Device Test

    8 Alarm messages, notifications and malfunctions Status and error messages during the device test Messages during the device test comprise status and error messages, sometimes accom- panied by a prompt to take action. In the case of error messages, an error message code is also displayed. Message Cause / Remedial action Battery...
  • Page 98 8 Alarm messages, notifications and malfunctions Message Cause / Remedial action Fill opening F001 The cover flap of the fill opening is open. Flap of fill opening open. Close the cover flap. After closing, the vaporizer continues with the device test. Close to continue.
  • Page 99 8 Alarm messages, notifications and malfunctions In very rare cases, errors may occur when starting the device, which are displayed even before the device test begins: Loss of date and time settings After a long period of storage without mains power supply, or if the battery which powers the internal clock is defective, the time and date settings can be lost.

  • Page 100: Messages On The Operating Screen

    8 Alarm messages, notifications and malfunctions Messages on the operating screen Message Description Dispensing DES not possible. In the event of a technical error (alarm Place vaporizer in standby mode and re- ID 01), this message is displayed as addi- start.

  • Page 101: Messages In Dialogs

    8 Alarm messages, notifications and malfunctions Messages in dialogs Data export Message Description Export stopped The last download was aborted. Export finished The data has been downloaded. Export running… The data is downloading. Export possible A suitable USB drive has been recognized and downloading of the data is possible.

  • Page 102: Malfunctions

    8 Alarm messages, notifications and malfunctions Malfunctions If malfunctions cannot be rectified with help of the table, stop using the vaporizer to avoid serious damage. Contact a service organization authorized by the manufacturer. Malfunction Cause Remedial action Alarm sound too low Volume has been set too Increase the volume: low.

  • Page 103: Cleaning

    9 Cleaning Cleaning In terms of hygiene, the vaporizer is a non-critical medical device with surfaces, such as the vaporizer surface and the cables, accessible to the user. The surface disinfectants listed in the following table are suitable for wipe disinfection. These disinfectants have been tested by the vaporizer manufacturer and they demon- strated material compatibility at the time of the test.
  • Page 104 9 Cleaning The use of other surface disinfectants is at the responsibility of the user. Many materials are damaged by certain organic solvents that are sometimes used in clean- ing and disinfecting agents (e.g. phenols, halogen-releasing compounds, strong organic acids, etc.) Furthermore, aside from their main constituents, cleaning and disinfecting agents may often contain additives that can damage the materials.
  • Page 105 9 Cleaning B Carry out wipe disinfection. C Remove any disinfectant residue after the contact time. D Allow the vaporizer to dry fully. Additional information about the outer materials of the vaporizer can be found in chap- ter 15.4. SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 106: Emptying The Vaporizer

    10 Emptying the vaporizer Emptying the vaporizer WARNING Risk of harm to persons and damage to the device from incor- rect emptying. The vaporizer must only be emptied by personnel in accord- ance with chapter 1.3.3. CAUTION Risk to persons from contamination of the environment with volatile anaesthetic.
  • Page 107 10 Emptying the vaporizer C Manually open the cover flap (1) of the fill opening on the vaporizer. D Screw the open anaesthetic bottle (2) onto the fill opening in a clockwise direction, until the end of the thread is reached. E Turn the vaporizer over so that the anaesthetic bottle points vertically downward.
  • Page 108 10 Emptying the vaporizer G To end the emptying, unscrew the anaesthetic bottle (2) by approximately a 1/3 turn in a counterclockwise direction. ► The bottle valve is closed. WARNING To ensure that no Desflurane leaks out, do not unscrew the an- aesthetic bottle while the vaporizer is upside down and the an- aesthetic bottle points downward.

  • Page 109: Service

    11 Service Service 11.1 Definition of terms Service is comprised of measures to preserve the specified condition of the vaporizer. These include:  Maintenance Preventive, recurring measures to keep the device in good condition and prevent technical malfunctions. These consist of inspection (assessment of the current condition of the vaporizer), replacement of wearing parts, and checking the func- tioning of individual vaporizer components.

  • Page 110: Schedule

    11 Service 11.2.2 Schedule Every 12 months: Action Component Done by Vaporizer Conduct a safety check Maintenance personnel or authorized service organiza- tion Every 24 months Action Component Done by Emergency battery Replace Maintenance personnel or authorized service organiza- tion When requested by the manufacturer Action Component...

  • Page 111: Safety Check

     The following vaporizer parts do not show any visible damage: o Mechanical lock (locking knob, locking pin) o Interlock pins (SmartVap S) and openings (SmartVap D) o Fresh gas flow inlet/outlet  The housing and accessories (power supply unit and power cable) show no dam- age.

  • Page 112: Software Update

    11 Service C Checking the dispensing accuracy Conduct a check under the following conditions:  Temperature: 22° ± 1°C,  Ambient pressure: 1013 ± 10 mbar  Fresh gas flow (medicated air): 2.5 ± 0.1 L/min  Fill level > 100 mL ...

  • Page 113: Replacing The Emergency Battery

    11 Service 11.2.5 Replacing the emergency battery Prerequisite: The vaporizer is turned off and disconnected from the mains power sup- ply. The connecting cable is not plugged into the vaporizer. Fixation screws Battery compartment cover Emergency battery A Undo the four screws (1). B Remove the battery compartment cover (2).

  • Page 114: Further Maintenance Work

    11 Service 11.2.6 Further maintenance work Any further maintenance work must only be done by a service organization authorized by the manufacturer. Additional information about further maintenance work can be found in the technical documentation for the vaporizer. 11.3 Repairs To repair a defective vaporizer, and in the case of errors that you cannot rectify yourself, contact a manufacturer-authorized service organization.

  • Page 115: Shipping A Vaporizer

    12 Shipping a vaporizer Shipping a vaporizer The vaporizer may be shipped to the manufacturer, or to a manufacturer-authorized ser- vice organization, for servicing or for disposal at the end of its service life. WARNING Risk to persons due to danger of infection The vaporizer may be contaminated by pathogens.

  • Page 116: Disposal

    13 Disposal Disposal 13.1 Disposing of the vaporizer At the end of its service life (10 years), dispose of the vaporizer in accordance with statu- tory regulations. For countries covered by the EU Directive 2012/19/EU The vaporizer falls within the scope of application of EU Directive 2012/19/EU (WEEE) on waste electrical and electronic equipment.

  • Page 117: Accessories And Spare Parts

    14 Accessories and spare parts Accessories and spare parts Description Order number Basic device SmartVap D SV-D-P SmartVap S SV-S-P Power supply unit Power supply unit (type GSM90A24-P2MR, by Meanwell) SV-SC-12882 Power cable CE (length: 2 m, angled connection socket)

  • Page 118: Technical Data

    15.1 General specifications Specification Device Dimensions (W x H x D) ≤100 x ≤250 x ≤245 mm SmartVap D (3.94 x 9.84 x 9.65 inches) ≤100 x ≤250 x ≤255 mm SmartVap S (3.94 x 9.84 x 10 inches) Weight ≤...
  • Page 119 In accordance with EN 60601-1-2 Class A Test parameters and threshold val- ues can be obtained from the man- ufacturer if needed. UMDNS code 10-144 UDI-DI GTIN codes SmartVap D 4260665920921 SmartVap S 4260665920754 Electrical supply Supply voltage 100 to 240 V ± 10% Frequency 50 to 60 Hz ±...
  • Page 120 15 Technical data Specification Device Display Screen 3.5" touchscreen USB interface Type USB 3.0, type A Pneumatic interfaces to the an- aesthesia workstation Back pressure 10 mbar to 80 mbar Flow resistance, vaporizer < 100 mbar @ 10 L/min fresh gas flow Units Dispensing quantity Desflurane Vol %...

  • Page 121: Values And Value Ranges

    15 Technical data 15.2 Values and value ranges Values Dosing of volatile anaesthetic Fresh gas flow 0.2 to 15 L/min Dosing range, Desflurane 2.0 to 12, 12.5 to 18.0 Vol % Increments: 0.5 Vol % Accuracy ±0.5 Vol % or ±15 % of the set value at 22°C, 1013 mbar, 2.5 L/min FGF, medicated air Reservoir Range...
  • Page 122 15 Technical data Values Safety check interval Range 0 to 365 days (d) Resolution Battery, charge level Range 0 to 100% Display area 1 to 100% Resolution SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 123: Device Settings

    15 Technical data 15.3 Device settings Values Alarm volume Range: 50 to 100% Increments: Standard setting: 100% Minimum alarm volume Range: 30 to 100% Increments: Standard setting: Brightness Range: 50 to 100% Increments: Standard setting: 100% Date and time 15.4 Outer materials used Component Material Housing...

  • Page 124: Terms And Abbreviations

    16 Terms and abbreviations Terms and abbreviations In alphabetical order: Desflurane Fresh gas flow Software Coordinated Universal Time SmartVap Vaporizer SW 1.n, Instructions for use (en-US)

  • Page 125: Pin Information

    17 PIN information PIN information PIN for the Expanded menu settings SmartVap vaporizer Extracted from the instructions for use SmartVap vaporizer SW 1.n (Document ID No.: 046-10107-E) The menu for the expanded settings is protected by this password to prevent unauthorized modification of the set- 3141 tings.
  • Page 126 17 PIN information SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 127 17 PIN information PIN information The Expanded settings menu is password protected to prevent unauthorized modification of the settings. It contains the following dialogs:  Minimum alarm volume  Date  Time  Software update  Battery information  Operating hours ...
  • Page 128 Notes SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 129 Notes SmartVap Vaporizer SW 1.n, Instructions for use (en-US)
  • Page 130 Notes SmartVap Vaporizer SW 1.n.m, Instructions for use (en-US)
  • Page 132 Tel.: +49 261 899 689 00 Fax: +49 261 899 689 09 info@tim-gmbh.de www.tim-gmbh.de 0044 Distributed by www.piramalcriticalcare.com This document SmartVap Vaporizer - Instructions for use (en-US) ID No. 046-10102-E Version 2021-03 Printed in Germany © Technologie Institut Medizin GmbH (TIM) All rights reserved...

This manual is also suitable for:

Smartvap s

Table of Contents