Lowenstein Medical prismaLINE Manual
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Lowenstein Medical prismaLINE Manual

Sleep therapy devices from firmware 5.05
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EN Additional information for experts for WM 100 TD devices
prismaLINE
Sleep therapy devices
from firmware 5.05

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Summary of Contents for Lowenstein Medical prismaLINE

  • Page 1 EN Additional information for experts for WM 100 TD devices prismaLINE Sleep therapy devices from firmware 5.05...

  • Page 2: Table Of Contents

    Table of contents Table of contents Introduction User qualifications ................. 4 Safety Safety information ................. 5 General information ..............7 Product description Display in the expert sector ............8 Symbols on the display ..............10 Components ................12 Accessories ................. 13 Preparation Connecting up a bacteria filter .............
  • Page 3 Table of contents S/T mode ..................54 T mode ..................58 autoS/T mode ................60 Particularities with prismaLAB Hygienic preparation General information ..............65 Intervals without a patient change ..........65 Intervals with a patient change ............ 66 Replacing the bacteria filter ............66 WM 100 TD...

  • Page 4: Introduction

    Introduction This document is intended as supplementary material for experts (hospital personnel and authorized dealers) and contains additional information about the prismaLINE sleep therapy devices. Please note: This document does not replace complete instructions for use. The following information can be found in the instructions for use for patients: •...

  • Page 5: Safety

    2 Safety Safety This chapter provides supplementary safety information for experts. Whenever using the therapy device, you should always also observe the safety information in the instructions for use for patients. 2.1 Safety information 2.1.1 Using the therapy device on the patient Warning Risk of injury for patients with impaired cardiac function! For patients with impaired cardiac function, cardiac output can be...
  • Page 6 2 Safety Risk of injury due to incorrect alarm presets! The use of different alarm presets for the same or similar devices can put the patient at risk. ⇒ Check the alarm presets again for each patient. 2.1.3 Safe handling of oxygen Warning The use of oxygen in combination with flammable substances poses a fire hazard!

  • Page 7: General Information

    2 Safety 2.2 General information • Use of third-party products may lead to functional failures and restricted fitness of purpose. Biocompatibility may also be compromised. Please note that in these cases, any claim under warranty and liability will be void if neither the accessories nor original replacement parts recommended in the instructions for use are used.

  • Page 8: Product Description

    3 Product description Product description This section describes the elements which are important for experts on the display and the components and accessories which are used for applications in clinical areas. A complete description of the whole therapy device and the respiratory air humidifier can be found in the instructions for use for patients.
  • Page 9 3 Product description Designation Description Starts the mask test and stops it prematurely. Mask test button Shows the remaining time in seconds. softSTART button Switches the softSTART on and off. Shows the set/remaining softSTART time in minutes. for prisma30ST, prisma30ST-C, In addition for prisma30ST, prisma30ST-C, prismaLAB: prismaLAB only: softSTART/ Switches off the current softSTOP.

  • Page 10: Symbols On The Display

    3 Product description 3.2 Symbols on the display Symbol Designation Description Device status symbols (shown on the top line of the display) The expert sector is open and the parameters can be set. Access symbol The expert sector is open and the settings are locked. It is not possible to set parameters.
  • Page 11 3 Product description Symbol Designation Description SD card in SD card slot. SD card symbol Symbol flashes: Data is being saved to the SD card. Symbols on the rest of the display Respiratory air humidifier is connected and switched off. Smart AQUA Control climate control is activated. (Gray symbol) The last set humidifier level is displayed.

  • Page 12: Components

    3 Product description Symbol Designation Description Shows the menu level that you are currently in: Menu level symbol The more green dots, the deeper you are in the menu structure. Alarm window Alarm symbol Low-priority alarm triggered. Alarm pause symbol Alarm paused for 2 minutes.

  • Page 13: Accessories

    3 Product description 3.4 Accessories 3-3 Additional accessories in clinical areas Designation Description Protects the patient against contaminations and infections, if the Bacteria filter therapy device is used by more than one patient. WM 100 TD...

  • Page 14: Preparation

    4 Preparation Preparation 4.1 Connecting up a bacteria filter A bacteria filter prevents against renewed infection of the patient in cases of infectious diseases and prevents contaminations or infections being passed on to the next patient when changing between patients. 1.

  • Page 15: Settings In The Expert Sector

    5 Settings in the expert sector Settings in the expert sector As an expert, you can view all the parameters and values for a patient and change the settings to set the therapy device up optimally for the therapy of the respective patient in the expert sector.

  • Page 16: Navigating In The Expert Sector

    5 Settings in the expert sector The values and setting options shown on the display depend on the mode the therapy device is in at that time: • Standby mode (no therapy in progress) • Therapy mode (therapy in progress) 5.2 Navigating in the expert sector You configure all the settings in the menu via the display.
  • Page 17 5 Settings in the expert sector 5.2.2 Navigating in the expert sector Button Function Button Go back a screen Button Go forward a screen Select values: • If the parameter can have exactly 2 possible values (e.g., on/off): Press the button. The value changes to the other one.
  • Page 18 5 Settings in the expert sector Requirement • The therapy device is in Standby mode. • The expert sector is opened (see "5.2.1 Opening and exiting the expert sector", page 16). 1. Press the info button 2. If necessary: To view therapy data from a night other than the previous night, select the desired date in the list 3.
  • Page 19 5 Settings in the expert sector 6. Press the respective field to see more detailed information. The content of the fields and the additional information vary in the different device versions. 7. In some modes, there are also additional pages displaying the required pressures and statistical parameters on respiratory rate and volume.
  • Page 20 5 Settings in the expert sector Abbreviation Description Device version Serial number Hardware version Firmware version Only relevant for service technicians Only relevant for service technicians System identification of the device. Therapy hours without artifacts or open mask. This counter is reset when therapy data in the device are deleted or the device is reset to the factory settings.
  • Page 21 5 Settings in the expert sector 5.2.4 Changing the ventilation mode Depending on the device version, you have the possibility of changing between different ventilation modes. Ventilation mode Device version CPAP APAP AcSV S autoS autoS/T S/T aPCV prisma20C prisma20A prismaCR prisma25S prisma25S-C...
  • Page 22 5 Settings in the expert sector Requirement • The therapy device is in one of the following modes: • AcSV • aPCV • autoS/T • • The Ventilation menu of the ventilation parameters is opened (see "5.3.1 Setting therapy parameters", page 24).

  • Page 23: Settings In The Expert Settings Menus

    5 Settings in the expert sector 5.3 Settings in the expert settings menus The settings options depend on the mode that the therapy device is currently in (Standby or Therapy). Settings menus Time Signal data Language Device Display Menu Settings Audio Ventilation mode* Main menu...
  • Page 24 5 Settings in the expert sector 5.3.1 Setting therapy parameters Requirement • The therapy device is in the Standby or Therapy mode. • The expert sector is open (see "5.2.1 Opening and exiting the expert sector", page 16). Risk of injury due to incorrect settings Incorrect accessory settings can lead to deviating therapy pressures and consequently an insufficient therapy.
  • Page 25 5 Settings in the expert sector Parameter Possible values Description You can set the minimum softSTART pressure for the softSTART function here. The patient can set the actual softSTART pressure between the pressure set here and softSTART the prescribed therapy pressure in the patient settings in 0.5 cmH pressure min menu.
  • Page 26 5 Settings in the expert sector Parameter Possible values Description Bacteria filter Here you can set whether a bacteria filter is used. 15 mm Tube type Here you select the diameter of the hose type used. 19-22 mm Accessories Here you can activate/deactivate an automatic Air filter reminder reminder for the next filter change.
  • Page 27 5 Settings in the expert sector 5.3.2 Setting device parameters Requirement • The therapy device is in Standby mode. • The expert sector is opened (see "5.2.1 Opening and exiting the expert sector", page 16). 1. Press the menu button 2.
  • Page 28 5 Settings in the expert sector Parameter Possible values Description Here you can set what quantity of signal data for a therapy are saved on the SD card or the USB storage device. Signal data None • None: Only the statistical data concerning Signal data 1 day the therapy device are saved and no signal...
  • Page 29 5 Settings in the expert sector Parameter Possible values Description English Deutsch 中文 Pу́ с ский Italiano Nederlands 日本語 한국어 Türkçe Here you can set the language in the menus for Expert Français the expert sector. Español Português (Br) Dansk Suomi Norsk Svenska...
  • Page 30 5 Settings in the expert sector Parameter Possible values Description Here you can set the brightness of the display, so that the patient's sleep during the night is Display not disturbed by a bright display, for example. brightness Level 1: Dark Level 2: Normal Level 3: Bright Here you can activate or deactivate whether the...
  • Page 31 5 Settings in the expert sector 5.3.3 Resetting settings and deleting data Requirement • The therapy device is in Standby mode. • The expert sector is open (see "5.2.1 Opening and exiting the expert sector", page 16). 1. Press the menu button 2.
  • Page 32 5 Settings in the expert sector 5.3.4 Demo mode You can have a variety of different screen views displayed in demo mode for demonstration and training purposes. Requirement • The therapy device is in Standby mode. • The expert sector is opened (see "5.2.1 Opening and exiting the expert sector", page 16).

  • Page 33: Description Of The Modes

    6 Description of the modes Description of the modes 6.1 CPAP mode In CPAP mode, the therapy device provides the patient with respiratory air at a constant overpressure continuously throughout the therapy. This keeps the patient's airways open. 6.1.1 Adjustable parameters in CPAP mode Parameter Possible values Description...

  • Page 34: Apap Mode

    6 Description of the modes 6.2 APAP mode In APAP mode, the ventilation is performed at a constant pressure, which adapts to suit the patient's fluctuating pressure requirements. 6.2.1 Adjustable parameters in APAP mode Possible Parameter Description values 4 cmH O to Pmax Here you can call up the scale and set the maximum pressure.

  • Page 35: Acsv Mode

    6 Description of the modes Possible Parameter Description values softPAP Here you can lock the softPAP function for this patient. If the lock is Lock on, the patient cannot change the setting selected. 6.3 AcSV mode In the AcSV mode, ventilation is performed following the anticyclic servo-ventilation method in combination with automatic pressure adjustment for treating obstructions in the upper airways.
  • Page 36 6 Description of the modes • Bi softPAP The classic Bi softPAP pressure profile includes a constant pressure level during expiration for splinting the upper airways. With the Bi softPAP pressure variant, the IPAP (pressure during inspiration) and the EPAP (pressure during expiration) are attained during one breathing cycle.
  • Page 37 6 Description of the modes Parameter Possible values Description The maximum IPAP (inspiratory positive airway pressure) is automatically adjusted accordingly if you 4 cmH O to IPAPmax change the values for PDIFFmax or EEPAPmax. 30 cmH It is not possible to change any settings here. The value is displayed for information purposes only.

  • Page 38: S Mode

    6 Description of the modes Presets SCOPE MIXED: Parameter Preset values PDIFFmax 12 cmH PDIFFnorm 5 cmH EPAPmax 13 cmH EPAPmin 7 cmH Bi softPAP autoF SCOPE MIXED is suitable for patients who, on top of periodic breathing, also suffer from a pronounced obstructive sleep apnea and/or require additional ventilation support.
  • Page 39 6 Description of the modes 6.4.1 Adjustable parameters in S mode Parameter Possible values Description IPAP 4 cmH O to 25 cmH O Here you can set the inspiratory positive airway pressure. EPAP 4 cmH O to 25 cmH O Here you can set the expiratory positive airway pressure. Here you can activate/deactivate the pressure variants.

  • Page 40: Autos Mode

    6 Description of the modes 6.5 autoS mode autoS mode combines the pressure support of a BiLevel S therapy with optional, automatic adjustment of pressure difference (autoPDIFF) and automatic adjustment of expiratory pressure against obstructions as in the case of APAP. 6.5.1 Adjustable parameters in autoS mode Parameter Possible values...

  • Page 41: Autos/T Mode

    6 Description of the modes 6.6 autoS/T mode The autoS/T mode combines • Pressure support of a BiLevel therapy • Backup frequency • Automatic regulation of the expiratory pressure and the pressure difference against obstructions This allows safe bridging of apneas and hypoventilation phases, standardizes the patient's blood gases, and reduces his breathing effort as necessary.
  • Page 42 6 Description of the modes Parameter Possible values Description Here you can activate/deactivate the pressure variants. • Off (Bi soft0 pressure variant): It is possible to set PDIFF and autoEPAP (within EPAPmin and EPAPmax). • Bi soft1: As for Bi soft0, with additional breathing relief Bi soft1* (1 hPa) at the start of expiration.
  • Page 43 6 Description of the modes 6.6.2 Presets of SCOPES (therapy goals) Presets SCOPE OVERLAP Parameter Preset values EPAPmin 6 cmH EPAPmax 16 cmH PDIFF 8 cmH autoPDIFF autoF Ramp IN Trigger IN Auto Bi softPAP SCOPE OVERLAP is suitable for patients with obstructive sleep apnea and mild to medium COPD.

  • Page 44: S/T Mode

    6 Description of the modes Presets SCOPE OSAS Parameter Preset values EPAPmin 6 cmH EPAPmax 20 cmH PDIFF 5 cmH autoPDIFF autoF F min 10 bpm Ti/T set 33 % Trigger IN Auto Ramp IN Bi softPAP SCOPE OSAS is suitable for patients with severe obstructive sleep apnea and a high pressure requirement.
  • Page 45 6 Description of the modes 6.7.1 Adjustable parameters in S/T mode Parameter Possible values Description 4 cmH O to IPAP Here you can set the inspiratory positive airway pressure. 25 cmH 4 cmH O to EPAP Here you can set the expiratory positive airway pressure. 25 cmH Here you can activate/deactivate the pressure variants.
  • Page 46 6 Description of the modes 6.7.2 Presets of SCOPES (therapy goals) Presets SCOPE OVERLAP Parameter Preset values EPAP 7 cmH IPAP 15 cmH Fmin 14 bpm Ti/T set Ramp IN Trigger IN Auto Bi softPAP SCOPE OVERLAP is suitable for patients with obstructive sleep apnea and mild to medium COPD.

  • Page 47: T Mode

    6 Description of the modes Presets SCOPE OSAS Parameter Preset values EPAP 8 cmH IPAP 13 cmH F min 10 bpm Ti/T set Ramp IN Trigger IN Auto Bi softPAP SCOPE OSAS is suitable for patients with severe obstructive sleep apnea and a high pressure requirement.

  • Page 48: Hft Mode (Prisma30St-Hft Only)

    6 Description of the modes 6.9 HFT mode (prisma30ST-HFT only) In High Flow mode (HFT mode), the device pumps the set flow rate to an external humidifier suitable for HFT. This conditions the respiratory gas in terms of temperature and humidity. The patient connection is made using accessories suitable for HFT.

  • Page 49: Advanced Bilevel Modes In Prisma30St-C, Prisma30St And Prisma30St-Hft

    7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT In the prisma30ST-C and prisma30ST therapy devices, the following ventilation modes have advanced settings. 7.1 aPCV mode In aPCV mode (assisted pressure-controlled ventilation) the therapy device offers the patient pressure support as in S/T mode.
  • Page 50 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description You can set the duration of the inspiration ramp here: • 0: Very steep pressure increase rate. The IPAP is reached after 10% of the inspiration time. •...
  • Page 51 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description Here you set the trigger sensitivity: • 1: Very sensitive • 2: Normal Trigger EX • 3: Very robust Auto • Auto: Automatic 300 ms to 4000 ms Here you can set the inspiration duration.

  • Page 52: S Mode

    7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT SCOPE HYPOV offers an increased pressure range for obstruction therapy (especially for OHS), a medium inspiratory ramp, and effective pressure support. Presets SCOPE COPD Parameter Preset values EPAP 6 cmH IPAP 20 cmH F min 16 bpm...
  • Page 53 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description You can set the duration of the inspiration ramp here: • 0: Very steep pressure increase rate. The IPAP is reached after 10% of the inspiration time. •...

  • Page 54: S/T Mode

    7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description Here you can set the target volume that should be attained. When the target volume is activated, you can also set the following parameters: Target volume • IPAPmin (4 cmH O to 30 cmH O, instead of IPAP)
  • Page 55 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT 7.3.1 Adjustable parameters in S/T mode Parameter Possible values Description EPAP 4 cmH O to 30 cmH O Here you can set the inspiratory positive airway pressure. IPAP 4 cmH O to 30 cmH O Here you can set the expiratory positive airway pressure.
  • Page 56 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description Here you can set the trigger sensitivity: • 1: Very sensitive • 2: Normal • 3: Very robust • Auto: Automatic Setting tips: • Reduce the trigger sensitivity if the therapy device reacts Trigger IN to flow increases which are too slight and thus reaches Auto...
  • Page 57 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT 7.3.2 Presets of SCOPES (therapy goals) Presets SCOPE HYPOV Parameter Preset values EPAP 8 cmH IPAP 18 cmH F min 14 bpm Ti min 0.5 s Ti max 1.7 s Ti timed 1.4 s Ramp IN Ramp EX...

  • Page 58: T Mode

    7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Preset values EPAP 6 cmH Trigger EX Target volume Bi softPAP SCOPE COPD is suitable for patients with chronic stable COPD. SCOPE COPD offers a low pressure for obstruction therapy, a dynamic inspiratory ramp, flatter expiratory ramp, effective pressure support and a shorter inspiration time.
  • Page 59 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT 7.4.1 Adjustable parameters in T mode Parameter Possible values Description EPAP 4 cmH O to 25 cmH O Here you can set the inspiratory positive airway pressure. IPAP 4 cmH O to 30 cmH O Here you can set the expiratory positive airway pressure.

  • Page 60: Autos/T Mode

    7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT 7.5 autoS/T mode The autoS/T mode combines • Pressure support of a BILevel therapy • Backup frequency • Automatic regulation of the expiratory pressure against obstructions • Optional target volume regulation. In combination with the automatic regulation of the pressure against obstructions, this makes it possible to achieve maximum pressure relief in phases with low therapy requirements (e.g., when lying on side) in...
  • Page 61 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description Here you can activate/deactivate the automatic backup frequency. If autoF is deactivated, you can set the parameters F min and Ti/T set, Ti min, Ti max and Ti timed: •...
  • Page 62 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT Parameter Possible values Description Here you can set the target volume that should be attained. When the target volume is activated, you can also set the following parameters: • IPAPmin (4 cmH O to 30 cmH O, instead of IPAP) Target volume...
  • Page 63 7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT SCOPE HYPOV is suitable for patients with obstructive sleep apnea and additional central apneas or pressure support requirements (e.g., intermittent hypoventilation, slight OHS). SCOPE HYPOV offers an increased pressure range for obstruction therapy (especially for OHS), a medium inspiratory ramp, and effective pressure support.

  • Page 64: Particularities With Prismalab

    8 Particularities with prismaLAB Particularities with prismaLAB In the prismaLAB titration device, both the ventilation modes without target volume (see "6 Description of the modes", page 33) and the advanced ventilation modes with target volumes (see "7 Advanced BiLevel modes in prisma30ST-C, prisma30ST and prisma30ST-HFT", page 49) are available to you.

  • Page 65: Hygienic Preparation

    9 Hygienic preparation Hygienic preparation This section describes the intervals for hygienic preparation and the replacement of the bacteria filter. A description of the hygienic preparation can be found in the instructions for use for the patient. 9.1 General information •...

  • Page 66: Intervals With A Patient Change

    9 Hygienic preparation Interval Action Every 6 months • Replace the air filter. Annually • Replace the respiration hose. • Descale the respiratory air humidifier. • Disinfect the respiration hose. As necessary • For hygienic reasons: Replace the housing components of the respiratory air humidifier if they are in poor condition (e.g., if cracks appear).
  • Page 68 Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F: +49 40 54702-461 www.loewensteinmedical.de...

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