Lowenstein Medical prisma20A Instructions For Use For Patients
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Lowenstein Medical prisma20A Instructions For Use For Patients

Sleep therapy device
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EN Instructions for Use for patients for devices of type WM100TD
prisma20A
prisma20C
prismaCR
prisma25S
Sleep therapy device
prisma25S-C
prisma25ST
prismaLAB
prisma30ST

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Summary of Contents for Lowenstein Medical prisma20A

  • Page 1 EN Instructions for Use for patients for devices of type WM100TD prisma20A prisma25S-C prisma20C prisma25ST prismaCR prismaLAB prisma25S prisma30ST Sleep therapy device...

  • Page 2: Table Of Contents

    Contents Contents Introduction 1.1 Intended use ..................... 4 1.2 Description of function ................4 1.3 User qualifications ................... 5 1.4 Indications ....................5 1.5 Contraindications ..................5 1.6 Side effects ....................5 1.7 Clinical benefit ..................6 Safety 2.1 Safety information ................... 7 2.2 General information ................
  • Page 3 Contents 6.3 Setting time parameters ............... 33 6.4 Setting device parameters ..............34 Hygiene treatment 7.1 General information ................35 7.2 Cleaning intervals .................. 35 7.3 Hygiene treatment for therapy device ..........36 7.4 Cleaning air filter (gray filter) ............... 37 7.5 Replacing optional pollen filter (white filter) ........
  • Page 4 Contents 14.6 Scope of supply ..................55 14.7 Warranty ....................56 14.8 Declaration of conformity ..............57 3 | EN...

  • Page 5: Introduction

    Introduction 1 Introduction 1.1 Intended use The WM100TD devices are pressure-controlled, non-invasive, non-life- sustaining therapy devices for the treatment of sleep-related breathing disorders by means of a mask. The WM100TD devices can be used on persons weighing above 30 kg. The CPAP mode can be used on persons above the age of 3 years, irrespective of their weight.

  • Page 6: User Qualifications

    Introduction 1.3 User qualifications The person operating the device is referred to in these instructions for use as the user. A patient, on the other hand, is the person receiving the therapy. Always follow all operating steps according to these instructions for use. Notice for blind or partially-sighted users An electronic version of the instructions for use is also available on the website.

  • Page 7: Clinical Benefit

    Introduction Experiencing the therapeutic pressure as unpleasant, especially in the upper respiratory tract or in the ribcage, aerophagia, flatulence, headache, earache, otitis, aspiration, fatigue, anxiety, feeling of dependence on the therapy device, tinnitus, gagging, periodic leg movements, hypoventilation, episodes of prolonged oxygen desaturation. If the following side effects occur, they may be reduced by using a humidifier and/or a perfectly suited breathing mask: Feeling of dryness in the mouth, throat or upper respiratory tract, (allergic)

  • Page 8: Safety

    Safety 2 Safety Read these instructions for use carefully. They are a constituent part of the devices described and must be available at all times. Use the device exclusively for the purpose described (see „1.1 Intended use“, page 4). For your own safety and the safety of your patients and in accordance with the requirements of (EU) Regulation 2017/745, follow the safety information below.
  • Page 9 Safety 2. Measure the blood pressure after 20 minutes of therapy with the expected medium pressure (e.g., 7 hPa). 3. Measure the blood pressure after 20 minutes of therapy with maximum pressure (e.g., 15 hPa). 2.1.4 USB connection If the USB connection is connected, the PC can cause a higher leakage current. The therapy device cannot detect a USB cable connected to a switched-off PC and an increased leakage current.
  • Page 10 Safety 2.1.8 Disposables Disposables are intended to be used only once. Reused disposables may be contaminated and/or their function impaired, causing injury to the patient.  Do not reuse disposables.  Follow the section on hygiene treatment (see „7 Hygiene treatment“, page 35) to avoid infection or bacterial contamination.

  • Page 11: General Information

    Safety  Maintain a minimum distance of 30 cm between the device and equipment that emits HF radiation (e.g., cell phones). This also applies to accessories such as antenna cables and external antennas.  Do not operate the device outside the EMC environment specified for this device (see „1.1 Intended use“, page 4) in order to prevent undesired...

  • Page 12: Warnings In This Document

    Safety • The owner/operator should regularly assess the effectiveness of the therapeutic settings. • You should also follow the instructions for use of the therapy device, the components, and the accessories. • The device is not suitable for patients requiring continuous support from the ventilation device.

  • Page 13: Product Description

    Product description 3 Product description 3.1 Overview of therapy device Designation Description Covers the humidifier connection if no humidifier is Cover connected. Unlocking button Makes it possible to remove the cover in order to therapy device connect the humidifier. Allows operation of the therapy device and the Display humidifier.
  • Page 14 Product description Designation Description Used for point-to-point connection with a PC on which Micro-USB port prismaTS is installed. Allows settings to be changed on the therapy device and data to be exported. Switches the therapy device on and off. On/off key Switches the therapy device to Standby mode.
  • Page 15 Product description 3.1.2 Symbols in display Symbol Description Expert area opens, allowing you to set the parameters. Expert area opens and the settings are locked. Parameter settings cannot be adjusted. Bacteria filter is connected and activated. If this symbol is displayed even though you are not using a bacteria filter, contact your specialist dealer.
  • Page 16 Product description Symbol Description No network connection available (gray symbol) SD card in SD card slot. Symbol flashes: Data is being saved to the SD card or read from the SD card. Humidifier is connected and switched off. smartAQUAcontrol climate control is switched on. Humidifier is connected and switched on.
  • Page 17 Product description Symbol Description Starts and stops the mask test prematurely. Shows the remaining time in seconds. Switches the softSTART on and off. Shows the set or remaining softSTART time in minutes. prisma30ST, prismaLAB: Switches off the current softSTOP. Shows the remaining softSTOP time in minutes.

  • Page 18: Preparation

    Preparation 4 Preparation 4.1 Setting up the therapy device NOTICE Material damage from overheating! Excessive temperatures may lead to the therapy device overheating and damage the device.  Do not cover therapy device and power supply unit with textiles (e.g., the blanket).
  • Page 19 Preparation 1. Connect the power cord to the power supply unit. 2. Plug the free plug on the power supply unit connecting cable into the power supply connection on the therapy device. Make sure the plug is aligned correctly. EN | 18...

  • Page 20: Connecting Breathing Tube

    Preparation If you want to operate the therapy device at 12 V or 24 V, connect the device to the optionally available inverter WM 24616 (12 V) or WM 24617 (24 V). 3. Plug the free end of the power cord in the power socket. The power supply unit adjusts to the power supply voltage automatically.
  • Page 21 Preparation CAUTION Risk of suffocation if full-face masks without an exhalation system are used! If full-face masks without an integrated exhalation system are used, the concentration may rise to critical values and put the patient at risk.  Use full-face masks with an external exhalation system if there is no integrated exhalation system.

  • Page 22: Operation

    Operation 5 Operation 5.1 Switching on the therapy device for the first time The therapy device must be configured before being used for the first therapy. If your specialist dealer has not yet done so, you must adjust the settings. NOTICE Material damage due to interruption of the power supply during configuration!

  • Page 23: Navigating In The Menu

    Operation 4. Setting the time: • Select summer time or winter time • Set the minutes using the right arrow keys. • Select hour format: 24 h (0 to 24 hours) or 12 h (0 to 12 hours) • To set the hours: Select a different time zone. 5.

  • Page 24: Switching Device On And Off / Starting And Ending Therapy

    Operation 5.3 Switching device on and off / Starting and ending therapy ACTION Key or action Result Standby mode. You can adjust Switching on Press on/off key the settings on the therapy the device device. Press on/off key Therapy mode. You can Starting perform the mask test and therapy...
  • Page 25 Operation • A softSTART pressure is set (see „6.1 Setting comfort parameters“, page 32). 1. Start therapy. 2. If softSTART was activated during the last therapy: softSTART starts automatically when the therapy starts. Press the softSTART key to switch on softSTART. The remaining time in minutes is shown.

  • Page 26: Using The Humidifier

    Operation 5.4.3 Therapy result The therapy data for the last therapy period is shown briefly after ending the therapy if the physician or specialist dealer has enabled this function. In all other cases, only the usage time is displayed. The more green checks are shown (max. 3), the better the result. 5.5 Using the humidifier You can activate smartAQUAcontrol climate control to keep humidification performance constant during therapy.

  • Page 27: Setting The Alarm

    Operation 2. The keys can be used to increase or decrease the humidifier level. The humidifier levels 1-7 are available. The setting suitable for you depends on the room temperature and humidity. Humidifier level 4 is the standard setting. If you have dry airways in the morning, heating output is set too low.

  • Page 28: Accessing Therapy Data And Device Information

    Operation 5. To set the wake-up time, use the left arrow keys to select the hours and the right arrow keys to select the minutes. 6. Confirm the settings with the key. 5.6.2 Switching off the alarm Requirement • The alarm is ringing. 1.

  • Page 29: Using The Sd Card

    Operation 2. If necessary, To view therapy data from a night other than the previous night, select the desired date in the list 3. To view the device information, navigate to the next screen using the arrow keys. 5.8 Using the SD card An SD card is not essential for operating the therapy device.
  • Page 30 Operation 2. Push the SD card into the SD card slot until you hear it engage. In doing so, please note: The beveled corner of the SD card must be at the top and facing the device during insertion. 3. Close the SD card slot cover. Saving therapy data to the SD card NOTICE Loss of data if power is interrupted!
  • Page 31 Operation • The info menu with the therapy data for the requested period is open (see „5.7 Accessing therapy data and device information“, page 27). 1. To save all the therapy data to the SD card, press the SD card key 2.
  • Page 32 Operation 1. Insert the SD card with the saved device settings (see „5.8.1 Inserting the SD card“, page 28). The message Configuration via SD card was successful appears on the display. You can continue the therapy with the new settings. If the new settings for your device were not suitable or could not be read, the message Configuration via SD card has failed appears on the display.

  • Page 33: Settings In The Menu

    Settings in the menu 6 Settings in the menu The settings menu lets you adjust the settings of the comfort, accessories and time parameters if the therapy device is in Standby mode. Only applies to prisma30ST/prismaLAB: If the softSTOP function is activated, ventilation pressures and background frequency are continuously reduced.

  • Page 34: Setting Accessory Parameters

    Settings in the menu Parameter Adjustable values Description Levels 1 and 2 (slight and normal breathing relief) of softPAP breathing relief are intended for patients who find it unpleasant to exhale against a high pressure. The breathing relief function reduces the pressure early during the transition to expiration, allowing you to breathe out more easily.

  • Page 35: Setting Device Parameters

    Settings in the menu 3. Configure the required settings and confirm. You can reset the time to the end of the last therapy at most. 6.4 Setting device parameters Requirement • The therapy device is in Standby mode. 1. Press the menu key 2.

  • Page 36: Hygiene Treatment

    Hygiene treatment 7 Hygiene treatment WARNING Risk of infection when the device is used again! If the device is used by several patients, infections may be transmitted to the next patient.  If the device is used again: have the device subjected to a hygiene treatment by the manufacturer or the authorized specialist dealer.

  • Page 37: Hygiene Treatment For Therapy Device

    Hygiene treatment Interval Action If the therapy device or humidifier has been used without a On change of bacteria filter: Have professional hygiene treatment performed patient before using the device again. Send therapy device to specialist dealer. 7.3 Hygiene treatment for therapy device CAUTION Risk of injury from electric shock! Penetration of fluids may lead to a short circuit, injure the user, and...

  • Page 38: Cleaning Air Filter (Gray Filter)

    Hygiene treatment 7.4 Cleaning air filter (gray filter) 1. Remove air filter. 2. Clean air filter under running water. 3. Allow air filter to dry. 4. Insert air filter in the holder. 7.5 Replacing optional pollen filter (white filter) 1. Remove air filter. 2.

  • Page 39: Hygiene Treatment For Breathing Tube

    Hygiene treatment 4. Insert air filter in the holder. 7.6 Hygiene treatment for breathing tube NOTICE Material damage as a result of ingress of liquids! The device may be damaged by the ingress of liquids.  Use the breathing tube only when completely dry. 1.

  • Page 40: Function Check

    Function check 8 Function check 8.1 Intervals Carry out a function check after every hygiene treatment and maintenance task, but at least every 6 months. 8.2 Checking therapy device Requirement • The patient has been disconnected from the therapy device. •...

  • Page 41: Alarms And Faults

    Alarms and faults 9 Alarms and faults If you are unable to remedy faults with the aid of the table, or in the event of unexpected operation or an incident, contact your authorized specialist dealer to have the device repaired. To avoid exacerbating the damage, do not continue operating the device.

  • Page 42: Therapy Device Faults

    Alarms and faults Requirement • An information signal is triggered. 1. Press the mute symbol The information signal is muted for 2 minutes. The symbol turns orange. After 2 minutes, the information signal sounds again. 9.1.2 Pausing information signals If an information signal sounds, you can pause the it for 2 minutes to operate the device normally in the meantime.

  • Page 43: Display Messages

    Alarms and faults Fault Cause Remedy autoSTOP function not Activate autoSTOP function (see 6.1, p. 32) activated. Therapy device does not switch off after approx. 5 autoSTOP function may be seconds once mask is restricted in the case of Contact your specialist dealer. removed.
  • Page 44 Alarms and faults Error code Cause Remedy Try again later. No mobile wireless Error occurs relatively frequently: Select a location network available with better reception. No remedy possible: Contact your specialist dealer. Mobile wireless network not Try again later. No remedy: Contact your specialist providing a data dealer.

  • Page 45: Servicing

    Servicing 10 Servicing The therapy device is designed for a service life of 6 years. If the therapy device is used as intended in accordance with the instructions for use, it does not require any maintenance within this period. If the therapy device is used beyond this period, we recommend having it checked by an authorized specialist dealer.

  • Page 46: Technical Data

    Technical data 13 Technical data 13.1 Technical data therapy device Specification Therapy device Product class to MDR (EU) 2017/745 Dimensions Width x Height x Depth 17 x 13.5 x 18 cm Weight 1.4 kg Temperature range - Operation +5°C to +40°C - Transport and storage -25 °C to +70 °C Allow to cool or heat up to room temperature...
  • Page 47 Technical data Specification Therapy device All device types Disconnection, high leak Information signals (optional) prisma30ST, prismaLAB Apnea, low minute volume, low tidal volume CPAP operating pressure range 4 hPa to 20 hPa AcSV pressure range 4 hPa to 30 hPa BiLevel pressure range 4 hPa to 30 hPa <...
  • Page 48 Technical data Pressure measured at the Mean flow rate prevai- Maximum flow rate to patient connection opening ling at the patient con- ISO 80601-2-70 at a flow rate of 40 l/min nection opening when using the 15 mm tube Test pressures: 4 hPa 4.0 hPa 204 l/min...

  • Page 49: Bilevel Device Variants

    Technical data No part of the therapy devices contains latex. Therapy devices of the type WM100TD use the following open-source software: FreeRTOS.org The software of this device contains code which is subject to the GPL. You can obtain the source code and the GPL on request. 13.2 BiLevel device variants SPECIFICATION prisma30ST...

  • Page 50: Filters And Smoothing Techniques

    Technical data 13.3 Filters and smoothing techniques Adjustable target volume: In the "slow" stage, the device checks after 8 breaths whether the target volume has been reached and changes the pressure by 0.5 hPa. If the pressure reaches a corridor around the target volume, the device switches to precise control.
  • Page 51 Technical data The power supply unit is part of the devices of type WM100TD. EN | 50...

  • Page 52: Annex

    Annex 14 Annex 14.1 Pressure/volume curve p/V curve at AV = 0.5 l and f = 20/min 0,00 5,00 10,00 15,00 20,00 Pressure Druck [hPa] 14.2 Pneumatics diagram pressure Flow adjuster source Patient mask Nasal or full-face mask Inlet Ambient air Optional Optional Breathing tube...

  • Page 53: Electromagnetic Interference Immunity

    Annex Group 1 / Class B* * Radiated emissions Class A when Conducted and radiated RF emissions CISPR 11 operated in combination with accessories WM090MC, WM100MC or WM100MP Harmonic distortion IEC 61000-3-2 Class A Voltage fluctuations and flicker IEC 61000-3-3 Complies Conducted and radiated RF emissions for airborne equipment RTCA DO-160G - Section 21,...

  • Page 54: Markings And Symbols

    Annex 14.5 Markings and symbols The following symbols may be applied to the device, the device ID plate, accessories, or packaging. Symbol Description Serial number Date of manufacture Follow the Instructions for Use Inlet Follow the Instructions for Use Slot for SD card USB port On/off key Outlet...
  • Page 55 Annex Symbol Description Suitable for use in aircraft. Meets RTCA/DO-160G Section 21, Category M. Applied part type BF Manufacturer CE symbol (confirms that the product conforms to the applicable European directives/regulations) Alternating current China RoHS label (confirms that the product does not produce toxic substances during the indicated service life).
  • Page 56 Annex Symbol Description Protect from moisture Lot number Order number 14.6 Scope of supply 14.6.1 Standard scope of delivery A current list of scopes of supply can be ordered on the manufacturer's website or through your specialist dealer. The parts below are included in the standard scope of supply: Part Article number Basic device...
  • Page 57 Annex Part Article number 3G modem WM110MW WM 31770 4G modem WM110MW EU LMT 31831 4G modem WM110MW Japan LMT 31832 4G modem WM110MW Canada LMT 31833 Cloud platform prisma CLOUD WM 29610 Software prismaTS WM 93335 Breathing tube 19 mm (22 mm) WM 24445 Breathing tube 19 mm (22 mm), can be autoclaved WM 24667...
  • Page 58 Annex Product Warranty periods Masks including accessories, rechargeable batteries, batteries (unless stated otherwise in the technical documentation), sensors, 6 months patient circuits Disposable products None 14.8 Declaration of conformity The manufacturer Löwenstein Medical Technology GmbH + Co. KG (Kronsaalsweg 40, 22525 Hamburg, Germany) hereby declares that the product complies with the relevant provisions of the Medical Device Regulation (EU) 2017/745.
  • Page 60 Manufacturer Löwenstein Medical Technology GmbH + Co. KG Kronsaalsweg 40 22525 Hamburg, Germany T: +49 40 54702-0 F:+49 40 54702-461 www.loewensteinmedical.com...

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