ResMed Lumis Series Clinical Manual
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ResMed Lumis Series Clinical Manual

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Clinical guide
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  • Page 1 Clinical guide English...

  • Page 2: Table Of Contents

    Contents Welcome ........................... 1 Indications for use ........................ 1 Lumis 150 VPAP ST-A ....................1 Clinical benefits ........................1 Intended patient population/medical conditions ..............1 Contraindications........................1 Adverse effects ........................2 At a glance ..........................2 About your device ........................ 3 About the control panel ......................
  • Page 3 Configuring iVAPS ......................25 Using Learn Targets ....................25 Entering the target values manually ................26 Working with alarms......................26 Muting activated alarms ....................26 Viewing the alarms ......................27 Alarm log ........................... 27 Alarm types ........................27 Testing the alarms ......................27 Starting therapy ........................
  • Page 4 Technical specifications ......................51 Guidance and manufacturer’s declaration electromagnetic emissions and immunity ..57 Guidance and manufacturer’s declaration—electromagnetic emissions ....... 57 Guidance and manufacturer’s declaration – electromagnetic immunity ......57 Recommended separation distances between portable and mobile RF communications equipment and the device ............59 Symbols ..........................

  • Page 5: Welcome

    Welcome The Lumis 150 VPAP ST-A is a bilevel positive airway pressure device. ™ WARNING • Read this entire guide before using the device. • Use the device according to the intended use provided in this guide. • The advice provided by your prescribing doctor should be followed ahead of the information provided in this guide.

  • Page 6: Adverse Effects

    ™ SD card reader • Air10 oximeter adapter • • Air10 USB adapter • Power Station II • Air10 tubing elbow Note: Make sure all parts and accessories used with the device are compatible. For compatibility information, refer to www.resmed.com.

  • Page 7: About Your Device

    About your device Air outlet HumidAir humidifier Air filter cover Screen Retention clip Adapter cover Power inlet SD card cover Serial number and device number 10 LED alarm indicator About the control panel Press to start/stop therapy. Start/Stop button Press and hold for three seconds to enter power save mode.

  • Page 8: Therapy Information

    Therapy information CPAP mode In CPAP mode, a fixed pressure is delivered. Bilevel modes The Lumis device assists spontaneous breathing by cycling between two pressures in response to the patient flow or a preset fixed time. The inspiratory positive airway pressure (IPAP, or the sum of EPAP and the pressure support level) assists inspiration.
  • Page 9 The following diagram illustrates these operating modes. English...
  • Page 10 The common adjustable parameters for different modes in the Lumis device are shown below. Parameter Mode iVAPS CPAP Set Pressure  IPAP     EPAP      Min PS  Max PS  Min EPAP* ...

  • Page 11: More About Ivaps

    This contributes to iVAPS’ ability to maintain its ventilation target and so stabilise blood gases even during sleep. iVAPS has ResMed’s leak compensation algorithm (Vsync). This promotes synchrony and • comfort even during significant leak.

  • Page 12: Target Alveolar Ventilation

    Target alveolar ventilation iVAPS targets alveolar ventilation. Alveolar ventilation was chosen because gas exchange occurs at the alveoli level. Total ventilation includes the ventilation devoted to the conducting airways, whereas alveolar ventilation best represents the useful portion of ventilation that reaches the alveoli. Alveolar ventilation cannot be measured directly, so iVAPS estimates it using a height approximated value of anatomical deadspace as shown in the graph below.

  • Page 13: Intelligent Backup Rate (Ibr)

    intelligent Backup Rate (iBR) ST and iVAPS modes only Instead of mandating a fixed backup rate, the intelligent Backup Rate (iBR) will shift automatically between two limits. During sustained apnoea, the iBR will adopt a pre-configured Target Patient Rate. This Target Patient Rate defines the upper boundary for iBR.

  • Page 14: Autoepap

    AutoEPAP iVAPS mode only The purpose of AutoEPAP is to maintain upper airway patency. AutoEPAP automatically adjusts pressure in response to flow limitation or obstruction of the upper airway. EPAP is adjusted within Min EPAP and Max EPAP settings with the response depending on the degree of the upper airway obstruction.

  • Page 15: Triggering And Cycling

    Note: In PAC mode, only Triggering is available. TiControl - Inspiratory time control S, ST and iVAPS modes only Unique to ResMed bilevel devices, TiControl allows the clinician to set minimum and maximum ™ limits on the time the device spends in IPAP. The minimum and maximum time limits are set at either side of the patient’s ideal spontaneous inspiratory time, providing a ’window of opportunity’...

  • Page 16: Rise Time Adjustment

    Ti Min or the patient's normal inspiratory time. Leak management with VSync Using ResMed's VSync algorithm, the Lumis device monitors and compensates for leak by continuously and automatically adjusting the baseline flow. This enables reliable delivery of therapy pressure while maintaining patient-device synchrony.

  • Page 17: Comfort Features

    Comfort features Ramp Designed to make the beginning of treatment more comfortable, ramp is available in all modes. In S, ST, T, PAC and iVAPS modes, the EPAP gradually increases from the Start EPAP to the prescribed treatment pressure. Throughout Ramp, Pressure Support is maintained at the same level as that set for treatment.

  • Page 18: Climate Control

    Climate Control Climate Control is an intelligent system that controls the humidifier and the ClimateLineAir heated air tubing to deliver constant, comfortable temperature and humidity levels during therapy. Designed to prevent dryness of the nose and mouth, it maintains the set temperature and relative humidity during sleep.

  • Page 19: Setup

    6. Connect the free end of the air tubing firmly onto the assembled mask. See the mask user guide for detailed information. Recommended masks are available on www.resmed.com. Note: Ensure the device is placed so that the LED alarm indicator is clearly visible.

  • Page 20: Performing A Functional Check

    Performing a functional check Perform a functional test under any of the following circumstances: • Prior to the initial use of the device In between patients • On long-term patients, periodically as per the facility policy • If any problems occur, see the Troubleshooting section of this guide. Also, refer to other provided User Instructions for troubleshooting information.

  • Page 21: Supplemental Oxygen

    Antibacterial filters increase resistance in the air circuit and may affect accuracy of displayed and delivered pressure, particularly at high flows. ResMed recommends using an antibacterial filter with a low impedance [eg, 2 cm H O (2 hPa) at 60 L/min], such as PALL (BB50T), GVS Filter without Luer Port (4222/702) or GVS Filter with Side Port 24966 (4222/701).

  • Page 22: Accessing And Exiting The Clinical Menu

    Accessing and exiting the Clinical Menu You can access, view and set parameters relating to a patient's therapy and device configuration in the Clinical Menu. To access the Clinical Menu: • Press and hold the dial and the Home button for three seconds. The Home screen is displayed with an unlock icon in the top right corner of the screen.

  • Page 23: Setting The Date And Time

    The settings can be changed in different ways depending on the type of screen: Turn the dial to edit live in the Turn the dial to change the Select from a list of options. menu. setting. Setting the date and time Before you set up a new patient and start therapy for the first time, make sure you set the correct local date and time on the device.

  • Page 24: Settings Menu

    Settings menu You set all parameters relating to a patient's therapy and device configuration in the Settings menu. Note: Not all parameters are available in all regions. The default and range values may differ between modes and regions. The range of parameters in the Settings menu are expressed in cm H O, where 1cm H O is equal to 0.98 hPa.
  • Page 25 Parameter Description Mode Range PAC iVAPS CPAP Enable / disable the Off / On (ST mode)   intelligent Backup Rate Always enabled (iVAPS mode) (iBR). Resp. Rate Sets the breaths per 5-50 BPM  minute (BPM). Backup Rate Sets a fixed backup rate. 5-50 BPM ...

  • Page 26: Comfort

    Full Face / Nasal / Pillows /       used by the patient. Pediatric Refer to Mask Device Compatibility List on www.resmed.com. Comfort Parameter Description Mode Range PAC iVAPS CPAP Ramp Time Set the ramp time. Off / 5–45 mins ...

  • Page 27: Alarms

    Parameter Description Range Ext. Select Yes if you connect an external humidifier. No / Yes humidifier View Displayed at all times when an oximeter is connected. 18-300 BPM* oximeter 0-100% SpO * Values from the finger pulse oximeter are averaged over 4 heartbeats. Disconnection or insufficient signal from the finger pulse oximeter would result in displayed value of “--"...

  • Page 28: Options

    Options Parameter Description Range Essentials Set the level of access available to the patient. On / Plus Leak Alert Enable / disable the Leak Alert feature. When enabled, leaks >40 L/min Off / On (0.7 L/s) for >20 sec result in an audible alert and a high leak message is displayed.

  • Page 29: Configuring Ivaps

    Parameter Description Selection Press. Units Set the unit of pressure in which pressure is displayed. cm H O / hPa Desat. Rule Set the oxygen desaturation threshold in accordance with the AASM 3% / 4% criteria. Temp. Units Set the temperature units. °C Restore Reset to default settings (except for language, date and time).

  • Page 30: Entering The Target Values Manually

    While Learn Targets is calculating, you can navigate to the Monitoring screens and back to Learn Targets. You can also exit the Clinical Menu and return later to view the outcome of Learn Targets. During Learn Targets the device delivers two pressures, EPAP and Pressure Support without backup breath (like S mode).

  • Page 31: Viewing The Alarms

    Viewing the alarms To view the alarm list: 1. From the Monitoring screen, turn the dial clockwise until the last Monitoring screen is displayed. 2. To view the alarm details, highlight the alarm and press the dial. Alarm log When an alarm is activated it is logged on the SD card. Ensure that the SD card is properly inserted into the device.
  • Page 32 Setup for testing the alarms: • Turn off all adjustable alarms. Set up the device with the air tubing attached, but no mask. • Set Ramp and SmartStart to Off . • To test the Power fail alarm: 1. Press Start/Stop. 2.

  • Page 33: Starting Therapy

    3. Adjust the mask, mask cushion and headgear until you get a Good result. To stop Mask Fit, press the dial or Start/Stop. If you are unable to get a good mask seal, assess whether you have the right mask size and/or type or contact your ResMed Representative. English...

  • Page 34: Stopping Therapy

    Stopping therapy 1. Direct the patient to remove the mask. 2. Direct the patient to press Start/Stop, or if SmartStart is enabled, therapy will stop automatically after a few seconds. Notes: • If Confirm Stop is enabled, a message is displayed asking if you want to stop therapy. Turn the dial to select Yes and then press the dial to stop therapy.
  • Page 35 Parameter Description More Info Set the time interval covered by the Sleep Report. Period The options are: 1 Day / 1 Week / 1 Month / 3 Months / 6 Months / 1 Year Days Used Number of days the device has been used during the selected period or since the last compliance data was reset.

  • Page 36: Cleaning And Maintenance

    Cleaning and Maintenance It is important that the Lumis device is cleaned regularly to ensure optimal therapy. The following sections will help with disassembling, cleaning, checking and reassembling the device. WARNING Regularly clean the tubing assembly, humidifier and mask for optimal therapy and to prevent the growth of germs that can adversely affect the patient's health.

  • Page 37: Cleaning

    Cleaning You should clean the device weekly as described. Refer to the mask user guide for detailed instructions on cleaning the mask. 1. Wash the humidifier and air tubing in warm water using mild detergent. 2. Rinse the humidifier and air tubing thoroughly and allow to dry out of direct sunlight and/or heat. 3.

  • Page 38: Reprocessing

    WARNING • ResMed cannot give any assurance that deviations from the procedures listed in this guide, and their effect on the performance of the product, will be acceptable. • When using detergents, disinfectants or sterilisation agents, always follow the manufacturer's instructions.

  • Page 39: Reprocessing The Air Tubing And Air10 Tubing Elbow

    2. Run the detergent solution through the air tubing repeatedly until no contamination is visible. 3. Thoroughly rinse each component according to the detergent manufacturer's instructions. ResMed has tested the following detergents according to the manufacturer’s instructions: Detergent Water temperature...

  • Page 40: Disinfecting

    Disinfecting In the procedures below, only one disinfection process needs to be performed. High level thermal disinfection Part Validated number of cycles Hot water: 75°C for 30 minutes OR 70°C for 100 minutes. SlimLine ClimateLineAir ClimateLineAir Oxy Standard Air10 tubing elbow 1.

  • Page 41: Sterilisation

    Sterilisation ResMed has validated the following parts with Sterrad NX/100S: Part Validated number of cycles Sterrad NX Sterrad 100S Standard and Advanced cycles Short cycle ClimateLineAir ClimateLineAir Oxy 1. Sterilize the air tubing using Sterrad by following the manufacturers instructions.

  • Page 42: Reprocessing The Humidifier And Air Outlet

    Reprocessing the humidifier and air outlet Disassembling The following instructions provide guidance on how to correctly disassemble the cleanable humidifier and the air outlet. 1. Remove the humidifier from the device, open it and discard any remaining water. 2. Hold the humidifier base and then fully open the humidifier lid and pull it away so that it easily detaches from the base.

  • Page 43: Decontaminating

    1. Clean all components with a soft bristled brush for one minute while soaking in detergent solution (see table below). Pay particular attention to all crevices and cavities. 2. Thoroughly rinse each component according to the detergent manufacturer's instructions. ResMed has tested the following detergents according to the manufacturer’s instructions: Detergent Water temperature...

  • Page 44: Sterilisation

    3. Repeat the rinse procedure two additional times using fresh water for a total of three rinses. 4. Air dry out of direct sunlight and/or heat. Sterilisation ResMed has validated the following parts with Sterrad NX/100S: Part Validated number of cycles...

  • Page 45: Reassembling

    Reassembling The following instructions provide guidance on how to correctly reassemble the air outlet and the humidifier. To reassemble the air outlet 1. Hold the air outlet with the seal pointing to the left and the clip pointing forward. 2. Make sure that the air outlet is correctly aligned and insert the air outlet into the socket. It will click in place.

  • Page 46: Packaging And Storage

    For therapy management, the Lumis device stores patient therapy data on the device and may have the ability to transfer it remotely to the care provider if wireless network is available. Data can then be accessed via ResMed's AirView therapy management solution.

  • Page 47: Data Storage

    To remove the SD card: 1. Open the SD card cover. 2. Push in the SD card to release it. Remove the SD card from the device. Do not remove the SD card from the device when the SD light is flashing, because data is being written to the card.

  • Page 48: Software Upgrade

    Detailed data are stored on the SD card and can be viewed via ResScan or AirView. Examples of detailed data available are shown below. Detailed data Parameter Sampling rate ResScan AirView Apnoea, hypopnoea or desaturation events aperiodic aperiodic 1/2 Hz (2 sec) 1 min Inspiratory and expiratory pressure (cm H O/hPa)

  • Page 49: Managing Patient Care

    The Lumis device can be used on a plane as it meets the Federal Aviation Administration (FAA) requirements. Air travel compliance letters can be downloaded and printed from www.resmed.com. When using the device on a plane: Make sure the humidifier is completely empty and inserted into the device.

  • Page 50: Troubleshooting

    Troubleshooting If there is a problem, try the following suggestions. If you are not able to fix the problem, contact your local ResMed dealer or ResMed office. Do not open the device. General troubleshooting Problem/possible cause Solution Air is leaking from around the mask Mask may be fitted incorrectly.
  • Page 51 Replace the humidifier. Sleep report for the humidifier indicates Humidifier fault Contact your local ResMed dealer or ResMed office. The patient's therapy data has not been transmitted Wireless coverage may be poor. Advise the patient to place the device where there is coverage (ie, on their bedside table, not in a drawer or on the floor).

  • Page 52: Alarms Troubleshooting

    Problem/possible cause Solution A pediatric mask with a set pressure less than 8 cm H Disable SmartStart. (8 hPa) is used. Displays message: Read only card, please remove, unlock and re-insert SD card SD card switch may be in the lock (read-only) position. Move the switch on the SD Card from the lock position the unlock position and then re-insert it.
  • Page 53 ResMed office. Do not open the device. All other error messages, for example, System fault, refer to user guide, Error 0XX An unrecoverable error has occurred on the device. Contact your local ResMed dealer or ResMed office. Do not open the device. English...

  • Page 54: General Warnings And Cautions

    CAUTION • Use only ResMed parts and accessories with the device. Non-ResMed parts may reduce the effectiveness of the treatment and/or damage the device. • Use only vented masks recommended by ResMed or by the prescribing doctor with this device.

  • Page 55: Technical Specifications

    • Make sure that the humidifier is empty before transporting the device. Note: For any serious incidents that occur in relation to this device, these should be reported to ResMed and the competent authority in your country. Technical specifications Units are expressed in cm H O and hPa.
  • Page 56 Efficiency: >98% for ~7-8 micron dust; >80% for ~0.5 micron dust Aircraft use ResMed confirms that device meets the Federal Aviation Administration (FAA) requirements (RTCA/DO-160, section 21, category M) for all phases of air travel. Wireless module Technology used: 2G GSM, 3G, 4G (LTE) It is recommended that the device is a minimum distance of 2 cm from the body during operation.
  • Page 57 Resmed.com/productsupport This device can be used in all European countries without any restrictions. All ResMed devices are classified as medical devices under the Medical Device Directive. Any labelling of the product and printed material, showing 0123, relates to the Council Directive 93/42/EEC including the Medical Device Directive amendment (2007/47/EC).
  • Page 58 Accuracy may be reduced by the presence of leaks, supplemental oxygen, tidal volumes <100 mL or minute ventilation <3 L/min. Measurement accuracy verified as per EN ISO 10651-6:2009 for Home Care Ventilatory Support Devices (Figure 101 and Table 101) using nominal ResMed mask vent flows. Measurement system uncertainties...
  • Page 59 Pressure accuracy - CPAP Maximum static pressure variation at 10 cm H O (10 hPa) according to ISO 80601-2-70:2015 Standard air tubing SlimLine air tubing Without humidification ± 0.5 cm H O (± 0.5 hPa) ± 0.5 cm H O (± 0.5 hPa) With humidification ±...
  • Page 60 Device without humidification and SlimLine air tubing / Device with humidification and SlimLine air tubing Breath rate Inspiratory pressure (cm H O [hPa]) (Means, Standard Deviations) 10 BPM -0.26, 0.01 / - -0.25, 0.02 / - -0.24, 0.02 / - -0.25, 0.02 / - -0.20, 0.02 / - -0.07, 0.09 / -...

  • Page 61: Guidance And Manufacturer's Declaration Electromagnetic Emissions And Immunity

    Compliance The table illustrates the compliance of air tubing: Air tubing Compliance (cm H O/L/min) with pressure of 60 cm H Air tubing with Air tubing with Air tubing with Air tubing only antibacterial filter antibacterial filter tubing elbow (PALL BB50T) (4222/701, 4222/702) Standard 1.193...
  • Page 62 IEC60601-1-2 test Immunity test Compliance level Electromagnetic environment — guidance level Surge ±1 kV differential ±1 kV differential Mains power quality should be that of a typical IEC 61000-4-5 mode mode commercial or hospital environment. ±2 kV common mode ±2 kV common mode Voltage dips, <5% Ut (>95% dip in 100V...

  • Page 63: Recommended Separation Distances Between Portable And Mobile Rf Communications Equipment And The Device

    Use distilled water only. Operating altitude. Atmospheric pressure limitation. Complies with RTCA DO-160 section 21, category M. MR unsafe (do not use in the vicinity of an MRI device). Date of manufacture. Importer. Medical device. See symbols glossary at ResMed.com/symbols. English...

  • Page 64: Servicing

    • Portable diagnostic/screening devices This warranty is only available to the initial consumer. It is not transferable. If the product fails under conditions of normal use, ResMed will repair or replace, at its option, the defective product or any of its components.
  • Page 65 ResMed shall not be responsible for any incidental or consequential damages claimed to have resulted from the sale, installation or use of any ResMed product. Some regions or states do not allow the exclusion or limitation of incidental or consequential damages, so the above limitation may not apply to you.
  • Page 66 Schülke & Mayr GmbH. Neodisher MediZym is a trademark of Chemische Fabrik Dr Weigert GmbH & Co. KG. Gigasept is a trademark of Schülke & Mayr. Sterrad is a trademark of Johnson & Johnson. SD Logo is a trademark of SD-3C, LLC. © 2019 ResMed Pty Ltd. 288244/4 2019-11...

This manual is also suitable for:

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