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LUVAR A/ LUVAR STA Instructions for use for patients www.heyermedical.de...
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These instructions for use include 76 content pages. The following documents are available in addition to these operating instructions for the LUVAR A/LUVAR STA are available: • LUVAR A / LUVAR STA Instructions for Use for physicians and medical care staff • Service manual...
Inhaltsverzeichnis General Information ..................5 Safety information ..................5 Electrical safety .....................6 Transport and storage information ..............7 Scope of delivery ...................8 Accessories (optional) ..................8 Symbols ......................9 Terms ......................12 Intended purpose ..................13 Indications ......................14 Contraindications ....................14 Side effects ......................14 User training ......................15 Principle of operation ...................15 Product description ..................
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Saving therapy data on the SD card ................25 Removing the SD card ....................26 Controls ......................26 Touch control ......................26 Setting a parameter ...................... 26 Rotary knob control .................... 27 Selection in the icon bar ....................28 Selecting from a list ......................28 Setting a parameter ......................29 Sensor buttons ....................31 Screens .......................
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Air filter modul ....................48 Using the PM2.5 air filter module ..............48 Warnings and troubleshooting ..............49 Warnings ......................49 Troubleshooting ....................50 Device malfunctions ......................50 Problems during therapy ....................51 Cleaning and disinfection ................53 Important information on cleaning and disinfection ........... 53 Cleaning at home ....................54 Cleaning instructions ..................55 Cleaning the respiratory mask ..................
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Maximum flow rate as per ISO 80601-2-70 ..............65 Pneumatic diagram .......................65 Accessories specifications .....................66 Consumables, accessories, and spare parts list ..........66 Consumables .........................66 Accessories ........................67 Spare parts ........................68 Electromagnetic compatibility ................70 Electromagnetic interference emission ................. 70 Electromagnetic immunity .....................71 Maintenance .......................
General Information General Information Read these instructions for use carefully before using the respiratory therapy de- vice for the first time. Follow the important information provided in these instruc- tions for use. Failure to do so may result in accidents as well as personal injury and damage to property.
Do not attempt to open the device or the power supply unit. Service and mainte- nance may only be carried out by persons authorized by heyer medical AG. • Do not touch any exposed, live parts of the power cable or power supply unit.
Transport and storage information WARNING: Risk of injury due to electromagnetic interference! • The use of accessories, transducers and cables not specified or supplied by the manufacturer of this device may result in increased electromagnetic emis- sions from, or decreased electromagnetic immunity for, this device and may result in this or other devices not functioning correctly.
Scope of delivery Scope of delivery After unpacking, make sure everything is present and undamaged. LUVAR respiratory H100 respiratory therapy device humidifier Power supply unit SD card Power cable Transport bag CPAP breathing Patient instruc- tube tions for use Leaflet current Air filter (set of 5) instruction for use patients...
Symbols Symbols Symbols on the device and humidifier „Humidifier“ sensor button „Ramp“ sensor button Observe instructions for use! Inlet (air inlet) Outlet (air outlet) SD card slot Maximum fill level Half fill level Minimum fill level Do not tilt Fill with water here Do not fill with water here Serial number Date of manufacture...
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Symbols Protection against harmful ingress of: • solid foreign bodies with a diameter of 12.5 mm and above, • falling dripping water when the housing is tilted by up to 15°. The device does not feature an alarm system Unique Device Identifier Manufacturer The product contains electrical and electronic components.
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Symbols The product contains electrical and electronic components. It must be disposed of in accordance with the appropriate local, state and federal regulations. Observe the instructions for use supplied! Symbols on the packaging This way up Fragile contents Keep dry Carton must not be rolled Permissible temperature range Permissible humidity range...
Terms In standby: Preheating function active on respiratory humidifier (30 minutes) During therapy: Respiratory humidifier active At least one wake-up alarm active Leakage detected Bacterial filter (activated pressure drop compensation) Filter life expired / change filter element Blower service cycle reached / service Electronic instruction for use Terms Apnea (A)
Intended purpose Other terms Terms Meaning Frequency (Freq) Breaths per minute (bpm) Tidal volume (VT) Volume of air inhaled and exhaled during one breath in milliliters (ml) Leakage Volume of air escaping unused between de- vice and patient in liters per minute (l/min). Minute volume (MV) Volume of air inhaled and exhaled over the course of one minute in liters (l/min).
Intended purpose Indications The LUVAR series devices can be used for the following indications:: LUVAR A • Obstruction sleep apnea syndrome (OSAS) LUVAR STA • Obstruction sleep apnea syndrome (OSAS) • Respiratory failure Contraindications WARNING: Risk of injury due to non-observance of contraindications! The use of respiratory therapy in conjunction with certain pre-existing conditions can lead to injuries to the patient.
AG or authorized dealers. These people must be familiar with how to operate the device and must have read and understood the in- structions for use in full before starting up the device.
Product description The LUVAR STA is a respiratory therapy device that alternates between different pressure levels for inhalation and exhalation (BiLevel). This change between pres- sure levels can be controlled by the patient’s breathing pattern or by time. The pressure levels are set to specific values by the physician in the standard modes.
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Product description LUVAR respiratory therapy device 2 Touch Screen Displays device information, selection and navigation within the menus and sets parameters by touching the screen 3 Rotary knob Selection and navigation within the menus and setting parameters 4 Sensor keys for humidifier and ramp function 5 Power supply connector for humidifier Supplies electrical voltage to the humidifier 6 IR data interface...
Product description Rear of device Water tank release button Water tank Humidifier housing 4 LUVAR respiratory therapy device Filter cover 6 SD card cover Respiratory therapy device power supply connection Supplies electrical voltage to the respiratory therapy device 8 Humidifier release button Page 18...
SD card cover on the left side of the respiratory therapy device. These slots are intended to be used • by patients and medical staff • with the SD cards and accessory modules provided by heyer medical AG. The slots are not intended for controlling the operation of any other medical device or accessory.
3. Lay the power cable so that no one can trip over it and insert the power plug into the mains socket (100-240 VAC, 50/60 Hz). The device will start up automatically. The flash screen showing the heyer logo is displayed for around 20 seconds. The display then switches to the home screen and the device is ready for operation.
Using for the first time 1. On the left of the device, remove the filter cover from the device inlet open- ing. 2. Remove a white air filter from its packaging and place it in the device inlet opening. 3. Replace the filter cover. It should click into place under slight pressure. Connecting the breathing tube system 1.
Using for the first time 4. Run a mask check every time the breathing tube system is changed or a new mask is being used. For instructions, refer to the “Patient settings” section under “Mask calibration”. Note: When using the tube and mask, follow the manufacturer’s specifications in the relevant instructions for use.
Using for the first time 2. Bring the humidifier towards the respiratory therapy device from the right and line up the device and humidifier housings side by side. 3. Press the humidifier gently against the device until it clicks into place. 4.
Using for the first time Note: Do not use any additives, such as fragrance oils or perfumes, as these can re- duce the humidifier output and damage the water tank material. 4. Push the water tank sideways into the humidifier until it clicks into place. 5.
Using for the first time Using an SD card An SD card is included in the scope of delivery for the respiratory therapy device. When the SD card is inserted, the data recorded during therapy are written to the SD card. Your physician can read out and evaluate the data from the SD card to monitor therapy.
Controls Removing the SD card Only remove the card with the device switched off or in standby mode to avoid corrupt data on the SD card. 1. Remove the SD card cover on the left side of the device. 2. Press the SD card momentarily, until you hear a soft click from the slot lock. The SD card then slightly protrudes from the slot.
Controls 2. Touch the check mark button to apply the new value and exit the parameter screen. Alternatively, touch the cancel button with the cross to exit the pa- rameter screen without accepting the new value. Rotary knob control When operating the device via the rotary knob, objects are selected on the display by turning the knob left/right.
Controls Selection in the icon bar Pressing the rotary button takes you back to the Home button (top right) is selected home screen. Turning to the left selects the back button. Pressing the rotary button takes you back to the Back button (top left) is selected previous screen.
Controls Turn the knob to the right in the “Comfort” menu un- til the “Ramp time” menu item is selected. “Comfort” menu is displayed Pressing the rotary knob selects the settings screen for the selected parame- “Ramp time” is selected ter.
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Controls Pressing the rotary knob applies the set value and exits the menu. Apply is selected Turning the knob to the left selects the cancel button. Pressing the rotary knob discards the set value and exits the menu item. Cancel is selected Page 30...
Controls Sensor buttons The sensor buttons above and below the rotary knob provide quick access to spe- cific functions or settings. Icon Meaning Device response • Pressing for approximately 1 second in standby mode: Activate/deactivate preheating for the respiratory humidifier. •...
Screens Screens Home screen Icon bar Date | Icons (see page 14) | Time “Info” button Access to the information menu “Start“ button Starts the predefined therapy “Settings” button Access to the patient settings menu Page 32...
Screens Therapy screen (standard) Icon bar Mode indicator | Icons (see page 14) | Time “Advanced therapy screen” button takes you to the advanced therapy screen during current therapy session Reading display Tidal volume and leakage “Comfort settings” button Shortcut to the settings for heating level and ramp time Reading display Airway pressure “Stop”...
Screens Therapy screen (advanced) Icon bar Mode indicator | Icons (see page 14) | Time “Back“ button switches back to the standard therapy screen Reading display graphic Pressure curve (“P“, depending on setting in hPa, mbar or cmH and flow curve (“V ̇ “, in l/min) Numeric display reading Tidal volume, minute volume, leakage and breathing frequency “Stop“...
Screens Info screen From the home screen, you can access the information area. This is where you can display analyses of the recorded data of your therapy for a selectable time period. Information Description Valid Days This value indicates the number of days when therapy was active for at least 4 hours.
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Screens Freq 95* The value indicates the result of the statistical calculation of the 95th percentile from respiratory rate. Freq 50* The value indicates the result of the statistical calculation of the 50th percentile from respiratory rate. Freq 5* The value indicates the result of the statistical calculation of the 5th percentile from respiratory rate..
Starting the therapy Setting range Parameter Description Standard Time period Last night This is where you can select the time period 1 week for which you want to display the information. 1 month 2 month 3 month 6 month 1 year Starting the therapy 1.
Terminating the therapy Note: The display automatically goes dark after 1 minute. The therapy continues as normal. Whenever you touch the display or operate the rotary knob, the therapy screen is displayed again. The automatic screen timeout can be deactivated (see “Setting device parameters”).
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Patient settings Setting range Parameter Description Standard Automatic Start Activate or deactivate automatic switch-on here. If this function is activated, therapy begins as soon as you inhale and exhale. If this function is deactivated, you must start therapy using the “Start” button. Automatic Stop Activate or deactivate automatic switch-off here.
Patient settings Setting range Parameter Description Standard breasyflex For a description of this function, see the “Comfort functions”. breasyflex in OFF 1 2 3 Note: The function is only available in the breasyflex ex OFF 1 2 3 CPAP and Auto CPAP modes. You can set the degree of reduction here.
Patient settings 4. After the mask has been successfully calibrated, the apply button with the check mark takes you back to the “Comfort” menu. Setting device parameters On the home screen, select the “Settings” button and navigate to the “Device” item in the “Settings”...
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Patient settings Setting range Parameter Description Standard Български Language Select the language for the user interface here. Hrvatski English Français Deutsch Ελληνική Magyar Italiano Lietuvių Nederlands Polski Portuguesa Românesc Español Türkçe Pressure Choose between the pressure units to be dis- unit played here.
Patient settings Setting range Parameter Description Standard Device info electronic Here you will find the link to download the instructions for current instructions for use as a PDF. use for patients Serial number device serial number Software version software version GUILIB Ver.
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Patient settings Setting range Function Parameter Description Standard Alarm Mode The wake-up alarm is disabled. clock Once The alarm will go off once at this time. Every day The alarm will go off every day at this time. Label Alarm clock You can assign a name to the alarm time here.
Patient settings Setting accessories parameters On the home screen, select the “Settings” button and navigate to the “Accessories” item in the “Settings” screen. Parameter Setting range Description Standard Humidifier Off 1 2 3 4 5 You can regulate the humidifier output in increments here.
Comfort functions Comfort functions Ramp The ramp function makes it easier to get used to the prescribed pressure while fall- ing asleep. It allows the pressure to increase steadily over the adjustable ramp time starting from a start pressure (ramp start pressure) up to the prescribed pressure. The start pressure can be set by the physician between 4 hPa and the prescribed pressure.
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Comfort functions breasyflex in: Level max. pressure support 1 hPa 2 hPa 3 hPa breasyflex ex: Level max. pressure support -1 hPa -2 hPa -3 hPa V [l/min] t [s] p [hPa] Δ Δ t [s] 12,0 15,0 18,0 30,0 33,0 Flow proportional pressure increase or decrease exemplarily shown with level 3 of the function breasyflex in and breasyflex ex at different strong respiratory flow curves...
Air fi lter modul Air filter modul The PM2.5 air filter module is available as an optional accessory. The filter module prevents the penetration of particles down to a size of 2.5 μm. Using the PM2.5 air filter module 1. On the left of the device, remove the filter cover from the device inlet open- ing.
Warnings and troubleshooting Warnings and troubleshooting CAUTION: Potentially worse damage to device! • If Ö you notice unexplained changes in the performance of the device, Ö it makes unusual or worrying noises, Ö the device or the power supply has been dropped or not used correctly, Ö...
Warnings and troubleshooting Warning Cause Remedy Change filter The service life for the Replace air filter and reset filter current air filter has been life. exceeded. SD card full No free memory on SD Replace SD card or delete data. card.
Warnings and troubleshooting Malfunctions Possible cause Remedy Display is blank. The screen timeout Touch the display or operate function is active. the rotary knob. The power supply is not Check the connections between connected properly. the power outlet and power cable, power cable and power supply unit, and power supply unit and device.
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Warnings and troubleshooting Problem Possible cause Remedy Skin irritation or Allergic reaction to Contact your physician. rash where the the mask material, Use a fabric mask or a mask cush- mask makes con- e.g. silicone allergy ion. tact Dirty mask Clean the mask daily.
Cleaning and disinfection Cleaning and disinfection Important information on cleaning and disinfection WARNING: Risk of infection due to inadequate cleaning and disinfection! • Compliance with the cycles for cleaning and disinfecting the device and ac- cessories is necessary to prevent respiratory infections. WARNING: Risk of injury from cleaning agents and disinfectants! •...
Cleaning and disinfection Cleaning at home If the respiratory therapy device is operated in a domestic setting without different patients, regularly cleaning the device and accessories is sufficient for hygienic re- processing. The domestic setting also includes shared apartments, nursing homes and care facilities where the respiratory therapy device is operated without chang- ing patients.
Cleaning and disinfection Cleaning instructions Cleaning the respiratory mask For hygienic reasons, clean the mask daily and the head strap weekly, or if you no- tice any contamination. Follow the mask manufacturer’s instructions for use when disassembling, cleaning and reassembling the mask. 1.
Cleaning and disinfection 1. Make sure that the device is disconnected from the power supply. 2. Disconnect the power cable from the power supply unit, the power supply unit from the respiratory therapy device and the humidifier from the respira- tory therapy device.
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Cleaning and disinfection 3. Remove the metal plate on the underside of the water tank by reaching into the recesses with your thumbs and gently forcing the metal plate upwards. Note: The water tank is not dishwasher proof and should therefore only be cleaned by hand.
Cleaning and disinfection Descaling the water tank The water tank can be descaled if required. 1. To do so, disassemble the water tank as you would for cleaning and use, for example, a mild acetic acid solution consisting of one part household vinegar and ten parts water.
Appendix Appendix Technical data Environmental conditions These environmental conditions apply to the device with or without respiratory humidifier. Operation Transport and storage Temperature + 5°C to +35°C -25°C to +70°C Relative humidity 10 % to 90 % 10 % to 90 % non-condensing non-condensing Atmospheric pressure...
Appendix Applied part (IEC 60601-1) Respiratory mask Protection of applied part against elec- Typ BF tric shock Humidifier classification (ISO 80601- Category 2 2-74) Conformity of device and humidifier The respiratory therapy device and humidifier comply with the requirements of the following standards: •...
Appendix Displayed values Displayed value Display range Reading Measurement accuracy accuracy Airway pressure 0 to 25 hPa 0.1 hPa ±(0.4 hPa + 4% of the displayed value) Tidal volume 0 to 3000 ml 1 ml ±20 % Leakage 0 to 170 l/min 0.1 l/min ±12 l/min or 20 % of the measured value, which-...
Humidifier output as per ISO 80601-2-74 >12.5 mg/l Stability of static pressure (long-term accuracy) at 10 hPa as per ISO 80601-2-70 Maximum deviation from set pressure for LUVAR A/STA without and with humidifi- er, with unheated breathing tube: Δp ≤ 0.39 hPa. Page 62...
Appendix Stability of dynamic pressure (short-term accuracy) as per ISO 80601-2-70 CPAP mode LUVAR A/STA with unheated breathing tube Stability of dynamic pressure in CPAP and Auto CPAP mode without humidifier with humidifier at 10 breaths/min 4 hPa Δp ≤ -0.21 hPa Δp ≤...
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Appendix BiLevel mode Deviation from the set pressure given as the mean value and standard deviation of the error between the set values and the supplied values in hPa. LUVAR STA without or with humidifier with unheated breathing tube IPAP 8 hPa 11 hPa 17 hPa...
Storage space min. 8 GByte, recommended 16 GByte Consumables, accessories, and spare parts list To order consumables, accessories and spare parts, please contact your healthcare provider, a heyer medical AG service partner or contact heyer medical AG directly. Consumables Item Image...
Appendix Item Image Item number Nasal pillow mask LuvON PR10 Typ Rolin 323340 Bacterial filter 371006 Instruction for use for physicians and medical care staff 320005 Spare parts Item Image Item number Power supply unit 321000 Page 68...
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Appendix Item Image Item number Power cable, Euro Standard C7 321002 Power cord, UK Standard C7 331033 SD card 321008 Transport bag 321010 CPAP breathing tube - Classic 19 White 320008 Page 69...
Appendix Item Image Item number Patient instruction for use 320003 Electromagnetic compatibility The device meets the requirements of standard IEC 60601-1-2:2014/AMD1:2020 and is intended for use in the electromagnetic environment described below. Environmental conditions deviating from this could impair the performance of the device or lead to failure of the device.
Appendix Interference Compliance Electromagnetic environment - guideline emission RF emissions as Group 1 The device uses RF energy only for per CISPR 11 its internal function. Therefore, its RF emissions are very low and unlikely to cause interference to nearby electronic equipment.
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Appendix Interference IEC 60601 test Compliance level Electromagnetic envi- emission level ronment - guidelines Electrostatic ± 8 kV contact ± 8 kV contact dis- Floors should be discharge (ESD) discharge charge made of wood, according to ± 15 kV air ±...
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Appendix Guidelines and manufacturer’s declaration – electromagnetic immunity The LUVAR respiratory therapy device with or without the H100 respiratory hu- midifier is intended for use in domestic settings as well as in appropriate clinical settings. Device users must ensure that it is used in such a setting. When used in a residential setting (for which Class B is typically required by CISPR 11), this device may not provide adequate protection from radio communication services.
Appendix Interference re- IEC 60601 test Compliance level Electromagnetic envi- sistance tests level ronment - guidelines Magnetic fields 30 A/m 30 A/m Magnetic fields at at supply fre- the mains frequency quency (50/60 should correspond Hz) as per IEC to the typical values 61000-4-8 found in business and hospital settings.
Appendix Packaging The device packaging (cardboard box) will be taken back by the distributor. Howev- er, it can also be disposed of as waste paper. Air filters Used air filter elements can be disposed of with household waste. Breathing tube, mask, bacterial filter In the clinical setting, all parts potentially contaminated by the patient’s breathing air must be disposed of following local regulations for used medical material.
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AG Carl-Heyer-Str. 1/3 56130 Bad Ems, Germany Phone: +49 2603 791 – 0 Fax: +49 2603 791 – 200 www.heyermedical.de This device meets the requirements of Regulation (EU) 2017/745 on medical devices (MDR).
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Scan the QR code for the current instructions for use to download as a PDF: heyer medical AG T +49 2603 791-0 Carl-Heyer-Str. 1/3 F +49 2603 791-200 56130 Bad Ems info@heyermedical.de DE / Germany www.heyermedical.de...
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How can I access the clinical menu to change from auto cpap to cpap mode