Viatom LeRe, Instructions For Use Manual

Page 1: ...1 Non invasive Ventilator Shenzhen Viatom Technology Co Ltd Instructions for Use ...

Page 2: ... 11 3 Preparation before use 16 4 Instructions for use 17 5 Common problem 27 6 Cleaning and maintenance 29 7 Maintain 30 8 Storage and disposal 30 9 Attachment list 32 Appendix A Technical Specifications 32 Appendix B Electromagnetic compatibility 41 ...

Page 3: ...ce when in use The device cannot be exposed to electrosurgery defibrillation X ray γ ray or infrared radiation When the electromagnetic field includes magnetic resonance MRI or CT inspection environment and radio interference environment the device will not operate normally in this environment Portable and mobile radio frequency communication device may affect the use of this device When using thi...

Page 4: ...sed by the use of breathing tubing and hoses Check the pipeline for damage or wear and replace the pipeline if necessary The patient is the intended operator The patient can safely use the treatment function of the device When the patient is using it the parts of the device cannot be maintained or repaired When using oxygen the oxygen supply must comply with local standards for medical oxygen It i...

Page 5: ...device please follow local environmental regulations When you need to measure blood oxygen and ECG please refer to the user manual of the appropriate oximeter and ECG Other equipment connected to the signal port of the product must meet the requirements of relevant standards such as IEC 60601 1 or IEC 62368 1 etc Do not place the device where it is difficult to disconnect the power supply Although...

Page 6: ...lectric shock Do not immerse the device in water or other liquids Please pay attention to waterproofing When the accidental damage of the physical media causes system failure power failure hardware failure and software failure the protection of the physical environment should be strengthened and the use of device should be strengthened When man made threats cause accidental loss of backup data net...

Page 7: ...ng the device and contact the device provider immediately Because it may cause allergies If the machine has abnormal working conditions such as abnormal noise falling water entering the machine or breaking of the machine shell please disconnect the power supply stop using the machine and contact the device provider immediately ...

Page 8: ...e or control close to where the symbol is placed or that the current situation needs operator awareness or operator action in order to avoid undesirable consequences Indicate separate collection for electrical and electronic device WEEE Indicates the medical device manufacturer Indicates the date when the medical device was manufactured Serial Number Indicates the date after which the medical devi...

Page 9: ...p therapy button This product complies with the Europea Council EU 2017 745 MDR Authorized representative in the European Community Indicates a carrier that contains unique device identifier information The product has passed FCC certification ...

Page 10: ...e range S mode Autonomous trigger mode When the device is ventilated the patient s own breathing is used to control the operation of the device the device provides inspiratory pressure when inhaling and the device provides expiratory pressure when exhaling and the breathing rate of the device is fully synchronized with that of the patient S T mode Autonomous trigger time mode When the device is ve...

Page 11: ... models are divided according to different product configurations see the table below for details Model configurations LeRes B R100 LeRes S R200 LeRes B1 R101 LeRes S1 R201 LeRes C R10 LeRes A R20 LeRes C1 R11 LeRes A1 R21 Colour Black Black Blue Black Black Blue Black Black Blue Black Black Blue White White Blue White White Blue White White Blue White White Blue CPAP mode APAP mode S mode S T mod...

Page 12: ...WIFI Bluetooth Turbo code B B B B C C C C A A A A C C C C Note 1 stands for standard configuration stands for optional configuration stands for none Turbine information is disclosed in technical documents ...

Page 13: ...on and diagnosis can this device be used for treatment Absolute contraindications pneumothorax pneumomediastinum cerebrospinal fluid leakage craniocerebral trauma or intracranial trauma or intracranial pneumoconiosis shock caused by various causes and has not been corrected epistaxis is active epistaxis has not been effectively controlled Gastrointestinal bleeding coma or unconsciousness that cann...

Page 14: ...ter needed for the humidifier 5 Indicator light Indicating effect 6 Home button Click to return to the main interface of the system 7 Delay boost button Click to set the delay boost time 8 Radiator cap Open the water tank cover to extract the water tank 9 Start stop button Start and stop device ventilation 10 Air inlet The air inlet of the device the installation position of the filter cotton 11 P...

Page 15: ...of the humidifier 2 Pour water into the water tank the water volume does not exceed the highest water level line of the water tank 3 Put the water tank back into the humidifier and buckle the water tank cover Notice Only distilled water or purified water can be filled and the amount of water added each time should not exceed the highest water level line of the water tank When the water volume of t...

Page 16: ...materials Do not place it directly on a container with water 3 2 Install the filter The air inlet of the device is equipped with reusable filter cotton and the device can only be used after the filter cotton is installed Please check the filter every 1 3 months If there is any foreign matter or dust blocking the air inlet please clean or replace the filter cotton Please follow the steps below to i...

Page 17: ... headband of the face mask so that the face mask fits the face and does not leak air Notice Do not pull the pipeline to avoid air leakage If the mask and pipeline are damaged please stop using it and replace it in time 3 5Device Operation Guide The user interface of this device allows you to adjust device settings and check your treatment information The user interface includes a display screen an...

Page 18: ...fore the power failure 2 Under normal conditions there is a leak hole on the full face mask When the patient exhales the exhaled carbon dioxide is squeezed out from the leak hole through the patient s exhaled pressure and the pressure output by the ventilator 3 In a single fault state when the power is off when the patient exhales the exhaled carbon dioxide is simultaneously squeezed out from the ...

Page 19: ...a will be displayed by default and you can select other usage times for query 4 6 Function menu description The system will display different menu items according to different user types including three modes of menus normal mode advanced mode and maintenance mode After the device is started it enters the normal mode by default Standby interface Ventilation interface 4 6 1Normal mode menu This mod...

Page 20: ...ears the mask and breathes Optional value on off the default value is on Automatic stop Turn on off the automatic stop ventilation function when turned on the device will automatically stop the ventilation after detecting that the user takes off the mask Optional value on off the default value is on Delay start pressure Set the starting pressure of the delay boost function Optional value 3 20cmH2O...

Page 21: ... optional values oronasal mask nasal mask nasal pillow default value nasal mask Mask test Test whether the mask is worn correctly If the test fails the position of the mask needs to be re adjusted Remind Set the reminder of the service life of accessories and consumables including filters masks pipes and other accessories optional values off 1 12 months default value off Bluetooth Bluetooth settin...

Page 22: ...t information etc About Display device information including model software version SN etc 4 6 2 Advanced mode menu The advanced mode menu is only for clinicians to operate and set or set according to doctors opinions In order to prevent patients from misoperation it is necessary to manually enter the password to switch to the advanced mode Click the More Parameters button to select the current ve...

Page 23: ...eater than the current expiratory pressure value Expiratory pressure Set the expiratory pressure of the device in S S T and T modes The available values are 4 0 25 0 cmH2O and the default value is 6 0 cmH2O Inspiration time Set the inspiratory time of the device in S T and T mode optional value 0 3 4 0 seconds the default value is 1 0 second Respiratory rate Set the inspiratory time of the device ...

Page 24: ...efer to the following table Tips Function Description High air leakage In the process of using the device if the mask and breathing tube are not properly connected or the water tank is not installed properly the screen will display a prompt message Asphyxia When apnea is detected during the use of the device and the set time is exceeded a prompt message will be displayed on the screen Pipe disconn...

Page 25: ...is turned on when the predetermined filter replacement time is reached the device will issue a reminder to remind you to replace the filter The expiration date of the mask is up please replace it If the mask reminder in the Consumables reminder function is turned on the device will send out a reminder to remind you to replace the mask when the scheduled time for mask replacement is reached 4 8 Con...

Page 26: ...Dynamic ECG Recorder in normal working condition 2 Select the Bluetooth menu in the device s menu turn on the Bluetooth function and wait for the device to search for Dynamic ECG Recorder 3 Select the name of the Dynamic ECG Recorder found and wait for the connection to be completed to see the measurement parameters of the Dynamic ECG Recorder on the device Note The device only supports the Dynami...

Page 27: ...r service Mask leaks Mask size is not suitable Make sure your mask is of the right size please refer to the mask user manual for specific information or use the mask test function to check whether the mask is leaking Dry or blocked nose The humidification gear is set too low Upgrading grade Water in the mask The humidification gear is set too high Lower the gear level or increase the indoor ambien...

Page 28: ... or shorten the delay boost time Leaking water tank The water tank is not installed correctly Damaged water tank Check if the water tank is installed correctly Check whether the water tank is damaged Contact customer service staff to replace the new water tank The touch screen is not responding Touch screen failure Restart if the problem persists please contact customer service Unable to connect t...

Page 29: ...dip in 75 ethanol After cleaning wait for the water tank to dry before installing the water tank back on the device It is recommended to clean the water tank once a week 6 3 Cleaning the mask and pipeline For the cleaning of the mask and pipeline please refer to the instructions in the cleaning section of the instructions attached to the mask and pipeline or consult customer service personnel Afte...

Page 30: ...ntact an authorized dealer 8 Storage and disposal 8 1 Storage 8 1 1 Store information Store the device under specified environmental conditions see Appendix A 8 1 2 Storage of treatment device Turn off the treatment machine Disconnect the treatment machine from the power supply Clean treatment machine parts and accessories Store the treatment machine parts and accessories in a dry place 8 2Discard...

Page 31: ...l interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television ...

Page 32: ... these accessories is detailed in their instructions Name Model Manufacturer Remark Masks 804 HSINER Co Ltd CE 2460 Tubes AT001 70243 HSINER Co Ltd CE 2460 Adapter MDA90B 220S24 18 Enargy Power Shenzhen Co Ltd TUV SUD Report No 68 270 15 017 01 Power line E JUN EJ 601 10A 250V Dongguan E jun Wire Co Ltd China ...

Page 33: ...5ºC 35 ºC Relative humidity 10 95 Non condensing Atmospheric pressure 70kPa 106kPa Storage environment Temperature 25ºC 60ºC Relative humidity 10 95 Non condensing Atmospheric pressure 70kPa 106kPa Running noise A weighted sound pressure level 30 dB A A weighted sound power level 38 dB A Electromagnetic compatibility RF emission level 1 group B grade Electrical Specifications AC input 100 240 V 50...

Page 34: ...allation and use classification Portable device Power connection Adapter detachable power cord Pressure Setting range 4 0 25cmH2O EPAP Maximum ultimate pressure 40cmH2O Single failure 25cmH2O Normal status Static pressure control accuracy 0 5 cmH2O Dynamic pressure control accuracy 1 cmH2O Flow Maximum flow rate 1 3 2 3 and maximum value of the maximum adjustable pressure 8 5cmH2O 120 L min 17 cmH...

Page 35: ...0BLE Support WIFI connection Transmitting frequency or frequency band MHz 2412 2472 Modulation type DSSS OFDM Effective radiated power dBm 16 49 IEEE 802 11b 15 13 IEEE 802 11g 14 96 IEEE 802 11n Connect to devices with blood oxygen module via Bluetooth Pulse oximeter Model Oxiband Oxiband01 manufactured by Viatom CE 0197 Connect to devices with ECG module via Bluetooth Dynamic ECG Recorder Model ...

Page 36: ...of breaths min 10 VT Tidal volume ml 500 Pressure volume curve and breathing pressure Change graph Fractional ratio of maximum adjustable pressure 1 3 IPAP 8 5 cmH2O EPAP 6 5 cmH2O f Respiration rate number of breaths min 15 VT Tidal volume ml 500 Pressure volume curve and breathing pressure Fractional ratio of maximum adjustable pressure 1 3 IPAP 8 5 cmH2O EPAP 6 5 cmH2O ...

Page 37: ... Fractional ratio of maximum adjustable pressure 2 3 IPAP 17 cmH2O EPAP 15 cmH2O f Respiration rate number of breaths min 10 VT Tidal volume ml 500 Pressure volume curve and breathing pressure Fractional ratio of maximum adjustable pressure 2 3 IPAP 17 cmH2O EPAP 15 cmH2O f Respiration rate number of breaths min 15 ...

Page 38: ...table pressure 2 3 IPAP 17 cmH2O EPAP 15 cmH2O f Respiration rate number of breaths min 20 VT Tidal volume ml 500 Pressure volume curve and breathing pressure Fractional ratio of maximum adjustable pressure 3 3 IPAP 25 cmH2O EPAP 23 cmH2O f Respiration rate number of breaths min 10 VT Tidal volume ml 500 ...

Page 39: ...ure 3 3 IPAP 25 cmH2O EPAP 23 cmH2O f Respiration rate number of breaths min 15 VT Tidal volume ml 500 Pressure volume curve and breathing pressure Fractional ratio of maximum adjustable pressure 3 3 IPAP 25 cmH2O EPAP 23 cmH2O f Respiration rate number of breaths min 20 VT Tidal volume ml 500 ...

Page 40: ...40 Pressure volume curve and breathing pressure ...

Page 41: ...oltage fluctuations flicker emissions IEC 61000 3 3 Comples Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity test IEC EN 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic discharge E...

Page 42: ...istic of a typical location in a typical commercial or hospital environment Note UT is the AC mains voltage prior to application of the test level Guidance and Manufacturer s Declaration Electromagnetic Immunity This device is intended for use in the electromagnetic environment specified below The user of this device should make sure it is used in such an environment Immunity Test IEC EN 60601 1 2...

Page 43: ... structures objects and people a The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 MHz to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz to 27 283 MHz and 40 66 MHz to 40 70 MHz b The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz and 2 5 GHz are intended to decrease the likelihood that mobile portable com...

Page 44: ...M bands d 0 35 P 150 kHz to 80 MHz in ISM bands d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 035m 0 12m 0 12m 0 23m 0 1 0 11m 0 38m 0 38m 0 73m 1 0 35m 1 2m 1 2m 2 3m 10 1 1m 3 8m 3 8m 7 3m 100 3 5m 12m 12m 23m For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be determined using the equation applicable to...

Page 45: ...n 518101 Guangdong China www viatomtech com MedNet EC REP GmbH Borkstrasse 10 48163 Muenster Germany PN 92 01650 00 Version A Contents of this manual are subject to changes without prior notice Copyright 2018 Shenzhen Viatom Technology Co Ltd All rights reserved Non invasive Ventilator Revision date July 2021 Non invasive Ventilator 0197 ...