ResMed lumis series, Clinical Manual

Page 1: ...Clinical guide English...

Page 2: ...t mode 4 More about iVAPS 7 Target alveolar ventilation 8 intelligent Backup Rate iBR 9 AutoEPAP 10 Triggering and cycling 11 TiControl Inspiratory time control 11 Rise time adjustment 12 Leak managem...

Page 3: ...the air tubing and Air10 tubing elbow 35 Disconnecting 35 Decontaminating 35 Disinfecting 36 Sterilisation 37 Inspecting 37 Reconnecting the air tubing 37 Packaging and storage 37 Reprocessing the hu...

Page 4: ...immunity 57 Guidance and manufacturer s declaration electromagnetic emissions 57 Guidance and manufacturer s declaration electromagnetic immunity 57 Recommended separation distances between portable...

Page 5: ...mproved quality of life The clinical benefits of bilevel therapy for the treatment of respiratory insufficiency may include improvement in overall survival daytime symptoms blood gases health related...

Page 6: ...lowing Device HumidAir humidifier if supplied Air tubing Power supply unit Travel bag SD card already inserted Contact your care provider for a range of accessories available for use with the device i...

Page 7: ...y Press and hold for three seconds to enter power save mode Dial Turn to navigate the menu and press to select an option Turn to adjust a selected option and press to save your change Home button Pres...

Page 8: ...e difference between IPAP and EPAP levels helps determine the tidal volume ST Spontaneous Timed mode In ST mode the device augments any breath initiated by the patient but will also supply additional...

Page 9: ...English 5 The following diagram illustrates these operating modes...

Page 10: ...wn below Parameter Mode S ST T PAC iVAPS CPAP Set Pressure IPAP EPAP Min PS Max PS Min EPAP Max EPAP Resp Rate Backup Rate Target Pt Rate Target Va Ti Ti Max Ti Min Rise Time Trigger Cycle Height Only...

Page 11: ...S offers the comfort and synchrony of pressure support but with the assurance offered by a volume target iVAPS has the following advantages over traditional VAPS schemes iVAPS is a unique combination...

Page 12: ...lar ventilation cannot be measured directly so iVAPS estimates it using a height approximated value of anatomical deadspace as shown in the graph below Anatomic deadspace is the amount of breath that...

Page 13: ...tion the iBR adjusts to remain in the background at two thirds of the Target Patient Rate This background backup rate is lower than a traditional S T rate so gives the patient maximum opportunity to s...

Page 14: ...upport is sacrificed to maintain airway patency ie EPAP However pressure support will not drop below the set minimum pressure Min PS a For flow limitation EPAP will increase at a maximum rate of 0 5 c...

Page 15: ...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 t...

Page 16: ...C and iVAPS modes Rise Time sets the time taken for the device to reach IPAP The greater the rise time value the longer it takes for pressure to increase from EPAP to IPAP Patients with a high ventila...

Page 17: ...support Min PS In CPAP mode the pressure increases from a low pressure Start Pressure to the prescribed treatment pressure Ramp Down S ST T PAC and iVAPS modes When stopping therapy Ramp Down gives pa...

Page 18: ...ient This ensures the temperature of the air delivered to the patient does not fall below the set minimum temperature therefore maximising breathing comfort for the patient Climate Control Manual Desi...

Page 19: ...power cord into the power supply unit and the other end into the power outlet 3 Connect the air tubing firmly to the air outlet located on the rear of the device 4 Open the humidifier and fill it with...

Page 20: ...onitoring screen will display at the bottom of screen if the humidifier is in use 4 Check the pulse oximeter if in use Attach the accessories according to the setup instructions in the Oximeter Adapte...

Page 21: ...ventilation and AHI Before adding oxygen familiarise yourself and your patient with the specific warnings relating to the use of supplemental oxygen These can be found at the end of this guide Antiba...

Page 22: ...of the screen To exit the Clinical Menu Press and hold the dial and the Home button for three seconds Select Exit Clinical Menu from the Home screen The device will automatically exit the Clinical Me...

Page 23: ...ect Date and change the setting to the correct date 2 Select Time and change it to the correct local time 3 Make sure the correct local time and date has been applied The Lumis settings must be config...

Page 24: ...is triggered into inspiration 4 30 cm H2O 4 30 hPa 0 2 cm H2O 0 2 hPa increments EPAP Sets the pressure to be delivered to the patient when the device is cycled into expiration 2 IPAP cm H2O 2 IPAP hP...

Page 25: ...4 0 sec 0 1 sec increments Dependent on Respiratory Rate Ti Max Set the maximum limit on the time the device spends in IPAP 0 3 4 0 sec 0 1 sec increments Dependent on Backup Rate Ti Min Set the minim...

Page 26: ...sure 0 2 cm H2O 0 2 hPa increments Start EPAP Set the pressure at the start of ramp up to minimum treatment pressure 2 EPAP or 2 Min EPAP if AutoEPAP is enabled 0 2 cm H2O 0 2 hPa increments Climate C...

Page 27: ...ilation alarm Activates within 20 40 seconds after the measured level remains below the set limit Note Alarm may not trigger reliably when using a P10 mask Off 1 10 L min 1 L min increments Low SpO2 S...

Page 28: ...ask Set a recurring reminder to the patient to replace the mask Off 1 24 mths 1 month increments Humidifier Set a recurring reminder to the patient to replace the humidifier Off 1 24 mths 1 month incr...

Page 29: ...ilation with the goal of learning the patient s Target Alveolar Ventilation Target Va and Target Patient Rate Target Pt Rate in preparation for iVAPS mode After the final circuit configuration include...

Page 30: ...itted with an alarm feature that monitors patient therapy and alerts you to changes that may affect treatment If the device has not been properly set up an alarm may be activated Check that the power...

Page 31: ...ice are classified as medium priority Fixed alarms Adjustable alarms The alarms pre set for the device are Power fail Blocked tube Tube disconnected System fault system error Alarms that can be set ar...

Page 32: ...for 120 150 seconds To test the Tube disconnect alarm 1 Disconnect air tubing at the air outlet 2 Press Start Stop The alarm activates after 5 10 seconds To test the High leak alarm 1 Set the High lea...

Page 33: ...contract as the patient breathes in and out The screen will go black automatically after a short period of time You can press Home or the dial to turn it back on If power is interrupted during therapy...

Page 34: ...scroll down to view more detailed usage data The parameters displayed will depend on the therapy mode Sleep Report screen parameters Parameter Description Usage hours Number of hours the device has be...

Page 35: ...centile for each day average of 95th percentile values for periods 1 day Leak Average of the 95th percentile values of leak during the selected period for days with usage only Vt Average of the 50th p...

Page 36: ...timal therapy and to prevent the growth of germs that can adversely affect the patient s health Disassembling 1 Hold the humidifier at the top and bottom press it gently and pull it away from the devi...

Page 37: ...mage 1 Check the humidifier Replace it if it is leaking or has become cracked cloudy or pitted Replace it if the seal is cracked or torn Remove any white powder deposits using a solution of one part h...

Page 38: ...s 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 Beware of electr...

Page 39: ...e table below Pay particular attention to all crevices and cavities 2 Run the detergent solution through the air tubing repeatedly until no contamination is visible 3 Thoroughly rinse each component a...

Page 40: ...ut of direct sunlight and or heat High level chemical disinfection Part Validated number of cycles CIDEX OPA Ortho phthalaldehyde 0 55 for 12 minutes Gigasept FF 5 for 15 minutes SlimLine 100 ClimateL...

Page 41: ...e excess water 4 Allow the air tubing to air dry out of direct sunlight Inspecting Perform a visual inspection of the components If any visible deterioration is apparent holes tears or cracks etc the...

Page 42: ...ully open the humidifier lid and pull it away so that it easily detaches from the base 3 Remove the humidifier seal from the humidifier lid by pulling it away 4 Align the swivel so that the connector...

Page 43: ...ed at 1 Hot water approx 60 C Warm water approx 45 to 60 C Room temperature water approx 21 C Gigazyme diluted at 1 0 Room temperature water approx 21 C Aniosyme DD1 Disinfecting In the procedures bel...

Page 44: ...rect sunlight and or heat Sterilisation ResMed has validated the following parts with Sterrad NX 100S Part Validated number of cycles Sterrad NX Standard and Advanced cycles Sterrad 100S Short cycle A...

Page 45: ...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 3 Check i...

Page 46: ...iew or ResScan refer to the manuals supplied with the software Remote monitoring If wireless network is available the Lumis device wireless communication capability can be used to automatically transm...

Page 47: ...l volume are stored on the SD card and can be viewed with AirView and ResScan High resolution flow and pressure data are stored on the SD card Data can be transmitted to therapy management software ei...

Page 48: ...and expiratory pressure cm H2O hPa 1 2 Hz 2 sec 1 min Leak L sec 1 2 Hz 2 sec 1 min Respiratory rate BPM 1 2 Hz 2 sec 1 min Tidal volume mL 1 2 Hz 2 sec 1 min Minute ventilation L min 1 2 Hz 2 sec 1 m...

Page 49: ...trength of coverage by the number of bars displayed the higher the number of bars the stronger the signal Travelling Patients can take their Lumis device wherever they go Advise patients of the follow...

Page 50: ...ser guide The patient is getting a very dry mouth Air may be escaping through the patient s mouth Increase the Humidity Level The patient may need a chin strap to keep the mouth closed or a full face...

Page 51: ...r on the floor The Wireless signal strength icon indicates good coverage when all bars are displayed and poor coverage when fewer bars are displayed The No wireless connection icon is displayed on the...

Page 52: ...has been turned off during therapy Ensure the power cord is connected and the mains power switch if available is on Displays message High leak detected check your water tub tub seal or side cover Hum...

Page 53: ...device Air filter may be blocked Check the air filter and replace it if there are any blockages Disconnect the power supply and then reconnect it to restart the device Air tubing may be blocked Check...

Page 54: ...necessary the device should be observed to verify normal operation in the configuration in which it will be used The use of accessories other than those specified for the device is not recommended The...

Page 55: ...ure 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 y...

Page 56: ...settings Low nominal 54 dBA Medium nominal 60 dBA High nominal 73 dBA Physical device and humidifier Dimensions H x W x D 116 mm x 255 mm x 150 mm Air outlet complies with ISO 5356 1 2015 22 mm Weigh...

Page 57: ...iVAPS 2 to 30 cm H2O 2 to 30 hPa CPAP 4 to 20 cm H2O 4 to 20 hPa Intended tidal volume range 100 2500 mL Supplemental oxygen Maximum flow 15 L min S ST T PAC CPAP 4 L min iVAPS Pneumatic flow path 1 F...

Page 58: ...Mask pressure2 0 5 cm H2O 0 5 hPa 4 of measured value Flow and flow derived values1 Flow 6 L min or 10 of reading whichever is greater at 0 to 150 L min positive flow Leak2 12 L min or 20 of reading w...

Page 59: ...racy bilevel Maximum dynamic pressure variation according to ISO 80601 2 70 2015 Device without humidification and Standard air tubing Device with humidification and Standard air tubing Breath rate In...

Page 60: ...tween 60 1 and 88 8 of the inspiratory phase and 66 1 and 93 4 of the expiratory phase durations These data time slots start immediately after the initial transient overshoot undershoot periods and en...

Page 61: ...omagnetic environment guidance RF emissions CISPR 11 Group 1 The device uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interferen...

Page 62: ...o 2 5 GHz Recommended separation distance d 0 35 P d 0 35 P 80 MHz to 800 MHz d 0 70 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the tran...

Page 63: ...ing to the transmitter manufacturer Notes At 80 MHz and 800 MHz the separation distance for the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagat...

Page 64: ...efects in material and workmanship from the date of purchase for the period specified below Product Warranty period Mask systems including mask frame cushion headgear and tubing excluding single use d...

Page 65: ...above limitation may not apply to you 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...

Page 66: ...tion see ResMed com ip Actichlor is a trademark of Ecolab US Inc Alconox is a trademark of Alconox Inc Cavicide is a registered trademark of Metrex Research LLC CIDEX is a registered trademark of Adva...