ResMed Stellar 100 and 150 manuale d’uso

Global leaders in sleep and respiratory medicine www .resmed.com Respiratory Care Solutions Making quality of care easy Ste lla r ™ 10 0 Ste lla r ™ 15 0 Inv asIve and nonInv asIve ventIla tors User Guide E nglis h[...]

Respiratory Care Solutions Making quality of care easy[...]

i Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications for use 1 Contraindications 1 Adv erse ef fects 1 Stellar at a glance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 P atient interface 3 Humidification 3 Internal bat ter y 3[...]

ii Data management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Daily 19 W eekly 20 Monthly 20 Replacing the air filter 20 Disinf ection 21 Multipatient use 21 Ser vicing 22 T roubleshooting . . . . . . . . . . .[...]

1 Introduction English Introduction Read the entire manual before usin g the device. This User Gui de is for a non-cl inician user, and does not contain all the informat ion provided in t he Clinical Guide. Indications for use The Stellar 100/150 is intended to provide ventilation for non- dependent, spontaneously breathing adult and paediatric pat[...]

2 Stellar at a glance The Stellar comprises: • Stellar device • Hypoallergenic air filter • AC power cord • Carry bag • 2 m air tubing • ResMed USB stick • Low pressure oxygen connector. The following optional components are com patible with Stellar: • 3 m air tubing • SlimLine™ air tub ing • Clear air tubing (disposable) • [...]

3 Stellar at a glance English Patient interf ace Both masks and tracheos tomy tubes can be used with Stella r. To set the pa tient interface type go to the Setup menu, select Clinical Set tings , then Advanced Set tings . For information on using masks, see the mask manual. For a full list of compatible masks for this device, see the Mask/Device Co[...]

4 Mobile use The Stellar Mobility bag allows the Stellar to be used in mobile situations, eg, in a wheelchair. For setup and correct use, see the Stellar Mobility Bag User Guide. Fo r extended mobile use, the Re sM ed Power Station II external power supply unit can be used as an additional power source. Limitations apply to the use of oxygen with t[...]

5 Setting up for invasive use English Note : Other external humidifiers can be used for noninvasiv e setup. ResMed recommends using a breath ing system (including antibacteria l filter , air t ubings, external humidifier) with an impeda nce of maximum 2 cm H 2 O at 30 L/min, 5 cm H 2 O at 60 L/min and 1 6 cm H 2 O at 1 20 L/min. 4 Connect one end o[...]

6 CAUTION When using a humidifier che ck the breat hing system regularly for accumulated wate r. Note: When the mask type is set to Tr a c h , the Non-V ented Mask alarm will be automatically enabled to alert you when the R e sMed Leak V alve has no vent holes or when the vent holes are bloc ked. 1 Connect the power cord. 2 Plug the free end of the[...]

7 W orking with other optional accessories English Working with other optional accessories Attaching the pulse oximeter Use of a pulse oximeter may be recomm ended by your clinician. Contraindication The pulse oximeter does not meet defibrilla tion-proof requirement per IEC 60601-1: 1990, clause 17.h. 1 Connect the plug of the finger pulse sensor t[...]

8 Starting therapy using oxygen 1 Fit the oxygen connector to t he oxyg en inlet of the device. 2 Attach the other end of the oxygen supply tubing to the oxygen supply. 3 Press to st art treatment. 4 Turn on oxygen. Stopping therapy using oxygen 1 Turn off oxygen. 2 Press to stop treatment. Using the FiO 2 monitoring sensor Use of the FiO 2 monitor[...]

9 W orking with other optional accessories English Connecting a sensor 1 Connect the air tubing to the T-piece adapter. 2 Connect the FiO 2 monitoring sensor to the T-piece adapter. 3 Connect the adapter to the air outlet of the device. 4 Connect one end of the cable to the FiO 2 monitoring sensor. 5 Connect the other end of the cable to th e rear [...]

10 Stellar basics About the control panel l Ke y F unction Start/Stop • S tarts or stops treatment. • Extended hold for at least three seco nds starts the maskfit ting feat ure. Alarm mute • During therapy: P ress once to mute an alarm. Press a second tim e to un-mute an alar m. If the proble m is still present, the alarm will sound again [...]

11 Starting therapy English LCD screen The LCD screen displays the menus, m onitoring screens a nd alarm status. Values on this LCD screen an d other scree ns throughout t he User Guide are examples only. Starting therapy Performing a functional test Make sure your device is functioning properly each time before starting therapy. If any problems oc[...]

12 6 Check H4i heated humidifier (if in use). Check that the warm-up feat ure is displayed in the T reatment screen. Start the warm-up feature. Check that the humidifier warm-up symbol is displayed on top of the screen. You can use the warm-up feature to pre-heat the water in the humidi fier prior to starting treatment. The humidifier will b e auto[...]

13 Starting therapy English Turning off the power 1 Stop the therapy. 2 Press the power switch at the back of the device once and follow the instructions on the display. Note : T o disconnect the device from the mains pow er pull out the power cord from the pow er soc ket. Working with alarms WARNING This device is not intended to b e used for vita[...]

14 Tailoring treatment setup options Setting Ramp Ramp time is a feature that can be enabled by your clinician by set ting a maximum ramp time. Designed to make the beginning of treatment more comfortable, ramp tim e is the period during which the pressure increases from a low start pressure to the treatment pressure. See “Setup men u: Options”[...]

15 Using the menus English Using the menus The device has three menus ( Monitoring , Setup, Inf o ) accessed by the equivalent buttons on the right of the LCD screen. In each menu there are screens that di splay settings, device or therapy information. Note : iV APS mode is only available in Stellar 1 50. MONIT ORING Monitoring Pressure / Flo w Min[...]

16 Setup menu Setup menu: Clinical Settings (Mask Type) 1 Press to display the Clinical Se t tings screen. 2 Use the push dial to scroll through the menu and change the Mask T ype in the Advanced Set tings screen. Mask type options: Nasal, Ultra, Pillow , Full F ace, T rac h, P ediatric. Note : When Mask T ype is set to Tr a c h or Ful l Fac e the [...]

17 Setup menu English Setup menu: Configuration Menu P arameter Description Learn Circuit The de vice is calibra ted according to your air t ubing system. 1 . If in use, turn of f the o xygen flow . 2. Select the mask type. 3. Set up the air circuit including a cces sories and patient interf ace. Note: For invasive use, do not connect a catheter mo[...]

18 Info menu Event Summary Event summary displays the summary of three types of events: ch anges in setti ngs, alarms and system events (eg, connection of ResMed USB stick). There are up to 200 events of each type, displayed in chronologica l order, with the most recent event displayed at the top by default. Used Hours Used Hours during the la st s[...]

19 Data management English Data management There are two data ports at the rear of the device for connecting a USB stick ( see “Stellar at a glance” on page 2 ). Therapy and device data can be st ored on it or read from it to be used with ResMed software applications. WARNING Do not connect any device to the data ports other th an specially des[...]

20 CAUTION • Do not hang the air tubing in di rect sunlight as the tubing may harden over time and eventually crac k. • Do not use bleach, c hlorine, alcohol or aro matic-based solutions (in cluding all scented oils), moisturising or antibacteria l soaps to clean the air tubing o r the device on a daily basis (other than the ap proved cleaning [...]

21 Cleaning and maintenance English . Disinfection Disinfection of your device helps to pr event the risk of cross contamination. Disinfect the exterior of the device, and especially the air outlet, with a dam p cloth and a disinfection soluti on (eg, Microzid). Multipatient use WARNING • An antibacterial filter is mandatory if th e device is use[...]

22 Servicing CAUTION Inspection and repair shou ld only be perf ormed by an authorised agent. Unde r no circumstances should you attempt to open, service or repair the device yourself. This product should be inspected b y an aut horised R esMed service c entre five years from the date of manufacture, except for the intern al battery whic h ResMed r[...]

23 T roubleshooting English LCD: Bloc ked T ube! Air path is bloc k ed. 1 . Chec k the air path for any bloc kages. 2. Remov e the bloc kages. 3. If the alarm is n ot cleared, stop treatment. 4. Re-start treatment. LCD: High T emperatur e [1 0, 1 1, 12, 23]! The temperat ure inside the device is too high . T reatment may lead to stop. Ensure the am[...]

24 LCD: Non-V ented Mask! • Connection of a non-vented mask. • Mask vents ma y be bloc ked. • ResMed L eak V alve is missin g or vent is bloc ked. • Ensure the mask has vent s. • Ensure the mask vents are not bloc ked. • Ensure the Re sMed Leak V alv e is inst alled and that the vent is not bloc ked. • Ensure oxy gen (if in use) has o[...]

25 T roubleshooting English Other troubleshooting LCD: External DC Po wer Use! The de vice is powered b y an external bat ter y . Chec k if the A C pow er cord is properly connected to the device if y ou want to run from mains po wer . Note : The alarm will be cleared autom atically af ter one minute. Pr oblem / possible cause Solu tio n No display[...]

26 There is a large impedance (eg, antibacterial filter) in the air circuit. P erform the L earn Circuit function. The device does not stop when y ou remove y our mask SmartSt art/St op is disabled. Consult your clinician. Use of a full face mask or trac heostom y t ube. SmartStart is disabled if F ull face mask or T rac h is selected as interf ace[...]

27 T echnical specifications English Technical specifications FiO 2 sensor is used or defectiv e. If the lif etime of the FiO 2 sensor has ex ceeded one year please replace the FiO 2 sensor and start calibration again. LCD: is displayed in the header . Bat ter y is not charging. • Ensure the ambient temperature conditions are within the specified[...]

28 Note s: • The manufacturer reserves the right to chan ge these spec ification s wi thout notice. • Pressure may be displayed in cm H 2 O or hPa. Pow e r su p p l y A C 1 00–240V , 50–60Hz, 2.2 A, max. 65 W Exter nal DC P ower Sup ply (isolated) 24 V , 3 A Inter nal Batt ery Lithium-Ion bat ter y , 1 4.4 V , 1 .6 Ah, 23 Wh Operating hours[...]

29 T echnical specifications English Guidance and manufacturer’s declaration – electromagnetic emissions and immunity Medical Electrical Equipment needs special precautions re g arding EMC and needs to be installed and put into servic e according to EM C informati on provided in this document. Guidance and manufact urer’ s declar ation – el[...]

30 P ortable and mobile RF communications equipment should be used no c loser to any part of the device , including cables, than the recommended separation distance calculated from the equation app licable to the frequency of the transmitter . Recommen ded separation distance: Conducted R F IEC 61 000-4-6 3 Vrms 1 50 kHz to 80 MHz 3 Vrms d = 1 .1 7[...]

31 T echnical specifications English Symbols Follow instructions for use; Class II equipment; Type BF applie d part; Bell (Remote Alarm); IP31 Device is protected agai nst solid foreign objects of 2. 5 mm diameter and greater and vertically falling water drops; Cau tion; General warning sign (see H4i connector p lug an d AC conn ection o n the devi[...]

32 General warnings and cautions WARNINGS A warnin g alerts you to possible injury. • Read the entire manual before using the de vice. • T his de vice should only be used w ith air tubing and accessories recommended by ResMed or the prescribing clin ician. Use of incorrect air tubing and accessories may af f ect the functioning of this device. [...]

33 General warnings and cautions English Note s: A note advises to special product f eatures. • The above are general wa rnings and cautions. Further s pecific warnings, cautions and notes appear next to the relevant instructions in the user guide. • Only trained and author ised personn el are allowed to ma ke clinical setting changes. • Posi[...]

34 Limited warranty ResMed Ltd (hereafter ’ResMed’) warrants that your ResMed produc t shall be free from defects in material and work manship from the date of pu rc hase for the period specified below. This warranty is only avail ab le to the initial consumer . It is not transferable. If the product fails under cond itions of normal use, ResMe[...]

Respiratory Care Solutions Making quality of care easy[...]

Global leaders in sleep and respiratory medicine www .resmed.com 248578-Eng/1 20 1 2-06 Stellar 1 00 Stellar 1 50 USER EUR1 For patent information, see www.resmed.com/ip ResMed, SlimLine, SmartStart, Stellar, and TiCONTROL are trademarks of ResMed Ltd. ResMed, SlimLine, SmartStart and Stellar are registered in U.S. Patent and Trademark Office. © 2[...]