Manuale d’uso / di manutenzione del prodotto Stellar 100 and 150 del fabbricante ResMed
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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 Us.
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 . . . . . . . . . . . . . . . . . . . . . . . .
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 maskfit 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 cludi.
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).
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.
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 .
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.
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.
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.
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 .
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.
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.
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 .
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.
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.
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.
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 .
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.
Un punto importante, dopo l’acquisto del dispositivo (o anche prima di acquisto) è quello di leggere il manuale. Dobbiamo farlo per diversi motivi semplici:
Se non hai ancora comprato il ResMed Stellar 100 and 150 è un buon momento per familiarizzare con i dati di base del prodotto. Prime consultare le pagine iniziali del manuale d’uso, che si trova al di sopra. Dovresti trovare lì i dati tecnici più importanti del ResMed Stellar 100 and 150 - in questo modo è possibile verificare se l’apparecchio soddisfa le tue esigenze. Esplorando le pagine segenti del manuali d’uso ResMed Stellar 100 and 150 imparerai tutte le caratteristiche del prodotto e le informazioni sul suo funzionamento. Le informazioni sul ResMed Stellar 100 and 150 ti aiuteranno sicuramente a prendere una decisione relativa all’acquisto.
In una situazione in cui hai già il ResMed Stellar 100 and 150, ma non hai ancora letto il manuale d’uso, dovresti farlo per le ragioni sopra descritte. Saprai quindi se hai correttamente usato le funzioni disponibili, e se hai commesso errori che possono ridurre la durata di vita del ResMed Stellar 100 and 150.
Tuttavia, uno dei ruoli più importanti per l’utente svolti dal manuale d’uso è quello di aiutare a risolvere i problemi con il ResMed Stellar 100 and 150. Quasi sempre, ci troverai Troubleshooting, cioè i guasti più frequenti e malfunzionamenti del dispositivo ResMed Stellar 100 and 150 insieme con le istruzioni su come risolverli. Anche se non si riesci a risolvere il problema, il manuale d’uso ti mostrerà il percorso di ulteriori procedimenti – il contatto con il centro servizio clienti o il servizio più vicino.
