ResMed 100 manuale d’uso

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 En glish[...]

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

Stellar ™ 10 0 Stellar ™ 15 0 User Guide English 248705 Stellar 100 and 150 User Guide EUR1.book Page 1 M onday, October 21, 2013 10:40 AM[...]

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

ii Data management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 9 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 compatible 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 A dvanced 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 C[...]

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 ca n be used for nonin vasive set up. ResMed recommends using a breath ing system (including antibacteria l filter , air tubings, e xternal 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 [...]

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 T rac h, t he Non-V ented Mask alarm will be aut omatically enabled to alert you when the ResMed Leak V a lv e has no vent holes or when the v ent holes are bloc ked. 1 Connect the power cord. 2 Plug the free end of th[...]

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 star t treatment. 4 Turn on oxygen. Stopping therapy using oxygen 1 Turn off oxygen. 2 Press to st op treatment. Using the FiO 2 monitoring sensor Use of the FiO 2 monito[...]

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 seconds starts the maskfit tin g f eature. Alarm mute • During therapy: P r ess once to mute an alarm. Press a second time 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 screens 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 occ[...]

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 be autom[...]

13 Starting therapy English Turning off the power 1 Stop the therapy. 2 Press the power switch at the back of the d evice once and follow the instructions on the display. Note: T o disconnect the device from the main s po wer pull out the power cord from the pow er sock et. Working with alarms WARNING This device is not intended to b e used for vit[...]

14 Tailoring treatment setup options Setting Ramp Ramp time is a feature that can be enabled by your clinician by setting 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 Adv anced Set tings screen. Mask type options: Nasal, Ultra, Pill ow , F ull Face, T rac h, P ediat ric. Note : When Mask T ype is set to Tr a c h or Ful l Face th[...]

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

18 Info menu Event Summary Event summary displays the summary of three types of events: changes 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 se[...]

19 Data management English Data management There are two data ports at the rear of the device for c onnecting a USB stick (see “Stellar at a glance” on page 2). Therapy and device data can be stored 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 desig[...]

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 aromatic-based so lutions (including 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 a[...]

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 damp cloth and a disinfection soluti on (eg, Microzid). Multipatient use WARNING • An antibacterial filter is mandatory if th e device is used[...]

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 ResMed service c entre five years from the date of manufacture, except for the intern al battery whic h ResMed re[...]

23 T roubleshooting English Component failure (sy stem failure 8, 25). 1 . P ower -off the de vice. 2. P ower -on the device again. LCD: Over P ressure! The de vice generates a pressure that is greater than 59 cm H 2 O. T reatment will be stopped. 1 . P ower -off the de vice. 2. Chec k that the air tubing is connected properly . 3. P ower -on the d[...]

24 LCD: Low Respiratory Rate!, High Respiratory Rate! The respiratory rate level has dropped below or has e xceeded the alarm set ting level. Contact your clinician. LCD: High Leak! High mask leak for more than 20 seconds. • Adjust the mask to minimise leak (see “Using mask-fit” on page 1 4). • Chec k the air circuit integrit y and reconnec[...]

25 T roubleshooting English Other troubleshooting LCD: K eypad Failure! One of the key s was held down for more than 1 0 seconds or got stuc k. Remo ve any bloc kages from the ke ypad. LCD: At tention High T e mp [42, 43, 44, 45]! The temperat ure inside the device is high. Ensure the ambient temperature conditions are within the specified operatin[...]

26 T re atment pressure seems high Pressure required f or treatment may hav e changed. Consult your clinician. There is a c hange in the impedance in the circuit configuration. P erform the L earn Circuit function . The device does not start when you breathe into the ma sk SmartStart/Stop not on. C onsult your clinician. Breath is not deep enough t[...]

27 T echnical specifications English Technical specifications The humidifier does not work. Ret urn the device and the humidifier for ser vicing. The w ater chamber is empty . Fill the water c hamber of the humidifier . USB stic k is not readable or writeable The USB stic k contains unreadable data, does not hav e e nough space av ailable, is not c[...]

28 Therap y pressur e tol era nc e IP AP: ± 0.5 cm H 2 O ± 1 0% of set pressure (end of inspirat ion) EP AP/PEEP: ± 0.5 cm H 2 O ± 4% of set pre ssure CP AP: ± 0.5 cm H 2 O ± 1 0% of set pressure T est condition: T mode, IP AP: 40 cm H 2 O, EP AP: 2 cm H 2 O, Rise Time: MIN, F a ll Time: MIN, Ti: 4.0 sec, Respiratory Rate: 1 0 bpm, with ResMe[...]

29 T echnical specifications English Notes: • The manufacturer reserves the right to change these spec ification s wi thout notice. • Pressure may be displayed in cm H 2 O or hPa. IEC 6060 1 -1 classifications • Class II (Clause 3.1 4—double insulation). This adherence means the need fo r an protective earthing (ie, an earthed plug) is not [...]

30 Guidance and manufacturer’s declaration – electromagnetic emissions and immunity Medical Electrical Equipment needs special precautions re garding EMC and needs to be installed and put into service according to E MC information prov ided in this document. Guidance and manufact u r er ’ s declar ation – electromagnetic emissions The de vi[...]

31 T echnical specifications English P ort able and mob ile RF communications equipment sh ould 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[...]

32 Symbols Follow instructions for use; Class II equipment; Type BF applied pa rt; Bell (Remote A larm); IP31 Device is protected agai nst solid foreign objects of 2. 5 mm diameter and greater and vertically fallin g wa ter drops; Caution; General warning sign (see H4i conne ctor plug and AC connecti on on the device); Standby or preparato ry state[...]

33 General warnings and cautions English General warnings and cautions WARNINGS A warnin g alerts you to possible injury. • Read the entire manual before using the de vice. • This de vice should only be used with air t ubing and accessories recomm ended by ResMed or the prescribing clin ician. Use of incorrect air t ubing and accessories may af[...]

34 • P ay at tention to leaks and other unusual s ounds. If there is a problem, cont act an authorised ser vice agent. • Do not replace any parts in t he breathing circuit while the device is in operation. Stop operation before c hanging parts. Notes: A note advises to special product f eatures. • The above are general wa rnings and cautions.[...]

35 Limited warranty English 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 purch ase for the period specified below. This warran ty is only available to the initial cons umer. It is not transferable. If the product fails under condition[...]

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

Global leaders in sleep and respiratory medicine www .resmed.com 2487 16 /1 201 4 - 02 Stellar 100 Stellar 1 50 USER EUR1 - ENG Manufacturer: ResMed Germany Inc. Fraunhoferstr. 16, 82152 Martinsried Germany. Distributed by: ResMed Ltd 1 Elizabeth Macarthur Drive Bella Vista NSW 2153 Australia. ResMed Corp 9001 Spectrum Center Blvd. San Diego, CA 92[...]