ResMed 248551/1 manuale d’uso

Ste lla r ™ 10 0 Ste lla r ™ 15 0 Inv asIve and nonInv asIve ventIla tor User Guide E nglis h Global leaders in sleep and respiratory medicine www .resmed.com 248551/1 20 1 1 -09 Stellar 1 00 Stellar 1 50 USER A PA C Protected by patents: AU 2002306200, AU 2002325399, AU 2003204620, AU 2004205275, AU 2004216918, AU 2005200987, AU 2006201573, AU[...]

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

Stellar™ 1 0 0 Stellar™ 1 50 User Guide English[...]

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 Cleaning and maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Daily 19 W eekly 20 Monthly 20 Replacing the air filter 20 Disinf ection 20 Multipatient use 21 Ser vicing 21 T roubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Alarm troubleshooting 21 Other trou[...]

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 is intended to pr ovide ventilation for non-dep endent, spontaneously breathing adult and paediatric patients ([...]

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 S tellar: • 3 m air tubing • SlimLine™ air tubing • Cl ear 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 Attaching the H4i heated humidifi er for noninvasive use Use of the H4i heated humidifier may be recomm ended by your clinician. For information on using the H4i, see the H4i user guide. WARNING • Always place the H4i on a level surface below the level o f the patient to prevent the mask and tubing from filli[...]

6 1 Connect the power cord. 2 Plug the free end of the power cord into a power outlet. 3 Connect the antibacterial fi lter firmly onto the ai r outlet of the device. 4 Connect the external humidifier to the o ther side of the antibacterial filter. *If not using an ex ternal humidifier, the HMEF can be connected to the leak port (at step 9). 5 Conne[...]

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 Pr ess to start treat ment. 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 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 Ke y F unction Start/Stop • S tarts or stops treatment. • Extended hold for at least three seco nds st arts 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-m ute 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. Starting therapy Performing a functional test Make sure your device is functioning properly each time before starting therapy. If any problems occur, see “Troubleshooting” on page 21 . Please al so check other provided User Instructi[...]

12 You can use the warm-up feature to pre-heat the water in the humidi fier prior to starting treatment. The humidifier will be automatically detected when the device is turned on. The T reatment screen provides the option to start warming the humidifier. If the humidifier is heating, the related symbol is displayed at the top of the LCD screen. Fo[...]

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 discon nect the device from the mains 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 sett ing 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 : iVAPS mode is only a vailable in Stellar 150. 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, Pill ow , F ull Face, T rac h, P ediat ric. Note : When Mask T yp e 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 calibra ted according to y our air tubing sy stem. 1 . If in use, turn of f the oxy gen flow . 2. Select the mask type. 3. Set up the air circuit including a ccess ories and patient interf ace. Note: For invasive u se, do not connect a catheter[...]

18 Info menu Event Summary Event summary displays the summary of three types of events: changes in se tti 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 Weekly 1 Remove the air tubi ng from the device and the patient i nterface. 2 Wash the air tubing in warm water using mild detergent. 3 Rinse thoroughly, hang and allow to dry. 4 Reconnect the air tubing to the air outlet and patient inte rface. CAUTION Do not use bleach, chlo rine, alcohol or aromatic-based solution s (including all scented oil[...]

21 T roubleshooting English Multipatient use WARNING An antibacterial filter is mandatory if th e device is used on multiple patient s. In a mulitpatient use environment, you must perform the following befo re the device is provided to a new patient: Servicing CAUTION Inspection and repair shou ld only be perf ormed by an authorised agent. Unde r n[...]

22 Pr oblem / possible cause Act io n LCD: Internal B a t tery Empt y! The remaining bat ter y c harge is below 1 5%. The device can be po wered b y the internal bat ter y for maximum 2 minutes. Connect the device to mains po wer . Note : In case of a tot al pow er failure, the therapy set tings will be store d and therapy will resume when the de v[...]

23 T roubleshooting English LCD: Circuit disconnected! The air t ubing is not connected properly to the humidifier or the device. 1 . Chec k that the air tubing is connected properly to the humidifier or the device. 2. If the alarm is n ot cleared , stop treatment. 3. Re-start treatment. LCD: Low Minute V entilation! Minute ventilation le vel has d[...]

24 Other troubleshooting LCD: Low FiO 2 Leve l! FiO 2 has dropped below the pre-set alarm level. • P erform FiO 2 sensor calibration. • If the problem persi sts cont act your clinician. LCD: High FiO 2 Level! FiO 2 has ex ceeded the pre- set alarm level. • P erform FiO 2 sensor calibration. • If the problem persi sts cont act your clinician[...]

25 T roubleshooting English Pressure required f or treatment may hav e changed. See your clinician to adjust the pressure. There is a large impedance (eg, antibacterial filter) in the air circuit. P erfom the Learn circuit function. Humidifier control dial set too high, resu lting in ac cumulat ion of water in the air tubing. T urn humidifier contr[...]

26 Technical specifications The delivered airflow is not humid/h eated although the H4i humidifier is in use The humidifier is not properly at t ac hed. Correctly at t ac h the humidifier . The humidifier does not heat. The de vice is currently powered b y bat t er y use or not connected to the mains. The humidifier does not work. Ret urn the devic[...]

27 T echnical specifications English 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 all Time : MIN, Ti: 4.0 sec, Res[...]

28 Note s: • 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. 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 servi[...]

29 T echnical specifications English V oltage dips, short interr uptions and voltage variat ions on pow e r supply input lines IEC 61 000-4-1 1 <5% Ut (>95 % dip in Ut) for 0. 5 cycle 40% Ut (60% dip in Ut) for 5 cy cles 70% Ut (30% dip in Ut) for 25 cy cles <5% Ut (>95 % dip in Ut) for 5 sec < 1 2 V (>95% dip in 240V) for 0 .5 cy[...]

30 Symbols Follow instructions for use; Class II eq u ipme nt; Type BF equipment; IP31 Device is protected against solid foreign objects of 2.5 mm diameter and greate r and vertically falling water drops; Caution; Standby or preparatory state for a part of equipment; Connection for oxygen supply; max 30 l/min (max 30 L/min); Data port; CE labeling [...]

31 General warnings and cautions English • The de vice must only be u sed with masks (and connectors 1 ) recommended by ResMed, or b y a clinician or resp iratory ther apist. A mask should not be used unless the device is t urned on and op erating proper ly . The vent hole or holes associated with the mask should nev er be block ed. Explanation: [...]

32 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 consum er . It is not transferable. If the product fails under conditions of n ormal use, ResM[...]

Ste lla r ™ 10 0 Ste lla r ™ 15 0 Inv asIve and nonInv asIve ventIla tor User Guide E nglis h • 简 体中文 • 繁 體中文 Global leaders in sleep and respiratory medicine www .resmed.com 248551/1 20 1 1 -09 Stellar 1 00 Stellar 1 50 USER A PA C Protected by patents: AU 2002306200, AU 2002325399, AU 2003204620, AU 2004205275, AU 20042169[...]