Operating instruction

Transcription

1 Operating instructin

2 TNI-System

3 FIRST STEPS These perating instructins apply t the TNI sft Flw 50, manufactured 2015 r later. Please read these instructins and all warnings carefully. Otherwise, injuries culd ccur. Stre them t be usable fr subsequent reference. Befre using TNI sft Flw 50 fr the first time, the device must be cnfigured as instructed in TNI sft Flw 50 manual. The TNI sft Flw 50 has t be cleaned and disinfected after use and change f patient. Please nte perating instructins, chapter Fr additinal infrmatin and supprt, please cntact yur lcal TNI medical AG custmer ser-vice. CONTENT 1) DESCRIPTION f TNI sft Flw ) METHOD ) INTENDED USE ) SAFETY NOTES ) THIS MANUAL ) APPROPRIATE APPLICATION ) CORRECT USE ) CORRECT SETUP ) ENVIRONMENTAL CONDITIONS ) USING OXYGEN ) CLEANING ) FILLING THE WATER CHAMBER TRANSPORT OF THE DEVICE ) DISPOSAL ) DESCRIPTION OF FUNCTION ) TRAINING OPTIONS ) SYSTEM COMPONENTS AND ACCESSORIES ) SCOPE OF SUPPLY f TNI sft Flw 50 clinic system ) HUMIDIFIER HOMECARE COMPLETE ) ACCESSORIES ) STARTUP OF TNI sft Flw 50 CLINIC SYSTEM ) ASSEMBLING AND CONFIGURING THE HUMIDIFIER CLINIC COMPLETE ) HUMIDIFIER CLINIC COMPLETE ) CONNECTING WATER BAG Operating Instructin TNI sft Flw 50 clinic system 3

4 3.1.3) FILLING AN INSERTING THE HUMIDIFIER HOMECARE ) INSERT THE APPLICATOR ) REMOVING APPLICATOR ) CONNECTING OXYGEN SUPPLY ) REPLACING DUST FILTER ) STARTING AND STOPPING THE TNI sft Flw ) SWITCHING ON / OFF ) DEACTIVATING STANDBY-MODE ) OPERATING ELEMENTS f TNI sft Flw ) OPERATING ELEMENTS f TNI sft Flw ) BASIC USER MENUE ) ATTACHING THE APPLICATOR ) CHOOSING THE APPLICATOR ) STARTING THERAPY ) ENDING THERAPY ) STARTING OXYGEN SUPPLY ) STOPPING OXYGEN SUPPLY ) SELECTING THE THERAPY PARAMETERS AND CONFIGURATION MENU ) THERAPY PARAMETERS ) STATEMENT ON THE INDICATED DISPLAY VALUES ) SETTING HUMIDITY (DEW POINT) ) FLOW RATE ) MENU ITEMS WHICH HAS BEEN APPROVED FOR SYSTEM CONFIGURATION ) CHOOSING TYPE OF HUMIDIFIER ) CHOOSING NEW PATIENT / CHANGE OF PATIENT ) SETTING THE LANGUAGE ) SETTING THE TIME ) SETTING THE DATE ) ALARM VOLUME ) SYSTEMINFORMATION ) READING OUT THERAPY HOURS ) CLINIC-MENUE ) SERVICE-MENUE ) HYGIENIC MEASURES ) CLEANING ) CLEANING- AND CHANGING CYCLES ) DETERGENTS ) HOUSING SURFACES Operating Instructin TNI sft Flw 50 clinic system

5 5.1.4) HUMIDIFIER CLINIC COMPLETE ) HUMIDIFIER HOME CARE COMPLETE; CLINICAL USE ) DUST FILTER ) APPLICATOR IN CLINICAL USE ) DESINFECTION ) TECHNICAL DATA ) SYMBOLS ON THE DEVICE ) PERFORMANCE PARAMETERS, TECHNICAL DATA, DEVICE PARAMETERS ) TECHNICAL DATA, DEVICE PARAMETERS ) FEHLERCODES ) SERVICE/MAINTENANCE ) WARRANTY ) DISPOSAL ) ELECTROMAGNETIC COMPATIBILITY (EMC) TABLES Table 1 - SCOPE OF SUPPLY OF THE CLINIC SYSTEM...13 Table 2 - FUNCTION KEYS f TNI sft Flw Table 3 - SYMBOLS ON THE DEVICE...42 Table 4 - TECHICAL DATA...43 Table 5 FEHLERCODES...46 Table 6 - ELECTROMAGNETIC COMPATIBILITY (EMC)...52 Operating Instructin TNI sft Flw 50 clinic system 5

6 1) DESCRIPTION f TNI sft Flw ) METHOD TNI sft Flw is a system managing therapy with nasal insufflatin which will be used fr the treatment f sleep-related breathing disrders in clinical intensive care and statinary settings as well as in hmecare settings. A cnstant, humidified and warm flw, which may als cmbined with xygen, is applied t the nse via applicatr (thin nasal cannula which act as an interface t the patient. Therapy with nasal insufflatin basically imprves ventilatin. 1.2) INTENDED USE Therapy with nasal insufflatin (TNI) is intended fr additinal treatment n patients with partial r glbal respiratry failure (insufficiency), such as COPD (chrnic bstructive pulmnary disrder, ILD (interstitial lung disease) r sleep apnea t relieve als breathing (respiratry) musculature and t imprve ventilatin as well as mucciliary clearance. Therapy with nasal insufflatin may nly be cmmenced with a medical prescriptin. Therapy with nasal insufflatin is nt intended fr life-supprt purpses. This therapy is dne n an individual basis accrding t the medical diagnsis. It can be applied n a daily basis (e.g. under sleeping perid) r spradically if needed. TNI sft Flw may be used n adults and children. Please nte that different, special applicatrs are available fr adults and children. The patient shuld be in gd cnditin if therapy is realized at hme and the device is perated by the patient. Otherwise, the peratin f the device has t be perfrmed by a qualified third persn (e.g. nurse). This has t be cnsidered especially if the device is used by infants r tddlers. Fr patients which are nt cmpliant t the device, please refer t 1.3) The TNI can be placed n an even hrizntal surface inhuse and is used as a statinary device. The lcatin can be changed as needed but during transit n peratin is allwed. In clinical settings the respective cmpnents have t be exchanged after use and change f patient. Please nte pint 5 (hygiene). In hmecare settings the respective cmpnents have t be cleaned peridically. 1.3) SAFETY NOTES Please read the fllwing instructins carefully as they cntain imprtant infrmatin n the safe and respnsible handling f the TNI sft Flw 50. An initial training has t be perfrmed befre the device can be used Fllwing instructins are the respnsibility f the user f this unit. Any nn-bservance will cause danger! The device can be used in a sitting r lying psitin. It is nt allwed t mve arund with a running device. If an infant r a tddler uses the device, a qualified third persn has t ensure prper use N mdificatin f this equipment is allwed Althugh a selftest f the device is perfrmed during start-up, it is recmmended t remve and insert the applicatr after start-up t verify the crrect alarm functinality. D nt use the TNI sft Flw 50 if yu shw allergic reactins when in cntact with silicn 6 Operating Instructin TNI sft Flw 50 clinic system

7 1.3.1) THIS MANUAL Exact adherence t the fllwing instructins is a prerequisite fr the safe and intended peratin f the TNI sft Flw 50 and its supplied parts. Any nn-bservance will endanger an effective therapy. With regard t the fundamental requirements f the currently valid directive fr medical devices, the instructins fr use describe the present state f the device, including sftware and supplies ) APPROPRIATE APPLICATION The TNI sft Flw 50 is nt intended fr life-supprt measures! A therapy may nly be started n prescriptin. Only healthcare prfessinals may adjust the prescribed flw rate. The TNI sft Flw is a system designed fr nasal insufflatin therapy. It can be used clinically in inpatient and intensive care as well as in hmecare t prvide respiratry assistance t spntaneusly breathing patients. A nasal supply f respiratry gases leads t a psitive airway pressure (PAP) depending n flw rates. This has t be cnsidered if the PAP culd cause the patient t shw undesirable results. The TNI sft Flw 50 is nt intended fr artificial life-supprt measures. The TNI sft Flw 50 is nt suitable fr treating acute failure f respiratry functins. The TNI sft Flw 50 may nt be used fr invasive ventilatin. The TNI sft Flw 50 may nt be used in case f cmplete clsure f the upper airways. The TNI sft Flw 50 may nt be used n patients whse airways are circumvented by a bypass. Due t humidificatin and a mre cmfrtable aerial applicatin, side effects such as an irritatin f the nasal mucsa, blcked nse, and (with patients suffering frm bld-cltting disrder) bleedings f the nse, are quite unlikely with the use f the TNI sft Flw 50. If such symptms ccur, the humidity needs t be set t a higher level (see chapter Setting Humitity ). When nt in use, the TNI sft Flw 50 shuld nt be left switched n fr several hurs. D nt use the device if yu suffer frm epileptic attacks r very agitated sleep D nt let children play with the hses r the cables t eliminate the danger f strangulatin and the inhalatin r swallwing f small parts 1.3.3) CORRECT USE The unit s husing may nly be pened by authrized persnnel. Excluded frm this is equipment which can be remved fr usage and cleaning purpses withut using tls. Prir t pening, the device has always t be switched ff and the system has t be discnnected frm the mains. If the TNI sft Flw 50 is nt being used ver a lng perid f time, switch ff the TNI sft Flw 50 discnnect the pwer crd frm the scket remve the applicatr and make sure that there is n water in the humidificatin chamber nr in the water cntainer Prir t switching n, the TNI sft Flw 50 always has t be checked fr crrect assembly. Check all parts fr damages and defects. Operating Instructin TNI sft Flw 50 clinic system 7

8 In case f any abnrmality, switch ff the pwer switch and discnnect the system frm the pwer supply in rder t prevent any damage r injuries. When in dubt, please cntact yur lcal TNI medical AG representative. During therapy, the applicatr tube has t lie freely. It may nt be cvered by any pillws, blankets r clthes. The patient shuld be careful nt t interfere r t restrict the airflw. If the applicatr is attached and the patient is turning in the same directin arund his/her bdy axis several times (especially during sleep), pressure marks might be caused and the bld flw might be impeded. The available USB-Cnnectr is fr service purpses nly 1.3.4) CORRECT SETUP Please make sure that the TNI sft Flw 50 is set up prperly and des nt shw any damages. Psitin the TNI sft Flw 50 crrectly: It has t be easy t reach frm the treatment area and the display shuld always be easy t read. Ensure an unbstructed air supply. The air supply as well as the air passage may nt be impeded. The TNI sft Flw 50 and its accessries can be used within patient surrundings. Use nly authrized accessries mentined in the instructins fr use. Use riginal accessries nly (humidifier chamber, applicatr - see chapter 2.2). Using thirdparty parts may result in functin failure and health hazards. Please nte that in such cases warranty and liability claim will expire. Prir t cnnecting the device t the pwer supply system, make sure that the TNI sft Flw 50 mains vltage ( V) and mains frequency (50-50 Hz) crrespnd t yur lcal characteristics. The required infrmatin is fund n the device s name plate as well as in chapter 7, Technical data. Cnnect nly if all data cmply! Use the supplied mains cable nly. Prir t switching n, the TNI sft Flw 50 always needs t be checked fr cmpleteness, crrect assembly and visible defects. Prir t switching n, the TNI sft Flw 50 always needs t be checked fr prper cnditin (cmpleteness, visible defects, etc.). Fr this, perfrm a visual inspectin f all single parts and check them fr damages. In case f abnrmalities, the device may nt be switched n. Please cntact yur lcal TNI medical AG representative. In case f damages, stp using the device. This particularly applies if the husing, plug cnnectin and cables are damaged as well as if liquids gt int the device. In such cases, please cntact yur lcal TNI medical AG representative immediately. Additinal parts which need t be cnnected t the device s analg and digital interfaces have t cmply verifiably with their crrespnding EN specificatins (e.g. EN fr data prcessing devices and EN fr medical electrical devices). Anybdy cnnecting additinal equipment t the signal input r utput unit cnfigures the system and is therefre respnsible that the valid versin f the system cmplies with the system standard EN Fr any queries, please cntact yur lcal TNI medical AG representative. The PC cnnectin lcated belw the carrying handle f the TNI sft Flw 50 may nly be used t cnnect a PC. 8 Operating Instructin TNI sft Flw 50 clinic system

9 Only trained persnnel r service technicians may use the system. The patient may nt tuch the cnnected PC r parts cnnected t the PC. The user may nt tuch the patient and the PC (r parts cnnected t the PC) at the same time. The sensr cnnectin lcated belw the carrying handle f the TNI sft Flw 50 may nly be used t cnnect the external temperature measuring element (item n ) r ther cmpnents authrized by the TNI medical AG. D nt cnnect unauthrized cmpnents t this scket! Please make sure that the device is psitined in a way that the pwer plug can be discnnected withut difficulties An SD-Card can be used t stre infrmatin independently frm the device 1.3.5) ENVIRONMENTAL CONDITIONS The TNI sft Flw 50 may nly be perated under admissible ambient cnditins (see chapter 7, Technical Data ). Operating the device under ambient cnditins ut f the range defined fr the guaranteed perfrmance parameters will result in reduced perfrmance parameters. If the ambient cnditins are ut f the given range, the device shuld stay in ff-mde due t safety reasns. In rder t ensure prper use, it is imprtant t let the TNI sft Flw 50 adapt t the ambient cnditins (rm temperature). Please wait abut 2-4 hurs befre starting up the device. This applies t the first usage f the TNI sft Flw 50 and t transprting the device, i.e. the transprt cnditins were ut f the given range f ambient cnditins. D nt use the device in humid and ptentially explsive rms r cmbustible atmsphere. Intended functining f the TNI sft Flw 50 may be impaired when it is perated right next t HF electrsurgery devices, defibrillatrs, X-rays, transmitted pulses, radi frequency interference r devices designed fr shrt wave therapy. D nt use the TNI sft Flw 50 while perfrming the measures mentined abve r during magnetic resnance tmgraphy (MRT, NMR, NMI). Active mbile phnes may nly be placed next t the device when a minimum distance f 1m is being kept. The system must nt be set up next t a heater and must nt be expsed t direct sunlight since this may interfere with a prper peratin f the device. The sensr measuring the ambient temperature is lcated n the right in the inside f the device. D nt pint any surce f heat (e.g. heater,...) twards this sensr. In rder t ensure a sufficient air circulatin arund the device, a minimum distance f 25 cm t all sides is t be kept. The device may nt be cvered. T avid a fast accumulatin f dust in the air filter, d nt place the TNI sft Flw 50 near the grund. The device is intended t be used indr and shuld be placed n an even hrizntal surface. T avid damage, cntaminatin r malfunctining, place the device ut f reach frm pets, pests r children Operating the device at a lw ambient air temperature may result in a frmatin f cndensate in the applicatr. Keep the bxed applicatr away frm direct sunlight and stre it in a dry place. Operating Instructin TNI sft Flw 50 clinic system 9

10 1.3.6) USING OXYGEN D nt put the applicatr n the TNI sft Flw 50 r any ther electrically driven device. The TNI sft Flw 50 may nly be perated using the prvided cnnectin units. It is nt allwed t perate the device using ther cnnectin units. Please make sure t read the user manual f yur xygen surce carefully. If there are any pen questins cncerning usage r cnnectin f the surce, please cntact yur xygen vendr r ur htline Munt yur xygen surce crrectly, especially if it s an xygen bttle, t prevent damage. Please refer t the user manual f the xygen surce. Oxygen valves may nt cme int cntact with il, grease r any flammable liquids. Due t the risk f fire, smking and pen fire are strictly prhibited! The device may nt be perated in clsed areas prducing r using anaesthetics and/r nitrus xide. Especially when adding clinical xygen, the fllwing safety guidelines need t be bserved: D nt place the TNI sft Flw 50 directly n the flr. Keep a minimum distance f 40 cm. Keep a minimum distance f 40 cm t the wall. Keep a minimum distance f 80 cm t ther electrical devices. Prir t switching n, always make sure that the cnnectin unit(s) is/are cnnected prperly t the intended gas sampling pint(s). Ensure a safe and slid cnnectin. Oxygen supprts cmbustin prcesses. When using xygen during therapy, smking and pen fire are strictly frbidden. Oxygen valves need t be kept free f grease. Imprper cnnectin f the external xygen surce may result in an insufficient therapy. Cautin when handling xygen! Risk f fire! Several deaths ccurred in hspitals in the past due t patients wh smked despite being treated with xygen. In rder t take a drag, the xygen tube was remved frm the face and put n the bed. This made it pssible fr the xygen t spread acrss the beddings and the patient s clthes. The patient fell asleep and the lit cigarette set the bedding n fire. It was nt pssible t fight the fire due t the spread xygen. It kept burning even after the attempts t extinguish it. The patient finally died f the burnings 1.3.7) CLEANING The device may nly be cleaned when being cmpletely discnnected frm the pwer supply system. Prir t any cleaning measure, switch ff the main switch lcated at the right side f the device and unplug the pwer crd frm the device s female cnnectr. Please nte chapter 6, Hygiene. Nt bserving the instructins n cleaning and disinfectin can lead t a bacterial cntaminatin and may endanger the patient! Overdsing disinfectants can cause material damages. Avid calcificatin (see chapter 6, Hygiene ). Please nte the replacement cycles f accessries and dispsables (see chapter 6, Hygiene ). When exceeding these time perids r nt replacing these items, prper use can n lnger be ensured. Due t bicmpatibility reasns, the applicatr may nt cntinuusly be wrn fr lnger than 24 hurs. Replace the applicatr every 24 hurs and nte the replacement cycles. 10 Operating Instructin TNI sft Flw 50 clinic system

11 The TNI sft Flw 50 is always t be cleaned and disinfected prir t the visit f a new patient (fr mre detailed infrmatin, see chapter 6, Hygiene ). The applicatr, MRP filter, air lift and humidifier chamber need t be replaced. Due t hygienic reasns, nt mre than ne patient may use the same applicatr ) FILLING THE WATER CHAMBER When pening the device immediately after turning it ff, please nte that the inner parts f the device (metallic bttm f the water cntainer, heating plate) might be ht and may therefre nt be tuched. Please wait a cuple f minutes until the device has cled dwn. Under n circumstances must fluids get int the device! Always take the water cntainer ut f the TNI sft Flw 50 t fill it up. Marks n the strage cntainer indicate minimum and maximum filling level. Fill up the cntainer within this area, maximum up t the mark labeled max. The water cntainer may nly be filled with drinking water. D nt use additives! (see chapter Humidifier clinic cmplete, und Filling and inserting the humidifier hmecare). If the device is filled with nn-recmmended additives, the patient s airways may be impaired! As sn as the humidifier is filled up with water and inserted in the TNI sft Flw 50 again, the TNI sft Flw 50 shuld nt be mved quickly, be extremely inclined nr transprted. With such activities, water might uncntrllably get ut f the humidifier int the device which may impair crrect functining f the device. Remve the humidifier befre transprting the device r changing its psitin TRANSPORT OF THE DEVICE In rder t avid damages, be careful when transprting r string the device! The water chamber may nt cntain water during transprtatin f the TNI sft Flw 50. The device may nly be transprted in an upright and intended psitin. D nt drp the device since this may cause husing damages and impair prper functining. In case f drpping the device nnetheless, make sure that the TNI is in prper cnditin (cmpleteness, n visible defects, etc.). In rder t ensure this, always perfrm a visual check fr damages f the single parts prir t starting up. In case f abnrmalities, immediately cntact yur lcal TNI medical AG representative. If yu are transprting the external xygen surce, please cnsult the user manual f that device fr transprt instructins ) DISPOSAL In accrdance with the German Electrical and Electrnic Equipment Act, the manufacturer is respnsible fr the dispsal f the TNI sft Flw 50 (fr mre infrmatin n dispsal, see chapter 11). T dispse f the unit, cntact: TNI medical AG Telephne: Hfmannstraße 8 Telefax: D Wuerzburg inf@tni-medical.de Operating Instructin TNI sft Flw 50 clinic system 11

12 1.4) DESCRIPTION OF FUNCTION TNI sft Flw is a system managing therapy with nasal insufflatin: A cnstant, humidified and warm flw, which may als cmbined with xygen, is applied in the nse via applicatr (thin nasal cannula which act as an interface t the patient). Technically, it cnsists f a ventilatin unit and a humidifier unit. The blwer absrbs air, cmpresses it and frwards it via humidifier. Here, the air flws ver heated water. The heated and humidified water thus btained achieves dew pints frm TP (can be set individually). 2 humidificatin mdels are prvided; bth can be used individually, Humidifier clinic cmplete and Humidifier hmecare cmplete. The heated and humidified air / air-xygen mixture flws in the nse and upper respiratry tract via applicatr. The air utflw at the applicatr in the nse simulates nasal cannula used in xygen therapy. Particular emphasis was given t a high wearing cmfrt and lw nise level. We wish yu a gd and recreative time with the TNI sft Flw ) TRAINING OPTIONS An initial training is perfrmed by TNI r an authrized partner befre the device is used. Fr mre training ptins (as an in-depth service training) r ther infrmatin, please cntact yur lcal TNI medical AG custmer service. 12 Operating Instructin TNI sft Flw 50 clinic system

13 2) SYSTEM COMPONENTS AND ACCESSORIES 2.1) SCOPE OF SUPPLY f TNI sft Flw 50 clinic system Scpe f delivery TNI sft Flw 50 clinic-system english Article N Humidifier clinic cmplete Set Pwer cnnecting cable TNI 1 Unit sft Flw 50, type C,1,8m Dust filter reserves 5 Unit Oxygen tube, 4m 1 Unit Operating instructins TNI sft Flw 50 clinic system 1 Unit Shrt manual TNI sft Flw 1 Unit clinic system Order frm Accessries TNI 1 Unit sft Flw 50 internatinal Declaratin 1 Unit SD card 4 GB TNI sft Flw 50 1 Unit Table 1 - Scpe f Delivery f the clinic system Operating Instructin TNI sft Flw 50 clinic system 13

14 2.2) HUMIDIFIER HOMECARE COMPLETE The standard package f TNI sft Flw 50 clinic system includes the humidifier clinic system cmplete (Art.N ). The system may be used alternatively with the humidifier hmecare cmplete. (Part-N ) Details cncerning crrect use please nte chapter WARNING USE OF THE HOMECARE HUMIDIFIER IN EVERYDAY HOSPITAL ROUTINES When using this type f humidifier, there is n MRP filter integrated. If the patient is likely t further use the system in his/her hme envirnment, this type f applicatin is recmmended t be used in hspital. The patient will becme acquainted with the system and the healthcare prfessinals can tell a safe cntinuatin f the fllwing hmecare therapy. When being reused in hspital, the system is t be disinfected thrughly befre being used n a new patient. SAFETY NOTE Please nte the hygiene measures (chapter 6). 2.3) ACCESSORIES Accessries, spare parts and a current list f applicatrs fr respective TNI sft Flw 50 systems are available at TNI medical AG. Order frm Article number Prduct catalgue Article number Fr further infrmatin please nte 14 Operating Instructin TNI sft Flw 50 clinic system

15 3) STARTUP OF TNI sft Flw 50 CLINIC SYSTEM 3.1) ASSEMBLING AND CONFIGURING THE HUMIDIFIER CLINIC COMPLETE Place the unit/system hrizntally n a plane surface. Make sure that the system is lcated belw head height. Insert the mains cable int the pwer scket at the right side f the device. then insert the pwer plug int the pwer utlet ) HUMIDIFIER CLINIC COMPLETE The humidifier clinic cmplete cntains: Humidifier rack clinic Clear-Guard 3 bacteria filter; MRP hygienic filter Humidifier chamber aut-fill Air lift Remve the humidifier rack clinic and the humidifier clinichygienic set frm the packaging and assemble them accrding t the perating instructins. Please refer additinally t the descriptive image sequence. Push the humidifier clinic cmplete frm frnt int the device and clse the frnt f the husing. Fix a sterile water bag t the respective hse f the aut-fill chamber. WARNING Hygiene Use authrized parts nly. Make sure that the hygiene regulatins are met. Use riginally packed and unexpired parts nly. D nt apply already used dispsables, e.g. humidifier chamber, MRP filter, air lift, etc. Use sterile water in clinical treatment. SAFETY NOTE In rder t ensure an ptimal treatment, D nt use the humidifier chamber autfill after it had been drpped r run dry, which will trigger the alarm Refill water. Remve the clinical humidifier cmpletely BEFORE transprting, tilting r mving the device. Operating Instructin TNI sft Flw 50 clinic system 15

16 ) CONNECTING WATER BAG Attach the sterile water bag t the hanging bracket app. 1m abve the unit, and push the bag spike int the fitting at the bttm f the bag. Open the vent cap n the side f the bag spike. The chamber will nw autmatically fill t the required level and maintain that level until the water bag is empty. T ensure cntinual humidificatin, make sure that the water chamber and/r water bag is always filled with water. Check that water flws int the chamber and is maintained belw the fill line. If the water level rises abve the fill line, replace the chamber immediately. 16 Operating Instructin TNI sft Flw 50 clinic system

17 3.1.3) FILLING AN INSERTING THE HUMIDIFIER HOMECARE The Humidifier hmecare cmplete cntains: Water chamber Cyclne element Lid Remve the preassembled humidifier hmecare cmplete frm the packaging r frm TNI sft Flw 50 Please refer additinally t the descriptive image sequence Remve the lid flapping the lcking tab upwards n all sides Remve the cyclne element (pull it ut upwards) Fill the water reservir with the recmmended water up t the max mark After filling the water level must be in the area f min/max The mark max must nt be exceeded Insert the cyclne element. Clse the lid and lck it. Carefully push the humidifier rack hmecare cmplete int the device Make sure that n water can access int the system Clse the husing frnt lid. WARNING Hygiene Use authrized parts nly. Make sure that the hygiene regulatins are met. Use riginally packed and unexpired parts nly. D nt apply already used dispsables, e.g. humidifier chamber, MRP filter, air lift, etc. Use sterile water in clinical treatment SAFETY NOTE In rder t ensure an ptimal treatment, D nt use the humidifier chamber autfill after it had been drpped r run dry, which will trigger the alarm Refill water. Remve the clinical humidifier cmpletely BEFORE transprting, tilting r mving the device. Operating Instructin TNI sft Flw 50 clinic system 17

18 max. min Operating Instructin TNI sft Flw 50 clinic system

19 3.1.4) INSERT THE APPLICATOR Chse the right applicatr. Remve it frm the packaging and insert the applicatr int the designated pening f the device. Insert the applicatr plug frm abve int the pening and press dwn with less frce until it snaps in. The lcking lever mves t the left stp. WARNING In rder t avid burnings, D nt mdify the applicatr in any way Make sure that the applicatr is nt heated up t mre than rm temperature (e.g. by means f a blanket, electric fire...) since this may cause serius injury. D nt use insulating sleeves r accessries that have nt been authrized r recmmended by TNI medical AG. SAFETY NOTE In rder t minimize interference with the supervised signal, psitin the heated applicatr tube away frm any electrnic mnitring electrde (EEG, ECG, EMG, etc.) ) REMOVING APPLICATOR WARNING In rder t prevent mechanical destructin, Remve the applicatr frm the retainer withut effrt. D nt use frce if it is nt pssible t remve the applicatr right away. D nt use any tls t remve the applicatr. SAFETY NOTE D nt let any freign substances r bjects get int the system s applicatr pening. Mve the lcking lever under the applicatr t the right The applicatr is released frm its lcking Remve the applicatr plug upwards frm the hlder Nw, the system can be used with anther applicatr ) CONNECTING OXYGEN SUPPLY WARNING In rder t prevent burnings, d nt mdify the applicatr in any way. nte the safety guidelines in chapter d nt place the TNI sft Flw 50 device n the flr. Keep a minimum distance f 40 cm! keep the minimum distance f 40 cm t the wall. keep the minimum distance f 80 cm t ther electric devices. nte that an external xygen surce nt being cmpletely cnnected may lead t an inadequate therapy. Be very careful when handling xygen! Fire hazard! Operating Instructin TNI sft Flw 50 clinic system 19

20 SAFETY NOTE Oxygen supprts cmbustin prcess. Smking and pen fire are nt permitted when xygen is used during therapy. Several deaths ccurred in hspitals in the past due t patients wh smked despite being treated with xygen. In rder t take a drag, the xygen tube was remved frm the face and put n the bed. This made it pssible fr the xygen t spread acrss the beddings and the patient s clthes. The patient fell asleep and the lit cigarette set the bedding n fire. It was nt pssible t fight the fire due t the spread xygen. It kept burning even after the attempts t extinguish it. The patient finally died f the burnings. The cnnectin t the xygen surce is lcated n the left side f the device. Cnnect the TNI sft Flw 50 with the xygen supply via the xygen tube supplied. D nt supply xygen befre the TNI sft Flw 50 has started. The required rate f xygen will be set / adjusted at the xygen supply ) REPLACING DUST FILTER Please change the dust filter at regular intervals (at least every 3 mnth) Take the dust filter cver ut f the hlder (at the backside) A light dwnward pressure t the flap releases the lck The dust filter cver can be remved dwnwards. Remve the dust filter. Insert a new dust filter in case f a change. Insert the dust filter cver frm belw and lck it with light pressure nt the upper part. Prtect the filter frm direct sunlight and humidity. 3.2) STARTING AND STOPPING THE TNI sft Flw 50 WARNING T avid electric shcks, Make sure that the TNI sft Flw 50 is dry befre cnnecting it t the pwer supply. Make sure that the vltage ( V) and mains frequency (50-60 Hz) admissible fr the TNI sft Flw 50 cmply with yur lcal characteristics. 20 Operating Instructin TNI sft Flw 50 clinic system

21 3.2.1) SWITCHING ON / OFF T turn n the TNI sft Flw 50 press the main switch at the right side f the device. Mve the rcker switch t 1. The device switches n shwing fr apprximately 5 secnds the firmware-status and the selected humidifier type and begins t perate During the first cmmissining the system starts with the factury-set system and parameter values (humidificatin =34 TP and flw rate = 15 l/min.) After the first applicatin the system starts with the previusly set values 3.2.2) ACTIVATING STANDBY-MODE Press The system turns ff. The TNI sft Flw 50 shws the standby display ) DEACTIVATING STANDBY-MODE Press The system turns n. The display shws the peratin mde. 3.3) OPERATING ELEMENTS f TNI sft Flw 50 The TNI sft Flw 50 is perated via membrane keys Operating Instructin TNI sft Flw 50 clinic system 21

22 3.3.1) OPERATING ELEMENTS f TNI sft Flw 50 The TNI sft Flw 50 functin keys are psitined t the left and right f the display. KEY FUNCTION Each keystrke increases the respective value r mves the selected cursr upwards thrugh the menu Each keystrke decreases the respective value r mves the selected cursr dwnwards thrugh the menu. Activates the setup menu cnfirms the data input Starts and stps the therapy Stps the menu input 3.3.2) BASIC USER MENUE The TNI sft Flw 50 has a sphisticated user menu. Humidity Type f humidifier Flw rate New patient Therapy hurs System inf Language Time Date Alarm vlume Service menu access blcked, fr technical staff nly! Clinic menu access is activated! Basic system settings and mdificatin f therapy parameters can be realized via menu Opens the menu display Mark mves upwards Mark mves dwnwards Takes the selected menu pint 22 Operating Instructin TNI sft Flw 50 clinic system

23 Increases the parameter value Decreases the parameter value Takes the mdified parameter value Clses the menu display All required settings are prvided via that perating prcedure. The TNI sft Flw 50 stres these settings in the device memry The TNI sft Flw 50 restarts the system with these settings. 3.4) ATTACHING THE APPLICATOR WARNING T avid electric shcks, Be careful nt t tuch the electric cnnectins f the TNI sft Flw 50 as sn as the applicatr has been put n. Hygiene Due t bicmpatibility reasns, the applicatr may nt cntinuusly be wrn fr mre than 24 hurs. The applicatr f the clinic series shuld be exchanged after 336 therapy hurs (i.e. 14 therapy days f 24 h each). The applicatr has t be exchanged after every patient. D nt put the heated applicatr tube n the device. Make sure that the applicatr is nt heated up t mre than rm temperature (additinal heating e.g. by means f a blanket r radiant heater) since this may cause serius injuries. D nt use accessries which have nt been authrized r recmmended by TNI medical AG. SAFETY NOTE Psitin the heated applicatr tube away frm any electrnic mnitring electrde (EEG, ECG, EMG, etc.) t avid ptential interference with the supervised signal. Carefully insert the nse pins f the applicatr int the nse and mve the tube ver the ears and place it frward again. Make sure that the slightly curved ends will shw tward the face (see images) T fix the applicatr, pull the fixing sleeve twards the chin Leave the tube f the applicatr free, make sure nt t jam r bend the tube. Operating Instructin TNI sft Flw 50 clinic system 23

24 3.5) CHOOSING THE APPLICATOR Chsing the applicatr Please read the separate perating instructins, including all warnings, fr the respective applicatr. The TNI sft Flw 50 supprts yu by means f an integrated recgnitin technique. Additinally, autmatically predefined flw rate limits are cnsidered TNI sft Flw 50 can be used with a large range f applicatrs. Applicatr Size Recmmended max. flw rate in l/min. Nte Small 20 Series prductin cmpnent Standard 25 Series prductin cmpnent Medium 25 Special prductin cmpnent (limited availability) Large 50 Series prductin cmpnent ) Xlarge 50 Special prductin cmpnent (limited availability) Applicatr-Family Applicatr clinic Applicatr clinic single use Applicatr hmecare Available series prductin cmpnents small / standard / large standard / large small / standard / large Descriptin max. 366 therapy hurs r 14 days á 24 h, single patient use max. 12 therapy hurs, shrt term treatment, single patient use max. 720 therapy hurs r 30 days á 24 h, single patient use 3.6) STARTING THERAPY WARNING Befre starting a therapy, please make sure that all cmpnents are inserted and /r cnnected crrectly (see chapter 3). Befre switching n the device, make sure that the water cntainer is filled up with water! Set the main pwer switch t psitin I The device switches n shwing fr apprx. 5 secnds the firmware-status and the selected humidifier type and begins t perate After the first applicatin the system starts with the previusly set values If the device is in the standby mde: Press The system switches n. 24 Operating Instructin TNI sft Flw 50 clinic system

25 By pressing the functin keys, the display illuminatin is activated in the peratin mde. The display shws the peratin mde and the current parameter The Humidity, dew pint in DP The applied flw rate in l/min The supplied xygen vlume in l/min The xygen cntent, FiO 2 -value in % When nne f the functin keys has been pressed fr a perid f >10 minutes, the display reduces brightness. 3.7) ENDING THERAPY WARNING D nt pen the device immediately after switching it ff since the inner parts f the device are ht. Please wait a cuple f minutes until the device has cled dwn. T switch ff press The system turns ff. Remve the applicatr The TNI sft Flw 50 shws nw the standby display. After each use clean the applicatr.. Prperly dispse the dispsables f the clinic chamber (please nte capture 5 Hygienic measures and capture 11 - Dispsal ). If yu d nt use the device remve the reservir fr hygienic reasns. S, the residual misture in the device is able t dry. If the TNI sft Flw 50 is nt being used ver a lng perid f time, switch ff the TNI sft Flw 50 (main switch right f the device), discnnect the pwer crd frm the scket, remve the applicatr and make sure that there is n water in the humidificatin chamber nr in the water cntainer. 3.8) STARTING OXYGEN SUPPLY SAFETY NOTE The cnnectin t the xygen surce needs t be set up crrectly as described in chapter The xygen supply may nly be released with the TNI sft Flw 50 running. Please nte chapter Press The system ges int peratin and supplies the required flw rate at the applicatr, the air Operating Instructin TNI sft Flw 50 clinic system 25

26 flw is perceptible, the value is bvius in the display. Supply the TNI sft Flw 50 with the required xygen, adjust the value. The xygen applied is shwn in the display in l/min. The system mixes the adjusted air-flw rate with the xygen. The flw rate is referred t as ttal flw; i.e. the air-xygen mixture is set t the flw rate specified in the nminal value. The real value and the xygen cncentratin, resulting frm it, FiO 2 in %, is shwn in the display. 3.9) STOPPING OXYGEN SUPPLY SAFETY NOTE The cnnectin t the xygen surce needs t be set up crrectly as described in chapter The xygen supply may nly be released with the TNI sft Flw 50 running. D nt supply the TNI sft Flw 50 with xygen during standby-mde! Please nte chapter The system still supplies the required flw rate at the applicatr, the air flw is perceptible. The real flw rate and the FiO 2, resulting frm it, is shwn in the display.# Switch ff the xygen supply at the xygen surce. The xygen shwn in the display rises t 0 l/min The FiO2 value shwn in the display indicates 21% With this display, press The system switches ff. The TNI sft Flw 50 nw indicates the standby display. 4) SELECTING THE THERAPY PARAMETERS AND SYSTEM CONFIGURATION MENU WARNING In rder t set the therapy parameters, the device has t be cmpletely assembled and als needs t be in perating mde as described in chapter 3. The parameters are called up via the menu and the functin keys and als adjusted and stred (please nte capture 3.3.) The device has stred the previus parameter settings and is started with these settings after a restart. The fllwing therapy parameter can be changed: Flw rate in l/min Humidity ( dew pint) in DP The fllwing menue pints are admitted fr system cnfiguratin: Humidifier type New patient Language Time 26 Operating Instructin TNI sft Flw 50 clinic system

27 Date Alarm vlume The fllwing menue pints, supply system infrmatin: System inf Therapy hurs Service menue access blcked, nly fr technical staff! Clinic menue access is activated 4.1) THERAPY PARAMETERS 4.1.1) STATEMENT ON THE INDICATED DISPLAY VALUES Nminal and Real value shwn n the perating display WARNING NOMINAL and REAL VALUE: The nminal value describes the value the system shuld deliver as a regulated therapy value. Reaching these therapy values and prviding them crrectly is described as the real value, meaning: In the settings, the nminal value defines the targeted value fr the system. In an ptimal situatin, the real value differs nly slightly frm the nminal value. Fr mre infrmatin n tlerance specificatins see chapter Technical Data. SAFETY NOTE The real value is mandatry fr therapy. The real value ensures a successful therapy. Alarms and ntes n the display indicate deviatins frm the tlerance limit. NOMINAL VALUES On the bttm line the display shws the prgrammed nminal values, which crrespnds t the last prgrammed therapy parameters. Humidity (dew pint) in DP Flw rate in l/min REAL VALUES n the display The first line shws the humidity (dew pint) real value and the system heats up and the system cls dwn The secnd line shws the Flw rate real value this value crrespnds t the current exact, regulated flw rate released in l/min cnsisting f air r Air-Oxygen mixture Additinally, the admixture f xygen O 2 admixture in l/min And the resulting xygen (cncentratin) in %, FiO 2 -value Operating Instructin TNI sft Flw 50 clinic system 27

28 4.1.2) SETTING HUMIDITY (DEW POINT) WARNING Humidity and dew pint: In rder t set a nminal value, the system requires a setup-time f abut 10 minutes. If the humidity value is altered (n matter if increasing r decreasing the value), the system will always require a physical setup-time f abut 10 minutes. The system is t be used in the crrespnding envirnment (see chapter Technical data ). SAFETY NOTE The Real value is bligatry fr therapy. If yur nse feels dry during therapy, check fr crrect chice and setting f the respective humidifier type. make sure that the humidity chamber cntains enugh water, increase humidity If yu feel a slight stinging in the nse, check fr the crrect chice and setting f the respective humidifier type. make sure that the humidity chamber cntains enugh water, increase humidity. If cndensate frms in the applicatr tube r interfering water drplets spurt ut f the applicatr, check fr crrect chice and setting f the respective humidifier type. check fr crrect ambient cnditins. The rm temperature might be t lw. reduce humidity; humidity might be set t high fr the valid ambient cnditins. The individual misture (humidity) cntent f the applied air / air-xygen mixture will be prvided via this parameter It is recmmended t perfrm the therapy with dew pint t ensure ptimum humidificatin f the mucsa (mucus membranes) The humidificatin (dew pint) can be set frm dew pint Adjustable in 1 C steps During therapy: Pssible via press press press increases the humidity value by 1 DP each further keystrke increases the humidity value by 1 DP decreases the humidity value by 1 DP each further keystrke decreases the humidity value by 1 DP accepts the value and retains the selected value 28 Operating Instructin TNI sft Flw 50 clinic system

29 Setting via menu, the system cnfiguratin: press mark humidity via cnfirm via set the required value via cnfirm via the system stres the therapy parameter end the adjustment via The changed value is displayed in the index value line The system readjusts the changed value 4.1.3) FLOW RATE WARNING It is recmmended t set the nminal flw rate befre using the applicatr SAFETY NOTE T set the flw rate is nly allwed t be set by qualified persnnel The flw rate can be adjusted frm 15 t 50 litres/min (l/min) Adjustable in 0,5 l/min steps Access this parameter via menue press mark the flw rate via cnfirm via Set the required value via Majr value changes can be perfrmed via r and keep the key depressed, autmatic scrlling starts. release the key, when the required value is reached. cnfirm via End the adjustment via The changed value is displayed in the index value line The system readjusts the changed value Operating Instructin TNI sft Flw 50 clinic system 29

30 4.2) MENU ITEMS WHICH HAS BEEN APPROVED FOR SYSTEM CONFIGURATION 4.2.1) CHOOSING TYPE OF HUMIDIFIER WARNING Reaching ptimal humidity cntrl: The TNI sft Flw 50 can be perated with 2 different types f humidifier: Humidifier clinic cmplete Humidifier hmecare cmplete Temperature and humidity cntrl are based n a very sensitive and cmplex cntrl algrithm. In rder t achieve an ptimal result, chse the crrect type f humidifier and make the crrespnding settings under the menu item type f humidifier. SAFETY NOTE Chsing the incrrect setting by mistake will nt lead t a prblem. Humidity generated by the Humidifier hmecare cmplete is higher than the humidity generated by the clinical humidifier due t the perfected cyclne principle. Unnminal side effects resulting frm incnsistent humidity (dew pint) may include a slight frmatin f cndensate r the inability f the user t increase the humidity. At n pint f time will the patient be endangered (see chapter 4.1). press mark the humidifier type via cnfirm via chse the required type via Humidifier clinic Humidifier hmecare Cnfirm via End the adjustment via 30 Operating Instructin TNI sft Flw 50 clinic system

31 4.2.2) CHOOSING NEW PATIENT / CHANGE OF PATIENT WARNING Registering times f therapy The TNI sft Flw 50 is able t save all actins and therapy sessins assigned t a patient. This gives the hspital the pprtunity t register the individual situatin f the patient. This parameter des nt influence the therapy. SAFETY NOTE Registering the real therapy hurs during a hspital stay allws t accunt fr treatment perids crrectly. The system basically recrds all parameters which were measured in the mst recently ending perid f 1 year. It is pssible t patient specifically capture the parameters n the integrated SD Card. press mark new patient via cnfirm via chse the required status N cntinues cunting Yes sets the therapy hurs t 0 cnfirm via end the adjustment via 4.2.3) SETTING THE LANGUAGE NOTE Language selectin and language diversity The TNI sft Flw 50 basically ffers 2 types f languages t select frm. Additinally, it is pssible t stre 4 additinal languages in the system and t select frm additinal 8 languages via SD Card. Safety nte Availability is nly realized with the market intrductin in the crrespnding cuntry. Please cntact yur lcal TNI medical AG agency. press mark the language via Operating Instructin TNI sft Flw 50 clinic system 31

32 cnfirm via chse the required language via cnfirm via End the adjustment via The previusly selected language nw is the system language 4.2.4) SETTING THE TIME NOTE Display frmat It is pssible t select frm 2 different clck displays 24 hur mde r 12 hur am / pm mde. SAFETY NOTE The time set n the device is cnsidered when entering smething in the strage. The clck is nt autmatically adjusted fr daylight saving changes. An autmatic radi adjustment is nt pssible. Please make sure that the lcal time f the system is set crrectly. In case f any questins, please cntact yur lcal TNI medical AG representative. press mark the time via cnfirm via chse the required status via 24 h 12 am / pm cnfirm via Chse the required hur via Cnfirm via the system marks the minute display Chse the required minutes via cnfirm via 32 Operating Instructin TNI sft Flw 50 clinic system

33 End the adjustment via 4.2.5) SETTING THE DATE NOTE Display frmat: It is pssible t chse frm 2 different date displays: DD:MM:YY (Day:Mnth:Year) YY:MM:DD (Year:Mnth:Day) SAFETY NOTE The date set n the device is cnsidered when entering smething in the strage. Adjustments/Settings d nt take place autmatically. An autmatic radi-adjustment is nt given. Please make sure that the date f the system is set crrectly. In case f any questins, please cntact yur lcal TNI medical AG representative. press mark the date cnfirm via chse the required status via TT.MM.JJ TT.MM.JJ cnfirm via chse the required day via cnfirm via the system marks the mnth display chse the required mnth via cnfirm via chse the required year cnfirm via end the adjustment via Operating Instructin TNI sft Flw 50 clinic system 33

34 4.2.6) ALARM VOLUME WARNING The TNI sft Flw 50 detects incnsistent situatins during peratin. This leads t ntificatins via display r t alarms. Alarms can be shwn in the display area r be indicated by sunds. The acustic alarm sund is adjustable t 4 levels f ludness. If necessary, cntact yur lcal TNI medical AG agency. SAFETY NOTE The acustic alarm can nt be suppressed. It is nt pssible t suppress the visual alarm n the display. press Mark the alarm vlume via cnfirm via Chse the required vlume Level 1 (lw) Level 2 Level 3 Level 4 (high) cnfirm via end the adjustment via 4.3) MENUE POINTS, SYSTEM INFORMATION System infrmatin Therapy hurs Service menue access blcked, nly fr technical staff! Clinic menue access is activated ) SYSTEM INFORMATION NOTE Infrmatin n the system When being delivered, the TNI sft Flw 50 is prvided with the latest firmware. The firmware is defined by the details given in the 3 categries PF/EF/LF. In case f failure, this infrmatin may be helpful t yur lcal TNI medical AG cntracting 34 Operating Instructin TNI sft Flw 50 clinic system

35 partner and shuld, if necessary, be kept at hand t prvide the respective data. In case f additins r updates ver the time, mdificatins can be made via SD card and by yur lcal TNI medical AG cntracting partner. SAFETY NOTE It is nt necessary t mdify the firmware. If required due t ccuring errrs, the manufacturer will autmatically perfrm an update. press mark the system infrmatin via cnfirm via The display shws: Serial number Firmware Type Applicatr PF and versin number EF and versin number LF and versin number end the adjustment via 4.3.2) READING OUT THERAPY HOURS NOTE The TNI sft Flw 50 cntinuusly saves every patient s therapy hurs. Since this data may be f interest t the hspital, it is pssible t reset the therapy hurs via the menu item New patient at each change f patient. Each activity and disfunctin data cllected during therapy hurs is saved t an additinal strage and can be read and evaluated by the service r an authrized cntracting partner f the TNI medical AG. SAFETY NOTE The data is stred n SD Card as well as n internal memry. The internal memry has the capacity t stre all data cllected during the previus 12 mnths. As sn as the maximum memry capacity is reached, the strage will always hld the data cllected during the previus 12 mnths available. press Operating Instructin TNI sft Flw 50 clinic system 35

36 mark the therapy hurs via cnfirm via Ttal Previus day Average day Therapy days end the adjustment via 4.3.3) CLINIC-MENUE WARNING The clinic menue is activated and enables the setting f all therapy parameters, system cnfiguratins and the direct system infrmatin ) SERVICE-MENUE WARNING Only technically qualified persnnel is allwed t access the clinic menu! 5) HYGIENIC MEASURES WARNING Prir t each hygiene measures, switch ff the main switch n the right side f the device and discnnect the pwer cnnecting cable! Under n circumstances must fluids get int the device! Nn-bservance f cleaning- and disinfectin instructins may result in bacterial cntaminatin r infectin! Overdsing disinfectrs may damage the material. Please nte the replacement cycles fr applicatr, (MRP) filter and air lift! With the exceeding f this given time perid, a prper use f the device cannt be ensured. Avid calcificatin f the respective parts! After a cleaning/disinfectin, please check all parts fr damages t the surface and fr prper functining! 5.1) CLEANING The Cleaning applies t the clinic status cnferred upn r r infrmatin in accrdance with RKI. The fllwing table cncerning cleaning and changing cycles r individual prducer infrmatin serves as guideline. When switching frm ne patient t the next, all cmpnents listed in the fllwing table has t be cleaned/replaced: Single use cmpnents have t be replaced Accessry parts have t be cleaned 36 Operating Instructin TNI sft Flw 50 clinic system

37 5.1.1) CLEANING- AND CHANGING CYCLES Cleaning and Daily r Weekly 366 Therapy 3 Single Single changing cycles 24 h r hurs r 14 mnths patient use 7 days days à 24h use Wipe disinfectin X Change X Change X Change X Wipe Cleaning X disinfectin Wipe disinfectin X Wipe X disinfectin Wipe X disinfectin TNI sft Flw 50 clinic system Humidifier rack clinic Humidifier chamber aut-fill Air lift humidifier clinic Clear-Guard 3 bacterial filter, angled filter Humidifier hmecare cmplete Water chamber humidifier Lid humidifier hmecare Cyclne element humidifier hmecare Oxygen tube Change X Applicatrs clinic serie All apprved types Wipe disinfectin Change X Dust filter Wash-ut Change X Wipe disinfectin X Operating Instructin TNI sft Flw 50 clinic system 37

38 5.1.2) DETERGENTS Prduct- Prducer Basis Cn- Plastic Elas- name material centra- t- tin mere antifect extra Schülke quaternary 0,5 t very very & Mayr ammnium 3% gd gd GmbH cmpunds and aldehydes mikrzid Schülke Ready-t-use Very gd ready sensitive & Mayr Alchl-free rapid fr liquid GmbH disinfectant based n use quaternary ammnium cmpunds mikrzid Schülke Ready-t-use quaternary ready sensitive & Mayr disinfectin tissues ammnium fr wipes GmbH mistened with nn- cmpunds use alchlic pure substance Pursept-AF Schülke disinfectants Guanidine, & Mayr N,N -1,3- GmbH Prpandiylbis-, NKksalkylderivates, Diacetate Pursept FD Merz Efficient surface disinfectin with extremely benefic effects 9,6 g Glyxal, 8,0 g Didecyldimethylammnium chlride, 3,5 g Frmaldehyde, 2,5 g Glutardialdehyde, < 5 % nn-inic surfactant, auxiliary materials, fragrances (e. g. Limnene) ready fr use 38 Operating Instructin TNI sft Flw 50 clinic system

39 terralin liquid terralin prtect Prducer Schülke & Mayr GmbH Schülke & Mayr GmbH Alchl-based disinfectants. Ready fr use Liquid disinfectin and cleaning cncentrate based n a cmbinatin f armatic alchls, quaternary ammnium cmpunds, amphtere Glycinderivates and nn-inic surfactant MELISEPTOL B.Braun Ready-t-use disinfectin fr spraying r wiping. Descgen ANTISEP- TICA Hexaquart plus Indicin Extra N Indicin FOAM B.Braun ECOLAP GmbH ECOLAP GmbH Surface disinfectin and cleaning f inventry and flrs. Surface disinfectin with Glucprtamin and QAV, free f aldehydes Ready-t-use fam spray fr alchlic quick disinfectin Basis material Alchl Alchl and quaternary ammnium cmpunds Prductname Cncentratin Plastic Elastmere ready fr use Ready fr use Alchl Ready fr use surface disinfectin, free f aldehydes and aminel Alchl Alchl Ultrasl F Fresenius Surface disinfectin n-alkylbenzyldimethylammniumchlride, Glutaral cncentrate Muccit-T Merz Aldehyd free pwerful free f aldehyde cncentrate maintaining high cleaning perfrmance Safe disinfectin apprx. frm 5 min. cncentrate Operating Instructin TNI sft Flw 50 clinic system 39

40 Prduct- Prducer Basis Cn- Plastic Elas- name material centra- t- tin mere Sprcid Instr. disinfektin) Fresenius Instrument disinfectin incl. cleaning used fr thermlabile and thermstable instruments, endscpes. See mre at: rg//0rcid%c2%ae/#sthash. sbibxq.dpuf Glutaral 4,5 g, Frmaldehyde 7,6 g. Sekusept ECOLAP GmbH Cleaning active instrument disinfectin tin free f aldehydes Glucprtamin 5.1.3) HOUSING SURFACES Cleaning cycle: daily Wipe the husing surface f the device dwn with a damp clth, mistened with disinfectants. Let the disinfectant wrk accrding t the instructins f the manufacturer and make sure that any cleaning residues has been remved. Calcificatins shuld be avided ) HUMIDIFIER CLINIC COMPLETE Cleaning cycle: daily Wipe the husing surface f the humidifier rack dwn with a damp clth, mistened with disinfectants. Let the disinfectant wrk accrding t the instructins f the manufacturer and make sure that any cleaning residues has been remved. Calcificatins shuld be avided. Der humidifier rack clinic is dishwasher safe and can be cleaned with a temperature f 65 C. Changing cycle: please nte the table abve Dispsable: Humidifier chamber aut Fill r humidifier chamber manual filling, air lift and Clear Gard 3 bacterial filter int the respective garbage cntainer (plastic-/dmestic waste). Please nte als chapter 11 Dispsal ) HUMIDIFIER HOME CARE COMPLETE; CLINICAL USE Cleaning cycle: daily Wipe the husing surface f the device dwn with a damp clth, mistened with disinfectant. Let the disinfectant wrk accrding t the instructins f the manufacturer and make sure that any cleaning residues has been remved. Calcificatins shuld be avided. Cleaning cycle: weekly Insert the fllwing individual parts f the disassembled humidifier hmecare cmplete int a cntainer filled with disinfectants: water chamber, cyclne element and lid humidifier. Wipe the husing surface f the device dwn with a damp clth, mistened with disinfectant. Let the disinfectant wrk accrding t the instructins f the manufacturer. Subsequently, rinse the individual parts with sufficient water and make sure that any cleaning residues has been remved. All individual parts are dishwasher safe and can be cleaned with a temperature f 65 C. 40 Operating Instructin TNI sft Flw 50 clinic system

41 5.1.6) DUST FILTER Cleaning cycle: weekly Changing cycle: 3 mnth Open the dust filter flap at the backside f the device. Slight pressure n the prtruding flapreleases the lck. The dust filter flap can be remved dwnwards Remve the dust filter. Clean the filter with bidegradable detergents. Carefully rinse the air filter with running water. It is washable t 30 C. Wring the filter ut and dry well. Ensure that n misture can get thrugh a wet air filter. Insert a dry air filter. In case f a change insert a new air filter. Insert the air filter flap with slight pressure until it lcks. Prtect the filter frm direct sunlight and humidity ) APPLICATOR IN CLINICAL USE The applicatr have t be exchanged after each change f patient. Cleaning cycle: daily The applicatr is disinfected daily by wiping. Carefully wipe the nasal cannula dwn with a damp clth, mistened with disinfectant. Wipe the cmplete applicatr tube and the plug dwn with a damp clth, mistened with disinfectant. Let the disinfectant wrk accrding t the instructins f the manufacturer and make sure that any cleaning residues has been remved. Wipe ptentially several times with the damp clth. Dispse the applicatr int the respective garbage cntainer (plastic-/dmestic waste). Please nte als chapter 11 Dispsal. 6) DESINFECTION Using and cleaning instructins are crrectly cmplied with capture 5, a TNI sft Flw 50 disinfectin is nt necessary. Shuld a system disinfectin be necessary due t a majr reasn, please cntact the manufacturer r yur respnsible and authrised TNI medical AG representative. They are exclusively allwed t perfrm this prcedure. Operating Instructin TNI sft Flw 50 clinic system 41

42 7) TECHNICAL DATA 7.1) SYMBOLS ON THE DEVICE Manufacturer TNI medical AG Internatinal Hfmannstraße D Wuerzburg Pwer switch: OFF On the switch The device is discnnected frm pwer supply Phne: Fax: inf@tni-medical.de Prductin date Indicates the date when the medical prduct was prduced I Pwer switch: ON On the switch The device is cnnected with pwer supply Applied part f type BF Prtectin degree fr applied part: BF The user is s well islated by CE mark Type label Cnfirms cnfrmity with the regulatin 93/42/EWG f medical prducts the device that the safety regulatins cncerning leakage current are met. IP 21 IP-prtectin class Prtected against slid freign bjects f 12.5 mm and greater. Prtected against Drpt frm abve Dispsal Type label r nly GAW The TNI sft Flw 50 must nt be dispsed f in husehld waste. Accrding t the new electric and electrnic equipment law (ElektrG) the manufacturer is respnsible fr the dispsal f TNI sft Flw 50. Please cntact TNI medical AG Batch cde Indicates the batch cde f the manufacturer, fr that the batch r das Ls can be identified Ambient temperature regarding the unit`s dispsal. The device may nly be perated with the ambient cnditins Item/article number Indicates the rder number f the manufacturer, fr that the medical prduct can be identified. Attentin t the user manual (perating instructins) Attentin t the user manual r please nte perating instructins Serial number Indicates the serial number f the manufacturer, fr that a particular medical prduct can be identified. max. 200 mbar Max. pressure Max. pressure allwed at the xygen intake Cautin: ht surface The s marked device parts may get ht surface Heating plate Hme care chamber Humidificatin chamber autfill Cautin Electrstatic sensitive Observe Precautins fr Handling electrstatic sensitive Devices 7.2) PERFORMANCE PARAMETERS, TECHNICAL DATA, DEVICE PARAMETERS TNI sft Flw 50 PERFORMANCE DATA: Flw rate Adjustable in Tlerances Admixture f xygen With l/min indicatr FiO 2 indicatr Humidity dew pint Adjustable in Cndensate-free gas-air flw 10 t 50 l/min 0,5 l/min steps, +/- 2 % f index value 0-20 l/min pssible in the display integrated in the display frm DP, 1 C-steps fr a pleasant therapy 42 Operating Instructin TNI sft Flw 50 clinic system

43 Event memry SD-Card Language selectin fr display indicatrs verwiew f the last 12 therapy mnths stres all events, mbile data transfer pssible individual language memry available as individual standard german and english 7.3) TECHNICAL DATA, DEVICE PARAMETERS Medical prduct class (93/42/EWG): IIa Safety class, electrically: II Sund level: < 30 db(a) alarm signal sund pressure > 60 db(a) Safety type: IP21 Applied part (Applicatr): BF Electrical safety Accrding t EN UL CSA C22.2/N Electrmagnetic cmpatibility Accrding t EN Operating vltage (nminal vltage): V AC, Hz Maximum pwer system 300 VA Maximum pwer heating plate 150 VA Maximum pwer applicatr heating 48 VA Device dimensins Width Depth: Height: Weight withut Humidifier Clinik and withut water Water reserve: Humidificatin chamber aut Fill Humidificatin chamber manual filling sterile water bag r bttle water chamber humidifier hmecare Applicatr Changing cycle Applicatr clinic serie (Expected Service Life): Safety level (applied part): ca. 315 mm ca. 320 mm ca. 140 mm < 5,6 kg ca. 150 ml ca. 380 ml > 1000ml ca. 650 ml Range f applicatrs Art-N. After < 366 therapy hurs, = 14 days á 24 h, Single patient use detailed instructins please nte chapter 3.5 BF Operating Instructin TNI sft Flw 50 clinic system 43

44 Tube lenght: 1,8 m Weight: apprx. 100 g typical Humidity dew pint Maximum temperature f flw vlume escaping 43 C t NC Shelf life f parts and accessries Same as TNI sft Flw 50, if n expiratin date stated Envirnmental cnditins Ambient temperature: 10 C t 30 C Recmmended ambient temperature: 18 C bis 28 C Ambient Humidity: 15 % t 93 % RH Ambient air pressure: 700 hpa t 1060 hpa Flwrate: l/min. Average warming-up duratin < 30 min. Envirnmental cnditins cncerning strage and transprt Temperature: -25 C bis 70 C Humidity: < 93 % RH Air pressure 700 hpa bis 1060 hpa Electrmagnetic cmpatibility: EN : 2007 Filter class f dust filter: G4 (EN 779: 2003) Dust filter changing cycle Please nte Expected perating time (Expected Service 3-6 years, depends n daily usage Life) f TNI sft Flw 50 Attached Oxygen surce Type Only medical apprved xygen surces may be cnnected (that includes, but is nt limited t IEC :2005 and fr hmecare use IEC :2010 cmpliance). Fr mre infrmatin, please cnsult the xygen user manual r yur xygen retailer. Fr handling and adjustment, please refer t the accrding user manual. Max. pressure allwed at the xygen intake 200 mbar 44 Operating Instructin TNI sft Flw 50 clinic system

45 8) ERRORCODES SAFETY NOTES Sme errrs lead t the result that the device can n lnger be perated In the case f a fault cntact yur respnsible TNI medical AG representative Alarm signals will sund t indicate danger fr the user t an errr that have ccurred. The delay between errr cnditin and errr signal can be up t ne minute max. The alarm signals are divided int tw steps: Alarms with lw pririty (severity cde I): 1 audible signal sunds This prcedure is repeated cyclically, The errr cde will be indicated in the display When the errr is cleared the device is again ready t perate The visual indicatin in the display cannt be switched ff. Alarms with medium pririty (severity cde II) 3 audible signals sunds This prcedure is repeated cyclically The errr cde will be indicated in the display These alarms cannt be switched ff via menue The device can n lnger be perated The user is nt able t crrect the fault Cntact yur respnsible TNI medical AG representative Operating Instructin TNI sft Flw 50 clinic system 45

46 In the event f failure, the fllwing errr cdes will be indicated n the display. I II Pririty acc. t IEC :2006 lw pririty medium pririty ALARM- AND ERROR CONCEPT Errr categry Pririty Errr Indicatin in the Descriptin number display 10 II 101 Pressure t high Internal pressure t high( > 90 mbar). 10 II 102 Sensr defective O2 flw sensr defective 10 II 103 Sensr defective Air flw sensr defective 10 II 104 N flw Flw rate is zer 10 I 151 Flwrate nt reachable Measured flw is lwer then the set flw ( abut 2 l/min, depending n the set flw) 10 I 153 Flwrate t high Measured flw is higher that the set flw ( abut 2 l/min, depending n the set flw) 10 I 154 Leakage detected Leakage: Humidificatin chamber nt available r leaking humidificatin chamber. 10 I 155 Ambient pressure ff limits Ambient pressure ff limits (limits see Chapter 7.3) 10 I 156 O 2 flw rate t high the added O 2 flw rate is t high 10 I: 157 Sensr defective Pressure sensr defective 20 I 251 Ambient temperature barmetic pressure ut f permitted range (limits see Chapter 7.3) 20 II 201 Air temperature t high Internal air Temperature t high (> 43 C). 20 I 254 Sensr defective Ambient temperature / humidity sensr defective 20 I 255 Dew pint nt reachable Selected dew pint nt reachable. (difference abut 1 C, depending n the set dew pint) 46 Operating Instructin TNI sft Flw 50 clinic system

47 Errr categry Pririty Errr number Indicatin in the display 30 II 301 Heating plate verheated Descriptin Heating plate verheated. Please check humidifier. Detectin: Heating plate temperature is htter than it shuld be (Limit depending n set temperature) 30 I 351 Please refill water Water chamber empty, fill up with water. The water level is nt measured directly, but can be determined with the heating plate characteristics. 30 I 352 Heating plate defective Heating plate defective (n pwer), cntact yur respnsible TNI medical AG representative. 30 I 353 Sensr defective Temperature sensr humidifier defective 30 I 354 Heating plate defective Heating plate defective (n current), cntact yur respnsible TNI medical AG representative. 30 I 355 Sensr defective System failure, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative 40 II 401 blwer defective Blwer blcked, please switch system ff/n. In the case f failure cntact yur respnsible TNI medical AG representative 40 II 402 Blwer verheated Blwer verheated. Mtr temperature is higher than 120 C. Mtr temperature is higher than 120 C. II 403 Blwer sensr defective Blwer temperature sensr defective Operating Instructin TNI sft Flw 50 clinic system 47

48 Errr categry Pririty Errr Indicatin in the Descriptin number display 40 II 404 Fan blwer defective Fan blwer defective, please cntact yur respnsible TNI medical AG representative 50 II Display defect, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. Display defect. Errr is nt displayed, but yu shuld hear an alarm signal. 50 II 502 System failure Sensr errrs n system startup, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 60 II 601 Sensr defective Temperature sensr applicatr defective 60 II 602 Air flw t ht Air temperature at nasal cannula higher than 43 C (external Measurement mandatry) 60 II 603 ext. Measuring element nt detected External measurement element at nasal cannula nt detected, please check. 60 I 651 Applicatr heating Applicatr heating defective. defective 60 I 652 Applicatr nt detected Applicatr nt detected, please change. 60 I 653 Type f applicatr! The selected real flw rate is t high fr this type f applicatr. Reduce flwrate r use a larger applicatr. 70 II 701 System failure EEPROM damaged, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 48 Operating Instructin TNI sft Flw 50 clinic system

49 Errr categry Pririty Errr Indicatin in the Descriptin number display 70 II 702 System failure Operating system errr, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 70 II 703 System failure EEPROM defective, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative 70 II 704 System failure User settings damaged, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 70 II 705 System failure Firmware nt usable with this device, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 70 I 751 SD-card nt available SD card nt available 70 I 752 SD-card r file SD-card checksum errr defective 70 I 753 System failure Battery vltage t lw, please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 70 I 754 System failure Firmware checksum errr (n SD card update), please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 70 I 755 System failure Firmware nt usable with this device (n SD card update), please restart system. In the case f failure cntact yur respnsible TNI medical AG representative. 80 I 851 Clean the filter NOTE: change filter; filter shuld be changed every 3 mnth Tabelle 5 - Fehlernummern Operating Instructin TNI sft Flw 50 clinic system 49

50 9) SERVICE/MAINTENANCE NOTE The user/clinic is respnsible fr the maintenance f the TNI sft Flw 50 Overhauling/service must exclusively be perfrmed by authrized TNI medical AG technical staff The device husing must exclusively be pened by authrized TNI medical AG technical staff, this includes the changing f the fuses. Excepted: using and cleaning f the remvable parts Only use pwer cnnecting cable distributed by TNI medical AG Discnnect always the pwer crd frm the plug befre pening the device Due t the technical innvatin the TNI sft Flw 50 des nt need any maintenance wrk, these systems are maintenance-free. Please fllw the instructins cncerning security and hygienic measures t guarantee a secure and lngterm peratin f the device. Furthermre, please perfrm a visual check befre every applicatin and check the crrect functining f TNI sft Flw 50. Please cntact yur respnsible TNI medical AG representative if any unexpected peratin, events, damages r malfunctins ccur. The technical service assigns a number in rder t guarantee an efficient prcessing f the incident. Please indicate this number at every further cntact with the technical service. The TNI sft Flw 50 shuld be checked every 2 years after cmmissining by the respnsible TNI medical AG representative in rder t guarantee the security fr the user and t meet the terms f TNI sft Flw 50 s quality. TNI medical AG Hfmannstr. 8 D Wuerzburg Phne Germany: free f charge Phne Internatinal: Fax: inf@tni-medical.de 10) WARRANTY The device was manufactured with the utmst care und tested in detail befre shipment The warranty perid is 1 year frm the date f purchase (prving an invice and/r guarantee certificate with dealer stamp). The TNI medical AG will replace defective parts f the device within the perid f guarantee. The perid f guarantee will nt be extended thrugh the case mentined abve. Warranty des nt cver peratinal wear and cnsumptin parts (e.g. dust filter, water chamber etc.) and assets subject t a restricted perid (e.g. applicatr etc.). Replaced parts becme the prperty f TNI medical AG, any further claims (by the purchaser) are excluded. Warranty expires thrugh: Assembly, extensins, resettings, changes r repairs by unauthrized persns. Nn-cmpliance with the perating instructins Damages caused as a result f perating errrs Imprper use r handling Use f nn-riginal spare parts Frce majeure (e.g. lightning etc.) Transprt damages due t imprper packaging when returning 50 Operating Instructin TNI sft Flw 50 clinic system

51 Opening f the husing by unauthrized persns. Exceptin: Using and cleaning f the remvable parts withut tls. If the cmplaint prves t be unjustified, the custmer must bear the csts f checking and shipping f the device. Please stre the riginal packaging in the case f service. If the riginal packaging is n lnger available cntact the custmer service. If yu send us yur device withut the riginal packaging and damage results frm this, we have t charge the repair. Furthermre, we have als t charge the special packaging fr the return. We thank yu fr yur understanding 11) DISPOSAL The TNI sft Flw 50 was prduced in accrdance with the relevant standards. The design tgether with the simple disassembly facilitate the dispsal. Electrnic waste Accrding t the new electric and electrnic equipment law (ElektrG) the manufacturer is respnsible fr the dispsal f TNI sft Flw 50 Please cntact TNI medical AG regarding the unit`s dispsal. Packaging material TNI sft Flw 50 Classificatin: d nt dispse Please stre the riginal packaging in the case f service. If the riginal packaging is n lnger available cntact the custmer service. If yu send us yur device withut the riginal packaging and damage results frm this, we have t charge the repair. Furthermre, we have als t charge the special packaging fr the return. Applicatr Classificatin: dmestic waste Used applicatrs can be dispsed with the nrmal husehld waste after expiry f change interval. Classificatin: dmestic waste MRP-Hygiene filter, MPR air lift Humidificatin camber aut fill Humidificatin chamber manual filling Used MRP can be dispsed with the nrmal husehld waste after expiry f change interval. Clinic chamber classificatin: dmestic waste Used clinic chambers can be dispsed with the nrmal husehld waste Hme care chamber, chamber cver, cycln element, classificatin: dmestic waste Used parts can be dispsed with the nrmal husehld waste Operating Instructin TNI sft Flw 50 clinic system 51

52 12) ELECTROMAGNETIC COMPATIBILITY (EMC) SAFETY NOTE The TNI sft Flw 50 is a MEDICAL ELECTRICAL EQUIPMENT and needs special pre-cautins regarding EMC and needs t be installed and put int service accrding t the EMC infrmatin prvided in the ACCOMPANYING DOCUMENTS. Prtable and mbile RF cmmunicatins equipment can affect MEDICAL ELECTRICAL EQUIP- MENT! The TNI sft Flw 50 shuld nt be used adjacent t r stacked with ther equipment. If adjacent r stacked use is necessary the TNI sft Flw 50 shuld be bserved t verify nrmal peratin in the cnfiguratin in which it will be used. The use f ther accessries, cables r cnverters t the device TNI sft Flw 50 can increase the emissin and reduce the immunity f the TNI sft Flw 50. In accrdance t the applicable standard the TNI sft Flw 50 has n essential perfrmance. The TNI sft Flw 50 may be interfered with by ther equipment, even if that ther equipment cmplies with CISPR EMISSION requirements. Guidance and manufacturer s declaratin - electrmagnetic emissins The TNI sft Flw 50 is intended fr use in the electrmagnetic envirnment specified belw. The custmer r the user f the TNI sft Flw 50 shuld assure that it is used in such an envirnment. Emissins test Cmpliance Electrmagnetic envirnment - guidance RF emissins CISPR 11 Grup 1 The TNI sft Flw 50 uses RF energy nly fr its internal functin. Therefre, its RF emissins are very lw and are nt likely t cause any interference in nearby electrnic equipment. RF emissins CISPR 11 Harmnic emissins IEC Vltage fluctuatins / flicker emissins IEC Class B Class A Cmplies The TNI sft Flw 50 is suitable fr use in all establishments, including dmestic establishments and thse directly cnnected t the public lw-vltage pwer supply netwrk that supplies buildings used fr dmestic purpses. Table 6 -Guidance and manufacturer s declaratin - electrmagnetic emissins 52 Operating Instructin TNI sft Flw 50 clinic system

53 Guidance and manufacturer s declaratin - electrmagnetic immunity The TNI sft Flw 50 is intended fr use in the electrmagnetic envirnment specified belw. The custmer r the user f the TNI sft Flw 50 shuld assure that it is used in such an envirnment. Immunity test IEC test level Cmpliance level Electrmagnetic envirnment - guidance Electrstatic discharge (ESD) IEC ± 8 kv cntact ± 15 kv air ± 8 kv cntact ± 15 kv air Flrs shuld be wd, cncrete r ceramic tile. If flrs are cvered with synthetic material, the relative humidity shuld be at least 30%. Electrical fast transient/burst IEC ± 2 kv fr pwer supply lines ± 1 kv fr input/ utput lines ± 2 kv fr pwer supply lines [n input/utput lines with > 3 m present] Mains pwer quality shuld be that f typical cmmercial r hspital envirnment. Surge ± 1 kv line(s) t Mains pwer quality shuld be line(s) ± 1 kv line(s) t that f typical cmmercial r IEC line(s) hspital envirnment. ± 2 kv line(s) t [n earth present] earth Vltage dips, shrt 0 % UT 0 % UT Mains pwer quality shuld be interruptins and vltage fr 0.5 cycle fr 0.5 cycle that f typical cmmercial r variatins n pwer supply at 0, 45,90, 135, at 0, 45,90, 135, hspital envirnment. If the user input lines 180, 225, 270 and 180, 225, 270 and f the TNI sft Flw 50 re quires cntinued peratin dur- IEC ing pwer mains interruptins, 0% UT 0% UT it is recmmended that the TNI 1 cycles 1 cycles sft Flw 50 be pwered frm and and an uninterruptible pwer supply 70 % UT 70 % UT r battery. fr 30 cycles fr 30 cycles at 0 at 0 0% UT fr 300cycles 0% UT fr 300cycles Operating Instructin TNI sft Flw 50 clinic system 53

54 Pwer frequency (50/60 Hz) magnetic field IEC A/m 30 A/m Pwer frequency magnetic fields shuld be at levels characteristic f a typical lcatin in a typical cmmercial r hspital envirnment NOTE UT is the a.c. mains vltage prir t applicatin f the test level. Table 7 - Guidance and manufacturer s declaratin - electrmagnetic immunity 1 Guidance and manufacturer s declaratin - electrmagnetic immunity The "TNI sft Flw 50" is intended fr use in the electrmagnetic envirnment specified belw. The custmer r the user f the "TNI sft Flw 50" shuld assure that it is used in such an envirnment. Immunity test IEC test level Cmpliance level Electrmagnetic envirnment - guidance Cnducted RF IEC Radiated RF IEC Vrms 150 khz t 80 MHz 10 V/m 80 MHz t 2.5 GHz 6 V 10 V/m Prtable and mbile RF cmmunicatins equipment shuld be used n clser t any part f the TNI sft Flw 50, including cables, than the recmmended separatin distance caculated frm the equatin applicable t the frequency f the transmitter. Recmmended separatin distance d = 1.2 P d = 1.2 P 80 MHz t 800 MHz d = 2.3 P 800 MHz t 2.5 GHz where P is the maximum utput pwer rating f the transmitter in watts (W) accrding t the transmitter manufacturer and d is the recmmended separatin distance in meters (m). Field strengths frm fixed RF transmitters, as determined by an electrmagnetic site survey,a shuld be less than the cmpliance level in each frequency range. b Interference may ccur in the vicinity f equipment marked with the fllwing symbl: NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may nt apply in all situatins. Electrmagnetic prpagatin is affected by absrptin and reflectin frm structures, bjects and peple. a Field strengths frm fixed transmitters, such as base statins fr radi (cellular/crdless) telephnes and land mbile radis, amateur radi, AM and FM radi bradcast and TV bradcast cannt be predicted theretically with accuracy. T assess the electrmagnetic envirnment due t fixed RF transmitters, an electrmagnetic site survey shuld be cnsidered. If the measured field strength in the lcatin in which the TNI sft Flw 50 is used exceeds the applicable RF cmpliance level abve, the TNI sft Flw 50 shuld be bserved t verify nrmal peratin. If abnrmal perfrmance is bserved, additinal measures may be necessary, such as rerienting r relcating the TNI sft Flw 50. b Over the frequency range 150 khz t 80 MHz, field strength shuld be less than 3 V/m. Table 8 - Guidance and manufacturer s declaratin - electrmagnetic immunity 2 54 Operating Instructin TNI sft Flw 50 clinic system

55 Recmmended separatin distances between prtable and mbile RF cmmunicatins equipment and the TNI sft Flw 50 The TNI sft Flw 50 is intended fr use in the electrmagnetic envirnment in which radiated RF disturbances are cntrlled. The custmer r the user f the TNI sft Flw 50 can help prevent electrmagnetic interference by maintaining a miminum distance between prtable and mbile RF cmmunicatins equipment (transmitters) and the TNI sft Flw 50 as recmmended belw, accrding t the maximum utput pwer f the cmmunicatin equipment. Rated maximum utput Separatin distance accrding t frequency f transmitter pwer f transmitter m W 150 khz t 80 MHz d = 1.2 P 80 MHz t 800 MHz d = 1.17 P 800 MHz t 2.5 GHz d = 2.3 P Fr transmitters rated at a maximum utput pwer nt listed abve, the recmmended separatin distance d in metres (m) can be determined using the equatin applicable t the frequency f the transmitter, where P is the maximum utput pwer rating f the transmitter in watts (W) accrding t the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separatin distance fr the higher frequency range applies. NOTE 2 These guidelines may nt apply in all situatins. Electrmagnetic prpagatin is affected by absrptin and reflectin frm structures, bjects and peple. Table 10 - Recmmended separatin distances between prtable and mbile RF cmmunicatins equipment and the TNI sft Flw 50 FROM THE CLINIC TO HOME CARE with the TNI sft Flw 50 system yu will be able t fulfill all clinical requirements with the TNI sft Flw 50 system yu will be able t fulfill all clinical requirements identically and safely in succeeding hme care therapy as well TNI sft Flw therapy fllws the patient! Operating Instructin TNI sft Flw 50 clinic system 55

56 Yur partner in breathing supprt Diagnstik Therapie TNI System TNI medical AG Hfmannstraße Wuerzburg inf@tni-medical.de 56 Operating Instructin TNI sft Flw 50 clinic system Art.N.: V Operating Instructin TNI sft Flw 50 clinic system