TREND II-eng-0409-02:TREND II Layout 1.qxd
Contents
1. PATIENT MENU Press and hold the lt key at least 1 second to move to the programming mode The Patient Menu will now appear on the display TREND II TREND II TREND II TREND II CPAP AUTO BILEVEL BILEVEL ST20 Wake Time Wake Time Wake Time Wake Time Delete Filter Delete Filter Delete Filter Delete Filter Ramp Mask Ramp Ramp Mask Test Ramp Mask Test Mask Test Automatic Mask Test Automatic Automatic Brightness Automatic Brightness Brightness Date Brightness Date Date Time Date Time Time Time Tere ratte Wake Time Exit Menu In this menu item you can set and change the wake time After pressing the lt key again the hour of the wake time will start flashing Now you can change it by using the A and W keys After pressing the lt key again the minute of the wake time will start flashing 45 46 Now you can change it by using the A and Y keys Pressing the lt key again ends the input and you get back to the menu Changing the wake time will automatically activate the alarm clock After leaving the menu the alarm clock can be acti vated and deactivated with the help of the A and V keys Press A to activate the alarm function The display briefly shows the wake time allowing you to verify it After that a bell symbol in front of the time display shows that the wake alarm function is activated Press W to deactivate the wake alarm function The bell symbol disappears Delete Filter In this menu item the filter coun2. Turbine by using the keys A and W Press the key Each time you press the key you see the next counter 69 TROUBLESHOOTING Problem Pain in nose paranasal sinuses or ears Unpleasent feeling of too high pressure Dryness and irritation of nose and throat Return of original sleep apnea symptoms 70 Possible cause Inflammation Unwellness with prescribed high pressure values Pressure tolerance not completely acquired yet Air too dry Different physical condition and different conditions of living Device failure Remedy Stop therapy and contact your physican If you think there is a mista ke consult a physician Relax use or alter the soft start function Device probably without air humidifier consult a physi cian and consider prescrip tion of retrofitting a humidi fier Inform the attending physi cian Return the device to the service to have it checked Problem Air sensed to be too warm No air flow Very low air flow Blower constantly at maxi mum speed Therapy pressure not steady Possible cause Filter dirty Air inlet obstructed Radiator in the vicinity of the device Device defective Water in the measuring tube Soft start function active Air ducts clogged Measuring tube not con nected or clogged Device leaky Water in the measuring tube Water in the measuring tube Device defective Measuring tube bent Remedy Exchange filter Ch
3. 56 CLINIC MENU In addition to the parameters in the Patient Menu in the Clinic Menu parameters relevant for the therapy can be set This menu is used only by health and ser vice professionals In the Clinic Menu the following patient and device relevant data can be shown and changed For some parameters wich are marked with a you have to enter a PIN first to prevent wrong parameter setting Your doctor and specialized dealer know this PIN Please do not try to find out the PIN If you are in doubt as to whether the set parameters are correct please consult your physician TREND II CPAP Mode Pressure FLEX Level Ramp lt P Ramp Mask test Automatic Brightness Language P Unit Turbine Filter Therapy lt Standby Delete Filter Date Time Wake Time TREND II AUTO Mode Pressure FLEX Level P Start P Min P Max Mask Ramp lt P Ramp ask test Automatic Brightness Language P Unit Turbine lt Filter Therapy lt Standby Delete Filter Date Time Wake Time TREND Il BILEVEL ode Pressure Pressure E Pressure Slope E Slope Trigger E Trigger Ramp lt P Ramp Mask test Automatic Brightness Language P Unit Turbine Filter lt q Therapy lt Standby Delete Filter Date Time Wake Time TREND II BILEVEL ST20 Mode Pressure Pressure E Pressure Slope E Slope Tri
4. CHECK POWER FAILURE WARNING NOTE To check the power failure alarm the device must have been connected to the power cord and turned on for at least half an hour 36 Power Failure Restart Turbine Mask Alarm Check Mask 1ds Use the device with running blower and then pull the power plug out of the wall socket Now the acoustic warning signal should sound Check once a month if the signal sounds long enough reference value at least 3 minutes After pushing the control key or turning on the power supply again the signal will stop MASK ALARM This alarm function is activated only if the automatic function is turned to OFF or START If the mask has slipped off your face or ifthe tube is pulled off the devi ce the device is not turned off automatically but emits a visual and audible alarm CHECK MASK ALARM Use the device with running turbine in the manual mode automatic function OFF or START The mask is open but not applied to your face After a short time an audible signal is emitted 37 PRESSURE ALARM If during the therapy a hardware error occurs or the Qa pressure becomes too high e g due to a bent measu EEM ew ETE ring tube the decive will generate an alarm sound and turn off the blower The alarm is turned off by pushing the control key and the therapy can be continued after solving the error ALARM CLOCK The device is provided with a comfortable integrated alarm clock
5. Using the program keys you can activa te and deactivate this alarm clock at any time The alarm clock emits an alarm at the programmed wake time Press the control key once to stop the alarm for the next 5 minutes can be set with the help of the PC software and twice to deactivate it completely These functions may have been deactivated through the software Please contact your specialized dealer or service technician for activating these functions 38 FAutcomatic OFF Exit Menu FUNCTIONS OF THE DEVICE You can program the functions of the device with the following three keys lt enter key A program key VY program key The display has two lines Using the A and W keys you can select the line to be displayed The triangular symbol preceding the line indicates that this line has been selected NOTE If you do not press any key for 30 seconds while programming the programming mode is automati cally exited for safety reasons Unless the changed value is confirmed with the enter key when the programming mode is exited the origi nal value remains as it is If you select the line exit menu and then press the key programming is ended 39 40 The device has three different menus 1 Info Menu In this menu the set parameters can be displayed 2 Patient Menu In this menu the patient can change settings 3 Clinic Menu In this menu only a doctor or service technicians c
6. Whenever you use the device check the tube connec tions for proper seating beforehand 31 32 FILTER CHANGE If the filter is polluted or the display shows the mes sage change filter the filter cassette must be changed 1 To change the cassette pull it out of the device 2 Separate filter cassette and filter frame cover by pul ling them apart 3 Replace the filter cassette 4 Mount the filter frame cover onto the new filter cas sette Make sure the upper part slit and the filter cassette pin are in the correct position To set back the message proceed as described in the chapter patient menu page 46 NOTE Never operate the device without filter cassette Only and exclusively use original HOFFRICHTER filter cassettes Otherwise the warranty for the respirato ry therapy device will become extinct Chanae 5 hP Filter CLEANING CLEANING THE MASK For reasons of hygiene the mask must be cleaned on a daily basis 1 Separate the mask from the therapy tube 2 Clean the mask as described in the mask manufac turer s User manual WEEKLY CLEANING OF THE THERAPY TUBE Make sure the measuring tube is unobstructed at all times Avoid ingress of water into the measuring tube during the weekly cleaning If water droplets should have accidentally entered the measuring tube they must be carefully and thoroughly removed 1 Close the measuring tube tightly with the stoppers befo
7. have been recommen ded and offered by your specialized dealer Regularly test the alarm function of your device Always ensure that the small hole in the mask or in the adapter between the mask and the tube is unobstructed so that the exhaled air that is loaded with CO2 can escape Never set up the device in a compartment of a cabi net nor under your bed Please make sure that air can easily circulate around the device Do not place the device in the vicinity of radiators Ensure that the device is positioned horizontally This is particularly necessary if a humidifier is con nected If you receive oxygen with your therapy please fol low all fire protection and safety regulations with regard to the use of oxygen Mobile use of the device is permitted only in a park ed vehicle Immediately see your physician if while using the device you develop one or more of the following symptoms dryness of the mucous membranes in nose and throat frontal sinus complaints earache a running nose hypersensitivity of the skin over sensitiveness loss of voice disturbances of orienta tion or memory Immediately notify your specialized dealer if the device fails to function properly Never place the respiration therapy device in the vicinity of other equipment or devices such as defi brillators diathermy equipment mobile phones microwave remote controlled toys etc Electroma gnetic fields greater than 3 V m may aff
8. inspiration time in relati EEE on to the time of the entire breath interval Activate the Clinic Menu to set the inspiration ratio Then select Inspiration by using the keys A and V Now the device will prompt you to enter the PIN After entering your PIN press the lt key again Set the desired inspiration ratio by using the keys A and W Press to confirm You can set values from 20 to 80 in 1 intervals Delay Time only in mode ST Delas Time 5s The delay time is the time after which the device Erw switches from S mode into T mode in the event of breath failure Activate the Clinic Menu to set the delay time Then select Delay Time by using the keys A and VW Now the device will prompt you to enter the PIN After entering your PIN press the lt key two times Set the desired delay time by using the keys A and Vv Press lt to confirm You can set values from O sec to 20 sec in 1 sec intervals FLaNsUSSe ENG Language Seat Kenn The device can emit display messages in German DEU English ENG Greek ELL Spanish SPA French FRA Italian ITA Dutch NLD Turkish TUR Polish PLK and Portuguese POR Further languages in preparation For changing the language go to the Clinic Menu hold down the lt key for approx 1 second Then select Language by using the keys A and W Press the lt key Each time you press the key anot her language will appear Leave the
9. of the PIN with the help of the A and Vv keys and proceed as described for the first digit Enter the third digit accordingly After entering the last digit of the PIN you can set the FLEX level by using the keys A and V Then confirm the selected level by pressing the key esta SHP P Start only in mode APAP Exit Menu You have to activate the Clinic Menu first for changing the start pressure Then select P start by using the keys A and VW Press the lt key Now the device will prompt you to enter the PIN By using the keys amp and W you can now set the start pressure Confirm with the lt key Next the para meter P min is set kP Hin za P Min only in mode APAP Exit Menu Press the lt key By using the keys A and W you can now set the minimum pressure Confirm with the lt key Next the parameter P max is set P Max only in mode APAP Press the lt key By using the keys A and VW you can now set the maximum pressure Confirm with the key 61 I Pressure only in modes S T and ST PEP 1 KPs Pressure during inspiration Bet rem For changing the I Pressure go to the Clinic Menu hold down the lt key for approx 1 second Then select l Pressure by using the keys A and V Press the lt key Now the device will prompt you to enter the PIN The first digit is flashing Enter the first digit of the PIN with the help of the A and Y keys After pressing the lt key the second
10. patient as low as possible the blower has been designed with a high reserve capacity and a quick control response The pressure is measured directly in the mask and constantly controlled by the device Consequently the breathing work for the patient is as easy as possible There are two separate tubings in the device One is for respiratory air and one is for the convection air required for cooling the electronics In addition to the mask alarm the device offers an other safety function the power failure alarm It auto matically restarts the motor after power restoration The device contains a built in microcontroller which controls all of its functions Press ON OFF Heat ins Z 21 45 A quartz alarm clock further adds to the comfort when using the device Further comfort functions include a soft start ramp the automatic start stop function and the adjustable display brightness While passing through the device the air is heated a little so that it has a higher water absorbency When indoor air is dry in winter the mucous membranes in mouth and nose may become particularly dry This is unpleasant and may even cause infections in exceptional cases For that reason a therapy might require air humidification AquaTREND uni a clip on humidifier is available as accessory for all TREND II devices If necessary just click the humidifier onto the device Remove it by pressing its release button The heater levels are
11. set in the heater menu The selected heater level is displayed as in the display of the device while the humidifier heating is switched on For more information please see your AquaTREND uni User manual or contact your specialized dealer TREND II CPAP The CPAP device is a therapy device for treating obstructive sleep apnea For this purpose the device provides a continous positive air preasure Apart from the conventionel CPAP mode the device offers a pro portional increase in pressure in the FLEXLINE mode to the individual breath flow during inspiration and a pressure drop during the expiration This intelligent method of pressure adjustment makes a careful thera py possible TREND II AUTO Within a certain pressure range the device automati cally controls the therapy pressure depending on the occurrence of respiratory events In sleep phases with no events the therapy pressure is lowered Starting obstructive events are treated effectively with a slight pressure increase For a high therapy comfort the the rapy pressure should always be only as high as neces sary and as low as possible The device can recognize the following respiratory events Obstuctive apnea Hypopnea Central apnea Snoring Normal respiration Increased airway resistance The identification of the different respiratory events is achieved via 3 channels 1 2 Measurement of any constriction of the respiratory tract Detection of flow limitat
12. these User s Manual at a safe place for immedia te consultation if necessary For the period stipulated by law HOFFRICHTER GmbH warrants that the product is free from any defects pro vided it is used as intended POWER SUPPLY TREND II has an internal switched mode power supply unit with a wide range input of 100 240 V 50 60 Hz This allows connection to all energy sup ply networks in the world It is also possible to operate the device with a direct voltage of 24 V DC e g for mobile use in a truck or mobile home When connecting the device to a DC supply source please only use the optional connecti on cable and do not use the device with a PC ATTENTION HOFFRICHTER GmbH is not liable for any damage and consequential damage nor for any effects on the safety reliability and performance of the device if e manipulations modifications expansions adjust ments repairs and maintenance measures are carried out by persons not authorized by HOFFRICH TER GmbH to do so e use is made of accessories and spare parts which come from other manufacturers and have not been released by HOFFRICHTER GmbH for use with the device e the device is used in a way that is different from that described in the User manual In order to prevent potential hazards please follow the instructions below Exclusively use the device for your own therapy which must have been prescribed by a physician Use accessories only which
13. you are not yet used to the respirati on therapy the soft start can help you get accus tomed to the device and fall asleep easily The device allows delay times ranging from zero the prescribed therapy pressure is applied at once to 60 minutes the prescribed therapy pressure is built up within 60 minutes The initial ramp pressure P ramp can be set by health professionals within a range from 4 hPa to the pressure prescribed To set the ramp first go to the Patient Menu press the lt key for approx 1 second then select Ramp with the key A and Vv Press the lt key Now select the desired time by using the key A and W Press to confirm FRamfr S min Exit Menu The pressure is gradually Pressure increased up to the therapeutic pressure TREND II CPAP O 20 40 60 TREND IL AUTO Programmed soft start time Ramp 0 60 minutes The pressure is gradually Pressure increased up to the hPa therapeutic pressure 10 pressure E pressure Time min TREND II BILEVEL 0 20 a a p80 ae TREND Il BILEVEL ST20 rogrammed soft start time Ramp minutes 49 50 Mask test This parameter determines the time when the devi ce performs a mask test Put on the mask and start the device To ensure that the mask is tight while the pressure slowly increases in the soft start ramp even with higher pressures you can program a mask testing time from 5 to 90 seconds in 5 second intervals This
14. HOFFRICHTER User s Manual TREND II CPAP AUTO BILEVEL BILEVEL ST20 SERIAL NUMBER HOFFRICHTER GmbH delivers all its systems with a seri al number in order to ensure traceability The serial number is indicated on the type label on the bottom of the system Please always specify the serial num ber in inquiries and complaints CONFORMITY The device complies with the requirements of the Directive 93 42 EEC CE Legend of Symbols Safety Instructions Intended Use Contraindications Technical description TREND II CPAP TREND II AUTO TREND II BILEVEL TREND II BILEVEL ST20 Notes prior to first use Front view Back view Scope of Delivery Use of the Device Use of Oxygen Filter Change Cleaning Alarm functions of the Device Functions of the Device Info Menu Patient Menu Clinic Menu Troubleshooting Display Messages Service Technical Data r EGEND OF SYMBOLS gose 0123 Xi mE Observe the accompanying documen tation Applied part type BF Electric safety class Il with protective insulation Observe the Users Manual Manufacturer CE Declaration of Conformity Do not dispose of the device with nor mal domestic waste For information on the proper disposal of the device please contact your responsible customer service SAFETY INSTRUCTIONS Before using your respiratory therapy device for the first time please thoroughly read these User s Manual Keep
15. Level Exit Menu P Start only in mode APAP FP Start Shows the selected start pressure Exit Menu 42 EEE 5 hra Exit Menu Exit Menu kl Pres 18hHPa Exit Menu FE PreS EhPa Exit Menu a e E 35 Exit Menu 5 IE 35 Exit Menu P Min only in mode APAP Shows the selected minimum pressure P Max only in mode APAP Shows the selected maximum pressure I Pressure only in modes S T and ST Shows the selected inspiration pressure E Pressure only in modes S T and ST Shows the selected expiration pressure I Slope only in modes S T and ST Shows the selected inspiration slope E Slope only in modes S T and ST Shows the selected expiration slope 43 44 Trigger only in mode T Shows if the inspiration trigger is activated or not I Trigger only in modes S T and ST Shows the selected inspiration trigger threshold E Trigger only in modes S and ST Shows the selected expiration trigger threshold Frequency only in modes T and ST Shows the selected number of breaths per minute Inspiration only in modes T and ST Shows the ratio of inspiration time proportionate to the entire breath Delay Time only in mode ST Shows the delay for switching from S mode to T mode KTrisser OFF Exit Menu kFI Trisser Exit Menu FKE Trisser Exit Menu FFresuencoe l1Zbrm Exit Menu kFinseiration 33 Exit Menu Delas Time 5s Exit Menu
16. Pressing the key lt again changes the setting from OFF to ON and vice versa I Trigger only in modes S T and ST The I Trigger determines the trigger sensitivity for detecting inspiration It can be set to three levels 1 10 ml 2 Ws inal 38 25m Go to the Clinic Menu to set the Trigger Then select l Trigger by using the keys A and V Press the lt key Now the device will prompt you to enter the PIN Now select the desired level by pressing the keys A and W Press to confirm Next the parameter E Trigger is set KTrisger 0FF Exit Menu A ak E zZ Exit Menu EP weer 2 E Trigger only in modes S and ST Se ee The E Trigger determines the trigger sensitivity for detecting expiration It can be set to three levels 1 60 of Peak flow 2 70 of Peak flow 3 80 of Peak flow Press the lt key Now select the desired level by using the keys A and W Press to confirm Pe as oe Frequency only in modes T and ST Exit lem The frequency determines the breathes per minute Activate the Clinic Menu to set the frequency Then select Frequency by using the keys A and V Now the device will prompt you to enter the PIN After entering the PIN set the desired frequency by using the keys A and V Press lt to confirm You can set values from 5 bpm to 30 bpm in 1 bpm intervals 65 Inspiration only in modes T and ST Kinseirstion The inspiration ratio is the
17. The device generates a continuous positive airway pressure in order to keep the upper respiratory tract unobstructed The device is not suitable for being used with patients who need artificial respiration This therapy device is no life preserving system The treatment pressure is applied through a breathing mask This breathing mask must be provided with an exhalation valve in order to ensure that the exhaled air is discharged Do not wear the breathing mask while the therapy device is turned off because otherwise you might rebreathe exhaled air Please also follow the manufacturer s instructions on use of the breathing mask CONTRAINDICATIONS Respiratory therapy may be contraindicated in patients with the following preexisting diseases Bullous lung diseases Pneumothorax Very low blood pressure Air accumulation after open craniocerebral trauma or other head injuries In case of an inflammation of the paranasal sinuses or the middle ear it might be indicated to stop the thera py Please consult your physician Devices which have been fitted with an AquaTREND uni humidifier may not be used with additives such as medication or aroma oils in the humidifier water TECHNICAL DESCRIPTION General remarks For all devices of the TREND II series the following characteristics apply To generate the necessary pressure the device is pro vided with an electronically controlled blower In order to keep the stress for the
18. an change settings INFO MENU By pressing the info key i you get to the Info Menu By pressing the key amp and W you can see the next para meters To exit the Info Menu select the line exit menu and then press the key If you do not press any keys for 30 seconds the devi ce will automatically switch back to the operating mode The chart on the next page shows which parameters are available for the different devices TREND II CPAP Therapy Filter Ramp P Ramp Mode Pressure FLEX Level TREND I AUTO Therapy Filter Ramp P Ramp Mode Pressure FLEX Level P Start P Min P Max TREND II BILEVEL Therapy Filter Ramp P Ramp Mode Pressure Pressure E Pressure Slope E Slope Trigger E Trigger TREND II BILEVEL ST20 Therapy Filter Ramp P Ramp Mode Pressure Pressure E Pressure Slope E Slope Trigger Trigger E Trigger Frequency Inspiration Delay Time 41 Therapy HK Therarfn 123h Shows the total therapy time of the device Exit Menu Filter HFilter 123h Shows the time since the last filter change Exit Menu Ramp PRaMP S min Shows the remaining time of the soft start ramp Beit Nenu P Ramp kP Ramnp Shows the ramp start pressure Exit Menu Mode 2 FLES Shows the selected mode Exit Menu Pressure FPress Shows the selected therapy pressure Exit Menu FLEX Level only in mode FLEX FFLE Level z Shows the selected FLEX
19. by using the keys A and V Press the key Now the device will prompt you to enter the PIN The first digit is flashing Enter the first digit of the PIN with the help of the A and W keys After pressing the lt key the second digit will flash Enter the second digit of the PIN with the help of the A and W keys and proceed as described for the first digit Enter the third digit accordingly After entering the last digit of the PIN you can set the pressure by using the keys A and V Then con firm the selected pressure by pressing the lt key KFLEX Level EB FLEX Level only in mode FLEX Exit Menu The value of pressure increase and pressure decrease depends on the value of the breathing flow the set FLEX level and the set therapy pressu re 59 60 The three FLEX levels 1 3 are for individual adjust ment to the patients requirements e FLEX Level 1 low pressure support AAPmax lt 1 hPa e FLEX Level 2 medium pressure support APma lt 2 hPa e FLEX Level 3 high pressure support APmax lt 3 hPa For changing the FLEX level go to the Clinic Menu hold down the lt key for approx 1 second Then select FLEX Level by using the keys A and V Press the lt key Now the device will prompt you to enter the PIN The first digit is flashing Enter the first digit of the PIN with the help of the A and W keys After pres sing the lt key the second digit will flash Enter the second digit
20. digit will flash Enter the second digit of the PIN with the help of the A and W keys and proceed as descri bed for the first digit Enter the third digit accordin gly After entering the last digit of the PIN you can set the pressure by using the keys A and V Then confirm the selected pressure by pressing the lt key Next the parameter E Pressure is set E Pressure only in modes S T and ST Pressure during expiration FE Pres 6hPa Exit Menu Press the lt key Now select the desired pressure by using the keys A and V Press lt to confirm Next the parameter I Slope is set PI SlOPB nn zu Slope only in modes S T and ST Eee Henn Time of pressure increase from E Pressure to I Pressure pressure increase rate Press the lt key Now select the desired time by using the keys A and VW Press lt to confirm Next the parameter E Slope is set Ti eee E Siope only in modes S T and ST Exit Menu Time of pressure decrease from I Pressure to E Pressure pressure decrease rate Press the lt key Now select the desired time by using the keys A and W Press lt to confirm hPa pressure i D KR O w O E pressure 0 35 0 35 l slope E slope 63 64 Trigger only in mode T Activate the Clinic Menu to set the trigger only possible in the T mode Then select Trigger by using the keys A and VW Press the lt key Now the device will prompt you to enter the PIN
21. eating source Air circulation particularly that below and behind the device must not be impaired by furni ture curtains or cushions e Set up the device next to your bed Place it on a firm and flat surface of your bedside cabinet e During mobile use the device must also be placed on a firm and flat base which must have an edge to protect the device from falling off 23 24 FRONT VIEW 1 Program keys 2 Filter cassette 3 Display 4 Heater LED 5 Info key 6 Heater key 7 Release button for accessories 8 Measuring tube connection 9 Air outlet 10 Contact socket for humidifier 11 Control key ON OFF button 12 DC Input 24 V DC 13 RS232 interface 14 Power connection 230 V AC BACK VIEW 25 SCOPE OF DELIVERY N SL RM un LUTZ j N Wt IS 26 SDL ite 5 tle GN 7 DIS iM ifr 7m IS m my D C 1 Therapy device 2 This User manual 3 Power cord 4 Therapy tube 1 80 m incl measuring tube 5 Stoppers 6 Carrier bag 7 Replacement filter cassette without frame cover TREND II CPAP TREND II AUTO TREND II BILEVEL TREND II BILEVEL ST 20 This User s manual Power cord Therapy tube measuring tube and stoppers Carrier bag Filter cassette A breathing mask that has been specially adjusted for Art No 0000 2061 0000 2062 0000 2063 0000 2064 5000 0201 3110 0015 0000 7116 0000 2437 0000 2058 the individual patient is requir
22. eck the device for pro per setup Increase the distance bet ween device and radiator Notify the service Remove the water Reduce soft start time Check the air inlet Check the measuring tube Return the device to the service to have it checked Remove the water Remove the water Notify the service Check for bends 71 Problem Irritation of the eyes or dry eyes Running nose urge to sneeze Cold nose Reddening of the skin in the area of the mask swelling of the skin 72 Possible cause Air escaping from between the mask and the skin of your face Reaction to the air flow Common cold Room temperature too low Wrong mask size Head gear too tight Allergic reaction Remedy Check the mask for proper positioning Replace the mask if its material has become brittle Increase the air humidity in the room or set the humidi fier to a higher level Consult a physician Increase the room tempera ture warm up the tube under your pillow Inform the attending physi cian Head straps loosened Inform the attending physi cian III 8hPs Mask Test 455 IHI Ramr Mask Alarm Check Mask s ON OFF m ON 87 68 DISPLAY MESSAGES The sections below describe the most important dis play messages All further messages will be clear from their context You have 45 sec left for seating the mask properly Once this time has elapsed the device starts with the soft start funct
23. ect the ope ration of the device When connecting the device to a DC supply sour ce please only use the optional connection cable listed under optional accessories and do not use the device with a PC To maintain electrical safety please observe the following instructions Do not put the device into operation if its housing and or cables are damaged Do not open the housing Notify your specialized dealer of any disturbances and failures Protect the device from water and moisture Never operate the device in moist rooms nor in a bathroom Do not place a vessel filled with fluid on the device Be absolutely sure not to seize the device if it has fallen into water Do not set up the device in the vicinity of water ves sels bath tubs Before cleaning the device always disconnect the power plug STANDBY MODE The device is in the standby mode as long as the tur bine is turned off The standby mode is indicated by the illuminated display showing date and time If a humidifier is connected with the device the humidifier as well will be in standby mode The preset heater level will be displayed Power consumption in this mode is approx 5 W In the standby mode the device TREND II may remain continuously switched on without posing any risk INTENDED USE The TREND II is intended for treating breathing dis function especially for nighttime sleep apnea in patients with a weight of 30 kg and higher
24. ed for start up and use of the device in the domestic area in addition to the the rapy device with power cord and therapy tube OPTIONAL ACCESSORIES AquaTREND uni Car cable 12 V auf 24 V converter Replacement filter cassette with frame cover Art No 0000 2073 0000 9212 0000 7133 0000 2057 27 28 USE OF THE DEVICE 1 After having set up the device properly connect the device using the supplied power cord The device displays a welcoming message the soft ware version and the current number of treatment hours Thereafter the display shows the date and time Connect the therapy tube a to the air outlet and b to the mask Also connect the measuring tube to the measuring tube connection Put on the mask If you have selected the automa tic mode the device will start on your first breath In the manual mode press the control key to start the device The device will then run through the mask test for the time selected and at the pressure prescribed You should now properly seat the mask in order to eliminate any potential leaks 7 Place the tube such that it does not exert any pul ling action on the mask while you are lying down 8 Breathe deeply and calmly only through your nose If you have activated the soft start function the devi ce initially reduces the pressure after completion of the mask test and will then slowly increase the pres sure automatica
25. ey the currently set brightness will flash and can then be adjusted by using the keys A and VW in intervals of 10 Press lt for accepting the 54 selected brightness If no key is pressed for 15 seconds the device will select the brightness pre viously set by you After pressing any key the brightness will automatically switch to 100 for better visibility Date Use this menu item to set the date To do so go to the Patient Menu hold down the key for approx 1 second Then select Date by using the keys A and W After using the lt key the year will flash and can be set by using the keys 4 and V After using the lt key again the month will flash and can be set by using the keys A and W After using the key again the day will flash and can be set by using the keys A and VW Press the lt key again to accept the set date FOate 49 Mss 07 Exit Menu Time 97 08 Time Use this menu item to set the time To do so go to the Patient Menu hold down the key for approx 1 second Then select Time by using the keys A and W After pressing the lt key the hour will flash and can be set by using the key A and V After pressing the lt key again the minutes will flash and can be set by using the keys A and V Press the lt key again to accept the set time With its built in battery the internal clock has a reserve power of 8 years without connection to the external power supply 55
26. gger Trigger E Trigger Frequency Inspiration Delay Time Ramp P Ramp Mask test Automatic Brightness Language P Unit Turbine lt Filter Therapy lt Standby Delete Filter Date Time Wake Time 57 Mode kiiocle FLE The devices can be operated in different modes Rayan ratn See the chart on the next page which modes are available for your device For changing the mode go to the Clinic Menu hold down the lt key for approx 1 second Then select Mode by using the keys A and W Press the key Now the device will prompt you to enter the PIN PAsAi Enni EA The first digit is flashing Enter the first digit of the FE Sima PIN with the help of the A and W keys After pressing the lt key the second digit will flash Enter the second digit of the PIN with the help of the A and VW keys and proceed as described for the first digit Enter the third digit accordingly After entering the last digit of the PIN you can switch between the modes by pressing the lt key Leave the menu once the desired mode is selec u Ir h ted The device will then save the new mode a y oss 3s sG5sa3 vu TAAN TREND II CPAP v v C TREND II AUTO v v LILIIN NNI TREND II BILEVEL v TREND II BILEVEL ST20 v 7 Pressure only in modes CPAP and FLEX Exit Menu For changing the pressure go to the Clinic Menu hold down the lt key for approx 1 second Then select Pressure
27. humidity operation and storage 400 m 3500 m 1060 hPa 700 hPa 99 5 22 mm conus acc ISO 5356 1 CE mark according to EC Directive 93 42 EEC device in compliance with MDD Class lla The technical specifications are subject to technical modification NOTES 81 82 NOTES NOTES 83 HOFFRICHTER GmbH Mettenheimer Str 12 14 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 www hoffrichter de info hoffrichter de TREND Il eng 0409 02
28. ion or the therapy There will be 10 min and 45 sec left until the full thera py pressure is reached The mask has slipped off your face or you failed to put the mask on your face while the automatic mode was turned off and the blower was running You pressed the A key during operation There will be a message that you will be wakened at 07 00 o clock 73 74 There will be 1 min and 18 sec left until the alarm clock will waken you again The wake alarm has been initiated Press the control key once to initiate the slumber phase Press the key once again to turn off the alarm clock completely You have pressed the control key and stopped the slumber phase You pressed the W key in the normal operating mode There will be a message that the alarm clock has been turned off The therapy pressure is too high and the turbine swit ches off MNI 5 hP Slumber 1 15 II 5 ahra Wake Alarm rFF Press ON OFF Alarm Clock OFF Press too hish 59 Ma4 07 Borde Power Failure Restart Turbine Watchdos der ect Turbine off 59 Mas 07 Bade Invalid PIN defect MemarsF Clinic MNenu activ After the line voltage has been restored the turbine restarts automatically There has been an error during the system start after switching on the voltage supply Contact your dealer You have taken down the mask or the mask has slip ped off your face while the automatic function was acti
29. ions by measuring the flow Detection of snoring with the help of sound detection 17 The combined analysis of all results facilitates a very precise differentiation between obstructive and cen tral events The device adjusts the therapy pressure according to the detected events as described below Increase of pressure for obstructive events Decrease of pressure for central events and normal respiration In addition the pressure increase can be adjusted in 5 levels according to special requirements and to the individual patient comfort These settings are perfor med by the doctor with the help of the PC software TRENDset In addition to normal APAP and CPAP mode the device offers the FLEXLINE mode a pressure increa se which is proportionate to the individual respiration flow during inspiration and a pressure decrease during expiration TREND II BILEVEL The device has two different adjustable pressure levels A higher level for inspiration and a lower level for expiration Trigger device The respiration trigger detects the patients efforts to breath in and out and signals these efforts to the con trol device A flow based trigger is integrated which can be set separately for inspiration and expiration While the pressure increases during inspiration it decreases during expiration In connection with an optimum slope adjustment this results in a ventilation which is very comfortable for the patient and which gives the pa
30. lly to the prescribed value allowing you to fall asleep at a lower pressure NOTE For information on how to adjust the soft start and mask test times to your individual demands plea se refer to the section entitled functions of the device 29 USE OF OXYGEN If you also have to inhale oxygen during your therapy please be absolutely sure to follow the instructions from the manufacturer or the dealer delivering the oxy gen to you If you supply the oxygen directly into the mask please use a non kinking tube that consists of a medically approved material You can also supply the oxygen through an adapter which is mounted to the air outlet In any case please be absolutely sure to follow the instructions of your physician Please contact your specialized dealer 30 ATTENTION Oxygen promotes combustion processes For that reason please observe the valid fire protec tion regulations for the use of oxygen Keep oxygen fittings free from fat do not smoke and do not handle the device near a naked flame ATTENTION If you are using oxygen together with the device the oxygen supply must always be deactivated as long as the device is in the standby mode or while it is turned off Always turn on the device first and only then the oxy gen supply Turn off the oxygen supply before turning off the device Activate the Automatic OFF as descri bed on page 52
31. mask test is carried out before the ramp is started It checks whether the mask is tight even under the maximum therapy pressure If the FLEXLINE mode is switched on the pressure is raised by 1 hPa at FLEX level 1 2 hPa at FLEX level 2 and 3 hPa at FLEX level 3 TREND II CPAP and TREND II AUTO If the APAP mode is swit ched on the pressure is raised to the max pressu re TREND II AUTO and in the devices TREND II BILEVEL and TREND II BILEVEL ST20 the pres sure in the modes S ST and T is raised to the l pressure To set the mask test first go to the Patient Menu press the lt key for approx 1 second then select Mask test with the keys A and W Press the key Now select the desired time by using the keys A and V Press to confirm kiask Test Exit Menu hee The pressure is gradually increased up to the therapeutic pressure l va l Ps S l Pa aro Io se fe oa I f l l Time TREND II CPAP 20 40 60 min TREND II AUTO Programmed soft start time Ramp 0 60 minutes Heel The pressure is gradually hPa increased up to the therapeutic pressure p l pressure 8 6 E pressure 4 Time TREND II BILEVEL O 20 40 60 min TREND II BILEVEL ST20 Programmed soft start time ramp 0 60 minutes 51 52 Automatic The automatic mode provides three settings OFF START STOP START Automatic OFF with mask alarm If you set Auto OFF the device must be turned o
32. menu once the desired language is selected The device will then save the new language PP Unit eg P Unit Seid Klemm The device can show the pressure in the pressure units hectopascal hPa millibar mbar and centi meters of water cmH2O For changing the pressure unit go to the Clinic Menu hold down the lt key for approx 1 second Then select P unit by using the keys A and V Press the lt key Each time you press the key ano ther pressure unit will appear Leave the menu once the desired pressure unit is selected The device will then save the new unit NOTE When changing the pressure unit from hPa or mbar to cmH20 the pressure will slightly change Conversion 1 hPa 4 1 mbar 1 02 cmH2O Example At 8 cmH20 the pressure is 7 8456 hPa mbar Turbine This menu item shows the total operating time of the turbine the filter and the therapy time Turbine The counter indicates the total turbine running time Filter The counter indicates the operating hours of the fil ter since the last reset 68 FTurbinms 123h Exit Menu FFilter 123h Exit Menu Therap Exit Henu FSt andby Exit Menu Therapy The counter indicates the operating time with the therapy pressure applied Standby This counter indicates the time the device was con nected to the mains supply To display the counter go to the Clinic Menu hold down the key for approx 1 second Then select
33. n in the evening and off in the morning with the ON OFF key If the mask slips off your face or a leak occurs while you are asleep a visual and audible warning is emitted Automatic START STOP If you set Auto START STOP you must simply put the mask on your face Once you start breat hing the turbine of the device is turned on If you take the mask off the turbine is automatically tur ned off after a delay time of 5 seconds In the automatic mode the turbine is turned off even if the mask or the tube slips off unnoticed during the night Automatic START with mask alarm The third option that can be selected is the Auto START mode In this mode the turbine is also turned on once you put the mask on your face Put on Mask 43 Hay 87 FAME 662055 Start Exit Menu However the turbine will not be turned off if the mask or the tube slips off unnoticed during the night It can only be turned off by pressing the ON OFF key NOTE The automatic function can be deactivated in the TREND I BILEVEL ST 20 with the PC software from the medical staff NOTE The device can be switched on or off in every mode by pressing the ON OFF key FEriashtness 100s Brightness Exit Menu In this menu item you can set the brightness of the display To do so go to the Patient Menu hold down the key for approx 1 second Then select Bright ness by using the key A and W After pressing the lt k
34. plan Disposal of the device For information on the proper disposal of the device please contact your responsible customer service Disposal of the packaging You can return the packaging to your marketing part ner or dispose it separately with your normal domestic waste TECHNICAL DATA Dimensions w x x h 215 x 195 x 105 Mass ca 2 3 kg Power supply 100 V 240 V 50 60 Hz 24 VDC 2 1 A Pressure range 4 20 hPa mbar Max limit pressure in the event of error lt 30 hPa CPAP APAP lt 40 hPa BILEVEL BILEVEL ST20 Power consumption max standby at 12 hPa without humidifier at 12 hPa with humidifier level 5 Short time pressure variance 20 hPa bpm 0 0 10 15 bpm 0 17 0 17 0 17 1 0 17 0 17 20 bpm 0 0 25 Values determined with and without AquaTREND uni Long time pressure variance lt 0 3 hPa Display accuracy pressure 0 5 hPa Average noise level lt 26 dB A at 10 hPa Operation in a distance of 1m corresponds to an sound power level of 34 dB A 79 80 Air delivery volume Operating temperatur Storage temperatur Air humidity Operating altitude Filtration efficiency up to 1 um Air Outlet gt 170 l min at 4 hPa therapy pressure gt 160 l min at 8 hPa therapy pressure gt 150 l min at 12 hPa therapy pressure gt 130 l min at 16 hPa therapy pressure gt 120 l min at 20 hPa therapy pressure 5 C 40 C 20 C 70 C 15 95 rel
35. re cleaning see page 26 2 Use mild soapy water for cleaning thoroughly rinse with clear water and let the tube dry in air 33 3 Remove the two stoppers from the measuring tube after cleaning NOTE If water should stay in the measuring tube it could adulterate the pressure measuring or delay the con trol Both could affect an optimal therapy CLEANING THE DEVICE For reasons of hygiene the device must be cleaned on a weekly basis 1 Disconnect the power plug 2 Wipe the device with a cloth slightly moistened with soapy water Then use a dry cloth to wipe the device dry You do not have to disinfect the device or parts of the device chemically or thermally 34 CLEANING THE HEAD GEAR Clean the head gear as required 1 Disconnect the head gear from the mask 2 Clean the head gear as described in the head gear manufacturer s User manual 35 ALARM FUNCTIONS OF THE DEVICE POWER FAILURE If a power faiure at night would go unnoticed as a result the patient would breathe used air from the the rapy tube all night To avoid this the device is equipped with an alarm mechanism that warns you if power or a fuse fail at night You will be woken up with an acou stic signal so you can take the mask off your face and breathe fresh air The alarm is turned off by pushing the control key After power supply is re established the motor starts automatically and the display will show the following message
36. ter can be reset This function should be used at every filter change so that always a current value is displayed To reset the filter counter go to the Patient Menu press the lt key for approx 1 second then select Delete filter with the keys A and VW Press the key The system will now ask you whether you are sure that you want to perform a reset Press ON OFF Alarm ON 47 68 Press ON OFF B9 May BF 09 42 Press ON OFF Alarm Clock OFF Delete Filter Exit Menu Press the lt key to perform the reset Now the fil ter counter is reset to zero If you do not want to reset the filter counter leave the menu by using the keys A and VW or wait until the system leaves the menu item automatically PHSR oe Nose Mask only in modus CPAP and APAP in TREND II AUTO Exit Menu In this menu item the type of mask can be chosen This is important for the correct function of the the rapy device It can be chosen between Nose and Mouth Nose Choose Nose for allnasal masks and pillow masks Choose Mouth Nose for all mouth nasal masks 47 48 Ramp Whenever the blower has been started the micro controller of the device checks whether a soft start ramp has been programmed While the program med time elapses the soft start function increases the pressure from an adjustable initial ramp pressu re P ramp up to the pressure prescribed thus allowing you to fall asleep more easily In particular if
37. tient the impression as if the device is fol lowing the natural respiration without delay NOTE During the expiration phase a negative pressure vacuum will not be created 20 TREND II BILEVEL ST20 The device has two different adjustable pressure levels A higher level for inspiration and a lower level for expiration Trigger device The respiration trigger detects the patients efforts to breath in and out and signals these efforts to the con trol device A flow based trigger is integrated which can be set separately for inspiration and expiration While the pressure increases during inspiration it decreases during expiration In connection with an optimum slope adjustment this results in a ventilation which is very comfortable for the patient and which gives the patient the impression as if the device is fol lowing the natural respiration without delay In the device are the modes S ST and T mode inte grated S mode Spontaneous trigger the change from one pressure level to another is triggered by starting respiration of the patient only A decline in pressure to the set lower pressure level also occurs once the inspiration flow ends ST mode Spontaneous breathing and Time as long as the patient is breathing independently the device is opera ting in the S mode Once the patient stops breathing the device automatically switches into the T mode and provides respiration for the patient in the prescribed safet
38. vated The turbine will turn off after 4 seconds The PIN you have entered is wrong Please enter the correct PIN There has been an error during the system start after switching on the voltage supply Contact your dealer The Clinic Menu has been activated 75 76 The Patient Menu has been activated Change filter Pat ient Menu actin M a h Chanas Filter SERVICE Although all parts of the device have a very long ser vice life the device should be checked from time to time We urgently recommend a technical service through our authorized customer service since only they have the necessary tools and measuring instruments In between service intervals you yourself can contribu te to increasing the service life and to maintaining pro per and reliable functioning 1 Please observe the cleaning instructions given on the pages 33 to 35 2 Check the system at regular intervals 77 78 Proceed according to the following check list e Visually check whether the device is damaged and or dirty on its outside e weekly check of the Power failure warning functi on see page 36 e weekly check of the Mask alarm function see page 37 Preparing the device for a different patient If the patient using the device changes the device must be hygienically prepared by a specialized dealer or by the manufacturer The necessary procedure is described in detail in the appropriate hygiene
39. y frequency The delay time after which the devi ce switches into the T mode can be set T mode Time respiration with prescribed set inspiration time If the trigger function is deactivated the patient is venti lated according to the set parameters If the trigger function is activated the device accepts only sponta neous trigger signals in the expiration phase NOTE During the expiration phase a negative pressure vacuum will not be created 21 22 NOTES PRIOR TO FIRST USE Never turn the device on if you kept it in a very cold environment Wait for approx 1 hour until its tempera ture compensation is completed Regularly check the air filter cassette and regularly exchange it as described on page 32 Never use the device without air filter Clean your mask system regularly and check all acces sory parts particularly the therapy tube the mask and the head gear We recommend that you wash your face before going to sleep in order to remove fat and cosmectics from your skin This increases the service life of the mask and helps to prevent irritations of the skin Make sure the measurement tube is unobstructed at all times Avoid ingress of water into the measurement tube during cleaning If water droplets should have accidentally entered the measurement tube they must be carefully and thoroughly removed Please strictly observe the following setup instructions e Do not place the device in the vicinity of a h
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