TREND II-eng-1009-04.indd
Contents
1. 0000 2064 Users Manuals 2 m ettet exea ee tees taste 5000 0201 Power CONG 22 toe Teens 3110 0015 Therapy tube measuring tube and stoppefs vv Inh 0000 7116 Gamier Di teet edema 0000 2437 Filter cassette nannten aan aan 0000 2058 A breathing mask that has been specially adjusted for the individual patient is required for start up and use of the device in the domestic area in addition to the therapy device with power cord and therapy tube OPTIONAL ACCESSORIES Art No AquaTREND uni 0000 2073 Bar cable dt i recte fidi 0000 9212 T2N to 24 V CONVENES as iioc 0000 7133 Replacement filter cassette with HEINE COVE s aes neret err era eorr 0000 2057 Optional Accessories 27 USE OF THE DEVICE 1 28 After having set up the device properly connect the device using the supplied power cord with the socket outlet The device displays a welcoming message the software version and the current number of treat ment 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 measur ing tube connection Put on the mask If you have selected the automatic mode the device will start on your first breath In the manual mode press the ON OFF 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 mas2. fier to a higher level Consult a physician Inform the attending physi cian Head straps loosened Inform the attending physi cian Exchange filter Check the device for proper setup Increase the distance between device and radia tor Notify the service Remove the water Very low air flow Soft start function active Air ducts clogged Blower constantly at maxi Measuring tube not con mum speed nected or clogged Device leaky Water in the measuring tube Therapy pressure not steady Water in the measuring tube Device defective Measuring tube bent 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 Troubleshooting 71 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 function or the therapy There will be 10 min and 45 sec left until the full therapy 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 There will be 1 min and 1
3. Press the key Now the device will prompt you to enter the PIN Now select the desired level by pressing the keys Aand V Press lt To confirm Next the parameter E Trigger is set E Trigger only in modes S and ST The E Trigger determines the trigger sensitivity for detecting expiration It can be set to three levels 1 6096 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 V Press to confirm 64 Functions of the Device Trisser Exit Menu E Trisser Exit Menu E en p bFrequency 12hpm Frequency only in modes T and ST Exit Menu 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 VW Press lt to confirm You can set values from 5 bpm to 30 bpm in 1 bpm intervals Inspiration only in modes T and ST Exit Menu The inspiration ratio is the inspiration time in relation 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 Y Now the device will prompt you to enter the PIN After enter ing your PIN press the key again Set the desired inspiration ratio by using the keys A and VW key again Set the desired inspiration
4. comfortable for the patient and which gives the patient the impression as if the device is following the natural respiration without delay NOTE During the expiration phase a negative pressure vacuum will not be created Technical Description 19 TREND II BILEVEL ST20 The device has two different adjustable pressure lev els 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 following 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 pres sure level also occurs once the inspiration flow ends 20 Technical Description ST mode Spontaneous breathing and Time as long as the patient is breathing independently the device is oper ating in the S mode Once the patient stops breathing the device
5. 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 man ufacturer s instructions on use of the breathing mask 12 Intended Use 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 ther apy Please consult your physician Devices which have been fitted with an AquaTREND uni humidifier may not be used with additives such as medi cation or aroma oils in the humidifier water Contraindications 13 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 patient as low as possible the blower has been designed with a high reserve capac ity and a quick control response The pressure is measured directly in the mask and constantly controll
6. Functions of the Device 35 Power Fallli e eit be 35 Mask Aldiana ann 36 Pressure Alarm dfe o d ue hlonl lela 36 MWakesAIartr o tu d d s 37 Functions of the Device 38 In tos MOFiUiss 35d ette d eto d tod doi 39 Patient MENU ti do s ds 44 Climies Merl oet datum use atu dts 56 Troubleshooting unse 69 Display Messages sssse eH 72 Refer 75 Preparing the Device for a Different Patient 76 IJiSBOSAal a ga rr eadera 77 DEVICE 77 Packages de 77 Technical Data iniiai aioin etosa kamand onane rno 78 4 Table of Contents LEGEND OF SYMBOLS Observe the accompanying documenta tion Applied part type BF Electric safety class II with protective insulation CE Declaration of Conformity Manufacturer Observe the User s Manual Do not dispose of the device with normal domestic waste For information on the proper disposal of the device please con tact your responsible customer service Legend of Symbols 5 SAFETY INSTRUCTIONS Before using your respiratory therapy device for the first time please thoroughly read these User s Manual Keep these User s Manual at a safe place for immedi ate 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 HOFFRICHTER GmbH is not liable for any damage and consequential damage nor for any effects on the safety reliabi
7. line to be displayed The triangu lar symbol k 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 f you select the line Exit Menu and then press the 4 key programming is ended 38 Functions of the Device 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 physician or service techni cians can change settings Use the A key for scrolling within the menus The sequence of the menu structure is shown in the table on page 40 INFO MENU By pressing the info key i you get to the Info Menu By pressing the key A and W you can see the next parameters To exit the Info Menu select the line Exit Henu and then press the key If you do not press any keys for 30 seconds the device will automatically Switch back to the operating mode The chart on the next page shows which parameters are available for the different devices Functions of the Device 39 TREND II CPAP TRENDIIAUTO TREND II BILEVEL TREND II BILEVEL ST20 Therapy Therapy Therapy Therapy Filter Filter Filter Filter Ramp Ramp Ramp
8. pressure Then select P Start by using the keys A and V Press the lt key Now the device will prompt you to enter the PIN By using the keys A and V you can now set the start pres sure Confirm with the lt key Next the parameter P Min is set Functions of the Device kP 5tart 7 5hPa Exit Menu T ENTE 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 T if GPs P Max only in mode ARANI Exit Menu Press the lt key By using the keys A and W you can now set the maximum pressure Confirm with the 4 key Pressure only in modes S T and ST Pressure during inspiration For changing the I Pressure go to the Clinic Menu hold down the lt key for approx 1 second Then select I Fress 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 V keys After pressing the lt key the second digit Functions of the Device 61 will flash Enter the second digit of the PIN with the help of the A and WV 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 confirm the selected pressure by pressing the key Next the parameter E P
9. ratio by using the keys 4 to confirm You can set values from 20 96 to 8096 in 1 96 intervals FInsPiratian 33 Functions of the Device 65 Delay Time only in mode ST The delay time is the time after which the device 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 Timme by using the keys A and WV Now the device will prompt you to enter the PIN After entering your PIN press the key two times Set the desired delay time by using the keys A and VW Press to confirm You can set values from O sec to 20 sec in 1 sec intervals Language 66 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 Fur ther 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 V Press the lt key Each time you press the key another language will appear Leave the menu once the desired language is selected The device will then save the new language Functions of the Device tc 2 Delas Time Exit Menu LaNsUS3E ENG Exit Menu P Unit Exit Menu The device can show the pressure in the pressure units hectopascal hPa millibar mbar and centi meters of water CMH20 P U
10. settings Your physician 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 56 Functions of the Device TREND II CPAP TREND Il AUTO TREND II BILEVEL TREND II BILEVEL ST20 Mode Pressure FLEX Level Ramp lt P Ramp ask Test Automatic Brightness Language P Unit Turbine Filter Therapy lt Standby Delete Filter Date Time Wake Time Mode Pressure FLEX Level P Start P Min P Max Mask Ramp lt P Ramp Mask Test Automatic Brightness Language P Unit Turbine Filter lt Therapy lt Standby Delete Filter Date Time Wake Time Mode Pressure Pressure E Pressure Slope E Slope Trigger E Trigger Ramp P Ramp Mask Test Automatic Brightness Language P Unit Turbine Filter Therapy lt Standby Delete Filter Date ime Wake Time Mode Pressure Pressure E Pressure Slope E Slope Trigger Trigger E Trigger Frequency Inspiration Delay Time Ramp P Ramp Mask Test Automatic Brightness Language P Unit Turbine Filter Therapy lt Standby Delete Filter Date Time Wake Time Functions of the Device 57 ipd TOTIS The devices can be operated in different modes Exit Menu See the chart on the page below whi
11. the selected expiration slope Exit Menu Trigger only in mode T Shows if the inspiration trigger is activated or not I Trigger only in modes S T and ST K Triaser Shows the selected inspiration trigger threshold Exit Merny 42 Functions of the Device 1 Menu InsPiration 3 Exit Menu Delas Time 3 Exit Men 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 Functions of the Device 43 PATIENT MENU Press and hold the enter key at least 1 second to move to the programming mode The Patient Menu will now appear on the display TREND II CPAP TRENDIIAUTO TREND II BILEVEL TREND II 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 44 Functions of the Device blake Time 67 tae Exit Menu Press ON OFF Alarm ON Brad Press ON OFF Press ON OFF Alarm Clock OFF Wake Time In this menu item you can set and chang
12. 8 sec left until the alarm clock will waken you again The wake alarm has been initiated Press the ON OFF key once to initiate the slumber phase Press the key once again to turn off the alarm clock completely 72 Display Messages VLLL IE Hask II 5 hPa Wake Alarm OFF ON OFF Clock OFF Put 25 134 493 on Mask 22 15 Power Failure Restart Turbine Watchdos defect Turbine 23 139 Invalid PIN You have pressed the ON OFF 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 Switches off The automatic function is turned on You will be requested to put on the mask and to breathe through the nose 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 slipped off your face while the automatic function was activated The turbine will turn off after 4 seconds The PIN you have entered is wrong Please enter the correct PIN Display Messages 73 There has been an error during the system start after switching on the voltage supply Contact your dealer The Clinic Menu has been activated Clinic Meru active The Patient Menu has been activated Pat
13. 95 x 105 mm Mass approx 2 3 kg Power supply 100V 240V 50 60Hz 24 VDC 2 1A 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 24 VDC power supply max 50 W 50W standby lt 5W lt 5W at 12 hPa without humidifier 10W 12W at 12 hPa with humidifier level 5 30W 33 W Short time pressure variance AhPa 8hPa 12hPa 16hPa 20hPa 10 bom 0 10 0 10 0 10 0 10 0 10 15 bpm 0 17 0 17 0 17 0 17 40 17 20 bpm 0 25 0 25 0 25 0 25 0 25 All values in the table in hPa Values determined with and without AquaTREND uni Long time pressure variance lt 0 3 hPa Display accuracy pressure 0 5 hPa Average noise level 26 dB A at 10 hPa Operation in a distance of 1m corresponds to an sound power level of 34 dB A 78 Technical Data Air delivery volume gt 170l min at 4 hPa therapy pressure gt 160 l min at 8 hPa therapy pressure gt 150l min at 12 hPa therapy pressure gt 130 l min at 16 hPa therapy pressure gt 120 l min at 20 hPa therapy pressure Operating temperature 5 C 40 C Storage temperature 20 C 70 C Rel air humidity operation and storage 15 95 96 Operating altitude altitude above MSL 400 m 3500 m 1060 hPa 700 hPa Filtration efficiency up to 1 uim 99 5 96 Air Outlet 22 mm conus acc to ISO 5356 1 CE mark ac
14. HOFFRICHTER Quality makes the Difference m m m m User s Manual CPAP AUTO BILEVEL BILEVEL ST20 SERIAL NUMBER HOFFRICHTER GmbH delivers all its systems with a serial 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 number in inquiries and complaints CONFORMITY C Eo The device complies with the requirements of the Direc tive 93 42 EEC 2 Info TABLE OF CONTENTS Legend OL Symbols tete eee ent 5 Safety Instructions aee ettet tees 6 Power Supply euere 10 Standby Modena 11 Intended Use tete teta 12 Coniraindications ette e eese cei its 13 Technical Description ssseeeees 14 General RermarkS uec ete ttt t e teens 14 TREND IFGBADP rn 16 TREND LAUT OI a 17 TREND IEBIEEMEL 5 55 ror rrt rrt 19 TREND IEBIEEMVEL ST20Q 5 20 Notes Prior to First USS ninaa 22 VIEWS nennen innen ah 24 FORT VIEW aan tn een 24 Back VIeW HH ann 25 SCOPE Of DEIIVErY winds een ettet eode 26 Optional Accessories ssssseseeseee 27 Use or the DEVICE iicet teet rr te trei redde 28 Use of Oxygen Aiea uae AE AE AE SE i i 30 riter Change ced he Behe Bake BABE BEBE ee we 32 Table of Contents 3 GIGINING Hoe GoGRc Gehan RR gn Qe ee amp 33 Cleaning the Maske xx Ree eee 33 Cleaning of the Therapy Tube 33 Cleaning the Device sssaaa 34 Cleaning the Head Gearin eiiiai aisia s 34 Alarm
15. Ramp P Ramp P Ramp P Ramp P Ramp Mode Mode Mode Mode Pressure Pressure Pressure Pressure FLEX Level FLEX Level Pressure Pressure P Start E Pressure E Pressure P Min I Slope I Slope P Max E Slope E Slope I Trigger Trigger E Trigger I Trigger E Trigger Frequency Inspiration Delay Time 40 Functions of the Device Therapy Exit Menu Exit Menu it Meru Kode Biley 5T Exit Menu Exit Menu FFLER Leuel 3 Exit Menu P Start 7 ShPa Exit Menu Therapy Shows the total therapy time of the device Filter Shows the time since the last filter change Ramp Shows the remaining time of the soft start ramp P Ramp Shows the ramp start pressure Mode Shows the selected mode Pressure Shows the selected therapy pressure FLEX Level only in mode FLEX Shows the selected FLEX Level P Start only in mode APAP Shows the selected start pressure Functions of the Device 41 P Min only in mode APAP KP Min ENTE Shows the selected minimum pressure Exit Menu P Max only in mode APAP KP Hax TENE Shows the selected maximum pressure Exit Menu I Pressure only in modes S T and ST TECEEEEETETTI Shows the selected inspiration pressure Exit Menu E Pressure only in modes S T and ST KE Prass 6 BhPa Shows the selected expiration pressure Exit Menu I Slope only in modes S T and ST TETTE Zs Shows the selected inspiration slope Exit Menu E Slope only in modes S T and ST E 5 lope Ts Shows
16. aily basis 1 Separate the mask from the therapy tube 2 Usemild soap water don t use other additives for cleaning thoroughly rinse with clear water and let the mask dry in air protected for direct sunlight CLEANING OF THE THERAPY TUBE For reasons of hygiene the therapy tube must be cleaned on a weekly basis 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 before cleaning see page 26 2 Usemild soapy water for cleaning thoroughly rinse with clear water and let the tube dry in air 3 Remove the two stoppers from the measuring tube after cleaning Cleaning 33 NOTE If water should stay in the measuring tube it could adulterate the pressure measuring or delay the control 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 CLEANING THE HEAD GEAR Clean the head gear as required 1 Disconnect the head gear from the mask 2 Clean the head gear a
17. 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 PRESSURE ALARM If during the therapy a hardware error occurs or the pressure becomes too high e g due to a bent measur ing tube the device will generate an alarm sound and turn off the blower The alarm is turned off by pushing the ON OFF key and the therapy can be continued after solving the error 36 Alarm Functions of the Device Mask Alarm Check Mask Press too hi SUE MS ish 21 3 WAKE ALARM The device is provided with a comfortable integrated alarm clock Using the program keys you can activate and deactivate this alarm clock at any time The alarm clock emits an alarm at the programmed wake time Press the ON OFF key once to stop the alarm for the next 5 minutes can be set with the help of the PC soft ware and twice to deactivate it completely The alarm clock function may have been deactivated through the software Please contact your specialized dealer or service technician for activating these func tions Alarm Functions of the Device 37 FUNCTIONS OF THE DEVICE You can program the functions of the device with the following three keys A program key W program key lt enter key The display has two lines Using the A and WV keys you can select the
18. asuring the flow 3 Detection of snoring with the help of sound detec tion Technical Description 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 e Increase of pressure for obstructive events e 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 per formed by the physician with the help of the PC soft ware TRENDset In addition to normal APAP and CPAP mode the device offers the FLEXLINE mode a pressure increase which is proportionate to the individual respiration flow during inspiration and a pressure decrease during expiration 18 Technical Description TREND II BILEVEL The device has two different adjustable pressure lev els 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
19. automatically switches into the T mode and provides respiration for the patient in the prescribed safety frequency The delay time after which the device 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 ven tilated 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 Technical Description 21 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 cos metics 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 remo
20. bine is turned off even if the mask or the tube slips off unnoticed dur ing the night 3 Auto Start with mask alarm Auto Start The third option that can be selected is the Auto Exi t i Herny ae a Start mode In this mode the turbine is also turned on once you put the mask on your face 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 52 Functions of the Device Mask Alarm Check Mask NOTES The automatic function can be deactivated in the TREND II BILEVEL ST20 with the PC soft ware from the medical staff The device can be switched on or off in every mode by pressing the ON OFF key TEPEE 3 rightness 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 lt key for approx 1 second Then select Bright ness by using the key A and W After pressing the lt key the currently set brightness will flash and can then be adjusted by using the keys A and Win intervals of 10 96 Press for accepting the selected brightness If no key is pressed for 15 seconds the device will select the brightness previously set by you After pressing any key the brightness will auto matically switch to 100 96 for better visibility Functions of the Device 53 Date 54 Use this menu item to set the date To do so goto the Patient Menu hold d
21. ch 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 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 sec ond digit of the PIN with the help of the A and Y 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 key Leave the menu once the desired mode is selected The device will then save the new mode CPAP FLEX AUTO BILEVEL BILEVEL BILEVEL S ST T e TREND II CPAP e TREND Il AUTO e e e TREND II BILEVEL e e TREND II BILEVEL ST20 e e e e 58 Functions of the Device 7 5hPa Pressure only in modes CPAP and FLEX For changing the pressure go to the Clinic Menu hold down the key for approx 1 second Then select Pressure 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 Wkeys After press ing 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 t
22. cording to EC Directive 93 42 EEC device in compliance with MDD Class lla Technical specifications are subject to technical modifications Technical Data 79 HOFFRICHTER GmbH Mettenheimer StraBe 12 14 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E Mail info hoffrichter de www hoffrichter de TREND Il eng 1009 04
23. device near a naked flame 30 Use Of Oxygen Tube Adapter 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 oxygen supply Turn off the oxygen supply before turning off the device Activate Auto OFF as described on page 52 Whenever you use the device check the tube con nections for proper seating beforehand Use Of Oxygen 31 FILTER CHANGE If the filter is polluted or the display shows the message m 5 BhPa Chanse Filter 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 pulling 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 on page 46 NOTE Never operate the device without filter cassette Only and exclusively use original HOFFRICHTER filter cassettes Otherwise the warranty for the respiratory therapy device will become extinct 32 Filter Change CLEANING CLEANING THE MASK For reasons of hygiene the mask must be cleaned on a d
24. e e Be absolutely sure not to seize the device if it has fallen into water e Do not set up the device in the vicinity of water vessels bath tubs e Before cleaning the device always disconnect the power plug Safety Instructions 9 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 supply networks in the world It is also possible to operate the de vice 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 connec tion cable and do not use the device with a PC 10 Power supply 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 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 Standby Mode 11 INTENDED USE The TREND Il is intended for treating breathing disfunc tion especially for nighttime sleep apnea in patients with a weight of 30 kg and higher 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
25. e humidifier heating is switched on Press ON OFF Heat 2 21 45 For more information please see your AquaTREND uni Users manual or contact your specialized dealer Technical Description 15 TREND II CPAP The CPAP device is a therapy device for treating obstruc tive sleep apnea For this purpose the device provides a continuous positive air pressure Apart from the con ventional CPAP mode the device offers a proportional increase in pressure in the FLEXLINE mode to the indi vidual breath flow during inspiration and a pressure drop during the expiration This intelligent method of pressure adjustment makes a careful therapy possible 16 Technical Description 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 obstruc tive events are treated effectively with a slight pressure increase For a high therapy comfort the therapy pressure should always be only as high as necessary and as low as pos sible 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 Measurement of any constriction of the respiratory tract 2 Detection of flow limitations by me
26. e 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 key again the minute of the wake time will start flash ing Now you can change it by using the A and Y keys Pressing the 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 Y 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 Functions of the Device 45 Delete Filter 46 In this menu item the filter counter 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 lt key The system will now ask you whether you are sure that you want to perform a reset Press the lt key to perform the reset Now the filter counter is reset to zero If you do not want to reset the filter counter leave the menu by using the keys A and W or wait until the s
27. ed 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 automatically restarts the motor after power restoration The device contains a built in microcontroller which controls all of its functions 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 14 Technical Description Air inlet Filter Blower Pressure _ Sensor l Connector Air outlet measuring tube 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 set in the heater menu The selected heater level is displayed as in the display of the device while th
28. hird digit accordingly After entering the last digit of the PIN you can set the pressure by using the keys A and VW Then confirm the selected pres sure by pressing the key hPL EY level 3 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 pressure The three FLEX Levels 1 3 are for individual adjust ment to the patients requirements e FLEX Level 1 low pressure support APmax lt 1 hPa e FLEX Level 2 medium pressure support APmax lt 2 hPa e FLEX Level 3 high pressure support A Pmax lt 3 hPa Functions of the Device 59 For changing the FLEX Level go to the Clinic Menu hold down the lt key for approx 1 second Then select FLE 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 Y keys After pressing the key the second digit will flash Enter the second digit of the PIN with the help of the A and Wkeys 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 P Start only in mode APAP 60 You have to activate the Clinic Menu first for chang ing the start
29. ient Menu active Change filter Chanse Filter 74 Display Messages SERVICE Although all parts of the device have a very long service 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 contribute to increasing the service life and to maintaining proper and reliable functioning 1 Please observe the cleaning instructions from page 33 2 Check the system at regular intervals 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 alarm function Power Failure see page 35 e weekly check of the alarm function Mask Alarm see page 36 Service 75 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 plan 76 Service DISPOSAL DEVICE For information on the proper disposal of the device please contact your responsible customer service PACKAGING You can return the packaging to your marketing part ner or dispose it separately with your normal domes tic waste Disposal 77 TECHNICAL DATA Dimensions WxDxH 215 x 1
30. k in order to eliminate any potential leaks Use of the Device Place the tube such that it does not exert any pull ing action on the mask while you are lying down Breathe deeply and calmly only through your nose If you have activated the soft start function the device initially reduces the pressure after comple tion of the mask test and will then slowly increase the pressure automatically 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 please refer to the chapter Functions of the Device from page 38 Use 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 Please consult your local dealer You can also supply the oxygen through an adapter which is mounted to the air outlet Please consult your local dealer In any case please be absolutely sure to follow your physician s instructions ATTENTION Oxygen promotes combustion processes For that reason please observe the valid fire protection regulations for the use of oxygen Keep oxygen fittings free from fat do not smoke and do not handle the
31. lity and performance of the device if e manipulations modifications expansions adjust ments repairs and maintenance measures are carried out by persons not authorized by us to do so e useis made of accessories and spare parts which come from other manufacturers and have not been released by us for use with the point e the device is used in a way that is different from that described in the User s Manual e the hygiene and cleaning instructions contained in these User s Manual fail to be observed 6 Safety Instructions In order to prevent potential hazards please fol low the instructions below e Exclusively use the device for your own therapy which must have been prescribed by a physician e Use accessories only which have been recom mended and offered by your specialized dealer e Regularly test the alarm function of your device from page 35 e 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 e Never set up the device in a compartment of a cabinet nor under your bed e Please make sure air can circulate around the device and the power plug is readily accessible e Do not place the device in the vicinity of radiators e Ensure that the device is positioned horizontally This is particularly necessary if a humidifier is con nected e f you receive oxygen with your therapy please f
32. nit mbar For changing the pressure unit go to the Olinic Menu hold down the key for approx 1 second Then select F Urit by using the keys A and V Press the lt key Each time you press the key another 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 cmH O the pressure will slightly change Conversion 1 hPa 4 1 mbar 4 1 02 cmH20 Example At 8 cmH20 the pressure is 7 8456 hPa mbar Functions of the Device 67 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 filter since the last reset Therapy The counter indicates the operating time with the therapy pressure applied Standby This counter indicates the time the device was connected to the mains supply To display the counter go to the Clinic Menu hold down the lt key for approx 1 second Then select Turbine by using the keys A and V Press the lt key Each time you press the key you see the next counter 68 Functions of the Device Turbine Z Exit Menu Exit Men Therapy Exit Menu Standby Neng verlassen TROUBLESHOOTING Pain in nose paranasal sinuses or ears Unpleasent feeling of too high pressure D
33. ollow all fire protection and safety regulations with regard to the use of oxygen Safety Instructions Mobile use of the device is permitted only in a parked 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 ear ache a running nose hypersensitivity of the skin oversensitiveness loss of voice disturbances of orientation 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 defibrillators diathermy equipment mobile phones microwave remote controlled toys etc Electro magnetic fields greater than 3 V m may affect the operation of the device When connecting the device to a DC supply source please only use the optional connection cable listed under optional accessories and do not use the device with a PC Safety Instructions To maintain electrical safety please observe the following instructions e Do not put the device into operation if its housing and or cables are damaged e Do not open the housing Notify your specialized dealer of any disturbances and failures e Protect the device from water and moisture e Never operate the device in moist rooms nor ina bathroom e Donot place a vessel filled with fluid on the devic
34. own 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 A 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 lt key again the day will flash and can be set by using the keys A and W Press the key again to accept the set date Functions of the Device Date 25 Hau H9 Exit Menu Time Time il Exit Menu 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 V After pressing the key the hour will flash and can be set by using the key A and V After pressing the 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 Functions of the Device 55 CLINIC MENU In addition to the parameters in the Clinic Menu in the Clinic Menu parameters relevant for the therapy can be set This menu is used only by health and service professionals In the Clinic Menu the following patient and device rel evant data can be shown and changed Enter the PIN code for parameters which are marked with a shown on page 57 for prevention of wrong param eter
35. ressure is set E Pressure only in modes S T and ST Pressure during expiration Press the lt key Now select the desired pressure by using the keys A and VW Press to confirm Next the parameter I Slope is set I Slope only in modes S T and ST 62 Time of pressure increase from E Pressure to I Pres sure 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 Functions of the Device KFE Praess 6 hPa Exit Menu F 5laore a Exit Menu Esir 7 E Slope 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 VW Press to confirm hPa 10 Pressure E Pressure 0 1 2 3 4 5 6 Trigger only in mode T Activate the Clinic Menu to set the trigger Then select Trigger by using the keys A and W Press the lt key Now the device will prompt you to enter the PIN Pressing the key lt again changes the set ting from OFF to ON and vice versa Functions of the Device 63 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 10ml 2 15ml 8 I 25ml Go to the Clinic Menu to set the l Trig ger Then select I Trigger by using the keys A and W
36. ryness and irritation of nose and throat Return of original sleep apnea symptoms Irritation of the eyes or dry eyes Inflammation of the para nasal sinuses or the middle ear 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 Air escaping from between the mask and the skin of your face Stop therapy and contact your physician If you think there is a mistake consult a physi cian 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 Check the mask for proper positioning Replace the mask if its material has become brittle Troubleshooting Cold nose Running nose urge to sneeze Reddening of the skin in the area of the mask swelling of the skin Air sensed to be too warm No air flow 70 Troubleshooting Room temperature too low Reaction to the air flow Common cold Wrong mask size Head gear too tight Allergic reaction Air inlet obstructed Radiator in the vicinity of Device defective Water in the measuring tube Increase the room tempera ture run the tube under the blanket Increase the air humidity in the room or set the humidi
37. s described in the head gear manufacturer s User s manual 34 Cleaning Power Failure Restart Turbine ALARM FUNCTIONS OF THE DEVICE POWER FAILURE If a power failure at night would go unnoticed as a result the patient would breathe used air from the ther apy 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 acous tic signal so you can take the mask off your face and breathe fresh air The alarm is turned off by pushing the ON OFF key After power supply is re established the motor starts automatically and the display will show the following message Checking the power failure function 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 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 Alarm Functions of the Device 35 MASK ALARM This alarm function is activated only if the auto matic function is turned to OFF or Start If the mask has slipped off your face or if the tube is pulled off the device the device is not turned off automatically but emits a visual
38. t go to the Patient Menu press the lt key for approx 1 second then select Mask Test with the keys A and V Press the key Now select the desired time by using the keys A and V Press to confirm Functions of the Device Mask Test 38 Exit Menu Pressure The pressure is gradually hPa increased up to the Mask Test therapeutic pressure l el uem g l 7 er Ze 3 4 vau MU l TREND II CPAP TREND II AUTO l Time i I H o 20 40 ep MM Programmed soft start time Ramp 0 60 minutes RE The pressure is gradually hPa increased up to the Mask Test therapeutic pressure 10 l Pressure 8 6 E Pressure TREND II BILVEL TREND II BILEVEL ST20 4 Time min 0 20 40 60 Programmed soft start time ramp 0 60 minutes Functions of the Device 51 Automatic The automatic mode provides three settings OFF Start Stop Start 1 Auto OFF with mask alarm If you set Auto OFF the device must be turned on 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 2 Auto Start Stop Put on Mask If you set Auto Start Stop you must simply put 25 Hau m3 the mask on your face Once you start breath ing the turbine of the device is turned on If you take the mask off the turbine is automatically turned off after a delay time of 5 seconds In the automatic mode the tur
39. to confirm Functions of the Device Ramf Jimin Exit Menu The pressure is gradually Pressure increased up to the therapeutic pressure 10 I 8 6 l TREND II CPAP TREND Il AUTO 3 i Time 0 20 40 60 Imin Programmed soft start time Ramp 0 60 minutes The pressure is gradually Pressure increased up to the hPa therapeutic pressure l Pressure E Pressure TREND II BILVEL TREND II BILEVEL ST20 Time min 0 20 40 60 Programmed soft start time Ramp 0 60 minutes Functions of the Device 49 Mask Test 50 This parameter determines the time when the device 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 test ing time from 5 to 90 seconds in 5 second inter vals This 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 pres sure is raised by 1 hPa at FLEX Level 1 2 hPa at FLEX Level and 3 hPa at FLEX Level 3 TREND II CPAP and TREND II AUTO If the APAP mode is Switched on the pressure is raised to the max pres sure TREND II AUTO and in the devices TREND II BILEVEL and TREND II BILEVEL ST20 the pressure in the modes S ST and T is raised to the I Pressure To set the mask test firs
40. ved 22 Notes Prior to First Use Please strictly observe the following setup instructions e Do not place the device in the vicinity of a heat ing source Air circulation particularly that below and behind the device must not be impaired by furniture curtains or cushions e Get up the device next to your bed Place it on a firm and flat surface of your bedside cabinet e Donot place the device in a way that it is exposed directly by sunlight or UV light 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 Notes Prior to First Use 23 VIEWS FRONT VIEW Program keys Filter cassette Display Heater LED Info key Heater key Release button for acces sories 8 Measuring tube connection 9 Air outlet 10 Contact socket for humidifier 11 ON OFF key 24 Views BACK VIEW 12 DC Input 24 V DC 13 RS232 interface 14 Power connection 230 V AC Views 25 SCOPE OF DELIVERY N VIT lij I lfe A DAM Pn I Mmm d 26 Scope of Delivery RON NO 01 Therapy device User s manual Power cord Therapy tube 1 80 m incl measuring tube Stoppers Carrier bag Replacement filter cas sette without frame cover Art No TRENBELGRAR Far re len 0000 2061 TREND I AUTO eeeem 0000 2062 TREND I BILEVEL eeeeeeees 0000 2063 TREND II BILEVEL ST 20
41. ystem leaves the menu item automatically Functions of the Device Mask only in modus CPAP and APAP in TREND Il AUTO In this menu item the type of mask can be cho sen This is important for the correct function of the therapy device It can be chosen between Nose and Nose Mouth e Choose Mose for all nasal masks and pillow masks e Choose NaseMauth for all nasal mouth masks Exit Menu Functions of the Device 47 Ramp 48 Whenever the blower has been started the micro controller of the device checks whether a soft start ramp has been programmed While the programmed time elapses the soft start function increases the pressure from an adjustable initial ramp pressure P Ramp up to the pressure prescribed thus allow ing you to fall asleep more easily In particular if you are not yet used to the respira tion 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 VW Press the key Now select the desired time by using the key A and WV Press
Download Pdf Manuals
Related Search