point 2 5.000 ENG_2014-06-24_09.indd
Contents
1. C 23 The device complies with the requirements of Directive 93 42 EEC 4 Info CONTENTS EES 9 ej 10 Information On E ERR le LEET 10 Sympos Used eg NEIEN 10 SYMDOIS On ThE packaging dtt td 11 SVMPO S OM IME rating EE 14 DALSLY IFfOF Weblo suos te vere RERO EDS hana sb as Banana EA GR had ROO GRE E e 12 General safety InStr cll RE 12 El ciriGal EE 13 Installation requirements and transport sssesssseem ee 13 BSTOFS COMMIS E e eR 14 Using fe 15 INLENG SD HE 16 COMMMAINGICATIONS eege 17 Ne SO rss ga ae Natt a ea ads ea et EEN 17 DEVICE desch UON M T 18 HOW THE el 19 General es addet a ua sat b a p e 19 ewe MUT 20 et lant 21 Eege 21 IADADP scio opo onto aono enata anao aao aaa B ODDO 22 BIEEVEL S Tand S T cese ttr be aa e erbe utut 25 USING ING o i e asthenia aad 28 Commissioning pirssin iA eene 28 Turning on and On Battery modestes 30 EE ln m pp A A E A E 30 Automatic zero point correction of pressure eerst 30 owerfallile ee Pee NE RN Een 31 WSIMG OXVOSN cc 32 DEVICE E veel EE 34 Parameters PONTZ CPAP eorr E 36 Parameters in point 2 Auto DAD 37 Parameter in point 2 BILEVEL GTO0 p Hee 38 I angudged oie eR tM MU LM LM LM I EE 39 PHU eegen erennere geed deed deed dee dee die 39 Sorek n nien nnn n FE E ERE ER 39 Bum 40 Dice T 40 NEE 41 fero cur E 42 Contents 5 IEPA Fs I 43 EPAP A eee enti ennbonb con benb conte conte bo e d o debes 44 Be2. e E FLEX Calibration e e Ramp 9 P Ramp Mask Test e Auto e Display Vt D e Bact Filter e Brightness e next parameter is displayed by pressing the enter key present not present only present if the alarm clock function is enabled see page 41 2 PIN code protected 38 Device functions LANGUAGE The device can display messages in German DEU English ENG Greek ELL Spanish SPA French FRA Italian ITA Dutch NLD Turkish TUR Polish PLK Portuguese POR and Czech CZE Setting the language 1 Select the complete menu see page 35 2 Use the selection keys 4 and Y to select Language bLanguage ENG E Meru 3 Set the desired language by pressing the enter key P UNIT The device can show the pressure in the pressure units hectopascal hPa mil libar mbar and centimeters of water cm cmH 0O Setting the pressure unit 1 Select the complete menu See page 35 2 Use the selection keys and y to select P Unit KP LInit mbar Exit Menu 3 Set the desired pressure unit by pressing the enter key OPERATING TIMES Under this menu item you will find the total operating time including standby mode of the device the blower running time the operating time of the filter and the therapy time Checking the device s operating times 1 Select the complete menu see page 35 2 Use the selection keys a and to
3. Bact Filter Yes Exit Menu 3 Press the the enter key and if necessary input the PIN code with the selection keys and Press the enter key after every digit 4 Press the enter key and then use the selection keys t and J to set Ces or Ma Confirm your setting by pressing the enter key NOTICE Whenever a bacterial filter is connected to or removed from the device it is necessary to calibrate the device see page 50 BRIGHTNESS You can set the brightness of the display from O 96 to 100 96 This value determines the brightness of the display 30 seconds after the last key was pressed When a key is pressed the display brightness is always 100 96 5096 during battery operation Setting the brightness 1 Select the complete menu see page 35 2 Use the selection keys 4 and V to select Brightness FBrishtness 1d88 Exit Menu 3 Press the enter key and then use the selection keys and X to set the desired brightness 4 QConfirm your setting by pressing the enter key Device functions 55 PARAMETER SETTINGS Settings range Dependency Setting steps Language DEU ENG ELL SPA FRA ITA NLD TUR PLK POR CZE P Unit hPa mbar cmH5O Press 4 20 257 hPa 0 5 hPa IPAP EPAP 20 257 hPa gt EPAP lt 20 257 hPa 0 5 hPa EPAP 4 hPa IPAP gt 4hPa lt IPAP 0 5 hPa l Slope 1 3 IPAP EPAP 1 Level Frequency I E E Slope ES IPAP EPAP 1
4. either change its coarse and fine filter and disinfect the surface of the filter System or replace the entire filter system with a new one NOTICE If there is any doubt it should be assumed that the device is contaminated and it should be hygienically prepared according to the hygiene concept Using bacterial filters 69 TROUBLESHOOTING Pain in the nose the para nasal sinuses or the ears Unpleasant feeling because of the high pres sure Dryness and irritation in the nose and throat Original symptoms of sleep apnea come back Irritated or dry eyes Cold nose Runny nose sneezing Reddening of the skin in the mask area skin swell ing Feeling that the air is too hot No air flow Very little air flow Blower is running constantly at maximum speed 70 Troubleshooting Inflammation of the para nasal sinuses or the middle ear Malaise with prescribed high pressure values Acclimatization phase to the pressure not yet completed Air is too dry Physical condition or life circumstances have changed Air escapes between mask and the skin of the face Room temperature too low Reaction to the air flow Normal cold ncorrect mask size Headgear too tight Allergic reaction Heater close to the device Device is defective Soft start function has been selected Air channels are blocked Leak in the device Stop the treatment and contact your physician If you suspect an error pl
5. Blower E e Filter Therapy Date e Time e Wake Time e Press FLEX E FLEX Calibration Ramp o P Ramp Mask Test Auto e Display Vt Bact Filter Brightness next parameter is displayed by pressing the enter key e present not present only present if the alarm clock function is enabled see page 41 PIN code protected 36 Device functions PARAMETERS IN point 2 AutoCPAP point 2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP ES e Language P Unit Power Blower e Filter Therapy Date Time Wake Time Q Mode Press e S P Min P Max 5 S Q P Start FLEX E FLEX Calibration e e Ramp a P Ramp Mask Test e Auto e Display Vt e Bact Filter Q Brightness S next parameter is displayed by pressing the enter key present not present only present if the alarm clock function is enabled see page 41 2 PIN code protected Device functions 37 PARAMETER IN point 2 BILEVEL ST20 25 point 2 BILEVEL ST20 25 Standard menu Complete menu Parameter ST T S ST T S Language P Unit e Power 9 Blower e Filter Therapy Date e Time es Wake Time e Mode 5 e kass z S IPAP2 EPAP 7 l Slope E Slope Frequency WE S e Delay Time Backup Freq H FLEX
6. Selection of P Min by the physician 1 Select the complete menu see page 35 2 Use the selection keys t and J to select Made 3 Press the the enter key and if necessary input the PIN code with the selection keys and Y Press the enter key after every digit 4 Use the selection keys 4 and 4 to select the AFAF mode 5 Press the selection key Q The menu item F Min is now displayed FEET m 3 BhPa Exit Menu 6 Press the enter key and then use the selection keys 4 and V to set the desired value Confirm your setting by pressing the enter key The parameter P Max is set next Device functions 47 P Max only point 2 AutoCPAP in APAP mode KP Hax EISE Exit Menu Selection of P Max by the physician 1 First set P Min 2 Use the selection keys Q and O to set the desired value Confirm your setting by pressing the enter key The parameter P Start is set next P Start only point 2 AutoCPAP in APAP mode KFP 5tart 7 5hPa Exit Menu Selection of P Start by the physician 1 First set P Min and P Max 2 Usethe selection keys Q and to set the desired value Confirm your setting by pressing the enter key I FLEX only in modes CPAP and APAP Inhaling under therapy pressure is always more difficult as the lungs are already partly filled and thus also prestressed Such additional stress from therapy can be reduced by means of a personaliz
7. 25 hPa 140l min 120l min Operating temperature 5 C 38 C 5 C 35 C Ambient temperatures up Ambient temperatures up to 40 C does not harm the to 40 C does not harm the device function at all device function at all Storage Transport 20 C 70 C temperature Therapy air heating at air outlet 0 3 K hPa via compression 0 2 K hPa via friction at end of tube 0 3 K hPa at 10 hPa 0 5l s Relative humidity 15 96 95 for operation storage and transport Ambient air pressure range Storage Transport 1060 hPa 265 hPa approx 400 m 10000 m Operation 1060 hPa 800 hPa approx 400 m 2000 m Filter Polyurethane foam on polyester basis 80 ppi 30 kg m Therapy tube connection 22 mm cone as per ISO 5356 1 Product class according lla to 93 42 EEC Classification according Protection class II protective insulation to EN 60601 1 With increasing altitude the air flow rate decreases 76 Technical data Factory settings Parameter point 2 CPAP point 2 AutoCPAP point 2 BILEVEL ST20 25 Menu Complete menu Language ENG P Unit hPa Mode APAP BILEVEL ST Press 6 hPa IPAP 10hPa EPAP 6hPa Slope 2 E Slope 2 Frequenz 12bpm HE 35 65 96 Delay Time 15s Backup freq OFF P Min 4hPa P Max 10 hPa P Start 6 hPa FLEX 2 E FLEX 2 Ramp Omin Mask Test Os Auto e Display Vt ER Bact Filter No Brightness 50 Alarm clock OFF IT It can be unlocked by
8. 34 Device functions The point 2 has two different menus e Standard menu e Complete menu The standard menu contains the menu items relevant to patients The complete menu contains all menu items of the standard menu as well as all menu items required for setting the therapy This menu is primarily intended for physicians and trained medical staff To switch between the menus first press the enter key Then hold both the selection keys and GE down at the same time for a prolonged period The display shows the message Complete Meru Standard Menu active active NOTICE If during programing you have not pressed a key for 30 seconds the stan dard or complete menu exits automatically for security reasons If a modi fied value is not confirmed by pressing the enter key and the standard or complete menu has exited the original value is retained To access a menu hold down the enter key for longer than 1 s You can access the menu items within menus by pressing the selection keys O or GE To acti vate a parameter press the enter key Some parameters may only be set by physicians or trained medical staff These parameters are protected by a PIN code PIN Coc Exit I CAUTION Please do not try to crack the PIN code Speak to your physician if you doubt the correctness of the pressure prescription Device functions 35 PARAMETERS IN point 2 CPAP point 2 CPAP Language e P Unit e Power
9. During therapy the device must not be operated in a drawer on a closet shelf or behind a partition It must be ensured that the air inlet at the rear of the device is accessible at all times and not obstructed Drapes cur tains paper or other objects must not be located behind the device Do not place the device on the floor or under the bed in order to maintain low dust exposure levels Do not put the device close to a source of heat Avoid setting up the device at locations where it will be exposed to direct sunlight Make sure you operate the device at a sufficient distance from other equipment which could emit electromagnetic waves such as diathermy devices cell phones remote controlled toys and microwave appliances Empty the humidifier optional accessory before packing it away in the carrying case Safety Information 13 BEFORE COMMISSIONING Do not switch the device on if it has previously been in a very cold environment Wait for about one hour for the temperature to balance out e Check for proper setup and proper condition of the device Check the condition of the breathing tube mask humidi fier and air filter Special attention should be paid to the maintenance instructions 14 Safety Information USING OXYGEN Oxygen supports combustion Therefore observe the fire protection regulations applicable for using oxygen Ensure that there is no grease on the oxygen fittings Do not smoke and
10. IEC 61000 4 2 Electrical fast tran sient Burst IEC 61000 4 4 Surges IEC 61000 4 5 Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 Magnetic field power frequency 50 60 Hz magnetic field IEC 61000 4 8 Conducted RF IEC 61000 4 6 IEC 60601 Test level 6 kV contact 8kV air 2kV power supply lines 1kV input output 1kV differential mode 2kV common mode gt 95 96 clip in U 0 5 cycles 60 clip in U 5 cycles 30 96 clip in U1 25 cycles gt 95 96 clip in Bio S 3 A m V28V 150 kHz 80 MHz Compliance level 6 kV contact 8kV air 2kV power supply lines 1 kV input output 1kV differential mode not applicable gt 95 96 clip in U1 0 5 cycles 60 96 clip in U 5 cycles 30 clip in U 25 cycles gt 95 96 clip in Ur 5s 3 A m 3V Electromagnetic environ ment guidance Floors should be made of wood concrete or ceramic tile If floors are covered with synthetic material the rela tive humidity should be at least 30 Mains power quality should be that of a typical commer cial or hospital environment Mains power quality should be that of a typical commer cial or hospital environment Mains power quality should be that of a typical commer cial or hospital environment If the user of the point 2 requires continued operation during power mains interrup tion it is recomm
11. MESSAGES Press ON OFF SD Error EZ Two different types of error can be distinguished errors with data loss and errors without data loss The display Exx denotes errors in which data may have been lost The display Wxx denotes errors in which data has not been lost To hide an error message press the enter key ATTENTION If error messages occur frequently we recommend that the device is examined by a service technician The following table shows all error codes that can occur in connection with the use of the SD card Error Remedy code EOO Writing data has failed Possible The SD card is probably faulty Remove causes are power failure removal of the SD card and then insert it into card during writing or a faulty SD card the device again If the error contin ues to occur send the card back to the physician E01 The SD card is faulty Obtain a new SD card from your phy sician or specialist dealer E02 File system or folder structure is faulty The SD card must be formatted by or cannot be read the physician using TRENDset E03 New files cannot be created or the The SD card must be formatted by SD card is full the physician using TRENDset E04 The device cannot adopt the ther The SD card must be returned to the apy data physician to check the therapy E05 The SD card was removed Insert the SD card again The SD card has fallen out of the card If this occurs frequently the device slot should be
12. NOTICE When using a humidifier the cleaning instructions in its user s manual must be observed Changing the filter cleaning 67 PREPARING THE DEVICE FOR A PATIENT CHANGE AWARNING Before every change of patient a hygienic preparation must be carried out in accordance with the HOFFRICHTER s hygiene concept When being given to another patient the device must be prepared hygieni cally by the specialist dealer or the manufacturer If reuse of the mask and the therapy tube is planned they must also be prepared by the specialist dealer or the manufacturer The preparation procedure is described in detail in the corresponding hygiene plan 68 Preparing the device for a patient change USING BACTERIAL FILTERS If the device is intended for use by more than one patient e g operation in clinics a suitable bacterial filter e g MEDISIZE BARR VENT S must continu ously be used to protect the device from contamination by human pathogens NOTICE Change the bacterial filter daily and follow the manufacturer s user s manual If the optionally available humidifier aquapoint 2 is used with the device a bacterial filter must not be used On a change of patient carry out the following steps e Replace the bacterial filter e Disinfect all the parts of the housing and the connections with a suitable agent e g Mikrozid Liquid e Change the filter or if you are using the optionally available filtersystempoint 2
13. device is started by pressing the ON OFF key 9 The device first of all runs for the time selected by you for the mask test at the prescribed pressure You should now ensure the mask s correct posi tioning to avoid potential leakages 10 Place the tube in such a way that it does not exert any strain on the mask when you lie down S G Z S ee 11 Now breath deeply and calmly just through your nose If the soft start func tion Ramp has been selected see page 51 the device reduces air pressure after the mask test has been performed It then increases pres sure automatically gradually up to the prescribed value while you can go to sleep under reduced pressure NOTICE Read how you can adapt the time settings for mask test and ramp to suit your personal requirements in section Device functions starting page 34 Using the device 29 TURNING ON AND OFF IN BATTERY MODE If the device is powered by the optional available powerpackpoint 2 press and hold the ON OFF key for approx 3 seconds to switch it on or off NOTICE In standby mode the device automatically switches itself off after 1 minute STANDBY MODE If the blower is switched off the device switches to standby mode discernible on the lit display with date and time Press ON OFF 2I Jan ZW 11 45 The point 2 can be kept in standby mode permanently This does not harm it If the powerpackpoint 2 is fitted on the device
14. do not handle naked flames Before using any oxygen equipment for the first time you must receive instruction from your specialist dealer in your home environment Be sure to observe the user s manual of the manufacturer or distributor from whom you obtain the oxygen Make sure that the distance between the oxygen source and device is at least 1 m Have your distributor advise you about the use of oxygen In any case follow your physician s instructions Safety Information 15 INTENDED USE A DANGER The device must not be used for patients weighing less than 30 kg An improper use may result a lung damage The point 2 is a respiratory therapy device designed for the treatment of sleep related breathing disorders in patients weighing 30 kg or more With increased demand of pressure and or forms of respiratory insufficiency the point 2 BILEVEL ST20 and the point 2 BILEVEL ST25 offers the classical non invasive ST Bilevel therapy The point 2 CPAP CPAP Continuous Positive Airway Pressure is a respiratory therapy device which applies a continuous positive airway pressure to the patient The point 2 AutoCPAP AutoCPAP Automatically Adjusting Continuous Posi tive Airway Pressure is a respiratory therapy device which provides an event driven therapy pressure adjustment within preset pressure limits The point 2 BILEVEL ST20 and the point 2 BILEVEL ST25 ST Spontaneous Timed are respiratory therapy devices wh
15. it is possible to oper ate it with a 24 V direct current DC For this you will need the optionally avail able DC vehicle cable AWARNING Only use the optional DC vehicle cable to connect the device to a DC power supply Battery pack To use point 2 while travelling and when mains current fails the device can be operated with the optionally available powerpackpoint 2 battery pack With the battery pack point 2 CPAP and point 2 AutoCPAP can be used at least 8 hours at 10hPa 12 bpm 500 ml tidal volume With the point 2 BILEVEL ST20 25 an operating time at least 7 hours is possible at IPAP 12 hPa EPAP 6 hPa 12 bpm 300 ml tidal volume I E 2 4096 60 T mode ATTENTION Before using the battery pack ensure that you have read the powerpackpoint 2 user s manual 20 How the device works THERAPY MODES The point 2 is equipped with the following therapy modes depending on the type of device CPAP APAP BILEVEL point 2 CPAP type 5CPJ00 point 2 AutoCPAP type 5CPJ10 e 5 7 point 2 BILEVEL ST20 Typ 5CPJ30 e e e e point 2 BILEVEL ST25 Typ 5CPJ50 e e e e CPAP In CPAP mode Continuous Positive Airway Pressure the point 2 supplies con tinuous positive pressure Pressure hPa CPAP 7 20 CPAP pressure 4 Time I Inspiration E Expiration How the device works 21 APAP only point 2 AutoCPAP In APAP mode Automatic Positive Airway
16. select Power The total operating time including standby is now displayed Kouer Kiel Ela Exit Menu 8 Press the enter key The total running time of the blower is now dis played 4 Press the enter key again The operating time of the filter is now dis played 5 Press the enter key again The therapy time is now displayed Device functions 39 DATE The day 1 31 the month Jan Dec and the year 00 99 can be set Setting the date 1 Press the enter key for 1 second 2 Use the selection keys 4 and to select Date Date 25 Jan L Exit Meru 3 Press the enter key and then use the selection keys t and J to set the year Confirm your setting by pressing the enter key 4 Use the selection keys and Y to set the month Confirm your setting by pressing the enter key 5 Use the selection keys and E to set the day Confirm your setting by pressing the enter key TIME The device has an internal clock In the event of a power failure the clock oper ates on inbuilt battery power The hour 00 23 and minutes 00 59 can be set Setting the time 1 2 40 Press the enter key for 1 second Use the selection keys Q and E to select Timme kl me 13 68 Exit Menu Press the enter key and then use the selection keys t and J to set the hour Confirm your setting by pressing the enter key Use the selection keys Q
17. the physician or dealer with TRENDset PC software CE marking as per EC directive 93 42 EEC The manufacturer reserves the right to make technical changes without notice Technical data 77 MANUFACTURER S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer s declaration electromagnetic emissions The point 2 is intended for use in the electromagnetic environment specified below The user of the point 2 should assure that it is used in such an environment Emissions test Compliance Electromagnetic environment guidance RF emissions CISPR 11 Group 1 The point 2 uses RF energy only for its internal function Therefore RF emis Sions are very low and are not likely to cause any interference in nearby elec tronic equipment RF emissions CISPR 11 Class B The point 2 is suitable in all establish e ments including domestic establish Harmonic emissons Class A ments and those directly connected IEC 61000 3 2 f to the public low voltage power supply network that supplies buildings used Voltage fluctuations flicker Complies EE emissions IEC 61000 3 3 78 Manufacturer s declaration on electromagnetic compatibility Guidance and manufacturer s declaration electromagnetic immunity The point 2 is intended for use in the electromagnetic environment specified below The user of the point 2 should assure that it is used in such an environment Immunity test Electrostatic dis charge ESD
18. 2 BILEVEL ST20 25 in modes BILEVEL T and ST Exit Men Selection of TE by the physician 1 First set Frequency 2 Use the selection keys O and O to set the desired value Confirm your setting by pressing the enter key The parameter Delay Time is set next only point 2 BILEVEL ST20 in BILEVEL ST mode DELAY TIME only point 2 BILEVEL ST20 25 in BILEVEL ST mode Delas Time 35 Exit Menu Selection of Delay Time by the physician 1 First set Frequency and LE 2 Use the selection keys E and ER to set the desired value Confirm your setting by pressing the enter key 46 Device functions BACKUP FREQ only point 2 BILEVEL ST20 25 in BILEVEL S mode By activating the backup frequency ventilation will be automatically restored if patient suffers from a persistent apnea gt 15 s Evolving mandatory ventilation is characterized by following fixed parameters e f 10bpm e Ez35 65 96 Selection of backup frequency the physician 1 Select the complete menu see page 35 2 Use the selection keys 4 and Y to select Backup freq Backup Frea ON Exit Menu 3 Press the the enter key and if necessary input the PIN code with the selection keys and A Press the enter key after every digit 4 Press the enter key and then use the selection keys 4 and to select OM or OFF Confirm your setting by pressing the enter key P Min only point 2 AutoCPAP in APAP mode
19. HOFFRICHTER Quality makes the Difference m m m m User s manual Respiratory Therapy Device CPAP AutoCPAP BILEVEL ST20 BILEVEL ST25 User s manual point 2 point 2 5 000 ENG 2014 06 24 09 Article no 5000 0510 as of device software 5 000 point 2 User s manual 2014 HOFFRICHTER GmbH All rights reserved The content published in this user s manual is the sole property of the HOFFRICHTER GmbH All forms of reproduction editing distribution and any kind of exploita tion even in part require the prior written consent of the HOFFRICHTER GmbH The HOFFRICHTER GmbH reserves the right to amend or replace this user s man ual without prior notice Please ensure that you are always working with the most current version of this user s manual Should you have any questions please contact the ventilation device provider or check our information at www hoffrichter de The respiratory device may only be operated and maintained by trained personnel The following documents are available for point 2 pro in addition to this user s manual e Brief instructions e Service manual e Hygiene concept SERIAL NUMBER Every HOFFRICHTER GmbH device is supplied with a serial number for trace ability purposes Please enter your device s serial number here You will find the serial number on the rating plate on the back of the device Please always quote the serial number for all queries and complaints CONFORMITY
20. Level Frequency I E Frequency 5 30bpm 1 bpm IS 20 80 5 Delay Time 0 20s ilS Backup freq ON OFF s P Min 4 20 hPa lt P Start 0 5 hPa P Max 4 20 hPa gt P Start 0 5hPa P Start 4 20 hPa gt P Min 0 5hPa lt P Max I FLEX 0 3 hPa l s 1 hPa el E FLEX 0 3 hPa l s 1 hPa el Ramp 0 45 min E 5 min P Ramp 4 hPa 20 257 hPa CPAP lt Press APAP lt P Start 0 5hPa SESS 1 lt EPAP Mask Test 0 90s 5s Auto OFF Start Stop Start Display Vt ON OFF Bact Filter Yes No z Brightness 0 100 96 10 1 only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20 25 in modes CPAP only point 2 BILEVEL ST20 25 only point 2 BILEVEL ST20 25 in modes BILEVEL T and ST only point 2 BILEVEL ST20 25 in BILEVEL ST mode only point 2 BILEVEL ST20 in BILEVEL S mode only point 2 AutoCPAP only point 2 BILEVEL ST25 Sy Gy ES Gay TS 56 Device functions ALARM FUNCTIONS OF THE DEVICE MASK ALARM If the mask slips off your face the tube is pulled out or any other leak occurs that cannot be compensated for the device does not switch off automatically but emits an acoustic and visual alarm Mask Alarm Check Mask The mask alarm is only active in the Auto OFF and Auto Start automatic modes Testing the mask alarm Start the device in Auto OFF mode The mask should be open not on the face After a short time an acoustic signal sounds PRESSURE ALARM Shou
21. Pressure the point 2 automatically controls the therapy pressure in relation to the respiratory events occurring The device is equipped with a special sensor system that can reliably distinguish between obstructive apnea airways are closed and central sleep apnea respi ratory arrest with open airways Obstructive apnea can be corrected with an automatic increase in pressure Central sleep apnea automatically results in a drop in pressure Hypopnea flow reduction snoring results in a rise in pressure with a lower speed Normal respiration results in a slow drop in pressure The maximum values to which the pressure level may rise or fall are specified by the selection of settings The device commences therapy once switched on with the starting pressure which is likewise adjustable Pressure hPa APAP with P Min and P Max limits i d I E 77 20 Le P Max P Min 4 Md Time I Inspiration E Expiration NOTICE The speed of pressure increase can be set to one of five levels via the PC software TRENDset 22 Therapy modes FLEX settings Breathing compressed air results in an increased burden for the respiratory muscles FLEX controls ease this burden on the respiratory muscles by reduc ing the effect of the flow resistance in the airway To this end the therapy pres sure needs to be increased during inspiration and reduced during expiration The degree of pressure control can be individually sele
22. ST As long as the patient is breathing spontaneously the device is operating in the S mode If the patient stops breathing the device automatically switches to the T mode Once a total time lag expiration time delay time has elapsed the device switches into the T mode Pressure hPa BILEVEL ST 20 IPAP EPAP Time Delay time LE t f Spontaneous breathing Total Spontaneous breathing time lag S mode T mode S mode I Inspiration E Expiration Therapy modes 27 USING THE DEVICE COMMISSIONING ACAUTION Before commissioning the device read section Safety Information start ing from page 12 1 Setup the device according to the installation requirements see page 13 2 Connect the power supply to the device 3 Connect the mains cable to the power supply and its plug to a power socket 4 The device starts up and successively displays a welcome text the device type its software version and the current number of therapy hours and then switches to the date and time display standby mode 5 Connect the therapy tube to the mask 28 Using the device 7 Calibrate the device as described in the chapter Calibration from page 50 8 Put the mask on If automatic mode has been selected see page 53 the device is turned on by the patient s breathing If automatic mode has been set to OFF the
23. and to set the minutes Confirm your set ting by pressing the enter key Device functions WAKE UP TIME NOTICE Ex factory the alarm clock function is not enabled But it can be unlocked by the physician or dealer with TRENDset PC software To activate the wake up alarm press D For checking purposes the programmed wake up time is displayed for a short time To deactivate the alarm press p The activated alarm is indicated by a bell symbol on the display Press ON OFF When the wake up alarm sounds there are two options 1 Press the ON OFF key once to stop the alarm for the next 5 minutes Slumber mode and twice to deactivate it completely Press ON OFF Slumber 2 Press J to end the alarm Setting the wake up time 1 Press the enter key for 1 second 2 Use the selection keys 4 and y to select Wake Time Make Time 47 68 Exit Menu 3 Press the enter key and then use the selection keys and J to set the hour Confirm your setting by pressing the enter key 4 Use the selection keys Q and to set the minutes Confirm your set ting by pressing the enter key Device functions 41 MODE only point 2 AutoCPAP and point 2 BILEVEL ST20 Selection of mode by the physician 1 Press the enter key for 1 second 2 Use the selection keys t and y to select Mode Bee ees HPRP Exit Menu 3 Press the the enter key and if necessary input the PIN code w
24. automatic mode The device can be switched on or off in any automatic mode by pressing the ON OFF key DISPLAY VT When the function Display Vt is activated the tidal volume is displayed in ml during therapy The value displayed is the arithmetic mean of the inspired air volume from the last four breathing periods The value is recalculated after each breathing period and shown on the display The leakage air flow must be cal culated before display is possible This is generally the case after about three breathing periods Activating deactivating the display of the tidal volume 1 Press the enter key for 1 second 2 Use the selection keys and Y to select Display Mi sPlay Ut ON xit Menu 3 Press the enter key to set ON or OFF NOTICE During the therapy the display of the tidal volume replaces the display of the date Possible displays states il Display of tidal volume in ml edzml No valid value for the tidal volume is available yet If the display shows the value O ml for the tidal volume an apnea has occurred 54 Device functions BACT FILTER As pressure measurement is influenced by the connection of a bacterial filter it must be specified on the device whether or not a bacterial filter has been connected Select whether a bacterial filter is connected by the physician 1 Select the complete menu see page 35 2 Use the selection keys 4 and J to select Bact Filter
25. blower is running In normal mode you have pressed the selection key Q and get the message that you will be woken up at 7 a m In normal mode you have pressed the selection key and get the message that the alarm clock has now been switched off The wake alarm has been triggered Press the ON OFF key once to initiate the slumber phase Press the key once again to turn off the alarm completely You still have 1 min and 18 s until the alarm clock will sound again You have pressed the ON OFF key and ended the slumber phase Important display messages ut ENTE The filter must be changed see page 65 To Thanage Fi tar reset the message hold the enter key down Ss em and while you are doing this insert the DC power supply plug into the device s DC power connection After the mains voltage is restored the blower re starts automatically Complete Merny The complete menu has been deactivated by the is inactive PC software TRENDset and cannot displayed NOTICE Ex factory the alarm clock function is not enabled But it can be unlocked by the physician or dealer with TRENDset PC software Important display messages 59 USING AN SD CARD GENERAL INFORMATION The use of an SD card during therapy enables the most important therapy data to be saved long term and detailed The physician can readout and evaluate this data via the TRENDset PC software Furthermore the physician may set up new therapy parameters us
26. cted for inspiration and expiration at four levels 0 1 2 3 The level selected is identical to the airway resistance value in hPa l s by which the effort for the patient s respiratory mus cles is relieved The specified curves of the FLEX transfer characteristics cor respond to the prevailing pressure and flow behavior of the airways Changes in pressure are only possible within the adjustable pressure range of the point 2 and are additionally limited to x 3 hPa FLEX settings are not activated until after the third breathing period as the point 2 takes a short period of time to calculate the leakage flow Pressure hPa CPAP with I FLEX and E FLEX I E I E 20 YW WD 7 CPAP NEM pressure 4 Time Pressure hPa APAP with I FLEX and E FLEX I E I E I E A A 20 P Max LN VJ P Min 4 E GE LMM Time I Inspiration E Expiration Therapy modes 23 FLEX settings Pressure hPa Pressure curve Flow l s a hPa Flow Leakage flow b Vs resistance 8 hPa s RSS 2 hPa s 1 hPa s Respiration flow curve 24 Therapy modes BILEVEL S T AND ST only point 2 BILEVEL ST20 25 General In BILEVEL S T and ST you can independently set the pressure during inspra tion IPAP and expiration EPAP Selecting an an optimal slope can facilitate patients therapy compliance A precise adjustment may f
27. e parameter E Slope is set next Calculation of the I Slope time Settings IPAP 10hPa lSlope 2 Frequency 12 bpm EPAP 6hPa E Slope 2 IPAP EPAP I Slope time _ I Slope Slope time 10 hPa 6hPa 0 2s 20 hPa s 44 Device functions E SLOPE only point 2 BILEVEL ST20 25 in modes BILEVEL S T and ST E 5laore d Exit Menu The E Slope determines the time of pressure decrease from IPAP to EPAP e evel 1 10hPa s e Level 2 20hPa s e evel 3 40 hPa s Selection of E Slope by the physician 1 First set IPAP EPAP and I Slope 2 Use the selection keys O and to set the desired value Confirm your setting by pressing the enter key Pressure hPa EPAP IT Slope E Slope Time The E Slope time is calculated as the I Slope time see page 44 Device functions 45 FREQUENCY only point 2 BILEVEL ST20 25 in modes BILEVEL T and ST Selection of Frequency by the physician 1 Select the complete menu see page 35 2 Use the selection keys 4 and X to select Frequency bFrequency 1Zbpm Exit Menu 3 Press the the enter key and if necessary input the PIN code with the selection keys and J Press the enter key after every digit 4 Press the enter key and then use the selection keys O and to set the desired value Confirm your setting by pressing the enter key The parameter E is set next E only point
28. ease ask your physician for help Try to relax Use or vary the soft start function Device probably does not have an air humidifier Speak to your physician about retrofitting an aqua point 2 humidifier Inform your physician Check the positioning of the mask Replace the mask if the material has become chapped Increase room tempera ture Warm up the tube under the pillow Either increase the humid ity in the room or the tem perature of the humidifier Contact your physician Inform your physician Loosen the headgear Inform your physician Move the device and the heater further apart Inform customer services Reduce soft start time Check air inlet Have the device checked by customer services MAINTENANCE ACAUTION Do not try to open the power supply Maintenance and repairs may only be performed by personnel authorized by us ATTENTION Do not try to open the device Maintenance and repairs may only be per formed by personnel authorized by us You yourself can help to increase the service life of the device and ensure that it continues to work safely e Follow the cleaning instructions from page 65 e Check the system regularly Conduct a visual check for external damage and dirt Check the mask alarm function once a week see page 57 Maintenance 71 DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment DEVICE The dev
29. ed I FLEX setting FLEX settings will only work if spontaneous respiration is actually present FLEXLINE is not a form of artificial respiration but merely a way of supporting the respiratory effort of the patient Selection of I FLEX by the physician 1 Select the complete menu see page 35 2 Use the selection keys and J to select I FLEX FICREERC S OS Exit Menu 3 Press the enter key and if necessary input the PIN code with the selection keys and Y Press the enter key after every digit 4 Press the enter key and then use the selection keys Q and to set the desired value Confirm your setting by pressing the enter key 48 Device functions E FLEX only in modes CPAP and APAP Although the point 2 is equipped with an excellent pressure control system an E FLEX setting can help make expiration easier This should however be adjusted individually for each patient Once again FLEX settings will only work if actual respiratory effort is present Selection of E FLEX by the physician 1 Select the complete menu See page 35 2 Use the selection keys 4 and V to select E FLEX kE FLEX 3 Exit Menu Press the enter key and if necessary input the PIN code with the selection keys and Press the enter key after every digit Press the enter key and then use the selection keys and J to set the desired value Confirm your setting by pressi
30. egula tions in force in the area of use must be observed A This symbol denotes general safety instructions Follow these instructions to avoid accidents personal injury or material damage A DANGER This symbol denotes hazardous situations that lead to serious injuries or death AWARNING This symbol denotes hazardous situations that may lead to serious inju ries or death A CAUTION This symbol denotes hazardous situations that may lead to moderately severe injuries NOTICE This symbol denotes situations that may lead to material damage or dam age to the device IMPORTANT This symbol denotes information tips and instructions for the efficient error free use of the device 10 General SYMBOLS ON THE PACKAGING 3 Range of humidity for storage and transport 15 e3 Range of ambient air pressure for storage and transport 265 hPa gg Range of temperature for storage and transport 20 C SYMBOLS ON THE RATING PLATE N Observe the warning and safety instructions in the user s manual BF application part Ii Protection class II protective insulation CE conformity declaration Manufacturer Serial number pH Follow the user s manual Do not dispose of the device in the household waste Please con tact the relevant customer services department to find out how to dispose of the device properly Be General 11 SAFETY INFORMATION GENERAL SAFETY INSTRUCTIONS 12 Only use the dev
31. ended that the Equipment or System is powered from an UPS or a battery Power frequency magnetic fields should be at levels characteristic of a typical location in a typical com mercial or hospital environ ment Portable and mobile com munications equipment should be used no closer to any part of the point 2 including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Dz1474PforV4 23V Manufacturer s declaration on electromagnetic compatibility 79 Guidance and manufacturer s declaration electromagnetic immunity Radiated RF E 2 3 V m 3 V m tele lol SP IEC 61000 4 3 80 MHz 2 5 GHz 80 MHz 800 MHz d 2 33 JP 800 MHz 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site Survey should be less than the compliance level in each frequency range Interfer ence may occur in the vicin ity of equipment marked with the following symbol b Uer Note 1 At 80 MHz and 800 MHz the higher frequency range is essential Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless tele phones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted the
32. examined by a service technician E06 The SD card or the device is faulty Change SD card If this occurs fre quently the device should be exam ined by a service technician WOO The device is attempting to repair the Confirm with key The old SD card is SD card But you have inserted anew defective Continue to use the new SD card into the device SD card W05 06 see error code E05 E06 see error code E05 E06 62 Using an SD card STORAGE OF THERAPY DATA Therapy data is stored internally in the device and alternatively on an SD card The data from the device and the SD card can be readout by the physician using the TRENDset PC software INTERNAL DEVICE MEMORY The internal device memory is limited to 30 days SD CARD In contrast to the internal device memory the SD card offers a capacity of more than one year 7 In addition to the therapy data the last 100 device events are saved on the SD card Events are changes of parameters such as therapy set tings resetting counters e g filter counters etc The parameters changes are saved with the date and time they were changed as well as the old and new value All alarms that occurred are also being saved with date and time point 2 CPAP AND point 2 AutoCPAP Therapy data Internal device SD card memory Frequency z e Central Sleep Apnea e e Obstruktive Sleep Apnea o e Mixed Sleep Apnea o e Hypopnea o e Snoring e e Mode o e Adjustment e e Leakage o e Hyperventilatio
33. ice for your own CPAP therapy prescribed by the physician Only use accessories and spare parts approved by us for use with the device Only use the mask and therapy tube for your own therapy Observe the mask manufacturer s usage instructions Check that the exhalation opening in the mask is not obstructed Make sure you use an exhalation valve if the mask has no exhalation opening Inform your specialist dealer immediately if the device is not working properly Please see your physician immediately if dryness of the mucous membranes in the nose and throat sinus discomfort ear ache runny nose over sensitive reactions of the skin irritabilities loss of voice orientation or memory impairment occur when using the device Safety Information ELECTRICAL SAFETY Do not use the device if its housing cables or power supply are damaged Do not open the device housing under any circumstances Inform your specialist dealer if the device develops a fault During therapy do not connect any other line powered devices via the RS232 interface at the rear of the device Protect the device from water and dampness Always unplug the device from the mains before cleaning Empty and thoroughly clean any optional humidifier if you do not plan to use it for a lengthy period of time INSTALLATION REQUIREMENTS AND TRANSPORT Place the device near your bed on a firm and level surface A bedside cabinet is ideally suited for this
34. ice must not be disposed of with the household waste Please contact the relevant customer services department to rs find out how to dispose of the device properly PACKAGING ON The packaging is taken back by the distributor but it can alternatively A be recycled ACCESSORIES The accessories such as the tubing mask filter cassettes etc should be dis posed of according to the manufacturer s instructions or with normal house hold waste 72 Disposal ACCESSORIES For ordering of accessories please contact a HOFFRICHTER service partner Scope of delivery Carrying case 0000 2080 Power supply 0000 2133 Mains cable 31100029 Filter 0000 2110 Spare filter 2 pack 0000 7801 Therapy tube inner diameter 22 mm length 1 80 m 0000 7875 User s manual 5000 0510 Brief instructions 5000 0519 Optional Article number Standard masks Standard Nasal Mask size S 0000 3440 Standard Nasal Mask size M 0000 3434 Standard Nasal Mask size L 0000 3435 Standard Full Face Mask size S 0000 3441 Standard Full Face Mask size M 0000 3436 Standard Full Face Mask size L 0000 3437 Cirri Mini Comfort Nasal Mask size Child S 0000 3551 Cirri Mini Comfort Nasal Mask size Child M 0000 3552 Cirri Mini Comfort Nasal Mask size Child L 0000 3498 Cirri Comfort Nasal Mask size XS 0000 3497 Cirri Comfort Nasal Mask size S 0000 3486 Cirri Comfort Nasal Mask size M 0000 3487 Cirri Comfort Nasal Mask size L 0000 3488 Cirri Comfort Fu
35. ich enables two independently adjust able pressure levels depending of inspiration and expiration The device generates positive airway pressure which keeps the patient s airways open whilst asleep The therapy pressure is administered via a respiratory mask nasal nasal cushion or full face mask which must be fitted with an exhalation valve to ensure that the exhaled air is discharged The point 2 is designed for use at home in hospitals and for portable operation The device is not suitable for use with patients in need of artificial respiration A DANGER This therapy device is no life support system 16 Safety Information CONTRAINDICATIONS AWARNING Respiratory therapy may be contraindicated for certain pre existing con ditions Therefore always talk to your treating physician before starting the therapy Contraindicating pre existing conditions include bullous lung diseases pneumothorax very low blood pressure pneumocephalus after open craniocerebral injury or other head injuries Inflammation of the paranasal sinuses or the middle ear may be an indication to stop the treatment Please speak to your physician about this SIDE EFFECTS There is the possibility of undesirable side effects occurring with respiratory therapy Reasons for side effects occurring could be unsuitable therapy set tings not using the device properly or not following the cleaning instructions Normally the side effects disappea
36. ing TRENDset and send them to the patient to update its therapy requirements As soon as the SD card is inserted the device imports the modified therapy parameters NOTICE Only SD cards with the specification 1 x lt 2 GB can be used The SD card must be formatted with TRENDset before use INSERTING THE SD CARD 1 Ensure that the device is in standby mode see page 30 2 Insert the SD card into the SD card slot Li ct gt 3 The device starts initializing while the message Do not remove the SD card is displayed Do not remove the 5D card ization depends on the device settings ATTENTION During the initialization process do not remove the SD card at any time This could lead to loss of data or damage the SD card 4 After successful initialization the message disappears If the SD card contains valid new therapy parameters the device is going to import them Finally New Parameters were accepted indicates initialization to be successful New Parameters were acceptet 5 By pressing the enter key or after 10s the message will be disappear automatically 60 Using an SD card REMOVING THE SD CARD ATTENTION Only remove the SD card in standby mode Otherwise data may be lost or the SD card might be damaged 1 Ensure that the device is in standby mode see page 30 2 Carefully push the SD card into the card slot 3 Remove the SD card Using an SD card 61 ERROR
37. int 2 has an inbuilt microcontroller to control allits functions Further comfort functions include a soft start ramp automatic start stop and adjust able display brightness Air going through the device is warmed slightly and therefore gains a higher water absorption capacity The mucous membranes in the mouth and nose can dry out particularly in winter when the ambi ent air is dry This is unpleasant and in some cases may also lead to infections Therefore a respiratory air humidifier may be necessary in conjunction with a treatment The plug in aquapoint 2 humidifier is available as an accessory to humidify respiratory air For more information on the humidifier read the aquapoint 2 user s manual or contact your spe cialist dealer Air inlet Filter Blower Pressure sensor D Internal pres sure measu ring tube Air outlet How the device works 19 POWER SUPPLY The point 2 s power can be supplied from one of three sources 1 External switched mode power supply included in scope of delivery 2 DC vehicle cable optional 3 powerpackpoint 2 battery pack optional External switched mode power supply For mains operation the point has an external switching power supply with a wide input range of 100 240 V alternating current AC 50 60 Hz Thus it is possible to connect it to an energy supply anywhere in the world DC vehicle cable For mobile use of the point 2 e g in a truck or a caravan
38. ion keys and Ke set the desired value Confirm your setting by pressing the enter key IPAP only point 2 BILEVEL ST20 25 in modes BILEVEL S T and ST Selection of inspiration pressure IPAP by the physician is 2 Select the complete menu see page 35 Use the selection keys O and E to select IPFAF Wl eer 14 ahPa Exit Menu Press the the enter key and if necessary input the PIN code with the selection keys and Y Press the enter key after every digit Press the enter key and then use the selection keys and 4 to set the desired value Confirm your setting by pressing the enter key The parameter EPAP is set next Device functions 43 EPAP only point 2 BILEVEL ST20 25 in modes BILEVEL S T and ST FERE amp HBhPa Exit Menu Selection of expiration pressure EPAP by the physician 1 First set IPAP 2 Use the selection keys Q and O to set the desired value Confirm your setting by pressing the enter key The parameter I Slope is set next I SLOPE only point 2 BILEVEL ST20 25 in modes BILEVEL S T and ST ECHT TR Z Exit Menu The I Slope determines the time of pressure increase from EPAP to IPAP e evel 1 10hPa s e Level 2 20hPa s e evel 3 40 hPa s Selection of I Slope by the physician 1 First set IPAP and EPAP 2 Use the selection keys O and E to set the desired value Confirm your setting by pressing the enter key Th
39. isted above the recommended separa tion distance d in metres m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range is essential Note 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Manufacturer s declaration on electromagnetic compatibility 81 DISCLAIMER HOFFRICHTER GmbH is not liable for consequences in terms of safety reli ability and performance of the product where e interventions modifications extensions calibration repairs and mainte nance are carried out by persons not authorized by us e other manufacturers accessories and spare parts are used that have not been approved by us for use on the product e the product is used other than as described in the user s manual or e the hygiene and cleaning instructions described in the user s manual have not been complied with Statutory guarantee rights remain unaffected by this 82 Disclaimer
40. ith the selection keys and LE Press the enter key after every digit 4 Use the selection keys Q and O to select the desired mode Confirm your setting by pressing the enter key PRESSURE only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20 25 in CPAP mode Selection of pressure by the physician NOTICE When the pressure parameter is changed during therapy titration the device adapts to the new setting slowly 25 Pa s This pressure ramp can be deactivated using the TRENDset PC software point 2 CPAP 1 Select the complete menu see page 35 2 Use the selection keys 4 and y to select Press T ShPa 3 Press the the enter key and if necessary input the PIN code with the selection keys and y Press the enter key after every digit 4 Press the enter key and then use the selection keys oO and to set the desired value Confirm your setting by pressing the enter key 42 Device functions point 2 AutoCPAP and point 2 BILEVEL ST20 25 1 Select the complete menu see page 35 2 Use the selection keys 4 and y to select Made 3 Press the the enter key and if necessary input the PIN code with the selection keys and J Press the enter key after every digit 4 Use the selection keys 4 and y to select the CPAF mode 5 Press the selection key D The menu item Press is now displayed 6 Press the enter key and then use the select
41. ld an excessively high pressure occur during the treatment due to a hard ware error or other circumstance the device emits an alarm sound and switches the blower off AERA The alarm is turned off by pressing the ON OFF key WAKE UP ALARM NOTICE Ex factory the alarm clock function is not enabled But it can be unlocked by the physician or dealer with TRENDset PC software If enabled you can activate or deactivate the alarm clock with the selection keys and J Pressing the ON OFF key once mutes the alarm for the next 5 minutes and pressing it twice stops it completely Alarm functions of the device 57 IMPORTANT DISPLAY MESSAGES The most important display messages are listed below All further messages will be clarified from the given context The values shown here are examples III Hach Test mr 642m III Alarm ON III Alarm Clock OFF ITT Wake Alarm 58 Slumber Bok ee 5 ohPa You still have 15 seconds to ensure that the mask is fitted correctly When the time is up the device starts the soft start function or the therapy There are still 8 minutes and 40 seconds until full therapy pressure is reached You have activated the display of the tidal volume as well as the wake up alarm The mask has slipped off your face or a leak that cannot be compensated for has occurred or you have not put the mask on in the Auto OFF or Auto Start automatic modes while the
42. le jT 44 B SODO ND 45 EO AEE E E E E 46 EE 46 B EVAUM 46 Backup te 47 lee ee ee ECH 47 PSMAX 48 ucc H 48 PERIGEE EE ML MP MEL D MEE RE i 48 e 49 AMT AM OM E 50 ED ssrsecenentohatendtudeteattatabentbes atucttatabetdtedatapttadabuadte eege ee beietege 51 Mies 52 AGOMA Tro Aeae 53 Display ME osi a RERBA GERE RR UR RERUM RU rect reer ee 54 srl HNIC 55 seg m P 55 Parameter settings dd d e a e RR daa oe e e FR ER a ada add 56 Alarm functions of the device sssssssssseeeeen menn 57 Mask alali aeann natn lont eld edt 57 Pressu alan aarin ETE 57 Wake Upsalan ii ER 57 Important display messages 58 Une ipsi Eolo UY 60 General information coa aote ta doe eH e o EE ER EE EUR RE Red 60 Irisertinig the SD Card iss kh E CE EXPE LEE Re 60 Se Olne ToD Ci M EE 61 Error Triessdges iei aded RR ER ERR RR RR ERR RR ERE RR RR RR E RR RR RR dd 62 Storage or therapy dataserie eet o n it e e Red 63 Intertial device memo isuna nanan RR CR AR EARLY deegd 63 SDC rl EE 63 Changing the filter deamimg 65 Eileen 66 CISAMING ANG therapy tUe se cete tette nett t neci e eti 66 Cleaning Me s ios PROPRE REPE teste tee RN ES 66 Cleaning the hieadgear sssrinin rte rte 67 er laliate mile eler eu E 67 Preparing the device for a pa
43. ll Face Mask size S 0000 3483 Cirri Comfort Full Face Mask size M 0000 3484 Cirri Comfort Full Face Mask size L 0000 3485 Nasal Pillow 4in1 size XS S M L 0000 3499 SD card formatted with TRENDset 11200010 ComfortTube System heated tubing system 0000 3479 Tube cover sleeve 0000 7161 Humidifier aquapoint 2 0001 2949 Electronics for humidifier aquapoint 2 0001 2286 Accessories 73 Optional Article number Battery pack powerpackpoint 2 0001 2846 AKKUPACK uni BASE Respiratory therapy 0001 1101 filtersystempoint 2 0001 2847 Fine filter for filtersystempoint 2 0000 2109 Coarse filter for filtersystempoint 2 0000 2108 Bacterial filter MEDISIZE BARR VENT S 0000 4932 O2 supply adapter 0000 4943 24 V DC vehicle cable 0000 2295 12 V to 24 V converter 0000 7133 74 Accessories TECHNICAL DATA Dimensions WxDxH Weight Power supply Mains power DC power Battery power per battery Operating time under battery power point 2 CPAP and AutoCPAP point 2 BILEVEL ST20 25 Running reserve of internal clock Pressure range 170 x 220 x 95 mm 180 x 350 x 110 mm approx 1 9 kg without water 1 5 kg 100 240 VAC 50 60Hz 24 V DC max 2 01A 11 1V 2200 mAh gt 8 hours at 10 hPa 12 bpm 500 ml tidal volume gt 7 hours at IPAP 12 hPa EPAP 6 hPa f 2 12 bpm 300 ml tidal volume I E 40 60 96 T mode up to 8 years 4 20 25 hPa mbar Max pressure limit in the lt 30hPa event of a fa
44. n e e Average System Flow o e Base Pressure eo ec Therapy Pressure low resolution no FLEX pressure changes visible Therapy Pressure high resolution FLEX pressure changes visible not saved e saved ee only saved when I FLEX or E FLEX are selected but not active 1 depending on the operating time and number of events 2 when using a 2 GB SD card Storage of therapy data 63 Therapy data Internal device SD card memory Respiratory Flow e Relative Respiratory Volume Q not saved e saved ee only saved when I FLEX or E FLEX are selected but not active point 2 BILEVEL ST20 25 Therapy data Internal device SD card memory Frequency 5 e Mode O e Adjustment e Leakage e Average System Flow e Therapy Pressure low resolution no Bilevel pressure changes visible Therapy Pressure high resolution Bilevel pressure changes visible Respiratory Flow e Relative Respiratory Volume not saved e saved 64 Storage of therapy data CHANGING THE FILTER CLEANING The filter prevents dust insects and airborne particles from entering the device Over time such substances would cause heavy soiling of the ducts inside the device and the blower parts As a result the device would no longer satisfy the hygiene requirements In extreme cases unpleasant odors might result after a while To ensure that the filter remains permeable to air it needs to be cleaned or replaced at certain intervals The
45. ng the enter key Device functions 49 CALIBRATION NOTICE Calibration guarantees an optimum performance of the automatic func tion and mask test It must be performed when e the device is used initially e the mask has been changed e there is a change within the therapy system If a bacterial filter or a humidifier is added removed the calibration has to be redone Ex factory the point 2 is pre calibrated for using with a Cirri Comfort nasal mask size M without humidifier and without bacterial filter Calibration is only possible during mains operation not in battery mode Calibrating the device 1 Connect the mask the therapy tube and if applicable the humidifier or bacterial filter to the device NOTICE Ensure that the air and exhalation openings in the mask are clear and the tube is not kinked Do not put the mask on 2 Press the enter key for 1 second 3 Use the selection keys and y to select Calibration Calibration E t Menu 4 Press the enter key 5 Start appears on the display Press the enter key If you do not press the key within 5 s the display jumps back See point 3 6 The blower starts and calibration begins Calibration active appears on the display Calibration takes 20 70 s The blower switches off after calibration is finished 7 If calibration has been successful SuccessFul appears on the display and if it has failed Failed appears on the di
46. nt 2 BILEVEL ST20 25 Device functions 51 CPAP and APAP modes Pressure hPa The pressure is increased gradually to the prescribed therapy pressure Eod ad a P3 Les 4 1 s 1 Udo 1 1 P 1 ui 1 ji l H I 1 I l l d T T TP Time min 20 30 45 Mask test Prescribed pressure 10hPa Programmed ramp 0 45 min BILEVEL S T and ST modes Pressure hPa The pressures is increased gradually to the prescribed therapy pressures IPAP i i d 1 1 I ih 1 I I I 1 1 I I 1 1 1 gt EPAP i ii I I 1 T Time min 0 10 20 30 45 Mask test Prescribed pressures IPAP 10 hPa EPAP 2 6 hPa Programmed ramp 10 min MASK TEST This ensures that the mask is airtight not only during the slow pressure increase during the soft start ramp but also at higher pressures The mask test can be programmed to last from 5 to 90 seconds in 5 second increments The mask test is performed before the ramp starts and tests the tightness under maxi mum therapy pressure see figures on page 52 Setting the mask test 1 Select the complete menu see page 35 2 Use the selection keys t and J to select Mask Test Mask Test Ap Exit Menu 3 Press the enter key and then use the selection keys t and J to set the seconds Confirm your setting by pressing the enter key 52 Device functions AUTOMATIC The automatic mode has three settings OFF Start Stop Start 1 A
47. oretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic side survey should be considered If the mea sured field strength outside the location in which the point 2 is used exceeds the compliance level the point 2 should be observed to verify normal operation If abnormal performance is observed additional measures my be necessary such as relocating or using another location of the point 2 D Over the frequency range from 150 kHz to 80 MHz the field strength should be lower than 3 V m 80 Manufacturer s declaration on electromagnetic compatibility Recommended separation distances between portable and mobile RF communication equipment and the point 2 The point 2 is intended for use in an electromagnetic environment in which radiated RF distur bances are controlled The user of the point 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the point 2 as recommended below according to the maximum output power of the communications equipment Rated maximum output Separation distance according to frequency power of transmitter W of transmitter m 150 kHz 80 MHz 80MHz 800MHz 800 MHz 2 5 GHz ol e TL SP le 3b ilr ste d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 il ied alil 2 89 10 3 70 3 70 TAS 100 alils illa 23 3 For transmitters rated at a maximum output power not l
48. pears on the display Press the enter key to confirm 4 Filter Counter deleted appears on the display CLEANING THE MASK For hygienic reasons clean the mask every day To do so proceed as follows Disconnect the mask from the therapy tube Clean the mask with mild soapy water Do not use any other agents 4 2 3 Rinse the mask thoroughly with clear water 4 Letthe mask dry completely CLEANING THE THERAPY TUBE For hygienic reasons clean the therapy tube weekly To do this proceed as follows 1 Disconnect the therapy tube from the mask and the device 2 Olean the therapy tube with mild soapy water Do not use any other agents 3 Rinse the therapy tube thoroughly with clear water 4 Letthe vertically suspended therapy tube dry completely CLEANING THE DEVICE Clean the device once a week To do this proceed as follows 1 Unplug the mains plug 2 Wipe the device with a cloth slightly dampened with soapy water 3 Rub the device dry with a cloth ATTENTION Chemical cleaning products or solvents should not be used to clean the surface of the device under any circumstances They might damage the high gloss finish of the device 66 Changing the filter cleaning CLEANING THE HEADGEAR You only need to clean the headgear if it is necessary To do this proceed as follows 1 Remove the headgear from the mask 2 Clean the headgear according to the manufacturer s instructions CLEANING THE HUMIDIFIER
49. pplicable correction factor the device requires a certain amount of time in standby mode We therefore recommend that the device is left in standby mode at least once a month between nightly therapies The zero point correction is particularly recommended if the device is used in a new location e g when travelling or if there are significant temperature fluc tuations in the room For the patient the automatic zero point correction system means that the device is always optimally adjusted leading to even better therapy POWER FAILURE After a power failure during therapy the motor re starts automatically and you will see a message on the display about the power failure and the blower re start NOTICE If you are using the optionally available powerpackpoint 2 the batteries provide the power for the device in the event of a power failure Using the device 31 USING OXYGEN A DANGER If oxygen is using the therapy setting must be set that no backflow of oxygen takes place into the device AWARNING Before using oxygen it is essential to read the safety information on page 14 When supplying oxygen please use a kink resistant tube made of a medically approved material In order to prevent back flow of oxygen into the device we recommend the use of an Oo pessure valve There are two variants to supply oxygen Variant 1 Supplying oxygen directly in the mask fo oP ME f a Mask O source ae O press
50. r when their causes have been eliminated You will find suitable counter measures for some side effects in the section Troubleshooting from page 70 The following side effects may occur during therapy Pain in the nose paranasal sinuses and ears Dryness and irritation in the nose and throat Nose bleeds runny nose sneezing colds Irritated or dry eyes Reddening of the skin swelling of the skin and pressure points in the mask area Difficulty in breathing claustrophobia e Stomach problems caused by air accumulating in the stomach ACAUTION If you experience side effects continuously contact your treating physi cian to clarify the causes Safety Information 17 DEVICE DESCRIPTION OOAONOAARWN Control panel and display Humidifier lock Therapy tube connection Contact socket for humidifier Control panel for humidifier SD card slot Rating plate Air inlet for baro sensor DC power connection RS232 interface Filter or connection port for the filtersystempoint 2 Display ON OFF key Selection keys Enter key 1 18 optional equipment variant for use with humidifier How the device works HOW THE DEVICE WORKS GENERAL The point 2 has an electronically controlled blower to create the air pressure In order to keep imposi tions to the patient at a minimum the blower has been fitted with high power reserve capacity and a rapid control response The po
51. splay 8 In both cases press the enter key NOTICE The old values will be retained if calibration has failed Start calibration again 50 Device functions RAMP After every blower start the device s microcontroller checks whether a soft start ramp has been programmed The soft start function slowly increases the pressure over the time programmed by you starting with a programmable ini tial ramp pressure P Ramp up to the prescribed pressure CPAP P Start APAP or IPAP EPAP BILEVEL S T ST in order to make it easier for you to get to sleep The soft start can bring relief particularly if you are not quite used to the respiratory therapy yet The device offers delay time settings from zero prescribed therapy pressure starts immediately to 45 minutes prescribed therapy pressure is gradually built up within 45 minutes KP RanP 3 5hPa Exit Menu The initial ramp pressure P Ramp can be set between 4 hPa and the pre Scribed pressure Setting the ramp 1 Select the complete menu see page 35 2 Use the selection keys 4 and y to select Ramp Exit Meru 3 Press the enter key and then use the selection keys and J to set the minutes Ramp Confirm your setting by pressing the enter key e 4 Use the selection keys 4 and Y to set the desired value for the initial pressure P Ramp Confirm your setting by pressing the enter key 1 only point 2 AutoCPAP 2 only poi
52. standard filter is only designed to offer a certain level of protection from bac teria and allergens Here we recommend using the optional fi tersystempoint 2 an attachable filter cassette with replaceable filter layers The large filter area means that a much denser filter material can be used here without there being any significant pressure loss When the filter is soiled or the display reads Chanae Filter the filter must be either replaced or rinsed out Changing the filter Pull out the filter on the back of the device and replace it with a new or cleaned one NOTICE Always use the device with the filter element inserted and clean the filter element regularly If the filter element is heavily soiled or not inserted this may damage the device and result in unpleasant odors Cleaning the filter 1 Clean the filter with mild soapy water Do not use any other agents 2 Rinse the filter thoroughly with clear water 3 Let the filter dry completely 4 Insert the cleaned filter into the device If the device is run with the optionally available filtersystempoint 2 according to the cleaning instructions in the filter system user s manual Changing the filter cleaning 65 Resetting the display message 1 Disconnect the DC power supply plug from the device 2 Hold the enter key down and while you are doing this reconnect the DC power supply plug to the device s DC power connection 3 Filter Counter Heset ap
53. the batteries are charged in standby mode The charging process is indicated by a flashing battery sym bol on the display AUTOMATIC ZERO POINT CORRECTION OF PRESSURE SENSOR Automatic zero point correction ensures the uniformly high precision of the pres sure measurements and takes account of aging effects Therefore the electric and electronic components are maintenance free Sensors are normally temperature compensated before being installed in CPAP devices This process requires certain compensation tools which are used solely by trained staff Unfortunately the selected values are not permanent as they vary over time due to aging vibrations or constant changes in climate This means that these values need to be checked for correctness at prolonged intervals and possibly readjusted HOFFRICHTER s technicians have however developed a new method in which the necessary compensation tools are so to speak permanently on board the point 2 It is thus no longer necessary to check measurement accuracy To allow this method to function the point 2 has to be put on standby from time to time Here it is sufficient to run the device in this mode for just a few sec onds before and after each starting up of the blower to allow the software to collect and apply the necessary data We also recommend running the device on standby for a longer period e g for a day once a month 30 Using the device NOTICE In order to determine an a
54. tient CHANGE ee 68 Usingibacterial fIt ES rt b he htt a ttt dad dida 69 6 Contents TROUBIESHOOTING aso dn RR 70 Eeler EE 71 DISPOSAls egene ege er geereegeeEegeeerer 72 Device 72 PRE I e E 72 eege 72 ee 73 TechiriiCal dates eth Pet eda v ab e t Er cer b rau S a o 75 Manufacturer s declaration on electromagnetic compatibility 78 BSc Ella Get ee oe RE DDR RU IR DDR ht eO RORIS 82 Contents 7 SCOPE OF DELIVERY SM SS o XY Respiratory therapy device point 2 Mains cable Power supply Therapy tube ID 22 mm length 1 80 m User s manual Brief instructions Spare filter 2 pack Carrying case Ventilation mask optional with exhalation valve Different of mask systems are available 10 Headgear OMAN OO P ON 1 optional equipment variant for use with humidifier Scope of delivery 9 GENERAL INFORMATION ON THIS USER S MANUAL Read this user s manual through carefully before using your therapy device for the first time Follow the safety and cleaning instructions in particular Keep the manual in a safe place close to the device so that you can refer to it immediately if necessary SYMBOLS USED IN THIS MANUAL Important information is denoted by symbols in this user s manual Be sure to follow these instructions in order to avoid accidents personal injury and mate rial damage In addition the local accident prevention regulations and general safety r
55. ult Power consumption DC power Mains power DC power Mains power Standby battery charging lt 26 W 35W Standby without batteries 3W 5W Operation at 25 hPa 17W 21W lt 39W 48W Operation at 20 hPa 14W lt 17W lt 38 W lt 42 W Operation at 12 hPa lt 10W lt 12 W lt 34 W lt 38 W Operation at 6 hPa 6W lt 9W lt 30W lt 35W Short term pressure variation in hPa 4 8 2 y 29 a 12 16 20 hPa hPa hPa hPa 10 bpm 0 15 0 15 0 17 0 20 15 bpm 0 23 0 24 0 27 0 32 20 bpm 0 36 0 32 0 37 0 43 hPa hPa hPa hPa hPa hPa 0 25 0 16 0 19 0 30 0 40 0 48 0 38 0 24 0 831 0 45 0 58 0 72 0 49 0 32 0 42 0 62 0 70 0 91 at heating level 3 The operating time is depending on the device settings and the age and stage of charge of the batteries point 2 BILEVEL ST25 Technical data 75 Long term pressure variation 0 1 hPa Pressure reading accuracy 0 5hPa Average sound pressure lt 30 dB A at 10hPa level operating at 1 m distance equivalent to a sound power level of 38 dB A Air flow rate point 2 CPAP AutoCPAP BILEVEL ST20 4hPa gt 205 l min gt 172 min 8hPa gt 189 l min gt 163l min 12 hPa gt 179 l min gt 150 l min 16 hPa gt 165 l min 137 l min 20hPa gt 148l min 127 l min Air flow rate point 2 BILEVEL ST25 4hPa gt 205 l min gt 187 l min 10 hPa gt 191 l min 175l min 15hPa 173Vl min gt 158l min 20hPa gt 152 l min gt 141 l min 25 hPa 137 l min gt 124 min
56. ure Variant 2 Supplying oxygen via an adapter between therapy tube and Oo safety valve Mask O source O pressure valve Therapy tube Op supply adapter The Os supply adapter you can order as accessory see page 74 32 Using the device Proceed as follows when using oxygen AWARNING If the device is in standby mode or switched off the oxygen supply must always be switched off 1 Before starting the treatment check that the tube connections are fitted correctly 2 Switch the device on first and then start the oxygen supply 3 Check whether the automatic mode is set to Auto OFF If not program it as described on page 54 4 Switch off the oxygen supply before switching off the device NOTICE Using oxygen influences the therapy pressure Therefore we recommend to inclose oxygen in the therapy pressure determination titration process for every patient who s therapy is intended to include an oxygen supply Using the device 33 DEVICE FUNCTIONS There are three keys for programming point 2 s functions Selection key Y Selection key ei Enter key If the enter key is pressed for a prolonged time you enter the programming mode and the menu appears on the display The device display has two lines By pressing O and GE you can select the top or bottom row A triangle symbol k in front of a row means that this row has been selected Flake Time Exit Menu
57. urther convey the feel ing of natural respiration without any delay BILEVEL S In BILEVEL S the transition from inspiration pressure IPAP to expiration pres sure EPAP is triggered once the patient starts to breath When the inspiration flow ends the pressure drops to the EPAP In addition a backup frequency Backup freq can be activated In the event of an apnea patients ventilation will be continuously restored at fixed parameters e DAP EPAP e Slope E Slope e Backup frequency The parameters will be set by the physician NOTICE During the expiration phase a negative pressure vacuum will not be created Pressure hPa BILEVEL S pe E 20 IPAP EPAP Time Backup f Delay time freq a o Spontaneous breathing 15s 10s IS amp Spontaneous breathing f 341 1288 Total time lag n Backup T mode I Inspiration E Expiration Therapy modes 25 BILEVEL T In contrast to BILEVLE S at BILEVEL T spontanous breating efforts will not be considered Based on fixied preset ventilation parameters IPAP EPAP I Slope E Slope I E ratio and frequency the machine performs a periodic tined mandatory pressure transition The parameters will be set by the physician Pressure hPa BILEVEL T 20 IPAP EPAP Time I Inspiration E Expiration 26 Therapy modes BILEVEL
58. uto OFF with mask alarm kguta c m OFF Exit Menu With the Auto OFF setting you must switch the device on with the ON OFF key when therapy starts and off with the same key when therapy ends Should the mask slip from your face or should a leak occur that cannot be compensated for you will be given an acoustic and visual warning Mask Alarm Check Mask Auto Start Stop Auto Start Stop Exit Menu With the Auto Start Stop setting you only have to put the mask on Put on Mask fo Has 11 As soon as you begin breathing the point 2 blower switches on When you take the mask off the blower switches off automatically after a 5 sec ond delay The blower also switches off when the mask slips off your face or a leak that cannot be compensated for occurs Auto Start with mask alarm Auto Start t Meru With the Auto Start setting you only have to put the mask on As soon as you begin breathing the point 2 blower switches on If you take the mask off or the mask slips off your face or a leak occurs which cannot be compensated for the blower does not switch off but you receive an acoustic and visual warning Mask Alarm Check Mask The blower can only be switched off by pressing the ON OFF key Device functions 53 Setting automatic mode 1 Select the complete menu see page 35 2 Use the selection keys 4 and y to select Auta 3 Press the enter key to set the desired
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