point re-eng-0910-06.indd
Contents
1. D 1 17 yP for V4 3V 70 Manufacturer s Declaration on Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic immunity Radiated RF E 8 V m 3 V m 1 17 61000 4 3 80 MHz 2 5 GHz 80 MHz 800 MHz d 2 33 P 800 MHz 2 5 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site sur vey 3 should be less than the compliance level in each fre quency range Interference may occur in the vicinity of equip ment marked with the follow ing symbol gt 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 telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic side survey should be considered If the measured field strength outside the location in which the point is used exceeds the compliance level the point 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 b Over the frequen2. A and Confirm your setting by pressing 46 Device Functions Mask Test Exit Menu 285 OFF Exit Menu Mask Alarm 16s Check Mask Auto Start Stop Exit Menu Auto Start Exit Menu AUTOMATIC The automatic mode has three settings OFF Start Stop Start 1 Auto OFF with mask alarm 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 Auto Start Stop With the Auto Start Stop setting you only have to put the mask on As soon as you begin breathing pow erfully the point turbine switches on If you take the mask off the turbine switches off automatically after a 5 second delay The turbine also switches off if the mask slips off your face or a leak that cannot be compensated for occurs Auto Start with mask alarm With the Auto Start setting you only have to put the mask on As soon as you begin breathing powerfully the point turbine switches on If you take the mask off or the mask slips off your face or a leak occurs which cannot be compensated Device Functions 47 for the turbine does not switch off but you receive Hask Alarm an acoustic and visual warning The turbine can Check Mask only be switched off by pressing the ON OFF
3. have read the powerpackpoint user s manual How the Device Works 23 DESCRIPTION OF THE DEVICE Keyboard and display Therapy tube connection Cover of contact sockets for humidifier Rating plate Pressure balance aperture grid cov ered pressure aperture Power socket RS232 interface Filter or connection port for the filtersystempoint 9 Display 10 ON OFF key 11 Programing keys 12 Enter key CON 24 How the Device Works USING THE DEVICE COMMISSIONING CAUTION Before commissioning the device read the section Safety Information from page 11 The device must not be operated without a filter because this could damage your health 1 Set the device up according to the installation instructions see page 15 2 Connect the power supply to the device 3 Connect the mains cable to the power supply and plug into a power socket 4 The device starts up and displays a welcome text the software version and the current number of therapy hours and then switches to the date and time display 5 Connect the therapy tube 8 to the air outlet and b to the mask 6 Calibrate the device as described in the section Calibration on page 42 Using the Device 25 7 Put the mask on If automatic mode has been selected the device is turned on by the patient breathing powerfully In manual mode press the ON OFF key to start the device 8 The device first
4. message that you will be woken up at 7 a m In normal mode you have pressed W and receive the message that the alarm clock has now been switched off 50 Device Functions 8 5hPa Mask Test 135 5 5 Ramp 5 48 Mask Alarm 185 Check Mask 8 5hPa Alarm 7 08 8 ShPa Alarm Clock OFF Press ON OFF Wake Alarm 87 88 Press ON OFF Slumber 1 18 Press ON OFF Wake Alarm OFF 3 BhPa 3 FILTERe 22 15 Power Failure Restart Turbine The wake up alarm has been triggered Press the ON OFF key 1x to start the slumber phase Press it once more to switch the alarm clock off permanently You still have 1 min and 18 s until the alarm clock will wake you up again You have pressed the ON OFF key and ended the slumber phase The filter must be changed see page 54 To reset the message hold the Enter key down and while you are doing this insert the power supply plug into the device s mains socket After the mains voltage is restored the turbine re starts automatically Device Functions 51 ALARM FUNCTIONS OF 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 The mask alarm is only active in the Auto OFF and Auto Start automatic modes Testing the mask alarm Start the device
5. 0 22 hPa 0 42 hPa at heating level 3 15bpm 0 34 hPa 0 76 hPa at heating level 3 20 bpm 0 52 hPa 0 92 hPa at heating level 3 Long term pressure variation 0 2hPa 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 lt 38 dB A Air flow rate at 4 hPa gt 165 l min at 8hPa gt 155 min at 12hPa gt 145 l min at 16hPa gt 125 l min at 20 hPa gt 115 Operating temperature 5 C 40 C Storage temperature 20 C 70 C Therapy air heating lt 3K depending on the heating level and the ambient conditions 66 Technical Data Relative humidity 10 95 for operation and storage Operating conditions 1060 hPa 700 hPa ca 400 m 3500 m Filter Polyurethane foam on polyester base 80 ppi 30 kg m3 Therapy tube connection 22 mm cone as per ISO 5356 1 Product class according to lla 93 42 EEC Classification according to Protection class II EN 60601 1 CE marking as per EC directive 93 42 EEC The manufacturer reserves the right to make technical changes without notice Technical Data 67 MANUFACTURER S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer s declaration electromagnetic emissions The point is intended for use in the electromagnetic environment specified below The user of the point should assure that it is used in such an environment Emissions test Compliance Electromag
6. display There are two ways to switch the alarm off 1 By pressing the ON OFF key the device switches to slumber mode After 5 minutes you are woken again To stop slumber mode prematurely press the ON OFF key 2 Press to unset the alarm Setting the wake up time 1 Press 2 Press and V to select lake Time 3 Press and set the hour by pressing and V Confirm your setting by pressing 4 Press A and V to set the minutes Confirm your setting by pressing 40 Device Functions tlake Time 67 06 Exit Menu Press ON OFF fo May 89 12 20 Press ON OFF Slumber 4 45 Press 7 5hpa PRESSURE Exit Menu The therapy pressure setting is PIN code secured Settings may only be performed by physicians and qualified personnel A CAUTION Please do not try to crack the PIN code Speak to your physician if you doubt the correctness of the pressure prescription Setting the pressure by the physician 1 Select the complete menu see page 33 2 Press A and V to select Press 3 Press and set the PIN code with A and V Press after each digit 4 Press A and V to select the required therapy pressure Confirm the setting by pressing Device Functions 41 CALIBRATION Calibration IMPORTANT Exit Meru Calibration guarantees optimum operation of the automatic function and the mask test It must be performed when e the device is used initially e the mask is changed or e the hum
7. even better therapy POWER FAILURE After power failure recovery the motor re starts auto matically and you will see a message on the display about the power failure and the turbine re start IMPORTANT If you are using the optionally available powerpackpoint the batteries provide the power for the device in the event of a power failure Using the Device 29 USING OXYGEN AWARNING 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 do not handle naked flames Please be sure to observe the user s manual of the manufacturer or distributor from whom you obtain the oxygen Have your distributor advise you about the use of oxygen In any case follow your physician s instructions When feeding oxygen directly into the mask please use a kink resistant tube made of a medically approved material Oxygen can also be fed in via an adapter fitted onto the air outlet 30 Using the Device Adapter Proceed as follows when using oxygen A WARNING 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 First of all switch the device on and then the oxygen supply 3 Check whether the Auto off automatic mode is active If not program it as d
8. in Auto OFF mode The mask should not be on the face It has to be laid motionless on a surface Ensure that the inside is exposed After a short time an acoustic signal sounds PRESSURE ALARM Should an excessively high pressure occur during the treatment due to a hardware error or other circum stance the device emits an alarm sound and switches the turbine off The alarm is turned off by pressing the ON OFF key 52 Alarm Functions of Device Mask Alarm Check Mask Press too hish 25 139 493 11 45 WAKE UP ALARM The device has an integrated alarm clock You can set or unset it at any time with the programing keys The alarm clock sets off an alarm at the programed wake up time Pressing the ON OFF key once mutes the alarm for the next 5 minutes and pressing it twice stops it completely Alarm Functions of Device 53 CHANGING THE FILTER CLEANING AWARNING Make sure that you follow the cleaning instruc tions If you do not do this it could damage your health because of germs CHANGING AND CLEANING THE FILTER CAUTION If the filter is dirty or fa gt FILTER message appears on the display the filter must be replaced or washed out Changing the filter Pull out the filter from the back of the device and replace it with a new one or a cleaned one 54 Changing the Filter Cleaning m F ILTER Seale Removing the filter Cleaning the filter 1 2
9. key i Setting automatic mode 1 Select the complete menu see page 33 2 Press A and V to select Auta 3 Press to set the required automatic mode The device can be switched on or off in any operating mode by pressing the ON OFF key 48 Device Functions Er ishtness 106 Exit Menu BRIGHTNESS You can set the brightness of the display from 0 to 100 The value set determines the brightness of the dis play that appears 30 seconds after the last key was pressed When a key is pressed the display bright ness is always 100 Setting the brightness 1 Select the complete menu see page 33 2 Press A and V to select Brightness 3 Press and set the required brightness by pressing and V 4 Confirm your setting by pressing Device Functions 49 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 You still have 15 seconds to ensure that the mask is fitted correctly When the time is up the device starts with the soft start function or the therapy There are still 8 minutes and 40 seconds until full therapy pressure is reached The mask has slipped off your face or a leak that can not be compensated for has occurred or you have not put the mask on in the Auto OFF or Auto Start auto matic modes and when the blower is running In normal mode you have pressed A and get the
10. s Declaration on Electromagnetic C mpatipilty 68 Disclaimer 2 dinh ssh Scho 73 Contents 5 SCOPE OF DELIVERY SS RUN ZI point respiratory therapy device Mains cable approx 2 30 m Power supply cable approx 1 93 m Therapy tube 1 80 m Ventilation mask optional with exhalation valve Different sorts of mask systems are available Headgear User s manual Brief instruction Spare filter 2 pack O Carrying case 0 0NO 6 Scope of Delivery GENERAL INFORMATION ON 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 General 7 SYMBOLS USED IN THIS USER S 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 regulations in force in the area of use must be observed 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
11. 1 kV input output 1kV differential mode not applicable gt 95 dip in U 0 5 cycles 60 dip in U 5 cycles 30 dip in U 25 cycles gt 95 dip inU 5s Electromagnetic environment guidance Floors should be wood con crete or ceramic tile If floors are covered with synthetic material the relative humid ity should be at least 3096 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 commercial or hospital environment If the user of the point requires con tinued operation during power mains interruption it is recom mended that the Equipment or System is powered from an UPS or a battery Manufacturer s Declaration on Electromagnetic Compatibility 69 Guidance and manufacturer s declaration electromagnetic immunity Magnetic field power 3 A m 3 A m Power frequency magnetic frequency 50 60 Hz fields should be at levels char magnetic field acteristic of a typical location IEC 61000 4 8 in a typical commercial or hospital environment Conducted RF V 3V 3V Portable and mobile commu IEC 61000 4 6 150 kHz 80 MHz nications equipment should be used no closer to any part of the point including cables than the recommended sep aration distance calculated from the equation applicable to the frequency of the trans mitter
12. 10 min increments P Ramp 4 20hPa in 0 5 hPa increments Mask Test 0 90s in 5s increments Auto OFF Start Stop Start Brightness 0 100 in 10 increments 34 Device Functions Standard menu Selection options Calibration Date Day Month Year Time Hour minute Wake up time Hour minute IMPORTANT If during programing you have not pressed a key for 30 seconds the standard 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 Device Functions 35 PANE ae Lansuase ENG The device can display messages in German DEU Exit Menu English ENG Greek ELL Spanish SPA French FRA Italian ITA Dutch NLD Turkish TUR Polish PLK and Portuguese POR Other languages can be implemented Setting the language 1 Select the complete menu see page 33 2 Press A and V to select Language Set the desired language by pressing 36 Device Functions MOperation 208h Exit Menu OPERATING TIMES Under this menu item you will find the total operating time including standby mode of the device the tur bine running time the operating time of the filter and the therapy time Calling up the device operating times 1 Select the complete menu see page 33 2 Press A and V to select Operation The total operating time including standby appears
13. 3 4 5 Pull out the filter from the back of the device Clean the filter with mild soapy water Do not use any other agents Rinse the filter thoroughly with clear water Let the filter dry completely in the air Replace the filter If the device is run with the optionally available filtersystempoint proceed according to the cleaning instructions in the filter system user s manual Resetting the display message 1 2 Unplug the power supply plug from the device Hold down and at the same time insert the power supply plug into the mains socket of the device Filter Counter Reset appears on the dis play Press Filter Counter deleted appears on the display Changing the Filter Cleaning 55 CLEANING THE MASK For hygienic reasons clean the mask every day To do so proceed as follows 1 Disconnect the mask from the therapy tube 2 Clean the mask with mild soapy water Do not use any other agents 3 Rinse the mask thoroughly with clear water 4 Let the mask dry completely in the air CLEANING THE THERAPY TUBE For hygienic reasons clean the therapy tube every day To do this proceed as follows 1 Disconnect the therapy tube from the mask and the device 2 Clean the therapy tube with mild soapy water Do not use any other agents 3 Rinse the therapy tube thoroughly with clear water 4 Let the therapy tube dry completely in the air 56 Changing the Filter Cleaning CLEANING THE DEV
14. 3 Press and the running time of the turbine appears 4 Press again and the operating time of the filter appears 5 Press again and the therapy time appears Device Functions 37 Sale Date 25 Mas 89 The day 1 31 the month Jan Dec and the year Exit Menu 00 99 can be set Setting the date 1 Press 2 Press A and V to select Date 3 Press and set the year by pressing and VW Confirm your setting by pressing 4 Press A and V to set the month Confirm your setting by pressing 5 Press A and V to set the day Confirm your setting by pressing 38 Device Functions Time 13 08 Exit Menu TIME The device has an internal clock In the event of a power failure the clock operates on inbuilt battery power The hour 00 24 and minutes 00 59 can be set The clock is used to give the correct date and the right alarm function Setting the time 1 Press 2 Press A and V to select Timme 3 Press and set the hour by pressing V Confirm your setting by pressing 4 Press A and V to set the minutes Confirm your setting by pressing Device Functions 39 WAKE UP TIME The wake up time is the time when the device sounds an alarm if the alarm is set To set the alarm press A For checking purposes the programed wake up time is displayed for a short time To unset the alarm press If the alarm is set a bell symbol appears before the time on the
15. C PRESSURE SENSOR ZERO POINT CALIBRATION The automatic zero point calibration system sets the pressure sensor to the zero point 0 hPa depending on the ambient temperature The pressure sensor in the device is already precisely calibrated at the factory In order to guarantee increased pressure accuracy when used with patients the device has an automatic zero point calibration system This zero point calibration system is necessary because pressure sensors are prone to measuring errors caused by the physical environment In practice the device con tinually measures the ambient temperature and deter mines a correction factor that is used as a basis for the pressure sensor s zero point calibration system This also takes into consideration the ageing effect on the pressure sensor and on other electronic components IMPORTANT order determine applicable correction factor the device requires a certain amount of time in standby mode We therefore recommend that the device is operated in standby mode at least once a month between nightly therapies 28 Using the Device Power Failure Restart Turbine The zero point calibration system is particularly recom mended if the device is used in a new location e Q when travelling or if there are significant temperature fluctuations in the room For the patient the automatic zero point calibration sys tem means that the device is always optimally adjusted leading to
16. HOFFRICHTER Quality makes the Difference m m m m User s Manual CPAP Respiratory Therapy Device as of device software 2 120 SERIAL NUMBER Every HOFFRICHTER GmbH device is supplied with a serial number for traceability 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 ELE Please always quote the serial number for all queries and complaints CONFORMITY C The device complies with the requirements of Directive 93 42 EEC 2 Info CONTENTS SCOPE OF DeliVerys ntc been 6 Ce keep en 7 Information on User s 7 Symbols used in this User s Manual 8 Symbols on the Rating Plate 10 Safety Inforrmatior deerit cet teniente 11 General Safety Instructions 11 Electrieal Safety ct ed en a 13 Installation Requirements and Transport 15 Instructions before Commissioning 17 Intended JS 18 Cornitrairidieations 19 Side edi ete edt et 20 How the Device 21 CCEE aano 21 Power Supply 22 Description of the Device 24 Using the DEVICE erriei nn 25 Commissioning EET 25
17. ICE For hygiene reasons 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 IMPORTANT Chemical or thermal disinfecting of the device or the device parts by the user is not necessary Changing the Filter Cleaning 57 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 AWARNING When using a humidifier the cleaning instructions in the user s manual must be observed 58 Changing the Filter Cleaning TROUBLESHOOTING Pain in the nose the paranasal sinuses or the ears Unpleasant feeling because of the high pressure Dryness and irritation in the nose and throat Original symptoms of sleep apnea come back Irritated or dry eyes Cold nose Inflammation of the para nasal sinuses or the middle ear Malaise with prescribed high pressure values Stop the treatment and contact your physician If you suspect an error please ask your physician for help Acclimatisation phase to the Try to relax Use or vary the pressure not yet completed Air is too dry Physical condition or life circumstances have changed Device error Air escapes between the mask and t
18. Turning and off in Battery 27 Standby 27 Automatic pressure sensor zero point he tS 28 Contents 3 Power Fallu re x 22202 na 29 Using Oxygaen cec e e rin ih 30 Device FUNCU N S s e e din 32 Languages ott ted bed beu 36 Operating TIMES aia d d a d d 37 Date imi E d 38 Messern ln 39 Wake up Times ios onde edid Ban 40 Pressure octies stai ste aepo o Ens 41 Calibration sn nn ptit pires 42 pino 44 MIELE an sn 46 AUTOMATIC ee en 47 BEIONEMESS s costo 49 Display Messages 50 Alarm Functions of 52 Mask Alain ee eben 52 Pressure Alarm anne ee 52 Wake up e 53 Changing the Filter 54 Changing and Cleaning the Filter 54 Gleaning the ttt ens 56 Cleaning the Therapy 56 Gleaning th Devices iet delen 57 4 Contents Cleaning the Ten e a 58 Cleaning the Humidifier 58 TVOUBIESHOOLING satiate atest 59 Maintenance itise ia a 61 Preparing the Device when Changing Patient 62 DISDOSAl re ee 63 ER 63 Packaging a 63 Accessories edt ee te tete 64 te 65 Manufacturer
19. cy range from 150 kHz to 80 MHz the field strength should be lower than 3 V m Manufacturer s Declaration on Electromagnetic Compatibility 71 Recommended separation distances between portable mobile communication equipment and the point The point is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The user of the point can help prevent electromagnetic interference by maintaining a mini mum distance between portable and mobile RF communications equipment transmitters and the point as recommended below according to the maximum output power of the communications equipment Rated maximum output power Separation distance according to frequency of transmitter W of transmitter m 150 kHz 80 MHz 800 MHz 80 MHz 800 MHz 2 5 GHz de 3 3 se 1 17 NP 2 8942 0 01 0 12 0 12 0 23 1 0 37 0 37 0 74 1 1 17 2 33 10 3 70 3 70 7 37 100 Tab 23 3 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equation applicable to the frequency of the trans mitter 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 fro
20. e respiratory therapy The device enables delay time settings from zero pre scribed therapy pressure starts immediately to 30 min utes prescribed therapy pressure is built up gradually within 30 minutes The initial ramp pressure P Ramp can be set between 4 hPa and the prescribed pressure Setting the ramp 1 Select the complete menu see page 33 2 Press A and V to select Rarnp 3 Press and set the minutes ramp by pressing A and VW Confirm your setting by pressing 4 Press A and V to set the initial pressure P Ramp Confirm your setting by pressing 44 Device Functions Exit Menu KF Rarp 3 5 hPa Exit Menu Prescribed pressure 10 hPa mbar Pressure in hPa dus 4 The pressure is increased gradually to the prescribed therapy pressure 10 j 1 a I 1 1 8 0 905 7 i gt 1 1 6 1 1 1 4 gt 0 10 20 30 Time in min Mask test Programed soft start 0 30 min Device Functions 45 MASK TEST This ensures that the mask is impermeable during the slow pressure increase in the soft start ramp and also at higher pressures A mask test can be programed from 5 90 seconds in 5 second increments This mask test is performed before the ramp starts and tests the impermeability under maximum therapy pressure Setting the mask test 1 Select the complete menu see page 33 2 Press A and V to select Mask Test 3 Press and set the seconds by pressing
21. escribed on page 48 4 Switch off the oxygen supply before switching the device off Using the Device 31 DEVICE FUNCTIONS There are three keys for programing the point s functions A Programing key Programing key Enter key CPAP HOFFRICHTER If the Enter key is pressed for a prolonged time you return to programing mode and the menu appears on the display 32 Device Functions blake Time 87 66 Exit Menu Example Wake up time The display has two rows If you press and V you can select the top or bottom row A triangle symbol k in front of a row means that this row has been selected The point has two different menus e Standard menu e Complete menu To switch between the menus first of all press Then hold A and W down at the same time for a prolonged period The display shows the message Standarcd Tlenu active or Complete Heny active Device Functions 33 You reach the menu items in the menus by press ing amp The order of the menu items is shown in the following two tables Complete menu Selection options Display Language DEU ENG ELL SPA FRA ITA NLD TUR PLK POR Operating times Time display in hours Turbine Time display in hours Filter Time display in hours Therapy Time display in hours Date Day Month Year Time Hour minute Wake up time Hour minute Pressure 4 20hPa in 0 5 hPa increments PIN protected Calibration Ramp 0 30 min in
22. he skin of the face Room temperature too low Soft start function Device probably does not have an air humidifier Speak to your physician about retrofitting an aquapoint humidifier Inform your physician Have the device checked by customer services Check the positioning of the mask Replace the mask if the material has become chapped Increase room temperature Warm up the tube under the pillow Troubleshooting 59 Runny nose sneezing Reddening of the skin in the mask area skin swelling Feeling that the air is too hot No air flow Very little air flow Blower is running con stantly at maximum speed 60 Troubleshooting Reaction to the air flow Normal cold Incorrect mask size Headgear too tight Allergic reaction Filter dirty Air inlet blocked Heater close to the device Device is defective Soft start function has been selected Air channels are blocked Leak in the device Either increase the humidity in the room or the temperature of the humidifier Contact your physician Inform your physician Loosen the headgear Inform your physician Change the filter Change the position of the device Keep the air inlet clear 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 CAUTION Do not try to open the device Maintenance repairs may only be pe
23. idifier is re connected Calibration is only possible when operated at mains supply and not in battery mode Calibrating the device 1 Connect the mask the therapy tube and if necessary the humidifier to the device IMPORTANT Ensure that the air and exhalation apertures in the mask are clear and the tube is not kinked Do not put the mask on 2 Press 3 Press A and V to select Calibration 4 Press 5 Start appears on the display Press If you gt 2 Device Functions 8 do not press the key within 5s the display jumps back see point 2 The turbine starts and calibration begins Cali bration active appears on the display Cali bration takes 20 70s The turbine switches off when calibration is finished If calibration has been successful Successful appears on the display and if it has failed Failed appears on the display In both cases press IMPORTANT The old values will be retained if calibration has failed Start calibration again Device Functions 43 RAMP After every turbine start the device s microcontroller checks whether a soft start ramp has been programed The soft start function slowly increases the pressure in the time programed by you starting with a programable initial ramp pressure P ramp up to the prescribed pres sure in order to make it easier for you to get to sleep The soft start can bring relief particularly if you are not yet quite used to th
24. ilter 00002110 Spare filter 2 pack 0000 7801 Power supply cable approx 1 93 m 0000 2021 Therapy tube 1 80 m 0000 7875 User s manual 5000 0280 Brief instruction 5000 0289 Optional Article number Respiratory mask with exhalation valve Different mask systems are available aquapoint humidifier incl electronics 0000 7945 aquapoint humidifier without electronics 0000 7949 powerpackpoint battery pack 0000 7846 filtersystempoint 0000 7847 Fine filter filtersystempoint 0000 2109 Coarse filter filtersystempoint 0000 2108 24 V DC vehicle cable 0000 2295 12V to 24V converter 0000 7133 64 Accessories TECHNICAL DATA 170 x 220 x 95 mm 1 42 kg Dimensions W x D x H Weight 180 x 350 x 110 mm approx 1 7 kg without water Power supply Mains power DC power 24 VDC 2 1A 11 1V 2150mAh Up to 8 hours Battery power per battery Operating time under battery power Running reserve of internal clock Up to 8 years Pressure range 4 20 hPa mbar Max limit pressure in the 30 hPa event of a fault Power consumption DC power Mains power DC power Standby battery charging 26W 35W Standby without battery pack lt 3W 5W Operation at 20 hPa lt 14W lt 17W lt 38W Operation at 12hPa lt 10W lt 12W lt 34W Operation at 6hPa lt 6W lt 9W lt 30W 100 240 VAC 50 60 Hz Mains power Technical Data 65 Short term pressure variation 4hPa 8hPa 12hPa 16hPa 20hPa 4hPa 8hPa 12hPa16hPa 20hPa 10bpm
25. iratory air humidifier may be nec How the Device Works 21 essary in conjunction with a CPAP treatment The plug in aquapoint humidifier is available as an accessory to humidify respiratory air You will find more information on the humidifier in the aquapoint user s manual or contact your specialist dealer POWER SUPPLY The point s power can be supplied from 3 sources 1 An external switching power supply included in the scope of delivery 2 DC vehicle cable optional 3 powerpackpoint battery pack optional External switching power supply For mains operation the point has an external switching power supply with a wide input range of 100 240 V alter nating current AC 50 60 Hz Thus it is possible to connect it to an energy supply anywhere in the world 22 How the Device Works DC vehicle cable For mobile use of the point e g in a truck or a car avan it is possible to operate it with a 24 V direct current DC For this you will need the optionally available DC vehicle cable A WARNING Only use the optional DC vehicle cable to con nect the device to a DC power supply and do not connect the device to a PC while it is being used Battery pack To use it when travelling and if the power fails the point can be operated with the optionally available powerpackpoint battery pack With the battery pack you can use the device for up to 8 hours NOTICE Before using the battery pack ensure that you
26. m structures objects and people 72 Manufacturer s Declaration on Electromagnetic Compatibility DISCLAIMER HOFFRICHTER GmbH is not liable for consequences in terms of safety reliability and performance of the product where e interventions modifications extensions calibration repairs and maintenance 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 hygiene and cleaning instructions described in the user s manual have not been complied with Statutory guarantee rights remain unaffected by this Disclaimer 73 Notes 75 HOFFRICHTER GmbH Mettenheimer Strasse 12 14 19061 Schwerin Germany Phone 49 385 39925 0 Fax 49 385 39925 25 E mail info hoffrichter de www hoffrichter de point re eng 0910 06 Art no 5000 0280
27. manufacturer s instructions Safety Information 11 Do not wear the mask if the therapy device is switched off because this could lead breathing air that has already been exhaled Observe the respiratory mask manufacturer s instructions Always ensure that the small aperture in the mask or the connecting piece between the mask and the tube is clear so that the CO2 laden exhaled air can escape If you are using oxygen with the CPAP therapy observe all fire protection and safety regulations for using oxygen Unless specified otherwise the mask and therapy tube must only be used by one patient 12 Safety Information Please see your physician immedi ately if dryness of the mucous mem branes in the nose and throat sinus discomfort ear ache runny nose over sensitive reactions of the skin irritability loss of voice orientation or memory impairment occur when using the device Inform your specialist dealer imme diately if the device is not working properly Check the device s alarm functions regularly see page 52 ELECTRICAL SAFETY Do not use the device if the housing or the cable of the device the power supply are damaged Do not open the device housing under any circumstances Inform your spe cialist dealer if the device develops a fault Safety Information 13 The use of accessories or power supplies approved by us for the device may lead to increased emis
28. netic environment guidance RF emissions CISPR 11 Group 1 The point 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 electronic equipment RF emissions CISPR 11 Class B The point is suitable in all establishments knee enses Gras A including domestic establishments and those directly connected to the public low IEC 61000 3 2 voltage power supply network that sup Voltage fluctuations flicker Complies plies buildings used for domestic purposes emissions IEC 61000 3 3 68 Manufacturer s Declaration on Electromagnetic Compatibility Guidance and manufacturer s declaration electromagnetic immunity The point is intended for use in the electromagnetic environment specified below The user of the point should assure that it is used in such an environment Immunity test Electrostatic discharge ESD IEC 61000 4 2 Electrical fast transient Burst IEC 61000 4 4 Surges IEC 61000 4 5 Voltage dips short interruptions and volt age variations on power supply input lines IEC 61000 4 11 IEC 60601 Test level 6 kV contact 8 kV air 2 kV power supply lines 1 kV input output 1kV differential mode 2kV common mode gt 95 dip in U 0 5 cycles 60 dip in U 5 cycles 30 Dip in U 25 cycles gt 95 dip in U 5s Compliance level x 6 kV contact x 8 kV air 2kV power supply lines
29. of all runs for the time selected by you for the mask test and at the prescribed pres sure You should now ensure that the mask is fit ted correctly to ensure that it does not leak 9 Place the tube in such a way that it does not exert any strain on the mask when you lie down 10 Now breath deeply and calmly still just through your nose If the soft start function has been selected the device first of all reduces its pressure after the mask test has been performed and then increases it automatically gradually up to the prescribed value while you can go to sleep under reduced pressure IMPORTANT In the section Device Functions from page 32 read how you can adapt the times for soft start and the mask test to suit your personal requirements 26 Using the Device TURNING ON AND OFF IN BATTERY MODE If the device is powered by the optionally available powerpackpoint press the ON OFF key to switch it on To switch the device off press and hold the ON OFF key for more than 3 seconds IMPORTANT In standby mode the device automatically switches itself off after 1 min STANDBY MODE If the turbine is switched off the device switches to standby mode discernable on the lit display with date and time The point can be kept in standby mode permanently This does not harm it If the powerpackpoint battery pack is fitted on the device the batteries are charged in standby mode Using the Device 27 AUTOMATI
30. of the skin swelling of the skin and pressure points in the mask area Difficulty breathing claustrophobia e Stomach problems because of air accumulating in the stomach A CAUTION Please contact your physician for an explanation of the causes should these complaints persist 20 Safety Information Air inlet Filter Blower Pressure _ sensor L Internal pres sure measur ing tube Air outlet HOW THE DEVICE WORKS GENERAL The point is a CPAP therapy device to treat obstruc tive sleep apnea The point has an electronically controlled blower to create the pressure In order to make things as easy as possible for the patient the blower has been fitted with high levels of power reserves and a rapid control response The air ducts for respiratory air patient and convec tion air electronics are separate in the point The point has an inbuilt microcontroller to control all functions An integrated quartz alarm clock increases the comfort level when using the device Further com fort functions include a soft start ramp function auto matic start stop function and the adjustable display brightness When air goes through the device it is warmed slightly It therefore has a higher water absorption capacity The mucous membranes in the mouth and nose can dry out particularly in winter when the ambient air is dry This is unpleasant and in some cases may also lead to infec tions Therefore a resp
31. r equipment such as defibrillators diathermy units mobile phones microwaves remote controlled toys etc Electromag netic fields that exceed 3 V m may adversely affect the operation of the point When used as a mobile unit it must also be placed on a level firm surface that has a raised edge so that the device cannot fall During mobile use of the device only operate it when the vehicle is stationary 16 Safety Information INSTRUCTIONS BEFORE COMMISSIONING Do not switch the device on if it has previously been in a very cold envi ronment Wait about 1 hour until the temperature has balanced out Check the air filter regularly Clean the filter regularly as described on page 55 Never use the device without the air filter Clean your mask system regularly and check all accessories particularly the therapy tube mask and head gear When doing this observe the manufacturer s safety and cleaning instructions Safety Information 17 INTENDED USE The point is used to treat obstructive sleep apnea in patients weighing more than 30 kg The device creates continuous positive airway pres sure to keep the upper respiratory tracts open The device is not suitable for use with patients under going artificial respiration A DANGER This therapy device is not a life supporting system The therapy pressure is administered via a breathing mask which must be fitted with an exhalation valve to ensure
32. rformed 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 54 e Check the system regularly Conduct a visual check for external damage and dirt Check the mask alarm function once a week see page 52 Maintenance 61 PREPARING THE DEVICE WHEN CHANGING PATIENT CAUTION If the device is to be used for another patient it must first of all be prepared hygienically When being given to another patient the device must be prepared hygienically 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 special ist dealer or the manufacturer The preparation procedure is described in detail in the corresponding hygiene plan 62 Maintenance 2 DISPOSAL DEVICE The device must not be disposed of with the house hold waste Please contact the relevant customer services depart ment to find out how to dispose of the device etc properly Proper disposal saves natural resources and prevents harmful substances being released into the environment PACKAGING The packaging is taken back by the distributor but it can alternatively be disposed of separately in the normal household waste Disposal 63 ACCESSORIES Scope of delivery Carrying case 00002111 Mains cable approx 2 30 m 31100012 F
33. sion of electromagnetic radiation or reduced resistence to interference Protect the device from water and dampness Never operate the device in damp places or in a bathroom Do not put any containers full of liquid on the device Do not reach for the device under any circumstances should it fall into water Do not put the device near water containers baths Always unplug it from the mains before cleaning 14 Safety Information INSTALLATION REQUIREMENTS AND TRANSPORT Place the device near the bed Ideally a firm level surface on your bedside cabinet is suitable Never put the device cupboard shelf or under the bed Do not put the device with its back to a wall Ensure that the filter sys tem and the grid covered pressure aperture are not covered Ensure that the device is in a hori zontal position especially if it is con nected to a humidifier Ensure that the air can circulate prop erly round the device Air circulation particularly under and behind the device must not be obstructed by furniture curtains or cushions Do not put the device close to a source of heat Safety Information 15 Place the device in such a way that the mains plug is easily accessible so that it unplugged quickly in the event of a hazard Place the device and accessories in such a position that they are not exposed to direct sunlight The device must never be put near other devices o
34. situations that may lead to serious injuries or death 8 General ACAUTION This symbol denotes hazardous situations that may lead to moderately severe injuries NOTICE This symbol denotes situations that may lead to material damage damage the device IMPORTANT This symbol denotes information tips and instruc tions for the efficient error free use of the device General 9 SYMBOLS ON THE RATING PLATE Observe the warning and safety instruc tions in the user s manual BF application part Protection class II protective insulation CE conformity declaration Manufacturer Follow the user s manual Do not dispose of the device in the house hold waste Please contact the relevant cus tomer services department to find out how to dispose of the device properly lt GE ORD 10 General SAFETY INFORMATION GENERAL SAFETY INSTRUCTIONS Only use the device 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 masks that have been prescribed for your treatment by a physician Only use the mask together with a respiratory therapy device and when the device is switched on Only use the mask after instruction by a qualified medical person clarify in particular the intake of medicines and possible contraindications and side effects associated with the use of the mask Observe the mask
35. that the exhaled air is discharged NOTICE If aquapoint humidifier is connected the device the water in the humidifier must not contain any additives such as medicines salts aromatic oils or other substances 18 Safety Information CONTRAINDICATIONS AWARNING Respiratory therapy may be contraindicated for certain pre existing conditions Therefore always talk to the physician treating you before starting the therapy 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 Safety Information 19 SIDE EFFECTS There is the possibility of undesirable side effects occur ring with respiratory therapy Reasons for side effects occurring could be unsuitable therapy settings not using the device properly or not following the clean ing instructions Normally the side effects disappear when the causes have been eliminated You will find suitable counter measures for some side effects in the section Troubleshooting on page 59 The following side effects may occur during therapy Pain in the nose the paranasal sinuses and the ears Dryness and irritation in the nose and throat Nose bleeds runny nose sneezing colds Irritated or dry eyes Reddening
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