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Manufacturer’s declaration on electromagnetic compatibility

Guidance and manufacturer‘s declaration – electromagnetic immunity

The point 2 is intended for use in the electromagnetic environment speci

ed below. The user of the

point 2 should assure that it is used in such an environment.

Immunity test

IEC 60601

Test level

Compliance level

Electromagnetic environ-

ment – guidance

Electrostatic dis-
charge (ESD)
IEC 61000-4-2

± 6 kV

contact

± 8 kV

air

± 6 kV

contact

± 8 kV

air

Floors should be made of
wood, concrete or ceramic
tile. If

oors are covered with

synthetic material, the rela-
tive humidity should be at
least 30%.

Electrical fast transient
(Burst) IEC 61000-4-4

± 2 kV

power supply lines

± 1 kV

input / output

± 2 kV

power supply lines

± 1 kV

input / output

Mains power quality should
be that of a typical commer-
cial or hospital environment.

Surges
IEC 61000-4-5

± 1 kV

differential mode

± 2 kV

common mode

± 1 kV

differential mode

not applicable

Mains power quality should
be that of a typical commer-
cial or hospital environment.

Содержание AutoCPAP

Страница 1: ...User s Manual CPAP AutoCPAP with FLEX function ...

Страница 2: ...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 Please always quote the serial number for all queries and complaints CONFORMITY The device complies with the requirements of Directive 93 42 EEC ...

Страница 3: ...ety instructions 11 Electrical safety 13 Installation requirements and transport 14 Before commissioning 16 Using oxygen 17 Intended use 18 Contraindications 19 Side effects 20 Device description 21 How the device works 22 Power supply 23 Therapy modes 25 Using the device 31 Commissioning 31 Turning on and off in battery mode 33 Standby mode 33 Automatic zero point correction 34 ...

Страница 4: ...40 Parameters in point 2 AutoCPAP 42 Language 44 P Unit 44 Operating times 45 Date 46 Time 47 Wake up time 48 Mode 49 Pressure 50 P Min 52 P Max 53 P Start 53 I FLEX 54 E FLEX 55 Calibration 56 Ramp 58 Mask Test 60 Automatic 61 Display Vt 62 Bact Filter 64 Brightness 65 Parameter settings 66 ...

Страница 5: ...ng the mask 76 Cleaning the therapy tube 76 Cleaning the device 77 Cleaning the headgear 78 Cleaning the humidifier 78 Preparing the device for a patient change 79 Using bacterial filters 80 Troubleshooting 82 Maintenance 84 Disposal 85 Device 85 Packaging 85 Accessories 85 Accessories 86 Technical data 88 Manufacturer s declaration on electromagnetic compatibility 92 Disclaimer 97 ...

Страница 6: ...supply 4 Therapy tube ID 22 mm length 1 80 m 5 Ventilation mask optional with exhalation valve Different sorts of mask systems are available 6 Headgear 7 User s manual 8 Brief instructions 9 Spare filter 2 pack 10 Carrying case 1 optional equipment variant for use with humidifier 3 1 2 4 5 6 7 8 10 9 ...

Страница 7: ...ead 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 ...

Страница 8: ...te rial damage This symbol denotes general safety instructions Follow these instructions to avoid accidents per sonal injury or material damage This symbol denotes hazardous situations that lead to serious injuries or death This symbol denotes hazardous situations that may lead to serious injuries or death This symbol denotes hazardous situations that may lead to moderately severe injuries ...

Страница 9: ...rial damage or damage to the device This symbol denotes information tips and instruc tions for efficient error free use of the device In addition the local accident prevention regulations and general safety regulations in force in the area of use must be observed ...

Страница 10: ...al BF application part Protection class II protective insulation CE conformity declaration Manufacturer Serial number 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 ...

Страница 11: ...e 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 imme diately if the device is not working properly ...

Страница 12: ...sician 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 irritabilities loss of voice orientation or memory impairment occur when using the device ...

Страница 13: ...m 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 ...

Страница 14: ... 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 curtains 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 loca tions ...

Страница 15: ...t a sufficient distance from other equipment which could emit electro magnetic waves such as diathermy devices cell phones remote con trolled toys and microwave appli ances Empty the humidifier optional acces sory before packing it away in the carrying case ...

Страница 16: ...ly been in a very cold environ ment Wait for about one hour for the temperature to balance out Check for proper setup and proper condition of the device Check the condition of the breathing tube mask humidifier and air filter Special attention should be paid to the maintenance instructions ...

Страница 17: ...ings Do not smoke and 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 Have your distributor advise you about the use of oxygen In any case follow your physician s instructions ...

Страница 18: ...tes 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 ...

Страница 19: ... 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 ...

Страница 20: ...ble counter measures for some side effects in the section Troubleshooting from page 82 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 claustr...

Страница 21: ...ntact socket for humidifier1 5 Control panel for humidifier1 6 Rating plate 7 Air inlet for baro sensor 8 DC power connection 9 RS232 interface 10 Filter or connection port for the filtersystempoint 2 11 Display 12 ON OFF key 13 Selection keys 14 Enter key 1 optional equipment variant for use with humidifier JAB122020 ...

Страница 22: ...and adjustable 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 ambient 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 CPAP treatment...

Страница 23: ...ed 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 ...

Страница 24: ...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 bat tery pack you can use the device for approx 8 hours at 8 hPa 12 bpm 500 ml tidal volume Before using the battery pack ensure that you have read the p...

Страница 25: ... depending on the type of device Mode Device type CPAP APAP point 2 CPAP type 5CPJ00 point 2 AutoCPAP type 5CPJ10 CPAP In CPAP mode Continuous Positive Airway Pressure the point 2 supplies continuous positive pressure 20 pressure hPa I time CPAP pressure 4 E E I I inspiration E expiration CPAP ...

Страница 26: ...ays 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 comme...

Страница 27: ...f pressure control can be individually selected for inspi ration 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 muscles is relieved The specified curves of the FLEX transfer characteristics correspond to the prevailing pressure and flow behavior of the airways Changes in pressure are ...

Страница 28: ...28 Device description 20 pressure hPa I time CPAP pressure 4 E E I CPAP with I FLEX and E FLEX 20 pressure hPa I time 4 E E I I inspiration E expiration P Max P Min APAP with I FLEX and E FLEX E I ...

Страница 29: ...Device description 29 pressure hPa flow l s 13 12 11 7 Leakage flow 8 9 10 3 hPa l s 2 hPa l s 1 hPa l s 0 b a Pressure curve 1 1 Respiration flow curve a b hPa l s Flow resistance FLEX settings ...

Страница 30: ...therapy The value displayed is the arithmetic mean of the inspired air vol ume 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 calculated before display is possible This is generally the case after about three breathing periods ...

Страница 31: ...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 5a and the unattached end of the tube to the air outlet 5b If you are using a bacterial filter fit it between the tube and air outlet...

Страница 32: ...to avoid potential leakages 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 just through your nose If the soft start function Ramp has been selected see page 58 the device reduces air pres sure after the mask test has been performed It then increases pressure automatically gradually up to the prescribed value while you ...

Страница 33: ...ode 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 The point 2 can be kept in standby mode permanently This does not harm it If the powerpackpoint 2 is fitted on the device the batteries are charged in standby mode The charg ing process is indicated by a fla...

Страница 34: ... permanent as they vary over time due to aging vibra tions 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 mea su...

Страница 35: ...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 trav elling or if there are significant temperature fluctua tions in the room For the patient the automatic zero point correction sys tem means that the device is always optimally adjust...

Страница 36: ... optionally available powerpackpoint 2 the batteries provide the power for the device in the event of a power failure USING OXYGEN Before using oxygen it is essential to read the safety information on page 17 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 fit ted onto the air outlet 0 3 3 1 ...

Страница 37: ... 2 Switch the device on first and then start the oxy gen supply 3 Check whether the automatic mode is set to Auto OFF If not program it as described on page 62 4 Switch off the oxygen supply before switching off the device Using oxygen influences the therapy pressure Therefore we recommend to inclose oxygen in the therapy pressure determination titration pro cess for every patient who s therapy is...

Страница 38: ...key 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 and you can select the top or bottom row A triangle symbol in front of a row means that this row has been selected 4 1 Q MM BL Example Wake Time ...

Страница 39: ...ended for physicians and trained medical staff To switch between the menus first press the enter key Then hold both the selection keys and down at the same time for a prolonged period The display shows the message or 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...

Страница 40: ...ns or trained medical staff These parameters are protected by a PIN code Please do not try to crack the PIN code Speak to your physician if you doubt the correctness of the pressure prescription PARAMETERS IN point 2 CPAP The following table shows which parameters can be selected in the complete and standard menu of the point 2 CPAP Parameter point 2 CPAP Standard menu Complete menu Language P Uni...

Страница 41: ...ter point 2 CPAP Standard menu Complete menu Wake Time Press 1 I FLEX1 E FLEX1 Calibration Ramp P Ramp Mask Test Auto Display Vt Bact Filter Brightness next parameter is displayed by pressing the enter key 1 1 PIN code protected ...

Страница 42: ...arameters can be selected in the complete and standard menu of the point 2 AutoCPAP Parameter point 2 AutoCPAP Standard menu Complete menu CPAP APAP CPAP APAP Language P Unit Power Blower Filter Therapy Date Time Wake Time Mode1 Press 1 P Min1 P Max P Start I FLEX1 E FLEX1 Calibration ...

Страница 43: ...s 43 Parameter point 2 AutoCPAP Standard menu Complete menu CPAP APAP CPAP APAP Ramp P Ramp Mask Test Auto Display Vt Bact Filter Brightness next parameter is displayed by pressing the enter key 1 1 PIN code protected ...

Страница 44: ... see page 39 2 Use the selection keys and to select Language 3 Set the desired language by pressing the enter key P UNIT The device can show the pressure in the pressure units hectopascal hPa millibar mbar and centimeters of water cm cmH2 O Setting the pressure unit 1 Select the complete menu see page 39 2 Use the selection keys and to select P Unit 3 Set the desired pressure unit by pressing the ...

Страница 45: ...cking the device s operating times 1 Select the complete menu see page 39 2 Use the selection keys and to select Power The total operating time including standby is now displayed 3 Press the enter key The total running time of the blower is now displayed 4 Press the enter key again The operating time of the filter is now displayed 5 Press the enter key again The therapy time is now displayed Q 3 M...

Страница 46: ...selection keys and to select Date 3 Press the enter key and then use the selec tion keys and to set the year Confirm your setting by pressing the enter key 4 Use the selection keys and to set the month Confirm your setting by pressing the enter key 5 Use the selection keys and to set the day Confirm your setting by pressing the enter key Q MMMM 4 1 ...

Страница 47: ...nutes 00 59 can be set Setting the time 1 Press the enter key for 1 second 2 Use the selection keys and to select Time 3 Press the enter key and then use the selec tion keys and to set the hour Confirm your setting by pressing the enter key 4 Use the selection keys and to set the minutes Confirm your setting by pressing the enter key 4 1 Q MMMMMMMMMMMM L ...

Страница 48: ... the ON OFF key once to stop the alarm for the next 5 minutes Slumber mode and twice to deactivate it completely 2 Press to end the alarm Setting the wake up time 1 Press the enter key for 1 second 2 Use the selection keys and to select Wake Time 3 Press the enter key and then use the selec tion keys and to set the hour Confirm your setting by pressing the enter key 4 Use the selection keys and to...

Страница 49: ...or 1 second 2 Use the selection keys and to select Mode 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 Use the selection keys and to select the desired mode Confirm your setting by pressing the enter key Q MMMMMMMMMMMMMM 4 1 ...

Страница 50: ...is pressure ramp can be deactivated using the TRENDset PC software point 2 CPAP 1 Select the complete menu see page 39 2 Use the selection keys and to select Press 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 selec tion keys and to set the desired value Confirm your setting by ...

Страница 51: ...and if necessary input the PIN code with the selection keys and Press the enter key after every digit 4 Use the selection keys and to select the CPAP mode 5 Press the selection key The menu item Press is now displayed 6 Press the enter key and then use the selec tion keys and to set the desired value Confirm your setting by pressing the enter key ...

Страница 52: ...r key and if necessary input the PIN code with the selection keys and Press the enter key after every digit 4 Use the selection keys and to select the APAP mode 5 Press the selection key The menu item P Min is now displayed 6 Press the enter key and then use the selec tion keys and to set the desired value Confirm your setting by pressing the enter key The parameter P Max is set next 4 1 Q MMMMMMM...

Страница 53: ...d 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 Selection of P Start by the physician 1 First set P Min and P Max 2 Use the selection keys and to set the desired value Confirm your setting by pressing the enter key 4 1 Q 4 MMMMMM Q MMMMB 4 1 ...

Страница 54: ... FLEXLINE is not a form of artificial respiration but merely a way of supporting the respi ratory effort of the patient Selection of I FLEX by the physician 1 Select the complete menu see page 39 2 Use the selection keys and to select I FLEX 3 Press 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...

Страница 55: ...nly work if actual respiratory effort is present Selection of E FLEX by the physician 1 Select the complete menu see page 39 2 Use the selection keys and to select E FLEX 3 Press 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 selec tion keys and to set the desired value Confirm your setting ...

Страница 56: ... with a bacterial filter or vice versa or there is a change from operation without a humidifier to with a humidifier or vice versa Calibration is only possible during mains opera tion and 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 Ensure that the air and exhalation openings in the mask are clear ...

Страница 57: ...y 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 display 8 In both cases press the enter key The old values will be retained if calibration has f...

Страница 58: ...pressure point 2 CPAP or P Start point 2 AutoCPAP 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 pre scribed therapy pressure starts immediately to 30 min utes prescribed therapy pressure is built up gradually within 30 minutes The initial ramp p...

Страница 59: ... Ramp Confirm your setting by pressing the enter key 4 Use the selection keys and to set the desired value for the initial pressure P Ramp Confirm your setting by pressing the enter key Prescribed pressure 10 hPa mbar pressure hPa Mask test time min Programmed soft start 0 30 min 0 90 s The pressure is increased gradually to the prescribed therapy pressure point 2 CPAP or P Start point 2 AutoCPAP ...

Страница 60: ...st from 5 to 90 seconds in 5 sec ond increments The mask test is performed before the ramp starts and tests the tightness under maximum therapy pressure Setting the mask test 1 Select the complete menu see page 39 2 Use the selection keys and to select Mask Test 3 Press the enter key and then use the selec tion keys and to set the seconds Confirm your setting by pressing the enter key 4 1 Q 0 0 MM...

Страница 61: ...ng you only have to put the mask on As soon as you begin breath ing the point 2 blower switches on When you take the mask off the blower switches off automatically after a 5 second delay The blower also switches off when the mask slips off your face or a leak that cannot be compensated for occurs 3 Auto Start with mask alarm With the Auto Start setting you only have to put the mask on As soon as y...

Страница 62: ...ect Auto 3 Press the enter key to set the desired auto matic mode The device can be switched on or off in any automatic mode by pressing the ON OFF key DISPLAY VT Here you can set whether the tidal volume is displayed during therapy Activating deactivating the display of the tidal volume 1 Press the enter key for 1 second 2 Use the selection keys and to select Display Vt 3 Press the enter key to s...

Страница 63: ...of the tidal volume replaces the display of the date Possible displays states Display of tidal volume in ml No valid value for the tidal volume is available yet If the display shows the value 0 ml for the tidal volume an apnea has occurred C L C L A C L ...

Страница 64: ...ct the complete menu see page 39 2 Use the selection keys and to select Bact Filter 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 selec tion keys and to set Yes or No Con firm your setting by pressing the enter key Whenever a bacterial filter is connected to or removed from the ...

Страница 65: ...key was pressed When a key is pressed the display brightness is always 100 50 during battery operation Setting the brightness 1 Select the complete menu see page 39 2 Use the selection keys and to select Brightness 3 Press the enter key and then use the selec tion keys and to set the desired bright ness 4 Confirm your setting by pressing the enter key Q 00MM N 4 1 ...

Страница 66: ...0 5 hPa P Min1 4 20 hPa P Start 0 5 hPa P Max1 4 20 hPa P Start 0 5 hPa P Start1 4 20 hPa P Min P Max 0 5 hPa I FLEX 0 3 hPa l s 1 hPa l s E FLEX 0 3 hPa l s 1 hPa l s Ramp 0 30 min 10 min P Ramp CPAP 4 hPa 20 hPa APAP1 4 hPa 20 hPa Press P Start 0 5 hPa Mask Test 0 90 s 5 s Auto OFF Start Stop Start Display Vt ON OFF Bact Filter Yes No Brightness 0 100 10 1 only point 2 AutoCPAP ...

Страница 67: ...e 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 acous tic 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 blower o...

Страница 68: ... UP ALARM The device has an integrated alarm clock You can activate or deactivate it at any time with the selec tion keys and Pressing the ON OFF key once mutes the alarm for the next 5 minutes and pressing it twice stops it completely BL ...

Страница 69: ...l full ther apy 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 can not be compensated for has occurred or you have not put the mask on in the Auto OFF or Auto Start automatic modes while the blower is running In normal mode you have pressed the selection key and get the message that you will be w...

Страница 70: ...1 min and 18 s until the alarm clock will sound again You have pressed the ON OFF key and ended the slumber phase The filter must be changed see page 74 To reset the message hold the enter key down 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 BL 1 MMMMMMMMMM L C 0 3 3 1 ...

Страница 71: ...ng the TRENDset PC software Furthermore the physician can set new therapy parameters using TRENDset and send them to the patient As soon as the SD card is inserted in the DATA box the point 2 adopts the therapy parameters The connection of a pulse oximeter to record and store the oxygen saturation values and pulse rate allows the medical staff in charge of the patient to analyze the success of the...

Страница 72: ...ata will be stored for up to 30 days1 The DATA box on the other hand can store data for at least one year 1 2 Therapy data point 2 point 2 with DATA box CPAP APAP CPAP APAP Central Sleep Apnea Obstruktive Sleep Apnea Mixed Sleep Apnea Hypopnea Airway Constriction Snoring Mode Adjustment Leakage Hyperventilation 1 depending on the operating time and number of events 2 when using a 2 GB SD card ...

Страница 73: ...sure Therapy Pressure low resolution no FLEX pressure changes visible Therapy Pressure high resolution FLEX pressure changes visible Respiratory Flow Relative Respiratory Volume Oxygen Pulse not saved saved only saved when I FLEX or E FLEX are selected but not active only saved while a pulse oximeter is connected ...

Страница 74: ...ter a while To ensure that the filter remains permeable to air it needs to be cleaned or replaced at certain intervals The standard filter is only designed to offer a certain level of protection from bacteria and allergens Here we recommend using the optional filtersystempoint 2 an attachable filter cassette with replaceable filter lay ers The large filter area means that a much denser fil ter mat...

Страница 75: ...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 instruc ti...

Страница 76: ... 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 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 CLEANING THE THERAPY TUBE For ...

Страница 77: ...the 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 Chemical cleaning products or solvents should not be used to clean the surface of the device under any circumstances They might damage the high ...

Страница 78: ... 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 manufac turer s instructions CLEANING THE HUMIDIFIER When using a humidifier the cleaning instructions in its user s manual must be observed ...

Страница 79: ...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 ...

Страница 80: ...r 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 Replace the bacterial filter Disinfect all the parts of the housing and the connec tions with a suitable agent e g Mikrozid Liquid Change the filter or if you are using the option ally available filtersystempoint 2 eit...

Страница 81: ...Using bacterial filters 81 If there is any doubt it should be assumed that the device is contaminated and it should be hygieni cally prepared according to the hygiene concept ...

Страница 82: ... yet completed Try to relax Use or vary the soft start function Dryness and irritation in the nose and throat Air is too dry Device probably does not have an air humidifier Speak to your physician about retrofitting an aquapoint 2 humidifier Original symptoms of sleep apnea come back Physical condition or life circumstances have changed Inform your physician Irritated or dry eyes Air escapes betwe...

Страница 83: ...your physician Headgear too tight Loosen the headgear Allergic reaction Inform your physician Feeling that the air is too hot Heater close to the device Move the device and the heater further apart No air flow Device is defective Inform customer services Very little air flow Soft start function has been selected Reduce soft start time Air channels are blocked Check air inlet Blower is running con ...

Страница 84: ...ply Maintenance and repairs may only be performed 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 Follow the cleaning instructions from page 74 Check the system regularly Conduct a visual check for external damage and dirt Check the mask alarm function once a week see page 67 ...

Страница 85: ...ehold waste Please contact the relevant customer services department to find out how to dispose of the device properly PACKAGING The packaging is taken back by the distributor but it can alternatively be recycled ACCESSORIES The accessories such as the tubing mask filter cas settes etc should be disposed of according to the manufacturer s instructions or with normal house hold waste ...

Страница 86: ...instructions 5000 0519 Optional Article number Standard masks CPAP nasal mask size S 0000 3440 CPAP nasal mask size M 0000 3434 CPAP nasal mask size L 0000 3435 CPAP full face mask size S 0000 3441 CPAP full face mask size M 0000 3436 CPAP full face mask size L 0000 3437 Cirri Comfort Mini masks Cirri Comfort Mini nasal mask size XXS 0000 3498 Cirri Comfort Mini nasal mask size XS 0000 3497 For or...

Страница 87: ...illow mask Nasal Pillow 4in1 size XS S M L 0000 3499 Other Accessories ComfortTube System heated tubing system 0000 3479 Tube cover sleeve 0000 7161 Humidifier aquapoint 2 0001 2949 Electronics for humidifier aquapoint 2 0001 2286 Battery pack powerpackpoint 2 0001 2846 filtersystempoint 2 0001 2847 Fine filter for filtersystempoint 2 0000 2109 Coarse filter for filtersystempoint 2 0000 2108 Bacte...

Страница 88: ...V 2150 mAh Operating time under battery power Approx 8 hours at 8hPa 12bpm 500ml tidal volume Running reserve of internal clock Up to 8 years Pressure range 4 20 hPa mbar Max pressure limit in the event of a fault 30 hPa Power consumption DC power Mains power DC power Mains power Standby battery charging 26 W 35 W Standby without batteries 3 W 5 W Operation at 20 hPa 14 W 17 W 38 W 42 W Operation ...

Страница 89: ...heating level 3 20 bpm 0 52 hPa 0 92hPa at heating level 3 Long term pressure variation 0 1 hPa Pressure reading accuracy 0 5 hPa Average sound pressure level operating at 1 m distance 30 dB A at 10 hPa equivalent to a sound power level of 38 dB A Air flow rate 4 hPa 165 l min 8 hPa 155 l min 12 hPa 145 l min 16 hPa 125 l min 20 hPa 115 l min Operating temperature 5 C 40 C Storage temperature 20 C...

Страница 90: ...ge Operating range 1060 hPa 700 hPa approx 400 m 3500 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 to 93 42 EEC IIa Classification according to EN 60601 1 Protection class II protective insulation Factory settings Parameter point 2 CPAP point 2 AutoCPAP Menu Complete menu Language ENG P Unit hPa Mode APAP ...

Страница 91: ... point 2 AutoCPAP P Max 10 hPa P Start 6 hPa I FLEX 2 E FLEX 2 Ramp 0 min Mask Test 0 s Auto OFF Display Vt OFF Bact Filter No Brightness 50 CE marking as per EC directive 93 42 EEC The manufacturer reserves the right to make technical changes without notice ...

Страница 92: ...lectromagnetic environment guid ance 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 establishments including domestic establishments and those directly connected to the public low volt...

Страница 93: ...ESD IEC 61000 4 2 6 kV contact 8 kV air 6 kV contact 8 kV air 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 Electrical fast transient Burst IEC 61000 4 4 2 kV power supply lines 1 kV input output 2 kV power supply lines 1 kV input output Mains power quality should be that of a typical commer cial or...

Страница 94: ... the user of the point 2 requires continued operation during power mains interruption it is recommended that the Equip ment or System is powered from an UPS or a battery Magnetic field power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels char acteristic of a typical location in a typical commercial or hos pital environment Conducted ...

Страница 95: ...on 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 ...

Страница 96: ...er of transmitter W Separation distance according to frequency of transmitter m 150 kHz 80 MHz d 1 17 P 80 MHz 800 MHz d 1 17 P 800 MHz 2 5 GHz d 2 33 P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 37 100 11 7 11 7 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 ap...

Страница 97: ...irs and maintenance are carried out by persons not authorized by us other manufacturers accessories and spare parts are used that have not been approved by us for use on the product the product is used other than as described in the user s manual or the hygiene and cleaning instructions described in the user s manual have not been complied with Statutory guarantee rights remain unaffected by this ...

Страница 98: ...98 Notes NOTES ...

Страница 99: ...Notes 99 NOTES ...

Страница 100: ...point 2 eng 030412 01 article no 5000 0510 HOFFRICHTER GmbH Mettenheimer Straße 12 14 19061 Schwerin Germany phone 49 385 39925 0 fax 49 385 39925 25 e mail info hoffrichter de web www hoffrichter de ...

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