Hoffrichter CPAP User Manual

Respiratory therapy device

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User's Manual

Respiratory Therapy Device

CPAP - AutoCPAP - BILEVEL ST20

as of device software 3.300

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Summary of Contents for Hoffrichter CPAP

Page 1 User‘s Manual Respiratory Therapy Device CPAP - AutoCPAP - BILEVEL ST20 as of device software 3.300...
Page 2 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 ﬁ nd the serial number on the rating plate on the back of the device..........
Page 3: Table Of Contents
Contraindications ..........21 Side effects ............22 Device description ..........23 How the device works .......... 24 General ............. 24 Power supply ............ 25 Therapy modes ............ 27 CPAP ..............28 APAP ............... 28 BILEVEL S, T and ST ........33 Contents...
Page 4 Automatic zero point correction ......40 Power failure ............. 42 Using oxygen ............ 42 Device functions ..........44 Parameters in point 2 CPAP ......47 Parameters in point 2 AutoCPAP ....... 48 Parameter in point 2 BILEVEL ST20 ....50 Language ............52 P-Unit ...............
Page 5 Delay Time ............65 Backup freq ............66 P-Min ..............67 P-Max ............... 68 P-Start .............. 68 I-FLEX ............... 69 E-FLEX ............. 70 Calibration ............71 Ramp ............... 73 Mask Test ............75 Automatic ............76 Display Vt ............77 Bact.Filter ............
Page 6 Error messages ..........92 Changing the ﬁ lter, cleaning........94 Cleaning the mask ..........96 Cleaning the therapy tube ......... 96 Cleaning the device ........... 97 Cleaning the headgear ........98 Cleaning the humidiﬁ er ........98 Preparing the device for a patient change ..... 99 Using bacterial ﬁ...
Page 7: Scope Of Delivery
SCOPE OF DELIVERY Respiratory therapy device point 2 Mains cable Power supply Therapy tube (ID = 22 mm, length = 1.80 m) Ventilation mask (optional) with exhalation valve Different sorts of mask systems are available. Headgear User‘s manual Brief instructions Spare ﬁ...
Page 8: General
GENERAL INFORMATION ON THIS USER‘S MANUAL Read this user‘s manual through carefully before using your therapy device for the ﬁ rst 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.
Page 9: Symbols Used In This Manual
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. This symbol denotes general safety instructions. Follow these instructions to avoid accidents, per- sonal injury or material damage.
Page 10 This symbol denotes situations that may lead to material damage or damage to the device. This symbol denotes information, tips and instruc- tions for efﬁ cient, 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.
Page 11: Symbols On The Rating Plate
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 Serial number Follow the user‘s manual. Do not dispose of the device in the house- hold waste.
Page 12: Safety Information
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 the mask and therapy tube for your own therapy.
Page 13 • 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, irritabilities, loss of voice, orientation or memory impairment occur when using the device.
Page 14: Electrical Safety
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.
Page 15: Installation Requirements And Transport
INSTALLATION REQUIREMENTS AND TRANSPORT • Place the device near your bed on a ﬁ rm and level surface. A bedside cabinet is ideally suited for this. • During therapy, the device must not be operated in a drawer, on a closet shelf or behind a partition.
Page 16 • Make sure you operate the device at a sufﬁ cient 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 humidiﬁ er (optional acces- sory) before packing it away in the carrying case.
Page 17: Before Commissioning
BEFORE COMMISSIONING • Do not switch the device on if it has previously 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. •...
Page 18: Using Oxygen
USING OXYGEN • Oxygen supports combustion. There- fore, observe the ﬁ re protection regu- lations applicable for using oxygen. • Ensure that there is no grease on the oxygen ﬁ ttings. Do not smoke and do not handle naked ﬂ ames. •...
Page 19: Intended Use
The point 2 CPAP (CPAP = Continuous Positive Airway Pressure) is a respiratory therapy device, which applies a continuous positive airway pressure to the patient.
Page 20 therapy pressure is administered via a respiratory mask (nasal, nasal cushion or full-face mask), which must be ﬁ tted 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.
Page 21: Contraindications
CONTRAINDICATIONS Respiratory therapy may be contraindicated for certain pre-existing conditions. 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 Inﬂ...
Page 22: Side Effects
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 cleaning instructions. Normally the side effects disappear when their causes have been eliminated.
Page 23: Device Description
DEVICE DESCRIPTION JAB122020 Control panel and display Humidiﬁ er lock Therapy tube connection Contact socket for humidiﬁ er Control panel for humidiﬁ er SD card slot Rating plate Air inlet for baro sensor DC power connection 10 RS232 interface 11 Filter or connection port for the ﬁ...
Page 24: 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 impositions Air inlet to the patient at a minimum, the blower has been ﬁ t- ted with high power reserve capacity and a rapid con- trol response.
Page 25: Power Supply
POWER SUPPLY The point 2‘s power can be supplied from one of three sources: External switched-mode power supply (included in scope of delivery) DC vehicle cable (optional) 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.
Page 26 2 battery pack. With the battery pack, point 2 CPAP and point 2 Auto CPAP can be used at least 8 hours (at 10 hPa, 12 bpm, 500 ml tidal volume). With the point 2 BILEVEL ST20 an operating time at least 7 hours is possible (at IPAP = 12 hPa, EPAP = 6 hPa, 12 bpm, 300 ml tidal vol- ume, I:E = 40% : 60%, T mode).
Page 27: Therapy Modes
THERAPY MODES The point 2 is equipped with the following therapy modes depending on the type of device: Mode CPAP APAP BILEVEL Device type point 2 CPAP • (type 5CPJ00) point 2 AutoCPAP • • (type 5CPJ10) point 2 BILEVEL ST20 •...
Page 28: Cpap
CPAP In CPAP mode (Continuous Positive Airway Pressure), the point 2 supplies continuous positive pressure. Pressure [hPa] CPAP CPAP pressure Time = Inspiration = Expiration APAP (only point 2 AutoCPAP) In APAP mode (Automatic Positive Airway Pressure), the point 2 automatically controls the therapy pressure in relation to the respiratory events occurring.
Page 29 Hypopnea (ﬂ ow 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 speciﬁ ed by the selection of settings. The device commences therapy once switched on with the starting pressure, which is likewise adjustable.
Page 30 FLEX settings Breathing compressed air results in an increased bur- den for the respiratory muscles. FLEX controls ease this burden on the respiratory muscles by reducing the effect of the ﬂ ow resistance in the airway. To this end, the therapy pressure needs to be increased during inspiration and reduced during expiration.
Page 31 Pressure [hPa] CPAP with I-FLEX and E-FLEX CPAP pressure Time Pressure [hPa] APAP with I-FLEX and E-FLEX P-Max P-Min Time = Inspiration = Expiration Therapy modes...
Page 32 FLEX settings Pressure [hPa] Pressure curve Flow [l/s] = Flow Leakage flow resistance 3 hPa/ (l/s) 2 hPa/ (l/s) 1 hPa/ (l/s) Respiration flow curve Therapy modes...
Page 33: Bilevel S, T And St
BILEVEL S, T AND ST (only point 2 BILEVEL ST20) General In BILEVEL S, T and ST you can independently set the pressure during inspration (IPAP) and expiration (EPAP). Selecting an an optimal slope can facilitate patients therapy compliance. A precise adjustment may further convey the feeling of natural respiration without any delay.
Page 34 During the expiration phase a negative pressure (vacuum) will not be created. Pressure [hPa] BILEVEL S IPAP EPAP Time Backup Delay time freq. = Spontaneous breathing = 15 s Spontaneous breathing 10 s Total time lag Backup T mode = Inspiration = Expiration Therapy modes...
Page 35 BILEVEL T In contrast to BILEVLE S, at BILEVEL T spontanous breating efforts will not be considered. Based on ﬁ xied preset ventilation parameters • IPAP, EPAP, • I-Slope, E-Slope, • I:E ratio and • frequency the machine performs a periodic timed mandatory pressure transition.
Page 36 BILEVEL 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.
Page 37: Using The Device
USING THE DEVICE COMMISSIONING Before commissioning the device, read section „Safety Information“ (starting from page 12). Set up the device according to the installation requirements (see page 15). 2. Connect the power supply to the device. 3. Connect the mains cable to the power supply and its plug to a power socket.
Page 38 Put the mask on. If automatic mode has been selected (see page 76), the device is turned on by the patient‘s breathing. If automatic mode has been set to „OFF“, the device is started by press- ing the ON/OFF key. 8 + 9 8.
Page 39: Turning On And Off In Battery Mode
TURNING ON AND OFF IN BATTERY MODE If the device is powered by the optionally available powerpackpoint 2, 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. In standby mode the device automatically switches itself off after 1 minute.
Page 40: Automatic Zero Point Correction
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, vibra- tions or constant changes in climate.
Page 41 We also recommend running the device on standby for a longer period, e.g. for a day, once a month. In order to determine an applicable correction fac- tor, 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.
Page 42: Power Failure
POWER FAILURE After a power failure during therapy, the motor re-starts automatically and you will see a message on the dis- play about the power failure and the blower re-start. If you are using the optionally available powerpackpoint 2, the batteries provide the power for the device in the event of a power failure.
Page 43 Proceed as follows when using oxygen: 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 ﬁ tted correctly. 2. Switch the device on ﬁ rst and then start the oxy- gen supply.
Page 44: Device Functions
DEVICE FUNCTIONS There are three keys for programming point 2‘s functions:  = Selection key  = Selection 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.
Page 45 The point 2 has two different menus: • Standard menu • 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.
Page 46 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 . To activate a parameter, press the enter key Some parameters may only be set by physicians or trained medical staff.
Page 47: Parameters In Point 2 Cpap
PARAMETERS IN point 2 CPAP point 2 CPAP Parameter Standard menu Complete menu Language • P-Unit • Power Blower • Filter Therapy Date • • Time • • Wake Time • • Press. • I-FLEX • E-FLEX • Calibration •...
Page 48: Parameters In Point 2 Autocpap
PARAMETERS IN point 2 AutoCPAP point 2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP Language • • P-Unit • • Power Blower • • Filter Therapy Date • • • • Time • • • • Wake Time •...
Page 49 2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP Display Vt • • • • Bact.Filter • • Brightness • • next parameter is displayed by pressing the enter key • present, - not present 1 PIN code protected...
Page 50: Parameter In Point 2 Bilevel St20
PARAMETER IN point 2 BILEVEL ST20 point 2 BILEVEL ST20 Standard menu Complete menu CPAP BILEVEL BILEVEL BILEVEL CPAP BILEVEL BILEVEL BILEVEL Parameter Language • P-Unit • Power Blower • Filter Therapy Date • • Time • • Wake Time •...
Page 51 2 BILEVEL ST20 Standard menu Complete menu CPAP BILEVEL BILEVEL BILEVEL CPAP BILEVEL BILEVEL BILEVEL Parameter E-FLEX • Calibration • • Ramp • P-Ramp Mask Test • Auto • Display Vt • • Bact.Filter • Brightness • next parameter is displayed by pressing the enter key •...
Page 52: Language
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 45). 2.
Page 53: Operating Times
OPERATING TIMES Under this menu item you will ﬁ nd the total operating time including standby mode of the device, the blower running time, the operating time of the ﬁ lter and the therapy time. Checking the device‘s operating times 1.
Page 54: Date
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 to select Date 3. Press the enter key and then use the selec- tion keys to set the year.
Page 55: Time
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. Setting the time 1. Press the enter key for 1 second.
Page 56: Wake Up Time
WAKE UP TIME To activate the wake up alarm, press . For check- ing purposes, the programmed wake up time is dis- played for a short time. To deactivate the alarm, press . The activated alarm is indicated by a bell symbol on the display.
Page 57: Mode
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 to select Mode 3. Press the the enter key and if necessary, input the PIN code with the selection keys .
Page 58: Pressure
PRESSURE (only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20 in CPAP mode) Selection of pressure by the physician 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.
Page 59 PIN code with the selection keys . Press the enter key after every digit. 4. Use the selection keys to select mode. CPAP 5. Press the selection key . The menu item is now displayed. Press 6. Press the enter key...
Page 60: Ipap
IPAP Q MMMMMMMM<; ;$ (only point 2 BILEVEL ST20 in modes BILEVEL S, T 4%/ !*1 and ST) Selection of inspiration pressure (IPAP) by the physician 1. Select the complete menu (see page 45). 2. Use the selection keys to select IPAP.
Page 61: Epap
EPAP Q MMMMMMMMMMA ;$ (only point 2 BILEVEL ST20 in modes BILEVEL S, T 4%/ !*1 and ST) Selection of expiration pressure (EPAP) by the physician 1. First set IPAP. 2. Use the selection keys to set the desired value.
Page 62: E-Slope
2. Use the selection keys to set the desired value. Conﬁ rm your setting by pressing the enter key The parameter E-Slope is set next. Calculation of the I-Slope time: Settings: IPAP = 10 hPa I-Slope = 2 Frequency = 12 bpm EPAP = 6 hPa E-Slope = 2 IPAP –...
Page 63 Selection of E-Slope by the physician 1. First set IPAP, EPAP and I-Slope. 2. Use the selection keys to set the desired value. Conﬁ rm your setting by pressing the enter key Pressure [hPa] IPAP EPAP I-Slope E-Slope Time The E-Slope time is calculated as the I-Slope time (see page 62).
Page 64: Frequency
FREQUENCY Q .!-1!*5MM<=,) (only point 2 BILEVEL ST20 in modes BILEVEL T and ST) 4%/ !*1 Selection of Frequency by the physician 1. Select the complete menu (see page 45). 2. Use the selection keys to select Frequency 3. Press the the enter key and if necessary, input the PIN code with the selection keys .
Page 65: I:e
Q L MMMMMMMM?;LA; N (only point 2 BILEVEL ST20 in modes BILEVEL T and ST) 4%/ !*1 Selection of I:E by the physician 1. First set Frequency. 2. Use the selection keys to set the desired value. Conﬁ rm your setting by pressing the enter key The parameter Delay Time is set next (only point 2 BILEVEL ST20 in BILEVEL ST mode).
Page 66: Backup Freq
BACKUP FREQ Q '1, ".!- MMMM (only point 2 BILEVEL ST20 in BILEVEL S mode) 4%/ !*1 By activating the backup frequency ventilation will be automatically restored if patient suffers from a persis- tent apnea (> 15 s). Evolving mandatory ventilation is characterized by following ﬁ...
Page 67: P-Min
P-Min (only point 2 AutoCPAP in APAP mode) Selection of P-Min by the physician 1. Select the complete menu (see page 45). 2. Use the selection keys to select Mode 3. Press the the enter key and if necessary, input the PIN code with the selection keys .
Page 68: P-Max
P-Max (only point 2 AutoCPAP in APAP mode) Selection of P-Max by the physician 1. First set P-Min. 2. Use the selection keys to set the desired value. Conﬁ rm 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...
Page 69: I-Flex
I-FLEX (only in modes CPAP and APAP) Inhaling under therapy pressure is always more difﬁ - cult as the lungs are already partly ﬁ lled and thus also pre stressed. Such additional stress from therapy can be reduced by means of a personalized I-FLEX setting.
Page 70: E-Flex
E-FLEX (only in modes CPAP and APAP) Although the point 2 is equipped with an excellent pres- sure control system, an E-FLEX setting can help make expiration easier. This should however be adjusted indi- vidually for each patient. Once again, FLEX settings will only work if actual respiratory effort is present.
Page 71: Calibration
CALIBRATION Calibration guarantees optimum performance of the automatic function and mask test. It must be performed when: • the device is used initially, • the mask has changed, • there is a change from operation without a bacterial ﬁ lter to with a bacterial ﬁ lter, or vice versa, or •...
Page 72 2. Press the enter key for 1 second. 3. Use the selection keys to select Calibration 4. Press the enter key appears on the display. Press the enter Start . If you do not press the key within 5 s, the display jumps back (see point 3).
Page 73: Ramp
(P-Ramp) up to the prescribed 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.
Page 74 Prescribed pressure: 10 hPa (mbar) Pressure The pressure is increased gradually to [hPa] the prescribed therapy pressure (point 2 CPAP) or P-Start (point 2 AutoCPAP) 0 - 90 s Time [min] Mask test Programmed soft start (0 - 45 min)
Page 75: Mask Test
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 sec- ond increments.
Page 76: Automatic
AUTOMATIC The automatic mode has three settings: OFF, Start/Stop, Start 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.
Page 77: Display Vt
not switch off but you receive an acoustic and visual warning. The blower can only be switched off by pressing the ON/OFF key. Setting automatic mode 1. Select the complete menu (see page 45). 2. Use the selection keys to select Auto 3.
Page 78 Activating/deactivating the display of the tidal volume 1. Press the enter key for 1 second. 2. Use the selection keys to select Display Vt 3. Press the enter key to set „ON“ or „OFF“. During the therapy the display of the tidal volume replaces the display of the date.
Page 79: Bact.filter
BACT.FILTER As pressure measurement is inﬂ uenced by the connec- tion of a bacterial ﬁ lter, it must be speciﬁ ed on the device whether or not a bacterial ﬁ lter has been connected. Select whether a bacterial ﬁ lter is connected (by the physician) 1.
Page 80: Brightness
BRIGHTNESS You can set the brightness of the display from 0 % to 100 %. 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 % (50% during battery operation).
Page 81: Parameter Settings
PARAMETER SETTINGS Parameter Settings range Dependency Setting steps Language DEU, ENG, ELL, SPA, FRA, ITA, NLD, TUR, PLK, POR, CZE P-Unit hPa, mbar, cmH Press. 4 – 20 hPa 0.5 hPa IPAP EPAP – 20 hPa  EPAP,  20 hPa 0.5 hPa ...
Page 82 0 – 100 % 10 % 1 only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20 in modes CPAP 2 only point 2 BILEVEL ST20 3 only point 2 BILEVEL ST20 in modes BILEVEL T and ST...
Page 83: Alarm Functions Of The Device
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. The mask alarm is only active in the „Auto OFF“...
Page 84: Wake Up Alarm
WAKE UP ALARM The device has an integrated alarm clock. You can activate or deactivate it at any time with the selec- tion keys . Pressing the ON/OFF key once mutes the alarm for the next 5 minutes and pressing it twice stops it completely.
Page 85: Important Display Messages
IMPORTANT DISPLAY MESSAGES The most important display messages are listed below. All further messages will be clariﬁ ed from the given context. The values shown here are examples. You still have 15 seconds to ensure that the mask is ﬁ tted correctly. When the time is up, the device starts the soft start function or the therapy.
Page 86 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.
Page 87: Using An Sd Card
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 evalu- ate this data via the TRENDset PC software. Further- more, the physician may set up new therapy param- eters using TRENDset and send them to the patient to update its therapy requirements.
Page 88: Inserting The Sd Card
INSERTING THE SD CARD 1. Ensure that the device is in standby mode (see page 39. 2. Insert the SD card into the SD card slot (see pic- ture). 3. The device starts initializing while the message “Do not remove the SD card” is displayed. Finally the symbol is shown at the display.
Page 89: Removing The Sd Card
After the takeover of the parameters enter the Info- Menu and validate the displayed parameters with the values of your prescription. REMOVING THE SD CARD Only remove the SD card in standby mode. Oth- erwise data may be lost or the SD card might be damaged.
Page 90: What Is Saved On The Sd Card
WHAT IS SAVED ON THE SD CARD The last 100 device events are saved on the SD card. Events are changes of parameters such as therapy settings, resetting counters (e.g., ﬁ lter counters) etc. The parameters changes are saved with the date and time they were changed, as well as the old and new value.
Page 91 Therapy data Internally of the SD card device CPAP APAP CPAP APAP Central Sleep Apnea • • Obstruktive Sleep Apnea • • Mixed Sleep Apnea • • Hypopnea • • Airway Constriction • • Snoring • • Mode • •...
Page 92: Error Messages
ERROR MESSAGES Two different types of error can be distinguished: errors .!00 E 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.
Page 93 Error code Meaning Remedy 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.
Page 94: Changing The Fi Lter, Cleaning
CHANGING THE FILTER, CLEANING The ﬁ lter 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.
Page 95 Changing the ﬁ lter Pull out the ﬁ lter on the back of the device and replace it with a new or cleaned one. JAB122020 Always use the device with the ﬁ lter element inserted and clean the ﬁ lter element regularly. If the ﬁ lter Removing the ﬁ...
Page 96: Cleaning The Mask
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. appears on the display. Filter Counter Reset Press the enter key to conﬁ...
Page 97: Cleaning The Device
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 vertically suspended therapy tube dry completely.
Page 98: Cleaning The Headgear
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 manufac- turer‘s instructions. CLEANING THE HUMIDIFIER When using a humidiﬁ...
Page 99: Preparing The Device For A Patient Change
PREPARING THE DEVICE FOR A PATIENT CHANGE If the device is to be used by another patient, it must prior be prepared hygienically. When being given to another patient, the device must be prepared hygienically by the specialist dealer or the manufacturer.
Page 100: Using Bacterial Fi Lters
USING BACTERIAL FILTERS If the device is intended for use by more than one patient (e.g., operation in clinics), a suitable bacterial ﬁ lter (e.g., MEDISIZE BARR-VENT S) must continuously be used to protect the device from contamination by human pathogens. Change the bacterial ﬁ...
Page 101: Troubleshooting
TROUBLESHOOTING Problem Possible cause Remedy Pain in the nose, the Inﬂ ammation of the para- Stop the treatment and paranasal sinuses or the nasal sinuses or the middle contact your physician ears Unpleasant feeling Malaise with prescribed If you suspect an error, please because of the high high pressure values ask your physician for help...
Page 102 Problem Possible cause Remedy Runny nose, sneezing Reaction to the air ﬂ ow Either increase the humidity in the room or the temperature of the humidiﬁ er Normal cold Contact your physician Reddening of the skin Incorrect mask size Inform your physician in the mask area, skin Headgear too tight Loosen the headgear...
Page 103: Maintenance
MAINTENANCE Do not try to open the device. Maintenance and repairs may only be performed by personnel autho- rized by us. Do not try to open the power supply. 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.
Page 104: Disposal
DISPOSAL Proper disposal saves natural resources and prevents harmful substances being released into the environment. DEVICE The device must not be disposed of with the household waste. Please contact the relevant customer services department to ﬁ nd out how to dispose of the device properly.
Page 105: Accessories
ACCESSORIES For ordering of accessories, please contact a HOFFRICHTER service partner. Scope of delivery Article number Carrying case 0000 2080 Power supply 0000 2133 Mains cable 3110 0029 Filter 0000 2110 Spare ﬁ lter (2 pack) 0000 7801 Therapy tube (inner diameter = 22 mm, length = 1,80 m) 0000 7875 User‘s manual...
Page 106 Optional Article number Cirri Comfort masks 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 full face mask, size S 0000 3483 Cirri Comfort full face mask, size M 0000 3484 Cirri Comfort full face mask, size L 0000 3485...
Page 107: Technical Data
24 V DC / 2.01 A Battery power (per battery) 11.1 V / 2200 mAh Operating time under battery power point 2 CPAP and > 8 hours (at 10 hPa, 12 bpm, AutoCPAP 500 ml tidal volume) point 2 BILEVEL ST20 >...
Page 108 point 2 point 2 with aquapoint 2 Operation at 20 hPa < 14 W < 17 W < 38 W < 42 W Operation at 12 hPa < 10 W < 12 W < 34 W < 38 W Operation at 6 hPa <...
Page 109 22 mm, cone (as per ISO 5356-1) Product class according to 93/42/EEC Classiﬁ cation according Protection class II (protective insulation) to EN 60601-1 Factory settings Parameter point 2 CPAP point 2 AutoCPAP point 2 BILEVEL ST20 Menu Complete menu Language P-Unit Mode...
Page 110 Factory settings Parameter point 2 CPAP point 2 AutoCPAP point 2 BILEVEL ST20 I-Slope E-Slope Frequenz 12 bpm 35:65 % Delay Time 15 s Backup freq P-Min 4 hPa P-Max 10 hPa P-Start 6 hPa I-FLEX E-FLEX Ramp 0 min...
Page 111: Manufacturer's Declaration On Electromagnetic Compatibility
MANUFACTURER’S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY Guidance and manufacturer‘s declaration – electromagnetic emissions The point 2 is intended for use in the electromagnetic environment speciﬁ ed below. The user of the point 2 should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –guid-...
Page 112 Guidance and manufacturer‘s declaration – electromagnetic immunity The point 2 is intended for use in the electromagnetic environment speciﬁ ed below. The user of the point 2 should assure that it is used in such an environment. Immunity test IEC 60601 Compliance level Electromagnetic environ- Test level...
Page 113 Guidance and manufacturer‘s declaration – electromagnetic immunity Voltage dips, short > 95 % clip in > 95 % clip in Mains power quality should interruptions and volt- / 0.5 cycles / 0.5 cycles be that of a typical commer- age variations on cial or hospital environment.
Page 114 Guidance and manufacturer‘s declaration – electromagnetic immunity Radiated RF = 3 V/m 3 V/m d = 1,17 √P IEC 61000-4-3 80 MHz – 2.5 GHz 80 MHz - 800 MHz d = 2,33 √P 800 MHz - 2.5 GHz Field strengths from ﬁ xed RF transmitters, as determined by an electromagnetic site survey...
Page 115 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 disturbances 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 communica- tions equipment.
Page 116: Disclaimer
DISCLAIMER HOFFRICHTER GmbH is not liable for consequences in terms of safety, reliability and performance of the product where: • interventions, modiﬁ cations, extensions, adjust- ments, repairs and maintenance are carried out by persons not authorized by us, • other manufacturers‘ accessories and spare parts...
Page 117 NOTES ..........................................................................................................................................................................................................................................................................................................Notes...
Page 118 NOTES ..........................................................................................................................................................................................................................................................................................................Notes...
Page 119 NOTES ..........................................................................................................................................................................................................................................................................................................Notes...
Page 120 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 point 2 ENG_2012-12-17_03 article no.: 5000 0510...

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