Hoffrichter Vector et CPAP User Manual

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User´s Manual
BILEVEL
HOFFRICHTER
VECTOR et CPAP
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SERIAL NUMBER
HOFFRICHTER GmbH delivers all its systems with a
CONFORMITY
The device complies with the requirements of the Directive 93/42/EEC.
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1 Legends of Symbols 4 2 Safety Instructions 5 3 Intended Use 8 4 Contraindications 9 5 Technical Description 10 6 Notes prior to first use 11 7 Components of the Device 12 8 Accessories 14 9 Use of the Device 16 10 Use of Oxygen 17 11 Clean and Change of the Filter 18 12 Alarm Functions 20 13 Functions of the Device 22 14 Troubleshooting 34 15 Display Messages 36 16 Maintenance 38 17 Technial Data 39
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CONTENTS
VECTOR et CPAP
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LEGENDS OF SYMBOLS
Observe the accompanying documentation
Applied part type BF
Electric safety class II (with protective insulation)
Observe the Operating Instructions
Manufacturer
CE Declaration of Conformity
Do not dispose of the device with normal domestic waste. For information on the proper disposal of the device, please contact your responsible customer service.
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SAFETY INSTRUCTIONS
Before using your respiratory therapy device for the first time, please thoroughly read these Operating Instructions.
Keep these Operating Instructions at a safe place for immediate consultation, if necessary.
For the period stipulated by law, HOFFRICHTER GmbH warrants that the product is free from any defects provided it is used as intended.
POWER SUPPLY
VVEECCTTOORR eett CCPPAAPP
has an external switched mode power supply unit with a wide range input of 100 ­240 V~, 50 - 60 Hz. This allows connection to all energy supply networks in the world.
It is also possible to operate the device with a direct voltage of 24 V DC, e.g. for mobile use in a truck or mobile home. When connecting the device to a DC supply source, please only use the optional connection cable and do not use the device with a PC.
ATTENTION!
HOFFRICHTER GmbH is not liable for any damage
and consequential damage nor for any effects on the safety, reliability and performance of the devi­ce, if:
• manipulations, modifications, expansions, adjustments, repairs and maintenance measures are carried out by persons not authorized by us to do so.
• use is made of accessories and spare parts which come from other manufacturers a n d have not been released by us for use with the
VVEECCTTOORR eett CCPPAAPP
device.
• the device is used in a way that is different from that described in the Operating Instructions.
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In order to prevent potential hazards, please fol­low the instructions below:
• Exclusively use the device for your own therapy, which must have been prescribed by a physician.
• Use accessories only which have been recommended and offered by your speciali­zed dealer.
• Regularly test the alarm function of your devi­ce.
• Always ensure that the small hole in the mask or in the adapter between the mask and the tubing is unobstructed so that the exhaled air that is loaded with CO2 can escape.
• Never set up the device in a compartment of a cabinet nor under your bed.
• Please make sure that air can easily circulate around the device.
• Do not place the device in the vicinity of radiators.
• Ensure that the device is positioned horizontally. This is particularly necessary if a humidifier is connected.
• If yo u receive oxygen with your therapy, please follow all fire protection and safety regulations with regard to the use of oxygen.
• Mobile use of the device is permitted only in a parked vehicle.
• Immediately see your physician if, while using the device, you develop one or more of the following symptoms: dryness of the mucous membranes in nose and throat, frontal sinus complaints, earache, a running nose, hypersensitivity of the skin, oversensitiveness, loss of voice, disturbances of orientation or memory.
• Immediately notify your specialized dealer if the device fails to function properly.
• Never place the respiration therapy device in the vicinity of other equipment or devices, such as defibrillators, diathermy equipment, mobile phones, microwave, remote-controlled toys, etc. Electromagnetic fields greater than 3 V/m ma y affect the operation of the device.
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To maintain electrical safety , please observe the following instructions:
• Do not put the device into operation if its housing and/or cables are damaged.
• Do not open the housing. Notify your specialized dealer of any disturbances and failures.
• Protect the device from water and moisture.
• Never operate the device in moist rooms nor in a bathroom.
• Do not place a vessel filled with fluid on the device.
• Be absolutely sure not t o seize the device if it has fallen into water.
• Do not set up the device in the vicinity of water vessels (bath tubs).
• Before cleaning the device, always disconnect the power plug.
• Use the supplied power supply pack only.
• When connecting the device to a DC supply source, please only use the optional connecti­on cable listed under optional accessories and do not use the device with a PC.
STANDBY-MODE
The device is in the standby mode as long as the turbine is turned off. The standby mode is indicated by the illuminated display showing date and time. If a humidifier is connected with the device, the humidifier as well will be in standby mode. The pre­set heater level will be displayed. Power consumption in this mode is approx. 5 W.
••
In the standby mode, the device
VVEECCTTOORR eett
CCPPAAPP
may remain continuously switched on
without posing any risk.
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INTENDED USE
The VECTOR et CPAP is intended for treating obstructive sleep apnea in patients with a weight of 30 kg and higher.
The device generates a continuous positive airway pressure in order to keep the upper respiratory tract unobstructed.
The device is not suitable for being used with patients who need artificial respiration. This therapy device is no life-preserving system.
The treatment pressure is applied through a ventilation mask. This ventilation mask must be provided with an exhalation valve in order to ensure that the exhaled air is discharged. Do not wear the ventilation mask while the therapy device is turned off because, otherwise, you might rebreathe exhaled air. Please also follow the manufacturer's instructions on use of the ventilation mask.
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CONTRAINDICATIONS
Respiratory therapy may be contraindicated in patients with the following preexisting diseases:
• Bullous lung diseases
• Pneumothorax
• Very low blood pressure
• Air accumulation after open craniocerebral trauma or other head injuries
In case of an inflammation of the paranasal sinuses or the middle ear, it might be indicated to stop the therapy. Please consult your physician.
Devices which have been fitted with an
AAqquuaaDDRROOPP eett
humidifier may not be used with additives such as medication or aroma oils in the humidifier water.
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TECHNICAL DESCRIPTION
The VECTOR et CPAP is a therapy device for trea­ting obstructive sleep apnea.
In addition to the conventional CPAP-mode, the device offers in FLEXLINE-mode a pressure increase during inspiration and pressure reduction during expiration which is proportional to the individual breath flow.
To generate the necessary pressure, the device is provided with an electronically controlled blower. In order to keep the stress for the patient as low as possible, the blower has been designed with a high reserve capacity and a quick control response.
The pressure is measured directly in the mask and constantly controlled by the device. Consequently, the breathing work for the patient is a easy as possible.
There are two separate tubings in the device. One is for respiratory air and one is for the convection air required for cooling the electronics.
In addition to the mask alarm, the device offers another safety function, the power failure alarm. It automatically restarts the motor after power restoration.
The device contains a built-in microcontroller which controls all of its functions. A quartz alarm clock further adds to the comfort when using the device. Further comfort functions include a soft start ramp, the automatic start-stop function and the adjustable display brightness. While passing through the device, the air is heated a little, so that it has a higher water absorbency. When indoor air is dry in winter, the mucous membranes in mouth and nose may become particularly dry. This is unpleasant and may even cause infections in exceptional cases. For that rea­son, a therapy might require air humidification.
AquaDROP et, a clip-on humidifier is available as
accessory for the device. If necessary, just click the humidifier onto the device. Remove it by pressing its locking key.
The heater levels are set in the heater menu. The selected heater level is displayed as in the display of the device while the humidifier heating is switched on.
For more information please see your
AquaDROP et operating instructions or contact
your specialized dealer.
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NOTES PRIOR TO FIRST USE
Never turn the device on if you kept it in a very cold environment. Wait for approx. 1 hour until its temperature compensation is completed.
Regularly check the air filter cassette and regularly exchange it as described on page 18. Never use the device without air filter.
Clean your mask system regularly and check all accessory parts, particularly the therapy tubing, the mask and the head gear. We recommend that you wash your face before going to sleep, in order to remove fat and cosmectics from your skin. This increases the service life of the mask and helps to prevent irritations of the skin.
Make sure the measurement tube is unobstructed at all times. Avoid ingress of water into the measurement tube during cleaning. If water droplets should have accidentally entered the measurement tube they must be carefully and thoroughly removed.
Please strictly observe the following setup instructions:
• Do not place the device in the vicinity of a heating source. Air circulation – particularly that below and behind the device – must not be impaired by furniture, curtains or cushions.
• Set up the device next to your bed. Place it on a firm and flat surface of your bedside cabinet.
• During mobile use, the device must also be placed on a firm and flat base, which must have an edge to protect the device from fal­ling off.
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COMPONENTS OF THE DEVICE FRONT VIEW
1 Program Keys 2 Filter cassette 3 Display 4 Heater LED 5 Info Key 6 Heater Key 7 Release button for accessories 8 Measurinng tube connection 9 Air outlet 10 Contact socket for humidifier
11. Control Key (ON/OFF button)
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2
45
6
7
11
8
9
10
3
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1 1
10 10
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REAR VIEW
12 Power connection 13 RS232 interface 14 Type identification plate
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12 13 14
CPAP
et
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Exhalation valve
Car Cabel
Carrier bag
Air Filter Cassette
Power cord
Power Supply Unit
Therapy Tube
(Length 1,80 m)
Measuring Tube
Breathing Mask
There are various mask systems available
Stoppers
,80 m)
ACCESSORIES
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SCOPE OF DELIVERY
Art.-No.:
VECTOR et CPAP 0000 2045
User´s manual 5000 0036 Power supply 0000 2020 Power supply cable 3110 0015 Therapy tube, measuring tube and stoppers 0000 7116 Filter cassette without frame cover 0000 2029 Carrier bag 0000 2080
A ventilation mask that has been specially adjusted for the individual patient is required for start-up and use of the device in the domestic area, in addition to the therapy device with power supply unit, power cord, and therapy tube.
OPTIONAL ACCESSORIES
Art.-No.:
AquaDROP et 0000 2015
Car cabel 0000 9212 12 V to 24 V converter 0000 7133 Replacement filter cassette with frame cover 0000 2028
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USE OF THE DEVICE
1. After having set up the device properly, connect the power supply unit to the device and, using the supplied power cord, to a grounded outlet.
2. The device displays a welcoming message, the software version and the current number of treatment hours. Thereafter, the display shows the date and time.
3. Connect the therapy tubing a) to the air outlet, and b) to the mask.
4. Also connect the measuring tube to the measuring tube outlet.
5. Apply the mask. If you have selected the automatic mode, the device will start on your first breath. In the manual mode, press the operator key to start the device.
6. The device will then run through the mask test for the time selected and at the pressure prescribed. You should now properly seat the mask in order to eliminate any potential leaks.
7. Place the tubing such that it does not exert any pulling action on the mask while you are lying down.
8. Breathe deeply and calmly only through your nose. If you have activated the soft start function, the device initially reduces the pressure after completion of the mask test and will then slowly increase the pressure automatically to the prescribed value, allowing you to fall asleep at a lower pressure.
NOTE: For information on how to adjust the soft start and mask test times to your individual demands, please refer to the section entitled functions of the device.
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3a
3b
4
7+8
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USE OF OXYGEN
If you also have to inhale oxygen during your CPAP therapy, please be absolutely sure to follow the instructions from the manufacturer or the dealer delivering the oxygen to you.
If you supply the oxygen directly into the mask, please use a non-kinking tube that consists of a medically approved material.
You can also supply the oxygen through an adapter which is mounted to the air outlet.
In any case, please be absolutely sure to follow the instructions of your physician.
Please contact your specialized dealer.
A TTENTION! Oxygen promotes combustion processes. For that reason, please observe the valid fire protection regulations for the use of oxygen. Keep oxygen fittings free from fat, do not smoke, and do not handle the device near a naked flame.
A TTENTION! If you are using oxygen together with the device, the oxygen supply must always be deactivated as long as the device is in the standby mode or while it is turned off.
Always turn on the device first and only then the oxygen supply. Turn off the oxygen supply before turning off the device. Activate the „Automatic OFF“ as described on page 27. Whenever you use the device, check the tube connections for proper seating beforehand.
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CLEANING AND CHANGE OF THE FILTER
CHANGE OF THE FILTER
If the filter is polluted or the display shows the message “change filter” the filter cassette must be changed.
1. To change the cassette, pull it upwards out of the device.
2. Separate filter cassette and filter frame cover by pulling them apart.
3. Replace the filter cassette.
4. Mount the filter frame cover onto the new filter cassette. Make sure the upper part (slit) and the filter cassette (pin) are in the correct position.
To set back the message proceed as described in the chapter Patient menu (page 24).
NOTE: Never operate the device without filter cassette. Only and exclusively use original HOFFRICHTER filter cassettes. Otherwise, the warranty for the ventila­tor will become extinct.
CLEANING THE MASK
For reasons of hygiene the mask must be cleaned on a daily basis:
1. Separate the mask from the therapy tubing
2. Clean the mask as described in the mask manufacturer's operating instructions
WEEKLY CLEANING OF THE THERAPY TUBING
Make sure the measurement tube is unobstructed at all times. Avoid ingress of water into the measurement tube during the weekly cleaning. If water droplets should have accidentally entered the measurement tube they must be carefully and thoroughly removed.
1. Close the therapy tubing tightly with the stoppers before cleaning (see page 14)
2. Use mild soapy water for cleaning, thoroughly rinse with clear water, and let the tubing dry in air
3. Remove the two plugs from the measuring tubing after cleaning
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CLEANING THE DEVICE
For reasons of hygiene the device must be cleaned on a weekly basis:
1. Disconnect the power plug
2. Wipe the device with a cloth slightly moistened with soapy water. Then use a dry cloth to wipe the device dry
You do not have to disinfect the device or parts of the device chemically or thermally.
CLEANING THE HEAD GEAR
Clean the head gear as required:
1. Disconnect the head gear from the mask
2. Clean the head gear as described in the head gear manufacturer's operating instructions
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ALARM FUNCTIONS
POWER FAILURE
If a power faiure at night would go unnoticed as a result the patient would breathe used air from the therapy tubing all night. To avoid this the device is equipped with an alarm mechanism that warns you with a 5 seconds delay if power or a fuse fail at night. You will be woken up with an acoustic signal so you can take the mask off your face and breathe fresh air. The alarm is turned off by pushing the operating button. After power supply is re-established the motor starts automatically and the display will show the following message:
CHECK POWER FAILURE WARNING
NOTE: T o check the power failure alarm, the device must have been connected to the power cord and tur­ned on for at least half an hour.
Use the device with running blower and then pull the power plug out of the wall socket. Now the acoustic warning signal should sound. Check once a month if the signal sounds long enough (refe­rence value: at least 3 minutes).
After pushing the operating button or turning on the power supply again the signal will stop.
MASK ALARM
This alarm function is activated only if the automatic function is turned off. If the mask has slipped off your face or if the tubing is pulled off the device, the device is not turned off automatically, but emits a visual and audible alarm. However, this additional safety function requires that you turn the device on in the evening and off and in the morning with the operating button (ON/OFF).
CHECK MASK ALARM
Use the device with running turbine in the manual mode (automatic mode OFF). The mask is open but not applied to your face. After a short time, an audible signal is emitted.
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PRESSURE ALARM
If during the therapy a hardware error occurs or the pressure becomes too high (e.g. due to a bent measuring tube) the decive will generate an alarm sound and turn off the turbine. The alarm is turned off by pushing the operating button and the therapy can be continued after solving the error.
ALARM CLOCK
The device is provided with a comfortable integrated alarm clock. Using the programming keys, you can activate and deactivate this alarm clock at any time, for example on weekends. The alarm clock emits an alarm at the programmed wake time. Press the operator key once to set the alarm for the next 5 minutes (can be set with the help of the computer software) and twice to deactivate it completely.
These functions may have been deactivated through the software. Please contact your speaiclized dealer or service technician for activating these functions.
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FUNCTIONS OF THE DEVICE
You can program the functions of the device with the following three keys:
= enter key= programming key= programming key
The display has two lines. Using the  and  keys, you can select the line to be displayed. The triangular symbol preceding the line indicates that this line has been selected.
NOTE: If you do not press any key for 30 seconds while programming, the programming mode is automa­tically exited for safety reasons.
Unless the changed value is confirmed with the enter key when the programming mode is exited, the original value remains as it is.
If you select the line »exit menu« and then press the key, programming is ended.
The device has three different menus:
1. Info Menu:
In this menu the set parameters can be displayed.
2. Patient Menu:
In this menu the patient can change settings.
3. Clinic Menu:
In this menu, only a doctor or service technicians can change settings.
INFO MENU
By pressing the Info button i you get to the Info menu. By pressing the buttons  and  you can see the next parameters. To exit the Info menu select the line »exit menu« and then press the button. If you do not press any buttons for 30 seconds the device will automatically switch back to the opera­ting mode.
The following parameters are shown:
1. Therapy
Shows the total therapy time of the device
2. Filter
Shows the time since the last filter change
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3. Ramp
Shows the remaining time of the soft start ramp
4. P-Ramp
Shows the ramp start pressure
5. Mode
Shows the selected mode
The device can operate in CPAP-mode as well as in FLEX-mode. The FLEX-mode is a comfortable mode in CPAP therapy. Proportional to the patientflow the pressure will be decreased while the patient exhales and increased when the patient inhales. The following effects take place:
• The breathes will become more natural and pleasent because of the diminution of breathingwork during in- and exhalation
• Reduction of the middle therapy pressure
6. Pressure
Shows the selected therapy pressure
7. FLEX-Level
Shows the selected FLEX level (only if the FLEX-mode is activated)
The value of pressure increase and pressure decrease depends on the value of the breath flow, the set FLEX levels and the set therapy pressure. The three FLEX levels (1-3) are for individual adjustment to the patients requirements:
• FLEX-Level 1 low pressure support
(P
max
< + 1 hPa)
• FLEX-Level 2 medium pressure support
(P
max
< + 2 hPa)
• FLEX-Level 3 high pressure support
(P
max
< + 3 hPa)
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PATIENT MENU
Press and hold the enter key (at least 1 second) to move to the programming mode. The Patient menu will now appear on the display. In the Patient menu you can set the following parameters:
1. Wake time
In this menu item you can set and change the wake time.
After pressing the key again the hour of the wake time will start flashing. Now you can change it by pressing the  and  keys. After pressing the key again the minute of the wake time will start flashing. Now you can change it by pressing the  and  keys. Pressing the button again ends the input and you get back to the menu. Changing the wake time will automatically activate the alarm clock.
After leaving the menu the alarm clock can be activated and deactivated with the help of the and buttons. Press to activate the alarm function. The display briefly shows the wake time allowing you to verify it.
After that a bell symbol in front of the time display shows that the alarm function is activated.
Press to deactivate the alarm function. The bell symbol disappears.
2. Reset filter
In this menu item the filter counter can be reset. This function should be used at every filter change so that always a current value is displayed.
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To reset the filter counter, go to the Patient menu (press the button for approx. 1 second), then select »Reset filter« with the buttons and . Press the button. The system will now ask you if you are sure that you want to perform a reset. Press the key to perform the reset.
Now the filter counter is reset to zero. If you do not want to reset the filter counter, leave the menu by pressing the buttons and or wait until the system leaves the menu item automatically.
3. Ramp
Whenever the turbine has been started, the microcontroller of the device checks whether a soft start ramp has been programmed.
While the programmed time elapses, the soft start function increases the pressure from an adjustable initial ramp pressure (P-ramp) up to the pressure prescribed, thus allowing you to fall asleep more easily.
In particular if you are not yet used to the respi­ration therapy the soft start can help you get accustomed to the device and fall asleep easily.
The device allows delay times ranging from zero (the prescribed therapy pressure is applied at once) to 60 minutes (the prescribed therapy pressure is built up within 60 minutes). The initial ramp pressure (P-ramp) can be set by health professionals within a range from 4 hPa to the pressure prescribed. To set the ramp, first go to the Patient menu (press the button for approx. 1 second), then select »Ramp« with the buttons  and . Press the button. Now select the desired time by pressing the buttons  and . Press to confirm.
CPAP
CPAP
CPAP
CPAP
The pressure is gradually increased up to the therapeutic pressure
Pressure prescribed: 10 hPa (mbar)
Time in min.
Programmed softstart time (0 - 60 min.)
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4. Mask test
This parameter determines the time when the device performs a mask test. Put on the mask and start the device.
To ensure that the mask is tight while the pres­sure slowly increases in the soft start ramp even with higher pressures, you can program a mask testing time of up to 90 seconds in 5­second intervals. This mask test is carried out before the ramp is started. It checks whether the mask is tight even under the maximum the­rapy pressure. If the FLEXLINE mode is switched on, the pressure is raised by 1 hPa at FLEX level 1, 2 hPa at FLEX level 2 and 3 hPa at FLEX level
3.
To set the mask test, first go to the Patient menu (press the button for approx. 1 second), then select »Mask test« with the buttons and . Press the button. Now select the desired time by pressing the buttons and . Press to confirm.
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CPAP
The pressure is gradually increased up to the therapeutic pressure
Pressure prescribed: 10 hPa (mbar)
Time in min.
Programmed softstart time (0 - 60 min.)
Pressure in hPa (mbar)
Mask Test
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5. Automatic mode
This parameter determines if the device starts the therapy automatically as soon as you put on the mask.
To program the automatic mode go th the Patient menu (hold down the for approx. 1 second) and then select the desired setting with the help of the button. If »OFF« is programmed you have to switch the device on and off by pressing the operating button.
If the automaic is set to »ON« you simply have to put on the mask and breathe normally. The device will then start the therapy automatically.
If you want to end the therapy simply take off the mask. After 5 seconds the device will switch off automatically. In the automatic mode, the device is turned off if the mask or the tubing slip off unnoticed during the night.
Therefore the device offers you the function »Automatic OFF« with mask alarm. Then you have to switch on the device in the evening and switch it off in the morning by pressing the operation button (ON/OFF) but you also receive an acoustic warning in case of a leakage.
Pressing the ON/OFF button will not end the therapy. You only get the message to take off the mask.
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6. Brightness
In this menu item you can set the brightness of the display.
To do so go to the Patient menu (hold down the button for approx. 1 second). Then select »Brightness« by pressing the buttons and . Press the button. After pressing the button the currently set brightness will flash and can then be adjusted by pressing the buttons  and  in intervals of 10%. Press for accepting the selected brightness. If no button is pressed for 15 seconds the device will select the brightness previously set by you. After pressing any button the brightness will automatically switch to 100% for better visibility.
7. Date
Use this menu item to set the date.
To do so go to the Patient menu (hold down the button for approx. 1 second). Then select »Date« by pressing the buttons and . Press the button. After pressing the button the year will flash and can be set by pressing the buttons  and . After pressing the button again the month will flash and can be set by pressing the buttons and . After pressing the button again the day will flash and can be set by pressing the buttons  and . Press the button again to accept the set date.
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8. Time
Use this menu item to set the time.
To do so go to the Patient menu (hold down the button for approx. 1 second). Then select »Time« by pressing the buttons and . Press the button. After pressing the button the hour will flash and can be set by pressing the buttons  and . After pressing the button again the minutes will flash and can be set by pressing the buttons and . Press the button again to accept the set time.
With its built-in battery, the internal clock has a reserve power of 8 years without connection to the external power supply.
CLINIC MENU
In addition to the parameters in the Patient menu, in the Clinic menu parameters relevant for the therapy can be set. This menu is used only by health and service professionals. In the Clinic menu the following patient and device relevant data can be shown and changed.
For some parameters you have to enter a PIN first to prevent wrong parameter setting. Your doctor and specialized dealer know this PIN.
Please do not try to find out the PIN. If you are in doubt as to whether the set parameters are cor­rect, please consult your physician.
1. Language
The device can emit display messages in German (DEU), English (ENG), French (FRA), Italian (ITA), Dutch (NLD), and Polish (PLK). Further languages can be implemented at any time.
For changing the language go to the Clinic menu (hold down the button for approx. 1 second). Then select »Language« by pressing the buttons  and . Press the button. Each time you press the button another language will appear. Leave the menu once the desired language is selected. The device will then save the new language.
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2. P-Unit
The device can show the pressure in the pressure units hectopascal (hPa), millibar (mbar), and und centimeters of water (cmH2O).
For changing the pressure unit go to the Clinic menu (hold down the button for approx. 1 second). Then select »P-unit« by pressing the buttons and . Press the button. Each time you press the button another pressure unit will appear. Leave the menu once the desired pressure unit is selected. The device will then save the new unit.
PLEASE NOTE! When changing the pressure unit from hPa or mbar to cmH2
O the pressure will slightly
change.
Example: 8 hPa = mbar are set. At 8 cmH
2O the pressure is 7.8456 hPa/mbar.
1 cmH2O = 0.9807 hPa.
3. Turbine
This menu item shows the total operating time of the turbine, the filter, and the therapy time.
3.1 Turbine
The counter indicates the total turbine running time.
3.2 Filter
The counter indicates the operating hours of the filter since the last reset.
3.3 Therapy
The counter indicates the operating time with the therapy pressure applied.
3.4 Standby
This counter indicates the time the device was in the standby mode.
To display the counter go to the Clinic menu (hold down the button for approx. 1 second). Then select »Turbine« by pressing the buttons and . Press the button. Each time you press the button now you see the next counter.
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4. Mode
The device can be operated in the CPAP-mode and in the FLEX-mode. The FLEXLINE mode is a comfort mode of the CPAP therapy.
Proportional to the patient flow, the pressure is increased during inspiration and reduced during expiration. This has the following results:
• Breaths come more natural and agreeable thanks to reduced breathing work during inspiration and expiration
• Reduction of the mean therapy pressure
For changing the mode go to the Clinic menu (hold down the button for approx. 1 second). Then select »Mode« by pressing the buttons and . Press the button.
Now the device will prompt you to enter the PIN. The first digit is flashing. Enter the first digit of the PIN with the help of the  and  buttons. After pressing the button the second digit will flash. Enter the second digit of the PIN with the help of the and buttons, and proceed as described for the first digit. Enter the third digit accordingly.
After entering the last digit of the PIN you can switch between the CPAP- and FLEX-mode by pressing the button. Leave the menu once the desired mode is selected. The device will then save the new mode.
5. Pressure
For changing the pressure go to the Clinic menu (hold down the button for approx. 1 second). Then select »Pressure« by pressing the buttons  and . Press the button. Now the device will prompt you to enter the PIN. The first digit is flashing. Enter the first digit of the PIN with the help of the  and  buttons. After pressing the button the second digit will flash. Enter the second digit of the PIN with the help of the and buttons, and proceed as described for the first digit. Enter the third digit accordingly. After entering the last digit of the PIN you can set the pressure by pressing the buttons and . The confirm the selected pressure by pressing the button.
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6. FLEX-Level (The FLEX level is shown only
if the FLEX-mode is activated.)
The value of pressure increase and pressure decrease depends on the value of the breath flow, the set FLEX levels and the set therapy pressure. The three FLEX levels (1-3) are for individual adjustment to the patients requirements:
• FLEX-Level 1 low pressure support
(P
max
< + 1 hPa)
• FLEX-Level 2 medium pressure support
(P
max
< + 2 hPa)
• FLEX-Level 3 high pressure support
(P
max
< + 3 hPa)
For changing the FLEX level go to the Clinic menu (hold down the button for approx. 1 second). Then select »FLEX-Level« by pressing the buttons  and . Press the button. Now the device will prompt you to enter the PIN. The first digit is flashing. Enter the first digit of the PIN with the help of the  and  buttons. After pressing the button the second digit will flash. Enter the second digit of the PIN with the help of the  and  buttons, and proceed as described for the first digit. Enter the third digit accordingly. After entering the last digit of the PIN you can set the FLEX level by pressing the buttons  and . Then confirm the selected level by pressing the button.
13
Examples for pressure changes in the FLEXLINE mode
respiratory rate = 20 bpm, R5, C50, therapy pressure 10 hPa
CPAP
FLEX-Level Peak flow
Inspiration [l/s]
Peak flow
Expiration [l/s]
Pressure increase
Inspiration [hPa]
Pressure decrease
Expiration [hPa]
1
0,25 0,20 0,35 0,35 0,50 0,40 0,65 0,55 0,75 0,65 0,95 0,70
2
1,00 0,85 1,00 1,00 0,25 0,20 0,50 0,45 0,50 0,35 0,85 0,65
3
0,75 0,65 1,35 1,00 1,00 0,95 1,85 1,40 1,25 1,35 2,00 2,00
0,50 0,35 1,05 0,95 0,75 0,65 1,70 1,35 1,00 0,90 2,20 1,80 1,25 1,15 2,85 2,55 1,40 1,35 3,00 3,00
0,25 0,20 0,55 0,60
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13
Therapy Filter Ramp P-Ramp
Info-Menu
MENU OVER
VIEW
Patient-Menu Clinic-Menu
Mode Pressure FLEX-Level
Wake Time Reset Filter Ramp Mask Test
Date Time
Automatic
Mode Pressure FLEX-Level Ramp
P-Ramp
Mask Test Automatic
Language P-Unit Turbine
Filter Therapy Standby
Date Time
Reset Filter
Wake Time
Brightness
Brightness
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14
Pain in nose, paranasal sinuses or ears
Inflammation Stop therapy and contact your
physician
Unpleasant feeling of too high pressure
Unwellness with prescribed high pressure values
If you think there is a mistake, consult a physician.
Pressure tolerance not comple­tely acquired yet
Relax, use or alter the soft start function
Dryness and irritation of nose and throat
Air too dry Device probably without air
humidifier; consult a physician and consider prescription of retrofitting a humidifier.
Inform the attending physicianReturn of original sleep apnea
symptoms
Different physical condition and different conditions of living
Return the device to the service to have it checked.
Device failure
Problem Possible Course Remedy
Check the device for proper setup
No air flow Device defective
Very low air flow Soft start function active Reduce softstart time
Air sensed to be too warm Filter dirty Exchange filter
Notify the service
Air ducts clogged Check air inlet
Air inlet obstructed
Increase the distance between device and radator
Radiator in the vicinity of the device
Water in the measuring tube Remove the water
TROUBLESHOOTING
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14
Blower constantly at maximum speed
Measuring tube not connected or clogged
Check the measuring tube
Device leaky Return the device to the service
to have it checked.
Water in the measuring tube Remove the water
Problem Possible Course Remedy
Therapy pressure not steady
Check of bendsMeasuring tube bent
Water in the measuring tube Remove the water Device defective Notify the service
Common cold
Replace the mask if its material has become brittle
Increase the air humidity in the room or set the humidifier to a higher level
Running nose, urge to sneeze Reaction to the air flow
Cold nose Room temperature too low Increase the room temperature,
warm up the tubing under your pillow
Irritation of the eyes or dry eyes Air escaping from between the
mask and the skin of your face
Check the mask for proper positioning
Consult a physician
Redding of the skin in the area of the mask, swelling of the skin
Wrong mask size Inform the attending physician Head gear too tight Head straps loosened allergical reaction Inform the attending physician
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15
DISPLAY MESSAGES
The sections below describe the most important display messages. All further messages will be clear from their context.
You have 45 sec left for seating the mask properly. Once this time has elapsed, the device starts with the soft start function or the therapy.
There will be 10 min and 45 sec left until the full therapy pressure is reached.
The mask has slipped off your face or you failed to put the mask on your face while the automatic mode was turned off and the blower was running.
You pressed the key during operation. There will be a message that you will be wakened at 07.00 hours.
There will be 1 min and 18 sec left until the alarm clock will waken you again.
The wake alarm has been initiated. Press the ON/OFF operator key once to initiate the slumber phase. Press the key once again to turn off the alarm clock completely.
You pressed the operator key and stopped the slumber phase.
You pressed the key in the normal operating mode. There will be a message that the alarm clock has been turned off.
The automatic function is turned on. You are prompted to put on the mask and breath through your nose.
CPAP
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15
The therapy pressure is too high and the turbine switches off.
There was an attempt to turn off the device manu­ally while the automatic function was activated. Please take off the mask. After a few seconds the device will turn off the therapy pressure.
After the line voltage has been restored, the turbine restarts automatically.
There has been an error during the system start after switching on the voltage supply.
Contact your dealer.
You have taken down the mask or the mask has slipped off your face while the automatic function was activated. The turbine will turn off after 4 seconds.
The PIN you have entered is wrong. Please enter the correct PIN.
There has been an error during the system start after switching on the voltage supply.
Contact your dealer.
The Clinic menu has been activated.
The Patient menu has been activated.
Exchange filter.
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MAINTENANCE
Although all parts of the device have a very long service life, the device should be maintenanced from time to time. The device should be maintenanced when the message:
apears in the display. We urgently recommend a technical maintenance through our authorized customer service, since only they have the necessary tools and measuring instruments. Even if »Maintenance« appears in the display the device is still fully functional.
ATTENTION! The display message »Maintenance« must not be removed during checks at non-authorized workshops.
In between maintenance intervals you yourself can contribute to increasing the service life and to maintaining proper and reliable functioning.
1. Please observe the cleaning instructions given on the pages 18 and 19.
2. Check the system at regular intervals.
Proceed according to the following check list:
• Visually check whether the device is damaged and/or dirty on its outside
• weekly check of the »Power failure« warning function (see page 20)
• weekly check of the »Mask alarm« function (see page 20)
Preparing the device for a different patient:
If the patient using the device changes, the device must be hygienically prepared by a specialized dealer or by the manufacturer. The necessary pro­cedure is described in detail in the appropriate hygiene plan.
Disposal of the device:
For information on the proper disposal of the device, please contact your responsible customer service.
Disposal of the packaging:
You can return the packaging to your marketing partner or dispose it separately with your normal domestic waste.
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CPAP
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TECHNICAL DATA
Dimensions (W x D x H) 230 x 212 x 107 mm Weight ca. 2,0 kg Power supply 100 V~ ... 240 V~, 50 ... 60 Hz, 24 V DC / 2,1 A Pressure range 4 … 20 hPa (mbar) Max. limit pressure in the event of an error < 30 hPa (due to engineering) Power consumption max. 50 W Power consumption at 12 hPa 10 W (24 V DC-operation) (without humidifier) 12 W (External power supply) Power consumption at 12 hPa 32 W (24 V DC-operation) (with humidifier, Step 5) 35 W (External power supply) Power consumption Stand-by < 5 W Pressure variance < 0,3 hPa (mbar) at 20/min acc. to DIN EN ISO 17510-1 Noise level without mask < 25 dB(A) at 10 hPa (mbar) Air delivery volume > 170 l/min at 6 hPa therapy pressure
> 160 l/min at 12 hPa therapy pressure > 150 l/min at 18 hPa therapy pressure
> 120 l/min at 20 hPa therapy pressure Air warming 2 - 3 °C at 10 hPa Heater level operating temperature + 5 °C ... + 40 °C Storage temperature - 20 °C ... + 70 °C Air Humidity 10 ... 95 % humidity (operation and storage) Operating Altitude - 400 m ... 3500 m (1060 hPa ... 700 hPa)
(height above sea level) Filtration efficiency up to 1 μm 99,5 %
CE mark according to EC Directive 93/42/EEC, device in compliance with MDD, Class IIa
The technical specifications are subject to technical modifications
17
Page 40
MANUFACTURER
VECTOR et-eng-0108-02
HOFFRICHTER GmbH
Mettenheimer Str. 12/14 D-19061 Schwerin Germany Telefon: +49-385-39925-0 Fax: +49-385-39925-25 www.hoffrichter.de [email protected]
CPAP
HOFFRICHTER
et
23
HOFFRICHTER G
m
bH
M
ettenheimer Str 12/14 19061 Schwerin G
erm
any
AXJ07 00001
VECTOR et
HOFFRICHTER
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