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Summary of Contents for Hoffrichter CPAP
- Page 1 Quality makes the Difference User‘s manual Respiratory Therapy Device CPAP - AutoCPAP - BILEVEL ST20 - BILEVEL ST25 as of device software 5.000 point 2 5.000 ENG_2015-09-01_11 Article no.: 5000 0510...
- Page 2 HOFFRICH- TER GmbH. The HOFFRICHTER GmbH reserves the right to amend or replace this user’s man- ual without prior notice. Please ensure that you are always working with the most current version of this user’s manual.
- Page 3 SERIAL NUMBER Every HOFFRICHTER GmbH device is supplied with a serial number for trace- ability purposes. Please enter your device‘s serial number here. You will fi nd the serial number on the rating plate on the back of the device.
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Page 4: Table Of Contents
Automatic zero point correction of pressure sensor .........30 Power failure ...................31 Using oxygen ..................32 Device functions ..................34 Parameters in point 2 CPAP ..............36 Parameters in point 2 AutoCPAP .............37 Parameter in point 2 BILEVEL ST20/25 ...........38 Language ....................39 P-Unit .....................39 Operating times ..................39... - Page 5 Error messages ..................62 Storage of therapy data ................63 Internal device memory ................63 SD card ....................63 point 2 CPAP and point 2 AutoCPAP ............63 point 2 BILEVEL ST20/25................64 Changing the fi lter, cleaning................65 Cleaning the mask ..................66 Cleaning the therapy tube ...............66 Cleaning the device .................66...
- Page 6 Preparing the device for a patient change ...........68 Using bacterial fi lters ..................69 Troubleshooting ..................70 Maintenance ....................71 Disposal.....................72 Device ....................72 Packaging ....................72 Accessories ....................72 Accessories ....................73 Technical data ....................75 Manufacturer’s declaration on electromagnetic compatibility .......78 Disclaimer ....................82 Contents...
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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) User‘s manual Brief instructions Spare fi lter (2 pack) Carrying case Ventilation mask (optional) with exhalation valve Different of mask systems are available. 10 Headgear 1 optional equipment variant for use with humidifi... -
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 On The Packaging
SYMBOLS ON THE PACKAGING Range of humidity for storage and transport 1060 hPa Range of ambient air pressure for storage and transport 265 hPa +70°C Range of temperature for storage and transport -20°C SYMBOLS ON THE RATING PLATE Observe the warning and safety instructions in the user‘s manual. BF application part Protection class II (protective insulation) CE conformity declaration... -
Page 10: 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 11: 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 12: Before Commissioning
BEFORE COMMISSIONING • Do not switch the device on if it has previously been in a very cold environment. Wait for about one hour for the temperature to balance out. • Check for proper setup and proper condition of the device. •... -
Page 13: Using Oxygen
USING OXYGEN • Oxygen supports combustion. Therefore, observe the fi re protection regulations 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. • Before using any oxygen equipment for the fi... -
Page 14: Intended Use
ST20 and the point 2 BILEVEL ST25 offers the classical non-invasive ST-Bilevel therapy. The point 2 CPAP (CPAP = Continuous Positive Airway Pressure) is a respiratory therapy device, which applies a continuous positive airway pressure to the patient. The point 2 AutoCPAP (AutoCPAP = Automatically Adjusting Continuous Posi- tive Airway Pressure) is a respiratory therapy device, which provides an event- driven therapy pressure adjustment within preset pressure limits. -
Page 15: Contraindications
CONTRAINDICATIONS Respiratory therapy may be contraindicated for certain pre-existing con- ditions. Therefore, always talk to your treating physician before starting the therapy. Contraindicating pre-existing conditions include: • bullous lung diseases • pneumothorax • very low blood pressure • pneumocephalus after open craniocerebral injury or other head injuries Infl... -
Page 16: 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 17: How The Device Works
HOW THE DEVICE WORKS GENERAL The point 2 has an electronically controlled blower Air inlet to create the air pressure. In order to keep imposi- tions to the patient at a minimum, the blower has been fi tted with high power reserve capacity and Filter a rapid control response. -
Page 18: Power Supply
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 ST20/25 an operating time at least 7 hours is possible (at IPAP = 12 hPa, EPAP = 6 hPa, 12 bpm, 300 ml tidal volume, I:E = 40% : 60%, T mode). -
Page 19: Therapy Modes
• • • • point 2 BILEVEL ST25 (Typ 5CPJ50) • • • • CPAP In CPAP mode (Continuous Positive Airway Pressure), the point 2 supplies con- tinuous positive pressure. Pressure [hPa] CPAP CPAP pressure Time = Inspiration = Expiration... -
Page 20: Apap
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. The device is equipped with a special sensor system that can reliably distinguish between obstructive apnea (airways are closed) and central sleep apnea (respi- ratory arrest with open airways). - Page 21 2 and are additionally limited to ± 3 hPa. FLEX settings are not activated until after the third breathing period, as the point 2 takes a short period of time to calculate the leakage fl ow. Pressure [hPa] CPAP with I-FLEX and E-FLEX CPAP pressure Time Pressure...
- Page 22 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...
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Page 23: Bilevel S, T And St
BILEVEL S, T AND ST (only point 2 BILEVEL ST20/25) General In BILEVEL S, T and ST you can independently set the pressure during inspra- tion (IPAP) and expiration (EPAP). Selecting an an optimal slope can facilitate patients therapy compliance. A precise adjustment may further convey the feel- ing of natural respiration without any delay. - Page 24 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. The parameters will be set by the physician.
- Page 25 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.
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Page 26: Using The Device
USING THE DEVICE COMMISSIONING Before commissioning the device, read section „Safety Information“ (start- ing from page 12). 1. Set up the device according to the installation requirements (see page 13). 2. Connect the power supply to the device. 3. Connect the mains cable to the power supply and its plug to a power socket. 4. - Page 27 7. Calibrate the device as described in the chapter „Calibration“ from page 50. 8. Put the mask on. If automatic mode has been selected (see page 53), the device is turned on by the patient‘s breathing. If automatic mode has been set to „OFF“, the device is started by pressing the ON/OFF key.
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Page 28: Turning On And Off In Battery Mode
Therefore the electric and electronic components are maintenance-free. Sensors are normally temperature-compensated before being installed in CPAP devices. This process requires certain compensation tools, which are used solely by trained staff. Unfortunately, the selected values are not permanent as they vary over time due to aging, vibrations or constant changes in climate. -
Page 29: Power Failure
In order to determine an applicable correction factor, the device requires a certain amount of time in standby mode. We therefore recommend that the device is left in standby mode at least once a month between nightly therapies. The zero-point correction is particularly recommended if the device is used in a new location (e.g., when travelling) or if there are signifi... -
Page 30: Using Oxygen
USING OXYGEN If oxygen is using the therapy setting must be set, that no backfl ow of oxygen takes place into the device. Before using oxygen, it is essential to read the safety information on page 14. When supplying oxygen, please use a kink-resistant tube made of a medically approved material. - Page 31 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 oxygen supply. 3.
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Page 32: 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. top or bottom row. - Page 33 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.
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Page 34: 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 35: 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 • • Mode • Press. •... -
Page 36: Parameter In Point 2 Bilevel St20/25
PARAMETER IN point 2 BILEVEL ST20/25 point 2 BILEVEL ST20/25 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 37: 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 35). 2. -
Page 38: 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 selection keys to set the year. -
Page 39: Wake Up Time
WAKE UP TIME Ex factory, the alarm clock function is not enabled. But it can be unlocked by the physician or dealer with TRENDset PC software. To activate the wake up alarm, press . For checking purposes, the programmed wake up time is displayed for a short time. To deactivate the alarm, press The activated alarm is indicated by a bell symbol on the display. -
Page 40: Mode
Confi rm your setting by pressing the enter key PRESSURE (only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20/25 in CPAP mode) Selection of pressure by the physician When the pressure parameter is changed during therapy/titration, the device adapts to the new setting slowly (25 Pa/s). -
Page 41: Ipap
. Press the enter key after every digit. 4. Use the selection keys to select the mode. CPAP 5. Press the selection key . The menu item is now displayed. Press 6. Press the enter key and then use the selection keys to set the desired value. -
Page 42: Epap
EPAP Q MMMMMMMMMMA ;$ (only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST) 4%/ !*1 Selection of expiration pressure (EPAP) by the physician 1. First set IPAP. 2. Use the selection keys to set the desired value. Confi rm your setting by pressing the enter key The parameter I-Slope is set next. -
Page 43: E-Slope
E-SLOPE (+,! MMMMMMMMMMMMMM= (only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST) 4%/ !*1 The E-Slope determines the time of pressure decrease from IPAP to EPAP. • Level 1 = 10 hPa/s • Level 2 = 20 hPa/s •... -
Page 44: Frequency
FREQUENCY (only point 2 BILEVEL ST20/25 in modes BILEVEL T and ST) Selection of Frequency by the physician 1. Select the complete menu (see page 35). Q .!-1!* 5MM<= ,) 2. Use the selection keys to select Frequency 4%/ !*1 3. Press the the enter key and if necessary, input the PIN code with the selection keys . -
Page 45: Backup Freq
BACKUP FREQ (only point 2 BILEVEL ST20/25 in BILEVEL S mode) By activating the backup frequency ventilation will be automatically restored if patient suffers from a persistent apnea (> 15 s). Evolving mandatory ventilation is characterized by following fi xed parameters: •... -
Page 46: P-Max
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 47: E-Flex
E-FLEX (only in modes CPAP and APAP) Although the point 2 is equipped with an excellent pressure control system, an E-FLEX setting can help make expiration easier. This should however be adjusted individually for each patient. Once again, FLEX settings will only work if actual respiratory effort is present. -
Page 48: Calibration
CALIBRATION Calibration guarantees an optimum performance of the automatic func- tion and mask test. It must be performed when: • the device is used initially, • the mask has been changed, • there is a change within the therapy system. If a bacterial fi lter or a humidifi... -
Page 49: Ramp
The soft start function slowly increases the pressure over the time programmed by you, starting with a programmable ini- tial ramp pressure (P-Ramp) up to the prescribed pressure (CPAP), P-Start (APAP ) or IPAP/EPAP (BILEVEL S, T, ST ) in order to make it easier for you to get to sleep. -
Page 50: Mask Test
CPAP and APAP modes Pressure [hPa] The pressure is increased gradually to the prescribed therapy pressure 0 - 90 s Time [min] Mask test Prescribed pressure: 10 hPa Programmed ramp (0 - 45 min) BILEVEL S, T and ST modes... -
Page 51: Automatic
AUTOMATIC The automatic mode has three settings: OFF, Start/Stop, Start 1. Auto OFF (with mask alarm) With the „Auto OFF“ setting, you must switch the device on with the ON/ OFF key when therapy starts and off with the same key when therapy ends. -
Page 52: Display Vt
Setting automatic mode 1. Select the complete menu (see page 35). 2. Use the selection keys to select Auto 3. Press the enter key to set the desired automatic mode. The device can be switched on or off in any automatic mode by pressing the ON/OFF key. -
Page 53: Bact.filter
BACT.FILTER As pressure measurement is infl uenced by the connection 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 54: Parameter Settings
Yes, No Brightness 0 – 100 % 10 % only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20/25 in modes CPAP only point 2 BILEVEL ST20/25 only point 2 BILEVEL ST20/25 in modes BILEVEL T and ST... -
Page 55: 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 56: 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 57 @ ;$ $ *#! %(/!. The fi lter must be changed (see page 65). 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.
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Page 58: Using An Sd Card
As soon as the SD card is inserted, the device imports the modifi ed therapy parameters. Only HOFFRICHTER SD cards can be used. These has to be formatted by TRENDset (see page 73). INSERTING THE SD CARD 1. -
Page 59: Removing The Sd Card
5. By pressing the enter key or after 10 s the message will be disappear automatically. REMOVING THE SD CARD Only remove the SD card in standby mode. Otherwise data may be lost or the SD card might be damaged. 1. -
Page 60: Error Messages
.!00 E ERROR MESSAGES ..+. Two different types of error can be distinguished: errors with data loss and errors without data loss. The display “Exx” denotes errors in which data may have been lost. The display “Wxx” denotes errors in which data has not been lost. To hide an error message, press the enter key If error messages occur frequently, we recommend that the device is examined by a service technician. -
Page 61: Storage Of Therapy Data
All alarms that occurred are also being saved with date and time. point 2 CPAP AND point 2 AutoCPAP Therapy data Internal device... -
Page 62: Point 2 Bilevel St20/25
Therapy data Internal device SD card memory Respiratory Flow • Relative Respiratory Volume • not saved • saved •• only saved, when I-FLEX or E-FLEX are selected, but not active point 2 BILEVEL ST20/25 Therapy data Internal device SD card memory Frequency •... -
Page 63: 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 64: 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. Press the enter key Filter Counter Reset confi... -
Page 65: 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 66: Preparing The Device For A Patient Change
PREPARING THE DEVICE FOR A PATIENT CHANGE Before every change of patient a hygienic preparation must be carried out in accordance with the HOFFRICHTER’s hygiene concept. When being given to another patient, the device must be prepared hygieni- cally by the specialist dealer or the manufacturer. If reuse of the mask and the therapy tube is planned, they must also be prepared by the specialist dealer or the manufacturer. -
Page 67: 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 continu- ously be used to protect the device from contamination by human pathogens. Change the bacterial fi... -
Page 68: Troubleshooting
TROUBLESHOOTING Problem Possible cause Remedy Pain in the nose, the para- Infl ammation of the para- Stop the treatment and nasal sinuses or the contact your physician nasal sinuses or the ears middle ear Unpleasant feeling Malaise with prescribed If you suspect an error, because of the high pres- high pressure values please ask your physician... -
Page 69: Maintenance
MAINTENANCE Do not try to open the power supply. Maintenance and repairs may only be performed by personnel authorized by us. Do not try to open the device. Maintenance and repairs may only be per- formed by personnel authorized by us. You yourself can help to increase the service life of the device and ensure that it continues to work safely. -
Page 70: 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. PACKAGING The packaging is taken back by the distributor but it can alternatively be recycled. -
Page 71: 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 72 Optional Article number Battery pack powerpackpoint 2 0001 2846 AKKUPACK uni BASE “Respiratory therapy” 0001 1101 0001 2847 fi ltersystempoint 2 Fine fi lter for 0000 2109 fi ltersystempoint 2 Coarse fi lter for 0000 2108 fi ltersystempoint 2 Bacterial fi lter MEDISIZE BARR-VENT S 0000 4932 supply adapter 0000 4943...
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Page 73: Technical Data
< 6 W < 9 W < 30 W < 35 W Short term pressure variation point 2 CPAP, AutoCPAP, BILEVEL ST20 in hPa 10 bpm 0.15 0.15 0.17 0.20 0.25 0.16 0.19 0.30 0.40 0.48 15 bpm 0.23 0.24 0.27 0.32 0.38 0.24 0.31 0.45 0.58 0.72 20 bpm 0.36 0.32 0.37 0.43 0.49 0.32 0.42 0.62 0.70 0.91... - Page 74 30 dB(A) at 10 hPa level (operating at 1 m distance) (equivalent to a sound power level of 38 dB[A]) Air fl ow rate point 2 CPAP, AutoCPAP, BILEVEL ST20 4 hPa 205 l/min 172 l/min 8 hPa 189 l/min...
- Page 75 2 with aquapoint 2 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 ST20/25 Menu Complete menu Language P-Unit Mode...
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Page 76: 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 –... - Page 77 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 78 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 79 Recommended separation distances between portable and mobile RF communication equipment and the point 2 The point 2 is intended for use in an electromagnetic environment in which radiated RF distur- bances are controlled. The user of the point 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the point 2 as recommended below, according to the maximum output power of the communications equipment.
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Page 80: Disclaimer
DISCLAIMER HOFFRICHTER GmbH is not liable for consequences in terms of safety, reli- ability and performance of the product where: • interventions, modifi cations, extensions, calibration, repairs and mainte- nance are carried out by persons not authorized by us, •...
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