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User‘s Manual CPAP - AutoCPAP with FLEX function...
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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..........
CONTENTS Scope of delivery ........... 6 General ..............7 Information on this user‘s manual ......7 Symbols used in this manual ....... 8 Symbols on the rating plate ....... 10 Safety Information ..........11 General safety instructions ........ 11 Electrical safety ..........13 Installation requirements and transport ....
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Power failure ............. 36 Using oxygen ............ 36 Device functions ..........38 Parameters in point 2 CPAP ......40 Parameters in point 2 AutoCPAP ....... 42 Language ............44 P-Unit ............... 44 Operating times ..........45 Date ..............46 Time ..............47 Wake up time ............
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Alarm functions of the device ....... 67 Mask alarm ............67 Pressure alarm ..........67 Wake up alarm ..........68 Important display messages ......... 69 Use of a DATA box ..........71 Changing the fi lter, cleaning........74 Cleaning the mask ..........76 Cleaning the therapy tube .........
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...
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.
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.
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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.
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.
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.
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• 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.
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.
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.
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• 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.
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. •...
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. •...
The point 2 is a respiratory therapy device designed for the treatment of sleep-related breathing disorders in patients weighing 30 kg or more. Unlike the point 2 CPAP, the point 2 AutoCPAP is a self-regulating ther- apy device. The device generates positive airway pressure which keeps the patient‘s airways open whilst asleep.
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...
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.
DEVICE DESCRIPTION JAB122020 Control panel and display Humidifi er lock Therapy tube connection Contact socket for humidifi er Control panel for humidifi er Rating plate Air inlet for baro sensor DC power connection RS232 interface 10 Filter or connection port for the fi...
This is unpleasant and in some cases may also lead to infections. Therefore, a respiratory air humidifi er may be necessary in conjunction with a CPAP treatment. Internal pres- The plug-in aquapoint 2 humidifi er is available as an sure measu- accessory to humidify respiratory air.
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.
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DC vehicle cable For mobile use of the point 2, e.g., in a truck or a car- avan, it is possible to operate it with a 24 V direct cur- rent (DC). For this you will need the optionally available DC vehicle cable.
Device type point 2 CPAP • (type 5CPJ00) point 2 AutoCPAP • • (type 5CPJ10) CPAP In CPAP mode (Continuous Positive Airway Pressure), the point 2 supplies continuous positive pressure. pressure [hPa] CPAP CPAP pressure time = inspiration = expiration...
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APAP (point 2 AutoCPAP only) In APAP mode (Automatic Positive Airway Pressure), the point 2 automatically controls the therapy pres- sure in relation to the respiratory events occurring. The device is equipped with a special sensor system that can reliably distinguish pressure between obstructive apnea [hPa]...
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The speed of pressure increase can be set to one of fi ve levels via the PC software TRENDset. 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...
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[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 Device description...
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Volume display When the function „Display Vt“ is activated, the tidal volume is displayed in ml during therapy. The value displayed is the arithmetic mean of the inspired air vol- ume from the last four breathing periods. The value is recalculated after each breathing period and shown on the display.
USING THE DEVICE COMMISSIONING Before commissioning the device, read section „Safety Information“ (starting from page 11). Set up the device according to the installation requirements (see page 14). 2. Connect the power supply to the device. 3. Connect the mains cable to the power supply and its plug to a power socket.
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Put the mask on. If automatic mode has been selected (see page 61), 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.
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.
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.
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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.
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.
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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.
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.
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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.
Please do not try to crack the PIN code. Speak to your physician if you doubt the correctness of the pressure prescription. PARAMETERS IN point 2 CPAP The following table shows which parameters can be selected in the complete and standard menu of the point 2 CPAP. point 2 CPAP Parameter Standard menu...
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2 CPAP Parameter Standard menu Complete menu Wake Time • • Press. • I-FLEX • E-FLEX • Calibration • • Ramp • P-Ramp Mask Test • Auto • Display Vt • • Bact.Filter • Brightness • next parameter is displayed by pressing the enter key...
PARAMETERS IN point 2 AutoCPAP The following table shows which parameters can be selected in the complete and standard menu of the point 2 AutoCPAP. point 2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP Language • •...
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2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP Ramp • • P-Ramp Mask Test • • Auto • • Display Vt • • • • Bact.Filter • • Brightness • • next parameter is displayed by pressing the enter key...
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 39). 2.
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.
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.
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.
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.
MODE (only point 2 AutoCPAP) 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 .
PRESSURE (only point 2 CPAP and point 2 AutoCPAP 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.
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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...
P-Min (only point 2 AutoCPAP in APAP mode) Selection of P-Min by the physician 1. Select the complete menu (see page 39). 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 .
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...
I-FLEX 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. FLEX settings will only work if spontaneous respiration is actually present.
E-FLEX 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. Selection of E-FLEX by the physician 1.
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 •...
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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).
(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.
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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 - 30 min)
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.
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.
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 39). 2. Use the selection keys to select Auto 3.
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During the therapy the display of the tidal volume replaces the display of the date. Possible displays states Display of tidal volume in ml. No valid value for the tidal volume is available yet. If the display shows the value 0 ml for the tidal volume, an apnea has occurred.
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.
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).
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“...
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.
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.
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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.
USE OF A DATA box The DATA box is an accessory that can be used in conjunction with the point 2 for the capture, storage and transmission of device and therapy data indepen- dently of the therapy device. Data is saved on an SD card which is inserted in the DATA box.
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30 days . The DATA box, on the other hand, can store data for at least one year 1, 2 Therapy data point 2 point 2 with DATA box CPAP APAP CPAP APAP Central Sleep Apnea • • Obstruktive Sleep •...
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Therapy data point 2 point 2 with DATA box CPAP APAP CPAP APAP Average System • • Flow Base Pressure •• •• Therapy Pressure (low resolution) • no FLEX pressure changes visible Therapy Pressure (high resolution) • FLEX pressure changes visible Respiratory Flow •...
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.
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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...
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...
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.
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...
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.
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...
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If there is any doubt, it should be assumed that the device is contaminated and it should be hygieni- cally prepared according to the hygiene concept. Using bacterial filters...
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...
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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...
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.
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.
0000 3440 CPAP nasal mask, size M 0000 3434 CPAP nasal mask, size L 0000 3435 CPAP full face mask, size S 0000 3441 CPAP full face mask, size M 0000 3436 CPAP full face mask, size L 0000 3437...
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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...
TECHNICAL DATA point 2 point 2 with aquapoint 2 Dimensions (W x D x H) 170 x 220 x 95 mm 180 x 350 x 110 mm Weight 1.5 kg Approx. 1.9 kg (without water) Power supply Mains power 100 … 240 V AC, 50 ... 60 Hz DC power 24 V DC / 2.01 A Battery power (per battery)
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22 mm, cone (as per ISO 5356-1) Product class according to 93/42/EEC Protection class II (protective insulation) Classifi cation according to EN 60601-1 Factory settings Parameter point 2 CPAP point 2 AutoCPAP Menu Complete menu Language P-Unit Mode APAP Press.
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Factory settings Parameter point 2 CPAP point 2 AutoCPAP P-Max 10 hPa P-Start 6 hPa I-FLEX E-FLEX Ramp 0 min Mask Test Auto Display Vt Bact.Filter Brightness 50 % CE marking as per EC directive 93 / 42 / EEC.
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-...
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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...
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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.
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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...
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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.
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...
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