Hoffrichter point 2 User Manual
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Hoffrichter point 2 User Manual

Respiratory therapy device
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HOFFRICHTER GmbH
Mettenheimer Straße 12 / 14
19061 Schwerin
Germany
Phone: +49 385 39925 - 0
Telefax: +49 385 39925 - 25
E-Mail: info@hoffrichter.de
www.hoffrichter.de
point 2 ENG_2019-06-05_16.0
5
0
0
0
0
5
1
0
point 2
Respiratory therapy device
User's manual
valid for:
point 2 CPAP (Device type 5CPJ00)
point 2 AutoCPAP (Device type 5CPJ10)
point 2 BILEVEL ST20 (Device type 5CPJ30)
point 2 BILEVEL ST25 (Device type 5CPJ50)
as of device software 5.000

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  • Page 1 E-Mail: info@hoffrichter.de www.hoffrichter.de User‘s manual valid for: point 2 CPAP (Device type 5CPJ00) point 2 AutoCPAP (Device type 5CPJ10) point 2 BILEVEL ST20 (Device type 5CPJ30) point 2 BILEVEL ST25 (Device type 5CPJ50) as of device software 5.000 point 2 ENG_2019-06-05_16.0...
  • Page 3 The respiratory device may only be operated and maintained by trained personnel. The following documents are available for point 2 pro in addition to this user’s manual: • Brief instructions • Service manual...
  • Page 4 Serial number Every HOFFRICHTER GmbH device is supplied with a serial number for traceability pur- poses. Please enter your device‘s serial number here. You will find the serial number on the rating plate on the back of the device..........

  • Page 5: Table Of Contents

    Contents Chapter 1 ..................7 Introduction ......................7 Scope of delivery ....................8 Symbole ........................ 9 Intended purpose ....................13 User qualifications ....................15 Chapter 2 ..................17 Safety Information ....................17 General safety instructions ................... 18 Electrical safety ....................20 Installation requirements and transport ..............21 Instructions before commissioning ...............
  • Page 6 Using an SD card ....................70 Storage of therapy data ..................73 Chapter 7 ..................77 Warnings ......................77 Mask warning ..................... 78 Pressure warning ....................78 Alarm clock ......................78 Chapter 8 ..................79 Cleaning and Disinfection ..................79 Important information ..................80 Cleaning the device .....................

  • Page 7: Chapter 1

    Chapter 1 Introduction Introduction...

  • Page 8: 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 filter (2 pack) Carrying case Ventilation mask (optional) with exhalation valve Different of mask systems are available.

  • Page 9: Symbole

    Symbole Symbols on the packaging Symbol Meaning European Article Number Article number Serial number CE mark and number of the notified body. The medical device complies with the relevant requirements of the EU Directive 93/42/EEC for medical devices. Transport and store the package with the arrows are pointing upwards Fragile package Keep dry! If the packaging is damaged, do not use the device.
  • Page 10 Symbols on the rating plate The rating plate is located on the back of the device. JAB122020 24V DC / max. 2.0A Symbol Meaning Protection class II (protective insulation) BF application part Serial number CE mark and number of the notified body. The medical device complies with the relevant requirements of the EU Directive 93/42/EEC for medical devices.
  • Page 11 Symbols on the device Symbol Meaning Connections 24 V DC DC connection RS232 interface Port : PC/RC Follow the user’s manual. Operation Selection keys Enter key ON/OFF key Introduction...
  • Page 12 Symbols used in this user’s 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 material damage. In addition, the local accident prevention regulations and general safety regulations in force in the area of use must be observed.

  • Page 13: Intended Purpose

    Pressure) is a respiratory therapy device, which provides an event-driven therapy pressure adjustment within preset pressure limits. The point 2 BILEVEL ST20 and the point 2 BILEVEL ST25 (ST = Spontaneous, Timed) are respiratory therapy devices, which enables two independently adjustable pressure levels depending of inspiration and expiration.
  • Page 14 Indication The point 2 can be used for the following indications: • Obstructive ventilation disorders (e.g., COPD) • Restrictive ventilation disorders (e.g., scoliosis, thorax deformities) • Neurological, muscular and neuromuscular disorders (e.g., diaphragmatic paralysis) • Central respiratory regulation disorders • Obstructive sleep apnoea syndrome (OSAS) •...

  • Page 15: User Qualifications

    Side effects There is the possibility of undesirable side effects occurring with respiratory the- rapy. 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. You will find suitable counter measures for some side effects in the section „Trou- bleshooting“...
  • Page 16 Introduction...

  • Page 17: Chapter 2

    Chapter 2 Safety Information Safety Information...

  • Page 18: General Safety Instructions

    General safety instructions Risk of injury from incorrect device settings! • Only qualified, trained, specialist medical staff under the supervision of a physician may make settings on the respira- tory therapy device. • Check the therapy parameter settings after servicing work. Risk of infection from germs! •...
  • Page 19 • Before being used again on another patient, all parts that come into contact with respiratory gas must be hygienically prepared. • Equipment which is not part of the respiratory therapy system must not be con- nected. Otherwise it can lead to functional deficiency or device failure. •...

  • Page 20: Electrical Safety

    • Do not try to open the device or the power supply unit. Maintenance and repairs may only be performed by personnel authorized by HOFFRICHTER GmbH. • Do not touch live parts of the power cable or power supply unit if they are faulty.

  • Page 21: Installation Requirements And Transport

    Installation requirements and transport Danger of injury due to insufficient air supply! The device must not be covered or positioned in such a way that its operation or function is adversely affected. Ö Do not place the device close to curtains that prevent the flow of cooling air and would lead to the device overheating.

  • Page 22: Instructions Before Commissioning

    Instructions before commissioning Risk of injury from incorrect pressure measurement! Nebulizing or humidification can increase the resistance of respiratory system filters. The user must regularly examine the respiratory system filter for increased resistance and blockage to ensure delivery of the therapeutic pressure. •...

  • Page 23: Using Oxygen

    Using oxygen • Please be sure to observe the user’s manual of the manufacturer or distributor from whom you obtain the oxygen. • The patient must be advised about the use of oxygen. • When oxygen is being used, appropriate training must be carried out in the home environment.
  • Page 24 Safety Information...

  • Page 25: Chapter 3

    Chapter 3 Description of Device Description of Device...

  • Page 26: Device Description

    Device description JAB122020 24V DC / 2.0A Control panel and display Humidifier lock Therapy tube connection Contact socket for humidifier Control panel for humidifier SD card slot Rating plate Air inlet for baro sensor DC power connection 10 RS232 interface 11 Filter or connection port for the filtersystempoint 2 12 Display 13 ON/OFF key...

  • Page 27: How The Device Works

    Control unit The point 2 has an inbuilt microcontroller to control all its functions. Further comfort functions include a soft start ramp, automatic start / stop and adjustable display brightness.

  • Page 28: 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 ope- rating 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 29: Chapter 4

    Chapter 4 Commissioning Commissioning...

  • Page 30: General Information

    • Never operate the device without the air filters. • Only use original HOFFRICHTER filters. • If the device was previously in an environment where the air temperature was very different from the operating location, you must wait at least 1 hour before starting it to allow the temperature to adjust.
  • Page 31 3. Connect the mains cable to the power supply and its plug to a power socket. Please note: Avoid placing the power supply unit and power supply cable in such a way that one can trip over it and accidentally disconnects the device from the power supply.
  • Page 32   The point 2 can be kept in standby mode permanently. This does not harm it. If the powerpackpoint 2 is fitted on the device, the batteries are charged in standby mode. The charging process is indicated by a flashing battery symbol on the display.

  • Page 33: Power Failure

    It is thus no longer necessary to check measurement accuracy. To allow this method to function, the point 2 has to be put on standby from time to time. Here it is sufficient to run the device in this mode for just a few seconds before and after each starting up of the blower to allow the software to collect and apply the necessary data.

  • Page 34: Using Oxygen

    Using oxygen Risk of fire and burns! Oxygen sources should be at a distance of more than 1 m from the device in order to avoid the risk of fires and burns. Please note: • Before using oxygen, the safety instructions as of page 23 must be read. •...
  • Page 35 Supplying oxygen via an adapter source Mask pressure valve Therapy tube supply adapter The O supply adapter and O pressure valve you can order as accessory (see page 98). Starting the supply of oxygen 1. Before starting the treatment, check that the tube connections are fitted correctly. 2.

  • Page 36: Operation With The Humidifier Aquapoint 2

    • The outer surface of the humidifier may become warm heating. To moisten the respiratory air, the device can be operated with the integrable aqua- point 2 humidifier. The humidifier features an integrated heating system for heating the humidifier water.

  • Page 37: Chapter 5

    Chapter 5 Therapy Modes Therapy Modes...
  • Page 38 The point 2 is equipped with the following therapy modes depending on the type of device: Mode CPAP APAP BILEVEL Device type point 2 CPAP (Type 5CPJ00) • point 2 AutoCPAP (Type 5CPJ10) • • point 2 BILEVEL ST20 (Type 5CPJ30) •...
  • Page 39 APAP (only point 2 AutoCPAP) In APAP mode (Automatic Positive Airway Pressure), the point 2 automatically con- trols the therapy pressure in relation to the respiratory events occurring. The device is equipped with a special sensor system that can reliably distinguish between obstruc- tive apnea (airways are closed) and central sleep apnea (respiratory arrest with open airways).
  • Page 40 Changes in pressure are only possible within the adjustable pressure range of the point 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 calcu- late the leakage flow.
  • Page 41 FLEX settings Pressure [hPa] Pressure curve Flow [l/s] = Flow Leakage flow resistance 3 hPa/ (l/s) 2 hPa/ (l/s) 1 hPa/ (l/s) Respiration flow curve Therapy Modes...
  • Page 42 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 inspration (IPAP) and expiration (EPAP). Selecting an an optimal slope can facilitate patients therapy compliance. A precise adjustment may further convey the feeling of natural respira- tion without any delay.
  • Page 43 BILEVEL T In contrast to BILEVLE S, at BILEVEL T spontanous breating efforts will not be conside- red. Based on fixied 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 44 BILEVEL ST As long as the patient is breathing spontaneously the device is operating in the S mode. If the patient stops breathing, the device automatically switches to the T mode. Once a total time lag (expiration time + delay time) has elapsed the device switches into the T mode.

  • Page 45: Chapter 6

    Chapter 6 Operating the Device Operating the Device...

  • Page 46: General Operating The Device

    General operating the device There are three keys for programming point 2‘s functions: = Selection key = Selection key = Enter key If the enter key is pressed for a prolonged time, you enter the programming mode and the menu appears on the display.
  • Page 47 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 set- ting the therapy.
  • Page 48 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 • •...
  • Page 49 Parameters in point 2 AutoCPAP point 2 AutoCPAP Standard menu Complete menu Parameter CPAP APAP CPAP APAP • • Language • • P-Unit Power Blower • • Filter Therapy Date • • • • Time • • • • Wake Time •...
  • Page 50 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...

  • Page 51: Description Of Parameters

    Description of parameters 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 47). ...
  • Page 52 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.     Date 2. Use the selection keys to select ...
  • Page 53 Wake up time Please note: Ex factory, the alarm clock function is not enabled. But it can be unlo- cked 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.
  • Page 54 Pressure (only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20/25 in CPAP mode) Selection of pressure by the physician Please note: When the pressure parameter is changed during therapy/titration, the device adapts to the new setting slowly (25 Pa/s).
  • Page 55 Confirm your setting by pressing the enter key IPAP (only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST) Selection of inspiration pressure (IPAP) by the physician 1. Select the complete menu (see page 47).
  • Page 56 EPAP (only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST) Q   MMMMMMMMMMA ;$ 4%/ !*1 Selection of expiration pressure (EPAP) by the physician 1. First set IPAP. 2. Use the selection keys to set the desired value. Confirm your setting by pressing the enter key The parameter I-Slope is set next.
  • Page 57 E-Slope (only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST) (+,! MMMMMMMMMMMMMM= 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 58 Confirm your setting by pressing the enter key The parameter Delay Time is set next (only point 2 BILEVEL ST20/25 in BILEVEL ST mode). Delay Time (only point 2 BILEVEL ST20/25 in BILEVEL ST mode) Q !(5 %)! MMMMMM>0...
  • Page 59 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 characte- rized by following fixed parameters: •...
  • Page 60 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. Confirm your setting by pressing the enter key The parameter P-Start is set next.
  • Page 61 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 62 • there is a change within the therapy system. If a bacterial filter or a humidifier is added/removed the calibration has to be redone. Ex factory, the point 2 is pre-calibrated for using with a Cirri Comfort nasal mask (size M) without humidifier and without bacterial filter.
  • Page 63 Ramp After every blower start, the device‘s microcontroller checks whether a soft start ramp has been programmed. The soft start function slowly increases the pressure over the time programmed by you, starting with a programmable initial 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 64 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 The pressures is increased gradually to Pressure [hPa] the prescribed therapy pressures...
  • Page 65 =@ 5 << ==L <@ As soon as you begin breathing, the point 2 blower switches on. When you take the mask off, the blower switches off automatically after a 5 second delay. The blower also switches off when the mask slips off your face or a leak that cannot be compensated for occurs.
  • Page 66 Setting automatic mode 1. Select the complete menu (see page 47). Auto 2. Use the selection keys to select 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. Display Vt When the function „Display Vt“...
  • Page 67 Bact.Filter As pressure measurement is influenced by the connection of a bacterial filter, it must be specified on the device whether or not a bacterial filter has been connected. Select whether a bacterial filter is connected (by the physician) 1. Select the complete menu (see page 47). ...

  • Page 68: Important Display Messages

    Important display messages The most important display messages are listed below. All further messages will be clarified from the given context.   The values shown here are examples.    You still have 15 seconds to ensure that the mask is fitted correctly.
  • Page 69     After the mains voltage is restored, the blower re-starts automatically.     The complete menu has been deactivated by the PC software TRENDset and cannot displayed. Please note: Ex factory, the alarm clock function is not enabled. But it can be unlo- cked by the physician or dealer with TRENDset PC software.

  • Page 70: Using An Sd Card

    TRENDset and send them to the patient to update its therapy requirements. As soon as the SD card is inserted, the device imports the modified therapy parameters. Please note: Only HOFFRICHTER SD cards can be used. These has to be formatted by TRENDset (see page 97).
  • Page 71 Removing the SD card Please note: Only remove the SD card in standby mode. Otherwise data may be lost or the SD card might be damaged. 1. Ensure that the device is in standby mode (see page 32). 2. Carefully push the SD card into the card slot. 3.
  • Page 72 The following table shows all error codes that can occur in connection with the use of the SD card. Error Meaning Remedy code Writing data has failed. Possible causes The SD card is probably faulty. Remove are power failure, removal of card during the SD card and then insert it into the writing or a faulty SD card.

  • Page 73: Storage Of Therapy Data

    Storage of therapy data Therapy data is stored internally in the device and alternatively on an SD card. The data from the device and the SD card can be readout by the physician using the TRENDset PC software. Internal device memory The internal device memory is limited to 30 days SD card In contrast to the internal device memory the SD card offers a capacity of more than...
  • Page 74 2 CPAP and point 2 AutoCPAP Therapy data Internal device SD card memory • Frequency • • Central Sleep Apnea • • Obstruktive Sleep Apnea • • Mixed Sleep Apnea • • Hypopnea • • Snoring • • Mode •...
  • Page 75 2 BILEVEL ST20/25 Therapy data Internal device SD card memory • Frequency • • Mode • • Adjustment • • Leakage • • Average System Flow Therapy Pressure (low resolution) • no Bilevel pressure changes visible Therapy Pressure (high resolution) •...
  • Page 76 Operating the Device...

  • Page 77: Chapter 7

    Chapter 7 Warnings Warnings...

  • Page 78: Mask Warning

    Mask warning If the mask slips off your face, the tube is pulled out or any other leak occurs that can- not be compensated for, the device does not switch off automatically but emits an    acoustic and visual warning. ...

  • Page 79: Chapter 8

    Chapter 8 Cleaning and Disinfection Cleaning and Disinfection...

  • Page 80: Important Information

    Important information • Before cleaning the device, remove the power plug from the power supply. • The directions given in this user’s manual and the applicable regulations of the hospital or nursing home must be adhered to when cleaning the device. •...

  • Page 81: Changing The Filter, Cleaning

    Changing the filter, cleaning The filter 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. In extreme cases, unpleasant odors might result after a while.
  • Page 82 Cleaning the filter 1. Clean the filter with mild soapy water. Do not use any other agents! 2. Rinse the filter thoroughly with clear water. 3. Let the filter dry completely. 4. Insert the cleaned filter into the device. If the device is run with the optionally available filtersystempoint 2 according to the cleaning instructions in the filter system user‘s manual.
  • Page 83 Cleaning the humidifier Please note: When using a humidifier, the cleaning instructions in its user‘s manual must be observed. Cleaning and Disinfection...

  • Page 84: Use Of The Device By Several Patients

    Use of the device by several patients If the device is intended for use by more than one patient (e.g., when operated in clin- ics), a suitable bacterial filter (e.g., Medisize Barr-vent S) must be used continuously to protect the device from contamination by human pathogens. The bacterial filter must be changed daily.
  • Page 85 The following measures must be taken before the device may be used on another patient: Component What must be done? Bacterial filter Replace Coarse and fine filters Replace Mask Replace or, if permitted, reprocess as per the manufacturer's instructions Tube system Replace or, if permitted, reprocess as per the manufacturer's instructions Humidifier...
  • Page 86 Cleaning and Disinfection...

  • Page 87: Chapter 9

    Chapter 9 Annex Annex...

  • Page 88: Instructions For Home Therapy

    Instructions for home therapy Before the patient uses the respiratory therapy device independently at home, please note the following: 1. Adjust all the parameters and settings to home therapy. 2. Instruct the patient or care staff in how to use the device. Also explain which accessories may be used and how the device must be maintained and looked after.

  • Page 89: Troubleshooting

    Troubleshooting Problem Possible cause Remedy Pain in the nose, the paranasal Inflammation of the parana- Stop the treatment and contact sinuses or the ears sal sinuses or the middle ear your physician Unpleasant feeling because of Malaise with prescribed high If you suspect an error, please the high pressure pressure values...

  • Page 90: 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 91 2 point 2 with aquapoint 2 Short term pressure variation point 2 ST25 in hPa 14.5 14.5 10 bpm 0.12 0.15 0.17 0.27 0.33 0.14 0.13 0.25 0.51 0.64 15 bpm 0.18 0.19 0.24 0.30 0.37 0.21 0.19 0.31 0.65 0.81 20 bpm 0.30 0.30 0.33 0.37 0.43 0.46 0.31 0.47 0.73 0.91...

  • Page 92: Measured Values

    2 point 2 with aquapoint 2 Filter Polyurethane foam on polyester basis, 80 ppi, 30 kg/m³ Therapy tube connection 22 mm, cone (as per ISO 5356-1) Product class according to 93/42/EEC Classification according to EN Protection class II (protective insulation) 60601-1 The manufacturer reserves the right to make technical changes without notice.

  • Page 93: Setting Ranges And Control Accuracy

    0.5 hPa BILEVEL S, T, ST ≤ EPAP 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 94 Parameter Settings range Dependency Setting steps Mask Test 0 – 90 s Auto OFF, Start/Stop, Start Display Vt ON, OFF Bact.Filter Yes, No Brightness 0 – 100 % 10 % Annex...
  • Page 95 Factory settings Parameter point 2 CPAP point 2 AutoCPAP point 2 BILEVEL ST20/25 Menu Complete menu Language P-Unit Mode APAP BILEVEL ST Press. 6 hPa IPAP 10 hPa EPAP 6 hPa I-Slope E-Slope Frequenz 12 bpm 35:65 % Delay Time...

  • Page 96: Compliance With Standards

    Compliance with standards The device satisfies the following standards: • DIN EN ISO17510-1:2009-07 Sleep apnea respiratory therapy - Part 1: Sleep apnoea respiratory therapy devices (ISO 17510-1:2007); German version EN ISO 17510-1:2009 • DIN EN 60601-1:2013-12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005 + Cor.

  • Page 97: Accessories

    Accessories Please note: Follow the general safety instructions when using accessories page 18. 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...
  • Page 98 Optional Article number Humidifier aquapoint 2 0001 2949 Electronics for humidifier aquapoint 2 0001 2286 Battery pack powerpackpoint 2 0001 2846 0001 1101 AKKUPACK uni BASE “Respiratory therapy” filtersystempoint 2 0001 2847 Fine filter for filtersystempoint 2 0000 2109 Coarse filter for filtersystempoint 2 0000 2108 Bacterial filter MEDISIZE BARR-VENT S 0000 4932...

  • Page 99: Manufacturer's Declaration On Electromagnetic Compatibility

    Guidance and manufacturer’s declaration – electromagnetic emissions The point 2 ventilator is intended for use in the electromagnetic environment specified below. The user of the point 2 ventilator should ensure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 100 Guidance and manufacturer’s declaration – electromagnetic immunity The point 2 ventilator is intended for use in the electromagnetic environment specified below. The user of the point 2 ventilator should ensure that it is used in such an environment. Immunity tests...
  • Page 101 150 kHz – 80 MHz communications to IEC 61000-4-6 equipment should be in ISM and used no closer to any part of the point 2, amateur radio bands between including cables, than 150 kHz – 80 MHz recommended separation...
  • Page 102 > 95 % dip in U 60 % dip in U pital environment. If the user of the point 2 venti- input lines acc. to 1 cycle 5 cycles IEC 61000-4-11 lator requires continued...

  • Page 103: 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 con- tact the responsible customer service department to find out about the cor- rect method of disposal.

  • Page 104: Disclaimer

    Disclaimer HOFFRICHTER GmbH is not liable for consequences in terms of safety, reliability and performance of the product where: • interventions, modifications, extensions, calibration, repairs and maintenance are carried out by persons not authorized by us, • other manufacturers’ accessories and spare parts are used that have not been approved by us for use on the product, •...
  • Page 105 Annex...
  • Page 106 Annex...

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