Hoffrichter TREND III CPAP User Manual
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Hoffrichter TREND III CPAP User Manual

Respiratory therapy device
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HOFFRICHTER GmbH
Mettenheimer Strasse 12 / 14
19061 Schwerin
Germany
Phone: +49 385 39925 - 0
Fax:
+49 385 39925 - 25
E-mail:
info@hoffrichter.de
www.hoffrichter.de
TREND III _ I Patient ENG_2022-01-18_2.0
5
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0
0
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7
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TREND III
Respiratory therapy device
User's manual
for patients
valid for:
TREND III CPAP (device type 5CPD20, 5CPD21)
TREND III BILEVEL S (device type 5CPD40, 5CPD41)
TREND III BILEVEL ST (device type 5CPD30, 5CPD31)
TREND III AutoCPAP (Gerätetyp 5CPD10, 5CPD11)
TREND III AutoBILEVEL S (device type 5CPD60, 5CPD61)
TREND III AutoBILEVEL ST (device type 5CPD50, 5CPD51)
from device software 2.01

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  • Page 1 User’s manual for patients valid for: TREND III CPAP (device type 5CPD20, 5CPD21) TREND III BILEVEL S (device type 5CPD40, 5CPD41) TREND III BILEVEL ST (device type 5CPD30, 5CPD31) TREND III AutoCPAP (Gerätetyp 5CPD10, 5CPD11) TREND III AutoBILEVEL S (device type 5CPD60, 5CPD61) TREND III AutoBILEVEL ST (device type 5CPD50, 5CPD51) from device software 2.01...
  • Page 3 ©2022 HOFFRICHTER GmbH All rights reserved. The content published in this user’s manual is the sole property of HOFFRICHTER GmbH. All forms of reproduction, editing, distribution and use of any kind, even in part, require the prior written consent of HOFFRICHTER GmbH.
  • Page 4 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 find the serial number on the rat- ing plate on the bottom of the device..........

  • Page 5: Table Of Contents

    Contents Chapter 1 ..................9 Introduction ......................9 Scope of delivery ...................... 10 Symbols ........................11 Intended use ......................15 User qualification ..................... 18 Chapter 2 ..................19 Safety Information ....................19 General safety instructions ..................20 Installation requirements and transport ..............23 Instructions before commissioning ................
  • Page 6 Operating the Device .................... 45 User profiles ......................45 Menu structure (patient mode) ................. 46 Home screen......................47 Info screen ....................... 49 Parameter screen ..................... 49 System screen ......................56 Chapter 6 ..................61 Notifications / Messages ..................61 General information ....................62 Technical messages ....................
  • Page 7 List of figures Figure 1: Rating plate (example) ..............12 Figure 2: Top of device ................... 28 Figure 3: Bottom of device ................29 Figure 4: Rear of device ................. 29 Figure 5: Setting up the device ............... 34 Figure 6: Mains connection via power supply unit ..........
  • Page 8 List of figures...

  • Page 9: Chapter 1

    Chapter 1 Introduction Please note: This patient manual is included. It does not replace the instructions for physicians and medical professionals. Chapter 1: Introduction...

  • Page 10: Scope Of Delivery

    Scope of delivery Figure Name Respiratory therapy device TREND III FUHUA ELECTRONIC CO., LTD. - UES65- Power supply 240270SPA1 Mains cable Leakage tube circuit (L = 180 cm, ∅ 22 mm) Carrying case Respiratory therapy device User’s manual for patients User’s manual for patients TREND III...

  • Page 11: Symbols

    Symbols Symbols on the packaging Symbol Meaning European Article Number Article number Serial number CE mark and number from the notified body. The medical device complies with the applicable regulations of EU 93/42/EEC for medical products. Transport and store package with arrows pointing up at all times. Fragile contents Protect from moisture! Do not use if packaging is damaged.

  • Page 12: Figure 1: Rating Plate (Example)

    TREND III AutoBILEVEL ST Type: 5CPD31 M a d e i n G e r m a n y DC-Input SN : max. 2.7 A DFmyyxxxxx HOFFRICHTER GmbH Mettenheimer Str. 12/14 IP22 19061 Schwerin Germany Figure 1: Rating plate (example) Symbol Meaning Follow the instructions in the user’s manual.
  • Page 13 Symbols on the device Symbol Meaning Connections DC connection USB interface and Micro-USB interface Control Home key Escape key On/off key Chapter 1: Introduction...
  • Page 14 Symbols used in this user’s manual Important information is denoted by symbols in this user’s manual. Please ensure that you follow these instructions in order to prevent accidents, personal injury and mate- rial damage. In addition, the local accident prevention regulations and general safety regulations in force in the area of use must be observed.

  • Page 15: Intended Use

    Intended use The device "TREND III" is used for non-invasive pressure-controlled breathing support. The device is suitable for the treatment of obstructive sleep apnea in patients over 30 kg, especially when required by higher pressures and / or forms of respiratory failure. Therapy pressure is administered via a breathing mask, which must be equipped with a passive exhalation valve to ensure exhalation air discharge.
  • Page 16 The following therapy modes are available with the TREND III, depending on the device type. Overview of the device types and modes Typ / Modus CPAP APAP TREND III CPAP • TREND III AutoCPAP • • TREND III BILEVEL S •...
  • Page 17 Combination of spontaneous breathing and controlled breathing (timed) - if the patient is capable of breathing on their own, the device works in S mode. If the patient is no longer able to breathe spontaneously, the device automati- cally enters T mode and ventilates the patient with the set frequency. The mode is switched to T mode after a set delay time lapses.

  • Page 18: User Qualification

    Side effects Administering respiratory therapy may result in undesired side effects. Causes for side effects can include improper therapy settings, incorrect use or non-compliance with cleaning instructions. Generally the side effects go away after the cause has been elim- inated. You will find suitable countermeasures for several side effects on Page 72. The following side effects may occur during therapy: •...

  • Page 19: Chapter 2

    Chapter 2 Safety Information Please note: Follow the important informations in this manual. Be sure to follow these instructions in order to avoid accidents, personal injury and material damage. Chapter 2: Safety Information...

  • Page 20: General Safety Instructions

    General safety instructions Risk of injury due to incorrect device settings! • Only qualified, trained, specialist medical staff under the specification of a physician may make adjustments to the respiratory therapy device. • Please be sure to check the therapy parameter settings after all servicing work.
  • Page 21 • For the operation of the device only the supplied power adapter may be used. Accessories or power supplies that have not been approved by HOFFRICHTER GmbH for this respiratory therapy device can lead to increased emission of electromagnetic radiation, reduced immunity to interference or increased patient leakage current.
  • Page 22 • Before cleaning the device, the plug must be disconnected from the electrical outlet. • To disconnect the device from the mains supply, unplug it. • Do not place any receptacles filled with liquids on the device. • Do not place the device anywhere near water containers (e.g. bathtubs). •...

  • Page 23: Installation Requirements And Transport

    Installation requirements and transport Risk of injury due to insufficient air supply! The device must not be covered or positioned in a way that impairs its operation or function. Ö Do not place the device near curtains that prohibit the flow of cooling air and thus can cause the device to overheat.

  • Page 24: Instructions Before Commissioning

    Instructions before commissioning Risk of injury due to incorrect pressure measurement! Atomisation or humidification can increase the resistance of respiratory system filters. The operator must regularly check the respiratory system filter for increased resistance and blockages to ensure the therapeutic pressure is generated. •...

  • Page 25: Using Oxygen

    IT network. • In the event of a cybersecurity-related accident, contact HOFFRICHTER Service if a HOFFRICHTER device is involved. Chapter 2: Safety Information...
  • Page 26 Chapter 2: Safety Information...

  • Page 27: Chapter 3

    Chapter 3 Description of Device Chapter 3: Description of Device...

  • Page 28: Top Of Device

    Top of device Display Housing panel Cover when the device is operated with- out a humidifier. Connection leakage tube circuit / inte- grable humidifier Figure 2: Top of device Multifunction knob MFK The multi-function button is used for menu navigation. Function Action Switch off the alarm clock signal...

  • Page 29: Bottom Of Device

    BILEVEL ST Type: 5CPD30 M a d e i n G e r m a n y DC-INPUT SN : DDA1700011 max. 3.75A HOFFRICHTER GmbH Mettenheimer Str. 12/14 IP22 19061 Schwerin Germany Figure 3: Bottom of device Rear of device...
  • Page 30 Explanation of symbols on the home screen Symbol Meaning Humidifier heating is on → Level 1 lowest heating level → Level 5 highest heating level Humidifier heating is in standby Humidifier heating is off Humidifier error Humidifier is not connected Alarm Clock on Alarm Clock off 1 You can find more detailed information in the instructions for use of the AquaTREND III-NG...
  • Page 31 Explanation of the toolbar icons Symbol Meaning Clinic mode active Home mode active PC is connected via the Micro-USB port, connection to “easySET” available USB stick is connected When warnings occur, no sound is emitted. There are currently device errors. A list of these errors can be called up in the sys- tem menu via the „Show Device Errors“...
  • Page 32 Explanation of symbols on the pressure bar Symbol Meaning Spontaneous breathing detected The device has detected spontaneous breathing by the patient. This triggered the inspiration trigger. The symbol will remain visible during inspiration and will shut off with the beginning of the expiration. Safety cycle active The patient is not breathing spontaneously.

  • Page 33: Chapter 4

    Chapter 4 Commissioning Chapter 4: Commissioning...

  • Page 34: General Information

    • Never operate the device without the air filter. • Only use original HOFFRICHTER filters. • If the device was previously in an environment where the air temperature was not the same as in the new operating location, allow approximately 1 hour until the temperatures have evened out before commissioning.

  • Page 35: Figure 6: Mains Connection Via Power Supply Unit

    After boot-up, the display switches to the home screen. The device requires up to 1 minute to boot Booting... before it is ready for use. SW-Version x.xxx TREND III CPAP A Loading bar B Status C Software version Figure 7: Start screen Chapter 4: Commissioning...

  • Page 36: Connect Bluetooth Adapter

    Connect Bluetooth adapter For the respiration therapy device to be connected to the "TRENDapp" patient app, a connection must be established via Bluetooth. A Bluetooth adapter B USB interface Figure 8: Connect Bluetooth adapter Plug the Bluetooth adapter into the USB interface. The connection is then automatically established between the adapter and the device.

  • Page 37: System Structure

    System structure Danger of suffocation! Use masks and accessories with the device in order to ensure the therapeutic pressure is generated and to reduce rebreathing of CO to a minimum. Ö Only use masks with exhalation valves and suitable accessories. During respiratory therapy, the user must always be able to exhale.

  • Page 38: Figure 10: Connecting Aquatrend Iii-Ng

    Operation with humidifier AquaTREND III-NG Risk of infection due to germs! Condensation of water in the tube circuit can result in germ formation. Ö Increase the room temperature, reduce the heat output of the humidifier or use heated tubes. Please note: Before using the AquaTREND III-NG, be sure to read the instructions for use of the humidifier AquaTREND III-NG, including the safety and cleaning instructions.

  • Page 39: Calibrating The Tube Circuit

    Calibrating the tube circuit Risk of injury due to incorrect pressure measurement! Atomisation or humidification can increase the resistance of respiratory system filters. The operator must regularly check the respiratory system filter for increased resistance and blockages to ensure the therapeutic pressure is generated. Ö...
  • Page 40 3. If the calibration was successful, “OK” will Tuesday l 22.03.2017 l 20:36 appear after a few seconds. Calibrate Tube 100 l/min To finish, press the MFK. The calibration data are then applied. Until then, you can cancel cali- bration at any time by pressing the Escape key. Press the MFK to continue 4.

  • Page 41: Figure 11: Connecting The Bacterial Filter

    Connecting additional accessories Connecting the bacterial filter If the device is intended for use by more than one patient (e.g., in operation in clinics), a suitable bacterial filter (e.g., Medisize Barr-vent S) should be used continuously to pro- tect the device from contamination by human pathogens. Please note: •...

  • Page 42: Figure 13: Inserting A Usb Stick

    2. On the home screen, navigate to “System” and press the MFK. 3. Navigate to “Copy Data” and press the MFK. Tuesday l 22.03.2017 l 20:36 Copy Data “Run...” is shown during the copying process. Runs... Please note: If the USB stick does not have sufficient memory, the message “USB stick full“...

  • Page 43: Beginning Therapy

    3. Navigate to “Format USB drive” and Tuesday l 22.03.2017 l 20:36 Format USB-Stick press the MFK. “Runs...” is shown during the formatting pro- cess. Runs... After formatting is successful, “Finished... Ok” Tuesday l 22.03.2017 l 20:36 Format USB-Stick appears. Please note: In the event of an error, “Fin- Finished...
  • Page 44 Chapter 4: Commissioning...

  • Page 45: Chapter 5

    Chapter 5 Operating the Device User profiles Please note: In an out-of-hospital application, the device must be operated in Home mode . If the device is in Clinic user mode , contact your local physician or reseller. Chapter 5: Operating the Device...

  • Page 46: Menu Structure (Patient Mode)

    Menu structure (patient mode) Start screen Booting... SW-Version x.xxx TREND III CPAP Home screen Humidifier settings Alarm Clock settings Tuesday l 22.03.2017 l 20:36 Tuesday l 22.03.2017 l 20:36 Tuesday l 22.03.2017 l 20:36 Level Heater Alarm Clock Brightness LED...

  • Page 47: Home Screen

    Home screen You can enable these screens from the home screen: • Monitoring screen • System screen Monitoring measurements (numerical) System settings, calibrations, counters and device information • Parameter screen • Report screen Setting the therapy parameters Therapy analyses In addition, you can switch the humidifier heating and alarm clock on and off as well as open the corresponding settings on the Tuesday l 22.03.2017 l 20:36...

  • Page 48: Figure 15: Standby Screen

    Changing the display mode In the factory state, the screen switches automatically 2 minutes after the last operation to the home screen. The time for changing the display can be modified on the system screen. If you do not want the screen to change automatically, set the parameter to "Off". Standby screen On the system screen, under “Standby”...

  • Page 49: Info Screen

    Info screen The information screen displays the following basic information about the device: • Type (device type) • Serial Number • Therapy Hours Total Tuesday l 22.03.2017 l 20:36 Type TREND III BILEVEL ST Serial Number DDA1700011 Therapy Hours Total 635 h A Type B Serial Number C Therapy Hours Total Figure 16: Info screen...
  • Page 50 Overview of therapy parameters Parameter Setting range Description • • The pressure is the CPAP mode Pressure therapy pressure, which is applied 4 – 20 hPa to the patient continuously. In APAP mode, this determines the start pressure of the therapy. •...
  • Page 51 Parameter Setting range Description • • In T mode, setting the frequency sets Frequency a fixed breathing rate for the machine 4 – 30 bpm (trigger off). In ST mode as well as T mode (trigger on), the set frequency is defined as the minimum frequency, which can be increased by sponta- neous breaths of the patient.
  • Page 52 Parameter Setting range Description • • • The "Ti Min” setting defines the mini- Ti Min mum inspiration time so that a pre- Off; 0.4 - 5 s mature switchover to the expiration phase is prevented. • • • • The I-Slope determines the pressure I-Slope increase at the outset of an inspira-...
  • Page 53 Parameter Setting range Description • • • • The inspiration trigger is a volume Inspiration Trigger trigger. It specifies the inspiration Auto; Level 1 – 10 efforts of patient required to obtain pressure or volume support from the Thresholds: ventilator in the case of spontaneous breathing.
  • Page 54 Parameter Setting range Description • • • To safeguard the minimum volume, Additional Pressure the IPAP is increased to the set addi- – 10 hPa tional pressure in gradual steps of [Additional Pressure max. 2 hPA per breath. The additional ≤...
  • Page 55 Overview of comfort parameters Parameter Setting range Description The duration of the soft start can be set here. Soft Start Time Off, 1 – 60 min Fixed pressure difference between IPAP and EPAP. Fixed Pressure Difference On, Off Initial pressure for soft start Soft Start Init.

  • Page 56: System Screen

    System screen On the system screen, you will find all general Tuesday l 22.03.2017 l 20:36 device system settings. Here, you can change Calibrate Tube basic settings such as the date, time, language Copy Data Format USB Flash Drive or Notification Sound. The Notification Sound Show Device Errors can be set "On"...
  • Page 57 Can be Parameter changed Setting range Description (Home mode)  Time Setting the time and time format Language  German, English and Setting the device language others Notification Sound Activate or deactivate the acoustic signaling of noti-  Off, On fications Setting when the device switches screens following the last operation action.

  • Page 58: Figure 20: Reports Screen In Home Mode: Ratings

    Reports screen: Home mode In home mode, the reports screen is split Tuesday l 22.03.2017 l 20:36 up into three areas: “Ratings”, “Indicators” Ratings Indicators Therapy and “Therapy”. Date 21.03.17 Usage 6:43 h In the "Ratings" section you will find rating Therapy Quality parameters such as usage, therapy quality Mask Fit...
  • Page 59 3. Navigate to the “Period” item and press the Tuesday l 22.03.2017 l 20:36 MFK to confirm your selection. Ratings Indicators Therapy Period ∅ Daily Usage 7:49 h 4. Select the desired period and press the MFK Usage > 4 h to confirm.
  • Page 60 Parameter Description Obstruc. Apnoeas Number of occurred obstructive apnoea events Number of occurred apnoea events for which no type could be deter- Unident. Apnoeas mined Ø Leakage Average leak rate in the period of observation Overview of therapy quality The quality of the parameters therapy quality, mask fit, humidifier and Heater Tube are rated and shown by coloured symbols on the reports screen.

  • Page 61: Chapter 6

    Chapter 6 Notifications / Messages Chapter 6: Notifications / Messages...

  • Page 62: General Information

    General information Sound Message Description yes/no  Power failure During ongoing therapy, this can result in the user rebreath- ing expired air. After restoring the power supply, the “Power failure” message appears. You can acknowledge it by pressing the MFK. ...
  • Page 63 Sound Message Description yes/no  Pressure Too High If the pressure is higher than the “High Pressure Toler- ance” setting, the message “Pressure Too High” appears. You can acknowledge it by pressing the MFK. Pressure Too Low If the pressure is lower than the “Low Pressure Tolerance” ...

  • Page 64: Technical Messages

    Technical messages Below, you will find an overview of technical messages that could appear on the TREND III unit. If one of these messages appears, restarting the device may be the solution. If restarting does not help, contact your dealer or service staff: Message sound Message yes/no...

  • Page 65: Chapter 7

    Chapter 7 Cleaning and Disinfection Chapter 7: Cleaning and Disinfection...

  • Page 66: Important Information

    • Do not immerse the device in water or solvents. • Follow the accessory manufacturer’s instructions for cleaning and disinfection. Overview The following overview table describes the cleaning intervals of articles delivered by HOFFRICHTER. For articles by other manufacturers, please follow their cleaning instructions. Component Name Cleaning...
  • Page 67 Component Name Cleaning Replace Filter cassette as needed (without filter) Coarse filter weekly instead of cleaning Fine filter monthly, if severely contaminated, or with every new patient Bacterial filter daily Chapter 7: Cleaning and Disinfection...

  • Page 68: Cleaning The Device

    Cleaning the device Domestic use Clean the device once a week. To do so, proceed as follows: 1. Unplug the mains plug. 2. Wipe the device with a cloth slightly dampened with soapy water. 3. Dry the device with a cloth. Please note: Do not use chemical cleaning agents or solvents to clean the device surface.

  • Page 69: Cleaning / Exchanging The Air Filter

    Cleaning / exchanging the air filter Please notes: • If the air filter is clogged, the breathing air may be overheated. • Under certain environmental conditions, germs may form in the air filter. Observe the instructions on exchanging and cleaning it. •...
  • Page 70 Replacing the fine filter Replace the white fine filter monthly, or in case of heavy soiling. 1. Pull the filter cassette from the device. 2. Remove the coarse filter (black). 3. Remove the fine filter (white) and replace it with a new one. 4.

  • Page 71: Chapter 8

    Chapter 8 Annex Chapter 8: Annex...

  • Page 72: Troubleshooting

    Troubleshooting Problem Possible cause Correction Nose or sinus pain, earache Sinus infection, ear infec- Stop therapy, consult doctor tion Uncomfortable feeling due Discomfort at prescribed If you suspect an error, ask the doc- to high pressure high pressures tor for help Phase for adapting to Try to relax, use or vary soft start func- pressure still not com-...

  • Page 73: Error Messages

    Error messages Error message Cause Solution Flash Not Working No access to the flash Device must be serviced Dafault Parameter Loaded No valid parameter set avail- The device uses the default able or faulty parameter set and can con- tinue to be utilised. Eventlog File Damaged Reading of event data failed Device must be serviced...

  • Page 74: Technical Data

    Technical data Supply voltage Mains operation : FUHUA ELECTRONIC CO., LTD. -UES65-240270SPA1 Power supply unit Power supply unit input 100 to 240 V AC (-20%, +10%), 50 to 60 Hz Power supply unit output 24 V/ 2.7 A External battery operation 20 to 26 V (nominal voltage) / 5 A (AKKUPACK uni BASE/PLUS) Max.
  • Page 75 Positive airway pressure with humidifier with two pressure levels Breathing frequency a) 10 / b) 15 / c) 20 (breaths/min) inspiratory (hPa or cmH expiratory (hPa or cmH a) -0.17 a) 0.25 a) -0.05 a) 0.37 a) 0.37 µ (hPa) b) 0.02 b) 0.45 b) 0.04...
  • Page 76 Specifications and performance characteristics Declared dual-number noise emis- A-rated sound pressure level sion value with humidifier (as per ISO 4871) 28.0 dB Measuring uncertainty (K) 3.2 dB A-rated sound power level 38.0 dB Measuring uncertainty (K) 3.2 dB Air filter Dimensions (W x D x H) Approx.
  • Page 77 Technical requirements for accessories Bacterial filter Connections 22/15 mm cone (according to EN1281-1) Resistance < 2.3 hPa at 60 l/min Compressible volume < 66 ml Internal volume < 200 ml The manufacturer reserves the right to make technical changes without notice. Chapter 8: Annex...

  • Page 78: Replacement Parts And Accessories

    Replacement parts and accessories Please note: Make sure to follow all general safety guidelines when using replacement parts and accessories from Page 20. For ordering of replacement parts and accessories, please contact a HOFFRICHTER service partner. Replacement parts Name Figure...
  • Page 79 Accessories Name Figure Article number Mask Size XS Size S Size M Size L Size XL Standard nose mask 00003440 00003434 00003435 Standard mouth/nose mask 00003441 00003436 00003437 Cirri Mini Comfort nose 00003551 00003552 00003498 mask Cirri Comfort nose mask 00003497 00003486 00003487...
  • Page 80 Bluetooth 4.0 Dual AKKUPACK uni PLUS Mode Class 2 USB Adapter-LM506 00011099 31200011 Chapter 8: Annex...

  • Page 81: Manufacturer's Declaration On Electromagnetic Compatibility

    Manufacturer’s declaration on electromagnetic compatibility TREND III complies with standard DIN EN 60601-1-2:2016-05 and is intended for use in the electromagnetic environment described in the following. Any deviating ambient conditions can affect its performance characteristics (e.g. pressure accuracy) or cause the device to fail.
  • Page 82 Guidance and manufacturer’s declaration - electromagnetic immunity The TREND III respiratory therapy device is intended for operation in environments as described below. The user of the Trend III respiratory therapy device must ensure it is operated in such an environment. Immunity tests IEC 60601 test level Compliance level Electromagnetic envi-...
  • Page 83 Guidance and manufacturer’s declaration - electromagnetic immunity Immunity tests IEC 60601 test level Compliance level Electromagnetic envi- ronment - guidance Rapid transient dis- ± 2 kV for power ± 2 kV for power The quality of the supply turbances/bursts as cables cables voltage should corre-...
  • Page 84 Guidance and manufacturer’s declaration - electromagnetic immunity Voltage dips, tem- > 95 % dip of U > 95 % dip of U The quality of the sup- porary interruptions 1/2 period 1/2 period ply voltage should cor- and voltage fluctua- respond to one of the tions in the voltage >...

  • Page 85: 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 find out how to dispose of the device, etc.

  • Page 86: Disclaimer

    Disclaimer HOFFRICHTER GmbH accepts no liability for consequences in terms of safety, reliability and performance of the product if: • Interventions, modifications, extensions, calibration, repairs and maintenance are carried out by persons not authorised by us, • Other manufacturers’ accessories and spare parts are used that have not been approved by us for use on the product, •...

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