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Chapter 9: Annex

125

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.

Guidance and manufacturer’s declaration - electromagnetic emissions

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.

Emitted interference

Compliance

Electromagnetic environment - guidance

HF emissions
as per CISPR 11

Group 1

The

TREND III

respiratory therapy device only

uses HF energy for its internal functions. Its HF
emissions are thus very low and interference with
nearby electronic devices is unlikely.

HF emissions
as per CISPR 11

Class B

The

TREND III

respiratory therapy device is suited

for use in all facilities including those connected
directly to a public supply network that also sup-
plies buildings used for residential purposes.

Emission of harmonic oscilla-
tions as per
IEC 61000-3-2

Class A

Emission of

voltage fluctuations/flickers

as per IEC 61000-3-3

In
compliance

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Содержание 5CPD10

Страница 1: ...11 TREND III AutoBILEVEL S device type 5CPD60 5CPD61 TREND III AutoBILEVEL ST device type 5CPD50 5CPD51 from device software 2 01 TREND III Respiratory therapy device 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 Klinik ENG_2022 01 18_4 0 User s manual TREND III for physicians ...

Страница 2: ......

Страница 3: ...Please ensure that you are always working with the most current version of this user s manual Should you have any questions please contact the operator of the respiration therapy device or go to www hoffrichter de for more information The following documents are available for TREND III in addition to this user s manual TREND III user s manual for patients TREND III quick reference guide Service ma...

Страница 4: ...ice s serial number here You will find the serial number on the rat ing plate on the bottom of the device Please always provide the serial number for all queries and complaints Conformity CE mark and number from the notified body The medical device complies with the appli cable regulations of EU 93 42 EEC for medical products ...

Страница 5: ...ctions before commissioning 26 Using oxygen 27 Integration into IT networks 27 Chapter 3 29 Description of Device 29 Top of device 30 Bottom of device 31 Rear of device 32 Chapter 4 37 Commissioning 37 General information 38 Setting up the device 38 Power supply 39 Connect Bluetooth adapter 41 System structure 42 Calibrating the tube circuit 47 Using oxygen 53 Switching the device on and off 54 Be...

Страница 6: ...oring screen 71 Parameter screen 73 System screen 82 Chapter 7 91 Notifications Messages 91 General information 92 Technical messages 94 Chapter 8 95 Cleaning and Disinfection 95 Important information 96 Overview 96 Cleaning the device 98 Cleaning the mask 98 Cleaning the tube circuit 99 Cleaning the humidifier 99 Cleaning exchanging the air filter 100 Using the device for more than one patient 10...

Страница 7: ...tions 108 Data management 109 Error messages 110 Technical data 111 Measured values 115 Setting ranges and control precision 116 Factory settings 119 Replacement parts and accessories 122 Manufacturer s declaration on electromagnetic compatibility 125 Disposal 129 Disclaimer 130 ...

Страница 8: ... 55 Figure 19 Example BILEVEL mask test and 20 min soft start ramp 55 Figure 20 CPAP mode diagram 58 Figure 21 APAP mode diagram 59 Figure 22 Diagram of T mode without trigger function 60 Figure 23 Flow diagram of T mode without trigger function 60 Figure 24 Diagram of T mode with trigger function 61 Figure 25 Flow diagram of T mode with trigger function 61 Figure 26 Diagram of ST mode 62 Figure 2...

Страница 9: ...igure 41 Reports screen in home mode Indicators 87 Figure 42 Reports screen in home mode Therapy 87 Figure 43 Filter cassette structure 100 Figure 44 Block diagram for the device 108 Figure 45 Pneumatic block diagram 109 ...

Страница 10: ...10 List of figures ...

Страница 11: ...Chapter 1 Introduction 11 Chapter 1 Introduction ...

Страница 12: ... ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 40 30 20 10 0 Humidifier Alarm Clock Parameter Info Reports System 09 25 4 5 6 7 3 2 1 Quick reference guide Art no 50000709 Gerätetyp Device type Seriennummer Serial number Gerätesoftware Version Device software version Gerätesprache Device language Datum Unterschrift des Prüfers Firmenstempel Date Signature of the tester Company stamp Endprüfung Fin...

Страница 13: ... 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 5 95 Humidity range during storage and transport 265 hPa 1060 hPa Air pressure range during storage and transport 25 C 70 C Temperature range during storage and transport ...

Страница 14: ...ser s manual BF application part IP22 Protection against solid foreign objects with diameters from 12 5 mm access to hazardous parts with a finger falling dripping water as long as the housing is tilted up to 15 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 Manufacturer Do not dispose of the ...

Страница 15: ...Chapter 1 Introduction 15 Symbols on the device Symbol Meaning Connections 24V DC connection USB interface and Micro USB interface Control Home key Escape key On off key ...

Страница 16: ...d general safety regulations in force in the area of use must be observed This symbol denotes hazardous situations that lead to serious injuries or death This symbol denotes hazardous situations that may lead to seri ous injuries or death This symbol denotes hazardous situations that may lead to light or severe injuries This symbol denotes situations that may lead to material dam age or damage to ...

Страница 17: ...ient at a set pressure via a leakage tube circuit Therapy is non invasive provided via a breathing mask So that the expired air can escape a vented CPAP mask must be used During therapy oxygen can be supplied Oxygen is either administered directly in the mask or in the tube circuit via an adapter When therapy is switched off no oxygen must not flow back into the device This must be ensured by usin...

Страница 18: ...TREND III AutoBILEVEL ST Description therapy modes Mode CPAP For therapy the device provides continuous positive pressure APAP APAP mode is an extension to CPAP mode and offers the additional function of automatic adjustment to the therapeutic pressure CPAP within specific limits In addition the speed of the pressure increase can be adapted to the patient s special needs in 5 stages S The transiti...

Страница 19: ...ollowing indications Obstructive sleep apnoea syndrome OSAS Obesity hypoventilation syndrome OHS TREND III BILEVEL devices can also be used with the following indications Obstructive ventilation disorders e g COPD Restrictive ventilation disorders e g scoliosis thorax deformities Neurological muscular and neuromuscular disorders e g paralysis of the dia phragm Central breathing regulation disorder...

Страница 20: ... irritation or dry eyes Skin flushing in the area of the mask skin swelling in the area of the mask Difficulty breathing claustrophobia Stomach issues due to air accumulated in the stomach Headache facial pain Bruises User qualification The therapy parameters may only be set by trained specialist personnel on the instruc tion of a doctor Patients have been instructed on how to use and handle the d...

Страница 21: ...Chapter 2 Safety Information 21 Chapter 2 Safety Information ...

Страница 22: ...he patient experiences dried mucous membranes in the nose and throat sinus complaints earache runny nose hypersensitivity reaction of the skin irritableness loss of voice disorientation or memory defects consult a doctor The device must only be used by persons who have fully read and understood this user s manual before commissioning and have familiarised themselves with the device The device must...

Страница 23: ...onditions The device should not be placed more than 30 cm away from other devices or devices such as defibrillators diathermy devices cell phones microwave ovens remote controlled toys etc Electromagnetic fields exceeding 10 V m may affect the operation of the respiratory therapy device During certain examinations or treatments there may be interference between the respiratory therapy device and o...

Страница 24: ...m 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 Do not reach for the device under any circumstances if it falls into water The device must not be used in wet rooms as humidity penetrating the device presents a risk of electric shock Contact a doctor if chest discomfort shortness of breat...

Страница 25: ...onditions other than those stipulated Excessive ambient tem peratures can result in an increased breathing air temperature Ö Please note the operating transport and storage conditions Place the device next to a bed on a solid level surface Make sure the device is in a horizontal position especially if a humidifier is connected Never place the device in a cabinet or under the bed The device and acc...

Страница 26: ...ust stop operating the device In such cases the service provider must be informed Do not turn the device on if it was located in a very cold environment beforehand Wait about 1 hour until it has reached the room temperature Regularly check the filter cassette Never use the device without a filter cassette Regularly clean your mask system and check all accessories in particular the therapy tube mas...

Страница 27: ...n concentration in the ambient air can occur The oxygen supply should be stopped before discontinuing therapy We also rec ommend to allow the device to run for several respiratory cycles without an oxygen supply after discontinuing therapy In the event of an oxygen leak the oxygen supply should be shut off immediately The room must be ventilated immediately Any sparks fire or potential fire source...

Страница 28: ...28 Chapter 2 Safety Information ...

Страница 29: ...Chapter 3 Description of Device 29 Chapter 3 Description of Device ...

Страница 30: ...midifier The leakage tube circuit is connected here 4 Multifunction knob MFK The multi function button is used for menu navigation parameter configuration and other operating actions Function Action Switch off the alarm clock signal press briefly Hide notes press briefly Select menu item Change parameter value rotate Edit parameters start function press briefly Confirm parameter change press brief...

Страница 31: ...er failure signal press briefly End the running therapy start function1 Mask test soft start press briefly 7 Home key Function Action Return to the home screen press briefly 11 Bottom of device SN DDA1700011 TREND III Type 5CPD30 BILEVEL ST Made in Germany HOFFRICHTER GmbH Mettenheimer Str 12 14 19061 Schwerin Germany DC INPUT 24V max 3 75A IP22 1 Figure 3 Bottom of device 1 Rating plate 1 With fi...

Страница 32: ...lled on the PC Please note Only devices that meet standards IEC 60601 1 and IEC 60950 1 may be connected 2 USB interface A USB stick can be connected here 3 The DC plug is connected here See also see also page 39 4 Filter cassette The ambient air is sucked in via the filter cassette It contains the two air filters coarse and fine filters For information on how to replace and clean the filter refer...

Страница 33: ...l 1 lowest heating level Level 5 highest heating level Humidifier heating is in standby Humidifier heating is off Humidifier error1 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 humidifier in the Error states section ...

Страница 34: ... can be called up in the sys tem menu via the Show Device Errors menu item TRENDapp is connected to the TREND III via Bluetooth Start Stop Automatic with countdown timer After the timer is up therapy stops 75 s Mask test with countdown timer After the timer is up either therapy or soft start begins 15 s Disconnection with countdown timer The tube circuit mask was disconnected After the timer is up...

Страница 35: ...his triggered the inspiration trigger The symbol will remain visible during inspiration and will shut off with the beginning of the expiration M Safety cycle active The patient is not breathing spontaneously In ST mode the patient continues to receive therapy in T mode If the device is in S mode and the safety frequency is activated therapy is provided with fixed parameters frequency I E ...

Страница 36: ...36 Chapter 3 Description of Device ...

Страница 37: ...Chapter 4 Commissioning 37 Chapter 4 Commissioning ...

Страница 38: ... stability of the connected accessories 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 A cooling time for the device is not required Setting up the dev...

Страница 39: ...nected to a power source continuously without posing a risk Mains operation via power supply unit Connect the device to the mains supply as follows D E A C B A Socket B Mains cable C Power supply unit D DC plug E DC connector socket Figure 6 Mains connection via power supply unit 1 Connect the mains cable to the power supply 2 Insert the DC plug into the DC connector socket 3 Insert the mains cabl...

Страница 40: ... boots SW Version x xxx TREND III CPAP Booting C B A A Loading bar B Status C Software version Figure 7 Start screen After boot up the display switches to the home screen The device requires up to 1 minute to boot before it is ready for use ...

Страница 41: ...he Bluetooth adapter into the USB interface The connection is then automatically established between the adapter and the device Please note Whether the respiratory therapy device is switched on or not is irrelevant when the Bluetooth adapter is plugged in As soon as the device is switched on the Blu etooth adapter automatically establishes a connection and is immediately functional No further step...

Страница 42: ...ation valves and suitable accessories During respiratory therapy the user must always be able to exhale For this reason a CPAP mask with integrated exhalation valve must be used for exhalation ST Dien stag l 22 0 3 20 17 l 20 3 6 40 30 20 10 0 Para mete r Mon itorin g Beric hte Syste m 40 30 20 10 0 Anfe ucht er Diens tag 06 3 0 Wec ker C A B A CPAP mask B Leakage tube C passive exhalation valve F...

Страница 43: ...up the humid ifier water Connecting the humidifier to the device COM 24V COM 24V ST Dien stag l 22 0 3 20 17 l 20 3 6 40 30 20 10 0 Para mete r Mon itorin g Beric hte Syste m 40 30 20 10 0 Anfe ucht er Diens tag 06 3 0 Wec ker B 1 2 3 C D A E F A Housing panel B Connection socket for humidifier electronics C Humidifier D Heater Tube contacts E Air outlet F Leakage tube or heated tube Figure 10 Con...

Страница 44: ...ettings 1 On the home screen navigate to Humidifier and press the MFK ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Parameter Monitoring Reports System 40 30 20 10 0 Humidifier 09 25 Alarm Clock 2 Navigate to the parameter you want to change and press the MFK ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Level Heater Brightness LED Heater Tube 3 30 On 3 Change the setting and press the MFK to con ...

Страница 45: ...ly switched on when therapy begins when the humidifier is in standby operation The same applies to the Heater Tube of the heated tube unless it has been disabled in the humidifier settings To preheat the water you can switch on the heating before beginning with therapy On the home screen navigate to Humidifier and the symbol then press the MFK If you use a heated tube it is also switched on provid...

Страница 46: ...ier from the device Figure 11 Disconnecting AquaTREND III NG from the device 1 Make sure that therapy has been switched off 2 Disconnect the tube circuit from the humidifier 3 Press the humidifier release button and remove the humidifier from the device ...

Страница 47: ...ncludes connecting and disconnecting of components such as the bac teria filter humidifier and tube circuit To calibrate the tube circuit Please note During tube calibration the patient side of the tube circuit must be open and therapy switched off Calibration may only be performed without a mask Make sure that the tube system lies straight on a surface that is as level as possible Failure to comp...

Страница 48: ...last tube calibra tion are used Therapy can be started as usual but the pressure measurement may be incorrect We recommend always performing tube calibration When commissioning the device for the first time without calibrating it the default cali bration data1 stored in the device are used 1 Operation without humidifier Leakage tube circuit 22 mm 1 80 m Height ca 44 m NHN air pressure approx 1008 ...

Страница 49: ...rom contamination by human pathogens Please note Please be sure to replace the bacterial filter daily and follow the manufacturer s user s manual If the optionally available humidifier AquaTREND III NG is used for therapy do not use a bacterial filter Connect the components as follows P A T I E N T A B A Leakage tube B Bacteria filter Figure 12 Connecting the bacterial filter 1 Connect all compone...

Страница 50: ...does not control the device or other devices on IT networks and does not affect the performance of the device directly The software may only be used by service staff and medical professionals Therapy parameters may only be changed if the patient is being closely monitored During titration changes can be made to the parameters in the sleep laboratory using easySET Connect a PC as follows Connect th...

Страница 51: ...r Figure 14 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 Runs is shown during the copying process Pleasenote IftheUSBstickdoesnothavesufficient memory the message USB stick full appears In this case use a USB stick with sufficient space Once successfully copied the following mes sage appears Finished ok Please note In the...

Страница 52: ...vigate to Format USB drive and press the MFK Runs is shown during the formatting pro cess After formatting is successful Finished ok appears Please note In the event of an error Fin ished Error appears In such a case repeat the operation If the error occurs again use a different stick ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Runs Format USB Stick ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 ...

Страница 53: ...ce is in standby mode or switched off Oxygen supply is possible in all modes Please note that any changes to the therapy param eters e g pressure I E ratio frequency will lead to a change of the FiO2 concentration When supplying oxygen make sure to use a kink resistant tube as per EN ISO 5359 made of a medically approved material To prevent oxygen from flowing back into the device an O2 safety val...

Страница 54: ...f oxygen 1 Before beginning with therapy check that the tube connections are fitted properly 2 Check whether the Start Stop Automatic comfort setting is set to Off 3 First switch on the device followed by the oxygen supply Stopping the supply of oxygen 1 Before switching off the device switch off the oxygen supply 2 Continue therapy for a number of respiratory cycles 3 Stop therapy Switching the d...

Страница 55: ...ic pressure 4 If soft start is enabled the pressure increases gradually in the set time from the Soft Start Init Pressure to the prescribed therapeutic pressure Please note The mask test and soft start can be cancelled by pressing the on off key Next therapy begins with the set therapy pressure Figure 18 20 10 4 0 20 40 60 mask test 0 90 s soft start time ramp 0 60 min CPAP P ramp t min p hPa CPAP...

Страница 56: ...56 Chapter 4 Commissioning ...

Страница 57: ...Chapter 5 Therapy Modes 57 Chapter 5 Therapy Modes ...

Страница 58: ...P TREND III BILEVEL S TREND III BILEVEL ST TREND III AutoBILEVEL S TREND III AutoBILEVEL ST CPAP mode Continuous positive airway pressure Main features Pressure controlled Independent respiration In the CPAP mode the device provides continuous positive pressure The patient must be able to breathe spontaneously 20 10 0 Pressure t P Pressure 8 hPa Figure 20 CPAP mode diagram ...

Страница 59: ...ssure limit is reached For high therapy comfort the therapeutic pressure should always be as high as necessary and as low as possible In addition the speed of the pressure increase can be adapted to the patient s special needs in 5 stages Secondary features Obstructive apnoea Central apnoea Hypopnoea Snoring Normal breathing 20 10 0 Pressure t p hPa Upper pressure limit Low pressure limit 1 2 3 4 ...

Страница 60: ... the set frequency and a defined I E ratio Please note During the exhalation phase no negative pressure vacuum is generated 20 10 0 0 5 10 15 20 25 IPAP EPAP t s p hPa 6 s 6 s 6 s Ⓜ Ⓜ Ⓜ Ⓜ IPAP 20 hPa EPAP 8 hPa I E 1 2 2 s 4 s f 10 bpm Ⓜ Mandatory ventilation Figure 22 Diagram of T mode without trigger function 0 5 10 15 20 25 t s l s Ⓜ V Ⓜ Ⓜ Ⓜ Figure 23 Flow diagram of T mode without trigger func...

Страница 61: ...breathing Ⓜ Mandatory ventilation Ⓐ Pressure controlled supported ventilation IPAP 20 hPa EPAP 8 hPa I E 1 2 2 s 4 s f 10 bpm IPAP 20 hPa EPAP 8 hPa I E 1 1 2 s 2 s f 15 bpm Figure 24 Diagram of T mode with trigger function 0 5 10 15 20 25 t s l s Ⓐ Ⓜ Ⓐ Ⓐ V Ⓜ Figure 25 Flow diagram of T mode with trigger function ...

Страница 62: ...eously the device automatically enters T mode and ventilates the patient with the set frequency The mode is switched to T mode after a set delay time lapses 20 10 0 0 5 10 15 20 25 IPAP EPAP t s p hPa Ⓐ Ⓜ Ⓐ Ⓐ IPAP 20 hPa EPAP 8 hPa spontaneous breathing Background frequency Apnoea Time expiration time Apnoea Time Expiration time Ⓜ Mandatory ventilation Ⓐ Pressure controlled supported ventilation F...

Страница 63: ... breath ing alone The pressure is decreased to the EPAP when the inspiration flow ends In addi tion a safety frequency can be activated This ensures patients are still ventilated with the set parameters frequency I E in case of respiratory arrest 20 10 0 0 5 10 15 20 25 IPAP EPAP t s p hPa Ⓐ Ⓐ Ⓐ Ⓐ IPAP 20 hPa EPAP 8 hPa spontaneous breathing t Apnoea Time Apnoea Warning Ⓐ Pressure controlled assis...

Страница 64: ...educed evenly2 until the expiratory pressure has reached the low pressure limit For high therapy comfort the expiratory pressure should always be as high as necessary and as low as possible In addition the speed of the pressure increase can be adapted to the patient s special needs in 5 stages Secondary features Obstructive apnoea Central apnoea Hypopnoea Snoring Normal breathing 20 10 0 IPAP EPAP...

Страница 65: ...Chapter 6 Operating the Device 65 Chapter 6 Operating the Device ...

Страница 66: ...20 36 40 30 20 10 0 Alarm Clock Hour Minute on 9 25 ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 12 f bpm f aus I E Leck l min p 0 570 VI l 14 8 p hPa Off 1 1 5 I E 25 0 l min Leak ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Soft Start Time Soft Start Init Pres Mask Test Start Stop Automatic Autostart Flow Stop Automatic Delay 3 min 4 0 hPa Off Off Medium 5 s Comfort Therapy ST Tuesday l 22 03 ...

Страница 67: ...e user profile Changing the user profile You can change the user profile at any time In clinic mode the user has access to all device settings In contrast therapy and warning signal parameters cannot be changed in home mode There are fewer system parameters and functions that can be set If you want to switch from home mode to clinic mode you need to enter a PIN code If the device is in the factory...

Страница 68: ...0 User Profile Mask Type Pressure Unit Volume Unit Display Time Insp Ratings Menu Factory Setting Change PIN Clinic B hPa l Seconds On 2 Enter the current PIN code and confirm it by pressing the MFK ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 New PIN Change PIN PIN Press to cancel 3 Then enter a new 4 digit PIN code and confirm it with MFK as well This stores the new PIN code Please note If you ...

Страница 69: ...pen the corresponding settings on the home screen To select the individual buttons turn the MFK To enable a selected button press the MFK ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Parameter Monitoring Reports System 40 30 20 10 0 Humidifier 09 25 Alarm Clock C D E H J K L I A G B F A Pressure bar B Heating level C Selected screen symbol D Screen symbol not selected E Title bar with day of week...

Страница 70: ...n home mode or when therapy is switched off 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 you can set or disable the time for switching to the standby screen After the set time lapses the screen auto matically switches to the s...

Страница 71: ...he following therapy parameters are shown Pressure p Volume VI Frequency f Leak rate l min Inspiration to expiration ratio I E ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 12 f bpm f aus I E Leck l min p 0 570 VI l 14 8 p hPa Off 1 1 5 I E 25 0 l min Leak A B A Measurement configured B No measurement configured Figure 34 Monitoring screen factory setting ...

Страница 72: ... you want to configure ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 12 f bpm f aus I E Leck l min p 0 570 VI l 14 8 p hPa Off 1 1 5 I E 25 0 l min Leak 3 Press the MFK to activate the measured value box ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 p 12 f bpm 0 570 VI l 14 8 p hPa Off 1 1 5 I E 25 0 Leak l min 4 Change the measurement and press the MFK to confirm the setting ST Tuesday l 22 03 20...

Страница 73: ...py area you will find the therapy and warning parameters In home mode you can view them but cannot change them In clinic mode all system parameters can be adjusted ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Soft Start Time Soft Start Init Pres Mask Test Start Stop Automatic Autostart Flow Stop Automatic Delay 3 min 4 0 hPa Off Off Medium 5 s Comfort Therapy ST Tuesday l 22 03 2017 l 20 36 40 30...

Страница 74: ...ow Medium High The E FLEX setting individually adapts the therapy pressure to the respira tory flow of the patient The decrease in pressure during the expiration phase depends on the respiratory flow volume the set E FLEX and the set therapy pressure Maximum Pressure Decrease 1 3 hPa Describes the maximum value by which the therapy pressure is reduced during expiration when the E FLEX function is ...

Страница 75: ...e is exceeded the device begins therapy with the set frequency If the apnoea time ends before the set frequency has lapsed the apnoea time is ignored Inspiration Time 0 4 8 s The inspiration time defines the dura tion of inspiration in seconds The frequency must be taken into account when setting the inspiration time Setting up a fixed inspiration time the I E ratio is calculated depending on the ...

Страница 76: ...s 0 75 s 0 5 s 0 3 s 0 15 s 1 Pressure increase time at IPAP 20 hPa EPAP 5 hPa The values specified are ref erence times and depends on the pressure range set and the lung condition of the patient E Slope Level 1 5 Slope set ting Pressure decrease time1 1 2 3 4 5 1 7 s 1 0 s 0 6 s 0 4 s 0 3 s 1 Pressure decrease time at IPAP 20 hPa EPAP 5 hPa The values specified are refer ence times and depends o...

Страница 77: ...e trigger levels in order to avoid the risk of auto triggering Level Volume Flow change in 30 ms 1 2 3 4 5 6 7 8 9 10 5 ml 10 ml 15 ml 20 ml 25 ml 30 ml 35 ml 40 ml 45 ml 50 ml 1 2 l min 1 5 l min 1 8 l min 2 1 l min 2 4 l min 2 7 l min 3 0 l min 3 3 l min 3 6 l min 3 9 l min 1 sensitive 10 non sensitive Expiration Trigger 10 90 V 20 40 80 t Expiration Trigger threshold The expiration trigger is a...

Страница 78: ...tional pressure as a maximum value and on the other by a max 2 hPa pressure increase per breath compared to the inspira tion pressure of the previous breath Upper Pressure Limit 4 25 hPa Up to this value the IPAP or CPAP pressure can increase automatically Low Pressure Limit 4 20 hPa Up to this value the EPAP or CPAP pressure can decrease automatically Pressure increase Level 1 5 The pressure incr...

Страница 79: ...ing pressure or IPAP see also page 55 Start Stop Automatic Off Start Stop Start The parameter determines how therapy starts or ends If Start Stop Automatic is set to Off therapy can only be started or ended by press ing the on off key With Start Stop therapy can also be started by the patient breathing and ended by taking off the mask With Start therapy can also be started by the patient breathing...

Страница 80: ...red frequency is higher than the set value the message High Frequency is issued Low Frequency Off 1 50 l min If the measured frequency is lower than the set value the message Low Frequency is issued High Inspiration Volume Off 0 2 2 5 l If the measured breath volume is higher than the set value the message High Inspiration Volume is issued Low Inspiration Volume Off 0 05 2 l If the measured breath...

Страница 81: ...ending on the user profile the selected profile differs In clinic mode Ther apy is selected by default while Comfort is the default setting in home mode Navigate to the Therapy area and press the MFK ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Soft Start Time Soft Start Init Pres Mask Test Start Stop Automatic Autostart Flow Stop Automatic Delay 3 min 4 0 hPa Off Off Medium 5 s Comfort Therapy 3...

Страница 82: ...parameters can be adjusted In home mode this is restricted ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Calibrate Tube Copy Data Format USB Flash Drive Show Device Errors Date Time Language Notification Sound 22 03 2017 20 36 English On Figure 37 System screen Change a system parameter as follows 1 On the home screen navigate to System and press the MFK 2 Navigate to the desired system parameter ...

Страница 83: ...evice errors Date Setting the date and the date format Time Setting the time and time format Language German English and others Setting the device language Notification Sound Off On Activate or deactivate the acoustic signaling of noti fications Timer Screen Change Off 5 s 20 min Setting when the device switches screens following the last operation action This depends on the user profile Clinic mo...

Страница 84: ...must be set to Home PIN code Necessary Pressure Unit hPa mbar cmH2O Setting for the display of pressure units Volume Unit l ml Setting for the display of volume units Display Time Insp Seconds I E Setting as to whether the inspiration time can be set in seconds or as an I E ratio on the parameter screen Ratings Menu On Off Setting as to whether the ratings screen should be shown in home mode Facto...

Страница 85: ... Home mode Operating Counter Hours during which the device was connected to the mains or operated with external battery Blower Service in Period after which the device has to be serviced for blower maintenance SW Version Software version of the device Serial Number Device serial number ...

Страница 86: ...gure 38 Reports screen in clinic mode Rat ings Figure 39 Reports screen in clinic mode Indi cators Navigating in the reports screen clinic mode 1 On the home screen navigate to Reports and press the MFK 2 The reports screen is divided into the Rat ings and Indicators areas For example navigate to the Indicators area and press the MFK to enable it ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Perio...

Страница 87: ...the set therapy parameters ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Date Usage Therapy Quality Mask Fit Indicators Ratings 21 03 17 6 43 h Therapy ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Period Daily Usage Usage 4 h AHI HI AI Central Apnoeas 1 d 7 49 h 5 d 15 7 8 10 Indicators Ratings Therapy Figure 40 Reports screen in home mode Ratings Figure 41 Reports screen in home mode Indicators ...

Страница 88: ... it ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Period Daily Usage Usage 4 h AHI HI AI Central Apnoeas 1 d 7 49 h 5 d 15 7 8 10 Indicators Ratings Therapy 3 Navigate to the Period item and press the MFK to confirm your selection 4 Select the desired period and press the MFK to confirm 5 An overview of the indicators is then shown ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 Period Daily Usage U...

Страница 89: ...le AHI values HI The hypopnea index HI describes the number of hypopneas per hour A hypopnea is shallow or very slow breathing lasting 10 seconds or longer In this case the maximum flow of a breath decreases by at least 40 compared to a comparison value The reference value is the average of the maximum flow values from previous breaths If hypo pnea is followed by apnea the hypopnea is not counted ...

Страница 90: ...t humidifier is considered high quality and is thus optimally set for the needs of the patient The completed therapy mask seat humidifier is considered average quality and is thus not optimal set for a consistently comfortable therapy To improve the quality of therapy the therapy parameters should be adjusted again The run therapy mask seat humidifier is not considered assessable The completed the...

Страница 91: ...Chapter 7 Notifications Messages 91 Chapter 7 Notifications Messages ...

Страница 92: ...tion is lower than the Min min ute ventilation the message Low Minute Ventilation appears The message is acknowledged when the min ute ventilation is above the Min minute ventilation or by pressing the MFK Apnoea Only in S mode When an apnoea event lasting longer than the set Apnoea parameter is detected the Apnoea mes sage appears This message is acknowledged by pressing the MFK or when the apnoe...

Страница 93: ... the Low Frequency message appears You can acknowledge it by pressing the MFK High Inspiration Volume If the inspiration volume is higher than the High Inspira tion Volume setting the message High volume appears You can acknowledge it by pressing the MFK Low Inspiration Volume If the inspiration volume is lower than the Low Inspiration Volume setting the message Low Inspiration Volume appears You ...

Страница 94: ...lp contact your dealer or service staff Message Message sound yes no Overcurrent Fuse Error Internal Communication Error Pressure Sensor Error Motor Control Motor Speed Too Low Motor Emergency Stop Therapy Locked Additional messages Here you will find additional messages that can occur on TREND III without an acous tic signal Message Message sound yes no Stop Automatic Delay Disconnection delay So...

Страница 95: ...Chapter 8 Cleaning and Disinfection 95 Chapter 8 Cleaning and Disinfection ...

Страница 96: ...rse 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 Disinfect Replace Respiratory therapy device TREND III as needed with every...

Страница 97: ...d no with every new patient Filter cassette without filter as needed with every new patient Coarse filter weekly no instead of cleaning with every new patient Fine filter no no monthly if severely contaminated or with every new patient PA T I E N T Bacterial filter no no daily and with every new patient ...

Страница 98: ...cted with germs pose a risk of the germs spread ing to other people Ö Disinfect the device surface on a regular basis or when there is any possibility of contamination Risk of injury due to disinfectant agents Certain disinfectant agents can cause skin eye or respiratory tract irritation Ö Do not use disinfectant agents that cause irritation We recommend an alcohol free surface disinfectant to dis...

Страница 99: ...or reasons of hygiene clean it once a week To do so proceed as follows 1 Clean the tube with mild soapy water Do not use any other agents 2 Rinse the tube thoroughly with clear water 3 Let the tube air dry completely When using other tube circuits the manufacturer s instructions must be observed Tube circuits not designed for reuse must be disposed of properly Cleaning the humidifier Clean the hum...

Страница 100: ...may be damaged and emit unpleasant odours A Coarse filter black B Fine filter white C Filter cassette Figure 43 Filter cassette structure Cleaning the coarse filter Clean the course filter once weekly 1 Remove the filter cassette from the device see Figure 43 2 Remove the coarse filter black from the filter cassette 3 Clean the filter with mild soapy water Do not use any other agents 4 Rinse the f...

Страница 101: ...ite 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 Insert the coarse filter back into the cassette 5 Slide the filter cassette into the device ...

Страница 102: ...ly clean and disinfect the device between use by different patients to ensure it is free of pathogenic germs Ö If in doubt always assume that the device is contami nated and has to be hygienically reconditioned accord ing to the hygienic concept Ö If contamination with multi resistant pathogens e g MRSA is suspected the device must be packaged with the appropriate labelling and disinfected accordi...

Страница 103: ...econdition according to the manufacturer s guide lines if possible Humidifier Recondition according to the manufacturer s guidelines Device Disinfect the device surfaces with a disposable germicidal wipe We recommend an alcohol free surface disinfectant e g schülke mikrozid sensitive wipes Make sure that no liquid is drawn into the device through the openings Let the disinfectant soak in according...

Страница 104: ...104 Chapter 8 Cleaning and Disinfection ...

Страница 105: ...Chapter 9 Annex 105 Chapter 9 Annex ...

Страница 106: ...n how to use oxygen on site in their home environment Maintenance work Device ageing and wear Component ageing and wear can impair device functioning Ö We recommend having the device serviced by an authorised service company every 2 years Please note No maintenance work may be performed when the patient is still con nected to the respiratory therapy device The device has an expected service life o...

Страница 107: ...have changed Inform treating doctor Eye irritation or dry eyes Air leakage between mask and face Check positioning of mask Use new mask if the material has become brittle Cold nose Room temperature too low Increase room temperature warm up tube under pillow Runny nose urge to sneeze Reaction to airflow Either increase the humidity in the room or the temperature of the humidifier Normal cold Consul...

Страница 108: ...lease note The performance characteristics may be affected by electromagnetic inter ference see section Manufacturer s declaration on electromagnetic compatibility on page 125 Important components The respiratory therapy device TREND III consists of the following components Input Keyboard MFK Tube circuit Humidifier optional Output Display Piezo buzzer Micro USB USB Motherboard Power Management Co...

Страница 109: ...nt The device has an internal memory to record data The following data will be saved Messages and events with date and time stamp approx 15000 entries Device settings and counter Update files Initialisation files Measurement parameters pressure volume flow approx 50 days with 20 values recorded per second Therapy related statistical data To be able to pass on the therapy data you can copy the data...

Страница 110: ...vice uses the default parameter set and can con tinue to be utilised Eventlog File Damaged Reading of event data failed Device must be serviced Booting Error Boot failed Device must be serviced Error Real Time Clock Button cell depleted Device must be serviced Blower Service Required Intended blower duration exceeded Device must be serviced Counters Corrupt Failed to read counter Device must be se...

Страница 111: ... W including humidifier and heated tube Electrical protection class Protection class II Specifications and performance characteristics Dimensions W x D x H 189 x168 x 96 mm Weight approx 1 kg device approx 1 7 kg device with humidifier approx 0 7 kg humidifier Power reserve of the clock battery Max 8 years Max stable limit pressure 25 hPa Min stable limit pressure 4 hPa Max inspiratory working pre...

Страница 112: ...ting level and ambient conditions Positive airway pressure with two pressure levels with humidifier Breathing frequency breaths min a 10 b 15 c 20 Pa inspiratory hPa or cmH2O 8 11 17 22 25 Pa expiratory hPa or cmH2O 4 7 13 18 20 Inspiration µ hPa a 0 17 b 0 02 c 0 01 a 0 25 b 0 45 c 0 07 a 0 05 b 0 04 c 0 11 a 0 37 b 0 40 c 0 18 a 0 37 b 0 25 c 0 23 σ hPa a 0 02 b 0 06 c 0 07 a 0 03 b 0 03 c 0 09 ...

Страница 113: ...per ISO 5356 1 Product class as per 93 42 EEC IIa Operating conditions Temperature range 5 C to 35 C Relative humidity 15 to 95 non condensing Air pressure range2 800 hPa to 1060 hPa approx 2000 to 400 m Storage and transport conditions Temperature range 25 C to 70 C Relative humidity 5 to 95 non condensing Air pressure range 265 hPa to 1060 hPa approx 10000 to 400 m Storage conditions Store in a ...

Страница 114: ...nts 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 ...

Страница 115: ...min 1 l min 0 200 l min 4 l min Frequency1 0 120 bpm 1 bpm Calculated from period of breaths taken 1 bpm I E1 1 0 1 1 25 0 1 Calculated from period of breaths taken 0 3 MV2 0 25 l 0 1 l calculated from flow measurements 0 05 l or 20 of the measured value3 Leakage1 0 230 l min 1 l min 0 230 l min 10 l min or 20 of the measured value3 All flow and volume values were determined under STPD conditions ...

Страница 116: ...AP 4 20 hPa EPAP IPAP 3 hPa 0 5 hPa 1 0 hPa or 5 of the measured value Frequency 4 30 bpm 1 bpm 1 bpm Safety Frequency On Off Apnoea Time 0 60 s 1 s 1 s I E 4 00 1 1 4 00 0 05 0 05 Inspiration Time 0 4 8 s 0 1 s 0 1 s Ti Max 1 10 s 0 1 s 0 1 s Ti Min Off 0 4 5 s 0 1 s 0 1 s I Slope Level 1 5 1 level E Slope Level 1 5 1 level Trigger On Off Inspiration Trigger auto Level 1 10 1 level Expiration Tri...

Страница 117: ...s Apnoea Off 1 60 s 1 s 1 s Leak Rate Off 20 100 l min 1 l min 1 l min Rebreathing Off On High Frequency Off 10 120 bpm 1 bpm 1 bpm Low Frequency Off 1 50 bpm 1 bpm 1 bpm High Inspiration Volume Off 0 2 2 5 l 0 01 l 0 05 l or 20 of the measured value Low Inspiration Volume Off 0 05 2 l 0 01 l 0 05 l or 20 of the measured value High Minute Ventilation Off 0 8 25 l 0 01 l 0 05 l or 20 of the measure...

Страница 118: ...hers Pressure Unit hPa mbar cmH2O Volume Unit l ml Display Time Insp Seconds I E User Profile Clinic Home Timer Screen Change 0 55 s 1 20 min 1 Standby 0 55 s 1 20 min 1 Standby Screen Black Clock Ratings Menu only in clinic mode On Off Humidifier parameters Parameter Setting range Setting increments Level Heater 1 5 1 Brightness LED 0 100 10 Heater Tube On Off ...

Страница 119: ...a 4 hPa Pressure Increase 3 3 3 Sens Obstr Detec tion Medium Medium Medium I FLEX Medium Medium Maximum Pressure Increase 2 hPa 2 hPa E FLEX Medium Medium Maximum Pressure Decrease 2 hPa 2 hPa IPAP 10 hPa 10 hPa 10 hPa 10 hPa EPAP 6 hPa 6 hPa 6 hPa 6 hPa Frequency 12 bpm Safety Frequency Off Apnoea Time 10 s Inspiration Time 2 0 s Ti Max 4 s 4 s 4 s 4 s Ti Min 0 4 s 0 4 s 0 4 s 0 4 s I Slope 3 3 3...

Страница 120: ...ning parameters Parameter TRENDIII CPAP TRENDIII APAP TRENDIII BILEVELS TRENDIII BILEVELST TRENDIII AutoBILEVELS TRENDIII AutoBILEVELST Disconnection 10 s 10 s 10 s 10 s 10 s 10 s Apnoea Warning 10 s 10 s 10 s Leak Rate Off Off Off Off Off Off Rebreathing Off Off Off Off Off Off High Frequency 30 bpm 30 bpm 30 bpm 30 bpm 30 bpm 30 bpm Low Frequency Off Off Off Off Off Off High Inspiration Volume 1...

Страница 121: ...y mm dd Delimiter Time Format 24 h Timer Screen Change 2 min Standby 10 s Standby Screen Clock Brightness Display 3 Language English Ratings Menu On Pressure Unit hPa Volume Unit l Display Time Insp Seconds User Profile Clinic Humidifier Level Heater 5 Brightness LED 50 Heater Tube Off Alarm Clock Alarm Clock Off Hour 6 Minute 0 ...

Страница 122: ...e partner Replacement parts Name Article number Figure Leakage tube L 180 cm 22 mm 00007875 Mains cable 31100015 Power supply unit FUHUA ELECTRONIC CO LTD UES65 240270SPA1 00013086 Housing panel 00015060 Filter cassette with filter 00015061 TREND III user s manual for physicians and medical professionals 50000767 User s manual for physicians and medical professionals TREND III user s manual for pa...

Страница 123: ...24V 9 8 10 11 ST Tuesday l 22 03 2017 l 20 36 40 30 20 10 0 40 30 20 10 0 Humidifier Alarm Clock Parameter Info Reports System 09 25 4 5 6 7 3 2 1 Carrying case 00002080 Accessories Name Article number Figure 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 mask 00003551 00003552 0000...

Страница 124: ...ety valve 00004947 AKKUPACK basic set AKKUPACK uni Base cable power cord switching power supply 00011103 TREND III AKKUPACK cable 000011105 AKKUPACK uni BASE Respiratory therapy 00011101 Mains Cable 31100023 Switching power Supply 00014207 AKKUPACK uni PLUS 00011099 Bluetooth 4 0 Dual Mode Class 2 USB Adapter LM506 31200011 ...

Страница 125: ...I respiratory therapy device must ensure it is operated in such an environment Emitted interference Compliance Electromagnetic environment guidance HF emissions as per CISPR 11 Group 1 The TREND III respiratory therapy device only uses HF energy for its internal functions Its HF emissions are thus very low and interference with nearby electronic devices is unlikely HF emissions as per CISPR 11 Cla...

Страница 126: ...s charge 2 4 8 15 kV air dis charge display Floors should be made of wood or concrete or be lined with ceramic tiles If the floor is lined with a synthetic material the relative humidity must be at least 30 Emitted HF distur bances as per IEC 61000 4 3 10 V m 80 MHz 2 7 GHz 80 AM at 1 kHz 10 V m Portable and mobile HF communication devices including wires and antenna should be used at least 0 3 m ...

Страница 127: ... conductor outer conductor 2 kV voltage outer conductor earth The quality of the supply voltage should corre spond to one of the typ ical business or hospital environments Conducted HF disturbances as per IEC 61000 4 6 3 VEffective value 150 kHz 80 MHz 6 VEffective valuein ISM and amateur radio bands between 150 kHz 80 MHz 3 V 6 V Portable and mobile radio devices should be used spaced at least at...

Страница 128: ...Hz periods 30 60 Hz periods 95 dip of UT for 250 50 Hz periods 300 60 Hz periods 95 dip of UT for 1 2 period 60 dip of UT for 5 periods 30 dip of UT for 25 periods 95 dip of UT for 5s or 6s The quality of the sup ply voltage should cor respond to one of the typical business or hos pital environments If the user of the TREND III respiratory therapy device requires contin ued functioning even in the...

Страница 129: ... Please contact the relevant customer services department to find out how to dispose of the device etc properly Packaging The packaging is taken back by the distributor but it can alternatively be dis posed of separately with the normal household waste Accessories Accessories such as the tube mask filter etc can be disposed of with normal house hold waste unless otherwise specified by the manufact...

Страница 130: ... 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 the product is used for purposes other than stipulated in the user s manual or the hygiene and cleaning instructions stipulated in the user s manual have not been complied with Statutory guarantee rights remain unaffected by ...

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