Hoffrichter TREND III CPAP User manual

User’s manual
for physicians and medical professionals
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
TREND III
Respiratory therapy device
HOFFRICHTER GmbH
Mettenheimer Strasse 12/14
19061 Schwerin
Germany
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
www.hoffrichter.de
TREND III _ I Klinik ENG_2022-01-18_4.0
User’s manual TREND III for physicians and medical professionals
50000767

3
TREND III
User's manual
for physicians and medical professionals
©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.
HOFFRICHTER GmbH reserves the right to amend or replace this user’s manual without
prior notice.
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 manual
•Hygiene concept
Licensing information
The device software is in part based on freeware. You can save and read the list of soft-
ware used as well as the corresponding licensing conditions by copying the data to a
USB stick.

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.
.................................................
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.

Contents 5
Contents
Chapter 1 .......................................................................................11
Introduction.......................................................................................................... 11
Scope of delivery...................................................................................................... 12
Symbols ................................................................................................................... 13
Intended use............................................................................................................ 17
User qualification ..................................................................................................... 20
Chapter 2 .......................................................................................21
Safety Information................................................................................................ 21
General safety instructions ....................................................................................... 22
Installation requirements and transport .................................................................... 25
Instructions 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
Beginning therapy.................................................................................................... 55
Ending therapy......................................................................................................... 55

6 Contents
Chapter 5 .......................................................................................57
Therapy Modes..................................................................................................... 57
CPAP mode.............................................................................................................. 58
APAP mode.............................................................................................................. 59
T mode.................................................................................................................... 60
ST mode .................................................................................................................. 62
S mode.................................................................................................................... 63
A-S mode (auto S mode) .......................................................................................... 64
Chapter 6 .......................................................................................65
Operating the Device ............................................................................................ 65
Menu structure (clinic mode).................................................................................... 66
User profiles............................................................................................................. 67
Changing the PIN code ............................................................................................ 68
Home screen............................................................................................................ 69
Monitoring 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............................................................ 102
Chapter 9 .....................................................................................105
Annex................................................................................................................. 105
Notes for home therapy......................................................................................... 106

Contents 7
Maintenance work................................................................................................. 106
Troubleshooting..................................................................................................... 107
Device technical specifications................................................................................ 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

8 List of figures
List of figures
Figure 1: Rating plate (example)..................................................................... 14
Figure 2: Top of device................................................................................... 30
Figure 3: Bottom of device............................................................................. 31
Figure 4: Rear of device ................................................................................. 32
Figure 5: Setting up the device....................................................................... 38
Figure 6: Mains connection via power supply unit.......................................... 39
Figure 7: Start screen ..................................................................................... 40
Figure 8: Connect Bluetooth adapter ............................................................. 41
Figure 9: System structure with CPAP mask .................................................... 42
Figure 10: Connecting AquaTREND III-NG........................................................ 43
Figure 11: Disconnecting AquaTREND III-NG from the device ........................... 46
Figure 12: Connecting the bacterial filter.......................................................... 49
Figure 13: Connecting a PC.............................................................................. 50
Figure 14: Inserting a USB stick ........................................................................ 51
Figure 15: nserting a USB stick......................................................................... 52
Figure 16: Supplying oxygen directly into the mask .......................................... 53
Figure 17: Supplying oxygen via an adapter ..................................................... 54
Figure 18: CPAP mask test and soft start .......................................................... 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 27: Flow diagram of ST mode................................................................ 62
Figure 28: Diagram of S mode ......................................................................... 63
Figure 29: Diagram of A-S mode...................................................................... 64
Figure 30: Changing the user profile ................................................................ 67
Figure 31: PIN prompt when changing the user profile..................................... 67
Figure 32: Home screen................................................................................... 69
Figure 33: Standby screen................................................................................ 70
Figure 34: Monitoring screen, factory setting ................................................... 71
Figure 35: Comfort screen ............................................................................... 73
Figure 36: Therapy screen................................................................................ 73
Figure 37: System screen ................................................................................. 82
Figure 38: Reports screen in clinic mode: Ratings ............................................. 86
Figure 39: Reports screen in clinic mode: Indicators ......................................... 86
Figure 40: Reports screen in home mode: Ratings............................................ 87

List of figures 9
Figure 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

10 List of figures

Chapter 1: Introduction 11
Chapter 1
Introduction

12 Chapter 1: Introduction
Scope of delivery
Figure Name
Respiratory therapy device TREND III
Power supply FUHUA ELECTRONIC CO., LTD. - UES65-
240270SPA1
Mains cable
Leakage tube circuit
(L = 180 cm, ∅22 mm)
Carrying case
User’s manual
for patients
Respiratory therapy device
User’s manual for patients
TREND III
Brief instruction for Patients
CPAP - AutoCPAP - BILEVEL S - BILEVEL ST
of device software 1.000
Operator controls
1 Display
2 Housing panel
3 Connection leakage
tube circuit/integrable humidifier
4 Multifunction knob MFK (MFK)
5 Escape key
6 on/off-key
7 Home-key
8 Micro-USB-connection
9 USB-interface
10 DC-plug
11 Filter-cassette
24V
24V
98 10
11
ST
Tuesdayl22.03.2017l 20:36
40
30
20
10
0
40
30
20
10
0Humidifier AlarmClock
ParameterInfo ReportsSystem
09:25
4567
3
2
1
Quick reference guide
Art.-no.:50000709
Gerätetyp/ Device type
Seriennummer/
Serialnumber
Gerätesoftware-Version/ Devicesoftware version
Gerätesprache/ Device language
Datum Unterschriftdes Prüfers / Firmenstempel
Date Signature of the tester / Company stamp
Endprüfung
Final Inspection
TREND III
Atemtherapiegerät
Respiratorytherapy device
DasGerät hat folgende Tests und Prüfungen
erfolgreichbestanden
Thedevice has successfully passed following
testsand checks:
•Funktionskontrolle aller Anschlüsse, Bedien-
elementeund des Displays
Functionalcheck of all connections, operating
elementsand the display
•Prüfprotokoll F10-235
Testprotocol F10-235
TRENDIII Endprüfung DEU-ENG_2017-07-13_1.0
Final inspection log

Chapter 1: Introduction 13
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.
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

14 Chapter 1: Introduction
Symbols on the rating plate
The rating plate is on the bottom of the device.
Figure 1:
SN :
DFmyyxxxxx
TREND III
Type: 5CPD31
AutoBILEVEL ST
Made in Germany
HOFFRICHTER GmbH
Mettenheimer Str. 12/14
19061 Schwerin
Germany
DC-Input
24V
max. 2.7 A
IP22
Rating plate (example)
Symbol Meaning
Follow the instructions in the user’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 device with the household waste. Please contact the
relevant customer services department to find out how to properly dispose
of the device.

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

16 Chapter 1: Introduction
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.
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 the device.
Please note:
Notes provide tips and information for the ecient, correct
use of the device.

Chapter 1: Introduction 17
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. Use of the device is intended
for home medical care and professional health care facilities such as sleep laboratories
and hospitals.
The "TREND III" is not suitable for use in motor vehicles, aircraft and helicopters.
General description of function
The blower sucks in the ambient air via a filter and transports it to the patient 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 using an O2 safety valve.
Respiration therapy is carried out according to therapy parameters set using the control
elements. In clinic mode, various measured values can be monitored via the display in
the menu item "Monitoring".
In the event of a misconduct of the set and permanently stored parameters in the device,
visual and audible warning signals are output. If the prescribed therapy is no longer pos-
sible due to a technical error, an acoustic signal is emitted for at least 2 minutes.
The therapy data can be evaluated via the USB interface with the "easySET" PC software.

18 Chapter 1: Introduction
The TREND III respiratory therapy device is available in the following types: CPAP, BILEVEL
S, BILEVEL ST, AutoCPAP, AutoBILEVEL S and AutoBILEVEL ST.
All TREND III devices have a respiratory trigger. The respiratory trigger recognises the
patient’s diculties in inhaling or exhaling and notifies the control equipment. A vol-
ume-based trigger can be set for inhaling, while a flow-based trigger is available for
exhaling (Values not adjustable for CPAP and AutoCPAP devices). In combination with
optimal slope adjustment, the device ensures very comfortable therapy for patients, who
feel like the device is gently supporting their natural breathing.
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 S T ST A-S
TREND III CPAP •
TREND III AutoCPAP • •
TREND III BILEVEL S • •
TREND III BILEVEL ST • • • •
TREND III AutoBILEVEL S • • • •
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 transition from one pressure level to the next is triggered when the patient
begins to breathe. The pressure is decreased to the set lower level when the
inspiration flow ends. In addition, a safety frequency (S frequency) can be acti-
vated. This ensures patients are still ventilated with the set parameters in case
of respiratory arrest.
A-S Auto S mode is an extension to S mode and offers the additional function of
automatic adjustment to the expiratory pressure (EPAP) within specific limits.
The IPAP is also increased so that the distance between the pressure levels
(pressure difference between IPAP and EPAP) always remains the same. In
addition, the speed of the pressure increase can be adapted to the patient’s
special needs in 5 stages.

Chapter 1: Introduction 19
ST 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.
T Ventilation (timed) – with fixed inspiration time. If the trigger function is dis-
abled, the patient is ventilated with the set parameters. If the trigger is enabled,
the device accepts spontaneous patient inspiratory efforts. The patient is then
able to increase the breathing rate through his own efforts.
Indication
All TREND III devices can be used in the following 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 disorders
Regardless of the indications named here, use of the device always depends on the doc-
tor’s individual diagnosis.
Contraindications
Risk of injury due to contraindications!
Respiratory therapy may be contraindicated for certain pre-ex-
isting conditions.
These pre-existing conditions include:
•Bullous lung disease
•Pneumothorax
•Very low blood pressure
• Air accumulation following an open traumatic brain injury
or other head injuries
In case of a sinus infection or an infection of the middle ear, the doctor must verify
that therapy may continue.

20 Chapter 1: Introduction
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 clean-
ing instructions. Generally the side effects go away after the cause has been eliminated.
You will find suitable countermeasures for several side effects on see also page 107.
The following side effects may occur during therapy:
•Nose or sinus pain, earache
•Nose and throat dryness and irritation
•Nose bleeds, runny nose, urge to sneeze, cold
•Eye irritation or dry eyes
•Skin flushing in the area of the mask, skin swelling in the area of the mask
•Diculty 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 device.
These people must be familiarised with operation of the device and must have read and
understood this user’s manual completely before commissioning the device. In addition,
the operator must inform the users of what accessories are compatible with the device.
Maintenance and repairs may only be performed by trained and authorised service com-
panies.