Hoffrichter TRENDvent User manual

User’s manual for patients
Ventilator
Quality makes the Difference
TRENDvent
as of device software 1.500

2 Info
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 num-
ber on the rating plate on the bottom of the device.
..................................................
Please always quote the serial number for all queries and complaints.
CONFORMITY
The device complies with the requirements of Directive 93/42/EEC.

Contents 3
CONTENTS
Scope of delivery ...............................................................................7
General...............................................................................................8
Information on user’s manual.............................................................8
Symbols on the rating plate...............................................................8
Symbols used in this user’s manual ...................................................9
Safety information............................................................................10
General safety instructions ..............................................................10
Electrical safety...............................................................................13
Installation requirements and transport ............................................ 14
Instructions before commissioning ..................................................15
Using oxygen.................................................................................. 16
Safety-related test...........................................................................17
Intended use...................................................................................18
Contraindications ............................................................................ 19
Side effects.....................................................................................20
How the device works .....................................................................21
Important components....................................................................21
How the device works.....................................................................25
Nurse call and remote alarm............................................................26
Ventilation modes ............................................................................27
PCV mode ......................................................................................28
APCV mode.................................................................................... 29
PSV mode ......................................................................................30
PSV-S mode ...................................................................................31
CPAP mode.................................................................................... 31
S mode........................................................................................... 31
T mode...........................................................................................31
ST mode.........................................................................................31
Description of device.......................................................................32
Housing, display and control elements ............................................32
Operating unit .................................................................................34
Operating unit elements ...............................................................34
LED functions ..............................................................................35
Button functions...........................................................................36

4 Contents
Commissioning ................................................................................38
Setting up the device ......................................................................38
Using the functional bag.................................................................. 39
Power supply..................................................................................40
Mains operation ...........................................................................40
Operation with internal battery...................................................... 41
Power failure ................................................................................41
Operation with external battery.....................................................42
Setting the tube system ..................................................................43
Connecting the valve tube system................................................... 44
Connecting the Leckage tube system..............................................45
Connecting the humidifier................................................................ 46
Connecting the bacterial filter ..........................................................47
Connecting the remote alarm box/nurse call....................................47
Switching the device on ..................................................................48
Switching the device off ..................................................................49
Starting ventilation ..........................................................................50
Stopping ventilation ........................................................................50
Operation with humidifier ................................................................51
Setting the humidifier heating level................................................ 51
Switching on the heating ..............................................................52
Switching oFF the heating ............................................................52
Using oxygen.................................................................................. 53
Supplying oxygen.........................................................................53
Stopping the supply of oxygen .....................................................53
Measuring oxygen concentration..................................................54
Operating the device .......................................................................56
Operating concept ..........................................................................56
Changing screens ...........................................................................57
Safety lock......................................................................................57
Activating the safety lock..............................................................57
Deactivating the safety lock.......................................................... 57
The patient screen ..........................................................................58
Symbol area.................................................................................59
Changing the ventilation set .........................................................60

Contents 5
The curve screen ............................................................................ 61
“Freezing” the curve screen.......................................................... 62
Scaling the time axis ....................................................................62
Changing the measured value ......................................................62
The ventilation sets .........................................................................63
Activating the ventilation set .........................................................64
The comfort screen......................................................................... 65
Changing the date .......................................................................66
Changing the time........................................................................66
Setting the automatic start ...........................................................67
Setting the softstart time ..............................................................68
Setting the mask test time............................................................69
Starting the mask test ...............................................................69
Setting the volume of the alarms ..................................................70
Setting the brightness of the display............................................. 71
Setting the contrast of the display ................................................71
The alarm screen ............................................................................72
The counter screen ......................................................................... 73
The service screen ..........................................................................74
The status screen ...........................................................................75
Alarms and error messages.............................................................76
General...........................................................................................76
Visual alarms...................................................................................76
Acoustic alarms ..............................................................................77
Suppressing alarm sounds...........................................................77
Adjustable alarms ...........................................................................78
Error messages, fixed alarms ..........................................................79
Hardware errors ...........................................................................79
Further error messages ................................................................80
Fixed alarms for power supply .....................................................82
Further messages ........................................................................82
Saving alarms .................................................................................83
Reading out the alarm memory on the device ...............................83
Forwarding alarms .......................................................................... 83

6 Contents
Cleaning and disinfection ................................................................ 84
Cleaning the device.........................................................................84
Cleaning the coarse filter................................................................. 85
Cleaning the mask ..........................................................................86
Cleaning the tube system................................................................ 86
Valve tube system ........................................................................86
Leakage tube system ...................................................................87
Cleaning the oxygen sensor ............................................................87
Cleaning the humidifier....................................................................87
Changing the bacterial filter ............................................................. 87
Preparing the device when changing patient....................................88
Functional test .................................................................................89
Checking the acoustic alarm ...........................................................89
Checking the alarm button light....................................................... 89
Checking the display....................................................................... 89
Checking the status screen for errors ..............................................90
Checking the date and time ............................................................90
Checking the “Battery operation” alarm ...........................................90
Checking the leakage alarm ............................................................90
Checking “Frequency too high” alarm.............................................. 90
Maintenance and safety-related test (SRT).....................................91
Disposal ...........................................................................................92
Device ............................................................................................92
Packaging.......................................................................................92
Oxygen sensor................................................................................92
Accessories......................................................................................93
Technical data..................................................................................95
Manufacturer’s declaration on electromagnetic compatibility .......98
Disclaimer ......................................................................................102

Scope of delivery 7
SCOPE OF DELIVERY
Power supply
Spare
fine filter
Spare
coarse filter
TRENDvent ventilator
Functional bag
Mains cable
Valve tube system with expiration valve
Leakage tube system
with pressure measuring
tube and 2 plugs
Spare filter
cassette
Adapter for oxygen
connection, straight
User’s manual and
brief instructions
Microfibre cloth CLICKpad

8 General
GENERAL
INFORMATION ON USER’S MANUAL
Read this user’s manual through carefully before using the ventilator for
the first time.
Follow the safety and cleaning instructions in particular.
Keep the manual in a safe place close to the device so that you can refer
to it immediately if necessary.
SYMBOLS ON THE RATING PLATE
Observe the warning and safety instructions in the user’s
manual.
BF application part
Protection class II (protective insulation)
CE conformity declaration
Manufacturer
Do not dispose of the device with the household waste. Please
contact the relevant customer services department to find out
how to dispose of the device properly.

General 9
SYMBOLS USED IN THIS USER’S MANUAL
Important information is denoted by symbols in this user’s manual. Be sure
to follow these instructions in order to avoid accidents, personal injury and
material damage.
In addition, the local accident prevention regulations and general safety
regulations in force in the area of use must be observed.
This symbol denotes general safety instructions. Follow these instruc-
tions to avoid accidents, personal injury or material damage.
This symbol denotes hazardous situations that lead to serious inju-
ries or death.
This symbol denotes hazardous situations that may lead to serious
injuries or death.
This symbol denotes hazardous situations that may lead to moder-
ately severe injuries.
This symbol denotes situations that may lead to material damage or
damage to the device.
This symbol denotes information, tips and instructions for the effi-
cient, error-free use of the device.

10 Safety information
SAFETY INFORMATION
GENERAL SAFETY INSTRUCTIONS
•Only qualified, trained, specialist medical staff under
the supervision of a physician may make adjust-
ments to the ventilator. The device must only be
used by persons who have fully read and understood
this user’s manual before commissioning and have
familiarized themselves with the device. Disregarding
these instructions can lead to life-threatening situa-
tions for the patient.
•In cases of emergency, an alternative ventilation
option, such as a second ventilator or an emergency
ventilation bag, must be available at all times and be
usable by the attending person.
•The device must only be used on the responsibility
and prescription of the physician.
•The device must only be used on patients whose
clinical picture requires its application.
•Please take the utmost care to ensure that the patient
remains connected to the tubing system during ventila-
tion.
•The device must not be used with flammable anes-
thetics or ambient air that contains explosive gases.
This may cause fires or explosions.
•Before being used again on another patient, all parts
that come into contact with respiratory gas must be
hygienically prepared (see page 83).
•The directions given in this user’s manual and the
applicable regulations of the hospital or nursing home
must be adhered to when hygienically preparing and
cleaning the device.

Safety information 11
•We recommend the use of the tube systems tested
and approved for use by the manufacturer. Using
other tube systems may lead to differing results.
•When a valve tube system and a nasal or full-face
mask is used for non-invasive ventilation, this mask
must not contain an expiration opening.
•Always ensure that when using a leakage tube sys-
tem, the small aperture in the mask or the connecting
piece between the mask and the tube is clear so that
the CO2-laden exhaled air can escape.
•When using a valve tube system, the controlled
expiration valve must not meet any resistance during
exhalation and must enable quick ventilation of the
ventilation tube system.
•Please observe the expiration date when using a
bacterial filter.
•In order to ensure patient safety, the device must be
operated in such a way that all adjustable alarms are
activated and adjusted to the patient.
•Acoustic alarms must not be ignored. They indicate
conditions that require an immediate reaction.
•In case of extraordinary efforts on the patient’s part,
there is a risk of hyperventilation in all ventilation
modes with inspiration triggering.
•The device’s housing provides only minimal protec-
tion against water penetration.
•The device must not be steam-sterilized in an auto-
clave.

12 Safety information
•Filters and other parts that are connected to the
device must be regularly replaced. Dispose of the
replaced parts according to the regulations for used
medical material and/or the local environmental
protection rules.
•A device that is not functioning properly may
endanger the patient or operator. If the device does
not start properly or if the self-tests, automatically
performed on system start, fail to be completed suc-
cessfully, the device must not continue to be used.
Please notify the service agency in such a case.
•The connection of accessories or other components
to the respiratory system of the ventilator can lead to
increased expiratory pressure at the patient connec-
tion opening.
•Please ensure that the total resistance of the ventila-
tion system does not exceed 6 hPa with a flow of
60 l/min for adults and 30 l/min for children.
•Any modification to the device poses a threat to its
serviceability and is not permitted.
•Masks may only be used on the prescription of a
physician and after training by qualified medical staff.
The intake of medicines and possible contraindica-
tions and side effects associated with the use of the
prescribed mask should be clarified.
•When the device is used in mobile operation, the
power must supplied by AKKUPACK uni or AKKU-
PACK CARAT.
•Please note the operating, transport and storage
conditions.

Safety information 13
ELECTRICAL SAFETY
•Do not use any electrically conductive or electrostati-
cally chargeable patient tubes.
•The device must never be put near other devices or
equipment such as defibrillators, diathermy units,
mobile phones, microwaves, remote controlled toys,
etc. Electromagnetic fields that exceed 10 V/m may
adversely affect the operation of the ventilator.
•Only the power supply cable supplied may be used
for operating the device.
•The use of accessories or power supplies not
approved for the ventilator may lead to increased
emission of electromagnetic radiation or reduced
resistance to interference.
•During certain examinations or treatments, mutual
interference between the ventilator and other medical
devices may occur. Observe the information regard-
ing electromagnetic compatibility and monitor the
devices with regard to error-free and proper opera-
tion.
•Do not reach for the device under any circumstances
should it fall into water.
•Do not try to open the device. Maintenance and
repairs may only be performed by personnel autho-
rized by HOFFRICHTER GmbH.

14 Safety information
INSTALLATION REQUIREMENTS AND TRANSPORT
•For operation, the device must be placed on a safe,
level base. The air inlet at the rear of the device, as
well as all ventilation slots, must not be blocked.
•The display and all operating and display elements
must not be covered and must be visible at all times.
•No objects must be placed on the device.
•Place the device in such a way that the mains plug is
easily accessible so that it can be unplugged quickly
in the event of a hazard.
•The device must not be exposed to direct sunlight.
•• The system must never be stored or transported t
ambient temperatures under - 10 °C and over + 50 °C.
•Due to electromagnetic interference, the ventilator
must not be set up in the immediate vicinity of other
devices. If this is unavoidable, the ventilator must
be monitored with respect to error-free and proper
operation.

Safety information 15
INSTRUCTIONS BEFORE COMMISSIONING
•A functional test must be carried out each time before
commissioning (see page 89).
•At temperatures below - 5 °C and over + 50 °C, the
function of the device may be impaired.
•Do not use the device if the housing or the cable of
the device or the power supply are damaged.
•The ventilation system, including all accessories such
as humidifiers, bacterial filters etc., must be checked
for leaks before ventilation. Leaks may lead to per-
sonal injury or inadequate therapy.
•Clean and check all accessories regularly, particularly
the tube/mask system. When doing this, observe the
manufacturer’s safety and cleaning instructions.

16 Safety information
USING OXYGEN
•Oxygen may only be supplied on the prescription of
a physician. An excessive oxygen supply can lead to
serious complications for the patient.
•Before commissioning, appropriate training must be
carried out on-site, in the home environment.
•Please be sure to observe the user’s manual of the
manufacturer or distributor from whom you obtain the
oxygen.
•Oxygen supports combustion. Therefore, observe
the fire protection regulations applicable for using
oxygen. Ensure that the oxygen fittings, as well as
all ports and surfaces near the oxygen lines are free
of grease. Do not smoke and do not handle naked
flames. When using oxygen, an increased oxygen
concentration in the ambient air can occur.
•If the patient is supplied with oxygen via the device,
the FiO2should be measured.
•The FiO2can be measured using the oxygen sensor
optionally available from HOFFRICHTER. We recom-
mend the exclusive use of these sensors
(see “Accessories” on page 93.)
•The oxygen sensor contains a caustic liquid. Avoid
skin or eye contact if there is a sensor leak!
•Please observe the expiration date when using an
oxygen sensor (see page 55).
•The oxygen supplied must not exceed a pressure of
1000 hPa and a flow of 15 l/min. The oxygen must be
dosed using an external flow meter.

Safety information 17
•When supplying oxygen, it should be ensured that
only dry gas (O2) is used. Increased residual moisture
may lead to device defects. If necessary, a humidifier
can be connected between the air outlet of the device
and the patient.
•The connection between the O2connection and
external O2source must be absolutely airtight. Other-
wise, leakage losses may occur during ventilation.
•The oxygen supply should be stopped before the
ventilation is interrupted. We further recommend that,
after stopping the ventilation, the device is allowed to
run for several respiratory cycles without an oxygen
supply.
•In the event of an oxygen leak, the oxygen supply
should be closed off immediately. The room must
immediately be ventilated. At the same time, any
sparks, fire or potential sources of fire in the vicinity of
the device must be avoided.
SAFETY-RELATED TEST
•In order to ensure the operating safety of the device,
a safety-related test or maintenance must be carried
out at the prescribed intervals.

18 Safety information
INTENDED USE
The use of the device contrary to its intended use can lead to a haz-
ard to the health of the patient.
The device is used for pressure-controlled respiratory support, as well as
the ventilation of patients who are not completely dependent on mechani-
cal ventilation. It is suitable for adults and children from a tidal volume of
50 ml onwards, and can be used both in the home or clinic.
The ventilation can be invasive (e.g. via a tracheotomy) as well as non-inva-
sive (via a mask). The device fulfils the technical requirements to be oper-
ated with a leakage tube system or a valve tube system with expiration
valve, as required. For ventilation with increased oxygen concentrations,
the device can be connected to a low-pressure gas source. Furthermore,
it is also possible to combine the device with the AquaTREND uni plug-in
humidifier or, during invasive ventilation, with an external humidifier.

Safety information 19
CONTRAINDICATIONS
Respiratory therapy may be contraindicated for certain pre-existing
conditions.
The following conditions may be a contraindication for non-invasive ven-
tilation:
•Severe cardiac arrhythmia
•Severe hypotension
•Severe epistaxis
•Pneumothorax or pneumomediastinum
•Pneumoencephalus
•Cranial trauma
•Status after cranial or brain surgery
•Acute inflammation of the paranasal sinuses, middle ear infection or
a perforated ear drum
•Aspiration hazard
In individual cases, the attending physician must decide on the therapy.

20 Safety information
SIDE EFFECTS
The following undesired side effects may occur in connection with artifi-
cial respiration:
Invasive ventilation:
•Complications due to tube / tracheal cannula
Mask ventilation:
•Pressure points and skin defects in the face
•Eye irritation due to leaks
•Gastric inflation
•Aspiration
•Sinusitis
•Nose bleeds
General complications of mechanical ventilation:
•Pulmonary barotrauma / volutrauma caused by ventilation
•Ventilator-associated pneumonia
•Effects on the cardio-vascular system