TRENDvent - Hoffrichter GmbH

User’s manual for patients
Ventilator
TRENDvent
Quality makes the Difference
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 rating plate on the bottom of the device.
Serial number: .....................................
Please always quote the serial number for all queries and complaints.
CONFORMITY
The device complies with the requirements of Directive 93/42/EEC.
2
Info
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
Contents
3
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 .............................................................. 51
Switching on the heating .............................................................. 51
Using oxygen .................................................................................. 52
Supplying oxygen......................................................................... 52
Stopping the supply of oxygen ..................................................... 52
Measuring oxygen concentration .................................................. 53
Operating the device ....................................................................... 55
Operating concept .......................................................................... 55
Changing screens ........................................................................... 56
Safety lock ...................................................................................... 56
Activating the safety lock .............................................................. 56
Deactivating the safety lock .......................................................... 56
The patient screen .......................................................................... 57
Symbol area................................................................................. 58
The curve screen ............................................................................ 60
4
Contents
“Freezing” the curve screen .......................................................... 61
Scaling the time axis .................................................................... 61
Changing the measured value ...................................................... 61
The ventilation sets ......................................................................... 62
Activating the ventilation set ......................................................... 63
The comfort screen .......................................................................... 64
Changing the date ....................................................................... 65
Changing the time ........................................................................ 65
Setting the automatic start ........................................................... 66
Setting the softstart time .............................................................. 67
Setting the mask test time ............................................................ 68
Starting the mask test ............................................................... 68
Setting the volume of the alarms .................................................. 69
Setting the brightness of the display ............................................. 70
Setting the contrast of the display ................................................ 70
The alarm screen ............................................................................ 71
The counter screen ......................................................................... 72
The service screen .......................................................................... 73
The status screen ........................................................................... 74
Alarms and error messages ............................................................. 75
General ........................................................................................... 75
Visual alarms................................................................................... 75
Acoustic alarms .............................................................................. 76
Suppressing alarm sounds ........................................................... 76
Adjustable alarms ........................................................................... 77
Error messages, fixed alarms .......................................................... 78
Hardware errors ........................................................................... 78
Further error messages ................................................................ 79
Fixed alarms for power supply ..................................................... 80
Further messages ........................................................................ 81
Saving alarms ................................................................................. 82
Reading out the alarm memory on the device ............................... 82
Forwarding alarms .......................................................................... 82
Cleaning and disinfection ................................................................ 83
Cleaning the device ......................................................................... 83
Contents
5
Cleaning the coarse filter ................................................................. 84
Cleaning the mask .......................................................................... 85
Cleaning the tube system ................................................................ 85
Valve tube system ........................................................................ 85
Leakage tube system ................................................................... 86
Cleaning the oxygen sensor ............................................................ 86
Cleaning the humidifier .................................................................... 86
Changing the bacterial filter ............................................................. 86
Preparing the device when changing patient .................................... 87
Functional test ................................................................................. 88
Checking the acoustic alarm ........................................................... 88
Checking the alarm button light ....................................................... 88
Checking the display ....................................................................... 88
Checking the status screen for errors .............................................. 89
Checking the “Battery operation” alarm ........................................... 89
Checking the leakage alarm ............................................................ 89
Checking “Frequency too high alarm” .............................................. 89
Maintenance and safety-related test (SRT) ..................................... 90
Disposal ........................................................................................... 91
Device ............................................................................................ 91
Packaging....................................................................................... 91
Oxygen sensor ................................................................................ 91
Accessories...................................................................................... 92
Technical data .................................................................................. 93
Manufacturer’s declaration on electromagnetic compatibility ....... 95
Disclaimer ........................................................................................ 99
6
Contents
SCOPE OF DELIVERY
User’s manual and
brief instructions
Microfibre cloth
Functional bag
TRENDvent ventilator
Adapter for oxygen
connection, straight
Mains cable
Power supply
Spare filter
cassette
Leakage tube system
with pressure measuring
tube and 2 plugs
Spare
fine filter
Spare
coarse filter
Valve tube system
with expiration valve
Scope of delivery
7
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)
IPX1
Drip-proof device
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.
8
General
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 instructions to avoid accidents, personal injury or material damage.
This symbol denotes hazardous situations that lead to serious injuries or death.
This symbol denotes hazardous situations that may lead to serious
injuries or death.
This symbol denotes hazardous situations that may lead to moderately 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 efficient, error-free use of the device.
General
9
SAFETY INFORMATION
GENERAL SAFETY INSTRUCTIONS
10
•
Only qualified, trained, specialist medical staff under
the supervision of a physician may make adjustments 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 situations 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 ventilation.
•
The device must not be used with flammable anesthetics 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 82).
•
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
•
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 system, 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 protection against water penetration.
•
The device must not be steam-sterilized in an autoclave.
Safety information
11
12
•
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 successfully, 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 connection opening.
•
Please ensure that the total resistance of the ventilation 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 contraindications 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 AKKUPACK CARAT.
•
Please note the operating, transport and storage
conditions.
Safety information
ELECTRICAL SAFETY
•
Do not use any electrically conductive or electrostatically 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 regarding electromagnetic compatibility and monitor the
devices with regard to error-free and proper operation.
•
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 authorized by HOFFRICHTER GmbH.
Safety information
13
INSTALLATION REQUIREMENTS AND TRANSPORT
14
•
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 at
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
INSTRUCTIONS BEFORE COMMISSIONING
•
A functional test must be carried out each time before
commissioning (see page 88).
•
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 personal 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.
Safety information
15
USING OXYGEN
16
•
Oxygen may only be supplied on the prescription of
a physician. An excessive oxygen supply can lead to
serious complications for the patient.
•
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 FiO2 should be measured.
•
Please be sure to observe the user’s manual of the
manufacturer or distributor from whom you obtain the
oxygen.
•
The FiO2 can be measured using the oxygen sensor
optionally available from HOFFRICHTER. We recommend the exclusive use of these sensors
(see “Accessories” on page 92.)
•
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 54).
•
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
•
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 O2 connection and
external O2 source must be absolutely airtight. Otherwise, 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.
Safety information
17
INTENDED USE
The use of the device contrary to its intended use can lead to a hazard 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 mechanical 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-invasive (via a mask). The device fulfils the technical requirements to be operated 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.
18
Safety information
CONTRAINDICATIONS
Respiratory therapy may be contraindicated for certain pre-existing
conditions.
The following conditions may be a contraindication for non-invasive ventilation:
•
•
•
•
•
•
•
•
•
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.
Safety information
19
SIDE EFFECTS
The following undesired side effects may occur in connection with artificial 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
20
Safety information
HOW THE DEVICE WORKS
IMPORTANT COMPONENTS
The TRENDvent ventilator comprises the following components:
• Blower
• DC / Communication
• Sensors / valves (compressed air distribution)
• Power supply
• Controller (control and operating unit)
• Interfaces
Switching
power supply
100 ... 240 V AC
(-20%, +10%)
Remote alarm
Nurse call
Accessories
PC
DC / Communication
Controller
(control and operating unit)
Blower
Humidifier
Tube system
Internal
battery
Sensors / valves
Oxygen supply
Controls / Display
Fig. 1:
Block diagram of entire device
How the device works
21
Blower
The blower provides a maximum pressure of 40 hPa at a flow of 200 l/min.
On the air inlet side there is an air filter cassette with a coarse and a fine filter.
Power supply
The device is supplied with power via an AC/DC switching power supply
or the internal battery. The device can also be provided with an external
power supply using the AKKUPACK uni or AKKUPACK CARAT. Ask your
specialist dealer about this.
22
How the device works
Distribution of air in the device
For the distribution of the compressed air, the device is composed of the
following units:
•
•
•
•
•
•
•
•
Blower (40 hPa at 200 l/min )
Air outlet (standardized tube connector [M22]) with flow element and
proportional valve
Non-return valve
Humidifier (optional)
Oxygen block including 3/2 directional valve and self-locking connection
Pressure measuring tube connection (= 3.5 mm)
Control pressure tube connection ( = 4.5 mm)
Connection for oxygen sensor (jack 2.5 mm)
Air inlet
Filter
Switch
Control unit
Non-return
valve
Blower
Valve
Flow sensor
Proportional
valve
Fig. 2:
Pressure sensors/excess
pressure
switch
Block diagram of
compressed air distribution
Oxygen
connection
Air outlet
Control tube
connection
Pressure
measuring tube
connection
How the device works
23
Interfaces
The device has an USB interface for connection to a PC. This interface
enables the PC software VENTcontrol to be used to communicate with
the device and software updates can be carried out. There is also a connection for the nurse call or a remote alarm box. For servicing, the device
has an RS232 interface.
24
How the device works
HOW THE DEVICE WORKS
The function of the TRENDvent ventilator is based on a control mechanism, which adjusts the power of the blower to the air output required for
therapy in a closed loop. The blower power is controlled by the signal of
the respiratory pressure and the signal of the inspiration flow.
Starting the device (initialization)
When the device is started, the parameters are read from the memory
(EEPROM) and checked for validity. The pressure, the flow sensor and the
acoustic alarm are also tested. In the event of an error, the error detection
is saved and shown on the screen.
The calibration data is loaded from the EEPROM and tested for validity.
If an oxygen sensor is connected, it is calibrated against the ambient air.
Parameter measurement
The device’s analog measurements are read in and analyzed. Target values are calculated on the basis of the set parameters and/or ventilation
modes. Then the target values are transferred to the motor control via a
digital-to-analog converter (DAC).
The proximal pressure, the valve-control pressure and inspiration flow
are measured. This data is used to calculate the inspiration volume and
respiratory frequency. In addition, the actual patient flow is calculated by
subtracting the leakage flow. If an oxygen sensor is present, the oxygen
content of the inspiration air FiO2 is measured.
The pressure or flow sensor detects the patient’s spontaneous respiration
and sets off the triggers, which compensate mask leaks. The sensitivity
of the trigger is adjustable. The inspiration trigger is a pressure or volume
trigger. The expiration trigger is a flow trigger, which is set as a percentage of the maximum inspiration flow.
How the device works
25
Alarms
The alarm conditions are continuously checked. In the event of an alarm,
an alarm tone sounds and the corresponding message appears on the
display. The alarm button also lights up depending on the priority of the
alarm. If the alarm conditions are no longer present, the alarm sound is
switched off. The message is displayed until the alarm is confirmed by
pressing the alarm button on the display. All alarms are saved in the device.
For further information about the alarms, refer to “Alarms and error messages”, as of page 75.
NURSE CALL AND REMOTE ALARM
To monitor the device during ventilation, the optionally available remote
alarm box or in-hospital nurse call can be connected to the rear of the
device (see page 33) in order to forward the alarms.
26
How the device works
VENTILATION MODES
Depending on the tube system used, the following ventilation modes can
be set in the device.
Valve tube system
Table 1: Valve tube system
ventilation modes
Mode
Description
PCV
Pressure Controlled Ventilation
APCV
Assisted Pressure Controlled Ventilation
PSV
Pressure Supported Ventilation
PSV-S
Pressure Supported Ventilation - Spontaneous
CPAP
Continuous Positive Airway Pressure
Leakage tube system
Table 2: Leakage tube system
ventilation modes
Mode
Description
CPAP
Continuous Positive Airway Pressure
S
Spontaneous Ventilation
T
Timed Ventilation
ST
Spontaneous and Timed Ventilation
Ventilation modes
27
PCV MODE
Specified pressure
In the PCV mode, the ventilation is controlled exclusively through the device.
The patient is unable to breathe spontaneously. For controlled ventilation,
the inspiration trigger must be set to “OFF”. The respiratory cycle is based
on the set frequency and a set I:E ratio. The inspiration pressure (IPAP)
and end expiration pressure (PEEP) define the pressure range in which
the patient is ventilated. The pressure increase can be selected by setting
a ramp. The inspiration volume adjusts itself to the condition of the lungs
(compliance and resistance). To safeguard a minimum volume (Vt min), a
value can be preset, with the option of using additional pressure (IPAP +
additional pressure) to reach this minimum volume.
Controlled
Inspiration
Controlled
Inspiration
Controlled
Inspiration
Controlled
Inspiration
IPAP
PEEP
Time
In the PCV mode, the maximum and minimum volumes, as well as a maximum frequency, can be set as alarm parameters.
28
Ventilation modes
Fig. 3:
PCV mode diagram
APCV MODE
Fig. 4:
APCV mode diagram
Specified pressure
The adjustable ventilation parameters in pressure controlled assisted ventilation, correspond to those in purely controlled ventilation. By setting an
inspiration trigger, the patient has the option to interrupt expiration and
trigger the next inspiration, by making an effort to breathe and reach the
trigger threshold. These additional breaths are, as in purely controlled ventilation, controlled exclusively through the device. The inspiration time is
predefined. The patient’s own respiratory effort is only able to shorten the
expiration time and thereby increase the set frequency.
Controlled
Inspiration
Assisted
Inspiration
Assisted
Inspiration
Controlled
Inspiration
IPAP
PEEP
Spontaneous
respiration triggger
Time
In the APCV mode, the maximum and minimum volumes, as well as a
maximum frequency, can be set as alarm parameters.
Ventilation modes
29
PSV MODE
Specified pressure
Pressure supported ventilation is intended to support spontaneous breathing and to initiate machine ventilation whenever spontaneous respiration
fails. The support pressure (IPAP) and expiration pressure (PEEP) define
the pressure range in which the patient is ventilated. The trigger thresholds of the inspiration trigger and the expiration trigger can be adjusted
to the patient’s requirements. The adjustable frequency is a background
frequency. As long as this frequency is reached or exceeded through the
patient’s spontaneous respiration, the device reacts to every spontaneous inspiration with supportive pressure and follows the patient’s breathing. If the background frequency is not reached, the device takes over the
mechanical ventilation until spontaneous respiration is registered again. To
allow pauses between the spontaneous respiratory efforts of the patient,
a delay of the time of the start of mechanical respiration is possible, by
setting an apnea limit. The increase in pressure between PEEP and IPAP
can be selected by setting a ramp, which prescribes the form of the flow
curve. The tidal volume adjusts itself to the condition of the lungs (compliance and resistance). To safeguard a minimum volume, a value can be
preset, with the option of using additional pressure (IPAP + additional pressure) to reach this minimum volume.
IPAP
PEEP
Supported
Inspiration and
Expiration
Spontaneous
respiration triggger
Supported
Inspiration and
Expiration
Supported
Inspiration and
Expiration
Supported
Inspiration and
Expiration
Spontaneous
respiration triggger
Time
In the PSV mode, the maximum and minimum volumes, as well as a maximum frequency, can be set as alarm parameters.
30
Ventilation modes
Fig. 5:
PSV mode diagram
PSV-S MODE
The PSV-S mode corresponds to the adjustable ventilation parameters of
the PSV mode. As the frequency is set to “OFF”, the trigger is only released
when the patient breathes spontaneously. The apnea limit automatically
becomes an alarm parameter.
In this setting, the device only reacts to the patient’s spontaneous
respiration
CPAP MODE
Fig. 6:
CPAP mode diagram
Specified pressure
In the CPAP mode, the device provides continuous positive pressure.
IPAP
Time
S MODE
In its adjustable ventilation parameters, the S mode corresponds to the
PSV-S mode.
T MODE
In its adjustable ventilation parameters, the T mode corresponds to the
PCV mode and with a set inspiration trigger to the APCV mode.
ST MODE
In its adjustable ventilation parameters, the ST mode corresponds to the
PSV mode.
Ventilation modes
31
DESCRIPTION OF DEVICE
HOUSING, DISPLAY AND CONTROL ELEMENTS
Display
Operating unit
Unlocking button
for humidifier
Connection for
tube system/
humidifier
Handle
Contact sockets
for humidifier
Oxygen sensor
cable connection
(jack = 2.5 mm)
Oxygen
Control tube
connection
connection
( = 4.5 mm)
Pressure measuring
tube connection
( = 3.5 mm)
Fig. 7:
32
Front view of device
Description of device
Oxygen
output
Tube system
switch
Sign
for power supply
Main switch
DC Mains socket
24V~/5A
Com Service connection
(RS232 interface,
RJ11)
Remote alarm LED
Air inlet with integrated
filter cassette (fine and
coarse filter), detachable
PC connection
(USB interface)
Remote alarm
connection (RJ10)
Connection
cover
Fig. 8:
Rear view of device
Description of device
33
OPERATING UNIT
OPERATING UNIT ELEMENTS
Power LED
Battery LED
esc button
Touch wheel
Cursor buttons
OK button
Alarm button
Heating button
ON/OFF button
Fig. 9:
34
Operating unit elements
Description of device
LED FUNCTIONS
Power LED
The power LED provides information about the power supply.
Table 3: Power LED
Color
Condition
Power supply
green
lit
Voltage > 22.0 V
red
flashing
Voltage < 22.0 V
none
off
Voltage > 22.0 V (confirmed)
Battery LED
The battery LED provides information about the capacity of the internal
battery.
Table 4: Battery LED
Color
Condition
Device Capacity
green
lit
on
> 80 %
yellow
lit
on
> 30 %
red
lit
on
< 30 %
red
flashing
on
Battery error
green
flashing
off
> 80 % (Battery charging)
yellow
flashing
off
> 30 % (Battery charging)
red
flashing
off
< 30 % (Battery charging)
yellow
lit
off
Battery charging error
(capacity < 80 %)
red
lit
off
Battery charging error
(capacity < 30 %)
Description of device
35
BUTTON FUNCTIONS
esc button
Essentially, the esc button has the following functions:
• Cancel calibrations, parameter changes or similar. The set values are
not applied. The old values are retained.
• Cancel marking a parameter.
• Switching the display to the superordinate screen, up to the patient
screen.
• In the curve screen, return to the patient screen.
Touch wheel
Use the touch wheel to navigate in a rotary motion through the menus
and to the menu items. The touch wheel can also be used to change
parameter values.
Cursor buttons
Use the cursor buttons to navigate through the menus and menu items by
touch. The cursor buttons can also be used to change parameter values.
OK button
Use the OK button to select menu items and confirm parameter changes.
Pressing the OK button in the patient screen, displays the curve screen.
Heating button
The heating button switches the humidifier heating on and off. The heating
button also provides information about the status of the heating.
36
Color
Condition
green
lit
green
flashing
white
lit
white
flashing
Description of device
Status
Heating on
Heating in Standby mode
Heating off
Heating deactivated by battery operation
Table 5: Heating button
Alarm button
The alarm button has a number of functions:
Event
Condition
Confirmation of a power failure alarm
Power failure
Confirmation of all current alarms and Active alarms
switching alarm sound off
Table 6: Alarm button functions
Confirmation of no longer active alarms
Saved alarms
Supressing the alarm sound for 2 min
None
Cancel alarm sound suppression
Paused alarm sound (mute)
If several of these events occur at the same time, pressing the button
confirms only one event, in the order shown above.
The alarm button also signals alarms and their priority.
Table 7: Alarm button
Color
Condition
Priority
red
flashing
HIGH
yellow
flashing
MEDIUM
yellow
lit
LOW or not yet confirmed alarm
ON/OFF button
Start and end ventilation by pressing the ON/OFF key.
Description of device
37
COMMISSIONING
•
Before commissioning the device, read the safety
information as of page 10 onwards.
•
A functional test must be carried out before every
commissioning (see page 88).
•
Before commissioning the ventilation system (ventilator, tube, humidifier, etc.), check all connections for
leaks, as well as the 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 very different from the operating location, you should wait approximately
1/2 an hour before commissioning until the temperatures have evened out.
SETTING UP THE DEVICE
Place the device on a flat and stable surface. The device can also be operated in an upright position, whereby care should be taken that the air inlet
at the rear of the device and all ventilation slots are not blocked.
38
Commissioning
USING THE FUNCTIONAL BAG
The device must not be operated in bags other than the HOFFRICHTER functional bag. The functional bag is optionally available from
HOFFRICHTER as an accessory. In order to ensure the operating
safety, the following instructions must be adhered to.
Set the alarm sound to maximum volume (
).
Make sure that the alarm button is visible through the viewing window and
that the bag’s ventilation openings are not blocked. The air supply for the
device must be guaranteed at all times. Use the bag in such a way that
the device is protected from overheating, dust and water. All accessories
connected, such as tube, filter, supply lines, etc, must be arranged such
that they cannot lead to any impedance or malfunction of the device.
Commissioning
39
POWER SUPPLY
The ventilator can be supplied with power from 3 different sources:
• Power supply from power socket
• Internal battery
• External battery pack (optional accessory)
The ventilator automatically detects which power sources are available. If
the device is connected to an external voltage source via the power supply unit, this is always used first, and then the internal battery. The current
power source is indicated by the corresponding LED.
MAINS OPERATION
Only the power supply cable supplied may be used for operating the
device from the mains.
1.
2.
3.
4.
Insert the power plug into the mains socket on the rear of the device.
Connect the mains cable to the power supply.
Plug the mains cable into a power socket.
The power LED lights up green and the battery LED shows the current charge status.
5. Switch the ventilator on using the main switch.
As soon as the ventilator is connected to a power supply of 100 - 240 V
(-20 %, +10 %), 50/60 Hz, the power LED lights up green.
The power LED is also lit when the main switch is off, as the internal battery is charged. The charging of the battery is additionally indicated by
the illuminated battery LED and, if the device is switched on, the battery
symbol is shown on the display.
40
Commissioning
OPERATION WITH INTERNAL BATTERY
To prevent the internal battery from discharging, the device should
stay connected to the mains power during standby times.
Charging a completely empty battery takes approximately 4 hours.
If the device is switched on without a connection to the mains power, or the
device is disconnected from the mains power during operation, an alarm
sounds and the message “Battery Operation” appears. To switch off the
alarm sound and delete the message, press the alarm button.
With a fully charged battery, the device can be operated for a maximum
of 5.5 hours. The battery LED (see page 35) and the battery symbol (see
page 58) provide more information about the battery’s capacity.
If the alarm “Internal Battery low” appears, the ventilator must immediately be connected to an alternative power source.
POWER FAILURE
During a power failure, the battery capacity display must be monitored and an alternative power source kept ready. For further details
on the display of the battery capacity, please refer to page 35.
If the power supply is interrupted by a power failure, the device is supplied
with power via the internal battery.
Commissioning
41
Power failure and thus the switch to the internal battery is indicated by an
alarm sound, as well as by the message “Battery Operation” (see Fig. 10). In
addition, the power LED will glow red and the alarm button will glow orange.
To switch the alarm off, press the alarm button. The alarm sound is switched
off, the message “Battery Operation” is hidden, and the power LED goes out.
When the power supply returns, the device is supplied with power from
the mains supply and the internal battery is charged and the power LED
is lit green again.
Fig. 10: Message “Battery Operation”
OPERATION WITH EXTERNAL BATTERY
Before initial commissioning, you must read the user’s manual for
the external battery pack.
The AKKUPACK uni or the AKKUPACK CARAT enable the device to be
operated independently of the mains power supply. The battery pack is
optionally available as an accessory.
To supply the battery pack with power, use the mains cable and the power
supply unit of the ventilator. If the battery pack is connected to the ventilator, the power LED lights green.
At full capacity and factory settings, the battery pack enables operation
for a maximum of 12 h.
For further information on connecting and handling the device, please refer
to the respective user’s manual.
Fig. 11: AKKUPACK CARAT
42
Commissioning
SETTING THE TUBE SYSTEM
The device is suitable for use with a valve tube system, as well as for use
with a leakage tube system. Before using the device for the first time, or if
switching to a different tube system, the type of tube system to be used
must be set on the device. To do this, proceed as follows:
1. Ensure that the device is switched off.
2. Remove the cover for the air inlet by gripping the cover from below
and pulling it from the device (see Fig. 12).
3. Set the switch to the correct position:
– For the use of a valve tube system, place the switch, by gently
lifting and turning, into the lower position (see Fig. 13).
– For the use of a leakage tube system, place the switch, by
gently lifting and turning, into the upper position (see Fig. 14).
4. Replace the cover for the air inlet.
Fig. 12: Removing the air inlet cover
Fig. 13: Switching to
valve tube system
Fig. 14: Switching to
leakage tube system
When you switch the device on after switching to a different tube system, the display indicates which tube system is active. Press the OK
button to reach the patient screen.
Commissioning
43
b
CONNECTING THE VALVE TUBE SYSTEM
The valve tube system consists of:
a Ventilation tube
b Expiration valve
c Patient connection
d Air outlet
e Device connection
f Valve control tube for the expiration valve
g Pressure measuring tube
Connect the valve tube system as follows:
1. Ensure that the device has been set up for the use of a valve tube
system (see page 43).
2. Attach the ventilation tube with the device-connection side to the
device’s tube connection.
3. Attach the valve control tube for the expiration valve to the control
tube connection .
4. Attach the pressure measuring tube to the pressure measuring tube
connection .
c
d
f
e
a
g
Fig. 15: Valve tube system
When a nasal or full-face mask is used for non-invasive ventilation,
this mask must not contain an expiration opening.
2
3
4
Fig. 16: Valve tube system connection
44
Commissioning
CONNECTING THE LECKAGE TUBE SYSTEM
Connect the leakage system as follows:
1. Ensure that the device has been set up for the use of a leakage tube
system (see page 43).
2. Attach the leakage tube system with the device-connection side to
the device’s tube connection.
3. Attach the pressure measuring tube to the pressure measuring tube
connection .
The leakage system must always provide the possibility for exhalation.
Exhalation may either be possible via a respiratory mask with an integrated
exhalation valve, or a separate exhalation system.
2
3
Fig. 17: Leakage tube system connection
The expiration valve must be open during ventilation. Ensure that
the opening is not covered, as the expiration air can otherwise not
escape and thereby hinder ventilation.
Commissioning
45
CONNECTING THE HUMIDIFIER
3
The AquaTREND uni humidifier must not be used for invasive ventilation.
The AquaTREND uni humidifier can be used to humidify the respiratory air.
1. Connect the humidifier to the device as in Fig. 18 until it locks into
place. Ensure that the contact pins and the air outlet of the humidifier are fitted to the device without being skewed and distorted. If the
device is set for operation with a valve tube system, the following message appears:
1
Fig. 18: Humidifier connection
2. Confirm the message by pressing the OK button.
3. Attach the ventilation tube to the humidifier’s tube connection.
It is imperative that, before using the AquaTREND uni humidifier, you
read the safety and cleaning instructions in the user’s manual.
The humidifier can only be used up to a pressure of max. 20 hPa.
46
Commissioning
CONNECTING THE BACTERIAL FILTER
To protect the patient from infection during patient changes, we recommend the use of bacterial filters. Connect the bacterial filter as follows:
1. Attach the bacterial filter to the device’s tube connection.
2. Connect the device-connection side of the tube system with the bacterial filter.
2
1
Fig. 19: Bacterial filter connection
b
a
c
Change the bacterial filter daily and follow the manufacturer’s user’s
manual.
If the optionally available AquaTREND uni humidifier is used during
ventilation, a bacterial filter may not be used.
CONNECTING THE REMOTE ALARM BOX/NURSE CALL
1. Pull off the rubber cover (a) on the rear of the device.
2. Attach the remote alarm box/nurse call to the middle socket (b).
If a remote alarm box is connected, the remote alarm LED (c) lights up
red when an alarm occurs. The light indicates that the alarm has been
forwarded to the remote alarm box.
Fig. 20: Remote alarm/
nurse call connection
Commissioning
47
SWITCHING THE DEVICE ON
An sound must be emitted when the device is switched on. If this is
not the case, the device must not be used and should be checked
by an authorized service technician.
The tube system may already be connected when the device is started,
but not yet connected to the patient.
Switch the ventilator on using the main switch at the rear of the device
(position “I”).
• A signal sounds.
• A hardware test is carried out internally and the parameters are
tested for plausibility. If the hardware test is successful, the device
switches to the patient screen.
• In case of an error, the status screen is displayed and the error is
indicated by the display “Error”.
• The device carries out a self-test of the alarm button. The button
lights up in the following order: white > red > yellow > white. The
light subsequently goes out.
After switching on, the device is in standby mode.
If using oxygen during ventilation, observe the chapter “Using oxygen” on
page 52.
48
Commissioning
SWITCHING THE DEVICE OFF
1. Stop ventilation by pressing the ON/OFF button. A signal sounds
and the display shows the query:
2. Press the cursor to select “Yes”, followed by the OK button. Subsequently, a signal sounds 3 times and the ventilation stops.
3. Switch the ventilator off using the main switch on the rear of the
device (setting “0”).
After switching off, all parameters set are retained.
If you switch off the device during running ventilation, a signal sounds and
the display shows the query:
Continue ventilation:
1. Press the OK button. The message “ATTENTION! Main Switch OFF”
appears .
2. Switch the ventilator on again using the main switch.
Stop ventilation:
1. Press the cursor to select “Yes”.
2. Press the OK button. Subsequently, a signal sounds 3 times and the
ventilation stops.
Commissioning
49
STARTING VENTILATION
The expiration valve must be open during ventilation. Ensure that
the opening is not covered, as the expiration air can otherwise not
escape and thereby hinder ventilation.
1.
2.
Switch the ventilator on.
Press the ON/OFF button. Ventilation starts.
The ON/OFF button lights up green and the pressure bar can be
seen in the patient screen. If the patient screen is not active, the
current ventilation parameters are shown at the bottom of the display.
STOPPING VENTILATION
1. Press the ON/OFF button during running ventilation. A signal sounds
and the display shows the query:
2. Press the cursor to select “Yes”, followed by the OK button. Subsequently, a signal sounds 3 times and the ventilation stops.
50
Commissioning
OPERATION WITH HUMIDIFIER
Connect the AquaTREND uni humidifier as described on page 46. The
humidifier features an integrated heating system for heating the humidifier
water. This enables the respiratory air to be preheated.
Fig. 21: Setting Heating Level
SETTING THE HUMIDIFIER HEATING LEVEL
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Heating Level” using the cursor or touch wheel.
Press the OK button.
Set the desired heating level using the cursors or or the touch
wheel. You can select a value between 1 to 5. Level 1 represents the
lowest heat output and level 5 represents the maximum heat output.
5. Confirm the settings using the OK button.
SWITCHING ON THE HEATING
To switch on the humidifier’s heating, press the heating button (function
description see page 36). The color of the heating button changes from white
to green. If the heating is in standby mode (heating button flashing green)
and you start ventilation, the heating is automatically started.
You can switch on the heating before starting ventilation in order to
preheat the water.
SWITCHING ON THE HEATING
To switch the heating off, press the heating button. The color of the heating button changes from green to white.
If the humidifier is in heating mode during ventilation and you stop ventilation, the humidifer’s heating automatically switches to standby mode
(heating button flashes green). As soon as you start the ventilation, the
heating is also re-activated.
Commissioning
51
USING OXYGEN
Before using oxygen, the safety instructions as of page 16 must be read.
The supply of oxygen is possible in all ventilation modes. Please note that
changes to the ventilation parameters, such as e.g. respiratory pressure,
I:E, respiratory frequency, will lead to a change in FiO2 content.
Oxygen may only be supplied during active ventilation.
SUPPLYING OXYGEN
1. Connect the tube from the oxygen source to the oxygen connection
adapter.
2. Insert the oxygen connection adapter into the oxygen connection ( ).
Only the oxygen connection adapter supplied may be used to
connect oxygen. Otherwise, there is a risk that the back-stop in
the connection is damaged.
3. Switch the device on.
4. Start ventilation and wait for several respiratory cycles.
5. Start supplying the oxygen.
STOPPING THE SUPPLY OF OXYGEN
1. Stop the supply of oxygen at the oxygen source.
2. Allow ventilation to continue for a number of respiratory cycles.
3. Stop ventilation.
52
Commissioning
1
2
Fig. 22: Oxygen connection
MEASURING OXYGEN CONCENTRATION
Oxygen can only be measured in combination with a valve tube system
with an expiration valve. Use the optionally available oxygen sensor for this.
Depending on the ambient conditions, the sensor can require up to 30 minutes after installation to reach signal stability.
1.
2.
3.
4.
5.
d
a
b
c
Fig. 23: Oxygen sensor connection
Ensure that the ventilator is switched off.
Screw the oxygen sensor (a) into the housing gas duct (b).
Insert the gas duct with the oxygen sensor into the T-adapter (c).
Insert the T-adapter into the device’s tube connection.
Connect the device-connection side of the ventilation tube with the
T-adapter.
6. Insert the angled plug of the connection lead (d) into the oxygen sensor at the top and the straight plug into the oxygen measuring tube
connection
. The alarm button lights up yellow.
7. Switch the ventilator on. When the device is started, the oxygen sensor is automatically calibrated and the alarm button is no longer lit. It
is calibrated against the ambient air. This presumes an oxygen content of 21 %. If the sensor is connected after the device is started, the
message “Calibrate O2 Sensor” appears on the display. The calibration of the oxygen sensor must now be started manually.
1. Ensure that the device is in standby mode.
2. Press the OK button. “Start O2 Sensor Calibration” appears on
the display.
3. Press the OK button. After successful calibration, “OK” appears
after several seconds. If calibration was not successful, “Error”
appears. In the event of error, repeat the calibration. Should this
not be successful, exchange the oxygen sensor.
If the contact between the oxygen sensor and the device is interrupted for more than 10 seconds, the O2 sensor calibration must be
carried out again.
Commissioning
53
Oxygen sensors have a limited durability. A durability of 15 months
after the date of manufacture applies for oxygen sensors supplied
by HOFFRICHTER. The service life of the sensors is 6 months. After
that, the oxygen sensor must be replaced by a new one. The date of
manufacture can be found on the oxygen sensor.
For the longest possible sensor service life, we recommend storage
at - 15 °C to + 5 °C.
54
Commissioning
OPERATING THE DEVICE
OPERATING CONCEPT
The device is operated via the controls on the operating unit. The principal operating structure is represented in the following figure. As soon as your hand comes near to the operating unit, the control elements and the display light up.
Patient screen
Curve screen
or on alarm
or
to last
active screen
Ventilation sets
Comfort screen
Alarm screen
Counter screen
Service screen
Status screen
Fig. 24: Operating concept
Operating the device
55
CHANGING SCREENS
Press the cursors or to switch to the previous or next screen. If the
patient screen is active, pressing the cursors
or
displays the last
screen selected.
SAFETY LOCK
To protect against accidental or unauthorized alteration of the ventilation
and alarm parameters, the device features a safety lock. Apart from switching to the curve and patient screens, no actions can be carried out if the
safety lock is activated. Changing the ventilation parameters in the curve
screen is also not possible.
The safety lock can only be activated and deactivated in the patient
screen.
ACTIVATING THE SAFETY LOCK
The safety lock can be activated manually or automatically after a defined
period of time.
Manual activation of the safety lock:
1. Press the esc button.
appears alternating in the symbol area.
2. As long as the symbol is visible, press the OK button. Thereupon
remains visible and the safety lock is active. If you do not press the
OK button, the symbol disappears after several seconds without the
safety lock being activated and
is then active again.
DEACTIVATING THE SAFETY LOCK
1. Press the esc button.
appears alternating in the symbol area.
2. While the symbol is flashing, press the OK button. The symbol subsequently disappears and the safety lock is deactivated and
is then
active again.
56
Operating the device
THE PATIENT SCREEN
During normal operation the patient screen is shown on the display. During ventilation the pressure bar provides constant information about the
pressure profile. Additionally, all relevant information, such as alarms, battery capacity, status information, etc. is displayed.
If no controls are actuated for 30 seconds, the device automatically
switches back to the patient screen. In the curve screen, the switch
only occurs in case of an alarm.
Active
ventilation mode
Standard display area
Pressure bar
Symbol area
Time
Fig. 25: Patient screen
Operating the device
57
SYMBOL AREA
Symbol
Meaning
The symbol indicates the remaining capacity of the
internal battery. The battery is charged during mains
operation. The constantly filling battery display indicates that the battery is charging.
The device is set for operation with a valve tube system (see page 43).
The device is set for operation with a leakage tube
system (see page 43).
The alarm sound has been muted for 2 min. The alarm
sound of any new alarm is also muted until the 2 min.
have expired. Pressing the alarm button can deactivate
the alarm sound before an alarm is triggered. Pressing
the button once more activates the alarm sound again
when an alarm occurs.
The safety lock is active.
The safety lock is inactive.
A continuous change from a closed to an open lock means
that the safety lock can be either activated or deactivated.
For further information, refer to page 56 onwards.
58
Operating the device
Symbol
Meaning
Once this symbol appears, the device may only continue to be operated for a maximum of 450 hours. Then
the blower must be exchanged by Service, at the latest
after a running time of 15000 hours (see counter screen
> Blower Service: 15000 h  100 %).
The symbol is only displayed if the mask test time or the
softstart ramp is not active.
The symbol indicates that the mask test is active. Once
the set mask test time has expired, the symbol vanishes.
The symbol indicates that the softstart ramp is active.
Once the set softstart time has expired, the symbol vanishes. The symbol is only displayed if the mask test time
is not active.
Table 8: Symbol area
The device has detected spontaneous patient respiration
and the trigger has been initiated. The symbol remains
visible during the entire inspiration time and vanishes with
the start of expiration.
Operating the device
59
THE CURVE SCREEN
The curve screen provides a graphical display of the pressure, volume and
flow in the form of a curve chart.
To activate the curve screen from the patient screen, press the OK button.
To leave the curve screen and return to the patient screen, press the esc
button. In the case of an alarm, the display automatically returns to the
patient screen, in order to show the alarm message.
Measured value
Time of triggering through
patient’s spontaneous
inspiration
Status of curve
recording
Unit of the
measured
value
Curve recorded for the
selected ventilation
parameter
Time axis of the curve
chart in seconds
Active
ventilation mode
Symbol area
Fig. 26: Layout of the curve screen
60
Operating the device
Time
Progress bar, indicates the current
ventilation status
Immediately after the activation of the curve screen during ventilation, the
curves are set up over the set period of time. The curves are then replaced
with the new values. The current ventilation status is shown via a white
progress bar.
If a new calculation of the curve starts at the beginning of the time axis,
this symbol is briefly shown in the upper right of the screen:
The recording of the curves within the time axis is indicated by the following symbol:
“FREEZING” THE CURVE SCREEN
To analyze and evaluate the curves, it is possible to “freeze” the current
curve recording. To do this, press the OK button. This symbol indicates
that the curve is “frozen”:
To start recording the curves again, press the OK button. The curve recording subsequently starts again at zero.
SCALING THE TIME AXIS
The scaling of the time axis can be adjusted as follows:
• 0 to 12.5 s,
• 0 to 25 s or
• 50 s.
Press the cursor , to decrease the time span and to increase the
time span.
CHANGING THE MEASURED VALUE
To display the curve chart for a different value, press the cursors
or
Operating the device
.
61
THE VENTILATION SETS
A ventilation set contains all ventilation parameters relevant to ventilation.
A maximum of 3 ventilation sets can be preconfigured by the physician.
Depending on this you have 1 to 3 ventilation sets.
Display of the
active set
Indication that by pressing the
cursor further screens can be
displayed
Active
ventilation mode
Scroll bar
Pressure bar
(only visible
during ventilation)
Fig. 27: Ventilation set 1
62
Operating the device
Ventilation parameter
Measured values of the
running ventilation (only
visible during ventilation)
ACTIVATING THE VENTILATION SET
To ventilate the patient with a ventilation set’s settings, the respective ventilation set must be activated. To do this, proceed as follows:
1. Activate the desired ventilation set using the cursors or .
2. Select “


Activate changes” using the cursor or touch wheel.
3. Press the OK button. This query appears:
4. Press the cursor
to select “Yes”, followed by the OK button.
Operating the device
63
THE COMFORT SCREEN
The comfort screen contains the following basic device settings:
• Date and time
• Volume of alarms
• Brightness and contrast of the display
In addition, the following comfort functions can be set:
• Heating Level
• Automatic Start
• Duration of the softstart ramp (Softstart)
• Duration of the mask test (Mask Test Time)
Indication that by pressing the
cursor further screens can be
displayed
Active
ventilation mode
Indication that by pressing
the cursor further screens
can be displayed
Scroll bar
Pressure bar
(only visible
during ventilation)
Fig. 28: Comfort screen
64
Operating the device
Adjustable parameters
Measured values of the running ventilation (only visible
during ventilation)
CHANGING THE DATE
1.
2.
3.
4.
5.
6.
7.
8.
9.
Activate the comfort screen using the cursors or .
Select “Date” using the cursor or the touch wheel.
Press the OK button.
Set the year using the cursors or or the touch wheel.
Press the OK button.
Set the month using the cursors or or the touch wheel.
Press the OK button.
Set the day using the cursors or or the touch wheel.
Confirm the settings using the OK button.
Fig. 29: Changing the date
If, before reaching point 9, you leave the menu item “Date” by pressing
the esc button, all changes are lost and the existing date is retained.
CHANGING THE TIME
1.
2.
3.
4.
5.
6.
7.
Activate the comfort screen using the cursors or .
Select “Time” using the cursor or touch wheel.
Press the OK button.
Set the hour using the cursors or or the touch wheel.
Press the OK button.
Set the minutes using the cursors or or the touch wheel.
Confirm the settings using the OK button.
Fig. 30: Changing the time
If, before reaching point 7, you leave the menu item “Time” by pressing
the esc button, all changes are lost and the existing time is retained.
Operating the device
65
SETTING THE AUTOMATIC START
The automatic start enables ventilation to be started through the patient’s
own efforts to breathe. If the mask slips, falls off or uncompensatable leaks
occur, ventilation continues and a signal sounds.
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Automatic start” using the cursor or the touch wheel.
Press the OK button.
Set the start automatic to “ON” or “OFF” using the cursors or
the touch wheel.
5. Confirm the settings using the OK button.
or
Fig. 31: Setting the automatic start
66
Operating the device
SETTING THE SOFTSTART TIME
The use of the “Softstart” function can bring some relief if the patient has
not really become accustomed to ventilation.
The softstart function slowly increases the pressure in the time programmed
by you starting with a defined initial ramp pressure, up to the prescribed
pressure.
Ventilation mode
IPAP
EPAP
CPAP
0 hPa
---
(A)PCV, PSV(-S)
4 hPa
0 hPa
S, T, ST
4 hPa
2 hPa
Fig. 32: Setting the softstart time
Starting ramp pressure
Table 9: Starting ramp pressures
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Softstart” using the cursor or the touch wheel.
Press the OK button.
Set the desired time using the cursors or or the touch wheel.
You can set the time that is set under “Max. Softstart” as a maximum.
5. Confirm the settings using the OK button.
(A)PCV/PSV(S) - mode
CPAP mode
Pressure [hPa]
Pressure [hPa]
S-/T-/ST - mode
Pressure [hPa]
IPAP
IPAP
IPAP
2
0
PEEP
4
0
PEEP
4
2
0
Softstart
Time [min]
Softstart
Time [min]
Softstart
Time [min]
Operating the device
67
SETTING THE MASK TEST TIME
The mask test time is the period in which the device carries out a mask test.
Here, the worn mask is tested for any leakage, at max. pressure (IPAP +
Additional Pressure). If the “Softstart” function is active, the mask test is
carried out before the softstart ramp begins.
Activate the comfort screen using the cursors or .
Select “Mask Test Time” using the cursor or touch wheel.
Press the OK button.
Set the desired time using the cursors or or the touch wheel. You
can select a value between 5 to 90 s. In the “OFF” setting, no mask
test is carried out.
5. Confirm the settings using the OK button.
1.
2.
3.
4.
Fig. 33: Setting the mask test time
Pressure [hPa]
IPAP +
additional
pressure
0
Mask test
Softstart
Time [min]
STARTING THE MASK TEST
To start the mask test, put the mask on and start the ventilation.
68
Operating the device
Fig. 34: Mask test time in the CPAP mode
in combination with the “Softstart”
function
SETTING THE VOLUME OF THE ALARMS
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Alarm Volume” using the cursor or the touch wheel.
Press the OK button.
Set the desired volume using the cursors or or the touch wheel.
3 settings are possible:
= quiet
= medium
= loud
5. Confirm the settings using the OK button. An alarm sounds at the set
volume.
Fig. 35: Setting the volume of the alarms
If you do not hear an alarm sound, the device must not be used, as
the acoustic alarms may be faulty. Have the device checked by an
authorized service technician.
Operating the device
69
SETTING THE BRIGHTNESS OF THE DISPLAY
During ventilation, the background light of the display is dimmed 30 seconds after touching a button or the occurence of an alarm. You can set
this value as follows:
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Brightness” using the cursor or touch wheel.
Press the OK button.
Set the desired value using the cursors or , or the touch wheel.
You can set the brightness to “OFF” or select a value between 10 and
100 %.
5. Confirm the settings using the OK button.
When an alarm occurs or a button is pressed, the background brightness
is automatically increased to 100 %.
Fig. 36: Setting the brightness of the
display
SETTING THE CONTRAST OF THE DISPLAY
The contrast is the brightness ratio between the display background and
elements such as text, symbols, diagrams etc.
1.
2.
3.
4.
Activate the comfort screen using the cursors or .
Select “Contrast” using the cursor or touch wheel.
Press the OK button.
Set the desired value using the cursors or , or the touch wheel.
Values between 1 to 10 are possible. The best contrast is achieved in
the middle settings range.
5. Confirm the settings using the OK button.
Fig. 37: Setting the contrast of the display
70
Operating the device
THE ALARM SCREEN
You can view the alarm memory in the alarm screen. For more information about the alarm memory, please refer to “Saving alarms” on page 82.
Indication that by pressing the
cursor, further screens can be
displayed
Date and time of
selected alarm
Indication that by pressing
the cursor, further screens
can be displayed
Active
ventilation mode
Total alarms
Location where alarm shown is
saved
Alarm cause
Pressure bar
(only visible
during ventilation)
Measured values at time of alarm
Measured values of the running ventilation (only visible
during ventilation)
Fig. 38: Alarm screen
Operating the device
71
THE COUNTER SCREEN
The counter screen contains the running times for ventilation, the device
and the blower.
Indication that by pressing the
cursor, further screens can be
displayed
Indication that by pressing
the cursor, further screens
can be displayed
Active
ventilation mode
Ventilation running time since last reset
Total ventilation time
Total device running time
Blower running time
Pressure bar
(only visible
during ventilation)
Fig. 39: Counter screen
72
Operating the device
Measured values of the
running ventilation (only
visible during ventilation)
THE SERVICE SCREEN
Via the service screen you can undertake the manual O2 sensor calibration (see page 53).
Indication that by pressing the
cursor, further screens can be
displayed
Indication that by pressing
the cursor, further screens
can be displayed
Active
ventilation mode
Fig. 40: Service screen
Operating the device
73
THE STATUS SCREEN
The status screen provides information about:
• the hardware status,
• operating voltage,
• date of last battery test,
• maximum battery capacity,
• the device’s serial number and
• the software version.
The parameters in the status screen are purely for information and cannot be changed.
Indication that by pressing the
cursor, further screens can be
displayed
Active
ventilation mode
Scroll bar
Pressure bar
(only visible
during ventilation)
Fig. 41: Counter screen
74
Operating the device
Status parameters
Measured values of the running ventilation (only visible
during ventilation)
ALARMS AND ERROR MESSAGES
GENERAL
The alarm limits may only be set by qualified, specialist staff, under
the supervision of a physician.
The TRENDvent ventilator has both fixed alarms and adjustable alarms
that apply to the respective ventilation mode. All adjustable alarms remain
saved when the device is switched off and are active again when it is
switched on. All alarms and error messages are displayed visually and/or
acoustically. Optionally, medium and high priority alarms can be emitted
via a remote alarm.
VISUAL ALARMS
Visual alarms and error messages are displayed
• via the alarm button
• and as highlighted text
Depending on the priority of the alarm, the alarm button flashes as follows:
• Priority HIGH
10 pulses fast (repeated every 5 seconds);
red flashes with 2 Hz
•
Priority MEDIUM
3 pulses slow (repeated every 5 seconds);
yellow flashes with 0.5 Hz
•
Priority LOW
1 pulse; lit yellow
Fig. 42: Alarm message “Pressure too low”
If several alarms are triggered at the same time or in quick succession, the
alarm with the highest priority is displayed.
Alarms and error messages
75
ACOUSTIC ALARMS
Acoustic alarms are emitted by an alarm sound.
As soon as the cause of the alarm disappears, the alarm sound is switched
off. The alarm continues to be indicated by the orange light of the alarm
button and a text message until it is confirmed by pressing the alarm button.
SUPPRESSING ALARM SOUNDS
The alarm sound can be supressed by pressing the alarm button for 2 minutes. During this time, the alarm sound for any possible further alarms is
also suppressed. One exception is the alarm for “Internal Battery empty”,
which cannot be muted. The alarm button continues to visually indicate
the alarm, even while the alarm sound is suppressed. If the cause of the
alarm is not remedied, the alarm sounds again after 2 minutes.
The alarm sound can be suppressed even before the occurrence of an
alarm situation by pressing the alarm button; e. g., before briefly disconnecting the tube system from the device for suction. Once the cause of
the alarm is remedied, the alarm sound can be reactivated within the
2 minutes by pressing the alarm button again.
The alarm for “Internal Battery empty” cannot be muted in battery
operation.
76
Alarms and error messages
ADJUSTABLE ALARMS
The parameters for the alarms shown in Table 10 will be adjusted by the
physician.
Table 10: Adjustable alarms - alarm
messages
Alarm parameter/ Priority
alarm message
Cause
Time delay
Pressure
Difference /
Pressure too high
HIGH
Positive pressure deviation
greater than set deviation
15 s or
3 breaths
consecutively
Pressure
Difference /
Pressure too low
HIGH
Negative pressure deviation
greater than set deviation
15 s or
3 breaths
consecutively
Max. Frequency /
Frequency too
high
HIGH
Measured frequency greater 3 breaths
than “Max. Frequency“
consecutively
Apnea
HIGH
Set apnea time exceeded (only none
with frequency “OFF”)
Leakage
HIGH
Leakage greater than set
leakage (volume too great for
3 breaths) or flow greater 1 l/s
(2 l/s in CPAP mode)
Max. Volume /
Volume too high
HIGH
Tidal volume greater than
“Max. Volume”
3 breaths
consecutively
Min. Volume /
Volume too low
HIGH
Tidal volume smaller than
“Min. Volume”
3 breaths
consecutively
Max. Oxygen /
Oxygen too high
MEDIUM Measured FiO2 greater than set none
“Max. Oxygen”
Min. Oxygen /
Oxygen too low
MEDIUM Measured FiO2 lower than set none
“Min. Oxygen”
Check Expiration
Outlet
MEDIUM In ventilation with valve tube sys- 3 breaths
tem, no expiration valve present consecutively
or expiration valve is not open
Minimum Volume
not reached
Note
Tidal volume smaller than set none
minimum volume - Additional
volume insufficient
Alarms and error messages
77
ERROR MESSAGES, FIXED ALARMS
HARDWARE ERRORS
Hardware errors are also shown in the status screen.
Error message
Priority
Pressure Sensor MEDIUM
Cause
Remedy
Offset values of the Device must be serviced
sensor are outside valid
range
Sensor defective or not
connected
Temperature
Sensor
MEDIUM
Value of the sensor is Device must be serviced
outside valid range
Flow Sensor
MEDIUM
Sensor defective or not Device must be serviced
connected
Operating
Voltage
MEDIUM
Values outside valid Device must be serviced
ranges (± 5 %, except
backup battery)
O2 Sensor
LOW
Offset values of the Replace oxygen sensor
sensor are outside valid
range
Calibration data LOW
Incorrect calibration
data
Device must be serviced
RTC
---
Value range
infringement in time
Device must be serviced
Flash
---
Error in Flash memory
Device must be serviced
RAM
---
Error in RAM memory
Device must be serviced
Parameter
---
Value range infringement or test number
infringement in parameters
Check parameters, as
after this message, the
default parameters are
used; if message occurs
frequently, device must be
serviced
78
Alarms and error messages
Table 11: Fixed alarms - software errors
FURTHER ERROR MESSAGES
Error
message
Priority
Cause
Remedy
Device Error
HIGH
General error (communi- Device must be serviced
cation to operating controller interrupted or error
detected in motor control)
Check Tube
System
Switch
HIGH
Setting of switch for tube
system was changed
during ventilation
Move position of setting for tube system on
rear of device to correct
position
Check
Expiration
Valve
HIGH
Expiration valve does not
allow respiratory air to
escape
Check expiration valve
and replace if necessary
Incorrect tube system con- Change setting of tube
nected (leakage tube)
system on rear of device
or replace tube system
Incorrect
HIGH
Tube System
Incorrect tube system
connected
(valve tube)
Change setting of tube
system on rear of device
or replace tube system
Check
Measuring
Tube
HIGH
Pressure difference to
2nd pressure sensor
greater 3 hPa (> 15 s)
Check connection
between measuring
tube and device
Error Pressure Sensor
HIGH
Offset outside range
Device must be serviced
Calibration error
Pressure constant over long
period (> 15 s)
Error Flow
Sensor
HIGH
Pressure constant over long Device must be serviced
period (> 15 s)
Stenosis
HIGH
Measured tidal volume Check tube system
lower than 30 xml
Flow constant over long
period (> 15 s)
Excess
Pressure
HIGH
Pressure greater 60 hPa
Device must be serviced
Device error

Emergency ventilation
Alarms and error messages
79
Error
message
Priority
Cause
Error O2 Sen- MEDIUM Sensor defective
sor
Calibration error
Calibrate
O2 Sensor
LOW
Remedy
Exchange or recalibrate
oxygen sensor
Oxygen sensor plugged in Calibrate oxygen sensor
after device was turned on with ventilation switched off
Table 12: Other alarms - alarm messages
FIXED ALARMS FOR POWER SUPPLY
Error message
Priority
Cause
Remedy
Error Backup
Battery
HIGH
Battery block
voltage too low
Device must be serviced
Internal Battery
empty
HIGH
Battery empty
Battery must be charged; 1 minute until the power supply fails
completely; ventilation only possible with external power supply
Error internal
Battery
Medium
Battery defective
Device must be serviced
Internal Battery MEDIUM
low
Battery capacity
 10 %
Battery must be charged
Charging of
Battery not
possible
Temperature
outside specified limits during
charging
(0 °C ... + 50 °C)
Device must be warmed up or
cooled down
80
LOW
Alarms and error messages
Table 13: Fixed alarms for power supply
FURTHER MESSAGES
Message
Table 14: Further messages
Priority
Cause
Battery Operation
---
Device was removed from the mains and
is now running on internal battery; confirm
the message by pressing the alarm button
Safety Mode active
---
Patient not breathing spontaneously; minimum frequency safeguard via the device;
only in PSV and ST mode
Switch OFF Ventilation? HIGH
Yes / No
ON/OFF button was pressed or main
switch was activated during ventilation,
alarm sound is active; to end ventilation,
the query must be answered with “Yes”.
ATTENTION!
Main Switch OFF
Main switch was activated during running ventilation; query whether ventilation
should be switched off was confirmed with
no; message remains until main switch is
switched on again
---
Alarms and error messages
81
SAVING ALARMS
All alarms are saved in the device, including date, alarm time, alarm cause,
and the measured values at the time of the alarm. The memory depth is
approximately 1 year.
READING OUT THE ALARM MEMORY ON THE DEVICE
You can view the last 200 alarm messages in the alarm screen. To do this,
proceed as follows:
1. Activate the alarm screen using the cursors or .
2. Select “Alarm” using the cursor or the touch wheel.
3. Press the OK button. The saving location of the alarms and the total
number of alarms are highlighted with a black bar.
4. Select the desired alarm using the cursors or , in order to view the
alarm time, alarm cause and measured values at the time of alarm.
Fig. 43: Reading out alarm memory
FORWARDING ALARMS
Alarms can be forwarded by means of a nurse call or the optionally available
remote alarm box. This allows even better monitoring of the device to be
achieved in the home or clinic. The use of the remote alarm box or a nurse
call is especially recommended when several ventilators are used in one
room, as this allows the device generating the alarm to be easily identified.
ALAR
M
Fig. 44: Remote alarm box
82
Alarms and error messages
CLEANING AND DISINFECTION
•
Before cleaning the device, remove the power plug
from the power supply.
•
The directions given in this user’s manual and the
applicable regulations of the hospital or nursing home
must be adhered to when hygienically preparing and
cleaning the device.
•
Standard sterilization methods are not recommended
for the device.
•
Do not use any aggressive or abrasive cleaning
agents (e. g., acetone).
•
Do not immerse the device in water or solvents.
•
Follow the accessory manufacturer’s instructions
about cleaning and disinfection.
•
Never operate the device without the air filter.
•
Only use original HOFFRICHTER filters.
CLEANING THE DEVICE
For cleaning the surface of the device, use a cloth moistened with soapy
water. Then, wipe with a cloth moistened with clear water, in order to
remove any remains of the soapy water. The device must be completely
dry before commissioning.
Cleaning and disinfection
83
CLEANING THE COARSE FILTER
The coarse filter must be cleaned once a week. To do this, proceed as
follows:
1.
2.
3.
4.
5.
6.
Pull the cover of the air inlet from the device, as shown in Fig. 45.
Slide the filter cassette out from the cover of the air inlet, as shown
in Fig. 46.
Remove the coarse filter (black) from the filter cassette.
Clean the filter with mild soapy water. Do not use any other agents!
Rinse the filter thoroughly with clear water.
Let the filter dry completely in the air.
Instead of cleaning the filter, you can insert a new one or replace the entire
filter cassette with a new one.
Fig. 45: Pulling out the air inlet cover
The white fine filter cannot be cleaned. It should be inspected visually
weekly and replaced monthly or more frequently if heavily soiled. To do
this, proceed as follows:
1.
2.
3.
4.
Pull the cover of the air inlet from the device, as shown in Fig. 45.
Slide the filter cassette out from the cover of the air inlet, as shown
in Fig. 46.
Remove the coarse filter (black) from the filter cassette.
Remove the fine filter and replace it with a new one.
Fig. 46: Sliding out the filter cassette
84
Cleaning and disinfection
CLEANING THE MASK
For hygienic reasons, clean the mask every day. To do this, proceed as
follows:
1.
2.
3.
4.
Disconnect the mask from the tube system.
Clean the mask with mild soapy water. Do not use any other
agents!
Rinse the mask thoroughly with clear water.
Let the mask dry completely in the air.
Heavily worn or damaged masks must not be reused and should be
disposed of correctly.
CLEANING THE TUBE SYSTEM
A heavily worn or damaged tube system should be disposed of correctly and replaced by a new one.
VALVE TUBE SYSTEM
The tube system supplied is intended for use on one patient only. It must
not be cleaned and used for other patients. When using other tube systems, the manufacturer’s instructions must be observed.
Cleaning and disinfection
85
LEAKAGE TUBE SYSTEM
The tube system supplied is intended for use on one patient only. For reasons
of hygiene, clean the leakage tube weekly. To do this, proceed as follows:
1.
2.
3.
4.
5.
Disconnect the leakage tube from the mask and the device.
Seal the pressure measuring tube on both sides using the plugs,
so that no water can penetrate.
Clean the leakage tube with mild soapy water. Do not use any
other agents!
Rinse the leakage tube thoroughly with clear water.
Let the leakage tube dry completely in the air.
CLEANING THE OXYGEN SENSOR
When necessary, clean the oxygen sensor with a damp cloth. Before reconnecting the oxygen sensor, leave it to dry completely in the air.
Do not use any cleaning solution and do not sterilize the oxygen sensor.
CLEANING THE HUMIDIFIER
Clean or disinfect the AquaTREND uni humidifier according to the user’s
manual. When using other humidifiers, the manufacturer’s instructions
must be observed.
CHANGING THE BACTERIAL FILTER
The bacterial filter must be exchanged according to the manufacturer’s
stated intervals.
86
Cleaning and disinfection
PREPARING THE DEVICE WHEN CHANGING PATIENT
Before the device is used on another patient, it must be so comprehensively cleaned and disinfected, that it is free of human pathogens.
If MRSA contamination is suspected, the device must be packaged,
with the appropriate labeling, and disinfected accordingly.
If the accessories (e.g., tube system, mask, filter, humidifier, etc.)
are intended for repeated use, the manufacturer’s provisions must
be followed.
The hygienic repreparation is described in the service manual and may
only carried out by an authorized service agency.
Cleaning and disinfection
87
FUNCTIONAL TEST
Until all tests have been passed, the device must not be used and
should be checked by an authorized service technician.
The tube system to be used and a test lung (optional accessory) are
required for the functional test.
1. Connect the tube system and the test lung to the ventilator.
2. Connect the device to the mains power, as described in the chapter
“Power supply” as of page 40.
3. Switch the ventilator on using the main switch on the rear of the device
(setting “I”).
4. Start ventilation by pressing the ON/OFF key.
CHECKING THE ACOUSTIC ALARM
Switch the ventilator on using the main switch on the rear of the device
(setting “I”). A signal must sound.
CHECKING THE ALARM BUTTON LIGHT
After the device is started, it carries out a self-test of the alarm button. The
button must light up in the following order: white > red > yellow > white.
The light subsequently goes out.
CHECKING THE DISPLAY
Switch through all screens and check that all display elements are present and legible and that the display’s lighting is functioning. If necessary,
check the “Contrast” and “Brightness” settings (see page 70).
88
Functional test
CHECKING THE STATUS SCREEN FOR ERRORS
When the device is started, it carries out a self-test. If any errors are detected,
the status screen is automatically displayed (see Fig. 47). Possible errors
must first be corrected before the device can be used.
CHECKING THE DATE AND TIME
Switch to the comfort screen and check the date and time. If necessary,
correct the setting (see page 65).
Fig. 47: Status screen with
error message
CHECKING THE “BATTERY OPERATION” ALARM
Remove the device from the mains power. An alarm must sound and the
message “Battery Operation” must appear in the display.
CHECKING THE LEAKAGE ALARM
Remove the test lung from the device. After at most 15 seconds, an alarm
must sound and the message “Leakage” must appear in the display.
CHECKING “FREQUENCY TOO HIGH ALARM”
Operate the device in the PSV mode. Set the value of the alarm parameter
“Max. Frequency” to lower than the currently measured frequency. Simulate spontaneous respiration, using the test lung, until the alarm sound is
triggered and the message “Frequency too high” appears on the display.
Functional test
89
MAINTENANCE AND SAFETY-RELATED TEST (SRT)
All procedures performed are to be recorded.
To maintain and check the device functions, the device must be subjected
to an annual maintenance or safety related test, carried out by an authorized service technician.
The maintenance intervals and all necessary tasks are described, in detail,
in the service manual.
90
Maintenance and safety-related test (SRT)
DISPOSAL
DEVICE
The device must not be disposed of with the household waste. Please
contact the relevant customer services department to find out how to dispose of the device, etc. properly.
Proper disposal saves natural resources and prevents harmful substances
being released into the environment.
PACKAGING
The packaging is taken back by the distributor but it can alternatively be
disposed of separately with the normal household waste.
OXYGEN SENSOR
The oxygen sensor must not be disposed of with the household waste.
Please contact the relevant customer services department to find out how
to dispose of the device, etc. properly.
Disposal
91
ACCESSORIES
Scope of Delivery
Article number
Functional bag
0001 4875
Power supply (cable approx. 1.80 m)
0001 4510
Mains cable (approx. 1.80 m)
3110 0023
Valve tube system 22 mm (1.80 m)
0000 7967
Leakage tube system with pressure measuring tube and
2 plugs 22 mm (1.80 m)
0000 7116
Filter cassette complete
0000 4880
Coarse filter (pack of 2)
0000 4950
Fine filter (pack of 5)
0000 4951
Oxygen connection adapter, straight
4100 0104
Microfibre cloth
---
User’s manual for patients
5000 0397
Patient brief instructions
5000 0405
Optional
Article number
FiO2 measuring set (oxygen sensor, T adapter, housing
gas duct, oxygen sensor connection cable)
0000 4021
Oxygen sensor
2300 0018
T adapter
2300 0019
Housing gas duct
2300 0020
Oxygen sensor connection cable
0000 4115
Oxygen connection adapter, angled
4100 0087
AKKUPACK uni incl. accessories
in preparation
AKKUPACK CARAT incl. accessories
0000 4030
Remote alarm box
0000 4035
92
Accessories
TECHNICAL DATA
Power supplies
Mains operation
100 ... 240 V AC (-20 %, +10 %),
50 ... 60 Hz
DC operation
24 V DC / 5 A
Internal battery operation
Lithium-ion battery,
28.8 V (nominal voltage); 2.25 Ah
External battery operation
AKKUPACK CARAT
AKKUPACK uni
25 V (nominal voltage), 7 Ah
in preparation
Maximum power consumption
90 W
Electrical protection
Class II, type BF
Comfort parameter settings
Factory settings
Settings range
Settings steps
Display brightness
10 %
0 to 100 %
10 %
Display contrast
Alarm volume
5
1 to 10
= quiet
= medium
= loud
1 Level
---
Softstart
OFF
OFF; 1 to 60 min
1 min
Mask test time
OFF
OFF; 5 to 90 sec
5 sec
Start automatic
OFF
OFF; ON
---
Heating level
3
1 to 5
1 Level
Specifications and performance
Dimensions (W x D x H)
330 x 280 x 115 mm
Weight
4.2 kg
Max. stable limit pressure
60 hPa
Min. stable limit pressure
0 hPa
Max. working pressure
40 hPa
Min. working pressure
0 hPa
Max. flow
200 l/min
Technical data
93
Sound pressure range of audible alarm signal (at 1 m distance)
Lowest value
> 71 dBA, setting
Medium value
> 75 dBA, setting
Highest value
> 77 dBA, setting
Resistance at 60 l/min
Inspiratory and expiratory resistance
of the device at the patient
connection port
Leakage tube system: < 2.6 hPa
Total resistance of the system
< 6 hPa
Valve tube system: < 3.4 hPa
Operating and transport conditions
Operating temperature
- 5 °C to + 50 °C
Relative humidity
10 % to 95 %
Air pressure
600 hPa ... 1100 hPa
Storage
Storage temperature
Storage conditions
- 10 °C to + 60 °C
Store in a dry, vibration-free place, in an
upright position; store device and accessories in their original packaging
.
Technical requirements for accessories (CE mark required!)
Oxygen inlet
Connection type
Quick-connect coupling
Pressure
< 1000 hPa
Flow
< 15 l/min
Bacterial filter
94
Connections
22 / 15 mm cone (acc. to EN1281-1)
Resistance
< 2.3 hPa at 60 l/min
Compressible volume
< 66 ml
Internal volume
< 200 ml
Technical data
CE marking as per EC directive 93 / 42 / EEC.
The manufacturer reserves the right to make
technical changes without notice.
MANUFACTURER’S DECLARATION ON ELECTROMAGNETIC COMPATIBILITY
Guidance and manufacturer’s declaration – electromagnetic emissions
The TRENDvent ventilator is intended for use in the electromagnetic environment specified below. The user1 of the TRENDvent
ventilator should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions acc. to CISPR 16-1-2
Group 1
The TRENDvent ventilator uses RF energy only for its internal function. Therefore, RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions acc. to CISPR 16-1-2
Class B
Harmonic emissons acc. to
IEC 61000-3-2
Class A
The TRENDvent ventilator is suitable for use in all establishments
including those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Voltage fluctuations / flicker emissions
acc. to IEC 61000-3-3
Complies
Guidance and manufacturer’s declaration – electromagnetic immunity
The TRENDvent ventilator is intended for use in the electromagnetic environment specified below. The user 1 of the TRENDvent
ventilator should assure that it is used in such an environment.
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment –
guidance
Electrostatic discharge (ESD) acc. to
IEC 61000-4-2
± 6 kV
contact
± 6 kV
contact
± 8 kV
air
± 8 kV
air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic material,
the relative humidity should be at least 30 %.
± 2 kV
power supply lines
± 2 kV
power supply lines
± 1 kV
input/output lines
± 1 kV
input/output lines
± 1 kV voltage
outer conductor outer conductor
± 1 kV voltage
outer conductor outer conductor
± 2 kV voltage
outer conductor ground
± 2 kV voltage
outer conductor ground
Electrical fast transient/burst acc. to
IEC 61000-4-4
Surge acc. to IEC 61000-4-5
1
Mains power quality should be that of a typical
commercial or hospital environment.
Mains power quality should be that of a typical
commercial or hospital environment.
Here user is meant in the sense of “Responsible Organization”
Manufacturer’s declaration on electromagnetic compatibility
95
Guidance and manufacturer’s declaration – electromagnetic immunity
Immunity test
IEC 60601
Test level
Compliance level
Electromagnetic environment –
guidance
Voltage dips, short interruptions and
voltage variations on power supply
input lines acc. to IEC 61000-4-11
< 5 % UT (> 95 %
dip in UT) for 0.5
cycle
> 95 % dip in UT
for 0.5 cycle
Mains power quality should be that of a typical
commercial or hospital environment. If the user
of the TRENDvent ventilator requires continued
operation during power mains interruption, it
is recommended that the TRENDvent ventilator is powered from an uninterrupted power
supply (UPS) or a battery.
40 % UT (60 % dip
in UT) for 5 cycles
70 % UT (30 % dip
in UT) for 25 cycles
< 5 % UT (> 95 %
dip in UT) for 5 s
60 % dip in UT for
5 cycles
30 % dip in UT for
25 cycles
> 95 % dip in UT
for 5 s
Power frequency (50/60 Hz) magnetic
field acc. to IEC 61000-4-8
3 A/m
3 A/m
Power frequency magnetic fields should be
at levels characteristic of a typical location in
a typical commercial or hospital environment.
Conducted RF acc. to IEC 61000-4-6
3 Veffective value
150 kHz – 80 MHz
3V
Portable and mobile communications equipment should be used no closer to any part of
the TRENDvent ventilator, including cables,
than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended safety distance:
d = 1.16 P
96
Manufacturer’s declaration on electromagnetic compatibility
Guidance and manufacturer’s declaration – electromagnetic immunity
Radiated RF acc. to IEC 61000-4-3
3 V/m
80 MHz – 2.5 GHz
3 V/m
d = 1.16 P for 800 MHz to 800 MHz
d = 2.33 P for 800 MHz to 2.5 GHz
with P as the rated maximum output power
of the transmitter in watts (W), according to
the transmitter’s manufacturer, and d as the
recommended safety distance in meters (m).
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey a, should be less than the compliance level
in each frequency range b.
Interference may occur in the vicinity of equipment marked with the following symbol.
UT is the mains alternating current before application of the test level.
Note 2 At 80 MHz and 800 MHz the higher frequency range is essential.
Note 3 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
a The field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the
electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength outside the location in which the TRENDvent ventilator is used exceeds the compliance level, the TRENDvent ventilator should be observed to verify normal operation. If abnormal performance is observed, additional measures may
be necessary, such as re-orienting or relocating the TRENDvent ventilator.
b Over the frequency range from 150 kHz to 80 MHz the field strength should be lower than 10 V/m.
Note 1
Manufacturer’s declaration on electromagnetic compatibility
97
Recommended separation distances between portable and mobile RF communication equipment and the TRENDvent
ventilator
The TRENDvent ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
The user1 of the TRENDvent ventilator can help prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile RF communications equipment (transmitters) and the TRENDvent ventilator as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power
of transmitter (W)
Separation distance according to frequency of transmitter (m)
150 kHz – 80 MHz
d = 1.16 P
80 MHz – 800 MHz
d = 1.16 P
800 MHz – 2.5 GHz
d = 2.33 P
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.743
1
1.17
1.17
2.3
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can
be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note 1
At 80 MHz and 800 MHz the higher frequency range is essential.
Note 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
1
98
Here user is meant in the sense of “Responsible Organization”
Manufacturer’s declaration on electromagnetic compatibility
DISCLAIMER
HOFFRICHTER GmbH is not liable for consequences in terms of safety,
reliability and performance of the product where:
• interventions, modifications, extensions, calibration, repairs and
maintenance are carried out by persons not authorized by us,
• other manufacturers’ accessories and spare parts are used that
have not been approved by us for use on the product,
• the product is used other than as described in the user’s manual or
• the hygiene and cleaning instructions described in the user’s manual
have not been complied with.
Statutory guarantee rights remain unaffected by this.
Disclaimer
99
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
TRENDvent-eng-1110-01
Art. no.: 5000 0397