Hoffrichter VECTOR et Bilevel User manual

User´s Manual
BILEVEL
HOFFRICHTER
VECTOR et BILEVEL

SERIAL NUMBER
HOFFRICHTER GmbH delivers all its systems with a
serial number (Seriennummer) in order to ensure
traceability. The serial number is indicated on the
type label on the rear of the system. Please always
specify the serial number in inquiries and com-
plaints.
CONFORMITY
The device complies with the requirements of the
Directive 93/42/EEC.
2VECTOR et BILEVEL

1Legend of Symbols 4
2Safety Instructions 5
3Intended Use 8
4Contraindications 9
5Technical Description 10
6Notes prior to first Use 11
7Components of the Device 12
8Accessories 14
9Use of the Device 16
10 Use of Oxygen 17
11 Cleaning and Change of the Filter 18
12 Alarm Functions 20
13 Functions of the Device 22
14 Troubleshooting 33
15 Display Messages 35
16 Maintenance 37
17 Technical Data 38
3
CONTENTS
VECTOR et BILEVEL

4VECTOR et BILEVEL
LEGEND OF SYMBOLS
Observe the accompanying documentation
Applied part type BF
Electric safety class II (with protective insulation)
Observe the Operating Instructions
Manufacturer
CE Declaration of Conformity
Do not dispose of the device with normal domestic waste.
For information on the proper disposal of the device,
please contact your responsible customer service.
1

SAFETY INSTRUCTIONS
Before using your respiratory therapy device for the
first time, please thoroughly read these Operating
Instructions.
Keep these Operating Instructions at a safe place
for immediate consultation, if necessary.
For the period stipulated by law, HOFFRICHTER
GmbH warrants that the product is free from any
defects provided it is used as intended.
POWER SUPPLY
VVEECCTTOORReettBBIILLEEVVEELLhas an external switched
mode power supply unit with a wide range input of
100 - 240 V~, 50 - 60 Hz. This allows connection
to all energy supply networks in the world.
It is also possible to operate the device with a
direct voltage of 24 V DC, e.g. for mobile use in a
truck or mobile home. When connecting the device
to a DC supply source, please only use the optional
connection cable and do not use the device with a
PC.
ATTENTION!
HOFFRICHTER GmbH is not liable for any damage
and consequential damage nor for any effects on
the safety, reliability and performance of the devi-
ce, if:
• manipulations, modifications, expansions,
adjustments, repairs and maintenance
measures are carried out by persons not
authorized by us to do so.
• use is made of accessories and spare parts
which come from other manufacturers and
have not been released by us for use with the
VVEECCTTOORReettBBIILLEEVVEELLdevice.
• the device is used in a way that is different
from that described in the Operating
Instructions.
5
VECTOR et BILEVEL
2

In order to prevent potential hazards, please fol-
low the instructions below:
• Exclusively use the device for your own
therapy, which must have been prescribed by
a physician.
• Use accessories only which have been
recommended and offered by your speciali-
zed dealer.
• Regularly test the alarm function of your devi-
ce.
• Always ensure that the small hole in the mask
or in the adapter between the mask and the
tubing is unobstructed so that the exhaled air
that is loaded with CO2can escape.
• Never set up the device in a compartment of
a cabinet nor under your bed.
• Please make sure that air can easily circulate
around the device.
• Do not place the device in the vicinity of
radiators.
• Ensure that the device is positioned
horizontally. This is particularly necessary if a
humidifier is connected.
• If you receive oxygen with your therapy,
please follow all fire protection and safety
regulations with regard to the use of oxygen.
• Mobile use of the device is permitted only in
a parked vehicle.
• Immediately see your physician if, while using
the device, you develop one or more of the
following symptoms: dryness of the mucous
membranes in nose and throat, frontal sinus
complaints, earache, a running nose,
hypersensitivity of the skin, oversensitiveness,
loss of voice, disturbances of orientation or
memory.
• Immediately notify your specialized dealer if
the device fails to function properly.
• Never place the respiration therapy device in
the vicinity of other equipment or devices,
such as defibrillators, diathermy equipment,
mobile phones, microwave, remote-controlled
toys, etc. Electromagnetic fields greater than
3 V/m may affect the operation of the device.
6
2
VECTOR et BILEVEL

7
VECTOR et BILEVEL
2
To maintain electrical safety, please observe the
following instructions:
• Do not put the device into operation if its
housing and/or cables are damaged.
• Do not open the housing of the VVEECCTTOORReett
BBIILLEEVVEELL..Notify your specialized dealer of
any disturbances and failures.
• Protect the device from water and moisture.
• Never operate the device in moist rooms nor
in a bathroom.
• Do not place a vessel filled with fluid on the
device.
• Be absolutely sure not to seize the device if it
has fallen into water.
• Do not set up the device in the vicinity of
water vessels (bath tubs).
• Before cleaning the device, always discon-
nect the power plug.
• Use the supplied power supply pack only.
• When connecting the device to a DC supply
source, please only use the optional connec-
tion cable listed under optional accessories
and do not use the device with a PC.
STANDBY MODE
The device is in the standby mode as long as the
turbine is turned off. The standby mode is indicated
by the illuminated display showing date and time. If
a humidifier is connected with the device, the humi-
difier as well will be in standby mode. The preset
heater level will be displayed. Power consumption
in this mode is approx. 5 W.
• In the standby mode, the device may remain
continuously switched on without posing any
risk.

INTENDED USE
VECTOR et BILEVEL is intended for treating
obstructive sleep apnea in patients with a weight of
30 kg and higher.
The device generates a continuous positive airway
pressure in order to keep the upper respiratory
tract unobstructed.
The device is not suitable for being used with
patients who need artificial respiration. This therapy
device is no life-preserving system.
The treatment pressure is applied through a ventila-
tion mask. This ventilation mask must be provided
with an exhalation valve in order to ensure that the
exhaled air is discharged. Do not wear the ventilati-
on mask while the therapy device is turned off
because, otherwise, you might rebreathe exhaled
air. Please also follow the manufacturer's instructi-
ons on use of the ventilation mask.
8
3
VECTOR et BILEVEL

CONTRAINDICATIONS
Respiratory therapy may be contraindicated in
patients with the following preexisting diseases:
• Bullous lung diseases
• Pneumothorax
• Very low blood pressure
• Air accumulation after open craniocerebral
trauma or other head injuries
In case of an inflammation of the paranasal sinuses
or the middle ear, it might be indicated to stop the
therapy. Please consult your physician.
Devices which have been fitted with an
AquaDROP et humidifier may not be used with
additives such as medication or aroma oils in the
humidifier water.
9
VECTOR et BILEVEL
4

TECHNICAL DESCRIPTION
The device is a therapy device in the BILEVEL
version for treating obstructive sleep apnea.
Trigger device
The respiration trigger detects the patients efforts
to breath in and out and signals these efforts to the
control device. A flow-based trigger is integrated
which can be set separately for inspiration and
expiration. While the pressure increases during
inspiration it decreases during expiration. In con-
nection with an optimum flank adjustment this
results in a ventilation which is very comfortable for
the patient and which gives the patient the impres-
sion as if the device is following the natural respira-
tion without delay.
NOTE:
During the expiration phase a negative pressure
(vacuum) will not be created.
To generate the necessary pressure, the device is
provided with an electronically controlled blower. In
order to keep the stress for the patient as low as
possible, the blower has been designed with a high
reserve capacity and a quick control response.
The pressure is measured directly in the mask and
constantly controlled by the device. Consequently,
the breathing work for the patient is a easy as pos-
sible. There are two separate tubings in the device.
One is for respiratory air and one is for the convec-
tion air required for cooling the electronics.
In addition to the mask alarm, the device offers
another safety function, the power failure alarm. It
automatically restarts the motor after power resto-
ration.
The device contains a built-in microcontroller which
controls all of its functions. For added comfort an
alarm clock is integrated in the device. Further
comfort functions include a soft start ramp, the
automatic start-stop function and the adjustable
display brightness. While passing through the devi-
ce, the air is heated a little, so that it has a higher
water absorbency. When indoor air is dry in the
heating period, the mucous membranes in mouth
and nose may become particularly dry. This is
unpleasant and may even cause infections in
exceptional cases. For that reason, a therapy might
require air humidification.
AquaDROP et, a clip-on humidifier is available as
accessory for the device. If necessary, just click the
humidifier onto the device. Remove it by pressing
its locking key.
The heater levels are set in the heater menu. The
selected heater level is displayed as a figure in the
display of the device while the humidifier heating is
switched on.
For more information please consult your
AquaDROP et operating instructions or contact
your specialized dealer.
10
5
VECTOR et BILEVEL
BILEVEL

NOTES PRIOR TO FIRST USE
Never turn the device on if you kept it in a very cold
environment. Wait for approx. 1 hour until its tem-
perature compensation is completed.
Regularly check the air filter cassette and regularly
exchange it as described on page 18. Never use
the device without air filter.
Clean your mask system regularly and check all
accessory parts, particularly the therapy tubing, the
mask and the head gear. We recommend that you
wash your face before going to sleep, in order to
remove fat and cosmectics from your skin. This
increases the service life of the mask and helps to
prevent irritations of the skin.
Make sure the measurement tube is unobstructed
at all times. Avoid ingress of water into the measu-
rement tube during cleaning. If water droplets
should have accidentally entered the measurement
tube they must be carefully and thoroughly remo-
ved.
Please strictly observe the following setup
instructions:
• Do not place the device in the vicinity of a
heating source. Air circulation – particularly
that below and behind the device – must not
be impaired by furniture, curtains or cushions.
• Set up the device next to your bed.
Place it on a firm and flat surface of your
bedside cabinet.
• During mobile use, the device must also be
placed on a firm and flat base, which must
have an edge to protect the device from fal-
ling off.
11
VECTOR et BILEVEL
6

12
7
VECTOR et BILEVEL
1
2
45
6
7
11
8
9
10
3
BILEVEL
VECTOR et
1 1
10 10
COMPONENTS OF THE DEVICE FRONT VIEW
1 Program keys
2 Filter Cassette
3 Display
4 Heater-LED
5 Info key
6 Heater key
7 Release button
8 Measuring tube connection
9 Air outlet
10 Contactors for humidifier
11 Control key (ON/OFF button)

REAR VIEW
12 Power connection
13 RS232 interface
14 Type identification plate
13
7
VECTOR et BILEVEL
12 13 14
BILEVEL
VECTOR et

14
8
VECTOR et BILEVEL
Exhalation valve
Car Cabel
Carrier bag
Air Filter Cassette
Power cord
Power Supply Unit
Therapy Tube
(Length 1,80 m)
Measuring Tube
reathing Mask
There are various mask
systems available
Stoppers
y Tube
,80 m)
ACCESSORIES

15
VECTOR et BILEVEL
8
SCOPE OF DELIVERY
Art.-No.:
VECTOR et BILEVEL 0000 2047
User´s manual 5000 0038
Power supply unit 0000 2020
Power cord 3110 0015
Therapy tube,
measurement tube and stoppers 0000 7116
Filter cassette without frame cover 0000 2029
Carrier bag 0000 2080
A ventilation mask that has been specially adjusted
for the individual patient is required for start-up and
use of the device in the domestic area, in addition
to the therapy device with power supply unit,
power cord, and therapy tube.
OPTIONAL ACCESSORIES
Art.-No.:
AquaDROP et 0000 2015
Car cabel 0000 9212
12 V to 24 V converter 0000 7133
Replacement filter cassette
with frame cover 0000 2028

USE OF THE DEVICE
1. After having set up the device properly, connect
the power supply unit to the device and, using
the supplied power cord, to a grounded outlet.
2. The device displays a welcoming message, the
software version and the current number of
treatment hours. Thereafter, the display shows
the date and time.
3. Connect the therapy tubing
a) to the air outlet, and
b) to the mask.
4. Also connect the measuring tube to the
measuring tube outlet.
5. Apply the mask. If you have selected the
automatic mode, the device will start on your
first breath. In the manual mode, press the
operator key to start the device.
6. The device will then run through the mask test
for the time selected and at the pressure
prescribed. You should now properly seat the
mask in order to eliminate any potential leaks.
7. Place the tubing such that it does not exert any
pulling action on the mask while you are lying
down.
8. Breathe deeply and calmly only through your
nose. If you have activated the soft start
function, the device initially reduces the
pressure after completion of the mask test and
will then slowly increase the pressure
automatically to the prescribed value, allowing
you to fall asleep at a lower pressure.
NOTE:
For information on how to adjust the soft start
and mask test times to your individual demands,
please refer to the section entitled functions of
the device.
16
9
VECTOR et BILEVEL
13a
3b 4
7+8

17
VECTOR et BILEVEL
10
USE OF OXYGEN
If you also have to inhale oxygen during your
therapy, please be absolutely sure to follow the
instructions from the manufacturer or the dealer
delivering the oxygen to you.
If you supply the oxy-
gen directly into the
mask, please use a
non-kinking tube that
consists of a medically
approved material.
You can also supply the
oxygen through an adapter
which is mounted to the air
outlet.
In any case, please be absolutely sure to follow the
instructions of your physician.
Please contact your specialized dealer.
ATTENTION!
Oxygen promotes combustion processes. For
that reason, please observe the valid fire protecti-
on regulations for the use of oxygen. Keep oxy-
gen fittings free from fat, do not smoke, and do
not handle the device near a naked flame.
ATTENTION!
If you are using oxygen together with the device,
the oxygen supply must always be deactivated
as long as the device is in the standby mode or
while it is turned off.
Always turn on the device first and only then the
oxygen supply. Turn off the oxygen supply before
turning off the device.
Activate the „Automatic OFF“ as described on page
26.
Whenever you use the device, check the tube con-
nections for proper seating beforehand.

CLEANING AND CHANGE OF THE FILTER
CHANGE OF THE FILTER
if the filter is polluted or the display shows the mes-
sage “change filter” the filter cassette must be
changed.
1. To change the cassette, pull it upwards out of
the device.
2. Separate filter cassette and filter frame cover by
pulling them apart.
3. Replace the filter cassette.
4. Mount the filter frame cover onto the new filter
cassette. Make sure the upper part (slit) and
the filter cassette (pin) are in the correct
position.
To set back the message proceed as described in
the chapter Patient menu (page 24).
NOTE:
Never operate the device without filter cassette.
Only and exclusively use original HOFFRICHTER filter
cassettes. Otherwise, the warranty for the ventila-
tor will become extinct.
CLEANING THE MASK
For reasons of hygiene the mask must be cleaned
on a daily basis:
1. Separate the mask from the therapy tubing
2. Clean the mask as described in the mask
manufacturer's operating instructions
WEEKLY CLEANING OF THE THERAPY TUBING
Make sure the measurement tube is unobstructed
at all times. Avoid ingress of water into the measu-
rement tube during the weekly cleaning. If water
droplets should have accidentally entered the mea-
surement tube they must be carefully and tho-
roughly removed.
1. Close the therapy tubing tightly with the
stoppers before cleaning (see page 14)
2. Use mild soapy water for cleaning, thoroughly
rinse with clear water, and let the tubing dry in
air
3. Remove the two plugs from the measuring
tubing after cleaning
18
11
VECTOR et BILEVEL
BILEVEL
124

19
VECTOR et BILEVEL
11
CLEANING THE DEVICE
For reasons of hygiene the device must be cleaned
on a weekly basis:
1. Disconnect the power plug
2. Wipe the device with a cloth slightly moistened
with soapy water. Then use a dry cloth to wipe
the device dry
You do not have to disinfect the device or parts of
the device chemically or thermally.
CLEANING THE HEAD GEAR
Clean the head gear as required:
1. Disconnect the head gear from the mask
2. Clean the head gear as described in the head
gear manufacturer's operating instructions

ALARM FUNCTIONS
POWER FAILURE
If a power failure at night would go unnoticed as a
result the patient would breathe used air from the
therapy tubing all night. To avoid this the device is
equipped with an alarm mechanism that warns you
with a 5 seconds delay if power or a fuse fail at
night. You will be woken up with an acoustic signal
so you can take the mask off your face and breathe
fresh air.
The alarm is turned off by pushing the operating
button. After power supply is re-established the
motor starts automatically and the display will show
the following message:
CHECK POWER FAILURE WARNING
NOTE:
To check the power failure alarm, the device must
have been connected to the power cord and tur-
ned on for at least half an hour.
Use the device with running blower and then pull
the power plug out of the wall socket. Now the
acoustic warning signal should sound. Check once
a month if the signal sounds long enough (refe-
rence value: at least 3 minutes).
After pushing the operating button or turning on the
power supply again the signal will stop.
MASK ALARM
This alarm function is activated only if the automatic
function is turned off. If the mask has slipped off
your face or if the tubing is pulled off the device,
the device is not turned off automatically, but emits
a visual and audible alarm. However, this additional
safety function requires that you turn the device on
in the evening and off and in the morning with the
operating button (ON/OFF).
CHECK MASK ALARM
Use the device with running turbine in the manual
mode (automatic mode OFF). The mask is open
but not applied to your face. After a short time, an
audible signal is emitted.
20
12
VECTOR et BILEVEL
BILEVEL
BILEVEL