point 2 5.000 ENG_2015-09-01_11 Article no.: 5000 0510
User‘s manual point 2
Quality makes the Difference
User‘s manual
Respiratory Therapy Device
CPAP - AutoCPAP - BILEVEL ST20 - BILEVEL ST25
as of device software 5.000
3
point 2
User's manual
©2015 HOFFRICHTER GmbH
All rights reserved.
The content published in this user’s manual is the sole property of the HOFFRICHTER GmbH. All forms of reproduction, editing, distribution and any kind
of exploitation, even in part, require the prior written consent of the HOFFRICHTER GmbH.
The HOFFRICHTER GmbH reserves the right to amend or replace this user’s manual without prior notice.
Please ensure that you are always working with the most current version of this
user’s manual. Should you have any questions, please contact the ventilation
device provider, or check our information at www.hoffrichter.de.
The respiratory device may only be operated and maintained by trained personnel.
The following documents are available for point 2 pro in addition to this user’s
manual:
•Brief instructions
•Service manual
•Hygiene concept
4 Info
SERIAL NUMBER
Every HOFFRICHTER GmbH device is supplied with a serial number for traceability purposes.
Please enter your device‘s serial number here. You will fi nd the serial number
on the rating plate on the back of the device.
...............................................
Please always quote the serial number for all queries and complaints.
CONFORMITY
The device complies with the requirements of Directive 93/42/EEC.
Contents 5
CONTENTS
Scope of delivery .........................................................................................9
General ......................................................................................................10
Information on this user‘s manual ............................................................10
Symbols used in this manual ...................................................................10
Symbols on the packaging ......................................................................11
Symbols on the rating plate .....................................................................11
Safety Information ......................................................................................12
General safety instructions ......................................................................12
Electrical safety .......................................................................................13
Installation requirements and transport ....................................................13
Before commissioning .............................................................................14
Using oxygen ..........................................................................................15
Intended use ...........................................................................................16
Contraindications ....................................................................................17
Side effects .............................................................................................17
Device description .....................................................................................18
How the device works ................................................................................19
General ...................................................................................................19
Power supply ..........................................................................................20
Therapy modes ..........................................................................................21
CPAP ......................................................................................................21
APAP .....................................................................................................22
BILEVEL S, T and ST .............................................................................25
Using the device ........................................................................................28
Commissioning .......................................................................................28
Tur ni ng o n and off in bat te ry m ode ..... .. .. .. ....... .. .. .. ....... .. .. .. ....... .. .. .. ........ 30
Standby mode ........................................................................................30
Automatic zero point correction of pressure sensor .................................30
Power failure ...........................................................................................31
Using oxygen ..........................................................................................32
Device functions ........................................................................................34
Parameters in point 2 CPAP ....................................................................36
Parameters in point 2 AutoCPAP .............................................................37
Parameter in point 2 BILEVEL ST20/25 ...................................................38
Language ...............................................................................................39
P-Unit .....................................................................................................39
Operating times ......................................................................................39
Date .......................................................................................................40
Time .......................................................................................................40
Wake up time .......................................................................................... 41
Mode .....................................................................................................42
6 Contents
Pressure .................................................................................................42
IPAP .......................................................................................................43
EPAP ......................................................................................................44
I-Slope ....................................................................................................44
E-Slope ..................................................................................................45
Frequency ...............................................................................................46
I:E ...........................................................................................................46
Delay Time ..............................................................................................46
Backup freq ............................................................................................47
P-Min ......................................................................................................47
P-Max .....................................................................................................48
P-Start ....................................................................................................48
I-FLEX .....................................................................................................48
E-FLEX ...................................................................................................49
Calibration ..............................................................................................50
Ramp .....................................................................................................51
Mask Test ...............................................................................................52
Automatic ...............................................................................................53
Display Vt ...............................................................................................54
Bact.Filter ...............................................................................................55
Brightness ..............................................................................................55
Parameter settings ..................................................................................56
Alarm functions of the device .....................................................................57
Mask alarm .............................................................................................57
Pressure alarm ........................................................................................57
Wake up alarm ........................................................................................57
Important display messages .......................................................................58
Using an SD card .......................................................................................60
General information .................................................................................60
Inserting the SD card ..............................................................................60
Removing the SD card ............................................................................61
Error messages .......................................................................................62
Storage of therapy data .............................................................................63
Internal device memory ...........................................................................63
SD card ..................................................................................................63
point 2 CPAP and point 2 AutoCPAP .......................................................63
point 2 BILEVEL ST20/25........................................................................64
Changing the fi lter, cleaning........................................................................ 65
Cleaning the mask ..................................................................................66
Cleaning the therapy tube .......................................................................66
Cleaning the device .................................................................................66
Cleaning the headgear ............................................................................67
Cleaning the humidifi er ............................................................................ 67
Contents 7
Preparing the device for a patient change ...................................................68
Using bacterial fi lters .................................................................................. 69
Troubles ho ot in g . .. .. ....... .. .. .. ....... .. .. .. ....... .. .. .. ....... .. .. .. .. ....... .. .. .. ....... .. .. .. .... 70
Maintenance ..............................................................................................71
Disposal.....................................................................................................72
Device ....................................................................................................72
Packaging ...............................................................................................72
Accessories ............................................................................................72
Accessories ...............................................................................................73
Tech ni ca l da ta . .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. .. . 75
Manufacturer’s declaration on electromagnetic compatibility .......................78
Disclaimer ..................................................................................................82
Scope of delivery 9
SCOPE OF DELIVERY
3
1
2
4
5
6
7
8
10
9
1 Respiratory therapy device point 2
1
2 Mains cable
3 Power supply
4 Therapy tube (ID = 22 mm, length = 1.80 m)
5 User‘s manual
6 Brief instructions
7 Spare fi lter (2 pack)
8 Carrying case
9 Ventilation mask (optional) with exhalation valve
Different of mask systems are available.
10 Headgear
1 optional equipment variant for use with humidifi er
10 General
GENERAL
INFORMATION ON THIS USER‘S MANUAL
Read this user‘s manual through carefully before using your therapy device for
the fi rst 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 USED IN THIS 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 effi cient,
error-free use of the device.
General 11
SYMBOLS ON THE PACKAGING
Range of humidity for storage and transport
Range of ambient air pressure for storage and transport
Range of temperature for storage and transport
SYMBOLS ON THE RATING PLATE
Observe the warning and safety instructions in the user‘s manual.
BF application part
Protection class II (protective insulation)
CE conformity declaration
Manufacturer
Serial number
Follow the user‘s manual.
Do not dispose of the device in the household waste. Please contact the relevant customer services department to fi nd out how to
dispose of the device properly.
15
95
265 hPa
1060 hPa
-20°C
+70°C
12 Safety Information
SAFETY INFORMATION
GENERAL SAFETY INSTRUCTIONS
•
Only use the device for your own CPAP therapy prescribed
by the physician.
• Only use accessories and spare parts approved by us for
use with the device.
•
Only use the mask and therapy tube for your own therapy.
• Observe the mask manufacturer‘s usage instructions.
•
Check that the exhalation opening in the mask is not
obstructed.
•
Make sure you use an exhalation valve if the mask has
no exhalation opening.
• Inform your specialist dealer immediately if the device is
not working properly.
•
Please see your physician immediately if dryness of the
mucous membranes in the nose and throat, sinus discomfort, ear ache, runny nose, over sensitive reactions of
the skin, irritabilities, loss of voice, orientation or memory
impairment occur when using the device.
Safety Information 13
ELECTRICAL SAFETY
•
Do not use the device if its housing, cables or power
supply are damaged.
•
Do not open the device housing under any circumstances.
Inform your specialist dealer if the device develops a fault.
•
During therapy, do not connect any other line-powered
devices via the RS232 interface at the rear of the device.
• Protect the device from water and dampness.
•
Always unplug the device from the mains before cleaning.
•
Empty and thoroughly clean any optional humidifi er if you
do not plan to use it for a lengthy period of time.
INSTALLATION REQUIREMENTS AND TRANSPORT
•
Place the device near your bed on a fi rm and level surface.
A bedside cabinet is ideally suited for this.
•
During therapy, the device must not be operated in a
drawer, on a closet shelf or behind a partition.
•
It must be ensured that the air inlet at the rear of the device
is accessible at all times and not obstructed. Drapes,
curtains, paper or other objects must not be located behind
the device.
•
Do not place the device on the fl oor or under the bed in
order to maintain low dust exposure levels.
• Do not put the device close to a source of heat.
•
Avoid setting up the device at locations where it will be
exposed to direct sunlight.
• Make sure you operate the device at a suffi cient distance
from other equipment which could emit electromagnetic
waves such as diathermy devices, cell phones, remotecontrolled toys and microwave appliances.
•
Empty the humidifi er (optional accessory) before packing
it away in the carrying case.
14 Safety Information
BEFORE COMMISSIONING
•
Do not switch the device on if it has previously been in
a very cold environment. Wait for about one hour for the
temperature to balance out.
•
Check for proper setup and proper condition of the device.
• Check the condition of the breathing tube, mask, humidi-
fi er and air fi lter. Special attention should be paid to the
maintenance instructions.
Safety Information 15
USING OXYGEN
•
Oxygen supports combustion. Therefore, observe the fi re
protection regulations applicable for using oxygen.
• Ensure that there is no grease on the oxygen fi ttings. Do
not smoke and do not handle naked fl ames.
•
Before using any oxygen equipment for the fi rst time, you
must receive instruction from your specialist dealer in your
home environment.
•
Be sure to observe the user‘s manual of the manufacturer
or distributor from whom you obtain the oxygen.
•
Make sure that the distance between the oxygen source
and device is at least 1 m.
•
Have your distributor advise you about the use of oxygen.
• In any case, follow your physician‘s instructions.
16 Safety Information
INTENDED USE
The device must not be used for patients weighing less than 30 kg. An
improper use may result a lung damage.
The point 2 is a respiratory therapy device designed for the treatment of sleep-
related breathing disorders in patients weighing 30 kg or more. With increased
demand of pressure and/or forms of respiratory insuffi ciency, the point 2 BILEVEL
ST20 and the point 2 BILEVEL ST25 offers the classical non-invasive ST-Bilevel
therapy.
The point 2 CPAP (CPAP = Continuous Positive Airway Pressure) is a respiratory
therapy device, which applies a continuous positive airway pressure to the patient.
The point 2 AutoCPAP (AutoCPAP = Automatically Adjusting Continuous Posi-
tive Airway Pressure) is a respiratory therapy device, which provides an eventdriven therapy pressure adjustment within preset pressure limits.
The point 2 BILEVEL ST20 and the point 2 BILEVEL ST25 (ST = Spontaneous,
Timed) are respiratory therapy devices, which enables two independently adjust-
able pressure levels depending of inspiration and expiration.
The device generates positive airway pressure which keeps the patient‘s airways
open whilst asleep. The therapy pressure is administered via a respiratory mask
(nasal, nasal cushion or full-face mask), which must be fi tted with an exhalation
valve to ensure that the exhaled air is discharged.
The point 2 is designed for use at home, in hospitals and for portable operation.
The device is not suitable for use with patients in need of artifi cial respiration.
This therapy device is no life-support system.
Safety Information 17
CONTRAINDICATIONS
Respiratory therapy may be contraindicated for certain pre-existing conditions. Therefore, always talk to your treating physician before starting
the therapy.
Contraindicating pre-existing conditions include:
•bullous lung diseases
• pneumothorax
• very low blood pressure
•pneumocephalus after open craniocerebral injury or other head injuries
Infl ammation of the paranasal sinuses or the middle ear may be an indication
to stop the treatment. Please speak to your physician about this.
SIDE EFFECTS
There is the possibility of undesirable side effects occurring with respiratory
therapy. Reasons for side effects occurring could be unsuitable therapy settings, not using the device properly or not following the cleaning instructions.
Normally the side effects disappear when their causes have been eliminated.
You will fi nd suitable counter measures for some side effects in the section
„Troubleshooting“ from page 70.
The following side effects may occur during therapy:
•Pain in the nose, paranasal sinuses and ears
•Dryness and irritation in the nose and throat
•Nose bleeds, runny nose, sneezing, colds
•Irritated or dry eyes
• Reddening of the skin, swelling of the skin and pressure points in the mask
area
•Diffi culty in breathing, claustrophobia
•Stomach problems caused by air accumulating in the stomach
If you experience side-effects continuously, contact your treating physician to clarify the causes.
18 How the device works
DEVICE DESCRIPTION
JAB122020
1 Control panel and display
2 Humidifi er lock
3 Therapy tube connection
4 Contact socket for humidifi er
1
5 Control panel for humidifi er
1
6 SD card slot
7 Rating plate
8 Air inlet for baro sensor
9 DC power connection
10 RS232 interface
11 Filter or connection port for the fi ltersystempoint 2
12 Display
13 ON/OFF key
14 Selection keys
15 Enter key
1 optional equipment variant for use with humidifi er
How the device works 19
HOW THE DEVICE WORKS
GENERAL
The point 2 has an electronically controlled blower
to create the air pressure. In order to keep impositions to the patient at a minimum, the blower has
been fi tted with high power reserve capacity and
a rapid control response.
The point 2 has an inbuilt microcontroller to control
all its functions. Further comfort functions include a
soft start ramp, automatic start / stop and adjustable display brightness.
Air going through the device is warmed slightly and
therefore gains a higher water absorption capacity.
The mucous membranes in the mouth and nose
can dry out, particularly in winter when the ambient air is dry. This is unpleasant and in some cases
may also lead to infections. Therefore, a respiratory
air humidifi er may be necessary in conjunction with
a treatment. The plug-in aquapoint 2 humidifi er is
available as an accessory to humidify respiratory air.
For more information on the humidifi er read the
aquapoint 2 user‘s manual or contact your spe-
cialist dealer.
Air inlet
Filter
Air outlet
Internal pressure measuring tube
Blower
Pressure
sensor
Control
unit
20 How the device works
POWER SUPPLY
The point 2‘s power can be supplied from one of three sources:
1 External switched-mode power supply (included in scope of delivery)
2 DC vehicle cable (optional)
3
powerpackpoint 2 battery pack (optional)
External switched-mode power supply
For mains operation the point 2 has an external switching power supply with a
wide input range of 100 - 240 V alternating current (AC), 50 - 60 Hz. Thus it is
possible to connect it to an energy supply anywhere in the world.
DC vehicle cable
For mobile use of the point 2, e.g., in a truck or a caravan, it is possible to operate it with a 24 V direct current (DC). For this you will need the optionally available DC vehicle cable.
Only use the optional DC vehicle cable to connect the device to a DC
power supply.
Battery pack
To use point 2 while travelling and when mains current fails, the device can
be operated with the optionally available powerpackpoint 2 battery pack.
With the battery pack, point 2 CPAP and point 2 Auto CPAP can be used at least 8
hours (at 10 hPa, 12 bpm, 500 ml tidal volume). With the point 2 BILEVEL ST20/25
an operating time at least 7 hours is possible (at IPAP = 12 hPa, EPAP = 6 hPa,
12 bpm, 300 ml tidal volume, I:E = 40% : 60%, T mode).
Before using the battery pack, ensure that you have read the powerpackpoint 2
user‘s manual.
How the device works 21
THERAPY MODES
The point 2 is equipped with the following therapy modes depending on the
type of device:
Mode
Device type
CPAP APAP BILEVEL
STST
point 2 CPAP (type 5CPJ00) • - - - -
point 2 AutoCPAP (type 5CPJ10) • • - - -
point 2 BILEVEL ST20 (Typ 5CPJ30) • - • • •
point 2 BILEVEL ST25 (Typ 5CPJ50) • - • • •
CPAP
In CPAP mode (Continuous Positive Airway Pressure), the point 2 supplies continuous positive pressure.
20
Pressure
[hPa]
I
Time
CPAP
pressure
4
EEI
I= Inspiration E= Expiration
CPAP
22 Therapy modes
APAP
(only point 2 AutoCPAP)
In APAP mode (Automatic Positive Airway Pressure), the point 2 automatically
controls the therapy pressure in relation to the respiratory events occurring. The
device is equipped with a special sensor system that can reliably distinguish
between obstructive apnea (airways are closed) and central sleep apnea (respiratory arrest with open airways). Obstructive apnea can be corrected with an
automatic increase in pressure. Central sleep apnea automatically results in a
drop in pressure.
Hypopnea (fl ow reduction, snoring) results in a rise in pressure with a lower
speed. Normal respiration results in a slow drop in pressure.
The maximum values to which the pressure level may rise or fall are specifi ed
by the selection of settings. The device commences therapy once switched on
with the starting pressure, which is likewise adjustable.
20
I
Time
P-Max
P-Min
4
EEI
I= Inspiration E= Expiration
Pressure
[hPa]
APAP with P-Min and P-Max limits
The speed of pressure increase can be set to one of fi ve levels via the PC
software TRENDset.
Therapy modes 23
FLEX settings
Breathing compressed air results in an increased burden for the respiratory
muscles. FLEX controls ease this burden on the respiratory muscles by reducing the effect of the fl ow resistance in the airway. To this end, the therapy pres-
sure needs to be increased during inspiration and reduced during expiration.
The degree of pressure control can be individually selected for inspiration and
expiration at four levels (0, 1, 2, 3). The level selected is identical to the airway
resistance value in hPa/(l/s) by which the effort for the patient‘s respiratory muscles is relieved. The specifi ed curves of the FLEX transfer characteristics cor-
respond to the prevailing pressure and fl ow behavior of the airways. Changes
in pressure are only possible within the adjustable pressure range of the point
2 and are additionally limited to ± 3 hPa. FLEX settings are not activated until
after the third breathing period, as the point 2 takes a short period of time to
calculate the leakage fl ow.
20
Pressure
[hPa]
I
Time
CPAP
pressure
4
EEI
CPAP with I-FLEX and E-FLEX
20
Pressure
[hPa]
I
Time
4
EEI
I= Inspiration E= Expiration
P-Max
P-Min
APAP with I-FLEX and E-FLEX
EI
24 Therapy modes
Pressure
[hPa]
Flow [l/s]
13
12
11
7
Leakage flow
8
9
10
3 hPa/ (l/s)
2 hPa/ (l/s)
1 hPa/ (l/s)
0
b
a
Pressure curve
1-1
Respiration flow curve
abhPa
l/s
==
Flow
resistance
FLEX settings
Therapy modes 25
BILEVEL S, T AND ST
(only point 2 BILEVEL ST20/25)
General
In BILEVEL S, T and ST you can independently set the pressure during inspration (IPAP) and expiration (EPAP). Selecting an an optimal slope can facilitate
patients therapy compliance. A precise adjustment may further convey the feeling of natural respiration without any delay.
BILEVEL S
In BILEVEL S the transition from inspiration pressure (IPAP) to expiration pressure (EPAP) is triggered once the patient starts to breath. When the inspiration
fl ow ends, the pressure drops to the EPAP. In addition, a backup frequency
(Backup freq) can be activated. In the event of an apnea patients ventilation will
be continuously restored at fi xed parameters:
•IPAP, EPAP
•I-Slope, E-Slope
•Backup frequency
The parameters will be set by the physician.
During the expiration phase a negative pressure (vacuum) will not be created.
20
Pressure [hPa]
I
Time
Spontaneous breathing Spontaneous breathing
Backup
freq. =
10 s
35% (2.1s)
65% (3.9s)
EPAP
IPAP
4
EEIEIIEEIIE EII
Delay time
= 15 s
Total
time lag Backup T mode
I= Inspiration E= Expiration
BILEVEL S
26 Therapy modes
BILEVEL T
In contrast to BILEVLE S, at BILEVEL T spontanous breating efforts will not be
considered. Based on fi xied preset ventilation parameters
•IPAP, EPAP,
•I-Slope, E-Slope,
•I:E ratio and
•frequency
the machine performs a periodic timed mandatory pressure transition.
The parameters will be set by the physician.
20
Pressure [hPa]
I
Time
EPAP
IPAP
4
EEIEIEI
I= Inspiration E= Expiration
BILEVEL T
Therapy modes 27
BILEVEL ST
As long as the patient is breathing spontaneously the device is operating in the
S mode. If the patient stops breathing, the device automatically switches to
the T mode. Once a total time lag (expiration time + delay time) has elapsed
the device switches into the T mode.
20
Pressure [hPa]
I
Time
S mode
Spontaneous breathing Spontaneous breathing
Delay
time
Total
time lag
I:E
T mode
T
EPAP
IPAP
4
EEEIEIIEEIIEI
I= Inspiration E= Expiration
S mode
BILEVEL ST
28 Using the device
USING THE DEVICE
COMMISSIONING
Before commissioning the device, read section „Safety Information“ (starting from page 12).
1. Set up the device according to the installation requirements (see page 13).
2. Connect the power supply to the device.
JAB122020
3.
Connect the mains cable to the power supply and its plug to a power socket.
4. The device starts up and successively displays a welcome text, the device
type, its software version and the current number of therapy hours and then
switches to the date and time display (standby mode).
5. Connect the therapy tube to the mask.
6. Connect the unattached end of the tube to the air outlet.
If you are using a bacterial fi lte r, fi t it be tween the tu be and ai r outl et.
Using the device 29
7.
Calibrate the device as described in the chapter „Calibration“ from page 50.
8.
Put the mask on. If automatic mode has been selected (see page 53), the
device is turned on by the patient‘s breathing. If automatic mode has been
set to „OFF“, the device is started by pressing the ON/OFF key.
9. The device fi rst of all runs (for the time selected by you for the mask test) at
the prescribed pressure. You should now ensure the mask‘s correct positioning to avoid potential leakages.
10. Place the tube in such a way that it does not exert any strain on the mask
when you lie down.
11. Now breath deeply and calmly, just through your nose. If the soft start function (Ramp) has been selected (see page 51), the device reduces air
pressure after the mask test has been performed. It then increases pressure automatically gradually up to the prescribed value while you can go to
sleep under reduced pressure.
Read how you can adapt the time settings for mask test and ramp to suit
your personal requirements in section „Device functions“ (starting page
34).
30 Using the device
TURNING ON AND OFF IN BATTERY MODE
If the device is powered by the optional available powerpackpoint 2, press and
hold the ON/OFF key for approx. 3 seconds to switch it on or off.
In standby mode the device automatically switches itself off after 1 minute.
STANDBY MODE
If the blower is switched off, the device switches to standby mode (discernible
on the lit display with date and time).
E .9'!*H
<<L?@
=@ % ;D
<<L?@
=@ *<=
.!00EH
The point 2 can be kept in standby mode permanently. This does not harm it.
If the powerpackpoint 2 is fi tted on the device, the batteries are charged in
standby mode. The charging process is indicated by a fl ashing battery sym-
bol on the display.
AUTOMATIC ZERO POINT CORRECTION OF PRESSURE SENSOR
Automatic zero point correction ensures the uniformly high precision of the pressure measurements and takes account of aging effects. Therefore the electric
and electronic components are maintenance-free.
Sensors are normally temperature-compensated before being installed in CPAP
devices. This process requires certain compensation tools, which are used
solely by trained staff. Unfortunately, the selected values are not permanent
as they vary over time due to aging, vibrations or constant changes in climate.
This means that these values need to be checked for correctness at prolonged
intervals and possibly readjusted.
HOFFRICHTER‘s technicians have however developed a new method in which
the necessary compensation tools are, so to speak, permanently „on board“
the point 2. It is thus no longer necessary to check measurement accuracy.
To allow this method to function, the point 2 has to be put on standby from time
to time. Here it is suffi cient to run the device in this mode for just a few sec-
onds before and after each starting up of the blower to allow the software to
collect and apply the necessary data. We also recommend running the device
on standby for a longer period, e.g. for a day, once a month.
Using the device 31
In order to determine an applicable correction factor, the device requires
a certain amount of time in standby mode. We therefore recommend that
the device is left in standby mode at least once a month between nightly
therapies.
The zero-point correction is particularly recommended if the device is used in a
new location (e.g., when travelling) or if there are signifi cant temperature fl uc-
tuations in the room.
For the patient the automatic zero-point correction system means that the device
is always optimally adjusted, leading to even better therapy.
POWER FAILURE
After a power failure during therapy, the motor re-starts automatically and you
will see a message on the display about the power failure and the blower re-start.
!0/./(+3!.
+3!.%(1.!
If you are using the optionally available powerpackpoint 2, the batteries
provide the power for the device in the event of a power failure.
32 Using the device
USING OXYGEN
If oxygen is using the therapy setting must be set, that no backfl ow of
oxygen takes place into the device.
Before using oxygen, it is essential to read the safety information on
page 14.
When supplying oxygen, please use a kink-resistant tube made of a medically
approved material. In order to prevent back fl ow of oxygen into the device, we
recommend the use of an O2 pressure valve.
There are two variants to supply oxygen.
Variant 1: Supplying oxygen directly in the mask
Mask
Therapy
tube
O
2
pressure valve
O
2
source
Variant 2: Supplying oxygen via an adapter between therapy tube and
O2 pressure valve
Mask
Therapy
tube
O
2
pressure valve
O2 supply
adapter
O2 source
The O2 supply adapter and O2 pressure valve you can order as accessory
(see page 74).
Using the device 33
Proceed as follows when using oxygen:
If the device is in standby mode or switched off, the oxygen supply must
always be switched off.
1. Before starting the treatment, check that the tube connections are fi tted
correctly.
2. Switch the device on fi rst and then start the oxygen supply.
3. Check whether the automatic mode is set to „Auto OFF“. If not, program
it as described on page 54.
4. Switch off the oxygen supply before switching off the device.
Using oxygen infl uences the therapy pressure. Therefore we recommend
to inclose oxygen in the therapy pressure determination / titration process,
for every patient who‘s therapy is intended to include an oxygen supply.
34 Device functions
DEVICE FUNCTIONS
There are three keys for programming point 2‘s functions:
= Selection key
= Selection key
= E n t e r k e y
If the enter key is pressed for a prolonged time, you enter the programming
mode and the menu appears on the display.
The device display has two lines. By pressing and you can select the
top or bottom row. A triangle symbol> in front of a row means that this row
has been selected.
4%/!*1
Q'!%)!MM ; BL ; ;
Device functions 35
The point 2 has two different menus:
•Standard
menu
•Complete menu
The standard menu contains the menu items relevant to patients. The complete
menu contains all menu items of the standard menu as well as all menu items
required for setting the therapy. This menu is primarily intended for physicians
and trained medical staff.
To s wi tc h be tw ee n th e me nu s, fi rst press the enter key . Then hold both the
selection keys and down at the same time for a prolonged period. The
display shows the message:
or
If during programing you have not pressed a key for 30 seconds, the standard or complete menu exits automatically for security reasons. If a modifi ed value is not confi rmed by pressing the enter key and the standard or
complete menu has exited, the original value is retained.
To access a menu, hold down the enter key for longer than 1 s. You can access
the menu items within menus by pressing the selection keys or . To activate a parameter, press the enter key .
Some parameters may only be set by physicians or trained medical staff. These
parameters are protected by a PIN code.
Q + !G ;;;;
4%/!*1
Please do not try to crack the PIN code. Speak to your physician if you
doubt the correctness of the pressure prescription.
/% 2!
/* . !*1
/% 2!
+),( !/!!*1
36 Device functions
PARAMETERS IN point 2 CPAP
Parameter
point 2 CPAP
Standard menu Complete menu
Language - •
P-Unit - •
Power
Blower
Filter
Therapy
-•
Date • •
Time • •
Wake Time
1
••
Press.
2
-•
I-FLEX
2
-•
E-FLEX
2
-•
Calibration • •
Ramp
P-Ramp
-•
Mask Test - •
Auto - •
Display Vt • •
Bact.Filter - •
Brightness - •
next parameter is displayed by pressing the enter key
• present, - not present
1
only present, if the alarm clock function is enabled (see page 41)
2
PIN code protected
Device functions 37
PARAMETERS IN point 2 AutoCPA P
Parameter
point 2 AutoCPAP
Standard menu Complete menu
CPAP APAP CPAP APAP
Language - •
P-Unit - •
Power
Blower
Filter
Therapy
-•
Date • •
Time • •
Wake Time
1
••
Mode2
-•
Press.
2
-•-
P-Min
2
P-Max
P-Start
--•
I-FLEX
2
-•
E-FLEX
2
-•
Calibration • •
Ramp
P-Ramp
-•
Mask Test - •
Auto - •
Display Vt • •
Bact.Filter - •
Brightness - •
next parameter is displayed by pressing the enter key
• present, - not present
1
only present, if the alarm clock function is enabled (see page 41)
2
PIN code protected
38 Device functions
PARAMETER IN p oint 2 BILEVEL ST2 0/25
Parameter
point 2 BILEVEL ST20/25
Standard menu Complete menu
CPAP
BILEVEL STBILEVEL TBILEVEL SCPAP
BILEVEL STBILEVEL TBILEVEL
S
Language - •
P-Unit - •
Power
Blower
Filter
Therapy
-•
Date • •
Time • •
Wake Time
1
••
Mode2
-•
Press.
2
-•-
IPAP
2
EPAP
I-Slope
E-Slope
--•
Frequency
2
I:E
Delay Time
--••-
•
-
Backup Freq.
2
--•
I-FLEX
2
-•-
E-FLEX
2
-•-
Calibration • •
Ramp
P-Ramp
-•
Mask Test - •
Auto - •
Display Vt • •
Bact.Filter - •
Brightness - •
next parameter is displayed by pressing the enter key
• present, - not present
1
only present, if the alarm clock function is enabled (see page 41)
2
PIN code protected
Device functions 39
LANGUAGE
The device can display messages in German (DEU), English (ENG), Greek (ELL),
Spanish (SPA), French (FRA), Italian (ITA), Dutch (NLD), Turkish (TUR), Polish
(PLK), Portuguese (POR) and Czech (CZE).
Setting the language
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Language.
4%/!*1
Q*#1#!MMMMMMMM
3. Set the desired language by pressing the enter key .
P-UNIT
The device can show the pressure in the pressure units hectopascal (hPa), mil-
libar (mbar), and centimeters of water (cm = cmH2O).
Setting the pressure unit
1. Select the complete menu (see page 35).
2. Use the selection keys and to select P-Unit.
!"#$ %&'()
*+ ,(#$----------./01
3. Set the desired pressure unit by pressing the enter key .
OPERATING TIMES
Under this menu item you will fi nd the total operating time including standby
mode of the device, the blower running time, the operating time of the fi lter
and the therapy time.
Checking the device‘s operating times
1. Select the complete menu (see page 35).
2. Use the selection keys and to select Power. The total operating
time including standby is now displayed.
Q+3!.MMMMMMMMMMMM=@ ; $
4%/!*1
3. Press the enter key . The total running time of the blower is now displayed.
4. Press the enter key again. The operating time of the fi lter is now dis-
played.
5. Press the enter key again. The therapy time is now displayed.
40 Device functions
DATE
The day (1 - 31), the month (Jan. - Dec.) and the year (00 - 99) can be set.
Setting the date
1. Press the enter key for 1 second.
2. Use the selection keys
and to select Date.
Q/!MMMM=@ *<=
4%/!*1
3. Press the enter key and then use the selection keys and to set
the year. Confi rm your setting by pressing the enter key .
4. Use the selection keys and to set the month. Confi rm your setting
by pressing the enter key .
5. Use the selection keys and to set the day. Confi rm your setting by
pressing the enter key .
TIME
The device has an internal clock. In the event of a power failure, the clock oper-
ates on inbuilt battery power. The hour (00 - 23) and minutes (00 - 59) can be set.
Setting the time
1. Press the enter key for 1 second.
2. Use the selection keys and to select Time.
4%/!*1
Q%)!MMMMMMMMMMMM < >L ; ;
3. Press the enter key and then use the selection keys and to set
the hour. Confi rm your setting by pressing the enter key .
4. Use the selection keys and to set the minutes. Confi rm your set-
ting by pressing the enter key .
Device functions 41
WAKE UP TIME
Ex factory, the alarm clock function is not enabled. But it can be unlocked
by the physician or dealer with TRENDset PC software.
To a ct iv at e t he wak e u p ala rm , p re ss . For checking purposes, the programmed
wake up time is displayed for a short time. To deactivate the alarm, press .
The activated alarm is indicated by a bell symbol on the display.
.!00EH
<=L=;
=@ *<=
When the wake up alarm sounds, there are two options:
1. Press the ON/OFF key once to stop the alarm for the next 5 minutes
(Slumber mode) and twice to deactivate it completely.
(1)!.MMMMMMMMMM ? L ? @
.!00EH
2. Press to end the alarm.
Setting the wake up time
1. Press the enter key for 1 second.
2. Use the selection keys and to select Wake Time.
4%/!*1
Q'!%)!MM ; BL ; ;
3. Press the enter key and then use the selection keys and to set
the hour. Confi rm your setting by pressing the enter key .
4. Use the selection keys and to set the minutes. Confi rm your set-
ting by pressing the enter key .
42 Device functions
MODE
(only point 2 AutoCPAP and point 2 BILEVEL ST20/ST25)
Selection of mode by the physician
1. Press the enter key for 1 second.
2. Use the selection keys
and to select Mode.
Q+ !MMMMMMMMMMMMMM
4%/!*1
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Use the selection keys and to select the desired mode. Confi rm
your setting by pressing the enter key .
PRESSURE
(only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20/25 in
CPAP mode)
Selection of pressure by the physician
When the pressure parameter is changed during therapy/titration, the
device adapts to the new setting slowly (25 Pa/s). This pressure ramp can
be deactivated using the TRENDset PC software.
point 2 CPAP:
1. Select the complete menu (see page 35).
2. Use the selection keys and to select Press..
4%/!*1
Q.!00MMMMMM B @$
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
Device functions 43
point 2 AutoCPAP and point 2 BILEVEL ST20/25:
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Mode.
3. Press the the enter key
and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Use the selection keys and to select the CPAP mode.
5. Press the selection key . The menu item Press. is now displayed.
6. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
IPAP
(only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST)
Selection of inspiration pressure (IPAP) by the physician
1. Select the complete menu (see page 35).
2. Use the selection keys and to select IPAP.
!"#$ %&'()
*2 +3+--------4 5 56 +0
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
The parameter EPAP is set next.
44 Device functions
EPAP
(only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST)
!"#$ %&'()
*!+3+---------- 7 56 +0
Selection of expiration pressure (EPAP) by the physician
1. First set IPAP.
2. Use the selection keys
and to set the desired value. Confi rm your
setting by pressing the enter key .
The parameter I-Slope is set next.
I-SLOPE
(only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST)
!"#$ %&'()
*2%89:;'-------------- <
The I-Slope determines the time of pressure increase from EPAP to IPAP.
•Level 1 = 10 hPa/s
•Level 2 = 20 hPa/s
•Level 3 = 40 hPa/s
Selection of I-Slope by the physician
1. First set IPAP and EPAP
2. Use the selection keys
and to set the desired value. Confi rm your
setting by pressing the enter key .
The parameter E-Slope is set next.
Calculation of the I-Slope time:
Settings:
IPAP = 10 hPa I-Slope = 2 Frequency = 12 bpm
EPAP = 6 hPa E-Slope = 2
I-Slope time =
IPAP – EPAP
I-Slope
I-Slope time =
10 hPa – 6 hPa
20 hPa/s
= 0.2 s
Device functions 45
E-SLOPE
(only point 2 BILEVEL ST20/25 in modes BILEVEL S, T and ST)
!"#$ %&'()
*!%89:;'-------------- <
The E-Slope determines the time of pressure decrease from IPAP to EPAP.
•Level 1 = 10 hPa/s
•Level 2 = 20 hPa/s
•Level 3 = 40 hPa/s
Selection of E-Slope by the physician
1. First set IPAP, EPAP and I-Slope.
2. Use the selection keys
and to set the desired value. Confi rm your
setting by pressing the enter key .
10
Pressure
[hPa]
IPAP
EPAP
E-SlopeI-Slope
Time
2
1
2
3
4
56
4
0
6
8
The E-Slope time is calculated as the I-Slope time (see page 44).
46 Device functions
FREQUENCY
(only point 2 BILEVEL ST20/25 in modes BILEVEL T and ST)
Selection of Frequency by the physician
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Frequency.
!"#$ %&'()
*=1'>)'(?@--4</;.
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
The parameter I:E is set next.
I:E
(only point 2 BILEVEL ST20/25 in modes BILEVEL T and ST)
!"#$ %&'()
*2 A !--------B5A75%C
Selection of I:E by the physician
1. First set Frequency.
2. Use the selection keys and to set the desired value. Confi rm your
setting by pressing the enter key .
The parameter Delay Time is set next (only point 2 BILEVEL ST20/25 in BILEVEL
ST mode).
DELAY TIME
(only point 2 BILEVEL ST20/25 in BILEVEL ST mode)
!"#$ %&'()
*D'90@%E#.'------ FG
Selection of Delay Time by the physician
1. First set Frequency and I:E.
2. Use the selection keys and to set the desired value. Confi rm your
setting by pressing the enter key .
Device functions 47
BACKUP FREQ
(only point 2 BILEVEL ST20/25 in BILEVEL S mode)
By activating the backup frequency ventilation will be automatically restored if
patient suffers from a persistent apnea (> 15 s). Evolving mandatory ventilation
is characterized by following fi xed parameters:
•f = 10 bpm
•I:E = 35:65 %.
Selection of backup frequency the physician
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Backup freq.
!"#$ %&'()
*H0?I);%J1'>---- K L
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to
select ON or OFF. Confi rm your setting by pressing the enter key .
P-Min
(only point 2 AutoCPAP in APAP mode)
Selection of P-Min by the physician
1. Select the complete menu (see page 35).
2. Use the selection keys and to select Mode.
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Use the selection keys and to select the APAP mode.
5. Press the selection key . The menu item P-Min is now displayed.
4%/!*1
Q
%
*MMMMMMMM @ ;$
6. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
The parameter P-Max is set next.
48 Device functions
P-Max
(only point 2 AutoCPAP in APAP mode)
4%/!*1
Q 4MMMMMM<; ;$
Selection of P-Max by the physician
1. First set P-Min.
2. Use the selection keys
and to set the desired value. Confi rm your
setting by pressing the enter key .
The parameter P-Start is set next.
P-Start
(only point 2 AutoCPAP in APAP mode)
Q /./MMMMB @$
4%/!*1
Selection of P-Start by the physician
1. First set P-Min and P-Max.
2. Use the selection keys
and to set the desired value. Confi rm your
setting by pressing the enter key .
I-FLEX
(only in modes CPAP and APAP)
Inhaling under therapy pressure is always more diffi cult as the lungs are already
partly fi lled and thus also pre stressed. Such additional stress from therapy can be
reduced by means of a personalized I-FLEX setting. FLEX settings will only work
if spontaneous respiration is actually present. FLEXLINE is not a form of artifi cial
respiration, but merely a way of supporting the respiratory effort of the patient.
Selection of I-FLEX by the physician
1. Select the complete menu (see page 35).
2. Use the selection keys and to select I-FLEX.
QMMMMMMMMMMMMMMMM >
4%/!*1
3. Press the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
Device functions 49
E-FLEX
(only in modes CPAP and APAP)
Although the point 2 is equipped with an excellent pressure control system,
an E-FLEX setting can help make expiration easier. This should however be
adjusted individually for each patient. Once again, FLEX settings will only work
if actual respiratory effort is present.
Selection of E-FLEX by the physician
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select E-FLEX.
QMMMMMMMMMMMMMMMM >
4%/!*1
3. Press the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
the desired value. Confi rm your setting by pressing the enter key .
50 Device functions
CALIBRATION
Calibration guarantees an optimum performance of the automatic function and mask test. It must be performed when:
• the device is used initially,
• the mask has been changed,
•
there is a change within the therapy system. If a bacterial fi lter or a
humidifi er is added/removed the calibration has to be redone.
Ex factory, the point 2 is pre-calibrated for using with a Cirri Comfort nasal
mask (size M) without humidifi er and without bacterial fi lter.
Calibration is only possible during mains operation not in battery mode.
Calibrating the device
1. Connect the mask, the therapy tube and, if applicable, the humidifi er or
bacterial fi lter to the device.
Ensure that the air and exhalation openings in the mask are clear and
the tube is not kinked. Do not put the mask on.
2. Press the enter key for 1 second.
3. Use the selection keys and to select Calibration.
Q(%./%+*
4%/!*1
4. Press the enter key .
5. Start appears on the display. Press the enter key . If you do not
press the key within 5 s, the display jumps back (see point 3).
6. The blower starts and calibration begins. Calibration active appears
on the display. Calibration takes 20 - 70 s. The blower switches off after
calibration is fi nished.
7. If calibration has been successful, Successful appears on the display
and if it has failed, Failed appears on the display.
8. In both cases press the enter key .
The old values will be retained if calibration
has failed. Start calibration again.
Device functions 51
RAMP
After every blower start, the device‘s microcontroller checks whether a soft
start ramp has been programmed. The soft start function slowly increases the
pressure over the time programmed by you, starting with a programmable initial ramp pressure (P-Ramp) up to the prescribed pressure (CPAP), P-Start
(APAP1) or IPAP/EPAP (BILEVEL S, T, ST2) in order to make it easier for you to
get to sleep. The soft start can bring relief particularly if you are not quite used
to the respiratory therapy yet.
The device offers delay time settings from zero (prescribed therapy pressure
starts immediately) to 45 minutes (prescribed therapy pressure is gradually built
up within 45 minutes).
Q ),MMMMMM? @$
4%/!*1
The initial ramp pressure (P-Ramp) can be set between 4 hPa and the pre-
scribed pressure.
Setting the ramp
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Ramp.
Q),MMMMMMMMMMMM = ;)% *
4%/!*1
3. Press the enter key and then use the selection keys and to set
the minutes (Ramp). Confi rm your setting by pressing the enter key .
4. Use the selection keys and to set the desired value for the initial
pressure (P-Ramp). Confi rm your setting by pressing the enter key .
1 only point 2 AutoCPAP
2 only point 2 BILEVEL ST20/25
52 Device functions
Pressure [hPa]
Mask test Prescribed pressure: 10 hPa
Programmed ramp (0 - 45 min)
0 - 90 s
45
The pressure is increased gradually to
the prescribed therapy pressure
Time [min]
CPAP and APAP modes
BILEVEL S, T and ST modes
Pressure [hPa]
Mask test Prescribed pressures: IPAP = 10 hPa, EPAP = 6 hPa
Programmed ramp = 10 min
0 - 90 s
45
The pressures is increased gradually to
the prescribed therapy pressures
Time [min]
EPAP
IPAP
MASK TEST
This ensures that the mask is airtight, not only during the slow pressure increase
during the soft start ramp, but also at higher pressures. The mask test can be
programmed to last from 5 to 90 seconds in 5 second increments. The mask
test is performed before the ramp starts and tests the tightness under maximum therapy pressure (see fi gures on page 52).
Setting the mask test
1. Select the complete menu (see page 35).
2. Use the selection keys and to select Mask Test.
4%/!*1
Q0'!0/MMMMMM > ;0
3. Press the enter key and then use the selection keys and to set
the seconds. Confi rm your setting by pressing the enter key .
Device functions 53
AUTOMATIC
The automatic mode has three settings:
OFF, Start/Stop, Start
1. Auto OFF (with mask alarm)
Q1/+MMMMMMMMMMMMMMMM
4%/!*1
With the „Auto OFF“ setting, you must switch the device on with the ON/
OFF key when therapy starts and off with the same key when therapy
ends. Should the mask slip from your face or should a leak occur that
cannot be compensated for, you will be given an acoustic and visual
warning.
$!'0'H
0'( .)MMMMMM<;0
2. Auto Start/Stop
Q1/+MM/./E/+,
4%/!*1
With the „Auto Start/Stop“ setting, you only have to put the mask on.
+)$%:(%&0GIM%
<<A 4 N
<N &0@ 4 4
As soon as you begin breathing, the point 2 blower switches on. When
you take the mask off, the blower switches off automatically after a 5 second delay. The blower also switches off when the mask slips off your face
or a leak that cannot be compensated for occurs.
3. Auto Start (with mask alarm)
Q1/+MMMMMMMMMMMM /./
4%/!*1
With the „Auto Start“ setting, you only have to put the mask on. As soon
as you begin breathing, the point 2 blower switches on. If you take the
mask off or the mask slips off your face or a leak occurs which cannot
be compensated for, the blower does not switch off but you receive an
acoustic and visual warning.
$!'0'H
0'( .)MMMMMM<;0
The blower can only be switched off by pressing the ON/OFF key.
54 Device functions
Setting automatic mode
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Auto.
3. Press the enter key
to set the desired automatic mode.
The device can be switched on or off in any automatic mode by pressing the
ON/OFF key.
DISPLAY VT
When the function „Display Vt“ is activated, the tidal volume is displayed in ml
during therapy. The value displayed is the arithmetic mean of the inspired air
volume from the last four breathing periods. The value is recalculated after each
breathing period and shown on the display. The leakage air fl ow must be cal-
culated before display is possible. This is generally the case after about three
breathing periods.
Activating/deactivating the display of the tidal volume
1. Press the enter key for 1 second.
2. Use the selection keys and to select Display Vt.
4%/!*1
Q%0,(5/MMMMMM
3. Press the enter key to set „ON“ or „OFF“.
During the therapy the display of the tidal volume replaces the display of
the date.
Possible displays states
C@$
)(
;@L >;
A?=
Display of tidal volume in ml.
C@$
)( ;@L >;
No valid value for the tidal volume is available yet.
C@$
)(
;@L >;
;
If the display shows the value 0 ml for the tidal
volume, an apnea has occurred.
Device functions 55
BACT.FILTER
As pressure measurement is infl uenced by the connection of a bacterial fi lter,
it must be specifi ed on the device whether or not a bacterial fi lter has been
connected.
Select whether a bacterial fi lter is connected (by the physician)
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Bact.Filter.
Q/%(/!.MM ! 0
4%/!*1
3. Press the the enter key and if necessary, input the PIN code with the
selection keys and . Press the enter key after every digit.
4. Press the enter key and then use the selection keys and to set
Yes or No. Confi rm your setting by pressing the enter key .
Whenever a bacterial fi lter is connected to or removed from the device, it
is necessary to calibrate the device (see page 50).
BRIGHTNESS
You can set the brightness of the display from 0 % to 100 %.
This value determines the brightness of the display 30 seconds after the last key
was pressed. When a key is pressed, the display brightness is always 100 %
(50% during battery operation).
Setting the brightness
1. Select the complete menu (see page 35).
2. Use the selection keys
and to select Brightness.
Q.%#$/*!00MM<;;N
4%/!*1
3. Press the enter key and then use the selection keys and to set
the desired brightness.
4. Confi rm your setting by pressing the enter key .
56 Device functions
PARAMETER SETT INGS
Parameter Settings range Dependency Setting steps
Language DEU, ENG, ELL, SPA, FRA, ITA,
NLD, TUR, PLK, POR, CZE
--
P-Unit hPa, mbar, cmH
2
O--
Press.
1
4 – 20 (257) hPa - 0.5 hPa
IPAP
2
EPAP – 20 (257) hPa
EPAP, 20 (257) hPa
0.5 hPa
EPAP
2
4 hPa – IPAP 4 hPa, IPAP 0.5 hPa
I-Slope
2
1 – 3
IPAP, EPAP,
Frequency, I:E
1 Level
E-Slope
2
1 – 3
IPAP, EPAP,
Frequency, I:E
1 Level
Frequency
3
5 – 30 bpm - 1 bpm
I:E
3
20 – 80 % - 5%
Delay Time
4
0 – 20 s - 1 s
Backup freq5ON, OFF - -
P-Min
6
4 – 20 hPa P-Start 0.5 hPa
P-Max
6
4 – 20 hPa P-Start 0.5 hPa
P-Start
6
4 – 20 hPa P-Min,
P-Max
0.5 hPa
I-FLEX 0 – 3 hPa/ (l/s) - 1 hPa/ (l/s)
E-FLEX 0 – 3 hPa/ (l/s) - 1 hPa/ (l/s)
Ramp 0 – 45 min - 5 min
P-Ramp 4 hPa – 20 (25
7
) hPa CPAP: Press.
APAP6: P-Start
BILEVEL S, T, ST
2
:
EPAP
0.5 hPa
Mask Test 0 – 90 s - 5 s
Auto OFF, Start/Stop, Start - -
Display Vt ON, OFF - -
Bact.Filter Yes, No - -
Brightness 0 – 100 % - 10 %
1
only point 2 CPAP and point 2 AutoCPAP and point 2 BILEVEL ST20/25 in
modes CPAP
2
only point 2 BILEVEL ST20/25
3
only point 2 BILEVEL ST20/25 in modes BILEVEL T and ST
4
only point 2 BILEVEL ST20/25 in BILEVEL ST mode
5
only point 2 BILEVEL ST20/25 in BILEVEL S mode
6
only point 2 AutoCPAP
7
only point 2 BILEVEL ST25
Alarm functions of the device 57
ALARM FUNCTIONS OF THE DEVICE
MASK ALARM
If the mask slips off your face, the tube is pulled out or any other leak occurs
that cannot be compensated for, the device does not switch off automatically
but emits an acoustic and visual alarm.
$!'0'H
0'( .)MMMMMM<;0
The mask alarm is only active in the „Auto OFF“ and „Auto Start“ automatic modes.
Test in g th e ma sk a la rm
Start the device in „Auto OFF“ mode. The mask should be open, not on the
face. After a short time an acoustic signal sounds.
PRESSURE ALARM
Should an excessively high pressure occur during the treatment due to a hardware error or other circumstance, the device emits an alarm sound and switches
the blower off.
.!00/++$%#$
=<L >>
=@ *<=
The alarm is turned off by pressing the ON/OFF key.
WAKE UP ALARM
'!(.);BL;;
@;$
Ex factory, the alarm clock function is not enabled. But it can be unlocked
by the physician or dealer with TRENDset PC software.
If enabled, you can activate or deactivate the alarm clock with the selection
keys and . Pressing the ON/OFF key once mutes the alarm for the next
5 minutes and pressing it twice stops it completely.
58 Important display messages
IMPORTANT DISPLAY MESSAGES
The most important display messages are listed below. All further messages
will be clarifi ed from the given context.
The values shown here are examples.
C@$
0'!0/MMMMMMMM < @0
You still have 15 seconds to ensure that the mask
is fi tted correctly. When the time is up, the device
starts the soft start function or the therapy.
),MMMMMMMMMMMMMMMM CL ?;
C@$
There are still 8 minutes and 40 seconds until full
therapy pressure is reached.
C@$
)(
;@L >;
A?=
You have activated the display of the tidal volume
as well as the wake up alarm.
$!'0'H
0'( .)MMMMMM < ; 0
The mask has slipped off your face or a leak that
cannot be compensated for has occurred or you
have not put the mask on in the „Auto OFF“ or
„Auto Start“ automatic modes while the blower
is running.
C@$
;BL ;;
(.)
In normal mode you have pressed the selection
key and get the message that you will be
woken up at 7 a.m.
C@$
(.)(+'
In normal mode you have pressed the selection key
and get the message that the alarm clock
has now been switched off.
'!(.);BL;;
@;$
The wake alarm has been triggered. Press the ON/
OFF key once to initiate the slumber phase. Press
the key once again to turn off the alarm completely.
(1)!.MMMMMMMMMM < L < C
@;$
You still have 1 min and 18 s until the alarm clock
will sound again.
'!(.)
@;$
You have pressed the ON/OFF key and ended
the slumber phase.
Important display messages 59
N56+0
O60(P'%=#9$'1
The fi lter must be changed (see page 65). To
reset the message, hold the enter key down
and, while you are doing this, insert the DC power
supply plug into the device‘s DC power connection.
!0/./(+3!.
+3!.%(1.!
After the mains voltage is restored, the blower re-
starts automatically.
%0%*/%2!
+),( !/!!*1
The complete menu has been deactivated by the
PC software TRENDset and cannot displayed.
Ex factory, the alarm clock function is not enabled. But it can be unlocked
by the physician or dealer with TRENDset PC software.
60 Using an SD card
USING AN SD CARD
GENERAL INFORMATION
The use of an SD card during therapy enables the most important therapy data
to be saved long-term and detailed. The physician can readout and evaluate
this data via the TRENDset PC software. Furthermore, the physician may set
up new therapy parameters using TRENDset and send them to the patient to
update its therapy requirements. As soon as the SD card is inserted, the device
imports the modifi ed therapy parameters.
Only HOFFRICHTER SD cards can be used. These has to be formatted
by TRENDset (see page 73).
INSERTING THE SD CARD
1. Ensure that the device is in standby mode (see page 30).
2. Insert the SD card into the SD card slot.
JAB122020
3. The device starts initializing while the message “Do not remove the SD
card” is displayed.
$6' 8D ?01Q
D: (:$ 1'.:R'
Finally the symbol is shown at the display. The time required for initialization depends on the device settings.
During the initialization process do not remove the SD card at any time!
This could lead to loss of data or damage the SD card.
4. After successful initialization, the message disappears. If the SD card
contains valid new therapy parameters, the device is going to import
them. Finally “New Parameters were accepted” indicates initialization to
be successful.
S'1' 0?? '; $'Q
L'S +010.'$'1G
Using an SD card 61
5. By pressing the enter key or after 10 s the message will be disappear
automatically.
REMOVING THE SD CARD
Only remove the SD card in standby mode. Otherwise data may be lost
or the SD card might be damaged.
1. Ensure that the device is in standby mode (see page 30).
2. Carefully push the SD card into the card slot.
JAB122020
3. Remove the SD card.
JAB122020
62 Using an SD card
ERROR MESSAGES
8D !11:1%%%% !5<
+1'GG%KLTK== M
Two different types of error can be distinguished: errors with data loss and
errors without data loss.
The display “Exx” denotes errors in which data may have been lost. The display
“Wxx” denotes errors in which data has not been lost.
To h id e an e rr or m es sa ge , pres s th e en te r ke y
.
If error messages occur frequently, we recommend that the device is
examined by a service technician.
The following table shows all error codes that can occur in connection with
the use of the SD card.
Error
code
Meaning Remedy
E00
Writing data has failed. Possible
causes are power failure, removal of
card during writing or a faulty SD card.
The SD card is probably faulty. Remove
the SD card and then insert it into
the device again. If the error continues to occur, send the card back to
the physician.
E01 The SD card is faulty. Obtain a new SD card from your phy-
sician or specialist dealer.
E02
File system or folder structure is faulty
or cannot be read.
The SD card must be formatted by
the physician using TRENDset.
E03
New fi les cannot be created or the
SD card is full.
The SD card must be formatted by
the physician using TRENDset.
E04
The device cannot adopt the ther-
apy data.
The SD card must be returned to the
physician to check the therapy.
E05 The SD card was removed. Insert the SD card again.
The SD card has fallen out of the card
slot.
If this occurs frequently, the device
should be examined by a service
technician.
E06 The SD card or the device is faulty.
Change SD card. If this occurs frequently, the device should be examined by a service technician.
W00
The device is attempting to repair the
SD card. But you have inserted a new
SD card into the device.
Confi rm with key. The old SD card is
defective. Continue to use the new
SD card.
W05/06
see error code E05/E06 see error code E05/E06
Storage of therapy data 63
STORAGE OF THERAPY DATA
Therapy data is stored internally in the device and alternatively on an SD card.
The data from the device and the SD card can be readout by the physician
using the TRENDset PC software.
INTERNAL DEVICE MEMORY
The internal device memory is limited to 30 days1.
SD CARD
In contrast to the internal device memory the SD card offers a capacity of more
than one year 1, 2. In addition to the therapy data the last 100 device events are
saved on the SD card. Events are changes of parameters such as therapy settings, resetting counters (e.g., fi lter counters) etc. The parameters changes are
saved with the date and time they were changed, as well as the old and new
value. All alarms that occurred are also being saved with date and time.
point 2 CPAP AND point 2 AutoCPAP
Therapy data Internal device
memory
SD card
Frequency
-
•
Central Sleep Apnea • •
Obstruktive Sleep Apnea • •
Mixed Sleep Apnea • •
Hypopnea • •
Snoring • •
Mode • •
Adjustment • •
Leakage • •
Hyperventilation • •
Average System Flow • •
Base Pressure •• ••
Therapy Pressure
(low resolution)
no FLEX pressure changes visible
•-
Therapy Pressure
(high resolution)
FLEX pressure changes visible
-
•
- not saved
• saved
•• only saved, when I-FLEX or E-FLEX are selected, but not active
1 depending on the operating time and number of events
2 when using a 2 GB SD card
64 Storage of therapy data
Therapy data Internal device
memory
SD card
Respiratory Flow
-
•
Relative Respiratory Volume
-
•
- not saved
• saved
•• only saved, when I-FLEX or E-FLEX are selected, but not active
point 2 BILEVEL ST20/25
Therapy data Internal device
memory
SD card
Frequency
-
•
Mode • •
Adjustment • •
Leakage • •
Average System Flow • •
Therapy Pressure
(low resolution)
no Bilevel pressure changes visible
•-
Therapy Pressure
(high resolution)
Bilevel pressure changes visible
-
•
Respiratory Flow
-
•
Relative Respiratory Volume
-
•
- not saved
• saved
Changing the filter, cleaning 65
CHANGING THE FILTER, CLEANING
The fi lter prevents dust, insects and airborne particles from entering the device.
Over time such substances would cause heavy soiling of the ducts inside the
device and the blower parts. As a result, the device would no longer satisfy the
hygiene requirements. In extreme cases, unpleasant odors might result after a
while. To ensure that the fi lter remains permeable to air, it needs to be cleaned
or replaced at certain intervals.
The standard fi lter is only designed to offer a certain level of protection from bac-
teria and allergens. Here, we recommend using the optional fi ltersystempoint 2,
an attachable fi lter cassette with replaceable fi lter layers. The large fi lter area
means that a much denser fi lter material can be used here without there being
any signifi cant pressure loss.
When the fi lter is soiled or the display reads Change Filter, the fi lter
must be either replaced or rinsed out.
N56+0
O60(P'%=#9$'1
Changing the fi lter
Pull out the fi lter on the back of the device and replace it with a new or cleaned one.
JAB122020
Always use the device with the fi lter element inserted and clean the fi lter
element regularly. If the fi lter element is heavily soiled or not inserted, this
may damage the device and result in unpleasant odors.
Cleaning the fi lter
1. Clean the fi lter with mild soapy water. Do not use any other agents!
2. Rinse the fi lter thoroughly with clear water.
3. Let the fi lter dry completely.
4. Insert the cleaned fi lter into the device.
If the device is run with the optionally available fi ltersystempoint 2 according to
the cleaning instructions in the fi lter system user‘s manual.
66 Changing the filter, cleaning
Resetting the display message
1. Disconnect the DC power supply plug from the device.
2. Hold the enter key
down and, while you are doing this, reconnect the
DC power supply plug to the device‘s DC power connection.
3.
Filter Counter Reset appears on the display. Press the enter key to
confi rm.
4. Filter Counter deleted appears on t he displ ay.
CLEANING THE MASK
For hygienic reasons, clean the mask every day. To do so, proceed as follows:
1. Disconnect the mask from the therapy tube.
2. Clean the mask with mild soapy water. Do not use any other agents!
3. Rinse the mask thoroughly with clear water.
4. Let the mask dry completely.
CLEANING THE THERAPY TUBE
For hygienic reasons, clean the therapy tube weekly. To do this, proceed as
follows:
1. Disconnect the therapy tube from the mask and the device.
2. Clean the therapy tube with mild soapy water. Do not use any other
agents!
3. Rinse the therapy tube thoroughly with clear water.
4. Let the vertically suspended therapy tube dry completely.
CLEANING THE DEVICE
Clean the device once a week. To do this, proceed as follows:
1. Unplug the mains plug.
2. Wipe the device with a cloth slightly dampened with soapy water.
3. Rub the device dry with a cloth.
Chemical cleaning products or solvents should not be used to clean the
surface of the device under any circumstances. They might damage the
high gloss fi nish of the device.
Changing the filter, cleaning 67
CLEANING THE HEADGEAR
You only need to clean the headgear if it is necessary. To do this, proceed as
follows:
1. Remove the headgear from the mask.
2. Clean the headgear according to the manufac turer‘s instructions.
CLEANING THE HUMIDIFIER
When using a humidifi er, the cleaning instructions in its user‘s manual
must be observed.
68 Preparing the device for a patient change
PREPARING THE DEVICE FOR A PATIENT CHANGE
Before every change of patient a hygienic preparation must be carried out
in accordance with the HOFFRICHTER’s hygiene concept.
When being given to another patient, the device must be prepared hygienically by the specialist dealer or the manufacturer. If reuse of the mask and the
therapy tube is planned, they must also be prepared by the specialist dealer
or the manufacturer.
The preparation procedure is described in detail in the corresponding hygiene plan.
Using bacterial filters 69
USING BACTERIAL FILTERS
If the device is intended for use by more than one patient (e.g., operation in
clinics), a suitable bacterial fi lter (e.g., MEDISIZE BARR-VENT S) must continu-
ously be used to protect the device from contamination by human pathogens.
Change the bacterial fi lter daily and follow the manufacturer’s user’s manual.
If the optionally available humidifi er aquapoint 2 is used with the device,
a bacterial fi lter must not be used.
On a change of patient, carry out the following steps:
•Replace the bacterial fi lter.
•
Disinfect all the parts of the housing and the connections with a suitable
agent, e.g., Mikrozid® Liquid.
•
Change the fi lter or if you are using the optionally available fi ltersystempoint 2,
either change its coarse and fi ne fi lter and disinfect the surface of the fi lter
system or replace the entire fi lter system with a new one.
If there is any doubt, it should be assumed that the device is contaminated
and it should be hygienically prepared according to the hygiene concept.
70 Troubleshooting
TROUBLESHOOTING
Problem Possible cause Remedy
Pain in the nose, the paranasal sinuses or the ears
Infl ammation of the para-
nasal sinuses or the
middle ear
Stop the treatment and
contact your physician
Unpleasant feeling
because of the high pressure
Malaise with prescribed
high pressure values
If you suspect an error,
please ask your physician
for help
Acclimatization phase
to the pressure not yet
completed
Try to relax. Use or vary
the soft start function
Dryness and irritation in
the nose and throat
Air is too dry Device probably does
not have an air humidifi er.
Speak to your physician
about retrofi tting an aqua-
point 2 humidifi er
Original symptoms of
sleep apnea come back
Physical condition or
life circumstances have
changed
Inform your physician
Irritated or dry eyes Air escapes between
mask and the skin of the
face
Check the positioning of
the mask
Replace the mask if the
material has become
chapped
Cold nose Room temperature too
low
Increase room temperature. Warm up the tube
under the pillow
Runny nose, sneezing Reaction to the air fl ow Either increase the humid-
ity in the room or the tem-
perature of the humidifi er
Normal cold Contact your physician
Reddening of the skin in
the mask area, skin swelling
Incorrect mask size Inform your physician
Headgear too tight Loosen the headgear
Allergic reaction Inform your physician
Feeling that the air is too
hot
Heater close to the device Move the device and the
heater further apart
No air fl ow Device is defective Inform customer services
Very little air fl ow
Soft start function has
been selected
Reduce soft start time
Air channels are blocked Check air inlet
Blower is running constantly
at maximum speed
Leak in the device Have the device checked
by customer services
Maintenance 71
MAINTENANCE
Do not try to open the power supply. Maintenance and repairs may only
be performed by personnel authorized by us.
Do not try to open the device. Maintenance and repairs may only be performed by personnel authorized by us.
You yourself can help to increase the service life of the device and ensure that
it continues to work safely.
• Follow the cleaning instructions from page 65.
•Check the system regularly:
–Conduct a visual check for external damage and dirt
– Check the mask alarm function once a week (see page 57)
72 Disposal
DISPOSAL
Proper disposal saves natural resources and prevents harmful substances being
released into the environment.
DEVICE
The device must not be disposed of with the household
waste. Please contact the relevant customer services department to
fi nd out how to dispose of the device properly.
PACKAGING
The packaging is taken back by the distributor but it can alternatively
be recycled.
ACCESSORIES
The accessories such as the tubing, mask, fi lter cassettes, etc. should be dis-
posed of according to the manufacturer’s instructions, or with normal household waste.
Accessories 73
ACCESSORIES
For ordering of accessories, please contact a HOFFRICHTER service partner.
Scope of delivery Article number
Carrying case 0000 2080
Power supply 0000 2133
Mains cable 3110 0029
Filter 0000 2110
Spare fi lter (2 pack) 0000 7801
Therapy tube (inner diameter = 22 mm, length = 1,80 m) 0000 7875
User‘s manual 5000 0510
Brief instructions 5000 0519
Optional Article number
Standard Masks
Standard Nasal Mask, Size S 0000 3440
Standard Nasal Mask, Size M 0000 3434
Standard Nasal Mask, Size L 0000 3435
Standard Full Facs Mask, Size S 0000 3441
Standard Full Facs Mask, Size Size M 0000 3436
Standard Full Facs Mask, Size L 0000 3437
Cirri Comfort Mini Masks
Cirri Mini Comfort Nasal Mask, Child-S 0000 3551
Cirri Mini Comfort Nasal Mask, Child-M 0000 3552
Cirri Mini Comfort Nasal Mask, Child-L 0000 3498
Cirri Comfort Masks
Cirri Comfort Nasal mask, Size XS 0000 3497
Cirri Comfort Nasal mask, Size S 0000 3486
Cirri Comfort Nasal mask, size M 0000 3487
Cirri Comfort Nasal mask, Size L 0000 3488
Cirri Comfort Full Face Mask, Size S 0000 3483
Cirri Comfort Full Face Mask, Size M 0000 3484
Cirri Comfort Full Face Mask, Size L 0000 3485
Pillow Mask
Nasal Pillow, 4in1 Sizes (XS, S, M, L) 0000 3499
Other Accessories
SD card, formatted with TRENDset 1120 0010
ComfortTube System (heated tubing system) 0000 3479
Tube cover sleeve 0000 7161
Humidifi er
aquapoint 2
0001 2949
Electronics for humidifi er
aquapoint 2
0001 2286
74 Accessories
Optional Article number
Battery pack powerpackpoint 2
0001 2846
AKKUPACK uni BASE “Respiratory therapy”
0001 1101
fi ltersystempoint 2
0001 2847
Fine fi lter for
fi ltersystempoint 2
0000 2109
Coarse fi lter for
fi ltersystempoint 2
0000 2108
Bacterial fi lter MEDISIZE BARR-VENT S 0000 4932
O
2
supply adapter 0000 4943
O
2
pressure valve 0000 4947
24 V DC vehicle cable 0000 2295
12 V to 24 V converter 0000 7133
Technical data 75
TECHNICAL DATA
point 2
point 2 with aquapoint 2
Dimensions (W x D x H) 170 x 220 x 95 mm 180 x 350 x 110 mm
Weight 1.5 kg
approx. 1.9 kg (without
water)
Power supply
Mains power 100 … 240 V AC, 50 ... 60 Hz
DC power 24 V DC / max. 2.01 A
Battery power (per battery) 11.1 V / 2200 mAh -
Operating time under
battery power
1
point 2 CPAP and
AutoCPAP
point 2 BILEVEL
ST20/25
> 8 hours (at 10 hPa,
12 bpm, 500 ml tidal volume)
> 7 hours (at IPAP = 12 hPa,
EPAP = 6 hPa, f = 12 bpm,
300 ml tidal volume,
I:E = 40 % : 60 %, T mode)
-
Running reserve of
internal clock
up to 8 years
Pressure range 4…20 (25
2
) hPa (mbar)
Max. pressure limit in the
event of a fault
3 0 h Pa
Power consumption
DC power
Mains power
DC power
Mains power
Standby
(battery charging)
< 26 W < 35 W
--
Standby (
without batteries)
< 3 W < 5 W
--
Operation at 25 hPa < 17 W < 21 W < 39 W < 48 W
Operation at 20 hPa < 14 W < 17 W < 38 W < 42 W
Operation at 12 hPa < 10 W < 12 W < 34 W < 38 W
Operation at 6 hPa < 6 W < 9 W < 30 W < 35 W
Short term pressure variation point 2 CPAP, AutoCPAP, BILEVEL ST20 in hPa
4
hPa8hPa12hPa16hPa20hPa4hPa8hPa12hPa16hPa20hPa
10 bpm 0.15 0.15 0.17 0.20 0.25 0.16 0.19 0.30 0.40 0.48
15 bpm 0.23 0.24 0.27 0.32 0.38 0.24 0.31 0.45 0.58 0.72
20 bpm 0.36 0.32 0.37 0.43 0.49 0.32 0.42 0.62 0.70 0.91
(at heating level 3)
1
The operating time is depending on the device settings and the age and stage
of charge of the batteries.
2 point 2 BILEVEL ST25
76 Technical data
point 2
point 2 with aquapoint 2
Short term pressure variation point 2 ST25 in hPa
4
hPa9hPa
14.5
hPa20hPa25hPa4hPa9hPa
14.5
hPa20hPa25hPa
10 bpm 0.12 0.15 0.17 0.27 0.33 0.14 0.13 0.25 0.51 0.64
15 bpm 0.18 0.19 0.24 0.30 0.37 0.21 0.19 0.31 0.65 0.81
20 bpm 0.30 0.30 0.33 0.37 0.43 0.46 0.31 0.47 0.73 0.91
(at heating level 3)
Long term pressure variation < 0.1 hPa
Pressure reading accuracy 0.5 hPa
Average sound pressure
level
(operating at 1 m distance)
30 dB(A) at 10 hPa
(equivalent to a sound power level of 3 8 d B[ A] )
Air fl ow rate point 2 CPAP, AutoCPAP, BILEVEL ST20
4 hPa 205 l/min 172 l/min
8 hPa 189 l/min 163 l/min
12 hPa 179 l/min 150 l/min
16 hPa 165 l/min 137 l/min
20 hPa 148 l/min 127 l/min
Air fl ow rate point 2 BILEVEL ST25
4 hPa 205 l/min 187 l/min
10 hPa 191 l/min 175 l/min
15 hPa 173 l/min 158 l/min
20 hPa 152 l/min 141 l/min
25 hPa 137 l/min 124 l/min
Operating temperature + 5 °C ... + 38 °C
(Ambient temperatures up
to 40°C does not harm the
device function at all.)
+ 5 °C ... + 35 °C
(Ambient temperatures up
to 40°C does not harm the
device function at all.)
Storage/Transport
temperature
- 20 °C ... + 70 °C
Therapy air heating
at air outlet
at end of tube
0.3 K/ hPa via compression
0.2 K/ hPa via friction
< 0.3 K/ hPa at 10 hPa;
0,5 l/s
Relative humidity 15 % ... 95 % for operation, storage and transport
Ambient air pressure
range
Storage/Transport
Operation
1060 hPa ... 265 hPa (approx. - 400 m ... 10000 m)
1060 hPa ... 800 hPa (approx. - 400 m ... 2000 m)
1
Filter Polyurethane foam on polyester basis, 80 ppi, 30 kg/m³
Therapy tube connection 22 mm, cone (as per ISO 5356-1)
1
With increasing altitude, the air fl ow rate decreases.
Technical data 77
point 2
point 2 with aquapoint 2
Product class according
to 93/42/EEC
IIa
Classifi cation according
to EN 60601-1
Protection class II (protective insulation)
Factory settings
Parameter point 2 CPAP point 2 AutoCPAP
point 2 BILEVEL
ST20/25
Menu Complete menu
Language ENG
P-Unit hPa
Mode - APAP BILEVEL ST
Press. 6 hPa -
IPAP
-
10 hPa
EPAP
-
6 hPa
I-Slope
-
2
E-Slope
-
2
Frequenz
-
12 bpm
I:E
-
35:65 %
Delay Time
-
15 s
Backup freq
-
OFF
P-Min - 4 hPa -
P-Max - 10 hPa -
P-Start - 6 hPa -
I-FLEX 2 -
E-FLEX 2 -
Ramp 0 min
Mask Test 0 s
Auto OFF
Display Vt OFF
Bact.Filter No
Brightness 50 %
Alarm clock OFF
1
1
It can be unlocked by the physician or dealer with TRENDset PC software.
CE marking as per EC directive 93/42/EEC.
The manufacturer reserves the right to make technical changes without notice.
78 Manufacturer’s declaration on electromagnetic compatibility
MANUFACTURER’S DECLARATION ON ELECTROMAGNETIC
COMPATIBILITY
Guidance and manufacturer‘s declaration – electromagnetic emissions
The point 2 is intended for use in the electromagnetic environment specifi ed below. The user of
the point 2 should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment –
guidance
RF emissions CISPR 11 Group 1 The point 2 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 CISPR 11 Class B
The point 2 is suitable in all establish-
ments, including domestic establishments and those directly connected
to the public low voltage power supply
network that supplies buildings used
for domestic purposes.
Harmonic emissons
IEC 61000-3-2
Class A
Voltage fl uctuati ons / fl icker
emissions IEC 61000-3-3
Complies
Manufacturer’s declaration on electromagnetic compatibility 79
Guidance and manufacturer‘s declaration – electromagnetic immunity
The point 2 is intended for use in the electromagnetic environment specifi ed below. The user of
the point 2 should assure that it is used in such an environment.
Immunity test IEC 60601
Tes t lev el
Compliance level Electromagnetic environ-
ment – guidance
Electrostatic discharge (ESD)
IEC 61000-4-2
± 6 kV
contact
± 8 kV
air
± 6 kV
contact
± 8 kV
air
Floors should be made of
wood, concrete or ceramic
tile. If fl oors are covered with
synthetic material, the relative humidity should be at
least 30%.
Electrical fast transient (Burst)
IEC 61000-4-4
± 2 kV
power supply lines
± 1 kV
input / output
± 2 kV
power supply lines
± 1 kV
input / output
Mains power quality should
be that of a typical commercial or hospital environment.
Surges
IEC 61000-4-5
± 1 kV
differential mode
± 2 kV
common mode
± 1 kV
differential mode
not applicable
Mains power quality should
be that of a typical commercial or hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines IEC 61000-4-11
> 95 % clip in
UT / 0 .5 cy cl es
60 % clip in
U
T
/ 5 c ycl es
30 % clip in
U
T
/ 25 cycles
> 95 % clip in
U
T
/ 5 s
> 95 % clip in
UT / 0 .5 cy cl es
60 % clip in
U
T
/ 5 cycles
30 % clip in
U
T
/ 2 5 cyc le s
> 95 % clip in
U
T
/ 5 s
Mains power quality should
be that of a typical commercial or hospital environment.
If the user of the point 2
requires continued operation
during power mains interruption, it is recommended that
the (Equipment or System)
is powered from an UPS or
a battery.
Magnetic fi eld power
frequency (50/60) Hz
magnetic fi eld
IEC 61000-4-8
3 A/m 3 A/m Power frequency magnetic
fi elds should be at levels
characteristic of a typical
location in a typical commercial or hospital environment.
Conducted RF
IEC 61000-4-6
V1 = 3 V
150 kHz – 80 MHz
3 V
Portable and mobile communications equipment
should be used no closer
to any part of the point 2,
including cables, than the
recommended separation
distance calculated from the
equation applicable to the
frequency of the transmitter:
D = 1.17 √P for V1 = 3 V
80 Manufacturer’s declaration on electromagnetic compatibility
Guidance and manufacturer‘s declaration – electromagnetic immunity
Radiated RF
IEC 61000-4-3
E1 = 3 V/m
80 MHz – 2.5 GHz
3 V/m
d = 1,17 √P
80 MHz - 800 MHz
d = 2,33 √P
800 MHz - 2.5 GHz
Field strengths from fi xed RF
transmitters, as determined
by an electromagnetic site
surveya, should be less than
the compliance level in each
frequency range. Interference may occur in the vicinity of equipment marked with
the following symbol b.
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 refl ecti on from structures, obj ects and p eople.
a
Field strengths from fi xe d transmi tters, suc h as base stations for radio (cellula r/cordl ess) tele -
phones 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 fi xe d RF transmitt ers, an electromagnet ic side survey should be consid ered. If th e m ea-
sured fi eld strength outside the location in which the point 2 is used exceeds the compliance
level, the point 2 should be observed to verify normal operation. If abnormal performance is
observed, additional measures my be necessary, such as relocating or using another location
of the point 2.
b
Over the frequency range from 150 kHz to 80 MHz the fi eld strength should be lower than
3 V/m.
Manufacturer’s declaration on electromagnetic compatibility 81
Recommended separation distances between portable and mobile RF communication
equipment and the point 2
The point 2 is intended for use in an electromagnetic environment in which radiated RF distur-
bances are controlled. The user of the point 2 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the point 2 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 = 1.17 √P
80 MHz – 800 MHz
d = 1.17 √P
800 MHz – 2.5 GHz
d = 2.33 √P
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
11.171.172.33
10 3.70 3.70 7.37
100 11.7 11.7 23.3
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (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 refl ection from structures, objects and people.
82 Disclaimer
DISCLAIMER
HOFFRICHTER GmbH is not liable for consequences in terms of safety, reliability and performance of the product where:
• interventions, modifi cations, extensions, calibration, repairs and mainte-
nance 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.
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