Hoffrichter CPAP User manual

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 HOF-
FRICHTER GmbH. All forms of reproduction, editing, distribution and any kind
of exploitation, even in part, require the prior written consent of the HOFFRICH-
TER GmbH.
The HOFFRICHTER GmbH reserves the right to amend or replace this user’s man-
ual 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 trace-
ability 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
Turning on and off in battery mode ..........................................................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
Troubleshooting .........................................................................................70
Maintenance ..............................................................................................71
Disposal.....................................................................................................72
Device ....................................................................................................72
Packaging ...............................................................................................72
Accessories ............................................................................................72
Accessories ...............................................................................................73
Technical data ............................................................................................75
Manufacturer’s declaration on electromagnetic compatibility .......................78
Disclaimer ..................................................................................................82

Scope of delivery 9
SCOPE OF DELIVERY
3
12
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 mate-
rial damage.
In addition, the local accident prevention regulations and general safety regula-
tions 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 inju-
ries 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 dam-
age 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 con-
tact 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 dis-
comfort, 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, remote-
controlled 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 event-
driven 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 con-
ditions. 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 set-
tings, 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 physi-
cian 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 er1
5 Control panel for humidifi er1
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 filtersystempoint 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 imposi-
tions 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 adjust-
able 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 ambi-
ent 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 pres-
sure measu-
ring 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 oper-
ate it with a 24 V direct current (DC). For this you will need the optionally avail-
able 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 con-
tinuous 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 (respi-
ratory 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.