Hoffrichter point 2 User manual

point 2 ENG_2019-06-05_16.0
User‘s manual point 2
point 2
Respiratory therapy device
User‘s manual
valid for:
point 2 CPAP (Device type 5CPJ00)
point 2 AutoCPAP (Device type 5CPJ10)
point 2 BILEVEL ST20 (Device type 5CPJ30)
point 2 BILEVEL ST25 (Device type 5CPJ50)
as of device software 5.000
HOFFRICHTER GmbH
Mettenheimer Straße 12/14
19061 Schwerin
Germany
Phone: [phone]
Telefax: [phone]
E-Mail: [e-mail]
www.hoffrichter.de
50000510

3
point 2
User's manual
©2019 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 wit-
hout 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 pur-
poses.
Please enter your device‘s serial number here. You will find 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
CE mark and number of the notified body. The medical device complies with the relevant
requirements of the EU Directive 93/42/EEC for medical devices.

Contents 5
Contents
Chapter 1 ......................................................................................7
Introduction........................................................................................................7
Scope of delivery................................................................................................... 8
Symbole................................................................................................................ 9
Intended purpose................................................................................................ 13
User qualifications ............................................................................................... 15
Chapter 2 ....................................................................................17
Safety Information ............................................................................................17
General safety instructions................................................................................... 18
Electrical safety ................................................................................................... 20
Installation requirements and transport................................................................ 21
Instructions before commissioning....................................................................... 22
Using oxygen ...................................................................................................... 23
Integration into IT networks ................................................................................ 23
Chapter 3 ....................................................................................25
Description of Device ........................................................................................25
Device description ............................................................................................... 26
How the device works......................................................................................... 27
Power supply....................................................................................................... 28
Chapter 4 ....................................................................................29
Commissioning .................................................................................................29
General information ............................................................................................ 30
Commissioning.................................................................................................... 30
Power failure....................................................................................................... 33
Using oxygen ...................................................................................................... 34
Operation with the humidifier aquapoint 2 .......................................................... 36
Chapter 5 ....................................................................................37
Therapy Modes .................................................................................................37
Chapter 6 ....................................................................................45
Operating the Device ........................................................................................45
General operating the device............................................................................... 46
Description of parameters.................................................................................... 51
Important display messages................................................................................. 68

6 Contents
Using an SD card................................................................................................. 70
Storage of therapy data....................................................................................... 73
Chapter 7 ....................................................................................77
Warnings ..........................................................................................................77
Mask warning ..................................................................................................... 78
Pressure warning................................................................................................. 78
Alarm clock......................................................................................................... 78
Chapter 8 ....................................................................................79
Cleaning and Disinfection..................................................................................79
Important information......................................................................................... 80
Cleaning the device............................................................................................. 80
Changing the filter, cleaning ................................................................................ 81
Use of the device by several patients.................................................................... 84
Chapter 9 ....................................................................................87
Annex...............................................................................................................87
Instructions for home therapy.............................................................................. 88
Maintenance work .............................................................................................. 88
Troubleshooting .................................................................................................. 89
Technical data ..................................................................................................... 90
Measured values ................................................................................................. 92
Setting ranges and control accuracy..................................................................... 93
Compliance with standards.................................................................................. 96
Accessories ......................................................................................................... 97
Manufacturer’s declaration on electromagnetic compatibility................................ 99
Disposal ............................................................................................................ 103
Disclaimer ......................................................................................................... 104

Introduction 7
Chapter 1
Introduction

8 Introduction
Scope of delivery
3
12
4
5
6
7
810
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 filter (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 humidifier

Introduction 9
Symbole
Symbols on the packaging
Symbol Meaning
European Article Number
Article number
Serial number
CE mark and number of the notified body. The medical device complies with
the relevant requirements of the EU Directive 93/42/EEC for medical devices.
Transport and store the package with the arrows are pointing upwards
Fragile package
Keep dry!
If the packaging is damaged, do not use the device.
15
95
Humidity range during storage and transportation
265 hPa
1060 hPa
Air pressure range during storage and transportation
-25°C
+70°C
Temperature range during transportation
-20°C
+45°C
Temperature range during storage up to 3 months

10 Introduction
Symbols on the rating plate
The rating plate is located on the back of the device.
JAB122020
24V DC / max. 2.0A
Symbol Meaning
Protection class II (protective insulation)
BF application part
Serial number
CE mark and number of the notified body. The medical device complies with
the relevant requirements of the EU Directive 93/42/EEC for medical devices.
Manufacturer
Do not dispose of the device with the household waste. Please contact
the relevant customer services department to find out how to dispose of
the device properly.

Introduction 11
Symbols on the device
Symbol Meaning
Connections
24 V DC DC connection
Port : PC/RC
RS232 interface
Follow the user’s manual.
Operation
Selection keys
Enter key
ON/OFF key

12 Introduction
Symbols used in this user’s manual
Important information is denoted by symbols in this user’s manual. Be sure to follow
these instructions in order to avoid accidents, personal injury and material damage.
In addition, the local accident prevention regulations and general safety regulations
in force in the area of use must be observed.
This symbol denotes 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.
Please note:
The words "Please note" indicate tips and information for
ecient and error-free use of the device.

Introduction 13
Intended purpose
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 insu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 Positive Air-
way 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 adjustable 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 fitted with an exhalation valve to ensure
that the exhaled air is discharged.
The point 2 is designed for use at home and in hospitals operation.
The device is not suitable for use with patients in need of artificial respiration.

14 Introduction
Indication
The point 2 can be used for the following indications:
•Obstructive ventilation disorders (e.g., COPD)
•Restrictive ventilation disorders (e.g., scoliosis, thorax deformities)
•Neurological, muscular and neuromuscular disorders (e.g., diaphragmatic paralysis)
•Central respiratory regulation disorders
•Obstructive sleep apnoea syndrome (OSAS)
•Obesity hypoventilation syndrome (OHS)
Irrespective of the indications listed here, the device must always be used in accordance
with the physician’s individual diagnosis.
Contraindications
Risk of injury from contraindications!
Respiratory therapy may be contraindicated for certain pre-
existing conditions.
Contraindicating pre-existing conditions include:
•bullous lung diseases
•pneumothorax
•very low blood pressure
•pneumocephalus after open craniocerebral injury or other head injuries
Inflammation of the paranasal sinuses or the middle ear may be an indication to stop
the treatment. Please speak to your physician about this.

Introduction 15
Side effects
There is the possibility of undesirable side effects occurring with respiratory the-
rapy. 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 nd suitable counter measures for some side effects in the section „Trou-
bleshooting“ from page 89.
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
•Difculty in breathing, claustrophobia
•Stomach problems caused by air accumulating in the stomach
User qualifications
The therapy parameters must only be set by qualified, specialist staff, under the supervision
of a physician. Nursing staff and patients should be instructed in the operation and
handling of the device. It is essential that these persons are familiar with operation of
the device and that they have read and understood the entire user’s manual before
commissioning. Furthermore, it must be ensured that users have been notified by the
provider as to which accessories are compatible with the device.
Repairs and maintenance work on the device may only be carried out by a qualified
and authorized service company.

16 Introduction

Safety Information 17
Chapter 2
Safety Information

18 Safety Information
General safety instructions
Risk of injury from incorrect device settings!
• Only qualified, trained, specialist medical staff under the
supervision of a physician may make settings on the respira-
tory therapy device.
•Check the therapy parameter settings after servicing work.
Risk of infection from germs!
• The directions given in this user’s manual and the applicable
regulations of the hospital or nursing home must be adhered
to when hygienically preparing and cleaning the device.
•Replacement intervals for consumables must be observed.
The expiry date must also be observed.
• Read this user’s manual through carefully before using the respiratory therapy
device for the first time.
• Keep the manual close to the device so that you can refer to it immediately if
necessary.
• In the event of problems, adverse events or unusual behavior of the device (e.g.
during commissioning, use or maintenance), the operator of the device must be
informed immediately and the incidents documented. The contact details of the
operator are usually found on the device.
• A doctor should be consulted if dryness of the mucous membranes in the nose
and throat, sinus discomfort, ear ache, runny nose, over sensitive reactions of
the skin, irritability, loss of voice, orientation or memory impairment occur when
using the device.
• The device must only be used by persons who have fully read and understood
this user’s manual before commissioning and have familiarized themselves with
the device.
• The device must only be used on the responsibility and prescription of the physician.
•Setting the therapy pressure and the device configuration (accessories) should be
carried out for each patient individually.
•The effectiveness of the therapy-relevant settings should be checked regularly.
•The device must only be used on patients whose clinical picture requires it.
•The responsible operator of the device must ensure that the accessories and other
components are compatible with the device. We recommend the use of the
accessories tested and approved by the manufacturer for the device.
• The device must not be used with flammable anesthetics or ambient air that
contains explosive gases. This may cause fires or explosions.

Safety Information 19
•Before being used again on another patient, all parts that come into contact with
respiratory gas must be hygienically prepared.
• Equipment which is not part of the respiratory therapy system must not be con-
nected. Otherwise it can lead to functional deficiency or device failure.
•The device must not be steam-sterilized in an autoclave.
• Filters and other parts that are connected to the patient must be regularly replaced.
Dispose of the replaced parts according to the regulations for used medical
material and/or the local environmental protection rules.
• Any modification to the device poses a threat to its serviceability and is not permitted.
•Only use masks that have been prescribed for the treatment by a physician.
•Observe the mask manufacturer’s instructions for use.
•The mask must not be worn after the therapy device is switched off because this
could lead to breathing in air that has already been exhaled. The air outlet openings
in the mask must always be free, so that the CO2-laden exhaled air can escape.
• The mask may only be used after instruction by a qualified medical person. In
particular, the taking of medicines and possible contraindications and side effects
associated with the use of the mask should be clarified.
•An incorrectly fitting mask will affect the proper operation and the success of the
therapy. The mask fit should be checked using the mask test function.
• Unless specified otherwise, the mask and therapy tube must only be used by
one patient.
•The operating, transport and storage conditions must be observed.
• At temperatures below +5°C and over +40°C, the function of the device may
be impaired.
• The power supply unit can reach a surface temperature of up to 57°C during
operation. Therefore, do not touch the power supply unit for longer than 1 minute
to avoid burning your skin.
• Ensure that small parts of the respiratory therapy system are kept out of the reach
of children and animals.

20 Safety Information
Electrical safety
•Do not try to open the device or the power supply unit. Maintenance and repairs
may only be performed by personnel authorized by HOFFRICHTER GmbH.
•Do not touch live parts of the power cable or power supply unit if they are faulty.
• The device must not be used in wet rooms, as there is a risk of electrical shock
from moisture in the device.
•Only the power supply unit supplied may be used for operating the device.
• Do not use any electrically conductive or electrostatically chargeable patient tubes.
• The device must not be closer than 30 cm to other devices such as defibrillators,
diathermy units, mobile phones, microwaves, remote controlled toys, etc. Elec-
tromagnetic fields that exceed 10 V/m may adversely affect the operation of the
ventilator.
• To disconnect the device from the power supply, the power plug must be pulled out.
•Do not put any containers which contain liquid on the device.
•Do not put the device near water containers (e.g. baths).
•The power plug must be unplugged before cleaning the device.
•Do not reach for the device under any circumstances should it fall into water.