Hoffrichter LAVI User manual

User's manual
for patients
Applies to device types 9LV401 and 9VL402 from device software 1.400
LAVI
Ventilator
HOFFRICHTER GmbH
Mettenheimer Straße 12/14
19061 Schwerin
Germany
Telephone: [phone]
Fax: [phone]
E-mail: [e-mail]
www.hoffrichter.de
LAVI Patient ENG_2019-09-25_5.0
LAVI user’s manual for patients
50000682

3
LAVI
User’s manual
for patients
©2019 HOFFRICHTER GmbH
All rights reserved.
The content published in this user’s manual is the sole property of HOFFRICHTER GmbH.
All forms of reproduction, editing, distribution and use of any kind, even in part, require
the prior written consent of HOFFRICHTER GmbH.
HOFFRICHTER GmbH reserves the right to amend or replace this user’s manual with-
out 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 following documents are available in addition to this user’s manual:
•LAVI user’s manual for physicians and medical professionals
•LAVI brief instruction
•Service manual
•Hygiene concept
•Maintenance schedule
Licensing information
The device software is in part based on freeware. You can save and read the list of
software used as well as the corresponding licensing conditions by copying the data
to an SD card.

4
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 bottom of the device.
.................................................
Please always provide the serial number in case of queries and complaints.
CE mark and number from the notified body. The medical device complies with the
applicable regulations of EU 93/42/EEC for medical products.

Inhaltsverzeichnis 5
Table of contents
Chapter 1 ......................................................................................9
Introduction........................................................................................................9
Scope of delivery................................................................................................. 10
Symbols .............................................................................................................. 11
Intended purpose................................................................................................ 15
User qualification ................................................................................................ 17
Chapter 2 ....................................................................................19
Safety Information ............................................................................................19
General safety instructions................................................................................... 20
Electrical safety ................................................................................................... 22
Installation requirements and transport ................................................................ 23
Instructions before commissioning....................................................................... 24
Using oxygen ...................................................................................................... 24
Safety-related test ............................................................................................... 25
Chapter 3 ....................................................................................27
Description of Device ........................................................................................27
Front side of device ............................................................................................. 28
Rear of device ..................................................................................................... 28
Bottom of device................................................................................................. 29
Top of device ...................................................................................................... 29
Chapter 4 ....................................................................................33
Commissioning .................................................................................................33
General information ............................................................................................ 34
Setting up the device........................................................................................... 34
Power supply....................................................................................................... 35
System setup, non-invasive ventilation ................................................................. 41
System setup, invasive ventilation ........................................................................ 42
Calibrating the tube circuit................................................................................... 45
Using the functional bag ..................................................................................... 49
Switching on the device....................................................................................... 50
Switching off the device ...................................................................................... 50
Start ventilation................................................................................................... 50
Stop ventilation................................................................................................... 50

6 Inhaltsverzeichnis
Chapter 5 ....................................................................................51
Operating the Device ........................................................................................51
Menu structure ................................................................................................... 53
Menu lock........................................................................................................... 54
User profiles........................................................................................................ 55
Home screen....................................................................................................... 56
Monitoring screen ............................................................................................... 58
Parameter screen................................................................................................. 59
Event log screen.................................................................................................. 61
System screen ..................................................................................................... 62
Statistics screen................................................................................................... 64
Service screen ..................................................................................................... 64
Chapter 6 ....................................................................................65
Alarms and Messages........................................................................................65
General information ............................................................................................ 65
Audible alarm output (audio alarms) .................................................................... 67
Visible alarm output ............................................................................................ 68
Alarm overview ................................................................................................... 69
Messages............................................................................................................ 74
Chapter 7 ....................................................................................75
Cleaning and Exchange of Components.............................................................75
Important information......................................................................................... 76
Overview............................................................................................................. 76
Cleaning the device ............................................................................................. 78
Cleaning the mask............................................................................................... 78
Cleaning the tube circuit...................................................................................... 78
Cleaning the exhalation valve .............................................................................. 79
Cleaning/exchanging the air filter......................................................................... 79
Chapter 8 ....................................................................................81
Routine Tests and Maintenance Work................................................................81
Overview............................................................................................................. 82
Battery maintenance ........................................................................................... 83
Chapter 9 ....................................................................................85
Annex...............................................................................................................85
Error messages.................................................................................................... 86
Technical data ..................................................................................................... 88
Accessories ......................................................................................................... 89

Inhaltsverzeichnis 7
Manufacturer’s declaration on electromagnetic compatibility................................ 92
Disposal .............................................................................................................. 96
Disclaimer ........................................................................................................... 97

8 List of figures
List of figures
Figure 1: Rating plate............................................................................... 12
Figure 2: Front side of device ................................................................... 28
Figure 3: Rear of device ........................................................................... 28
Figure 4: Left device side.......................................................................... 28
Figure 5: Bottom of device....................................................................... 29
Figure 6: Top of device............................................................................. 29
Figure 7: Setting up the device................................................................. 34
Figure 8: Assembling the power supply unit and power supply unit holder 35
Figure 9: Mains connection via power supply unit..................................... 36
Figure 10: Start screen ............................................................................... 37
Figure 11: System setup, non-invasive ventilation with vented mask............ 41
Figure 12: System setup, non-invasive ventilation with non-vented mask..... 41
Figure 13: System setup, invasive ventilation with external humidifier.......... 43
Figure 14: System setup, invasive ventilation with HME filter....................... 44
Figure 15: Inserting the SD card ................................................................. 47
Figure 16: Removing SD card ..................................................................... 48
Figure 17: Functional bag........................................................................... 49
Figure 18: Home screen ............................................................................. 56
Figure 19: Measurement screen, factory setting.......................................... 58
Figure 20: Graph screen............................................................................. 58
Figure 21: Parameter screen....................................................................... 59
Figure 22: Event log screen (alarms) ........................................................... 61
Figure 23: Event log screen (events)............................................................ 61
Figure 24: System screen............................................................................ 62
Figure 25: Statistics screen ......................................................................... 64
Figure 26: Alarm displays on the toolbar .................................................... 67
Figure 27: Alarm output on the toolbar...................................................... 68
Figure 28: Messages on the toolbar ........................................................... 74
Figure 29: Filter cassette structure .............................................................. 79
Figure 30: Error list .................................................................................... 87

Chapter 1: Introduction 9
Chapter 1
Introduction
Please note: This user’s manual for patients is included in the scope of delivery. It does
not replace the user’s manual for physicians and medical professionals.

10 Chapter 1: Introduction
Scope of delivery
Figure Name
FiO
2
LAVI ventilator
Softkeys
The softkeys can be assigned
different functions:
Alarm key
•Confirmation of all current
alarms and no longer
active alarms
•Muting of alarm for
•Cancel alarm sound
suppression
Escape key
•Exit current screen or
selected parameter
•Cancel action
Heater key
Switch the heater of the
plug-in humidifier on and off
Return to Home screen
Unlocking key
Disconnect Aqua-
TREND uni from LAVI
for device types 9LV401 and 9LV402 as of device
software 1.300
LAVI Brief instruction
Operator controls
Info LED
HIGH MEDIUM LOW
Multifunction knob MFK
•Navigate in the menus
•Set parameters
•Other actions
on/off key
•Start ventilation: press briefly
•Stop ventilation: press briefly + MFK
•Switch device on: Press ≥ 4 s
•Switch device off: Press ≥ 4 s
PCV
Set1 75%
50
40
30
20
10
0
p
19.8
hPa f
12
bpm VI
0.570
lI:E
1:1.5
Set3Set 2
Mode
IPAP
PEEP
Frequency
TimeInspiration
I-Slope
E-Slope
PCV
20.0hPa
5.0hPa
12bpm
2.0s
3
3
Set1
Device is powering
up or is running on
line power
Brief instructions
Mains cable
Ventilateur pulmonaire
User´s manual
for patients
for device types 9LV401 and 9LV402 as of device software x.xxx
User’s manual for patients
Internal battery RRC2054
(Only LAVI 40) Final inspection log
Carrying case
Spare filter cassette, com-
plete (open) with filters
Switched-mode power
supply
FSP090-RACM1
Spare course filter,
1 pack (2 units)
Power supply unit
holder with integrated
strain relief
Spare fine filter,
1 pack (5 units)
Leakage tube circuit
(L = 180 cm, ∅22 mm)
Straight O2connec-
tion adapter

Chapter 1: Introduction 11
Symbols
Symbols on the packaging
Symbol Meaning
European Article Number
Article number
Serial number
CE mark and number from the notified body. The medical device complies
with the applicable regulations of EU 93/42/EEC for medical products.
Transport and store package with arrows pointing up at all times.
Fragile contents
Protect from moisture!
5
90
Humidity range during storage and transport
250 hPa
1100 hPa
Air pressure range during storage and transport
-20°C
+50°C
Temperature range during storage and transport
HANDLE
WITH CARE
IF DAMAGED
KEEP
UPRIGHT
LITHIUM ION RECHARGEABLE
BATTERIES INSIDE
(No lithium metal)
Do not damage or mishandle this package. If package
is damaged, batteries must be quarantined, inspected
and repacked. For additional emergency information call:
 [phone]
ENTHÄLT WIEDERAUFLADBARE
LITHIUM-IONEN BATTERIEN
(Kein Lithium-Metall)
Vorsichtig behandeln! Bei Beschädigungen der Ver-
packung müssen die Batterien ausgesondert, überprüft
und neu verpackt werden! Informationen für den Notfall:
 [phone]
CAUTION
VORSICHT
IF DAMAGED
For more information, call [phone]
Lithium-ion Batteries
DO NOT LOAD OR TRANSPORT
PACKAGE IF DAMAGED
CAUTION!
CAUTION! Device contains lithium-ion batteries

12 Chapter 1: Introduction
Symbols on the rating plate
The rating plate is on the bottom of the device.
Figure 1:
SN: CEA1700011
LAVI 40 Ventilator
Type: 9LV402
IP22
Made in Germany
HOFFRICHTER GmbH
Mettenheimer Str. 12/14
19061 Schwerin
GERMANY
O2-INPUT
max. 15l/min
500 hPa
Li-Ion RRC2054
15V / 3.2Ah / 48Wh
DC-INPUT
24V max. 3.75A
Rating plate
Symbol Meaning
Follow the instructions in the user’s manual.
Protection class II (protective insulation)
BF application part
IP22 Protection against:
•solid foreign objects with diameters from 12.5 mm
•access to hazardous parts with a finger
•falling/dripping water, as long as the housing is tilted up to 15°
Serial number
CE mark and number from the notified body. The medical device complies
with the applicable regulations of EU 93/42/EEC for medical products.
Manufacturer
Do not dispose of the device with the household waste. Please contact the
relevant customer services department to find out how to properly dispose
of the device.

Chapter 1: Introduction 13
Symbols on the device
Symbol Meaning
Housing
Follow the instructions in the user’s manual.
Connections
FiO2FiO2sensor connection
DC
DC connection
COM COM interface
Connection of remote alarm/nurse call
(ESD-sensitive component – do not touch!)
USB interface
O
2Oxygen connection
Control
Release button for the integrable humidifier
On/off button

14 Chapter 1: Introduction
Symbols used in this user’s manual
Important information is denoted by symbols in this user’s manual. Please ensure that
you follow these instructions in order to prevent accidents, personal injury and mate-
rial 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 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
moderate injuries.
This symbol denotes situations that may lead to material dam-
age or damage to the device.
Please note:
Notes provide tips and information for the ecient, correct
use of the device.

Chapter 1: Introduction 15
Intended purpose
The LAVI ventilator device may only be used for non-life-supporting respiration. It serves
as intermittent respiration support as well as to provide respiration to patients with
insucient spontaneous breathing ability. The device is suitable for adults and chil-
dren from a tidal volume of 100 ml and higher and is designed for home care and/or
use in professional health care facilities. It must not be used for intensive ventilation.
LAVI is not intended for use in vehicles, planes or helicopters.
Description of function
The blower sucks in the ambient air via a filter and transports it to the patient at a set
pressure via a leakage tube circuit (with passive exhalation valve). Ventilation can be
invasive (e.g. using a tracheostoma) or non-invasive (using a mask).
Ventilation is carried out according to ventilation parameters set using the control ele-
ments. Ventilation can be monitored based on measurements and graphs on the display.
In case the custom and permanent alarm parameters are violated, visual and acoustic
alarms are emitted. If the prescribed ventilation is no longer possible due to a techni-
cal error, an acoustic alarm is emitted for at least 2 minutes.
If LAVI is operated with an internal battery, ventilation can continue on without dis-
ruption in the event of a power failure.
LAVI can be connected to a low-pressure source of oxygen for ventilation with increased
oxygen concentration. When oxygen is introduced but ventilation is not started, the
oxygen supply is interrupted by a safety valve. Remaining oxygen can be released from
the device via the oxygen outlet.
It is also possible to combine LAVI with the integrable humidifier “AquaTREND uni” or
an external humidifier.
Therapy and statistical data, including alarms and events, can be copied onto an SD
card and analysed using the PC software “easySET”.
For service purposes, LAVI features one USB and one COM interface.

16 Chapter 1: Introduction
Indication
LAVI 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. paralysis of the diaphragm)
•Central breathing regulation disorders
Regardless of the indications named here, use of the device always depends on the
doctor’s individual diagnosis.
Contraindications
Risk of injury due to contraindications!
Ventilation may be contraindicated for certain pre-existing
conditions.
The following conditions may be a contraindication for non-invasive ventilation:
•Severe cardiac arrhythmia
•Severe hypotension
•Severe epistaxis
•Pneumothorax or pneumomediastinum
•Pneumoencephalus
•Cranial trauma
•Status after cranial or brain surgery
•Acute inflammation of the paranasal sinuses, middle ear infection or a perforated
ear drum
•Aspiration hazard
In individual cases, the attending physician must decide on the therapy.

Chapter 1: Introduction 17
Side effects
The following undesired side effects may occur in connection with artificial respiration:
Invasive ventilation:
•Complications due to tube / tracheal cannula
•Gastric inflation
Mask ventilation:
•Pressure points and skin defects in the face
•Eye irritation due to leaks
•Gastric inflation
•Aspiration
•Sinusitis
•Nose bleeds
General complications of mechanical ventilation:
•Pulmonary barotrauma / volutrauma caused by ventilation
•Ventilator-associated pneumonia
•Effects on the cardio-vascular system
User qualification
The respiration and alarm parameters may only be set by trained specialist personnel
under the supervision of a doctor. Care staff and patients have been instructed on how
to use and handle the device. These people must be familiarised with operation of the
device and must have read all of and understood this user’s manual before commis-
sioning the device. In addition, the operator must inform the users of what accesso-
ries are compatible with the device.
Maintenance and repairs may only be performed by trained and authorised service
companies.

18 Chapter 1: Introduction

Chapter 2: Safety warnings 19
Chapter 2
Safety Information
Please note: Heed all important information in this user’s manual. Otherwise, there
is a risk of accidents, injury and material damage.

20 Chapter 2: Safety warnings
General safety instructions
Risk of infection due to germs!
Hygienically preparing and cleaning the device must be per-
formed according to this user’s manual and the applicable
regulations of the hospital or nursing home.
Risk of injury due to incorrect device settings!
• Only qualified, trained, specialist medical staff under the
supervision of a physician may make adjustments to the
ventilator.
Risk of injury due to incorrect accessories!
Manufacturer tested and approved accessories are recom-
mended for the device. If other accessories are used, this may
lead to insucient ventilation or the use of hazardous mate-
rials may lead to further, secondary complications.
• Please read first this user’s manual carefully and in its entirety before first using
the ventilator.
• Keep the instructions in close proximity to the device for immediate reference if
necessary.
•In case of problems, unexpected events or unusual device behaviour (e.g. during
commissioning, use or maintenance), inform the device operator immediately and
document the incidents. You will generally find the operator contact data on the
device as well as in the medical device book.
• The device must only be used by persons who have fully read and understood
this user’s manual before commissioning and have familiarised themselves with
the device. Disregarding these instructions can lead to life-threatening situations
for the patient.
• In cases of emergency, an alternative ventilation option, such as a second ventilator
or an emergency ventilation bag, must be available at all times and for use by
the attending person.
• The device must only be used on the responsibility and prescription of the physician.
•The device must only be used on patients whose clinical record indicate it.
•LAVI is not intended for use in vehicles, planes or helicopters.
• Please take the care to ensure that the patient remains connected to the tubing
circuit during ventilation.
• The device must not be used with flammable anaesthetics or ambient air that
contains explosive gases. This may cause fires or explosions.
•Before being used again on another patient, all parts that come into contact with
respiratory gas must be treated hygienically.
•Equipment that is not part of the ventilation system must not be connected.