Hoffrichter CARAT II pro User manual

User’s manual
for physicians and medical professionals
as of device software 3.300
CARAT II pro
Ventilator
Device type 9LV203
HOFFRICHTER GmbH
Mettenheimer Straße 12/14
19061 Schwerin
Germany
Telephone: [phone]
Fax: [phone]
Email: [e-mail]
www.hoffrichter.de
CARAT II pro Klinik ENG_2019-11-22_12.0
User’s manual CARAT II pro for physicians and medical professionals
50000625

3
CARAT II pro
User's manual
for physicians and medical professionals
©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 exploita-
tion, 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 CARAT II pro in addition to this user's
manual:
• User's manual for CARAT II pro for patients
• Brief instructions for CARAT II pro
• Service manual
• Hygiene concept
• Maintenance plan

4
Please read rst this user's manual carefully and in its entirety before rst
using the ventilator.
In particular, follow all safety and cleaning instructions.
Keep the instructions in close proximity to the device for immediate re-
ference if necessary.
Every HOFFRICHTER GmbH device is supplied with a serial number for tracea-
bility purposes.
Please enter your device’s serial number here. You will nd the serial number on
the rating plate on the bottom of the device.
.............................................
Please always quote the serial number for all queries and complaints.
CE mark and number of the notied body. The medical device complies with the
relevant requirements of the EU Directive 93/42/EEC for medical devices.

Table of contents 5
TABLE OF CONTENTS
CHAPTER 1 ............................................................................ 11
INTRODUCTION...........................................................................................11
Scope of delivery ...........................................................................................12
Symbols ........................................................................................................14
Intended purpose...........................................................................................19
User qualications..........................................................................................21
CHAPTER 2 ............................................................................ 23
SAFETY INFORMATION ...............................................................................23
General safety instructions .............................................................................24
Electrical safety..............................................................................................26
Installation requirements and transport ...........................................................27
Instructions before commissioning .................................................................29
Using of oxygen .............................................................................................29
Integration into IT networks ............................................................................30
Safety-related test..........................................................................................30
CHAPTER 3 ............................................................................ 31
DESCRIPTION OF DEVICE ..........................................................................31
Front side connecting points ..........................................................................32
Rear side connecting points...........................................................................33
Control elements............................................................................................35
LED displays..................................................................................................37
Movable and removable housing parts ...........................................................39
CHAPTER 4 ............................................................................ 41
COMMISSIONING ........................................................................................41
Setting up the device .....................................................................................42
Power supply.................................................................................................42
Connecting the tube circuit ............................................................................49
Setting an alarm to detect disconnection of the tube system ..........................55
Calibrating the tube circuit..............................................................................56
Connecting the alarm box or the nurse call.....................................................59
SpO2sensor connection ................................................................................60
Inserting the SD card .....................................................................................61
Removing the SD card safely .........................................................................62
Connecting a PC ...........................................................................................64

6Table of contents
Using oxygen.................................................................................................65
Determining oxygen concentration .................................................................71
Using the functional bag.................................................................................73
Switching the device on .................................................................................74
Switching the device off .................................................................................74
CHAPTER 5 ............................................................................ 75
VENTILATION MODES .................................................................................75
PCV mode ....................................................................................................76
APCV mode...................................................................................................78
PSV mode .....................................................................................................80
PSV-S mode ..................................................................................................82
P-SIMV mode ................................................................................................84
VCV mode .....................................................................................................86
AVCV mode ...................................................................................................88
V-SIMV mode.................................................................................................90
CPAP mode...................................................................................................92
Overview of ventilation modes ........................................................................93
Ventilation parameters pescription..................................................................95
Description of alarm parameters...................................................................103
CHAPTER 6 .......................................................................... 107
DEVICE OPERATION..................................................................................107
Key lock.......................................................................................................107
User proles.................................................................................................107
Menu structure ............................................................................................109
Basic operation............................................................................................109
Basic screen layout......................................................................................112
Explanation of toolbar icons .........................................................................113
Enabling a screen ........................................................................................115
Monitoring ...................................................................................................117
To change ventilator and alarm parameters ..................................................126
Activating a ventilation set ............................................................................129
Changing a ventilation mode during ventilation .............................................131
Display of stored alarms...............................................................................132
System settings ...........................................................................................133
Statistics......................................................................................................142
NIGHT SCREEN ..........................................................................................145
Starting ventilation .......................................................................................147
Stopping ventilation .....................................................................................147

Table of contents 7
CHAPTER 7 .......................................................................... 149
ALARMS AND MESSAGES ........................................................................149
General information......................................................................................150
Alarm sound test..........................................................................................150
Audible alarm output (audio alarms)..............................................................151
Visible alarm output .....................................................................................152
Alarm log .....................................................................................................154
Forwarding alarms .......................................................................................154
Alarm overview ............................................................................................155
Messages ....................................................................................................160
CHAPTER 8 .......................................................................... 161
CLEANING AND DISINFECTION................................................................161
Overview......................................................................................................162
Cleaning the device......................................................................................164
Cleaning the tube circuit...............................................................................164
Cleaning the mask .......................................................................................164
Cleaning the headgear .................................................................................165
Cleaning / Replacing the lter........................................................................165
Using the device for more than one patient...................................................167
CHAPTER 9 .......................................................................... 169
ROUTINE CHECKS AND MAINTENANCE WORK......................................169
Overview......................................................................................................170
Safety-related test (SRT) ..............................................................................171
Replacing the valve membrane (expiration) ...................................................172
Battery maintenance ....................................................................................173
CHAPTER 10 ........................................................................ 175
APPENDIX..................................................................................................175
Instructions for ventilation outSIde of a clinical setting...................................176
Technical specications for the device ..........................................................176
Data management .......................................................................................179
Error messages............................................................................................180
Technical data..............................................................................................182
Settings ranges and control accuracy...........................................................185
Factory settings ...........................................................................................188
Replacement parts and accessories.............................................................192
Manufacturer’s declaration on electromagnetic compatibility .........................198
Disposal.......................................................................................................201
Disclaimer....................................................................................................202

8List of gures
LIST OF FIGURES
Figure 1: Rating plate..................................................................................15
Figure 2: Connections at the front side of the device ...................................32
Figure 3: Connections at the rear side of the device ....................................33
Figure 4: Control elements..........................................................................35
Figure 5: LED displays ................................................................................37
Figure 6: Left device side ............................................................................39
Figure 7: Right device side..........................................................................39
Figure 8: Setting up the device....................................................................42
Figure 9: Mains connection via power supply unit........................................43
Figure 10: Start screen .................................................................................44
Figure 11: Standby screen............................................................................44
Figure 12: AKKUPACK uni BASE (right) / AKKUPACK uni PLUS (left) .............47
Figure 13: Connecting AKKUPACK uni BASE................................................48
Figure 14: Connecting a single line patient circuit with pressure measur-
ing tube .......................................................................................50
Figure 15: Connecting a single line patient circuit without pressure measur-
ing tube .......................................................................................50
Figure 16: Connecting a double line patient circuit with pressure measur-
ing tube .......................................................................................51
Figure 17: Connecting a double line patient circuit with pressure measur-
ing tube .......................................................................................51
Figure 18: Connecting the humidier - single line patient circuit .....................52
Figure 19: Connecting the humidier - double line patient circuit....................53
Figure 20: Using HME lter - double line patient circuit with pressure measur-
ing tube .......................................................................................54
Figure 21: "Measurement without pressure tube" message box.....................58
Figure 22: Connecting alarm box ..................................................................59
Figure 23: Connecting the SpO2sensor ........................................................60
Figure 24: Inserting SD card .........................................................................61
Figure 25: Removing the SD card safely........................................................62
Figure 26: Removing SD card .......................................................................63
Figure 27: Connecting a PC..........................................................................64
Figure 28: Connecting the oxygen source (rear of unit) ..................................65
Figure 29: Connecting the FiO2sensor (single line patient circuit example).....69
Figure 30: Functional Bag .............................................................................73
Figure 31: Switching on the device ...............................................................74
Figure 32: Switching off the device................................................................74
Figure 33: Ventilation modes overview..........................................................75
Figure 34: PCV mode diagram......................................................................77
Figure 35: APCV mode diagram....................................................................79
Figure 36: PSV mode diagram ......................................................................81

List of gures 9
Figure 37: PSV-S mode diagram...................................................................83
Figure 38: P-SIMV mode diagram .................................................................85
Figure 39: VCV mode diagram ......................................................................87
Figure 40: AVCV mode diagram ...................................................................89
Figure 41: V-SIMV mode diagram .................................................................91
Figure 42: CPAP mode diagram....................................................................92
Figure 43: Flow trigger (setting a percentage value) .......................................99
Figure 44: Inspiration trigger without SMART Function ................................100
Figure 45: Inspiration trigger using SMART Function ...................................101
Figure 46: User prole in the toolbar............................................................107
Figure 47: Basic screen layout ....................................................................112
Figure 48: Home screen .............................................................................115
Figure 49: Monitoring screen (data), factory setting .....................................118
Figure 50: Monitoring screen (graphs) .........................................................120
Figure 51: Monitoring screen (change the parameters) ................................121
Figure 52: Monitoring screen (freeze graphs) ...............................................122
Figure 53: Flow-Volume-Loop .....................................................................123
Figure 54: Volume-Pressure-Loop...............................................................123
Figure 55: Flow-Volume-Loop .....................................................................124
Figure 56: Monitoring screen (change the loop) ...........................................125
Figure 57: Parameter screen.......................................................................126
Figure 58: Parameter screen ......................................................................129
Figure 59: Alarm log screen ........................................................................132
Figure 60: System screen ...........................................................................134
Figure 61: Circuit conguration tightness check single line patient circuit .....139
Figure 62: Circuit conguration tightness check double line patient circuit ...139
Figure 63: Statistics screen (1 ventilation parameter) ...................................143
Figure 64: Statistics screen (2 ventilation parameter) ...................................144
Figure 65: "Measurements" night screen.....................................................145
Figure 66: "Light" night screen (with moon) .................................................145
Figure 67: "Dark" night screen (without moon).............................................145
Figure 68: Stop ventilation ..........................................................................147
Figure 69: Alarm displays in the toolbar.......................................................151
Figure 70: Alarm output in the toolbar .........................................................153
Figure 71: Alarm output in the textbox ........................................................153
Figure 72: Alarm box ..................................................................................154
Figure 73: Messages in the toolbar .............................................................160
Figure 74: Filter cassette structure ..............................................................165
Figure 75: Replacing valve membrane (expiration) .......................................172
Figure 76: Block diagram for the device ......................................................177
Figure 77: Pneumatic block diagram ...........................................................178

10 List of tables
LIST OF TABLES
Table 1: Operating time with battery power and factory default settings ........45
Table 2: Alarms for detecting a disconnection...............................................55
Table 3: Overview of the ventilation and alarm parameter (adjustable)............93
Table 4: Pressure increase times of the ramp................................................97
Table 5: Thresholds inspiratory trigger...........................................................98
Table 6: System Settings- Overview............................................................133
Table 7: Adjustable alarms..........................................................................155
Table 8: Fixed Alarms .................................................................................157
Table 9: Messages .....................................................................................160
Table 10: Cleaning intervals - overview .........................................................162
Table 11: Service intervals - overview ...........................................................170
Table 12: Data management.........................................................................179
Table 13: Error messages during operation and at device start-up ................180
Table 14: Setting ranges and control accuracy of ventilation parameters .......185
Table 15: Setting ranges and control accuracy of alarm parameters ..............186
Table 16: Factory settings of ventilation parameter........................................188
Table 17: Factory settings of alarm parameter...............................................189
Table 18: Factory settings of device parameters ...........................................190

Chapter 1: Introduction 11
CHAPTER 1
INTRODUCTION
This chapter contains general information on the use and operation of the ventilator.

12 Chapter 1: Introduction
SCOPE OF DELIVERY
Illustration Name
CARAT II pro Ventilator
Switched-mode power supply
Mains cable
Disposable double line patient circuit for adults
with pressure measuring tube
(L = 180 cm, ∅22 mm)
Adapter for bacterial lter
SD card
Straight FiO2 connection adapter
Carrying case

Chapter 1: Introduction 13
Illustration Name
Spare lter cassette, complete (open) with lters
Spare coarse lter, 1 pack (2 ea)
Spare ne lter, 1 pack (5 ea)
User's manual for the patient
Brief instructions
Final inspection certicate

14 Chapter 1: Introduction
SYMBOLS
PACKAGING SYMBOLS
Symbol Meaning
European Article Number
Article number
Serial number
CE mark and number of the notied body. The medical device com-
plies with the relevant requirements of the EU Directive 93/42/EEC for
medical devices.
Transport and store package with arrows pointing up at all times
Fragile contents
Protect from moisture!
5
95
Humidity range during storage and transport
250 hPa
1100 hPa
Air pressure range during storage and transport
-20°C
+55°C
Temperature range for storage and transport up to 1 month
-20°C
+45°C
Temperature range for storage and transport up to 6 months
-20°C
+35°C
Temperature range for storage and transport longer than 6 months
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

Chapter 1: Introduction 15
SYMBOLS ON THE RATING PLATE
The rating plate is on the back of the device
Figure 1:
SN
EAG1300001
IP22
CARAT II pro
Ventilator Type: 9LV203
Quality makes the Difference
Li-Ion ICR 18650
14.8V; 4400mAh; 65.12Wh
DC-INPUT O2-INPUT
24V
12V
max. 5A max. 15l/min
1000 hPamax. 10A
Rating plate
Symbol Meaning
Protection class II (protective insulation)
BF application part
IP22 Protect against:
• solid foreign objects with diameters from 12.5 mm
• access to hazardous parts with a nger
• falling / dripping water, as long as the housing is tilted
up to15°
Serial number
CE mark and number of the notied body. The medical device com-
plies 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 nd out how to properly
dispose of the device.

16 Chapter 1: Introduction
SYMBOLS ON THE DEVICE
Symbol Meaning
General
Follow the user's manual.
Connecting points
Inspiration tube connection
Expiration tube connection
Control tube connection
Pressure measuring tube connection
FiO2 sensor connection
DC DC connection
SpO2SpO2 sensor connection
Com Com-interface
Remote alarm/nurse call connection
USB interface
O2O2connection

Chapter 1: Introduction 17
Symbol Meaning
O2O2output
SD card slot
Operation
Alarm key
ON/OFF key
Safe key
Home key
Escape key
LEDs
Alarm LED
Mains LED
Battery LED

18 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 avoid accidents, personal injury and
material 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 injuries
or death.
This symbol denotes hazardous situations that may lead to light or 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 efcient, cor-
rect use of the device.

Chapter 1: Introduction 19
INTENDED PURPOSE
The CARAT II pro ventilator may be used for life-sustaining ventilation and, when
using a two-tube system, provides continuous respiratory support and ventilation
of patients without spontaneous respiration.
When using a single-tube system, the CARAT II pro may only be used for non-life-
sustaining ventilation and provides intermittent respiratory support and ventilation of
patients who demonstrate sufcient spontaneous breathing.
The device is suitable for adults and children from a tidal volume of 50 ml and higher
and can be used in home health care and/or in professional healthcare facilities.
It must not be used for intensive care ventilation.
The CARAT II pro is not suitable for use in vehicles, airplanes and helicopters.
FUNCTION DESCRIPTION
The blower sucks in the ambient air via a lter and conveys it at the set pressure
via a single line patient circuit with exhalation valve or with a double line patient
circuit to the patient. The ventilation can be invasive (e.g. via a tracheostomy) or
non-invasive (via a mask).
Ventilation is based on ventilation parameters which are set using the controls.
Ventilation can be monitored on the display using the measurements and graphs.
If the alarm parameters which have been set and stored in the device are breached,
visual and acoustic alarms are emitted. If the prescribed ventilation is no longer
possible due to a technical error, an alarm will sound for at least 2 minutes.
If the CARAT II pro is operated with an internal battery, it can continue to be
operated without any interruption in the event of a power failure.
For ventilation with an increased oxygen concentration, the CARAT II pro can
be connected to a low-pressure oxygen source. If oxygen is introduced and the
ventilation is not running, the oxygen supply is interrupted by a safety valve. Residual
oxygen can escape from the device via the oxygen outlet.
Furthermore, it is also possible to combine the CARAT II pro with an external
humidier.
The therapy and statistic data can be evaluated with the PC software "easySET".
The CARAT II pro has a USB port and a COM port for service purposes.

20 Chapter 1: Introduction
INDICATION
The CARAT II pro 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
Irrespective of the indications listed here, the device must always be used in
accordance with the physician's individual diagnosis.
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 inammation of the paranasal sinuses, middle ear infection or a perfo-
rated ear drum
• Aspiration hazard
In individual cases, the attending physician must decide on the therapy.