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CARAT PRO

USER TRAINING

Trainer Willi Schmied-Wellnitz

Location Germany

Date June 17th 2020

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 1 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 2 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 3 |


Intended use

■ CARAT II pro may be used for life-sustaining ventilation and, when using a double-tube system, provides
continuous respiratory support and ventilation of patients without spontaneous respiration.
■ When using single-tube system, CARAT II pro may only be used for non-life sustaining ventilation and
provides intermittent respiratory support and ventilation of patients who demonstrate sufficient
spontaneous breathing.
■ Adults and children with a tidal volume of 50 ml and or more.
■ Can be used in home care, clinic and professional healthcare facilities.
■ CARAT pro has both pressure- and volume-controlled ventilation modes. Ventilation can be invasive (e.g.
tracheostoma) or non-invasive (mask)
■ CARAT II pro is technical able to run with a single line circuit with exhalation valve or with a double line
circuit.
■ Device can be connected to a low-pressure
source of oxygen, CARAT pro can be
combined with an external
humidifier.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 4 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 5 |


Safety information

■ 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.
■ For patients who are unable to breathe independently or are completely dependent on the ventilation
system, additional monitoring depending on and adapted to the disability is recommended.
■ When a nasal or full face mask is used for noninvasive ventilation, this mask must not contain any
expiration opening.
■ If used with a single line patient circuit, the controlled expiration valve must not meet any resistance during
exhalation and must allow quick ventilation of the ventilation tube system.
■ An malfunctioning device can endanger the patient or operator. Should the appliance not start properly, or
if the device's automatically carried out self-tests should fail, you must stop operating the device. In such
cases, the service provider must be informed.
■ The oxygen supplied must not exceed a pressure of 1000 hPa and a flow of 15 l/min. The oxygen must be
dosed using an external flow meter. When supplying oxygen, please ensure that only dry gas (FiO2) is used.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 6 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 7 |


Indications

■ The CARAT 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.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 8 |


Contraindications

■ 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

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 9 |


Side effects

The following undesired side effects may occur in connection with ventilation:

Invasive Ventilation: Mask Ventilation:


■ Complications due to tube / tracheal cannula ■ Pressure points and skin defects in the face
■ Gastric inflation
■ Eye irritation due to leaks
■ Aspiration
■ Sinusitis
■ Nose bleeds
■ Gastric inflation
General complications of mechanical ventilation:
■ Pulmonary barotrauma / volutrauma caused
by ventilation
■ Ventilator-associated pneumonia
■ Effects on the cardiovascular system

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 10 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 11 |


Description of device

Front of the device


■ Tube circuit – inspiration
for inspiratory line of circuit with
22 mm outer diameter connection
■ Pressure measuring tube
for proximal pressure measurement, optional!
for tube with 3.5 mm inner diameter

■ FiO2 sensor cable


Connect the FiO2 sensor cable here, for measuring
the oxygen concentration of the inspiratory flow
■ Tube circuit – expiration
for expiratory line of circuit with
22 mm inner diameter connection
■ Valve control tube
for expiratory valve line, for tube with 4.5 mm ID
(only single tube systems)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 12 |


Description of device

Front of the device

ON/OFF-Key

Function Action

Start ventilation Press briefly

Stop ventilation Press briefly and confirm with MFK

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 13 |


Description of device

Front of the device

Alarm-key

Function Condition Action

Confirm all current alarms Active alarms Press briefly

Confirm no longer active alarms Stored alarms press briefly

Mute the audible alarm for 2 min


Active alarms Press briefly
(audio alarm pause)

Cancel the audible alarm


Audio alarm paused Press briefly
suppression

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 14 |


Description of device

Front of the device

Multifunctional key MFK

Function Action

Select another parameter Turn

Turn
Set parameters

Press briefly
Confirm parameter selection

Press briefly
Confirm modified parameter value

Open adjustment window for graphs and loops in the Press briefly
monitoring screen

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 15 |


Description of device

Front of the device

Safe-key

Function Action

Activate key lock Press briefly and confirm with MFK

Deactivate key lock Press briefly and confirm with MFK

Home-key

Function Action

Return to the home screen Press briefly

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 16 |


Description of device

Front of the device

Escape-Key

Function Action

Exit the current screen Press briefly

Leave selected parameter Press briefly

Cancel Press briefly

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 17 |


Description of device

Front of the device

Battery-LED

Colour Status (light) Battery charge state

Green Glows steadily ≥ 60 %

Yellow Glows steadily ≥ 20 % ... < 60 %

Red Glows steadily ≥ 0 % ... < 20 %

White Glows steadily Device booting

White Flashes Device shutting down

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 18 |


Description of device

Front of the device

Power-LED

Colour Status (light) Status

Green Glows steadily Mains operation

Yellow Glows steadily Unacknowledged power failure

White Glows steadily Device boots

White Flashes Device shuts down

Confirmed AC power failure or no mains


None Off
voltage / battery power

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 19 |


Description of device

Front of the device

Alarm-LED

Colour Status (light) Priority/ Status

Red Flashes HIGH

Yellow Flashes MEDIUM

Turquoise Glows steadily LOW

White Glows steadily Device boots

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 20 |


Description of device

Back of the device

Main power switch

Position Action

Without power supply:


booting, user interface appears
Position I
With power supply:
stand-by mode off, user interface appears

Without power supply:


shutting down
Position O
With power supply:
user interface off, stand-by mode on

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 21 |


Description of device

Back of the device

DC connection
The power supply plug is connected here.

Connection of SpO2 sensor


A SpO2 and pulse rate sensor can be connected here.

O2 connection
During oxygen input the oxygen source is connected here. Use
the supplied oxygen connection adaptor for this purpose.

SD card slot
An SD card here can be inserted here

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 22 |


Description of device

Data Storage

Data and Parameters Device Memory SD-Card

Alarms and events with date and time Yes Yes


approx. 15.000 entries approx. 150.000 entries

Statistics Yes No

Device settings and counter Yes No

Update files No Yes

Initialization files No Yes

Measurement parameter (Pressure/ No Yes


volume/ flow/ FiO2) approx. 50 days
data recording rate of 20 values per second

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 23 |


Description of device

Back of the device

O2 output

Oxygen monitoring:
Exit for oxygen from the oxygen valve when ventilation has
been turned off.

Pressure monitoring:
Excess oxygen pressure is exhausted here during oxygen
therapy.

Pressure ventilation:
Opens when the pressure is more than 1 hPa above the set
ventilation pressure setting.

Volume ventilation:
The valve also opens when the measured breathing volume is
more than 10% higher than the set value.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 24 |


Description of device

Back of the device

RS232 interface (service interface)


Accessories connection

Connection of remote alarm/nurse call


An alarm box (optional accessory) or a nurse call system can be
connected here.

USB interface (Connection of PC)


A PC can be connected here with a USB cable (optional
accessory).
To communicate with the device, the PC software “easySET"
must be installed on the PC.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 25 |


Description of device

Left and right Side of device

Filter cassette
The filter cassette contains the two air filters
(coarse and fine filter).
For information on how to replace and clean the filter.
Handle (pull-out)
The handle may be pulled out for device transport.

Bottom flap
Valve membrane (expiration) is located under the bottom flap.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 26 |


Description of Device

Meaning of the icons in the icon bar

Icon Meaning Icon Meaning

Clinic mode active Trigger lock "On„ / momentarily active

Home mode active internal FiO2-Monitoring

Alarm active external FiO2-Monitoring

Audio Alarm paused SD card is located in the device

Counter for paused alarm SpO2 sensor connected

PC connected via the Micro USB port Charge state of internal battery

Key lock activated Error detected

Spontaneous breathing detected Switching on night screen

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 27 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 28 |


Commissioning

Power supply
■ The ventilator may be supplied by three different power sources.
● Mains connection, via switched-mode power supply unit

● Internal battery
● External battery pack uni BASE and uni PLUS (optional accessory)

■ Ventilator automatically detects which power sources are available.


■ If connected to an external power source (power supply or external battery pack), this source is used first
then switch to the internal battery as needed.
■ In each case, the used power source being drawn on will be indicated by the power LED or battery LED

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 29 |


Commissioning

Mains operation
■ The device can remain permanently on the mains without any harm.
■ Internal battery is charged as soon as the power supply is plugged in.
■ Device boots up and performs the following hardware tests:
● Testing all 3 LEDs (white) during start-up.

● Testing of primary and secondary alarms, testing of other hardware

● Display of detected error, every error must be confirmed by pressing the MFK
● Error message "System locked": Serious fault detected, device can not be put into service, service required.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 30 |


Commissioning

Booting and stand-by mode


■ The device boots and performs the following hardware tests:
● Testing the primary and secondary alarm sounds:
Both alarm sounds give a short beep one-by-one.

● Checking of other hardware components.

■ If errors are detected during the hardware test, they will be


displayed at the bottom left of the screen.
■ If no errors were detected during the hardware test or the
errors have been confirmed, the display will switch to the
stand-by screen.
● The current level of battery charge will be displayed on the
stand-by screen

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 31 |


Commissioning

Operating with internal battery


■ with fully charged battery the device can be operated up to 4 hours (default settings).
■ Internal battery must enables operation of at least 1 hour at maximum power consumption. Information
about battery charge level is indicated by LED and when touching the battery icon.
■ Full recharging takes approximately 3.5 hours. Device is fully functional during recharging.
■ When switched on without having mains power supply, an alarm will sound and alarm message "Battery
Operation" will appear, and the alarm LED will flash yellow, battery LED glows.
■ If the power supply is interrupted by power failure, the device is supplied with power via the internal
battery.
■ Power failure and thus the switch to the internal battery is indicated by an alarm sound, as well as by
message "Power Failure".
■ In addition, alarm LED flashes yellow and power LED glows yellow.
Battery LED glows according to the state of charge.
■ When power supply returns, the device is supplied with power
from mains supply, the internal battery is charged, the power
LED glows green again.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 32 |


Commissioning

Operating with external battery


■ For independent operation of the electricity network.
■ The AKKUPACK uni is optionally available as an accessory.
■ Power the AKKUPACK uni by using the power supply of the ventilator.
■ When ACKUPACK uni is connected to the ventilator, the power LED is green.
■ Operation with batteries:
● with internal battery: approx. 4h
● with internal battery & uni BASE: approx. 12h

● with internal battery & uni BASE & uni PLUS: approx. 20h

Note:
For further information on connecting and
handling the device, please refer to the
AKKUPACK uni BASE user’s manual.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 33 |


Commissioning

Connecting a single limb circuit


■ Connecting a single limb patient circuit
■ using proximal pressure measurement is optional

A patient connector B expiration valve C inspiration tube D bacterial filter

E adaptor for bac. filter F pressure measuring tube G valve control tube H air outlet

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 34 |


Commissioning

Connecting a humidifier with single tube system


■ Heated moistener is integrated in the Inspiration branch and should be positioned below the patient and
the device, so that no water flows into the patient's lungs or into the device.

Note:
When using bacterial filters
(recommended) follow the
manufacturer's instructions!

A patient connector B proximal pressure tube C inspiratory tube D bacterial filter

E adaptor for bac. filter F inspiration tube G valve control tube H external humidifier

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 35 |


Commissioning

Connecting a double limb circuit


■ Connecting a double limb patient circuit with proximal pressure measurement

A patient connector B proximal pressure tube C expiration tube D inspiration tube

E bacterial filter F adaptor for bac. filter G adaptor for bac. filter H bacterial filter

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 36 |


Commissioning

Connecting a double limb circuit


■ Connecting a double limb patient circuit without proximal pressure measurement

A bacterial filter B expiration tube C inspiration tube D patient connector

E closed connector for proximal pressure measurement tube

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 37 |


Commissioning

Connecting a double limb circuit


■ Connecting a double limb patient circuit with proximal pressure measurement

E B
D

A HME / bacterial filter B expiration tube C inspiration tube D patient connector

E closed connector for proximal pressure measurement tube F adaptor with proximal pressure tube connection

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 38 |


Commisioning

Connecting a heated moistener with double tube system


■ Heated moistener is integrated in the inspiration branch and should be positioned below the patient and
the device, so that no water flows into the patient's lungs or into the device.
■ If water is still collected in the hose system use water traps!
J

A patient connector B proximal pressure tube C expiration tube D moistener chamber

E bacterial filter F adaptor for bac. filter G hydrophobic/bac. filter H external humidifier

I inspiration tube from chamber to patient J inspiration tube from ventilator to chamber

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 39 |


Commissioning

Application without tube calibration


■ On initial commissioning, the standard calibration data stored in the device are used
■ If no tube calibration is made, calibration data of the last calibration is used
■ Note window hint:
“tubeless pressure measurement" will be displayed at start of the breathing
■ Note is hidden by pressing the MFK
■ The ventilation will continue, but pressure measurement can be falsified. Tube calibration therefore
recommended!

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 40 |


Commissioning

Calibrating the tube


■ Necessary after changes to the system, including, for example the following components:
● Bacterial filter

● Moistener
● Tubing system

● Mask

● FiO2-Sensor
● Water trap

● etc.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 41 |


Commissioning

Calibrating the tube


■ Disconnect the hose system from the patient. During calibration, patient connection side of the hose
system must be open (mask can be connected)
■ In the home screen, navigate to "system" and confirm with MFK
■ By rotating the MFK, navigate to "calibrate tube"
■ Press MFK the tube calibration starts
■ “OK” on successful calibration
■ "Error" if not successful
● In case of failure, check the overall system, resistance
in the system may be too high

● For example, replace the bacterial filter or use a


different humidifier

● Then repeat the calibration

■ Press MFK again to exit the tube calibration

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 42 |


Commissioning

Alarm setting to detect a disconnection of the hose system


■ due to the use of filters or other components with high resistance in the hose system, detection of a
disconnection is often not possible, so that the device in this case is not alarming.
■ For life-dependent ventilated patients this poses a life-threatening danger. Therefore, the alarms must be
set in such a way that an alarm is triggered in the case of a disconnection.
■ The setting of the alarms listed in the table below is suitable for detecting a disconnection.
■ After you have set the alarms check whether the alarm(s) is/are triggered as followed
● Start patient's respiration and let it run for a few breaths
● Disconnect tube system directly on the patient

● Check if at least one of the set alarms is activated

● Re-connect the tube system, alarm(s) should automatically turn off again
● Repeat the alarm test by disconnecting other parts within the tube system

Tube system Pressure modes Volume modes

Single tube system min. pressure, apnoea alarm, max. / min. tidal volume, min. SpO 2 min. pressure, apnoea alarm

Double tube system min. pressure, apnoea alarm, max. / min. tidal volume, SpO 2, leakage min. pressure, apnoea alarm

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 43 |


Commissioning

Connecting accessories
■ Connection of an in-house nurse's call system or the external alarm box is carried out at the socket “remote
alarm/nurse call”
■ Connection cable with RJ10 plug is required

Note:
You can order the cable as an accessory
You can order the alarm box and the set as an accessory

C
A
B

A alarm box set B nurse call connection cable C external alarm socket

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 44 |


Commissioning

Connecting accessories
■ Connect the SpO2 sensor to the device, then the following icon appears in the toolbar

■ When sensor is connected to patient, oxygen saturation and heart rate


are displayed in the monitoring screen.
■ Set Pulse and SpO2 alarms function completely independently
of ventilation.
■ Device can be used as a stand-alone pulse oximeter B
A
C

Note:
You can order the extension cable as an accessory.
You can order the SpO2 sensor as an accessory.

A SpO2 finger clip B SpO2 socket C extension cable

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 45 |


Commissioning

Connecting accessories
■ Data evaluation and adjustment of the device parameters directly on the device or with the help of the PC
software “easySET"
■ easySET offers the following functions:
● Read out and adjusting the device parameters

● Read out and evaluating the therapy and statistic data

● Read out of alarms and events


B
● service functions (only possible by authorized service personnel) C D

Note:
The pre-terminated cable is available as an accessory

A USB-A connector B USB-B connector C data cable D USB port

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 46 |


Commissioning

Connecting accessories

■ Use SD card to pass therapy data on to the doctor


■ SD and SD-HC cards up to 32 GB
■ Data can be transferred to SD card directly on the device (System)

Note:
Additional SD-cards are available as an accessory

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 47 |


Commissioning

Connecting accessories
■ Using oxygen is possible in all ventilation modes
■ Changes in ventilation parameters, such as I:E, breathing frequency,
or applicate volume lead to change of the FiO2 content
■ Starting Initiation of oxygen: A
B
● Start ventilation, wait for some breathing cycles C

● Then start initiating the oxygen

● max. 15 l/min input, low pressure connection

■ Discharge of oxygen end: D

● End of oxygen discharge at the oxygen source

● Then leave ventilation activated for some breathing cycles. End ventilation

Note:
The O2 adaptors are available as an accessory

A Oxygen inlet B O2 adaptor, straight C O2 tube D O2 adaptor, angled

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 48 |


Commissioning

Connecting accessories
■ In the case of a fix oxygen flow (FlowO2), the oxygen concentration may not be constant
■ Inspiratory oxygen concentration (FiO2) varies depending on pressure, patient's breathing pattern, choice
of mask or amount of leakage
■ During the oxygen discharge, the oxygen concentration should therefore be measured with FiO2 sensor
■ The FiO2 sensor must be calibrated for
accurate measurement
■ Calibrate the FiO2 sensor:
● calibration is carried out using the ambient air

● Oxygen content of 21% is based

Note:
The O2 measuring-kit and the individual components
are available as an accessory
A connection cable B measuring cell C adaptor for measuring cell D T-adaptor

E inspiration tube F O2 socket

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 49 |


Commissioning

Connecting accessories
■ Use the functional bag for transporting the CARAT pro on wheelchairs, rollators or in transport vehicles
■ when operating in a functional bag, the following notes must be observed for safe and trouble-free
ventilation:
● Set the alarm volume to Level 3

● Make sure that all the necessary alarm messages can be read through the viewing window

● Make sure the ventilation openings of the bag are not blocked

● The air supply for the unit must always be guaranteed

● Use the bag so that the device is protected from overheating, dust and water

● All connected accessories such as hose, filters, supply lines etc.


must be relocated in such a way that they cannot cause any
obstruction or malfunction of the function of the device

Note:
The function bag and the transport bag are available as an accessory

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 50 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 51 |


Ventilation modes

The device offers three basic types of ventilation:


■ Mandatory breathing modes
in which the unit fully controls the breathing work
■ Augmented breathing modes
in which the device and the patient perform the respiratory work alternately or overlaying
■ Spontaneous breathing modes
in which the patient, with the help of the device, does the breathing work. The patient determines the
time of inspiration and breathing frequency

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 52 |


Ventilation modes

PCV (pressure controlled ventilation)


■ Ventilation controlled by device only
■ Spontaneous breathing of the patient is not possible
■ I:E - ratio and frequency indicate respiratory cycle
■ IPAP and PEEP specify the pressure range (Δp) for
ventilation (maximum and minimum pressure)
■ I-flank regulates time for pressure rise, E-flank regulates
time for pressure drop
■ Inspirational volume is dependent on compliance and
resistance

Note:
A minimum volume can be preset in the CARAT pro respirator
to ensure minimum ventilation, with the option of reaching
this via a pressure addition (IPAP + additional pressure)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 53 |


Ventilation modes

PCV (pressure controlled ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 54 |


Ventilation modes

APCV (assisted pressure controlled ventilation)

■ Corresponds to the adjustable ventilation parameters of


the purely controlled ventilation (PCV)
■ When the inspiratory trigger threshold is reached by
patient’s inhaling, it is possible to abort the expiratory
phase and trigger the next inspiration
■ These additional breathing strokes are controlled solely by
the device as with purely controlled ventilation
■ Fix inspiratory time, patient can only shorten the
expiratory phase and thus increase the set frequency

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 55 |


Ventilation modes

APCV (assisted pressure controlled ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 56 |


Ventilation modes

VCV (volume controlled ventilation)

■ Ventilation exclusively controlled by the device


■ Inspiration volume is determined, so that the appropriate
pressure depends on the condition of the lung
(compliance and resistance)
■ An end-expiratory pressure (PEEP) is also adjustable
■ The inspiratory flow (flow ramp) can be selected:

● constant flow
● decelerating flow

● accelerating / decelerating flow

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 57 |


Ventilation modes

VCV (volume controlled ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 58 |


Ventilation modes

AVCV (assisted volume controlled ventilation)

■ Corresponds to the adjustable ventilation parameters of


the purely controlled ventilation (VCV)
■ By inhaling the patient, when the inspiratory trigger
threshold is reached, it is possible to abort the expiratory
phase and trigger the next inspiration
■ These additional breathing strokes are controlled solely by
the device as with purely controlled ventilation
■ Fix inspiratory time, patient can only shorten the
expiratory phase and thus increase the set frequency

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 59 |


Ventilation modes

AVCV (assisted volume controlled ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 60 |


Ventilation modes

PSV (pressure supported ventilation)


■ Serves spontaneous breathing as well as the mechanical taking over of the ventilation, if spontaneous
breathing does not occur
■ IPAP and PEEP specify the pressure range (Δp) for ventilation (maximum and minimum pressure)
■ I-flank regulates time for pressure rise, E-flank regulates time for pressure drop
■ Inspiratory volume depends on compliance and resistance
■ Trigger sensitivity adjustable for inspiration and expiration
■ Adjustable frequency = background frequency, pressure support for spontaneous breathing as long as the
frequency is reached / exceeded by spontaneous breathing
■ Mandatory ventilation is given when the background frequency is subtracted until spontaneous respiration
is registered again
■ Adjust the apnoea time to allow the patient to breathe spontaneously. Pressure support (IPAP + pressure
support) can be set to ensure a minimum volume

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 61 |


Ventilation modes

PSV (pressure supported ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 62 |


Ventilation modes

PSV-S (pressure supported ventilation - synchronized)

■ Corresponds to the PSV mode in the adjustable ventilation


parameters
■ Since no (background) frequency is adjustable, ventilation
is triggered only in spontaneous respiration of the patient
■ Apnea time is an alarm parameter

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 63 |


Ventilation modes

PSV-S (pressure supported ventilation - synchronized)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 64 |


Ventilation modes

P-SIMV (pressure - synchronized intermittent mandatory ventilation)


■ Combination of pressure-controlled, mechanical ventilation and pressure-assisted spontaneous breathing
■ Mechanical ventilation is based on fixed frequency and inspiratory time
■ I:E - ratio and frequency indicate respiratory cycle
■ IPAP and PEEP specify the pressure range (Δp) for ventilation (maximum and minimum pressure)
■ I-slope regulates time for pressure rise, E-slope regulates time for pressure drop
■ Inspirational volume depends on compliance and resistance
■ Breath support only by means of set pressure support (PS) if spontaneous breathing is outside the
expectation time window (independent of IPAP)
■ Mandatory ventilation (IPAP / PEEP) only if spontaneous breathing within the expectation window
■ By adjusting the time intervals between the mandatory breaths, the set frequency is ensured, thus
spontaneous breathing within the expectation time window does not increase the overall frequency

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 65 |


Ventilation modes

P-SIMV (pressure - synchronized intermittent mandatory ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 66 |


Ventilation modes

V-SIMV (volume - synchronized intermittent mandatory ventilation)


■ combination of volume-controlled ventilation (VCV) with (PSV) during the expiratory phases
■ Mechanical ventilation is based on a fixed frequency and inspiratory time
■ Between machine breathing strokes patient can reach the triggers' thresholds for the spontaneously
inspiration and expiration
■ Inspirational volume depends on compliance and resistance
■ Breath support only by means of set pressure support (PS) if spontaneous breathing is outside the
expectation time window (independent of IPAP)
■ Mandatory ventilation (set volume parameter) only if spontaneous breathing is within the expectation
window
■ By adjusting the time intervals between the mandatory breaths, the set frequency is ensured, thus
spontaneous breathing within the expectation time window does not increase the overall frequency

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 67 |


Ventilation modes

V-SIMV (volume - synchronized intermittent mandatory ventilation)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 68 |


Ventilation modes

CPAP (continuous positive airway pressure)


■ Continuous, positive pressure helps the patient to facilitate the inspiration
■ At the same time, the patient exerts pressure against this pressure. (Compare PEEP)
■ The prerequisite is that the patient has self-breathing

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 69 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 70 |


Operating the device

Home Screen
■ From the home screen, you can activate the six individual screens:
● Monitoring

● Parameter
● Alarm log

● System

● Statistics
● Service

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 71 |


Operating the device

Monitoring means to show the measured and calculated values of


the ventilation parameters in real time
■ Monitoring → Measurements
Depending on the configuration, only with active ventilation:
● Pressure (p), Frequency (f)

● Relationship of inspiration to expiration (I: E)

● Breath minute volume (MV) and inspiration volume (VI)

● leakage, FiO2 concentration

■ Monitoring → Graphs
● Display with active ventilation

● pressure, flow, volume or FiO2

■ Monitoring → Loops
● Graphical display of loops
● flow:volume

● volume:pressure

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 72 |


Operating the device

Parameter screen
■ For set the ventilation- and alarm parameters
■ Up to 3 sets with different ventilation modes and parameters
- Determine the number of sets in the system screen
■ Active sets (green) can not be deactivated under System
to avoid accidental deletion of the set
■ Active set (green) starts when the on / off button is pressed
■ The currently edited set is blue.
■ Thus, for example, set 1 can be edited
(blue) while set 2 (green) is actively
ventilating.

Note:
The ventilation and alarm parameters can
only be set in clinical mode

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 73 |


Operating the device

Event Log screen


■ This screen can display tree types of messages:
● Alarm

● Events
● Errors

■ View the last 50 incidents with the date and time of occurrence
■ Sorted chronologically

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 74 |


Operating the device

Service screen
■ PIN code protected
■ For service by authorized service companies Content:
● Calibrate flow sensor
● Calibrate the FiO2 sensor

● Calibrate the tube system

● Pressure switch test


● Change PIN

● Default settings

● SW version

● Serial number

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 75 |


Operating the device

Statistics screen
■ Statistical evaluation of the ventilation parameters is performed for each ventilation set using percentiles
■ Percentiles are measures for the spread of statistical distribution of measured values
■ Statistics are available for the following ventilation parameters:
● minute volume

● frequency

● tidal volume
● I: E ratio

● leaks

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 76 |


Operating the device

System screen
■ Make basic device settings
■ Perform calibrations
■ See the device information
■ Some system settings can not be changed in Home mode

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 77 |


Operating the device

Night Screen

■ For operation in darkened surroundings


■ Highly reduced background lighting, MFK lighting is disabled
■ Power LED and battery LED are darkened
■ Preservation of all important functions, pressure bar
and toolbar is very easy to read.
■ Night screen is displayed both in standby mode and
during ventilation.
■ Layout of the night image can be set in the
system screen:
● “Monitoring"
● "Bright" (with moon picture)

● "Dark" (without moon)

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 78 |


Operating the device

Key lock
■ To protect against accidental changes to device settings
■ The functions of all control elements are deactivated, except:
● ON / OFF button to start ventilation
● ON / OFF button + MFK to stop ventilation

● Alarm button

■ Activate and deactivate key lock


● Press the Safe button

● The symbol bar flashes for


approx. 5sec

● Press the MFK within this time

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 79 |


Operating the device

User modes
■ Device has two user modes: Clinic and Home
■ Activated user mode is displayed in the toolbar
■ User mode can be set in the system screen

■ Clinic mode:
User has full access to all device settings

■ Home mode:
ventilation and alarm
parameters can not be changed
■ switching from one set to another
remains possible

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 80 |


Operating the device

Before you discharge the patient into home ventilation, you should observe the following:
■ Limit the number of ventilation sets to those used by the patient
■ Adjust all the patient's parameters and settings for home ventilation
■ Finally, set the user mode to "Home"
● if necessary, additionally use key lock

■ Instruction manual for users


● Use of accessories

● Maintenance, battery care

● Hygiene, cleaning

● Behavioral rules, in particular in the case of danger and alarm situations

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 81 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 82 |


Alarms

The alarms related to the respective ventilation mode are distinguished in 3 alarm priorities:
■ HIGH
Immediate action is required. Monitor the patient and set the alarm off immediately
■ MIDDLE
Medium priority requires fast action. Clear the cause of the alarm
■ LOW
For low alarm priority the user's attention is required. Low priority alarms indicate a change in the
"normal" device operation. Clear the cause of the alarm
Volume of audio alarms
■ Audio alarm volume can be adjusted in the system screen
■ Level 1 and 2 are dynamically raised to level 3 if the alarm condition persists after 1 minute

Alarm sound encoder test


■ Check whether both signal generators can be heard shortly after each other during the start-up of the
device.
■ If not, the unit must be returned for service.

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 83 |


Alarms

Alarm output via the Info-LED


■ The Info LED can accept 3 states to indicate the priority of the alarm:
RED fast flashing (2 Hz) High priority alarm

YELLOW flashing (0.5 Hz) Middle priority alarm

TURQUOISE permanently Low priority alarm

■ If several alarms appear consecutively or simultaneously, then alarm with highest priority is displayed

Alarm output in the status bar


■ Alarms are indicated in the toolbar by the "Alarm active" symbol and by an alarm message
■ The color of the symbol indicates the priority of the alarm:

RED High priority alarm

YELLOW Middle priority alarm

TURQUOISE Low priority alarm

■ If several alarms are displayed consecutively or simultaneously, then display the alarm with the highest
priority
© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 84 |
Alarms

Alarm output in the text box:


■ 120 seconds after the last operation, alarms are displayed in text box
■ Textbox is blanked out by pressing the alarm mute button
■ Colour of the text box corresponds to the alarm with the highest priority:
Red text box High priority alarm

Yellow text box Middle priority alarm

Turquoise text box Low priority alarm

■ Simultaneously occurring alarms are


sorted according to priority
■ Alarms are permanently stored even if power
supply is completely lost

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 85 |


Alarms

Forwarding of alarms
■ Alarms can be forwarded by means of a nurse call or an optional alarm box
■ Thus even better monitoring of the device in the home and hospital area. Especially when using multiple
ventilation devices in a room
■ All alarms are forwarded without delay to the nurse call system or alarm box
■ All alarms, including mains voltage failure, are transmitted.
■ Setting the alarm volume (SYSTEM) does not affect
external alarms

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 86 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 87 |


Cleaning and Maintenance

Changing expiratory membrane Clean the air filter


■ Open the cover and unscrew the black cap ■ Black coarse filter: weekly cleaning, replace if
necessary
■ Change the membrane if necessary
■ White fine filter: to be replaced monthly or with
heavy contamination by a new
one

Note: Note:
The membrane change kit is available as an accessory Filter cassette or its filters are available as an
© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN
accessory | 88 |
Cleaning and Maintenance

Common (home) application


■ Clean the surface of the appliance by means of a damp cloth moistened with soapy water
■ Afterwards, wipe with cloth moistened with clear water to remove soaps scum
■ Device must be completely dried before commissioning

Clinical application
■ We recommend a non-alcohol desinfect, e.g. schülke mikrozid sensitive wipes
■ Similar disinfectant wipes are also acceptable as well
■ Device must be completely dried before commissioning
■ When used by several patients (in clinic), to protect the device from
contamination by human pathogenic germs, suitable bacterial filters
(e.g., Medisize Barr-vent S) throughout
■ Bacterial filters must be changed daily

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Cleaning and Maintenance

Safety Checks
■ To maintain and verify the device functions
■ always before commissioning
■ By an authorized service technician

Maintenance

WHEN WHAT WHO


every week Cleaning / changing filters User
If necessary Change the expiration membrane User / Operator / Service
Every 6 months Charge battery of stored device User
Maintenance 2
After 2 years Operator / Service
Safety check
Maintenance 5
After 5 years / 15000h turbine runtime Operator / Service
Safety check

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 90 |


Cleaning and Maintenance

Battery care
■ In order to get the full capacity of the batteries, it is important to recharge the batteries on a regular basis
■ The number of charging cycles of lithium-ion batteries is limited, so batteries must be changed regularly
■ This is the case when the battery test at service menu is not passed, but at the latest after 2 years

Charge the batteries


■ Charge the batteries during storage every 6 months to 100% charge

Replace batteries
■ Exchange every 2 years by an authorized service technician
■ The procedure is described in the service manual of the CARAT pro

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 91 |


Cleaning and Maintenance

Perform quick battery test


■ To check whether the device can be used for at least 1h in the case of a power failure
■ When using the device every six months, to be performed by the operator or user
■ Monthly execution is however recommended:
● Make sure the batteries are fully charged (100%)

● Disconnect the device from the power supply and use it for 1h in battery operation

■ Passed:
● if after 1 hour the battery charge is > 10% and the alarm
"Internal battery low" has not occurred

■ Failure:
● If battery charge drops below 10% and the “low battery"
alarm has occurred, have the battery replaced by an authorized service center

■ Recharge batteries to 100%. To do this, operate the device on the power supply

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 92 |


Content

1 Usage Purpose

2 Safety Information

3 Indications / Contraindications / Side Effects

4 Description of Device

5 Commissioning

6 Ventilation Modes

7 Operating the Device

8 Alarms and Messages

9 Cleaning and Maintenance

10 Practical Exercise

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 93 |


Practical Exercise

Exercises:
■ System assembly with filter or humidifier
■ Power on the unit
■ Setting of ventilation parameters and alarms
■ Activation of home or clinic mode and using the key lock
■ Suppression of alarms
■ Change of ventilation parameters and alarms
■ Change of coarse and fine filters as well
as the expiratory membrane

© HOFFRICHTER 2018 |CARAT II pro | User | SW Ver. 3.105 | Rev. 3.105 EN | 94 |

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