Weinmann VENTIlogic LS, VENTIlogic plus Instructions For Use Manual

Ventilation device
Description of device and instructions for use
for devices from serial number 20,000
VENTIlogic LS VENTIlogic plus
Contents
2 Contents
EN
1. Overview . . . . . . . . . . . . . . . . . . . . . 4
1.1 Special markings on the device. . . . .12
1.2 Safety information in the instructions
for use . . . . . . . . . . . . . . . . . . . . . . .22
2. Description of device . . . . . . . . . . 23
2.1 Intended use . . . . . . . . . . . . . . . . . .23
2.2 Owner/operator and user
qualification . . . . . . . . . . . . . . . . . . .24
2.3 Description of function. . . . . . . . . . .24
3. Safety instructions . . . . . . . . . . . . 29
3.1 Safety information . . . . . . . . . . . . . .29
3.2 Contraindications . . . . . . . . . . . . . . .36
3.3 Side effects . . . . . . . . . . . . . . . . . . .37
4. Set up device . . . . . . . . . . . . . . . . . 38
4.1 Set up and connect the device . . . . .38
4.2 Patient/ventilator interfaces . . . . . . .39
4.3 Connect valve ventilation . . . . . . . . .39
4.4 Connect leakage ventilation . . . . . . .41
4.5 Connect humidifier . . . . . . . . . . . . .43
4.6 Connect bacteria filter . . . . . . . . . . .43
4.7 Therapy with oxygen supply . . . . . . .45
4.8 Operation in the event of a power
failure . . . . . . . . . . . . . . . . . . . . . . .48
5. Operation . . . . . . . . . . . . . . . . . . . . 49
5.1 Controls . . . . . . . . . . . . . . . . . . . . . .49
5.2 Start up the device . . . . . . . . . . . . . .51
5.3 Handling batteries . . . . . . . . . . . . . .53
5.4 Activate/deactivate Auto switch-on
(only leakage ventilation) . . . . . . . . .55
5.5 Alarm list . . . . . . . . . . . . . . . . . . . . .56
5.6 Adjust brightness . . . . . . . . . . . . . . .56
5.7 LIAM info . . . . . . . . . . . . . . . . . . . . .57
5.8 Overview . . . . . . . . . . . . . . . . . . . . .58
5.9 Humidifier for patient circuits with
patient valve. . . . . . . . . . . . . . . . . . .58
5.10 LIAM (insufflation) . . . . . . . . . . . . . .58
5.11 Select a program . . . . . . . . . . . . . . .61
5.12 After use . . . . . . . . . . . . . . . . . . . . .62
5.13 Travel with the therapy device . . . . .64
6. Hygiene treatment . . . . . . . . . . . . 67
6.1 Intervals . . . . . . . . . . . . . . . . . . . . . .67
6.2 Clean leakage ventilation . . . . . . . . .68
6.3 Clean the housing. . . . . . . . . . . . . . 70
6.4 Clean coarse dust filter/change fine
filter . . . . . . . . . . . . . . . . . . . . . . . . 70
6.5 Clean the fan filter . . . . . . . . . . . . . 71
6.6 Clean the accessories . . . . . . . . . . . 71
6.7 Clean the SpO
2
module . . . . . . . . . . 71
6.8 Disinfect, sterilize . . . . . . . . . . . . . . 71
6.9 Change in patients . . . . . . . . . . . . . 73
7. Function check . . . . . . . . . . . . . . . . 74
7.1 Intervals . . . . . . . . . . . . . . . . . . . . . 74
7.2 Method . . . . . . . . . . . . . . . . . . . . . 74
7.3 Calibrate oxygen sensor
(only valve ventilation). . . . . . . . . . . 78
7.4 Energy supply . . . . . . . . . . . . . . . . . 80
8. Troubleshooting . . . . . . . . . . . . . . . 81
8.1 Faults . . . . . . . . . . . . . . . . . . . . . . . 81
8.2 Alarms . . . . . . . . . . . . . . . . . . . . . . 83
9. Maintenance and safety checks . . 95
9.1 Intervals . . . . . . . . . . . . . . . . . . . . . 95
9.2 Batteries . . . . . . . . . . . . . . . . . . . . . 96
9.3 Change filter. . . . . . . . . . . . . . . . . . 97
9.4 Change pressure-measurement tube (only leakage ventilation) . . . 100
9.5 Safety check . . . . . . . . . . . . . . . . . 100
9.6 Disposal . . . . . . . . . . . . . . . . . . . . 101
10. Scope of supply . . . . . . . . . . . . . . . 103
10.1 Standard scope of supply . . . . . . . 103
10.2 Accessories and spare parts. . . . . . 107
11. Technical data . . . . . . . . . . . . . . . . 108
11.1 Therapy device . . . . . . . . . . . . . . . 108
11.2 System resistances . . . . . . . . . . . . 112
11.3 Bacteria filter WM 24148 and
WM 27591 . . . . . . . . . . . . . . . . . . 112
11.4 Oxygen sensor . . . . . . . . . . . . . . . 113
11.5 SpO
2
module . . . . . . . . . . . . . . . . . 114
11.6 Analog box with therapy device . . 115
11.7 Pneumatic diagrams . . . . . . . . . . . 116
11.8 Safety distances . . . . . . . . . . . . . . 119
11.9 Emission of electromagnetic
interference . . . . . . . . . . . . . . . . . 120
11.10Electromagnetic interference
immunity . . . . . . . . . . . . . . . . . . . 121
3
EN
11.11Electromagnetic interference immunity for life-supporting medical electrical devices and medical
electrical systems. . . . . . . . . . . . . . 123
11.12Electromagnetic interference immunity for NON-LIFE-SUPPORTING medical electrical devices or
medical electrical systems . . . . . . . 124
12. Warranty . . . . . . . . . . . . . . . . . . . . 125
13. Declaration of conformity . . . . . 125
4 Overview
EN
English
1. Overview
Therapy device, general
5 Power cord
6 Compartment for
replaceable battery available as an option
3 Control panel
and displays
4 Handle
1 Device outlet port
16 Housing fan
8 Card reader
9 Serial ports
13 Power connection
15 Oxygen
connection
11 Remote alarm
connection
14 Device ID plate
10 Filter
compartment lid, air inlet
12 Cable-securing clip
2 O2 coupling
7 Replaceable battery
(optional)
Overview 5
EN
Key
1 Device outlet port
The respiratory air flows to the patient from here via the patient circuit and the patient/ventilator interface.
2 O2 coupling
Serves as an adapter for connecting the oxygen source to the therapy device.
3 Control panel and displays
For controlling and monitoring the therapy device and connected accessories.
4 Handle
For transporting the device.
5 Power cord
For connecting the therapy device to the power supply.
6 Compartment for replaceable
battery available as an option
For connecting a replaceable battery, available as an option. If you are not using a replaceable battery, the compartment is sealed with a panel.
7 Replaceable battery (optional)
Available as an accessory. For mobile power supply to the therapy device.
8 Card reader
Slot for a Weinmann memory card. Therapy data are stored on the memory card which the doctor can call up.
9 Serial ports
For connecting devices for displaying and evaluating therapy data.
10 Filter compartment lid, air inlet
For covering and securely positioning the coarse dust and fine filters.
11 Remote alarm connection
For connecting the hospital's internal nurse call system or the VENTIremote alarm remote alarm case for use outside the hospital.
12 Cable-securing clip
Prevents the device being disconnected from the power supply inadvertently.
13 Power connection
This is where the power cord is connected to the device.
14 Device ID plate
Provides information about the device, such as serial number and year of manufacture, for example.
15 Oxygen connection
For connecting the oxygen supply if oxygen supply has been prescribed.
16 Housing fan
Protects the device from overheating.
6 Overview
EN
Therapy device with leakage ventilation
Key
17 Patient circuit
The air flows to the patient/ventilator interface through the patient circuit. The patient circuit consists of creased hose, pressure measuring tube and adapter.
18 Adapter
For connecting the patient circuit to the device outlet port.
19 Pressure measuring tube
For measuring therapy pressure.
20 Creased tube
Delivers respiratory air to the patient.
21 Sealing plug (2x)
For sealing off the pressure measuring tube during cleaning (only with leakage ventilation).
22 Drying adapter
Required to dry the patient circuit with the aid of the therapy device and for the function check.
23 Exhalation system
Carbon dioxide-enriched exhaled air escapes here during therapy.
24 Connection for O2 sensor
For connecting an oxygen sensor which can be used to measure oxygen concentration in respiratory air.
17 Patient circuit
22 Drying adapter
21 Sealing plug (2x)
19 Pressure
measuring tube
18 Adapter
23 Exhalation
system
24 Connection for O2 sensor
20 Creased tube
17 Patient circuit
Overview 7
EN
Therapy device, single patient circuit with patient valve
Key
25 Connection for O2 sensor
For connecting an oxygen sensor which can be used to measure oxygen concentration in respiratory air (only with patient circuits with a patient valve).
26 Connection for pressure measuring
tube (marked blue)
For connecting the pressure measuring tube to the device.
27 Test adapter
Required for the function check of the therapy device.
28 Connection for valve control tube
For connecting the valve control tube to the device.
29 Single patient circuit
Delivers respiratory air to the patient.
26 Connection for pressure
measuring tube (marked blue)
29 Single patient circuit
30 Pressure-
measurement tube (marked blue)
31 Valve control
tube
32 Patient valve
28 Connection for
valve control tube
33 Connection for
patient
34 Connection for
device outlet port
27 Test adapter
25 Connection for O2 sensor
8 Overview
EN
30 Pressure-measurement tube (marked
blue)
For measuring therapy pressure.
31 Valve control tube
For controlling (opening and closing) the patient valve.
32 Patient valve
For routing the patient's exhaled air out of the patient circuit.
33 Connection for patient
This is where the patient/ventilator interface is connected.
34 Connection for device outlet port
This is where the patient circuit is connected to the device outlet port of the therapy device.
Overview 9
EN
Therapy device, double patient circuit with patient valve (VENTIlogic LS only)
35 Connection for O2 sensor
For connecting an oxygen sensor which can be used to measure oxygen concentration in respiratory air (only with patient circuits with a patient valve).
36 Connection for pressure-
measurement tube (marked blue)
For connecting the pressure measuring tube to the device.
37 Test adapter
Required for the function check of the therapy device.
38 Connection for valve control tube
For connecting the valve control tube to the device.
39 Device connection for patient valve
For connecting the patient valve to the device inlet port of the therapy device.
39 Device connection for
patient valve
36 Connection for pressure-
measurement tube (marked blue)
41 Double patient circuit
43 Y-adapter
44 Patient valve
46 Valve control
tube
48 Pressure-
measurement tube (marked blue)
38 Connection for
valve control tube
40 Opening for
exhaled air
42 Connection
for patient
45 Connection for
device inlet port
47 Connection for
device outlet port
37 Test adapter
35 Connection for O2 sensor
10 Overview
EN
40 Opening for exhaled air
This is where the patient's exhaled air is routed out of the device.
41 Double patient circuit
Delivers respiratory air to the patient and from the patient back to the device.
42 Connection for patient
This is where the patient/ventilator interface is connected.
43 Y-adapter
When the double patient circuit is used, this brings the inspiration and exhalation tubes together and serves as an adapter for connection to the patient/ventilator interface.
44 Patient valve
For routing the patient's exhaled air out of the patient circuit.
45 Connection for device inlet port
This is where the patient circuit is connected to the device outlet port of the therapy device.
46 Valve control tube
For controlling (opening and closing) the patient valve.
47 Connection for device outlet port
This is where the patient circuit is connected to the device inlet port for the patient valve (only with double patient circuit with patient valve).
48 Pressure-measurement tube (marked
blue)
For measuring therapy pressure.
Overview 11
EN
Accessories
Key
49 Replaceable battery WM 27880
Available as an accessory, for mobile power supply to the therapy device.
50 Carrying bag WM 27976
For mobile use of the therapy device.
51 Bacteria filter WM 24148 (only leakage ventilation) and 52 Bacteria filter WM 27591 (only valve ventilation)
For protecting the device from contamination, in particular when the device is used by several patients (patient change).
53 Set, O2 sensor WM 15732
For measuring oxygen concentration at the device outlet port.
54 Protective bag WM 27106
For protecting the therapy device during transport.
50 Carrying bag
WM 27976
54 Protective bag
WM 27106
53 Set, O2 sensor WM 15732
52 Bacteria filter
WM 27591 (only valve ventilation)
51 Bacteria filter WM 24148
(only leakage ventilation)
49 Replaceable battery WM 27880
12 Overview
EN
1.1 Special markings on the device
Left-hand side
1
Oxygen connection: maximum supply rate: 15 l/min at < 1000 hPa
2
VENTIlogic LS:
Opening for exhaled air when operated with double patient circuit with patient valve; do not seal opening or block in any other way.
VENTIlogic plus:
Opening is not used with VENTIlogic plus.
7
6
5
4
3
2
1
12
11
10
9
15
18
14
16 17
8
13
Overview 13
EN
Front
3
VENTIlogic LS:
Connection for patient's exhaled air with double patient circuit with patient valve.
VENTIlogic plus:
Opening is not used with VENTIlogic plus.
4
Jack: electrical connection for oxygen sensor; max. 100 mV DC
5
Connection: pressure measuring tube (marked blue). Therapy pressure 0 - 50 hPa (only for patient circuit with patient valve)
6
Connection: control tube for patient valve 0 - 50 hPa (only patient circuit with patient valve)
7
Device outlet port: outlet for exhaled air at 0 - 45 hPa with patient circuits with patient valve, 0 - 40 hPa with leakage ventilation
8
Device outlet port: only patient circuits with a diameter of Ø 15 mm - 22 mm are permitted.
Right-hand side
9
Connection for optional attachments, e.g. Analog box D/A; max. current delivery at 5 V: 50 mA
10
Connection for specialist staff to set therapy parameters using VENTIviews; max. current delivery at 12 V: 50 mA
11
SD card slot
12
Replaceable battery
Rear
13
Connector for power supply input 115/230 V AC; 50/60 Hz
14
Follow instructions for use
15
Connection for remote alarm: connection for nurse call system and VENTIremote alarm remote alarm case. Breaking capacity: 60 V DC/2 A; 42 V AC/2 A
P
~
14 Overview
EN
16
Servicing label: indicates when the next service is due
17
Safety check label: (in Germany only) marks when the next safety check as per §6 of the German law relating to users of medical devices is required
18
Device inlet port: inlet port for ambient air at room temperature
Device ID plate (rear)
Type BF application part
Protection class II, protective insulation
Year of manufacture
Do not dispose of device in domestic waste!
SN Serial number
100 V/230 V ~, 50-60 Hz
Electrical rating
CE 0197 symbol: Confirms that the product conforms to the applicable European directives
Protect device from wet
STK
Overview 15
EN
Control panel
Key
1 On/Off key
For switching the therapy device on and off.
2 Alarm acknowledgement key
The alarm acknowledgement key is for the temporary muting of alarms. The LED displays alarms visually.
3 Operating keys
For quick-setting by a doctor; deactivated in patient mode.
4 Dial
Central control of the therapy device, for navigating in the menu.
5 O2 key
Starts calibration of the O2 sensor. Has other functions in the Clinical menu.
6 Menu key
For switching from the default display to the menu and vice versa.
7 LED for power supply
The green LED comes on when there is a power supply.
8 LIAM (insufflation)
For triggering a coughing episode or ventilating a sigh.
9 Program key
For switching to one of the three pre-configured programs manually.
Vt
PEEP
IPAP
F
I : E
8 LIAM (insufflation)
1 On/Off key
2 Alarm acknowledgement
key
3 Operating keys
7 LED for power supply
4 Dial
5 O2 key
6 Menu key
9 Program key
16 Overview
EN
Default display during therapy
Key
1 Active ventilation mode
The active ventilation mode is displayed at this point in the status line.
2 Status line
This is where device status information (such as alarm state display, filter change or servicing due) is displayed.
3 Alarm display
If an alarm has been muted, it is then shown in the status line for 120 seconds.
4 Active program
Indicates the ventilation program currently active.
5 Battery charge status of internal
battery
Displays the charge status of the internal battery. When the battery is charging, the segments are shown consecutively.
6 Battery charge status of replaceable
battery (optional)
Displays the charge status of the replaceable battery available as an option. If the battery is being charged, the segments are shown in succession.
7 Memory card symbol
Appears if a memory card is present and there is data saved on the memory card.
8 Respiratory phase change display
Indicates whether the current respiratory phase change is spontaneous or mandatory (spontaneous: S, mandatory: T); the display changes from left (inspiration) to right (exhalation) depending on respiratory phase; mandatory exhalation is shown here.
Also indicates whether the trigger for inspiration is blocked due to an activated trigger lockout time at the start of expiration ( ).
1 Active ventilation
mode
10 Bar chart for pressure display
9 Access to patient
menu
8 Respiratory phase
change display
12 Ventilation
parameters
13 Patient circuit
2 Status line
7 Memory card symbol
11 Oxygen
concentration (optional)
6 Battery charge status of
replaceable battery (optional)
5 Battery charge status of internal
battery
3 Alarm display
4 Active program
Overview 17
EN
9 Access to patient menu
Use the key adjacent to this menu item to switch to the patient menu and back to the default display.
10 Bar chart for pressure display
For the graphical display of therapy pressure.
11 Oxygen concentration (optional)
Gives oxygen concentration in respiratory air in percent.
12 Ventilation parameters
The relevant current ventilation parameters are displayed depending on the active mode.
13 Patient circuit
The relevant text to suit the set patient circuit appears in the status line.
18 Overview
EN
Symbols used in the display
Symbol Significance
Status line:
Filter change required
Servicing required
Acoustic signal of alarms muted for 120 seconds
All physiological alarms deactivated (exception for
VENTIlogic LS: In VCV and
aVCV modes, the Pressure
high
and Pressure
low
alarms cannot be
deactivated)
Blower off (standby mode)
Battery display green (2-5 segments): battery capacity over 25 %
Battery display orange: battery capacity below 25 %
Battery display red: battery capacity below 10 %
Segments are displayed in succession: device operated by power supply, battery charging
Battery not present
Battery not ready for use: – battery defective or – battery too cold or – battery too hot
Battery not recognized as a Weinmann battery. Replace battery.
Device in internal battery mode.
Measured values are written to the SD card
Overview 19
EN
SD card is write-protected or defective. No data can be recorded.
Alarm window:
Low-priority alarm triggered
Medium-priority alarm triggered
High-priority alarm triggered
Main window:
Plateau signal switched on
Plateau signal switched off
Symbol Significance
20 Overview
EN
Abbreviations used in the display
Symbol Significance
Status line:
S
S mode active
ST
ST mode active
T
T mode active
CPAP
CPAP mode active
PCV
PCV mode active
PSV
PSV mode active
aPCV
aPCV mode active
VCV
VCV mode active (VENTIlogic LS only)
aVCV
aVCV mode active (VENTIlogic LS only)
SIMV
SIMV mode active
MPVp MPVp mode active
MPVv MPVv mode active
+V
Volume compensation activated (after mode: e.g PCV+V)
+A
AirTrapControl activated (after mode: e.g. ST +A)
+LIAM
LIAM enabled: displayed under the current mode, e.g.:
PCV
+LIAM
LIAM
LIAM (Lung Insufflation Assist Maneuver) active
Prog.
Active ventilation program
Main window (Monitor):
IPAP
Inspiration pressure
EPAP / PEEP
Exhalation pressure
P
SIMV
Specifies the inspiration pressure level of the back-up ventilation (SIMV mode only)
hPa
Pressure given in hectopascals; 1.01973 hPa corresponds to 1 cm H2O.
f
Respiratory frequency
S
Respiratory phase switch triggered - spontaneous
Overview 21
EN
Markings on the packaging
T
Respiratory phase switch triggered - mandatory
B
Trigger for inspiration blocked during expiration
Ti/T
Proportion of inspiration time in a respiratory cycle
VT
Tidal volume
VTi
Tidal volume on inspiration
VTe
Tidal volume on exhalation
Ti
Inspiration time
Te
Exhalation time
O2 (21%)
Mean oxygen concentration Shown in brackets: measuring cell not calibrated, perform oxygen calibration
SpO2 (%)
Oxygen saturation
bpm
Pulse beats per minute
Tapnoe
Time since patient's last spontaneous breath (only in MPVv and MPVp modes)
Symbol Significance
Therapy device:
SN Serial number of device
Permitted temperature for storage: -40 °C to +70 °C
Permitted humidity for storage: max. 95 % relative humidity
Protect pack from wet
Do not tip over or drop pack
Symbol Significance
%
%
5
1
0
22 Overview
EN
1.2 Safety information in the instructions for use
Safety information in these instructions for use is marked as follows:
Warning!
Warns of risk of injury and potential material damage.
Caution!
Warns of material damage and potentially false therapy results.
Note:
Contains useful tips.
Description of device 23
EN
2. Description of device
2.1 Intended use
2.1.1 VENTIlogic LS
VENTIlogic
LS is used for invasive and non-invasive life-support ventilation in accordance
with ISO 10651-2 and for non-life-support mouthpiece ventilation in MPV mode.
The device can be used in both static or mobile operation, both at home and in appropriate hospital departments.
Note
VENTIlogic LS is not a ventilator for intensive care purposes in accordance with ISO 80601-2-12.
The device can be used for weaning off invasive ventilation and converting to mask ventilation. It is used on patients with medium to severe acute and chronic global respiratory insufficiency with a tidal volume of at least 50 ml and a body weight of at least 5 kg.
2.1.2 VENTIlogic plus
VENTIlogic plus is used for invasive and non-invasive non-life-support ventilation in accordance with ISO 10651-6.
The device can be used in both static or mobile operation, both at home and in appropriate hospital departments.
Note
VENTIlogic plus is not a ventilator for intensive care purposes in accordance with ISO 80601-2-12.
The device can be used for weaning off invasive ventilation and converting to mask ventilation
. It is used on patients with medium to severe acute and chronic global respiratory insufficiency with a tidal volume of at least 50 ml and a body weight of at least 5 kg.
Indication
This corresponds to the following clinical pictures:
• obstructive respiratory disorders, such as COPD
• restrictive respiratory disorders such as scolioses, deformities of the thorax
24 Description of device
EN
• neurological, muscular and neuromuscular disorders, such as muscular dystrophies, pareses of the diaphragm etc.
• central respiratory regulation disorders
• hypoventilation syndrome associated with obesity
2.2 Owner/operator and user qualification
As an owner/operator or user, you must be familiar with the operation of this medical device. Observe the legal requirements for operation and use (in Germany, the regulations governing owner/operators of medical devices apply in particular). Basic recommendation: get a person authorized by Weinmann to provide you with proper instruction about the handling, use and operation of this medical device.
2.3 Description of function
2.3.1 Providing the therapy pressure
An electronically-controlled blower draws in ambient air through a filter and delivers it to the device outlet port. From here, air flows through the patient circuit and the patient/ ventilator interface to the patient.
Sensors detect the pressure at the patient/ventilator interface and in the patient circuit, as well as the respiratory phase change. The blower accordingly provides the respiratory volume and the IPAP and EPAP / PEEP pressures prescribed by the doctor.
2.3.2 Display and operation
The display shows the therapy mode and, as a function of the mode, the currently applied values for CPAP, IPAP and EPAP / PEEP, respiratory frequency (f) and volume. Spontaneous or mechanical respiratory phase switches and the pressure change are also shown in graphical form. Ventilation parameters can be set in standby mode and in ventilation mode. The device is operated by a number of keys that give direct access to the most important parameters, such as IPAP, EPAP / PEEP, frequency, inspiration time and volume. A dial is used to navigate through the menu. Parameters are shown in an LC display.
A key code is used to prevent therapy values from being adjusted inadvertently. Operation is locked when a padlock symbol is shown on the display. In the Clinical menu, it is possible to show ventilation curves such as flow curves and pressure/volume loops (VENTIlogic LS only) in addition to therapy values.
Description of device 25
EN
2.3.3 Operating status
Three operating states are possible on the therapy device: on, off and standby.
If the device is switched on, therapy is in progress. In standby, the fan is switched off but the device is ready for immediate operation by briefly pressing the on/off switch, provided that the patient circuit is connected correctly. The settings on the device can be adjusted in standby mode. If the device is switched off completely, the fan and display are also switched off and no settings can be adjusted on the device.
2.3.4 Leakage ventilation
When leakage ventilation is used, an exhalation system continuously flushes out the CO2­containing exhaled air.
2.3.5 Valve ventilation
In this case, exhalation is controlled by the patient valve.
When the single patient circuit with patient valve is used, the patient's exhaled air escapes into the environment through the patient valve. The device controls the patient valve by means of the valve control tube.
When the double patient circuit with patient valve is used (VENTIlogic LS only), an exhalation tube also routes exhaled air into the ambient air through the device.
2.3.6 Therapy modes
The therapy device can be operated in the following therapy modes:
• leakage ventilation: S, T, ST, CPAP, MPVp, MPVv
• valve ventilation: PCV, aPCV, PSV, VCV (VENTIlogic LS only), aVCV (VENTIlogic LS only), SIMV, MPVp, MPVv
The mode required for therapy is set on the device by the doctor supervising treatment.
The doctor can activate volume compensation in pressure-controlled modes S, T, ST, TA, PCV, PSV and aPCV. A minimum volume and maximum pressure rise are set to achieve this. If the minimum volume is undershot, the device automatically and continuously increases pressure up to the set maximum pressure (therapy pressure + max. pressure rise).
In controlled modes T, PCV and VCV (VENTIlogic LS only) and in assisted-controlled modes ST, PSV, aVCV (VENTIlogic LS only) and aPCV, the doctor can set respiratory frequency in the range from 5 to 45 breaths per minute and inspiration time in the range from 15 % to 67 % of the respiratory period.
26 Description of device
EN
In S, ST, PSV, aPCV, aVCV (VENTIlogic LS only), SIMV, MPVp and MPVv modes, the doctor can select one of 8 trigger stages for inspiration and one of 14 trigger stages for exhalation (not with aPCV, aVCV, MPVp and MPVv).
In ST mode the expiratory trigger can be deactivated. The switch to exhalation is then on a time-controlled basis.
Mouthpiece ventilation can be used in the form of volume-controlled mode MPVv, or pressure-controlled mode MPVp.
If no breath into the device is taken in S mode, therapy pressure is automatically provided at a minimum frequency of 5 breaths a minute.
CPAP mode does not provide any respiratory assistance. The therapy device provides a constant positive therapy pressure in this mode.
The display shows therapy pressure and, as a function of mode, current values for IPAP and EPAP / PEEP and respiratory frequency (f). Depending on the patient circuit used, tidal volume (VT) is displayed in the case of a leakage system and tidal volume on inspiration (VTi) in the case of valve ventilation. When the single patient circuit is used, only tidal volume on inspiration can be measured, whilst with the double patient circuit (VENTIlogic LS only), total tidal volume can be measured.
Spontaneous or mechanical respiratory phase switches and the pressure change are also shown in graphical form.
2.3.7 SIMV mode
SIMV mode (synchronized intermittent mandatory ventilation) is a mixture of mandatory and assisted ventilation.
If there is no spontaneous respiration the device will mandatorily ventilate the patient once the T
apnea
time has elapsed at a respiratory frequency of f
backup
, a ratio of Ti/Tba (backup)
and an inspirational pressure level of P
SIMV
.
In the case of spontaneous respiration the device switches to assisted ventilation using the set IPAP value. The pressure level will then fluctuate cyclically at a frequency of f
SIMV
, a
ratio of Ti/T
ba
and an inspirational pressure level of P
SIMV
. The respiratory frequency in this
case is dictated by the patient.
2.3.8 Mouthpiece ventilation (MPV)
Ventilation modes MPVp and MPVv are a pressure-controlled and a volume-controlled mode for patients with spontaneous breathing who are not subject to invasive ventilation. The MPV modes are typically used with a mouthpiece. The patient has to be capable of closing his or her lips adequately for this purpose.
Description of device 27
EN
The MPV modes allow breathing as required and are available for leakage ventilation, single patient circuit ventilation and double patient circuit ventilation systems. The MPV modes have no background frequency. A ventilation stroke is delivered only if the patient triggers inspiration.
Trigger sensitivity, trigger lockout time and pressure rise can all be set individually. LIAM can also be switched on and can be activated via the LIAM key.
If the patient would like to breathe back into the tubing system, a tubing system with an active exhalation valve must be used.
2.3.9 Auto switch-on (only leakage ventilation)
The device has an automatic switch-on function. If this is activated, the device can be switched on by taking a breath into the breathing mask. The device is still switched off using the On/Off key .
2.3.10 Uninterrupted power supply (UPS)
A built-in battery ensures an uninterrupted power supply in the event of a power outage. Battery running time will depend on the load and operating temperature in question. Detailed information on the different loads with the corresponding battery operating times are provided in section 11. on page 108. The internal battery is automatically charged or maintained in a charged state as long as the device is supplied with power.
2.3.11 Mobile power supply
There is the additional option of a mobile power supply by means of one or more replaceable batteries which can be changed while the device is in operation and which are available as accessories.
2.3.12 LIAM (insufflation)
The Lung Insufflation Assist Maneuver function allows a higher volume to be administered to the patient if the corresponding key is pressed; this supports coughing. This function has to be enabled by the doctor supervising treatment.
2.3.13 Nurse call and remote alarm
The device has a remote alarm connection to support the monitoring of patient and device, especially when VENTIlogic LS is used for life-support ventilation. All high and medium­priority alarms, together with the No power supply alarm are passed to this connection. All other alarms are displayed only on the device itself.
28 Description of device
EN
The remote alarm connection can be used to connect the device to the VENTIremote alarm remote alarm case. In hospital, the device can be connected directly to the hospital's own internal alarm system.
2.3.14 Recording therapy data
Therapy data are stored in the device on a removable SD card. The VENTIviews PC software can be used to enable a doctor to evaluate the therapy data.
2.3.15 Analog output of therapy data
The device has an interface for connecting to analog box WM 27560. It is used for a time­synchronized display of therapy data such as pressure, flow, leakage and volumes e.g. on a PSG. Mode-specific data, such as trigger times in S mode, can likewise be visualized.
Safety instructions 29
EN
3. Safety instructions
3.1 Safety information
Read these instructions for use carefully. They are a component of the device and must be available at all times. Use the device exclusively for the intended purpose described (see “2.1 Intended use” on page 23).
For your own safety and the safety of your patients and in accordance with the requirements of Directive 93/42/EEC, please note the following.
3.1.1 Life-support ventilation
Danger! Increased resistance in the patient circuit can cause the alarm to fail!
Attaching an accessory can increase the resistance in the patient circuit. Depending on the settings, this could prevent life-saving alarms from being triggered. For example, if the Disconnection alarm fails then the patient may be put at risk.
– Make absolutely certain that the VT
low
and VT
high
alarms are active.
– Ensure that appropriate values are used for the VT
low
and VT
high
alarms.
– Check that the alarms are working.
– Carry out an alarm check every time an accessory is changed.
Warning! Device failure if incorrect patient circuits used!
If patient circuits with a diameter smaller than Ø 15 mm are used, the device may overheat.
– Use only patient circuits with a diameter of Ø 15 mm or more.
– Note that total permitted resistance may be exceeded even in patient circuits
with a diameter of Ø 15 mm when these are combined with bacteria filters.
30 Safety instructions
EN
Danger! The alarm will not work if the wrong settings are used!
If the VT
low
alarm has been deactivated, or incorrect settings have been used, then the alarm will not be triggered. If the patient is dependent on the ventilation device then they are placed at great risk if the alarm fails.
– It is essential to ensure that alarm VT
low
is activated for life-support ventilation (VENTIlogic LS only). Only if these conditions are met can a blockage (stenosis) be detected.
– Set the VT
low
alarm appropriately.
Danger! Failure of alarm function due to incorrect alarm settings in VCV and aVCV
modes (VENTIlogic LS only)!
If the Pressure
high
and Pressure
low
alarms have not been properly set in VCV and aVCV ventilation modes, then these alarms will not be triggered. If these alarms are not triggered the patient may be put at risk.
– Make absolutely certain that the Pressure
high
and Pressure
low
alarms are
active in the VCV and aVCV ventilation modes.
– Ensure that appropriate values are used for the Pressure
high
and Pressure
low
alarms.
Warning!
• An alternative ventilation option (e.g. a replacement device or a manual
ventilating bag) needs to be kept to hand for patients who are dependent on a ventilation device, in case the device fails.
• It is critical that patients who are dependent on the ventilation device are
monitored by the person caring for the patient. Otherwise it is possible that there will be no reaction to any alarms occurring on the device.
• Ensure that any alarms and malfunctions can be seen at all times and that the
person caring for the patient can take the necessary measures. Recourse can be had to the VENTIremote alarm remote alarm case or the hospital's own internal alarm system to support monitoring.
• With the single patient circuit and patient valve, the system only allows the
volume given off by the device to be displayed and monitored. With the valve system, exhaled volume can only be displayed reliably with a double patient circuit with patient valve (VENTIlogic LS only). For this reason, you should ensure that patients dependent on the ventilation device are ventilated with a double
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