Weinmann MEDUMAT Transport Ventilator Operating instructions

Type
Operating instructions
MEDUMAT Transport
Ventilator
Instructions for Use for Devices from Software Version 6.9
2EN Contents
Contents
1. Overview . . . . . . . . . . . . . . . . . . . . . 4
2. Description . . . . . . . . . . . . . . . . . . . 21
2.1 Intended use. . . . . . . . . . . . . . . . . 21
2.2 Applications . . . . . . . . . . . . . . . . . 21
2.3 Operator and user qualification. . . 22
2.4 Function . . . . . . . . . . . . . . . . . . . . 22
3. Safety information . . . . . . . . . . . . . 24
4. Installation . . . . . . . . . . . . . . . . . . . 30
4.1 Connecting oxygen cylinder . . . . . 30
4.2 Connecting the hose system . . . . . 32
4.3 Connecting the inhalation
adapter. . . . . . . . . . . . . . . . . . . . . 34
4.4 Accessories from other
manufacturers . . . . . . . . . . . . . . . 35
4.5 Permanent installation of the
unit . . . . . . . . . . . . . . . . . . . . . . . 37
5. Operation . . . . . . . . . . . . . . . . . . . . 38
5.1 Controls . . . . . . . . . . . . . . . . . . . . 38
5.2 Switching the unit on/Self-test . . . 41
5.3 Navigating in menus . . . . . . . . . . . 44
5.4 Selecting emergency mode . . . . . . 46
5.5 Selecting a ventilation mode . . . . . 47
5.6 Changing the ventilation mode. . . 48
5.7 Selecting additional ventilation
functions . . . . . . . . . . . . . . . . . . . 49
5.8 Performing ventilation. . . . . . . . . . 50
5.9 Monitoring ventilation . . . . . . . . . 51
5.10 Performing inhalation . . . . . . . . . . 53
5.11 Alarm signals . . . . . . . . . . . . . . . . 54
5.12 Ventilation with breathing
system filters (not supplied with
the unit) . . . . . . . . . . . . . . . . . . . . 56
5.13 Ending ventilation. . . . . . . . . . . . . 56
5.14 Calculating the Oxygen level/
Operating time . . . . . . . . . . . . . . . 57
5.15 Alternative ventilation. . . . . . . . . . 58
5.16 Changing the battery . . . . . . . . . . 58
5.17 Battery management . . . . . . . . . . 59
5.18 Using the simulation mode . . . . . . 63
6. Ventilation modes . . . . . . . . . . . . . 64
6.1 Classification of the ventilation
modes . . . . . . . . . . . . . . . . . . . . . 65
6.2 Important ventilation parameters . .66
6.3 Additional functions and safety
functions . . . . . . . . . . . . . . . . . . . 67
6.4 Pressure-controlled ventilation
modes . . . . . . . . . . . . . . . . . . . . . 69
6.5 Volume-controlled ventilation
modes . . . . . . . . . . . . . . . . . . . . . 79
7. Main menu . . . . . . . . . . . . . . . . . . . 85
7.1 Activating automatic alarm limits . . 85
7.2 Alarm Limits . . . . . . . . . . . . . . . . . 86
7.3 Curves . . . . . . . . . . . . . . . . . . . . . 87
7.4 Advanced ventilation parameters . .88
7.5 Apnea ventilation parameters . . . . 90
7.6 Audio/Video . . . . . . . . . . . . . . . . . 91
7.7 Options. . . . . . . . . . . . . . . . . . . . . 92
7.8 Night colors . . . . . . . . . . . . . . . . . 95
7.9 NVG (Night Vision Goggles) . . . . . 95
8. Operator menu . . . . . . . . . . . . . . . 97
8.1 Password Page . . . . . . . . . . . . . . 100
8.2 Ventilation Modes. . . . . . . . . . . . 100
8.3 File Export/Import . . . . . . . . . . . . 102
8.4 Software Update. . . . . . . . . . . . . 104
8.5 Options. . . . . . . . . . . . . . . . . . . . 106
8.6 User Settings. . . . . . . . . . . . . . . . 106
9. Hygienic preparation . . . . . . . . . . 110
9.1 MEDUMAT Transport . . . . . . . . . 110
9.2 Hose systems . . . . . . . . . . . . . . . 110
9.3 Parts and accessories. . . . . . . . . . 111
9.4 BiCheck flow sensor . . . . . . . . . . 111
9.5 Fittings . . . . . . . . . . . . . . . . . . . . 112
9.6 Hygiene input filter (optional) . . . 112
9.7 Cleaning, disinfection and
sterilization . . . . . . . . . . . . . . . . . 112
Contents EN 3
10. Function check . . . . . . . . . . . . . . . 116
10.1 Intervals . . . . . . . . . . . . . . . . . . . 117
10.2 Checking the system for leaks . . 118
10.3 Checking the patient valve
(reusable hose system only) . . . . 119
10.4 Performing a function check. . . . 120
11. Troubleshooting . . . . . . . . . . . . . . 124
11.1 Troubleshooting . . . . . . . . . . . . . 124
11.2 System alarms . . . . . . . . . . . . . . 125
11.3 Physiologic alarms . . . . . . . . . . . 128
12. Maintenance . . . . . . . . . . . . . . . . . 130
12.1 MEDUMAT Transport . . . . . . . . . 130
12.2 Sending in device . . . . . . . . . . . . 131
12.3 Batteries. . . . . . . . . . . . . . . . . . . 132
12.4 Accessories. . . . . . . . . . . . . . . . . 132
12.5 Changing the suction filter . . . . . 132
12.6 Changing the hygiene input
filter . . . . . . . . . . . . . . . . . . . . . . 133
12.7 Storage . . . . . . . . . . . . . . . . . . . 135
12.8 Disposal . . . . . . . . . . . . . . . . . . . 135
13. Product, accessories . . . . . . . . . . . 136
13.1 Standard scope of supply . . . . . . 136
13.2 Accessories. . . . . . . . . . . . . . . . . 137
13.3 Options . . . . . . . . . . . . . . . . . . . 141
13.4 Replacement parts . . . . . . . . . . . 141
14. Technical Data . . . . . . . . . . . . . . . 143
14.1 Specifications . . . . . . . . . . . . . . . 143
14.2 Battery specifications . . . . . . . . . 148
14.3 Block diagram . . . . . . . . . . . . . . 149
14.4 Technical data on electromagnetic
compatibility (EMC) . . . . . . . . . . 149
14.5 O2 consumption of the unit . . . . 150
14.6 Possible O2 concentration with
counterpressure . . . . . . . . . . . . . 151
14.7 Attainable tidal volume with
counterpressure . . . . . . . . . . . . . 152
14.8 Calculation of body weight on
the basis of body height . . . . . . . 153
15. Glossary . . . . . . . . . . . . . . . . . . . . 154
16. Warranty . . . . . . . . . . . . . . . . . . . . 157
17. Declaration of Conformity . . . . . . 157
4EN Overview
1. Overview
1 Alarm LED
Lights up to indicate alarms.
2 USB port
Means of data transfer for servicing and
maintenance purposes.
3 O2/Air inlet
Connection point, e.g., for an oxygen cylinder or
sterile compressed air.
4 O2/Air inlet/outlet
This connection point enables oxygen to be
extracted, e.g., using an inhalation device, or an
oxygen or sterile compressed air source to be
connected.
5 Filter compartment cover, air inlet
Covers the filter and ensures it is securely
positioned.
6 Ventilation connection terminal
The tube system is connected here.
7 Battery
Provides mobile power supply to the device.
8 DC connection
For DC power supply via an external power supply
unit or via the electrical circuit of an ambulance or
rescue vehicle.
9 External power supply unit
Supplies power to the device via a 100 - 240 V
grid.
MEDUMAT Transport connections
5Filter compartment
cover, air inlet
1Alarm LED
3O2/Air inlet
2USB port
7Battery
8DC connection
6Ventilation connection
terminal
9External power supply unit
4O2/Air inlet/outlet
Overview EN 5
1 CO2 measuring hose connection
The CO2 measuring hose of the patient hose
system is attached to this connection via the
connection plug.
2 PEEP control hose connection
The PEEP control hose of the patient hose system
is connected at this connection point via the
connection plug.
3 Pressure-measurement hose
connection
The pressure-measurement hose of the patient
hose system is connected at this connection point
via the connection plug.
4 Ventilation hose/inhalation adapter
connection
The ventilation hose of the patient hose system or
the inhalation adapter for an inhalation mask is
connected at this connection point.
5 Connection point connection BiCheck
flow sensor
The BiCheck flow sensor connection line of the
patient hose system is attached to this connection.
Ventilation connection terminal
1CO2 measuring hose connection
2PEEP control hose connection
3Pressure-measurement hose
connection
4Ventilation hose/inhalation adapter
connection
5Connection point connection
BiCheck flow sensor
6EN Overview
1, 3, 5 Context-dependent function
button
These buttons are used to set various ventilation
parameters, depending on the ventilation mode
selected.
2 Alarm mute button with LED
You can silence these acoustic alarms temporarily
(for 2 minutes) by pressing this button briefly
(< 1 s). If alarms are muted, the LED lights up.
Visual alarms are still displayed. The alarm menu
opens if this button is held depressed for longer
(> 2 s).
4 Function button for main menu
This button calls up the main menu.
6 Function button for 100% O2
This button calls up the 100% O2 function to
ventilate the patient briefly (for 2 minutes) with
100% O2 (FiO2 = 1.0).
7 Function button for inspiratory O2
concentration
This button calls up the O2 concentration menu.
The required inspiratory O2 concentration in the
respiratory gas can be set in this menu.
8 On/Standby/Off button
A short press switches the device on and off. A
long press switches it off completely.
9 Navigation knob
For navigating in menus and confirming your
settings on the device. During ventilation, this
knob is used to set the I:E ratio.
10 Context-dependent control knobs
For setting various parameters, depending on
which ventilation mode is active. Settings made
here must be confirmed with the navigation knob.
11 Function buttons for emergency
ventilation
These buttons start emergency ventilation. By
pressing the buttons, preset parameters for
infants, children or adults are activated.
MEDUMAT Transport controls 1Context-dependent
function button
11 Function buttons for
emergency ventilation
9Navigation knob
10 Context-dependent control knobs
4Function button for
main menu
3Context-dependent
function button
6Function button for
100% O2
7Function button for
inspiratory O2
concentration
5Context-dependent
function button
8On/Standby/Off
button
2Alarm mute button with
LED
Overview EN 7
1 Battery/Line operation indicators
Indicates whether the device is being operated
over the external power supply unit (upper LED) or
the internal battery (lower LED).
2 Function indicator for context-
dependent function buttons
The currently available function of the context-
dependent function buttons is indicated here.
3 Ventilation progress display
The ventilation procedure is shown here as a curve
or pressure gauge, depending on the selected
display mode.
4 Function indicator for context-
dependent control knobs
The currently available function of the context-
dependent control knobs is indicated here.
5 Function indicator for context-
dependent function buttons
The three directly selectable emergency
ventilation modes (Infant, child, adult) are
indicated here.
6 Numeric measurement display
The current measurements are shown here
numerically along with the corresponding alarm
limits.
7 Battery charge status
The battery charge status is indicated here.
8 Numeric measurement display
The measured inspiratory O2 concentration (FiO2)
is indicated here.
9 Info field
Information (error messages, visual alarms) about
the state of the patient and the ventilator is
displayed here. The time of day is also displayed in
this field.
10 Mode indicator
The ventilation mode set by the user is indicated
here.
MEDUMAT Transport display
2Function
indicator for
context-
dependent
function
buttons
9Info field 10 Mode indicator
8Numeric measurement
display
7Battery
charge status
6Numeric
measurement
display
3Ventilation progress display
1Battery/Line operation indicators
4Function
indicator for
context-
dependent
control knobs
5Function indicator
for context-
dependent
function buttons
8EN Overview
1 Ventilation hose
The respiratory gas flows through the ventilation
hose to the patient valve.
2 Water filter for CO2 measurement
The water filter protects the measuring chamber
of MEDUMAT Transport against moisture and
contamination from the patient's respiratory gas.
3 Connector
The measurement hose system is connected to
MEDUMAT Transport by means of this connector.
4 PEEP control hose
With this hose, MEDUMAT Transport controls the
patient valve and the PEEP.
5 BiCheck flow sensor connection line
This electric line transfers the measuring signals
from the BiCheck flow sensor to the MEDUMAT
Transport.
6 BiCheck flow sensor
This sensor supplies monitoring data on flow,
MVe, Vte and f.
7 Elbow
The mask/tube is connected here. The elbow is
removable, i.e., the mask/tube can also be
connected to the BiCheck flow sensor itself,
depending on the position of the patient.
8 Blanking plug
The blanking plug (Luer lock) is used to seal off the
CO2 outlet if your MEDUMAT Transport is not
equipped with CO2 measurement or if this is not
activated.
9 Patient valve
Switchover between inspiration and expiration
happens here.
10 CO2 measuring hose
Test gas is removed via this hose if your device is
equipped with the optional CO2 measurement
facility.
11 Pressure measuring tube
For patient-side measurement of ventilation
pressure.
Hose system (reusable and disposable versions available)
5BiCheck flow sensor
connection line
10 CO2 measuring hose
4PEEP control hose
11 Pressure measuring tube
1Ventilation hose
7Elbow
6BiCheck flow sensor
9Patient valve
13 Hose protec-
tion sleeve
2Water filter for CO2
measurement
3Connector
8Blanking plug
12 Velcro strap
with clip
Overview EN 9
12 Velcro strap with clip
Used for fixing the patient hose system to the
patient's clothing.
13 Hose protection sleeve
Protects hoses and leads against soiling and
damage.
Notice:
Detailed information about the hose systems can be found in the "Patient Hose
System" instructions for use WM 66696.
1 Filter grommet
Holds the suction filter in position.
2 Filter holder
For installing a hygiene input filter in the device.
3 Hygiene input filter
Protects the device from viral and bacterial
contamination.
Hygiene input filter (optional)
3Hygiene input filter
2Filter holder
1Filter grommet
10 EN Overview
1 Cover
Blocks the top two measuring ports on the device
during inhalation.
2 Inhalation mask
The patient inhales oxygen through the inhalation
mask.
3 Inhalation adapter
For connecting an inhalation mask to the device.
Inhalation adapter
2Inhalation mask
3Inhalation adapter
1Cover
Overview EN 11
Alarm limits
AActivate automatic alarm limits
Curves
Audio/Video
Options
Night colors
PPressure, flow
Pressure, CO
2
Pressure, flow, CO
2
Pressure, flow,
measurements
Pressure, CO
2
,
measurements
Pressure gauge
Automatic alarm limits
MVe n
MVe p
f n
Apnea
etCO
2
n
etCO
2
p
Advanced ventilation parameters
Brightness/Day
Brightness/Night
Brightness/NVG
Volume
Alarm LED
Year
Month
Day
Hour
Minute
CO
2
configuration
Date, time
Device data
Pressure ramp
Flow ramp
Flow progress
decreasing
constant
Plateau time
Trigger thresholds
Inspiration
Expiration
Trigger time slot
Apnea ventilation parameters
AActivated
Apnea mode
BiLevel + ASB
SIMV + ASB
Settings
PEEP
pInsp
Vt
Freq
I:E
Suction activated
Unit
mmHG
Vol%
kPa
Med. O΍
Compressed air
Concentrator O΍
Bluetooth
Compressed gas supply
Hygiene input filter
NVG
MEDUMAT Transport main menu
12 EN Overview
NIV
BiLevel + ASB
aPCV
PCV
CPAP + ASB
PRVC + ASB
IPPV
S-IPPV
SIMV + ASB
Inhalation
Pre-oxygenation
Mode menu
Overview EN 13
Symbols used on the display
Symbol Meaning
Emergency mode – Infant (up to approx. 1 year)
Emergency mode – Child (approx 1-12 years)
Emergency mode – Adult (approx 13 years and over)
Battery status indicator
Tick box: option activated
Radio button: function selected
Navigate upwards
Navigate downwards
Increase value
Decrease value
Confirm your selection
14 EN Overview
Navigation knob active
Bluetooth® connection:
When connection is activated, symbol is: Blue
When option is activated and no connection is active, symbol is: Black
Acoustic alarm output activated
Acoustic alarm output deactivated
Alarm volume set to < 50%
Acoustic alarm output permanently muted (NVG mode only)
Time
Trigger time slot
Symbol Meaning
Overview EN 15
Function of the controls during ventilation
Depending on the ventilation mode selected, the controls can be used to set the following
ventilation parameters
Ventilation
mode
Control
knob 1
Control
knob 2
Control
knob 3
Control
knob 4
Navigation
knob 5
Function
button 6
Function
button 7
Function
button 8
BiLevel +
ASB PEEP pInsp pMax Freq.
I:E and
Selection/
Confirmation
Δ pASB Trigger Mode
aPCV PEEP pInsp pMax Freq.
I:E and
Selection/
Confirmation
Trigger
time slot Trigger Mode
PCV PEEP pInsp pMax Freq.
I:E and
Selection/
Confirmation
--Mode
CPAP + ASB PEEP - pMax -
Only
Selection/
Confirmation
Δ pASB Trigger Mode
PRVC +
ASB PEEP Vt pMax Freq.
I:E and
Selection/
Confirmation
Δ pASB Trigger Mode
IPPV PEEP Vt pMax Freq.
I:E and
Selection/
Confirmation
--Mode
S-IPPV PEEP Vt pMax Freq.
I:E and
Selection/
Confirmation
- Trigger Mode
12345
6
7
8
16 EN Overview
Special markings
SIMV +
ASB PEEP Vt pMax Freq.
I:E and
Selection/
Confirmation
Δ pASB Trigger Mode
Inhalation - - - - Flow - - Mode
Pre-
oxygenation - - - - Flow - - Mode
Ventilation
mode
Control
knob 1
Control
knob 2
Control
knob 3
Control
knob 4
Navigation
knob 5
Function
button 6
Function
button 7
Function
button 8
MEDUMAT Transport
Battery
1MEDUMAT Transport type plate
3Safety check and service label
11 Rechargeable battery type plate
9Cover of USB interface
8Filter compartment
cover
7O2/Air inlet
2Voltage input
6O2/Air inlet/outlet
5Ventilation hose connection
Hygiene input filter (optional)
12 Hygiene input filter
4Follow the instructions for use
10 Battery clicks audibly into place
Overview EN 17
Symbol Meaning
MEDUMAT Transport type plate
1
Observe the instructions for use
1
Date of manufacture
1
Degree of protection against electric shock: Type BF device
1
Inlet
1
DC voltage
1Imin
Imax
Minimum and maximum current
1
Do not dispose of device in household waste.
1
Type of protection against electric shock: Protection class II device
1IPX4 Protection against ingress of water
1
CE mark (confirms that the device complies with the applicable European
Directives).
1SN Serial number
Other marks
2
Input voltage
18 EN Overview
3
Service label: Indicates when the next maintenance is required.
3STK label: (only in the Federal Republic of Germany) indicates when the
next safety check in accordance with §6 of the MPBetreibV (German
regulations governing owners/operators of medical devices) is required.
4
Follow the instructions for use
5
Maximum pressure 100 mbar
6
Volume flow rate
7
Input 2.7 bar–6 bar O2 or sterile compressed air
8, 9
Observe the instructions for use
10
Battery clicks audibly into place
Rechargeable battery type plate
11
Do not dispose of device in household waste.
11
Do not subject the device to hard knocks or shocks.
Symbol Meaning
O
2
/ AIR
270 – 600 kPa
80 – 150 l/min
Overview EN 19
Markings on the packaging
11
Do not use force to open the device.
11
Protect the device against heat.
11
Protect the device against moisture.
Hygiene input filter (optional)
12
Inlet
Observe the instructions for use
Do not reuse
Symbol Meaning
MEDUMAT Transport:
SN Serial number of the device
Permissible storage temperature: -30°C to +70°C
RH % 0-95 Permissible humidity for storage: max 95% relative humidity.
Symbol Meaning
3
20 EN Overview
Safety information in these instructions for use
The safety instructions in these instructions for use are marked as follows:
Warning!
Warns of the risk of injury and possible damage to the device.
Caution!
Warns of material damage and possibly incorrect therapy results.
Notice:
Offers useful tips.
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Weinmann MEDUMAT Transport Ventilator Operating instructions

Type
Operating instructions

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