Weinmann MEDUMAT Transport nstructions for Use for Devices from Software Version 6.7

MEDUMAT Transport
Ventilator
Instructions for Use for Devices from Software Version 6.7
Contents
1. Overview . . . . . . . . . . . . . . . . . . . . . 4
2. Description . . . . . . . . . . . . . . . . . . . 21
2.1 Intended use. . . . . . . . . . . . . . . . . 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 battery during use . . . . 58
5.17 Battery management . . . . . . . . . . 59
6. Ventilation modes . . . . . . . . . . . . . 63
6.1 Classification of the ventilation
modes . . . . . . . . . . . . . . . . . . . . . 63
6.2 Important ventilation parameters . . 65
6.3 Additional functions and safety
functions . . . . . . . . . . . . . . . . . . . 66
6.4 Pressure-controlled ventilation
modes . . . . . . . . . . . . . . . . . . . . . 68
6.5 Volume-controlled ventilation
modes . . . . . . . . . . . . . . . . . . . . . 78
7. Main menu . . . . . . . . . . . . . . . . . . . 84
7.1 Activating automatic alarm
limits. . . . . . . . . . . . . . . . . . . . . . . 84
7.2 Alarm Limits . . . . . . . . . . . . . . . . . 85
7.3 Curves . . . . . . . . . . . . . . . . . . . . . 86
7.4 Advanced ventilation
parameters . . . . . . . . . . . . . . . . . . 87
7.5 Apnea ventilation parameters . . . . 89
7.6 Audio/Video . . . . . . . . . . . . . . . . . 90
7.7 Options. . . . . . . . . . . . . . . . . . . . . 91
7.8 Night colors . . . . . . . . . . . . . . . . . 94
7.9 NVG (Night Vision Goggles) . . . . . 94
8. Operator menu . . . . . . . . . . . . . . . 96
8.1 Password Page . . . . . . . . . . . . . . . 99
8.2 Ventilation Modes. . . . . . . . . . . . . 99
8.3 File Export/Import . . . . . . . . . . . . 101
8.4 Software Update. . . . . . . . . . . . . 103
8.5 Options. . . . . . . . . . . . . . . . . . . . 105
8.6 User Settings. . . . . . . . . . . . . . . . 105
9. Hygienic preparation . . . . . . . . . . 109
9.1 MEDUMAT Transport . . . . . . . . . 109
9.2 Hose systems . . . . . . . . . . . . . . . 109
9.3 Parts and accessories. . . . . . . . . . 110
9.4 BiCheck flow sensor . . . . . . . . . . 110
9.5 Fittings . . . . . . . . . . . . . . . . . . . . 111
9.6 Hygiene input filter (optional) . . . 111
9.7 Cleaning, disinfection and
sterilization . . . . . . . . . . . . . . . . . 111
10. Function check . . . . . . . . . . . . . . . 115
10.1 Intervals . . . . . . . . . . . . . . . . . . . 116
10.2 Checking the system for leaks. . . 117
10.3 Checking the patient valve
(reusable hose system only). . . . . 118
10.4 Performing a function check . . . . 119
11. Troubleshooting . . . . . . . . . . . . . 123
2 EN Contents
11.1 Troubleshooting . . . . . . . . . . . . . 123
11.2 System alarms . . . . . . . . . . . . . . 125
11.3 Physiologic alarms . . . . . . . . . . . 127
12. Maintenance . . . . . . . . . . . . . . . . .129
12.1 MEDUMAT Transport . . . . . . . . . 129
12.2 Sending in device . . . . . . . . . . . . 130
12.3 Batteries. . . . . . . . . . . . . . . . . . . 131
12.4 Accessories. . . . . . . . . . . . . . . . . 131
12.5 Changing the suction filter . . . . . 131
12.6 Changing the hygiene input
filter . . . . . . . . . . . . . . . . . . . . . . 132
12.7 Storage . . . . . . . . . . . . . . . . . . . 133
12.8 Disposal . . . . . . . . . . . . . . . . . . . 134
13. Product, accessories . . . . . . . . . . . 135
13.1 Standard scope of supply . . . . . . 135
13.2 Accessories. . . . . . . . . . . . . . . . . 136
13.3 Options . . . . . . . . . . . . . . . . . . . 139
13.4 Replacement parts . . . . . . . . . . . 140
14. Technical Data . . . . . . . . . . . . . . . 142
14.1 Specifications . . . . . . . . . . . . . . . 142
14.2 Battery specifications . . . . . . . . . 147
14.3 Block diagram . . . . . . . . . . . . . . 148
14.4 Separation distances. . . . . . . . . . 148
14.5 O
consumption of the unit . . . . 149
2
14.6 Possible O2 concentration with
counterpressure . . . . . . . . . . . . . 149
14.7 Attainable tidal volume with
counterpressure . . . . . . . . . . . . . 151
14.8 Calculation of body weight on the
basis of body height . . . . . . . . . . 152
15. Glossary . . . . . . . . . . . . . . . . . . . .153
16. Warranty . . . . . . . . . . . . . . . . . . . . 156
17. Declaration of Conformity . . . . . . 156
Contents EN 3

1. Overview

Connections on MEDUMAT Transport
5 Filter compartment
cover, air inlet
1 Alarm LED
3 O2/AIR inlet
2 USB interface
7 Rechargeable
battery
8 DC connection
6 Ventilation connection
terminal
9 External power supply unit
4 O2/AIR inlet/
outlet
1 Alarm LED
Glows to indicate alarms.
2 USB interface
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 Rechargeable battery
Provides mobile power supply to the unit.
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
Provides power supply to the unit via a 100V - 240V grid.
4 EN Overview
1 CO2 measuring hose connection
Ventilation connection terminal
1 CO2 measuring hose connection
2 PEEP control hose connection
3 Pressure-measurement hose
connection
4 Ventilation hose/inhalation adapter
connection
5 BiCheck flow sensor connection line 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 attached to this connection via the connection plug.
3 Pressure-measurement hose connection
The pressure-measurement hose of the patient hose system is attached to this connection 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 BiCheck flow sensor connection line
connection
The BiCheck flow sensor connection line of the patient hose system is attached to this connec­tion.
Overview EN 5
1, 3, 5 Context-dependent function button
Controls of MEDUMAT Transport
1 Context-dependent
function button
11Function buttons for
emergency ventilation
9 Navigation knob
10 Context-dependent control knobs
4 Function button for
main menu
3 Context-dependent
function button
6 Function button for
100% O
2
7 Function button for
inspiratory O
2
concentration
5 Context-dependent
function button
8 On/Standby/Off
button
2 Alarm mute button with
LED
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% O
This button calls up the 100% O2 function to ven­tilate the patient briefly (for 2 minutes) with 100% O
(FiO2 = 1.0).
2
7 Function button for inspiratory O2
concentration
This button calls up the O2 concentration menu. The required inspiratory O respiratory gas can be set in this menu.
concentration in the
2
6 EN Overview
2
8 On/Standby/Off button
A short press switches the unit on and off. A long press switches it off completely.
9 Navigation knob
For navigating in menus and confirming your set­tings on the unit. During ventilation, this knob is 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.
1 Battery/Line operation indicators
Display of MEDUMAT Transport
2 Function
indicator for context­dependent function buttons
9 Info field
10 Mode indicator
8 Numeric measurement display
7 Battery
charge status
6 Numeric mea-
surement display
3 Ventilation progress display
1 Battery/Line operation indicators
4 Function indica-
tor for context­dependent con­trol knobs
5 Function indica-
tor for context­dependent func­tion buttons
Indicates whether the unit is being operated with the external power supply unit (upper LED) or with the internal battery (lower LED).
2 Function indicator for context-
dependent function buttons
The currently available function of the context­dependent 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 context­dependent 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
Displays the measured inspiratory O2 concentra­tion (FiO
).
2
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.
Overview EN 7
1 Ventilation hose
Hose system (reusable and disposable versions available)
5 BiCheck flow sensor
connection line
10 CO
2
measuring hose
4 PEEP control tube
11 Pressure-
measurement tube
1 Ventilation hose
7 Elbow
6 BiCheck flow sensor
9 Patient valve
12 Velcro strap
with clip
2 Water filter for CO2
measurement
3 Connector
8 Blanking plug
13 Tube
protection sleeve
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 the MEDUMAT Transport against moisture and contamination from the patient's respiratory gas.
3 Connector
The measurement-tube system is connected to MEDUMAT Transport by means of this connector.
4 PEEP control tube
With this tube, MEDUMAT Transport controls the patient valve and the PEEP.
5 BiCheck flow sensor connection line
This electric lead transfers the measuring signals from the BiCheck flow sensor to the MEDUMAT Transport.
6 BiCheck flow sensor
This sensor supplies monitoring data on flow, MV
, Vte and f.
e
7 Elbow
The mask/tube is connected here. The elbow is removable, i.e., the mask/tube can also be
Notice:
Detailed information about the hose systems can be found in the "Patient Hose System" instructions for use WM 66696.
8 EN Overview
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 CO
outlet if your MEDUMAT Transport is not
2
equipped with CO activated.
9 Patient valve
Switchover between inspiration and expiration happens here.
10 CO2 measuring hose
Test gas is removed via this tube if your unit is equipped with the optional CO facility.
11 Pressure- measurement tube
For patient-side measurement of ventilation pressure.
12 Velcro strap with clip
Used for fixing the patient hose system to the patient's clothing.
13 Tube protection sleeve
Protects tubes and leads against soiling and damage.
measurement or this is not
2
measurement
2
1 Filter grommet
Hygiene input filter (optional)
3 Hygiene input filter
2 Filter mount
1 Filter grommet
Holds the suction filter in position.
2 Filter mount
For installing a hygiene input filter in the device.
3 Hygiene input filter
Protects the device from viral and bacterial contamination.
Overview EN 9
1 Cover
Inhalation adapter
2 Inhalation mask
3 Inhalation adapter
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.
10 EN Overview
MEDUMAT Transport Main menu
Alarm limits
AActivate automatic alarm limits
Curves
Audio/Video
Options
Night colors
PPr essure, 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
CO2 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
Overview EN 11
Mode menu
NIV
BiLevel + ASB
aPCV
PCV
CPAP + ASB
PRVC + ASB
IPPV
S-IPPV
SIMV + ASB
Inhalation
Pre-oxygenation
Symbols used on the display
12 EN Overview
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
Symbol Meaning
Tick box: option activated
Radio button: function selected
Navigate upwards
Navigate downwards
Increase value
Decrease value
Confirm your selection
Navigation knob active
Bluetooth connection: – Symbol is gray when connection has been activated – Symbol is blue during communication
Acoustic alarm output activated
Acoustic alarm output deactivated
Alarm volume set to < 50%
Overview EN 13
Symbol Meaning
Acoustic alarm output permanently muted (NVG mode only)
Time
Trigger time slot
14 EN Overview
Function of the controls during ventilation
1 2 345
6
7
8
Depending on the ventilation mode selected, you can set the following ventilation parameters using the controls:
Ventilation
mode
BiLevel +
ASB
aPCV
PCV
CPAP + ASB
PRVC + ASB
IPPV
S-IPPV
Control
knob
PEEP pInsp pMax Freq.
PEEP pInsp pMax
PEEP pInsp pMax Freq.
PEEP - pMax -
PEEP Vt pMax Freq.
PEEP Vt pMax Freq.
PEEP Vt pMax Freq.
1
Control
knob 2
Control knob 3
Control knob 4
Freq.
Navigation
knob 5
I:E and Selection/ Confirmation
I:E and Selection/ Confirmation
I:E and Selection/ Confirmation
Only Selection/ Confirmation
I:E and Selection/ Confirmation
I:E and Selection/ Confirmation
I:E and Selection/ Confirmation
Function
button 6
Δ
pASB Trigger Mode
Trigger time slot
--Mode
Δ
pASB Trigger Mode
Δ
pASB Trigger Mode
--Mode
- Trigger Mode
Function
button 7
Trigger Mode
Function
button 8
Overview EN 15
Ventilation
mode
SIMV + ASB
Inhalation
Pre-
oxygenation
Control
knob
PEEP Vt pMax Freq.
----Flow --Mode
----Flow --Mode
1
Control knob 2
Control
knob 3
Control
knob 4
Navigation
knob 5
I:E and Selection/ Confirmation
Function button 6
Δ
pASB Trigger Mode
Function
button 7
button 8
Function
16 EN Overview
Special markings
MEDUMAT Transport
Battery
1 MEDUMAT Transport type plate
3 STK and service label
9 Cover of USB interface
8 Filter compartment
cover
6 O2/AIR inlet/outlet
2 Voltage input
5 Ventilation hose connection
4 Follow the instructions for use
7 O2/AIR inlet
10 Rechargeable battery type plate
Hygiene input filter (optional)
11 Hygiene input filter
Symbol Meaning
1
1
MEDUMAT Transport type plate
Consult instructions for use
Date of manufacture
1
Degree of protection against electric shock: type BF device
1
Input
Overview EN 17
Symbol Meaning
1
DC voltage
1
1
1
1
1
1
Other marks 2
3
3
4
I
min
I
max
IPX4
SN
Minimum and maximum current
Do not dispose of the unit in the household waste.
Type of protection against electric shock: protection class II device
Protection against ingress of water
CE mark (confirms that the device complies with the applicable European Directives).
Serial number
Input voltage
Service label: indicates when the next service is required.
STK label: (only in the Federal Republic of Germany) indicates when the next safety check in accordance with §6 Medical Device Operator Ordinance (MPBetreibV) is required.
Follow the instructions for use
5
18 EN Overview
Maximum pressure 100 mbar
6
O2 / AIR
7
8,9
10
10
10
10
Symbol Meaning
270 – 600 kPa
80 – 150 l/min
Volume flow rate
Input 2.7 bar–6 bar O2 or sterile compressed air
Consult instructions for use
Rechargeable battery type plate
Do not dispose of the unit in the household waste.
Do not subject the unit to hard knocks or shocks.
Do not open the unit using force.
Protect the unit against heat.
10
Protect the unit against moisture.
Overview EN 19
Symbol Meaning
3
Hygiene input filter (optional)
11
Input
Consult instructions for use
Do not reuse
Labeling on the packaging
Symbol Meaning
MEDUMAT Transport:
SN
Serial number of the unit
Permissible storage temperature: -30°C to +70°C
RH % 0-95
Permissible humidity for storage: up to 95% relative humidity
Safety information in these instructions for use
The safety instructions in these instructions for use are marked as follows:
Warning!
Warns of risk of injury and possible damage to the unit.
Caution!
Warns of material damage and possibly incorrect therapy results.
Notice:
Offers useful tips.
20 EN Overview

2. Description

2.1 Intended use

The MEDUMAT Transport is an automatic oxygen ventilator with additional preoxygen­ation and monitoring functions (pressure, flow and CO
MEDUMAT Transport is used for the controlled and assisted, as well as invasive and non-inva­sive, ventilation of adults, children, and infants. tidal volumes of 50ml or more are possible. Smaller tidal volumes are also possible in the case of pressure-controlled ventilation.
MEDUMAT Transport must only be operated when installed permanently or on approved por­table systems.
In the case of volume-controlled ventilation,

2.2 Applications

MEDUMAT Transport can be used in the following cases for up to 30 days:
Emergency
for resuscitation at the place of the emergency
for longer-tem use in continuing emergency situations
for preoxygenation via a ventilation mask
for inhalation via an oxygen mask or nasal cannula
).
2
Transport
in ground, sea and air emergency medical service
between hospital rooms and departments
between a hospital and other locations (secondary transport)
Ventilation in hospitals
recovery room
intensive care unit
surgery preparation and follow-up
emergency department
MEDUMAT Transport is also suitable for gentle ventilation of anesthetized patients (TIVA: total intravenous anesthesia).
Description EN 21

2.3 Operator and user qualification

MEDUMAT Transport must only be used by persons who can verify that they have the following qualifications:
A medical qualification and training in ventilation techniques
Training in the use of the MEDUMAT Transport by a person authorized by WEINMANN Emergency
Improper use may lead to serious physical injury.
As the operator or user, you must be fully familiar with the correct operation of this medical device. Observe the statutory requirements for operation and use (in Germany, particularly the German regulations governing owners/operators of medical devices (MPBetreibV)). General recommendation: You should seek instruction on the correct handling, use and operation of this medical device from a person authorized by WEINMANN Emergency.

2.4 Function

The unit
MEDUMAT Transport is used to treat apnea and to provide respiratory support. By means of adjustable ventilation parameters, the unit ensures uniform ventilation tailored to the patient.
Pressure-controlled and volume-controlled ventilation modes can be selected for optimum patient ventilation.
In CPAP + ASB mode, the unit enables assisted spontaneous breathing with continuous positive airway pressure and respiration-controlled oxygen inhalation. In addition, the unit permits O
The unit allows the oxygen concentration of the respiratory gas to be adjusted.
Depending on the version, the unit's large display can show up to three spirometric curves (pressure, flow and CO
For emergency situations, rapid selection of default types of ventilation is possible.
With the data communication option enabled, the device can transmit its application data to an application documentation system via Bluetooth.
inhalation for preoxygenating the patient.
2
) or two curves and additional measured values.
2
22 EN Description
Patient Hose System
The ventilation gas is supplied to the patient via the Patient Hose System, comprising the ventilation hose and all leads necessary for comprehensive ventilation and monitoring.
The Patient Hose System is designed to permit spontaneous respiration even if the MEDUMAT Transport malfunctions.
The following versions of the patient hose system are available:
Reusable hose system with CO
Reusable hose system without CO
Disposable hose system with CO
Disposable hose system without CO
Disposable hose system with reduced dead space with CO
measuring hose
2
measuring hose
2
measuring hose
2
measuring hose
2
measuring
2
hose
Disposable hose system with reduced dead space without CO
2
measuring hose
Disposable hose system with reduced dead space with CO
measuring
2
hose for adults and children
Disposable hose system with reduced dead space without CO
2
measuring hose for adults and children
Hygiene input filter (optional)
For ventilation in a contaminated atmosphere, MEDUMAT Transport can be used with a hygiene input filter. This protects the device from viral and bacterial contamination.
Inhalation adapter
The ventilation gas can alternatively be supplied to the patient via the inhalation adapter and the inhalation hose. During inhalation the measuring ports on the device are blocked by a cover so the device does not take in ambient air.
Description EN 23

3. Safety information

Read these instructions for use carefully. It is part of the unit and must be available at all times.
For your own safety and that of your patients, and in accordance with the requirements of Directive 93/42/EEC, please observe the following points:
General
Always carry out a functional check before using the unit (see "10. Function check" on page 115).
Please observe the section "9. Hygienic preparation" on page 109 in order to avoid infection or bacterial contamination.
Warning!
Risk of injury. Only use MEDUMAT Transport if you are a qualified medical professional and have received training in respiration techniques. Improper use may lead to serious physical injury.
Risk of injury. Never leave the patient or the ventilator unattended during ventilation. Only then can you respond quickly if the patient's condition deteriorates or in the event of an alarm or malfunction. Delayed response on the part of medical personnel may lead to serious physical injury.
Risk of injury from deactivated alarm LED, deactivated acoustic alarm output and darkened display in NVG mode! The alarms are barely perceptible as a result of the deactivated alarm LED, the deactivated acoustic alarm output and the darkened display in NVG mode. This can injure the patient.
– Always monitor the patient during ventilation.
– Only use the NVG option in the military sector.
Only use MEDUMAT Transport for the designated purpose (see "2.1 Intended use" on page 21).
MEDUMAT Transport is not suitable for hyperbaric use (pressure chamber).
The unit is not licensed for use in explosive atmospheres. The unit must not be used in combination with flammable gases or anesthetics.
The unit is not licensed for use in poisonous atmospheres.
Only operate the unit in a contaminated atmosphere with a hygiene in­put filter.
24 EN Safety information
Only operate the unit with a filter compartment cover or hygiene input filter to prevent any liquids from entering the unit.
Always keep the air inlet openings on the filter compartment cover or the suction inlets on the hygiene input filter clear.
Only have modifications to the unit carried out by the manufacturer, WEINMANN Emergency, or by a technician expressly authorized by WEINMANN Emergency.
Caution!
Do not place a switched-on cellular phone or radio closer than 1 m from the MEDUMAT Transport, as this could cause malfunctions.
Remember that the respiratory resistance of the system as a whole may increase beyond the level specified by the standard when an HME filter (heat and moisture exchanger), a bacterial filter or a combined HME bacterial filter is used. Please also follow the manufacturer's instructions for use for the filter being used.
When operating the unit with the power supply unit, always connect the unit to an easily accessible outlet so that it can be unplugged quickly in the event of a malfunction.
When operating the unit with the power supply unit, make sure that the power cord cannot cause anyone to trip or cause any obstruction. If necessary, do not use an external power supply, but operate the unit with the battery instead.
When operating the unit with the 12 V supply cord, always connect the unit to an easily accessible vehicle electrical system receptacle so that it can be unplugged quickly in the event of a malfunction.
When operating the unit with the 12 V supply cord, make sure that the cord cannot cause anyone to trip or cause any obstruction. If necessary, do not use the vehicle electrical system, but operate the unit with the battery instead.
An alternative ventilation unit must be kept available in case a unit fails.
After using the unit in a dusty environment (e.g., a gravel plant), change the suction filter (see "12.5 Changing the suction filter" on page 131) or the hygiene input filter (see "12.6 Changing the hygiene input filter" on page 132).
Only operate a unit with hygiene input filter with software version 6.1 or higher.
Safety information EN 25
Safe handling of oxygen
Warning!
Risk of explosion! In combination with combustible substances (grease, oil, alcohol etc.), highly compressed oxygen may give rise to spontaneous explosive reactions.
Risk of fire! If only the O2/AIR inlet/outlet is used, close the O2/AIR inlet on the side with a suitable cap. Otherwise, gas will escape from the O2/ AIR inlet on the side.
Risk of poisoning! Highly concentrated oxygen can have a toxic effect on the patient if administered for too long and depending on the age of the patient. When ventilating with pure oxygen or an oxygen-air mixture, make sure that oxygen is only administered for an appropriate period.
Keep the units and all screwed unions absolutely free from oil and grease.
Be sure to wash your hands before working on the oxygen supply.
Smoking and open flames are strictly prohibited in the vicinity of fittings containing oxygen.
Caution!
When assembling the unit, and when changing cylinders, tighten all screwed unions on the oxygen cylinder and pressure reducer by hand only. Never use tools. Overtightening damages the threads and seals, resulting in leaks.
Secure the oxygen cylinders so that they cannot fall over. If a cylinder falls on the pressure reducer or valve, these could break off, causing a violent explosion.
Risk of insufficient oxygen supply! Two oxygen sources can be connected to this unit simultaneously. Make sure that only one oxygen source is open at any given time and that there is no gas reflux. Otherwise, one of the oxygen sources may empty itself unnoticed. Sufficient oxygen supply to the patient can then no longer be guaranteed when the unit is in use.
Always open the cylinder valve slowly to prevent pressure hammer on the fittings.
Do not empty oxygen cylinders completely, as this may allow moist ambient air to enter and cause corrosion.
26 EN Safety information
Ventilation/Handling
Caution!
The USB port on the device must only be used for the application scenarios outlined in the instructions for use. Only USB sticks which conform to the USB standard 2.0 should be inserted in the USB port, otherwise this interferes with operation of the unit, putting the patient at risk.
Patient and ventilator must be kept under continuous observation during ventilation.
Prolonged ventilation can lead to atrophy of the muscles (dependency of the patient on ventilation).
Prolonged ventilation may lead to the airway drying out. Ensure adequate conditioning of the respiratory gas.
Only apply high ventilation pressures for short periods and only if medically indicated. Permanently applied high ventilation pressures can be injurious to the patient.
Make sure that the patient valve is not covered or its function impaired, e.g. by the patient's position.
The patient hose systems for the device have different dead spaces. Please take the dead space into consideration when selecting the ventilation parameters, particularly when ventilating infants with very small tidal volumes. Otherwise, there is a risk of insufficient ventilation.
Do not place the patient valve of the disposable hose system with reduced dead space near the O2/Air inlet of the MEDUMAT Transport, in order to prevent the device sucking in CO
Please note that the inspiratory resistance of a disposable hose system with reduced dead space increases during adult ventilation.
Please note that the use of additional accessories between the ventilation hose and patient (e.g., humidifiers, nebulizers, and goosenecks) increas­es the dead space.
The device is not suitable for the ventilation of premature babies (born before the end of the 36th week of pregnancy).
Please note that if concentrator oxygen with an oxygen concentration outside of the specifications is used (see 14.1, page 142), the tolerances specified for the O
measurement may also vary.
2
Risk of injury from switching on a device with activated NVG mode during daylight or without a night vision device! A device with activated NVG mode cannot be used straight away during daylight or without a night vision device. This can injure the patient.
– Keep an alternative ventilation unit at the ready.
.
2
Safety information EN 27
When performing ventilation with a tidal volume Vt < 200 ml, a PEEP > 0 mbar and an inspiratory O the inspiratory O2 concentration administered can deviate from the set value. Reduce the PEEP to decrease the administered inspiratory O2 concentration.
concentration set to FiO2 <70%,
2
Patient Hose System
Warning!
Risk of injury. Only use the Patient Hose System if you are a qualified medical professional and have received training in respiration techniques. Improper use may lead to serious physical injury.
• The Patient Hose System must be subjected to a functional check and visual inspection by the user before use. For this, refer to the instructions for use for the Patient Hose System.
• When connecting the patient valve, check that the direction of flow of the respiratory gas is correct. Make sure that the expiration opening of the patient valve is not covered or prevented from functioning, e.g., by the patient's position.
• Only use the Patient Hose System for the purpose described. For this, refer to the instructions for use for the Patient Hose System.
• The Patient Hose System is not suitable for hyperbaric use (pressure chamber).
• Also refer to the instructions for use for the Patient Hose System.
Software
Risks due to software errors have been minimized by means of extensive qualification measures.
This unit‘s software contains code which is subject to the GPL. You will receive the source code and the GPL upon request.
Accessories/Repairs/Replacement parts
Caution!
Protect silicone/rubber parts against UV light and prolonged direct exposure to sunlight to prevent them becoming brittle.
We recommend that work such as inspections and repairs should be carried out by the manufacturer, WEINMANN Emergency, or by a technician expressly authorized by WEINMANN Emergency.
28 EN Safety information
If third-party items are used, functional failures may occur and fitness for use may be restricted. Biocompatibility requirements may also not be met. Please note that in such cases, any claim under warranty and liability will be voided if neither the accessories nor genuine replacement parts recommended in the instructions for use are used.
This product may contain disposable items. Disposable items are intended to be used only once. So use these items only once and do not reprocess them. Reprocessing disposable items may impair the functionality and safety of the product and lead to unforeseeable reactions as a result of ageing, embrittlement, wear, thermal load, the effects of chemical processes, etc.
Safety information EN 29

4. Installation

As a rule, MEDUMAT Transport only has to be installed for stationary use in rescue vehicles, helicopters or aircraft. In this case, fastening sets can be supplied as accessories.
If MEDUMAT Transport is supplied complete on a portable system, the unit is ready for operation and no further installation work is required. There are separate instructions for use for the portable systems.
Warning!
After installation, you must perform a functional check (see "10. Function check" on page 115) to ensure reliable operation.

4.1 Connecting oxygen cylinder

Warning!
Risk of explosion! Wash your hands thoroughly before doing any work on the oxygen supply. Hydrocarbon compounds (e.g. oil, grease, cleaning alcohol, hand cream or adhesive plasters) can cause explosive reactions if they come into contact with highly compressed oxygen.
Never use wrenches or other tools to tighten or unscrew the union nuts.
Notice:
Only use the High Flow OXYWAY Fast II and OXYWAY Fix III pressure reducers on the MEDUMAT Transport. Foreign pressure reducers can impair the unit's efficiency.
Removing the empty cylinder
1. Close the valve on the oxygen cylinder.
2. Switch MEDUMAT Transport off again.
3. Undo the screwed union at the cylinder by hand.
30 EN Installation
Switch on MEDUMAT Transport at the On/Standby/Off switch. This allows the remaining oxygen to escape and the unit is pressure-free. Only when the contents gauge on the pressure reducer indicates 0 bar, can the screwed union be undone by hand.
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