Weinmann MEDUVENT Standard User manual

MEDUVENT Standard
Ventilator
Instructions for Use for Devices from Software Version 2.1
Read these instructions for use before using the product. Ignoring the
instructions for use might lead to serious injury or death.

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Table of contents
Table of contents
1 Introduction 6
1.1 About this document ..................................................................... 6
1.2 Explanation of warnings ................................................................ 6
2 Safety 7
2.1 Intended purpose .......................................................................... 7
2.2 Clinical benefit of the product ........................................................ 8
2.3 Requirements on the user .............................................................. 9
2.4 Using the device safely .................................................................. 9
3 Description 20
3.1 Overview ..................................................................................... 20
3.2 Control panel and display ............................................................ 22
3.3 Symbols in the display ................................................................. 25
3.4 Accessories and other parts ......................................................... 26
3.5 Rechargeable battery and battery status indicator ........................ 32
3.6 Transport options ........................................................................ 33
4 Preparation 34
4.1 Mounting the device ................................................................... 34
4.2 Connecting a power supply ......................................................... 34
4.3 Connecting the breathing circuit .................................................. 36
4.4 Connecting the oxygen supply ..................................................... 41
4.5 Converting the device .................................................................. 43
5 Function check 45
5.1 Intervals ...................................................................................... 45
5.2 Preparing for the function check .................................................. 45
5.3 Performing the function check ..................................................... 46
5.4 Checking reusable breathing circuit ............................................. 53
6 Operation 54
6.1 Switching on the device ............................................................... 55
6.2 Navigating in the device .............................................................. 56
6.3 Starting ventilation ...................................................................... 57

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6.4 Changing ventilation mode .......................................................... 61
6.5 Changing ventilation parameters ................................................. 63
6.6 Changing patient group .............................................................. 65
6.7 Supplying oxygen ........................................................................ 66
6.8 Switching off the device .............................................................. 69
6.9 Disconnecting the oxygen supply ................................................. 69
6.10 After use ..................................................................................... 69
7 Hygienic reprocessing 70
7.1 Hygienic reprocessing intervals .................................................... 73
7.2 Preparing for hygienic reprocessing .............................................. 74
7.3 Disassembling/assembling the reusable breathing circuit .............. 74
7.4 Cleaning parts manually .............................................................. 79
7.5 Disinfecting parts by wiping ......................................................... 83
7.6 Disinfecting parts by immersion ................................................... 84
7.7 Disinfecting the reusable measuring circuit by immersion ............. 86
7.8 Reprocessing parts mechanically .................................................. 88
7.9 Steam-sterilizing parts (optional) ................................................. 90
7.10 Preparing parts for reuse ............................................................. 91
7.11 Cleaning and disinfection plan ..................................................... 92
8 User menu 98
8.1 Navigating the user menu ........................................................... 98
8.2 User menu structure .................................................................... 99
8.3 Settings in the user menu .......................................................... 100
9 Operator menu 105
9.1 Activating the operator menu .................................................... 105
9.2 Operator menu structure ........................................................... 106
9.3 Device settings .......................................................................... 107
9.4 Patient presets .......................................................................... 109
9.5 Changing the access code ......................................................... 111
9.6 Options ..................................................................................... 112
9.7 Importing/exporting data ........................................................... 114
9.8 Software update ........................................................................ 117

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9.9 Device information .................................................................... 119
9.10 Battery information ................................................................... 120
10 Description of the modes 121
10.1 IPPV .......................................................................................... 121
10.2 CPAP ........................................................................................ 122
10.3 CPAP + PS (optional) ................................................................ 123
10.4 PRVC + PS (optional) ................................................................ 125
10.5 SIMV (optional) ......................................................................... 126
10.6 S-IPPV (optional) ....................................................................... 127
10.7 Manual ..................................................................................... 129
11 Alarms and faults 131
11.1 Alarm messages ........................................................................ 132
11.2 Faults ........................................................................................ 135
12 Maintenance 137
12.1 Intervals .................................................................................... 137
12.2 Maintenance reminder .............................................................. 139
12.3 Maintaining the reusable breathing circuit ................................. 140
12.4 Replacing the hygiene filter ....................................................... 140
12.5 Replacing the rechargeable battery ............................................ 142
12.6 Sending in parts ........................................................................ 147
13 Storage 148
14 Disposal 149
14.1 Electronic waste ........................................................................ 149
14.2 Rechargeable battery ................................................................ 149
14.3 Plastics ..................................................................................... 149
14.4 Hygiene filter ............................................................................. 149
14.5 Contaminated parts .................................................................. 150
15 Scope of supply 151
15.1 Standard scope of supply ........................................................... 151
15.2 Accessories and other parts ....................................................... 152
16 Technical data 157
16.1 Device ....................................................................................... 157

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16.2 Rechargeable battery ................................................................. 163
16.3 Power supply unit and charger ................................................... 164
16.4 Breathing circuits ...................................................................... 165
16.5 Block diagram ........................................................................... 167
16.6 Electromagnetic compatibility (EMC) .......................................... 167
16.7 Calculating tidal volume on the basis of height .......................... 173
16.8 Exported service data ................................................................ 174
16.9 Alarm delay times ...................................................................... 176
17 Symbols and labels 177
17.1 Labels on the device .................................................................. 177
17.2 Labels on the accessories ........................................................... 181
17.3 Labels on the packaging ............................................................ 183
18 Warranty 184
19 EC Declaration of Conformity on Medical
Devices 184

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1 Introduction
1 Introduction
1.1 About this document
This document describes all possible versions of the device.
The functions, accessories and other parts described in this
document or shown in illustrations depend on the version
procured, and are not available in all cases.
If functions of the device can only be enabled by purchasing a
specific option, this document makes this clear by appending
“(optional)” and “(only with option XXXX)” to the text.
Illustrations in these instructions for use are for general
understanding, and may differ from the actual version. No claims
can be brought on the basis of any deviations.
Texts shown in the device display appear in this document in bold.
Example: Select Start.
1.2 Explanation of warnings
Danger!
DANGER indicates a dangerous situation which will result in death
or serious injury if not prevented.
Warning!
WARNING indicates a dangerous situation which might result in
death or serious injury if not prevented.
Caution!
CAUTION indicates a dangerous situation which might result in
minor injury if not prevented.
Notice!
NOTICE indicates risks which might possibly cause material or
environmental damage.
Designates useful tips relating to a particular sequence of actions.

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2 Safety
2 Safety
The instructions for use are part of the device. If the instructions for
use and the following safety instructions are not followed in their
entirety, therapy might fail or be put at risk. This could cause the
patient, the user and bystanders serious or life-threatening injury.
Follow instructions for use in their entirety.
Keep the instructions for use accessible and near the device at
all times.
Use the device only for the intended purpose (see
“2.1 Intended purpose”, page 7).
Do not use the device if it is contra-indicated.
Follow the instructions for use of accessories and other parts.
Report any serious incidents involving the device to the
manufacturer and to the responsible authority.
2.1 Intended purpose
Indications
MEDUVENT Standard is an emergency and transport ventilator
with functions for the monitoring of respiratory values. The device
can be used for invasive and non-invasive ventilation via the nose,
mouth and trachea.
Patient target group(s)
MEDUVENT Standard is used in the treatment of infants, children,
and adults with a body weight of 7 kg and more where
spontaneous breathing has failed or is inadequate. In the case of
volume-controlled ventilation, tidal volumes of 50 ml or more are
possible.
Intended users
Qualified medical personnel (e.g. paramedics, emergency
physicians).
Contra-indications
There are no known contra-indications for the use of this product.

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2 Safety
2.1.1 Intended areas of application
• Mobile use in emergency medicine or primary care at the site
of the emergency, e.g. for resuscitation or to initiate and
execute anesthesia (including TIVA: total intravenous
anesthesia)
• During transport between hospital rooms and departments
• During transport between the hospital and other premises by
ambulance, aircraft, helicopter or ship
• In hospital in the shock room or recovery room
2.1.2 Possible side effects and complications
• Undesired effect on the cardiovascular system (e.g. reduced
cardiac output, reduced venous return)
• Drying of the airways
• Hyperinflation of lung tissue (e.g. lung rupture)
• Gastric insufflation during mask ventilation (e.g. aspiration of
stomach contents)
2.1.3 Exclusions and limitations of the intended use
The device has not been approved for the following applications:
• Operation in hyperbaric chambers
• Operation in conjunction with magnetic resonance imaging
machines
• Use in sustained ventilation for longer than 24 hours
2.2 Clinical benefit of the product
The medical benefit of ventilation therapy is the sustained
oxygenation and ventilation (CO2evacuation) of the lungs in the
event that spontaneous breathing fails. A mechanical ventilator
also offers the following benefits relative to a bag-valve mask:
• More constant tidal volume and lower peak pressures

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2 Safety
• Less risk of hyperventilation
• Less risk of undesired hypoventilation
• Less risk of gastric insufflation
2.3 Requirements on the user
The user must meet the following requirements:
• The user is medically trained and has the necessary technical
knowledge and experience in the emergency medical
treatment of patients.
• On the basis of this technical knowledge and experience, the
user is in a position to perform the tasks assigned to him or her
safely, and to independently recognize, assess and avoid
potential risks to him or herself, to the patient or to bystanders.
• The user has been trained and has received instruction in the
use of the device.
• The user has been trained to apply the necessary hygiene
procedures.
2.4 Using the device safely
Risk of injury from device being used for too long without
further humidification of the respiratory gas!
If the device is used for too long, the patient might be ventilated
with dry gas for too long. This can cause serious or life-threatening
injury to the patient.
Do not use the device for sustained ventilation (longer than
24 hours).

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2 Safety
Hazardous therapy as a result of inadequate patient
monitoring!
If the patient and the device are not observed and monitored
during ventilation, delayed response by medical personnel to
alarms and faults might result in serious or life-threatening injury
to the patient and incorrect therapy.
Continuously observe and monitor the patient and device
during ventilation.
Additionally use external monitoring (e.g. SpO2and/or etCO2).
Failure of therapy as a result of device malfunction or loss of
pneumatic or electric power!
A device failure might result in failure of the therapy. This can
cause serious or life-threatening injury to the patient.
Have an alternative means of ventilation at the ready.
Risk of injury resulting from incorrectly set limitation of
maximum airway pressure!
An excessively high airway pressure might cause the patient
serious or life-threatening injury.
Always set the pressure limit pMax to match the current patient
and the current therapy.
Risk of suffocation resulting from extubation during patient
transport!
If the device falls off, or the breathing circuit becomes
disconnected during patient transport, the patient might be
extubated, resulting in laryngospasm. This can cause serious or
life-threatening injury to the patient.
Secure the device against falling while transporting the patient
on a stretcher.
Always fix the breathing circuit in place while transporting the
patient.
Risk of asphyxia as a result of aspiration!
Mask ventilation at excessive ventilation pressures can lead to
gastric insufflation and aspiration of stomach contents. This can
cause serious or life-threatening injury to the patient.
Avoid high pressures during mask ventilation.

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2 Safety
Hazardous therapy due to leaks during ventilation!
The measured MVi value indicates the volume the device is
administering to the patient. In the event of leaks during
ventilation, the measured MVi value will not match the tidal
volume actually administered. If this is not observed, the patient
might suffer serious or life-threatening injury.
Check that the mask or tracheal tube is correctly positioned.
Do not use the measured MVi value as an adequate means of
assessing ventilation.
Use external monitoring (etCO2, SpO2or expiratory volume
measurement).
Risk of infection resulting from failure to use hygiene filter!
If the device is used without a hygiene filter in a contaminated
environment, it might draw in contaminated ambient air. This
might cause the patient and the user serious or life-threatening
injury.
Always use a hygiene filter when operating the device in a
contaminated environment.
Reduced ventilation performance resulting from increased
device input resistance as a result of using the device in a very
dusty atmosphere!
If the device is operated in a very dusty atmosphere, it might draw
in dust and dirt from the ambient air, which might get into the
patient's lungs. Ventilation performance might also be reduced by
increased device input resistance. This can cause serious or life-
threatening injury to the patient, and damage the device.
Only operate the device with a hygiene filter.
Replace the hygiene filter after operating the device in a very
dusty atmosphere.

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2 Safety
Disrupted or failed therapy due to defective or non-
operational device or accessories!
Using defective devices or defective accessories may result in
device malfunctions. This might cause the patient and the user
serious or life-threatening injury.
Perform a complete function check prior to every use.
Only operate the device and accessories if they are externally
undamaged.
Only use devices and accessories which have passed the
function check.
Have defective devices repaired.
Have defective accessories repaired, or replace them.
Follow the instructions for use of the accessories.
Observe maintenance intervals.
Disrupted or failed therapy due to inadequate protection
from dust and damp!
If the interfaces for the SD card or the breathing circuit are not
protected when transporting the device in a dusty or damp
environment, disruption or failure of therapy might occur as a
result of device failure. This can cause serious or life-threatening
injury to the patient, and damage the device.
Close the SD card cover to assure IP protection.
Connect the breathing circuit or close the protective caps to
assure IP protection.
Inadequate patient monitoring and device operability
resulting from device being operated in an unsuitable
position!
Operating the device in an unsuitable position might mean that
alarm transmitters cannot be heard or the display is hard to read.
This can cause serious or life-threatening injury to the patient.
Use the device only in the following positions:
• Display facing upward (when the device is standing on a
table for example).
• Display facing forward (when the device is mounted on a
wall by a portable unit for example).

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2 Safety
Risk of injury and treatment delay due to imperceptible alarm
signals!
Alarm signals below the noise level in the
environment prevent alarm situations being detected. This might
result in treatment delays and thus to injury to the patient.
Always set the device volume to be louder than ambient noise
level.
Electric shock resulting from incompatibility with other
devices!
Connecting a different device or non-approved accessories might
cause voltage on a part of the device which can be contacted, and
so lead to electric shock. This can cause serious or life-threatening
injuries to the user.
Use only approved accessories.
Disrupted or failed therapy due to operation of the device and
accessories outside the specified ambient conditions!
Using the device and accessories outside the specified ambient
conditions might result in tolerances being exceeded, and in
device failure. This can cause serious or life-threatening injury to
the patient.
Only operate the device and accessories within the specified
ambient conditions (see “16 Technical data”, page 157).
Never use the device and accessories in hyperbaric chambers.
Risk of explosion if the device is used in hyperbaric chambers!
If the device is used in a hyperbaric chamber, this may lead to
explosions.
Never use the device in hyperbaric chambers.
Disrupted or failed therapy due to use of bubble humidifiers!
Using bubble humidifiers might cause moisture at the oxygen inlet
and result in malfunctions and device failure. This can cause
serious or life-threatening injury to the patient.
Do not use bubble humidifiers.
Risk of injury from operating the device in a toxic
environment!
Operating the device in a toxic environment may cause toxic gases
to reach the patient’s lung, causing him or her serious or life-
threatening injury.
Do not use the device in a toxic environment.

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2 Safety
Disrupted or failed therapy due to lack of maintenance!
If maintenance intervals are not observed, malfunctions might
occur. This can cause serious or life-threatening injury to the
patient.
Observe the maintenance schedule according to the
instructions for use and the displays on the device.
Observe the maintenance schedule even for devices and
accessories in storage.
Disrupted or failed therapy due to modifications to the design
of the device or accessories!
Modifications to the design of the device might result in disruption
or failure of therapy. This can cause serious or life-threatening
injury to the patient.
Do not make any modifications to the design of the device or
accessories.
Risk of fire and explosion resulting from incorrect handling of
highly compressed oxygen/oxygen cylinder!
Compressed oxygen in combination with combustible substances
in an oxygen-enriched environment might cause fires and
explosions. This can cause serious or life-threatening injury to the
patient, user and bystanders.
Never smoke near oxygen-carrying fittings.
Keep the oxygen supply away from naked flames and other
ignition sources.
Ensure adequate ventilation.
Keep the device and screw fittings free of oil and grease.
Wash your hands to remove any oil or grease before working
on the oxygen supply.
Secure the oxygen cylinder against toppling over.
Tighten or loosen all screw fittings on the oxygen cylinder and
on the pressure reducer by hand only.
Risk of fire resulting from use of the device in conjunction
with anesthetics!
Flammable gases and anesthetics can cause spontaneous
explosions. This might cause the patient, user and bystanders
serious or life-threatening injury, as well as damage the device.
Do not use the device in conjunction with flammable gases or
gaseous and ignitable anesthetics.

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2 Safety
Risk of injury resulting from incorrect handling of the
rechargeable battery!
Incorrect handling of the rechargeable battery might cause the
patient, user and bystanders serious or life-threatening injury.
Do not throw the rechargeable battery into a fire, and never
expose it to high temperatures.
Do not open the rechargeable battery.
Do not deform the rechargeable battery.
Do not short-circuit the rechargeable battery.
Protect the rechargeable battery from moisture.
Protect the rechargeable battery from high temperatures.
Do not subject the rechargeable battery to high pressure.
Have the rechargeable battery replaced only by trained
personnel.
Premature failure of therapy resulting from use of a
rechargeable battery with a low state of charge at low
temperatures!
Using a rechargeable battery with a low state of charge at low
temperatures of < 0 °C might result in a much reduced device
operating time, and thus to premature failure of therapy. This can
cause serious or life-threatening injury to the patient.
Always use a fully charged rechargeable battery at low
temperatures.
Disrupted or failed therapy due to interaction between
medical electrical devices!
Medical electrical devices which are operated directly next to or on
top of one another can cause mutual interference to functionality.
This can cause serious or life-threatening injury to the patient.
Do not stack the device with other medical electrical devices.
Do not operate the device in the direct vicinity of other medical
electrical devices (exception: WEINMANN Emergency devices
which have been tested to ensure that they can be operated
alongside the device without problems. A list of the tested
devices can be provided on request).
If stacking or operation in the immediate vicinity cannot be
avoided: Closely monitor the functioning of all affected
medical electrical devices, and do not use if functions are
disrupted.

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2 Safety
Disrupted or failed therapy due to magnetic resonance
imaging machines in the immediate vicinity of the device!
The magnetic action of magnetic resonance imaging machines in
the immediate vicinity of the device might throw the device
around. This might lead to therapy being interrupted, and cause
the patient serious or life-threatening injury.
Never operate device in conjunction with magnetic resonance
imaging machines.
Disrupted or failed therapy due to portable radio-frequency
communication equipment in the immediate vicinity of the
device!
Portable high-frequency communication equipment (e.g. radios,
antennas and antenna cables) in the immediate vicinity of the
device may impair the performance characteristics of the device,
and injure the patient.
Keep portable radio-frequency communication equipment a
minimum distance of 30 cm away from the device and its
accessories.
Faults in, or failure of, the device or its accessories during
therapy as a result of high-frequency surgical equipment in
the immediate vicinity of the device!
High-frequency surgical equipment in the immediate vicinity of
the device or its accessories may lead to faults or failure of the
device or its accessories. This can cause serious or life-threatening
injury to the patient.
Do not use the device and its accessories in the vicinity of high-
frequency surgical equipment.
Disrupted or failed therapy due to incompatibility of the
device with consumables, accessories and other medical
devices!
Defective or non-approved accessories might cause malfunctions,
increased electromagnetic interference or reduced
electromagnetic immunity of the device, incorrect output values,
and reduced ventilation performance. This can cause serious or
life-threatening injury to the patient.
Use only approved accessories.
Follow the instructions for use of the accessories.

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2 Safety
Disrupted and failed therapy due to incorrect use of
disposables!
Reusing and reprocessing disposables might induce unpredictable
reactions as a result of aging, embrittlement, wear, thermal
loading, and chemical action. This might place the functionality
and safety of the device at risk, and cause the patient or user
serious or life-threatening injury.
Do not reuse disposables.
Do not subject disposables to hygienic reprocessing.
Risk of infection and contamination from contaminated
disposables!
Reused disposables may cause infections and contamination if
they come into contact with airways. This might cause the
patient and the user serious or life-threatening injury.
Do not reuse disposables.
Do not subject disposables to hygienic reprocessing.
Risk of injury resulting from condensation in the patient valve
at temperatures below 0 °C!
If patients are subjected to sustained ventilation at temperatures
below 0 °C, the exhalation moisture in the patient valve might
condense and impair the function of the parts. This can cause
serious or life-threatening injury to the patient.
Quickly move the patient to a warmer location.
At temperatures below 5 °C, use a breathing system filter to
extend application time.
Delayed or incorrect therapy as a result of illegible labeling
on device!
Unsuitable cleaning agents and disinfectants may remove device
labeling and markings, and lead to material damage, with the
result that the user is unable to use the device and its accessories
properly in an emergency situation. This can cause serious or life-
threatening injury to the patient.
Only use the recommended cleaning agents and disinfectants.
Replace illegible labels.

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2 Safety
Risk of infection resulting from use of a contaminated device
for subsequent ventilation procedures!
If the device is used in a contaminated environment, the patient
might suffer serious or life-threatening injury.
If you suspect that the interior of the device has been
contaminated, take the device out of service and contact the
manufacturer.
Increased spontaneous breathing resistance and reduced
ventilation performance resulting from blocked intake
opening/blocked hygiene filter!
A blocked intake opening/blocked hygiene filter will reduce
ventilation performance in operation, and in the event of device
failure will result in increased spontaneous breathing resistance.
This might injure the patient.
Do not conceal or block the intake opening/hygiene filter.
Hazardous therapy due to lack of monitoring of the oxygen
concentration administered!
The device does not monitor inspiratory oxygen concentration in
the same way as an RGM (respiratory gas monitor), and has no
corresponding alarm. Dispensing respiratory gas with a slightly
different oxygen concentration might put the therapy at risk. This
might injure the patient.
Use a separate respiratory gas monitor to monitor the oxygen
concentration administered to the patient.
Inadequate oxygen concentration due to leaks during
ventilation!
Leaks during ventilation may lead to the concentration of oxygen
administered in the respiratory gas being reduced. This might
injure the patient.
Check that the mask or tracheal tube is correctly positioned.
Note measured value O2i for assessing ventilation. Also correct
oxygen supply if necessary.
Use suitable external patient monitoring methods.

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2 Safety
Risk of injury as a result of using the device at high ambient
temperatures!
Using the device at high ambient temperatures might result in the
temperatures of the respiratory gas and of applied parts rising.
Temperatures > 41 °C might injure the patient if applied for a
prolonged period.
Note that all applied parts can warm up to ambient
temperature.
Note that the applied respiratory gas can reach a temperature
> 41 °C.
Shorten the application time at ambient temperatures > 41 °C.

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3 Description
3 Description
3.1 Overview
3-1 Device overview
1 2 36
8
9
5
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17
7
18
4
19
11
No. Designation Description
1 Display Displays settings and current values (see
“3.3 Symbols in the display”, page 25).
2 Alarm light Displays high-priority alarms visually.
3 Oxygen inlet Used to connect the oxygen supply.
4 Protective cap for oxygen inlet Protects the oxygen inlet when it is not in use.
5 Filter compartment Holds the hygiene filter.
6 Power supply connection Connects the device to the power supply.
7 Battery compartment cover Covers the battery compartment.
8 Security seal Indicates whether the device has been opened
without authorization.
9 SD card slot with splash guard For inserting an SD card.
10 Measuring circuit connection Connects the device to the measuring circuit of the
breathing circuit.
11 Protective cap for connection terminal Covers the bore in the measuring circuit connection.