Weinmann MEDUVENT Standard User manual

MEDUVENT Standard
Ventilator
Instructions for Use
Read these instructions for use before using the product.
Ignoring the instructions for use can lead to severe injury or death.

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Table of Contents
Table of Contents
1 Introduction 6
1.1 Intended purpose .......................................................................... 6
1.2 Owner/operator and user qualification ........................................... 8
2 Safety 9
2.1 Safety information in these instructions for use .............................. 9
2.2 Using the device safely .................................................................. 9
3 Description 20
3.1 Overview ..................................................................................... 20
3.2 Control panel and display ............................................................ 21
3.3 Symbols in the display ................................................................. 24
3.4 Accessories ................................................................................. 25
3.5 Rechargeable battery and battery status indicator ........................ 31
3.6 Transport options ........................................................................ 32
4 Preparation 33
4.1 Assembling the device ................................................................. 33
4.2 Connecting a power supply ......................................................... 34
4.3 Connecting the breathing circuit .................................................. 35
4.4 Connecting the oxygen supply ..................................................... 40
4.5 Converting the device .................................................................. 42
5 Function check 44
5.1 Intervals ...................................................................................... 44
5.2 Preparing for the function check .................................................. 45
5.3 Performing the function check ..................................................... 45
5.4 Checking the reusable breathing circuit ....................................... 52
6 Operation 53
6.1 Switching on the device ............................................................... 54
6.2 Navigating in the device .............................................................. 55
6.3 Starting ventilation ...................................................................... 56
6.4 Switching ventilation mode ......................................................... 60
6.5 Changing ventilation parameters ................................................. 61

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6.6 Switching patient group .............................................................. 62
6.7 Introducing oxygen ..................................................................... 63
6.8 Switching the device off .............................................................. 65
6.9 Disconnecting the oxygen supply ................................................. 66
6.10 After use ..................................................................................... 66
7 Operator menu 67
7.1 Activating the operator menu ...................................................... 67
7.2 Menu structure ............................................................................ 68
7.3 Device settings ............................................................................ 69
7.4 Patient presets ............................................................................ 71
7.5 Changing the access code ........................................................... 73
7.6 Options ....................................................................................... 74
7.7 Importing/exporting data ............................................................. 76
7.8 Updating software ....................................................................... 79
7.9 Device information ...................................................................... 81
7.10 Battery information ..................................................................... 82
8 Hygienic reprocessing 83
8.1 Intervals ...................................................................................... 86
8.2 Preparing for hygienic reprocessing .............................................. 87
8.3 Removing/installing the reusable breathing circuit ........................ 87
8.4 Cleaning parts manually .............................................................. 92
8.5 Disinfecting parts by wiping ......................................................... 96
8.6 Disinfecting parts by immersion ................................................... 98
8.7 Disinfecting the reusable measuring circuit by immersion ........... 100
8.8 Reprocessing parts mechanically ................................................ 101
8.9 Steam-sterilizing parts (optional) ............................................... 103
8.10 Preparing parts for reuse ........................................................... 104
8.11 Cleaning and disinfection plan ................................................... 105
9 Description of the modes 109
9.1 CPAP ........................................................................................ 109
9.2 IPPV .......................................................................................... 110
9.3 SIMV ......................................................................................... 111

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9.4 S-IPPV ....................................................................................... 112
9.5 Manual ..................................................................................... 114
10 Alarms and faults 116
10.1 Alarm messages ....................................................................... 117
10.2 Faults ........................................................................................ 120
11 Maintenance 122
11.1 Intervals .................................................................................... 122
11.2 Maintaining the breathing circuit (reusable) ............................... 123
11.3 Replacing the hygiene filter ....................................................... 124
11.4 Replacing rechargeable battery .................................................. 126
11.5 Sending in the device ................................................................ 130
12 Storage 131
13 Disposal 132
13.1 Electronic waste ........................................................................ 132
13.2 Rechargeable battery ................................................................ 132
13.3 Breathing circuit/oxygen inlet tube ............................................. 132
13.4 Hygiene filter ............................................................................. 132
14 Scope of supply and accessories 133
14.1 Standard product ...................................................................... 133
14.2 Accessories and other parts ....................................................... 133
14.3 Spare parts ............................................................................... 137
15 Technical data 138
15.1 Technical data, device ............................................................... 138
15.2 Technical data, rechargeable battery .......................................... 143
15.3 Technical data, power supply unit and charger ........................... 144
15.4 Technical data, breathing circuits ............................................... 144
15.5 Block diagram ........................................................................... 145
15.6 Technical data on electromagnetic compatibility (EMC) .............. 146
15.7 Calculating tidal volume on the basis of height .......................... 152
15.8 Exported log files ...................................................................... 153
15.9 Alarm delay times ..................................................................... 155

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16 Symbols and labels 156
16.1 Labels on the device .................................................................. 156
16.2 Labels on the accessories ........................................................... 158
16.3 Labels on the packaging ............................................................ 161
17 Warranty 162
18 EC Declaration of Conformity on Medical
Devices 162

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1 Introduction
1 Introduction
1.1 Intended purpose
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 groups
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.
Users
Qualified medical personnel (e.g. paramedics, emergency
physicians).
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

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1 Introduction
Contraindications
None known to date.
Possible side effects / complications
• Unwanted influencing of 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)
Risk of injury from misuse due to disregard of the information
in the instructions for use!
Intended use includes compliance with all the information in these
instructions for use. Any use other than or in addition to intended
use is considered misuse. Failure to comply with the information
in these instructions for use might result in a misuse of the product
and may cause serious or life-threatening injury to the patient, the
user, or persons in the vicinity.
⇒Use the device only for the intended purpose
(see “1.1 Intended purpose”, page 6).
⇒Observe any exclusions and limitations of the intended purpose
(see “1.1.1 Exclusions and limitations of the intended
purpose”, page 8).
⇒Observe the safety information in the instructions for use.
⇒Observe all the sections of the instructions for use.

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1 Introduction
1.1.1 Exclusions and limitations of the intended
purpose
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
1.2 Owner/operator and user
qualification
The device must only be used by persons with medical training
who have received instruction in ventilation technique.
As the operator or user, you must familiarize yourself with the
method of operation and use of this medical device by reference
to the instructions for use before using it for the first time.
You should also get yourself trained in the operation and use of
this medical device. Follow the statutory requirements for
operation and use (in Germany, particularly the Medizinprodukte-
Betreiberverordnung [German regulation concerning the operators
of medical devices]).

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2 Safety
2 Safety
Read these instructions for use carefully. They form part of the
devices described, and must be available at all times.
2.1 Safety information in these
instructions for use
2.2 Using the device safely
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 damage to
property or environmental damage.
Designates useful tips relating to a particular sequence of actions.
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 might expose the patient to the risk
of serious or life-threatening injury.
⇒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 responses 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 might
expose the patient to the risk of serious or life-threatening injury.
⇒Provide alternative ventilation option.
Risk of injury resulting from incorrectly set limitation of
maximum airway pressure!
An excessively high airway pressure might expose the patient to
serious or life-threatening injury.
⇒Always set the pressure limit pMax to suit 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 detaches during
patient transport, the patient might be extubated, resulting in
laryngospasm. This might expose the patient to the risk of serious
or life-threatening injury.
⇒Secure the device against falling while transporting the patient
on a stretcher.
⇒Always fix the breathing circuit in place while transporting the
patient.

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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.
⇒Do not use the measured MVi value as an adequate means
of assessing ventilation.
⇒Use external monitoring (etCO2or expiratory volume
measurement).
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.
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 expose the patient and the user to the risk of 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 might expose the patient to
the risk of serious or life-threatening injury 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 and defective accessories might result in
device malfunctions. This might expose the patient and the user
to the risk of 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.
⇒Also 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 might expose the patient to the risk
of serious or life-threatening injury 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 might expose the patient to the risk of serious or life-
threatening injury.
⇒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 system for example).

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2 Safety
Risk of injury and delayed therapy due to
alarm signals being unable to be heard!
Alarm signals quieter than 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 the 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 might expose the user to the risk of
serious or life-threatening injury.
⇒Use only approved accessories.
Disrupted or failed therapy due to operation of the device and
its accessories outside the specified ambient conditions!
Using the device and its accessories outside the specified ambient
conditions might result in tolerances being exceeded and in device
failure. This might expose the patient to the risk of serious or life-
threatening injury.
⇒Only operate the device and its accessories within the specified
ambient conditions (see “15 Technical data”, page 138).
⇒Never use the device and its 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 might expose
the patient to the risk of serious or life-threatening injury.
⇒Do not use bubble humidifiers.

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2 Safety
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, exposing him or her to the risk of
serious of life-threatening injury.
⇒Do not use device in a toxic environment.
Disrupted or failed therapy due to lack of maintenance!
If maintenance intervals are not observed, malfunctions might
occur. This might expose the patient to the risk of serious or
life-threatening injury.
⇒Observe the maintenance intervals according to the
instructions for use and the displays on the device.
⇒Also observe the maintenance intervals 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 might expose the patient to the risk of
serious or life-threatening injury.
⇒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 might expose the patient, user and persons in the
vicinity to the risk of serious or life-threatening injury.
⇒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.

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2 Safety
Risk of fire resulting from use of the device in conjunction
with anesthetics!
Flammable gases and anesthetics can cause spontaneous
explosions. This might expose the patient, user and persons in the
vicinity to the risk of serious or life-threatening injury, as well as
damaging the device.
⇒Do not use the device in conjunction with flammable gases or
gaseous and ignitable anesthetics.
Risk of injury resulting from incorrect handling of the
rechargeable battery!
Incorrect handling of the rechargeable battery might expose the
patient, user and persons in the vicinity to the risk of 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
might expose the patient to the risk of serious or life-threatening
injury.
⇒Always use a fully charged rechargeable battery at low
temperatures.

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2 Safety
Disrupted or failed therapy due to interaction between
medical electrical devices!
Medical electrical devices which are operated directly next to or on
top of each other can cause mutual interference to functionality.
This might expose the patient to the risk of serious or life-
threatening injury.
⇒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: Other WEINMANN Emergency
devices which have been tested to ensure that they can operate
without problem alongside the device. A list of the other
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.
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 may lead to therapy being interrupted and expose
the patient to the risk of serious or life-threatening injury.
⇒Never operate device in conjunction with magnetic resonance
imaging machines.
Disrupted or failed therapy due to portable high-frequency
communication equipment in the immediate vicinity of the
device!
Portable radio-frequency communication equipment (e.g. mobile
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 high-frequency communication equipment
a minimum distance of 30 cm away from the device and its
accessories.

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2 Safety
Fault 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 might expose the patient to the risk
of serious or life-threatening injury.
⇒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 might expose the
patient to the risk of serious or life-threatening injury.
⇒Use only approved accessories.
⇒Follow the instructions for use of the accessories.
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 to
suffer 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 expose the
patient and the user to the risk of serious or life-threatening
injury.
⇒Do not reuse disposables.
⇒Do not subject disposables to hygienic reprocessing.

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2 Safety
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 might expose
the patient to the risk of serious or life-threatening injury.
⇒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 and disinfectant products may remove the
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 might expose
the patient to the risk of serious or life-threatening injury.
⇒Only use the recommended cleaning and disinfectant products.
⇒Replace illegible labels.
Increased spontaneous breathing resistance and reduced
ventilation performance resulting from blocked intake
opening/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.

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2 Safety
Risk of injury resulting from temperatures on application
parts and in the respiratory gas when 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 application parts
increasing in line with the ambient temperature. Temperatures
>41 °C might injure the patient if applied for a protracted period
of time.
⇒Note that all application parts can warm up to ambient
temperature.
⇒Note that the applied respiratory gas can reach a temperature
above 41 °C.
⇒Shorten the application time at high 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
10
11
12
13
14
15
16
7
17
4
18
No. Designation Description
1 Display Displays settings and current values
(see “3.3 Symbols in the display”, page 24).
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 Accessories connection Connects the device to the MEDUtrigger.