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.