Weinmann MEDUMAT Standard2 User manual

MEDUMAT Standard2
Ventilator
Instructions for Use for Devices from Software Version 5.1

2EN MEDUMAT Standard2
WM 68071 05/2021
Table of Contents
Table of Contents
1 Introduction 6
1.1 About this document ..................................................................... 6
1.2 Explanation of warning notices ...................................................... 7
2 Safety 8
2.1 Intended purpose .......................................................................... 8
2.2 Requirements for the user ........................................................... 10
2.3 Safety information ....................................................................... 10
2.4 General instructions .................................................................... 20
3 Description 23
3.1 Overview ..................................................................................... 23
3.2 Control panel .............................................................................. 25
3.3 Display ........................................................................................ 27
3.4 Symbols on the display ................................................................ 31
3.5 Components ............................................................................... 33
3.6 Accessories ................................................................................. 40
3.7 Options ....................................................................................... 41
3.8 Symbols ...................................................................................... 41
4 Preparation and operation 45
4.1 Mounting the device ................................................................... 45
4.2 Connecting to a power supply ..................................................... 45
4.3 Using the rechargeable battery .................................................... 46
4.4 Connecting components .............................................................. 51
4.5 Switching the device on ............................................................... 64
4.6 Switching the device off .............................................................. 65
4.7 Ventilating the patient ................................................................. 66
4.8 Monitoring the patient ................................................................ 88
4.9 Audio alarm output ..................................................................... 89
4.10 Transporting the device ............................................................... 90
4.11 Feeding in oxygen ....................................................................... 91
4.12 After use ..................................................................................... 94

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4.13 Setting the date and time ............................................................ 95
4.14 Using the SD card ........................................................................ 97
4.15 Unlocking options ....................................................................... 99
4.16 Updating the software ............................................................... 102
4.17 Pairing an external data documentation system with the device
for the first time (via Bluetooth®data transmission) ................... 104
4.18 Using the simulation mode ........................................................ 106
5 User menu 108
5.1 Navigating the user menu ......................................................... 108
5.2 Structure of the user menu ........................................................ 109
5.3 Settings in the user menu .......................................................... 110
6 Operator menu 120
6.1 Navigating the operator menu ................................................... 120
6.2 Structure of the operator menu .................................................. 122
6.3 Settings in the operator menu .................................................... 123
7 Description of the modes 140
7.1 Classification of the ventilation modes ....................................... 140
7.2 Ventilation parameters .............................................................. 141
7.3 Ventilation modes ..................................................................... 144
7.4 Additional functions .................................................................. 162
8 Hygienic reprocessing 171
8.1 General instructions .................................................................. 174
8.2 Intervals .................................................................................... 175
8.3 Preparing hygienic reprocessing ................................................. 175
8.4 Disassembly of the reusable breathing circuit ............................. 176
8.5 Cleaning parts manually ............................................................ 181
8.6 Wipe disinfecting parts .............................................................. 184
8.7 Immersion disinfecting parts ...................................................... 185
8.8 Reprocessing parts mechanically ................................................ 187
8.9 Preparing parts for reuse ........................................................... 190
8.10 Assembling reusable breathing circuit ........................................ 190
8.11 Cleaning and disinfection plan ................................................... 196

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Table of Contents
9 Function check 200
9.1 Intervals .................................................................................... 200
9.2 Preparing for the function check ................................................ 200
9.3 Performing a function check ...................................................... 201
9.4 Failed function check ................................................................. 209
9.5 Testing the reusable breathing circuit ........................................ 210
9.6 Checking the system for leaks .................................................... 210
9.7 Rectifying leaks in the system .................................................... 211
10 Alarms and error messages 212
10.1 General instructions .................................................................. 212
10.2 Alarm messages ........................................................................ 214
10.3 Faults ........................................................................................ 219
11 Maintenance 223
11.1 General instructions .................................................................. 223
11.2 Intervals .................................................................................... 223
11.3 Sending in device ...................................................................... 224
11.4 Maintaining the reusable breathing circuit ................................. 225
11.5 Replacing the hygiene filter ....................................................... 226
12 Storage 227
12.1 General instructions .................................................................. 227
12.2 Storing the device ..................................................................... 227
12.3 Storing breathing circuits ........................................................... 228
12.4 Storing the battery .................................................................... 229
13 Proper disposal 230
13.1 Electronic waste ........................................................................ 230
13.2 Battery ...................................................................................... 230
13.3 Breathing circuit ........................................................................ 230
13.4 Hygiene filter ............................................................................. 230
14 Appendix 231
14.1 Technical data ........................................................................... 231
14.2 Calculation of body weight on the basis of body height .............. 258
14.3 Exported service data ................................................................ 259

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14.4 Scope of supply ......................................................................... 261
14.5 Warranty ................................................................................... 267
14.6 Declaration of Conformity .......................................................... 268

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1 Introduction
1 Introduction
1.1 About this document
This document describes all possible versions of the device.
Functions, accessories and other parts which are described in this
document or shown in the images depend on the version
purchased and are not always available.
If device functions can only be enabled through procurement of a
certain option, this is marked in this document by the amendments
"(optional)" and "(only with option XXXX)".
Diagrams in these instructions for use serve to improve basic
understanding and may differ from the actual design. No claims
can be derived from any deviations.
Texts shown in the display of the device are marked bold in this
document. Example: Press the Charge function button.
Voice prompts of the device are marked italic in this document.
Example: Do not touch the patient.

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1 Introduction
1.2 Explanation of warning notices
Danger!
DANGER indicates a hazardous situation that, if not avoided,
will result in death or serious injury.
Warning!
WARNING indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
Caution!
CAUTION indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
Notice!
NOTICE indicates information considered important, but not
hazard-related (e.g., messages related to damage to property
or the environment).
Designates useful tips relating to a particular action.

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2 Safety
2 Safety
The instructions for use form part of the device. If the instructions
for use and the following safety information are not fully complied
with, the treatment may fail or be compromised. This could cause
severe or life-threatening injuries to the patient, user or bystanders.
Fully comply with the instructions for use.
Keep the instructions for use with the device so that they can
be accessed at any time.
Only use the device as defined by the intended purpose
(see "2.1 Intended purpose", page 8).
Do not use the device in the event of contraindications.
Follow the instructions for use for the components and
accessories.
Any serious incident that has occurred in relation to the device
should be reported to the manufacturer and the competent
authority of the Member State.
2.1 Intended purpose
MEDUMAT Standard2is 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
patient's nose, mouth or trachea. In the case of volume-controlled
ventilation, tidal volumes of 50 ml or more are possible. Smaller
tidal volumes are also possible in the case of pressure-controlled
ventilation.
2.1.1 Patient groups
MEDUMAT Standard2is used in the treatment of infants, children
and adults weighing 3 kg or more where spontaneous breathing
has failed or is inadequate.
2.1.2 User
Qualified medical personnel (e.g., paramedics, emergency
physicians).

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2 Safety
2.1.3 Intended application areas
• Primary care at the site of the emergency, e.g., to resuscitate
or induce and maintain anesthesia
• Transport between hospital rooms and departments
• Transport between the hospital and other sites in an
ambulance, ship, airplane or helicopter
• Intra-hospital in the trauma or recovery room
2.1.4 Contraindications
None currently known.
2.1.5 Possible side effects and complications
• Undesirable effects on the cardiovascular system
(e.g., reduction of cardiac output, reduction of venous
return flow)
• Dehydration of the respiratory tract (e.g., mucositis,
sicca syndrome)
• Overinflation of the lung tissue (e.g., lung rupture)
• Gastric insufflation during mask ventilation
(e.g., aspiration of stomach contents)
Risk of injury from misuse due to disregarding the
information in the instructions for use!
Only use the device as defined by the intended purpose
(see "2.1 Intended purpose", page 8).
Note the exclusions and restrictions for intended purpose
(see "2.1.6 Exclusions and restrictions for intended purpose",
page 10).
Observe the safety information in the instructions for use.
Observe all the chapters in the instructions for use.
Intended use includes compliance with all the specifications in
these instructions for use. Any usage which goes beyond or which
is in contradiction to the intended use shall be regarded as misuse.
Failure to observe the information in the instructions for use can
result in incorrect operation of the device and may result in serious
injury or death for the patient, user or bystanders.

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2 Safety
2.1.6 Exclusions and restrictions for intended
purpose
The device is not approved for the following applications:
• Operation in hyperbaric chambers
• Operation in combination with magnetic resonance scanners
(MRT, NMR, NMI)
• Ventilation of premature babies (born before the end of
the 36th week of pregnancy)
• Use for long-term ventilation in excess of 24 hours
2.2 Requirements for the user
MEDUMAT Standard2must only be used by persons who possess
a medical qualification and have received training in ventilation
techniques.
All operators/users must familiarize themselves with the operation
and use of this medical device as described in the instructions for
use before using the device for the first time.
They should also receive formal instruction on the operation and
use of this medical device.
Always ensure adherence to the statutory requirements for
operation and use of the device (in Germany, the Medical Device
Directive (MPBetreibV) in particular).
2.3 Safety information
2.3.1 How to use the device
Warning Risk of poisoning if the device is used in a toxic atmosphere!
If the device is used in a toxic atmosphere, it can suck in toxic
gases from the ambient air. These toxic gases may reach the lungs
of the patient and poison them.
Do not use the device in a toxic atmosphere.