Weinmann MEDUMAT Standard2 User manual

MEDUMAT Standard
2
Ventilator
Instructions for use for devices from software version 4.15

2E MEDUMAT Standard
2
WM 68011g 08/2020
Table of Contents
Table of Contents
1 Introduction 6
1.1 About this document ..................................................................... 6
1.2 Explanation of warnings ................................................................ 7
2 Safety 8
2.1 Safety information ......................................................................... 8
2.2 ntended purpose .......................................................................... 8
2.3 Requirements for the user ........................................................... 10
2.4 Safety information ....................................................................... 11
2.5 General instructions .................................................................... 21
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 Labels and symbols ..................................................................... 42
4 Preparation and operation 50
4.1 Mounting the device ................................................................... 50
4.2 Connecting to a power supply ..................................................... 50
4.3 Using the rechargeable battery .................................................... 51
4.4 Connecting components .............................................................. 55
4.5 Switching the device on ............................................................... 68
4.6 Switching the device off .............................................................. 70
4.7 Ventilating the patient ................................................................. 70
4.8 Monitoring the patient ................................................................ 91
4.9 Audio alarm output ..................................................................... 92
4.10 Transporting the device ............................................................... 93
4.11 Feeding in oxygen ....................................................................... 94

WM 68011g 08/2020
MEDUMAT Standard
2
E 3
Table of Contents
4.12 After use ..................................................................................... 97
4.13 Using the SD card ........................................................................ 98
4.14 Enabling options ....................................................................... 100
4.15 Updating the software ............................................................... 102
4.16 Pairing an external data documentation system with the device for
the first time (using the Bluetooth data transmission option) ...... 105
4.17 Using the simulation mode ........................................................ 106
5 ser 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 121
6.1 Navigating the operator menu ................................................... 121
6.2 Structure of the operator menu .................................................. 123
6.3 Settings in the operator menu .................................................... 124
7 Description of the modes 141
7.1 Classification of the ventilation modes ....................................... 141
7.2 Ventilation parameters .............................................................. 143
7.3 Ventilation modes ..................................................................... 145
7.4 Additional functions .................................................................. 163
8 Hygienic reprocessing 172
8.1 General instructions .................................................................. 175
8.2 ntervals .................................................................................... 176
8.3 Preparing hygienic reprocessing ................................................. 176
8.4 Disassembly of the reusable hose system ................................... 177
8.5 Cleaning parts manually ............................................................ 182
8.6 Wipe disinfecting parts .............................................................. 185
8.7 mmersion disinfecting parts ...................................................... 186
8.8 Reprocessing parts mechanically ................................................ 188
8.9 Steam sterilizing parts (optional) ................................................ 189
8.10 Preparing parts for reuse ........................................................... 190
8.11 Assembling reusable hose system .............................................. 190

4E MEDUMAT Standard
2
WM 68011g 08/2020
Table of Contents
8.12 Cleaning and disinfection plan ................................................... 196
9 Function check 201
9.1 ntervals .................................................................................... 201
9.2 Preparing for the function check ................................................ 201
9.3 Performing a function check ...................................................... 202
9.4 Failed function check ................................................................. 210
9.5 Testing the reusable hose system ............................................... 210
9.6 Checking the system for leaks .................................................... 211
9.7 Rectifying leaks in the system .................................................... 211
10 Alarms and error messages 213
10.1 General instructions .................................................................. 213
10.2 Alarm messages ........................................................................ 215
10.3 Faults ........................................................................................ 219
11 Maintenance 224
11.1 General instructions .................................................................. 224
11.2 ntervals .................................................................................... 224
11.3 Sending in device ...................................................................... 225
11.4 Maintaining the reusable hose system ....................................... 225
11.5 Replacing the hygiene filter ....................................................... 226
12 Storage 228
12.1 General instructions .................................................................. 228
12.2 Storing the device ..................................................................... 228
12.3 Storing patient hose systems ..................................................... 229
12.4 Storing the battery .................................................................... 230
13 Disposal 231
13.1 Electronic waste ........................................................................ 231
13.2 Battery ...................................................................................... 231
13.3 Patient hose system .................................................................. 231
13.4 Hygiene filter ............................................................................. 231
14 Appendix 232
14.1 Technical data ........................................................................... 232
14.2 Calculation of body weight on the basis of body height .............. 258

WM 68011g 08/2020
MEDUMAT Standard
2
E 5
Table of Contents
14.3 Exported log files ....................................................................... 259
14.4 Scope of supply ......................................................................... 261
14.5 Warranty ................................................................................... 267
14.6 Declaration of Conformity .......................................................... 268

6E MEDUMAT Standard
2
WM 68011g 08/2020
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. o claims
can be derived from any deviations.
Texts shown in the display of the device are marked bold in this
document. Example: Press the Chrg. function button.
Voice prompts of the device are marked italic in this document.
Example: Do not touch the patient.

WM 68011g 08/2020
MEDUMAT Standard
2
E 7
1 Introduction
1.2 Explanation of warnings
Danger!
DA GER indicates a hazardous situation that, if not avoided,
will result in death or serious injury.
Warning!
WAR I G indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
Caution!
CAUTIO indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
Notice!
OTICE 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.

8E MEDUMAT Standard
2
WM 68011g 08/2020
2 Safety
2 Safety
2.1 Safety information
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 "2.2 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.
2.2 Intended purpose
MEDUMAT Standard
2
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
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.
2.2.1 Patient groups
MEDUMAT Standard
2
is used in the treatment of infants, children
and adults weighing 3 kg or more where spontaneous respiration
has failed or is inadequate.

WM 68011g 08/2020
MEDUMAT Standard
2
E 9
2 Safety
2.2.2 ser
Qualified medical personnel (e.g., paramedics, emergency
physicians).
2.2.3 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
2.2.4 Contraindications
one currently known.
2.2.5 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)
Risk of injury from misuse due to disregarding the
information in the instructions for use!
⇒Only use the device as defined by the intended use
(see "2.2 Intended purpose", page 8).
⇒ote the exclusions and restrictions for intended purpose
(see "2.2.6 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.

10 E MEDUMAT Standard
2
WM 68011g 08/2020
2 Safety
• Overinflation of the lung tissue (e.g., lung rupture)
• Overinflation of the stomach during mask ventilation
(e.g., aspiration of stomach contents)
2.2.6 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, MR, MI)
• Ventilation of premature babies (born before the end of the
36th week of pregnancy)
• Use for long-term ventilation in excess of 24 hours
2.3 Requirements for the user
MEDUMAT Standard
2
must 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).