Weinmann MEDUMAT Standard2 User manual

MEDUMAT Standard2
Ventilator
Instructions for Use for Devices from Software Version 4.1

2EN MEDUMAT Standard2
WM 68011d 07/2017
Table of Contents
Table of Contents
1 Introduction 5
1.1 Intended use ................................................................................. 5
1.2 Operator and user qualification ..................................................... 6
1.3 Contraindications .......................................................................... 6
1.4 Side effects ................................................................................... 6
2 Safety 7
2.1 Safety information ......................................................................... 7
2.2 General instructions .................................................................... 16
2.3 Warnings in this document .......................................................... 17
3 Description 18
3.1 Overview ..................................................................................... 18
3.2 Control panel .............................................................................. 20
3.3 Display ........................................................................................ 22
3.4 Symbols on the display ................................................................ 26
3.5 Components ............................................................................... 28
3.6 Accessories ................................................................................. 35
3.7 Options ....................................................................................... 36
3.8 Labels and symbols ..................................................................... 37
4 Preparation and operation 46
4.1 Mounting the device ................................................................... 46
4.2 Connecting to a power supply ..................................................... 46
4.3 Using the rechargeable battery .................................................... 47
4.4 Connecting components .............................................................. 51
4.5 Switching the device on ............................................................... 65
4.6 Switching the device off .............................................................. 66
4.7 Ventilating the patient ................................................................. 67
4.8 Monitoring the patient ................................................................ 88
4.9 Audio alarm output ..................................................................... 89
4.10 Transporting the device ............................................................... 90
4.11 Feeding in oxygen ....................................................................... 91

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Table of Contents
4.12 After use ..................................................................................... 94
4.13 Using the SD card ........................................................................ 95
4.14 Enabling options ......................................................................... 97
4.15 Updating the software ............................................................... 100
4.16 Pairing an external data documentation system with
MEDUMAT Standard2for the first time (via Bluetooth®) ............ 102
5 User menu 104
5.1 Navigating the user menu ......................................................... 104
5.2 Structure of the user menu ........................................................ 105
5.3 Settings in the user menu .......................................................... 106
6 Operator menu 116
6.1 Navigating the operator menu ................................................... 116
6.2 Structure of the operator menu .................................................. 118
6.3 Settings in the operator menu .................................................... 119
7 Description of the modes 136
7.1 Classification of the ventilation modes ....................................... 136
7.2 Ventilation parameters .............................................................. 138
7.3 Ventilation modes ..................................................................... 140
7.4 Additional functions .................................................................. 156
8 Hygienic reprocessing 164
8.1 General instructions .................................................................. 164
8.2 Intervals .................................................................................... 165
8.3 Hygienic reprocessing of the device ............................................ 165
8.4 Hygienic reprocessing of the reusable hose system ..................... 168
8.5 Hygienic reprocessing of the disposable hose system .................. 170
8.6 Disassembly/assembly of the reusable hose system .................... 172
8.7 Disinfecting the reusable measuring hose system ....................... 181
9 Function check 183
9.1 Intervals .................................................................................... 183
9.2 Preparing for the function check ................................................ 183
9.3 Performing a function check ...................................................... 184
9.4 Failed function check ................................................................. 191

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9.5 Testing the reusable hose system ............................................... 191
9.6 Checking the system for leaks .................................................... 192
9.7 Rectifying leaks in the system .................................................... 192
10 Alarms and error messages 194
10.1 General instructions .................................................................. 194
10.2 Alarm messages ........................................................................ 196
10.3 Faults ........................................................................................ 201
11 Maintenance 205
11.1 General instructions .................................................................. 205
11.2 Intervals .................................................................................... 205
11.3 Sending in device ...................................................................... 206
11.4 Maintaining the reusable hose system ....................................... 207
11.5 Replacing the hygiene filter ....................................................... 208
11.6 Replacing the device input filter ................................................. 209
12 Storage 211
12.1 General instructions .................................................................. 211
12.2 Storing the device ..................................................................... 211
12.3 Storing the battery .................................................................... 212
13 Disposal 213
13.1 Electronic waste ........................................................................ 213
13.2 Battery ...................................................................................... 213
13.3 Patient hose system .................................................................. 213
13.4 Hygiene filter/device input filter ................................................. 213
14 Appendix 214
14.1 Technical data ........................................................................... 214
14.2 Calculation of body weight on the basis of body height .............. 234
14.3 Exported log files ...................................................................... 235
14.4 Scope of supply ......................................................................... 238
14.5 Warranty ................................................................................... 244
14.6 Declaration of Conformity .......................................................... 244

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MEDUMAT Standard2EN 5
1 Introduction
1 Introduction
1.1 Intended use
MEDUMAT Standard2is an automatic oxygen emergency
ventilator with functions for the monitoring of respiratory values.
MEDUMAT Standard2is used in the treatment of infants, children
and adults where spontaneous respiration has failed or is
inadequate. The device can be used for invasive and non-invasive
ventilation. 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.
Emergency applications:
• For resuscitation at the scene of an emergency
• For longer-term use in continuing emergency situations
• For the supportive induction of anesthesia (TIVA: total
intravenous anesthesia)
Applications during transportation:
• In ground, sea and air emergency medical service
• Between hospital rooms and departments
• Between a hospital and other locations (secondary transport)
MEDUMAT Standard2is also suitable for gentle ventilation of
anesthetized patients (TIVA: total intravenous anesthesia).

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1 Introduction
1.2 Operator and user qualification
MEDUMAT Standard2must only be used by persons who possess
a medical qualification and have received training in ventilation
techniques.
As the operator or user, you must be fully familiar with the correct
operation of this medical device. Observe the statutory
requirements for operation and use (in Germany, particularly the
German regulations governing owners/operators of medical
devices (MPBetreibV)). General recommendation: You should seek
instruction on the correct handling, use and operation of this
medical device from a person authorized by WEINMANN
Emergency.
1.3 Contraindications
Possible contraindications for ventilation include:
• High risk of a barotrauma
• Pneumothorax or pneumomediastinum
1.4 Side effects
Possible side effects of ventilation are:
• Atrophy of the respiratory muscles
• Drying out of the airways
• Gastrointestinal air insufflation in the case of mask ventilation

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2 Safety
2 Safety
2.1 Safety information
Read these instructions for use carefully. They form part of the
devices described, and must be available at all times.
Use the device for the designated purpose only (see "1.1Intended
use", page5).
For your own safety as well as that of your patients, and in
accordance with the requirements of Directive 93/42/EEC, please
observe the following safety instructions.
2.1.1 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.
Risk of infection if the device is used in a contaminated
atmosphere!
If the device is used in a contaminated atmosphere, it may suck in
contaminated or infected ambient air and harm the patient.
Only operate the device in a contaminated atmosphere with a
hygiene filter.
Risk of injury if the device is used in a dusty atmosphere!
If the device is used in a dusty atmosphere, it can suck in dust and
contaminants from the ambient air. Dust and contaminants may
reach the lungs of the patient and harm them.
Only operate the device with a hygiene filter/device input filter.
Change the hygiene filter/device input filter following
operation in a very dusty atmosphere.
Risk of explosion if the device is used in explosive
atmospheres!
Flammable gases and anesthetics may cause spontaneous
explosions and thereby bring about injury to the patient, user and
bystanders.
Do not use the device in combination with flammable gases or
anesthetic gases.

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Risk of injury due to device or component malfunction!
A damaged device or damaged components may result in injury
to the patient, user or bystanders.
Only operate the device and components if they are externally
undamaged.
Only operate the device and components if the function check
has been successfully completed.
Only operate the device if the display is functional.
Keep an alternative ventilation unit at the ready.
Risk of injury if the pneumatic connections within the device
are closed off or blocked!
When oxygen is supplied via a central gas supply system which has
not been properly cleaned or is moist, the pneumatic connections
within the device may become blocked by contaminants or
particles or suck in moisture.
Only operate the device from central gas connections which
are clean and dry.
Risk of injury in the event of device failure resulting from
blocked suction inlets on the hygiene filter/device input filter!
Blocked suction inlets on the hygiene filter/device input filter may
cause injury to the patient in the event of device failure as a result
of excessively high pressures, and may prevent the patient from
breathing on his/her own.
Always keep the suction inlets on the hygiene filter/device
input filter clear.
Risk of injury due to sparks during defibrillation in the
presence of oxygen and combustible materials!
In the event that a ventilator and defibrillator are used at the same
time, defibrillation in an oxygen-enriched atmosphere and in the
presence of combustible materials (e.g., textiles) combined with
sparks generated by the defibrillation may cause explosions and
fire, which may result in injury to the patient, user or bystanders.
During defibrillation, only use adhesive electrodes or ensure
that the oxygen-air mixture coming from the exhalation valve
flows away from the torso of the patient.
Risk of injury due to concealed alarm!
A concealed alarm light, loudspeaker and display will prevent the
user from noticing any alarms and reacting to dangerous
situations. This may result in injury to the patient.
Always keep the alarm (alarm light, loudspeaker and display)
free.

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2 Safety
Do not operate the device in a closed bag.
Risk of injury if an incorrect volume is applied in hyperbaric
environments!
Use of the device in hyperbaric environments (pressure chambers)
leads to the application of incorrect volumes and may result in an
injury to the patient.
Do not use the device in hyperbaric environments.
Risk of injury if the device is operated outside of the
prescribed ambient conditions!
Use of the device outside of the prescribed ambient conditions
may mean that tolerances are not adhered to and result in device
failure and injury to the patient.
Only operate the device within the prescribed ambient
conditions (see "14.1.1Technical data on device", page214).
Risk of injury due to reuse of disposable items!
Disposable items are intended for single use. Disposable items
which are reused may be contaminated and/or impaired in their
function and therefore cause injury to the patient.
Do not reuse disposable items.
Therapy prevented by increased oxygen consumption when
using CCSV mode!
The increased ventilation rate in CCSV mode results in increased
oxygen consumption during resuscitation (approx. 12-30 l/min)
compared with IPPV ventilation.
Check the fill pressure in the oxygen cylinder regularly.
Keep reserve oxygen at the ready.
Risk of injury from deactivated alarm light, deactivated audio
alarm output and darkened display in NVG mode!
The alarms are barely perceptible as a result of the deactivated
alarm light, the deactivated audio alarm output and the darkened
display in NVG mode. This can injure the patient.
Always monitor patients during ventilation.
Only use the NVG option in the military sector.
Caution Risk of injury through electric shock if the device is touched!
Accessories which are connected to the device may cause an
electrical potential in the device. This may lead to an electric shock
on contact with the device and result in injury to the user.
Only use accessories from WEINMANN Emergency.

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2 Safety
Risk of injury as a result of pressure variations during use in
combination with devices from the WEINMANN Emergency
MODUL range!
If the device is used together with devices from the WEINMANN
Emergency MODUL range, the flow used by devices from the
WEINMANN Emergency MODUL series may cause pressure
variations in the device. This can injure the patient.
Only use the device and devices from the WEINMANN
Emergency MODUL range in combinations approved by
WEINMANN Emergency.
Delay in treatment due to interference caused by electric and
magnetic fields!
Electric and magnetic fields may interfere with device functioning,
and delay treatment.
Maintain separation distances between the device and mobile
telephones, radio units and X-ray apparatus.
Notice Damage to the device caused by ingress of liquids!
The device is rated IP54 (splash-proof). This only applies when the
battery is located in the battery compartment, the SD card
compartment is closed, there is a filter in the filter compartment,
and there is a patient hose system connected. Ingress of liquids
may damage the device, components and accessories.
Do not immerse the device, components, or accessories in
liquids.
Clean the battery compartment carefully so that no liquids
enter the device.
2.1.2 Power supply
Warning Risk of injury due to missing, flat, or defective battery!
A missing, flat or defective battery prevents treatment.
Only operate the device with a charged battery.
Keep an alternative ventilation unit at the ready.
Treatment prevented by defective power cord or power
supply!
A defective power cord or power supply prevents the battery in
the device from charging and thus impairs the operational
readiness of the device.
Inspect the power cord and power supply regularly.
Only operate the device with a charged battery.
Keep an alternative ventilation unit at the ready.

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2 Safety
Risk of injury due to electric shock when connecting an
incorrect power supply to the line power!
The power supply contains a safety device to prevent electric
shock. The use of a non-original power supply may result in injury
to the user.
Only operate the device on line power using the power supply
recommended by WEINMANN Emergency.
Caution Risk of injury from touching the contacts in the battery
compartment and the patient at the same time!
The contacts in the battery compartment are live. Touching the
contacts and the patient at the same time can injure the user or
the patient.
Do not touch the contacts in the battery compartment and the
patient at the same time.
Notice Material damage due to prolonged storage of the battery
without recharging!
Storing the battery for a prolonged period of time without
recharging can result in the rapid shutdown of and irreparable
damage to the battery.
When the battery is stored in the device without a power
connection: Charge battery every 3 months.
If the battery is not stored in the device: Charge battery every
5 months.
2.1.3 How to use the patient hose system
Warning Risk of injury due to contaminated or infected patient hose
system!
A patient hose system which is contaminated or infected as a
result of hygienic reprocessing not being performed or being
performed incorrectly may transmit contamination or infections to
the next patient and harm them.
Do not reprocess disposable hose systems.
Perform the hygienic reprocessing of reusable hose systems
correctly (see "8.4Hygienic reprocessing of the reusable hose
system", page168).

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2 Safety
Caution Risk of injury from touching the contacts on the FlowCheck
sensor connection line/FlowCheck sensor connection line with
MEDUtrigger and the patient at the same time!
The contacts on the FlowCheck sensor connection line/FlowCheck
sensor connection line with MEDUtrigger are live. Touching the
contacts and the patient at the same time can injure the user or
the patient.
Do not touch the contacts on the FlowCheck sensor
connection line/FlowCheck sensor connection line with
MEDUtrigger and the patient at the same time.
2.1.4 Ventilation
Warning Risk of injury due to lack of patient monitoring!
If the patient is not supervised during ventilation, delayed
responses of medical personnel to alarms and error messages may
result in serious injuries to the patient.
Always monitor patients during ventilation.
Be sure to react immediately to alarms and error messages as
well as a deterioration in the condition of the patient.
Risk of injury from condensate in the FlowCheck sensor and
the patient valve at temperatures below 5°C!
With longer term ventilation of patients at temperatures below
5°C, the moisture from expiratory breath can condense in the
FlowCheck sensor and patient valve. This may interfere with the
functioning of the parts and injure the patient.
Quickly transfer the patient to a warmer location.
At temperatures below 5°C use a breathing system filter to
extend the period of application.
Risk of poisoning due to an overly high concentration of
oxygen during ventilation!
Highly concentrated oxygen can have a toxic effect on the patient
if administered for too long and depending on the age of the
patient.
Do not use highly concentrated oxygen on a patient for too
long during ventilation.
Do not use the device for the ventilation of premature babies
(born before the end of the 36th week of pregnancy).

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2 Safety
Risk of injury due to airway pressures which are excessively
high or too low!
Airway pressures which are excessively high or too low may result
in injury to the patient.
Check correct ventilation on the display.
Adjust the pressure limitation (pMax) to suit the connected
patient.
Risk of injury due to alarm limits which are too high or too
low!
Alarm limits which are either too high or too low can prevent the
device from emitting an alarm, thereby putting the patient at risk.
Always set alarm limits which have been adapted to the
patient.
Risk of injury from switching on a device with activated NVG
mode during daylight or without a night vision device!
A device with activated NVG mode cannot be used straight away
during daylight or without a night vision device. This can injure the
patient.
Keep an alternative ventilation unit at the ready.
Risk of injury if CCSV mode is used on infants!
Use of the CCSV mode can result in increased intrathoracic
pressures and thus injure infants'lungs.
Do not use CCSV mode on patients weighing less than 10 kg.
Risk of injury from use of pneumatic nebulizers during
volume-controlled ventilation!
The use of pneumatic nebulizers increases the minute volume
administered to the patient.
Do not use pneumatic nebulizers during volume-controlled
ventilation.
Caution Risk of injury due to operation of the device with compressed
air!
During operation with compressed air, the volume delivered by the
device is excessively high and the oxygen concentration of the
output is too low. This may lead to volutrauma and hypoxia in the
patient.
Only operate the device with medical oxygen or concentrator
oxygen.
Risk of injury due to drying out of the airways!
Prolonged ventilation using the device may dry out the airways of
the patient and cause them an injury.
Do not use the device for long-term ventilation.

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Risk of injury due to unsuitable concentrator gas!
Unsuitable concentrator gas may distort treatment and result in
injury to the patient.
Only use concentrator oxygen (90% to 96% oxygen) or
medical oxygen.
Risk of injury if the patient valve is covered!
The patient valve may be covered due to the position of the
patient and prevented from functioning properly.
Always keep the patient valve clear.
Risk of injury if dead space is not taken into consideration!
The patient hose systems for the device have different dead
spaces. The use of additional accessories between the ventilation
hose and patient (e.g.,humidifiers, nebulizers and goosenecks)
increases the dead space. Failure to take dead space into
consideration may lead to insufficient ventilation, especially in the
ventilation of infants with very small tidal volumes.
Take dead space into consideration when choosing the
ventilation parameters.
Do not use the device for the ventilation of premature babies
(born before the end of the 36th week of pregnancy).
Risk of injury from autotriggering!
Automatic triggering of the inspiration trigger by artifacts
(autotrigger) can result in hyperventilation of the patient.
Reduce the sensitivity of the inspiration trigger in case of
autotriggers.
Risk of injury from incompatible hoses!
The use of too high ventilation pressures with incompatible hoses
can result in insufflation of the stomach and cause injury to the
patient.
Only use compatible hoses.
2.1.5 Safe handling of oxygen
Warning Risk of fire if oxygen is used in combination with combustible
substances!
The combination of oxygen and combustible substances may lead
to spontaneous explosions. Where ventilation is inadequate,
oxygen may build up in the environment (e.g., clothing, hair, bed
linen) and cause fires and thereby injuries to the patient, user and
bystanders.

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2 Safety
Do not smoke.
Do not use open flames.
Ensure adequate ventilation.
Keep the device and screwed unions free from oil and grease.
Always close the SD card cover again following the insertion
and removal of the SD card.
Risk of injury if oxygen escapes from damaged oxygen
cylinders or pressure reducers!
Oxygen can escape unchecked from damaged oxygen cylinders or
pressure reducers. This may lead to explosions and cause injury to
the patient, user and bystanders.
Tighten all screwed unions on the oxygen cylinder and on the
pressure reducer by hand only.
Secure the oxygen cylinder so that it cannot fall over.
Risk of fire due to inadequate ventilation in an oxygen-
enriched environment!
Where ventilation is inadequate, oxygen may build up in the
environment and cause fires. This may result in injury to the
patient, user and bystanders.
Make provisions for adequate ventilation.
Risk of injury due to empty oxygen cylinder!
An empty oxygen cylinder prevents ventilation and may cause
injury to the patient.
Keep a full oxygen cylinder at the ready.
Keep an alternative ventilation unit at the ready.
Notice Damage to the device due to corrosion!
Moist ambient air may enter oxygen cylinders which have been
completely emptied and cause corrosion.
Do not empty oxygen cylinders completely.
Damage to the device due to pressure hammer on fittings!
Opening the valve on the oxygen cylinder too quickly may lead to
pressure hammer on the fittings.
Always open the valve of the oxygen cylinder slowly.

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2 Safety
2.2 General instructions
• If third-party items are used, malfunctions may occur and
fitness for use may be restricted. Biocompatibility requirements
may also not be met. Please note that in such cases, any
warranty claim and liability will be voided if neither the
accessories recommended in the instructions for use nor
genuine replacement parts are used. Third-party items may
increase the radiation output or reduce the interference
immunity.
• Repairs, servicing and maintenance should only be carried out
by the manufacturer, WEINMANN Emergency, or by a
technician expressly authorized by WEINMANN Emergency.
• Only have modifications to the device carried out by the
manufacturer, WEINMANN Emergency, or by a technician
expressly authorized by WEINMANN Emergency.
• Any constructive changes made to the device may put the
patient and the user at risk and are not permitted.
• The device is protected against unauthorized access by means
of a colored security seal on the rear of the housing. Please
note that any damage to the security seal voids any warranty
claims.
• Please observe the section on hygienic reprocessing in order to
avoid infection or bacterial contamination (see "8Hygienic
reprocessing", page164).
• Also observe the respective instructions for use for the device,
the components and the accessories.
• Always carry out a function check before using the device
(see "9Function check", page183).
• Risks due to software errors have been minimized by means of
extensive qualification measures.
• This device's software contains code which is subject to the
General Public License (GPL). You will receive the source code
and the GPL upon request.

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2 Safety
• The software for the FlowCheck sensor connection line with
MEDUtrigger/FlowCheck sensor connection line was created
with FreeRTOS (www.freertos.org).
2.3 Warnings in this document
Warnings are used to flag up safety-relevant information.
You will find a warning preceding any action that entails a hazard
for persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
• a signal word designating the hazard level,
• information about the hazard and
• instructions for avoiding the hazard.
The warnings appear in three hazard levels depending on the
degree of danger:
Danger!
Designates an extremely dangerous situation. Failure to observe
this warning will lead to serious, irreversible injury or death.
Warning!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious, irreversible or fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this warning
may lead to minor or moderately serious injury.
Notice!
Indicates a hazardous situation. Failure to observe this warning
may lead to damage to equipment.
Designates useful information relating to a particular action.

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3 Description
3 Description
3.1 Overview
3-1 Device
134
267 8
9
5
10
121314
1516
11
No. Designation Description
1 Display Displays settings and current values (see
"3.4Symbols on the display", page26).
2 Service cover
Used for servicing purposes. May only be opened by
the manufacturer or persons authorized by the
manufacturer.
3 Alarm light Indicates high-priority alarms visually.
4 Accessory connection
• Connects the device to MEDUtrigger.
• Connects the device to the FlowCheck sensor
connection line.
• Connects the device to the FlowCheck sensor
connection line with MEDUtrigger.

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3 Description
5 Filter compartment Houses the hygiene filter/device input filter.
6 Battery compartment with battery Houses the battery.
7 Power connection Connects the device to the power supply.
8 Compressed gas connection Used for connecting the oxygen supply (e.g., an
oxygen cylinder).
9 SD card slot For inserting an SD card.
10 Loudspeaker Emits audible alarms and metronome sounds.
11 Security seal Indicates whether the device has been opened
without authorization.
12 Connection for measuring hose system Connects the device to the measuring hose system of
the patient hose system.
13 Connection for ventilation hose Connects the device to the ventilation hose of the
patient hose system.
14 Connection for CO2measuring hose
Connects the device to the CO2measuring hose (only
with capnography option). This connection is included
with devices without a capnography option, however
it has no function.
15 Connection for pressure-measurement
hose
Connects the device to the pressure-measurement
hose.
16 Connection for PEEP control hose Connects the device to the PEEP control hose.
No. Designation Description

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3 Description
3.2 Control panel
3-2 Controls
1
2
4
3
5
6
7
89
No. Designation Description
1 Line power indicator
• Steady green light: Indicates that the device is
connected to line power.
• No light: The device is operating on battery power
and not on line power.
or
The device is in NVG mode.
2 Battery status indicator
• Steady green light: The battery is full or is not
being charged because it is outside the charging
temperature range.
• Flashing green light: The battery is being charged.
• Steady red light: The battery is defective or not in
the device.
• No light: The device is operating on battery power
and not on line power.
or
The device is in NVG mode.