Weinmann MEDUMAT Standard2 User manual

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

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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

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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

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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

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14.3 Exported log files ....................................................................... 259
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. 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.

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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.

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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
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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
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is used in the treatment of infants, children
and adults weighing 3 kg or more where spontaneous respiration
has failed or is inadequate.

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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.

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• 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
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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).

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2.4 Safety information
2.4.1 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.
⇒ Change the hygiene 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.
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.

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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!
Blocked suction inlets on the hygiene 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 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 patient 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.
⇒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.

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Risk of injury from operating the device, accessories and
components outside of the prescribed ambient conditions!
Use of the device, accessories and components 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, accessories and components within
the prescribed ambient conditions (see "14.1.1 Technical data
on device", page 232).
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 VG mode. This can injure the patient.
⇒Always monitor patients during ventilation.
⇒Only use the VG option in the military sector.
Fault or failure of the device or accessory during therapy due
to high-frequency surgical devices in close proximity to the
device!
High-frequency surgical devices in close proximity to the device or
accessory can cause malfunctioning or failure of the device or
accessory. This can result in serious or life-threatening injury to the
patient.
⇒Do not use the device and accessories in close proximity to
high-frequency surgical devices.

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Fault or treatment failure due to incompatibility of the device
with consumables, accessories or other medical devices!
Defective and unauthorized accessories can result in malfunctions,
increased electromagnetic interference emissions and reduced
electromagnetic immunity of the device, incorrect output values
and reduced ventilation performance. This can result in serious or
life-threatening injury to the patient.
⇒Only connect approved accessories.
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 WEI MA Emergency.
Risk of injury as a result of pressure variations during use in
combination with devices from the WEINMANN Emergency
MOD L range!
If the device is used together with devices from the
WEI MA Emergency MODUL range, the flow used by devices
from the WEI MA Emergency MODUL series may cause
pressure variations in the device. This can injure the patient.
⇒Only use the device and devices from the
WEI MA Emergency MODUL range in combinations
approved by WEI MA Emergency.
Prevent interference between the devices!
Electrical devices which are operated directly next to or on top of
each other can cause mutual interference to functionality.
Portable high-frequency communication devices in the direct
vicinity of the device can also influence the functioning of the
device.
⇒Do not stack the device with other electrical devices.
⇒Do not operate the device directly next to other electrical
devices. Exception: Other WEI MA Emergency devices
which have been tested and shown to guarantee interference-
free operation with the adjacent device. A list of other devices
is available 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.

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⇒With portable RF communication devices, maintain a minimum
distance of 30 cm (approx 12 inches) to the device and
accessories. Examples: Wireless device, mobile telephone.
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.
2.4.2 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.
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 WEI MA Emergency.

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Risk of injury due to incorrect maintenance of the Li-ion
battery!
An open, non-original or damaged Li-ion battery can lead to
excessive temperatures, fire or explosions. This can lead to injuries
to the user, patient or third parties.
⇒Only operate the device using the battery recommended by
WEI MA Emergency.
⇒Only use an unopened, undamaged battery.
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 with
S < 20000 every 5 months and battery with S ≥ 20000
every 9 months.
2.4.3 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 Hygienic reprocessing", page 172).

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Caution Risk of injury from touching the contacts on the FlowCheck
sensor connection line/FlowCheck sensor connection line with
MED trigger 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.
2.4.4 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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Risk of injury due to ventilation pressures which are too high
or too low!
Ventilation pressures which are too high or too low may result in
injury to the patient.
⇒Check correct ventilation on the display.
⇒Adjust the maximum ventilation pressure (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 VG 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.
2.4.5 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.
⇒Do not smoke.

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⇒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.