15.2Declaration of Conformity .......................................................... 147
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1 Information on these instructions for use
1Information on these
instructions for use
These instructions for use are meant to enable the safe and
efficient handling of the emergency and transport ventilator
MEDUMAT Easy
instructions for use form part of the device and must be kept in the
vicinity thereof and be accessible at all times.
Read these instructions for use carefully before any use, care or
maintenance of the device. To ensure the safe use of the device,
compliance with all the safety information, warning notices and
operating procedures stated in these instructions must be ensured.
In addition, the local accident prevention regulations and general
safety provisions for use of the device apply.
Report all serious incidents arising in connection with the device to
the manufacturer and the responsible body in your Member State.
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.
CPR
(referred to below as the “device”). These
1.1Copyright protection
The contents of these instructions for use are protected by
copyright.
It is not permitted, except for internal purposes, to make these
instructions for use available to third parties, to make
reproductions of any kind, including excerpts, or to use and/or
communicate the content thereof without the written permission
of WEINMANN Emergency Medical Technology GmbH + Co. KG
(referred to below as the “manufacturer”).
Infringements will lead to liability for damages. The manufacturer
reserves the right to assert further claims.
Copyright is owned by the manufacturer.
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EN 5
1 Information on these instructions for use
1.2Customer Service
Should you have any questions, the WEINMANN Emergency
Customer Service will be delighted to be of assistance:
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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1 Information on these instructions for use
Warning notices in actions
Safety information can relate to individual actions. To avoid
interrupting the reading flow, this safety information is embedded
in the action. The symbols and signal words described above are
used.
Example of embedded safety information:
1. Undo screw.
2.CAUTION!
Risk of pinching on lid!
Carefully close the lid.
3. Tighten the screw.
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2 Safety
2Safety
2.1Intended use
The instructions for use are 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 and user.
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 use (see
“2.1 Intended use”, page 8).
Do not use the device in the event of contraindications.
MEDUMAT Easy
emergency and transport ventilator used for ventilation and
oxygen inhalation with either a mask or tube.
CPR
is an electrical, pneumatically operated
Patient groups
Adults and children with a body weight of over 10 kg (22 lbs)
where spontaneous respiration has failed or is inadequate.
User
Qualified medical specialists (e.g., paramedics, emergency
physicians).
Intended application areas
• Mobile use for emergency medicine and primary care during
emergency deployments
• During transport between hospital rooms and departments
• During transport between the hospital and other sites in an
ambulance, airplane, helicopter, or ship
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2 Safety
Contraindications
None currently known.
Possible side effects and complications
• Undesirable effects on the cardiovascular system (e.g.,
reduction of cardiac output, reduction of venous return flow)
• Drying out of the airways
• Overinflation of the lung tissue (lung rupture)
• Overinflation of the stomach during mask ventilation (e.g.,
aspiration of stomach contents)
2.1.1Exclusions and restrictions of intended use
The device is not approved for the following applications:
• Operation for long-term ventilation in excess of 24 hours
• Operation in hyperbaric chambers
• Operation in combination with magnetic resonance scanners
(MRT, NMR, NMI)
2.2Personnel requirements
Personnel must meet the following requirements:
• Personnel must have a medical qualification and the necessary
specialist knowledge and experience in the ventilation of
patients.
• As a result of this specialist knowledge and experience, the
personnel must be able to safely perform the tasks they have
been assigned, and must be able to independently recognize,
evaluate and prevent any possible risks for themselves or the
patient.
• The personnel must have been trained and instructed in the
operation of the device.
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2 Safety
2.3Preventing a device failure
2.3.1Pay attention to the correct ambient conditions
If the device or accessories are operated in a non-specified
environment, the treatment may be compromised as a result of
malfunctions.
Do not operate the device and accessories outside of the
2.3.2Only operate the device and accessories in
perfect condition
If the device is not in perfect condition, this can lead to
malfunctions and a loss of pneumatic and electrical energy, and
can compromise the treatment.
Perform a full function check before every use (see “5 Function
check”, page 51).
Only use devices and accessories that have successfully passed
the function check.
2.3.3Ensuring correct maintenance
Inadequate or incorrect maintenance will impair the functioning of
the device and can compromise the treatment.
Do not open the device.
Follow the maintenance intervals as stated on the device
labeling.
Make sure that the maintenance work is performed. This work
must only be carried out by the manufacturer or by specialist
personnel who have been explicitly authorized by the
manufacturer.
Also observe and comply with the maintenance intervals for
devices in storage (see “10.1 Intervals”, page 125).
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2 Safety
2.3.4Do not perform any modifications to the
construction of the device or accessories
If modifications are performed to the construction of the device or
accessories, the treatment may be compromised as a result of
malfunctions.
Do not perform any modifications to the construction of the
device or accessories.
2.3.5Provide alternative respiration units
If the device fails or the oxygen supply is interrupted: Provide
alternative respiration units.
2.3.6Keep spare battery available
The battery may die during longer uses and result in failure of the
device during the treatment.
Always keep a spare battery available.
2.3.7Note shorter battery life at temperatures
below 0°C!
Failure to note that the battery life can be significantly shortened
at temperatures below 0°C can result in failure of the device during
the treatment.
Note shorter battery life as of temperatures below 0°C!
2.4Ensuring good hygiene practices
2.4.1Device and accessories
Inadequate hygiene causes the following risks:
• Inadequately cleaned and disinfected devices or accessories
can infect the user or patient via the skin or airways.
• Unsuitable cleaning products or disinfectants can damage the
device and lead to malfunctions.
Carry out cleaning and disinfection of the device and
accessories after every use in accordance with the cleaning and
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2 Safety
disinfection plan (see “8.2 Cleaning and disinfection plan”,
page 100).
Wear suitable protective equipment (e.g., gloves) during
cleaning and disinfection.
Only use the specified products for cleaning and disinfection.
2.4.2Disposable items
Re-using disposable items causes the following risks:
• Infection if items come into contact with airways
• Malfunctions when using the device
• Unforeseeable reactions as a result of aging, embrittlement,
wear, thermal load and the effects of chemical processes
Never perform cleaning and disinfection of disposable items.
Never use disposable items more than once.
2.5Safe use of the device and accessories
2.5.1Preventing 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 WEINMANN Emergency devices
which have been tested and shown to guarantee interferencefree 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.
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.
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2.5.2Do not use the device in magnetic resonance
scanners
Use of the device in magnetic resonance scanners can cause the
device to malfunction and compromise the treatment.
Never operate the device in combination with magnetic
resonance scanners (MRT, NMR, NMI).
2.5.3Use of approved accessories and approved
spare parts
Non-approved accessories or non-approved spare parts can lead to
device malfunctions or interfere with other devices. For example,
the connection of non-approved accessories can result in increased
electromagnetic interference or reduced electromagnetic
immunity.
Only use approved accessories.
Only use spare parts from WEINMANN Emergency or spare
parts that have been approved by WEINMANN Emergency.
2.5.4Monitoring the patient and the device
If alarm lights and loudspeakers are covered up, the personnel will
not be able to see or hear the alarms and will therefore not be able
to respond to dangerous situations.
Always keep alarm lights and loudspeakers clear and
uncovered.
The patient and device must be continually monitored during
ventilation.
Use additional external monitoring during ventilation (e.g.,
SpO
or etCO2).
2
2.5.5Avoid oxygen poisoning as a result of
prolonged ventilation
Prolonged use of the device with a high oxygen concentration can
result in oxygen poisoning of the patient.
Do not use the device for long-term ventilation (in excess of
24 hours).
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2 Safety
2.5.6Preventing the risk of fire and explosion during
defibrillation
Simultaneous use of the ventilator and the defibrillator can cause
explosion and fire in oxygen-enriched atmospheres.
Wherever possible, use adhesive electrodes for defibrillation.
Ensure that the oxygen-air mixture coming from the patient
valve flows away from the patient’s torso.
Ensure adequate ventilation.
2.5.7Preventing the risk of fire and explosion as a
result of oxygen
Compressed oxygen can quickly enrich the atmosphere with
oxygen and lead to fire or explosion of combustible substances.
Ensure adequate ventilation.
Never smoke in the vicinity of fittings carrying oxygen.
Keep the oxygen supply away from naked flames or other
ignition sources.
Keep the device and screwed unions free from oil and grease.
Wash your hands before working on the oxygen supply to
remove any oil or grease.
Secure the oxygen cylinder so that it cannot fall over.
Tighten or loosen all screwed unions on the oxygen cylinder
and on the pressure reducer by hand only. If necessary, use a
wrench suitable for pin index oxygen cylinders.
2.5.8Preventing the risk of fire and explosion due to
flammable anesthetic gases or gases
Flammable gases and anesthetic gases may cause explosions.
Do not use the device in combination with flammable gases or
flammable anesthetic gases.
2.5.9Risk of explosion if the device is used in
hyperbaric chambers
The device may produce explosions if used in hyperbaric chambers.
Never use the device in hyperbaric chambers.
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2.5.10Risk of poisoning if the device is used in a toxic
environment
Use of the device in a toxic environment can allow toxic gases to
enter the patient’s lungs.
Do not operate the device in a toxic environment.
2.5.11Keeping the device labeling legible
Unsuitable wipe disinfectants could remove the device’s labeling
and markings and cause material damage meaning that the user
may not be able to use the device and accessories correctly in an
emergency.
Only use the recommended wipe disinfectants.
Replace illegible labels.
2.5.12Batteries
Handling batteries incorrectly can lead to injuries.
Do not throw the battery into the fire.
Never expose the battery to high temperatures.
Note shorter battery life as of temperatures below 0°C!
Do not open the battery and do not disassemble the battery.
Do not recharge the battery.
Do not short circuit the battery.
Protect the battery from moisture.
Do not expose the battery to high pressures.
Prevent escaping battery fluid from coming into contact with
skin or eyes. If battery fluid comes into contact with skin or
eyes, immediately rinse the skin or eye thoroughly with plenty
of water and consult a doctor.
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EN15
3 Description
3
1
2
9
or
4
5
7
8
6
11
10
12
15
14
13
16
Disposable hose
system
or
17
Reusable
hose system
3Description
3.1Overview of device and accessories
3-1 Device and accessories
No.DesignationDescription
CPR
The device ventilates the patient.
Used to hold and transport the device and other therapy
devices as well as the requisite components.
1
MEDUMAT Easy
2 Pressure measuring tubeMeasures the ventilation pressure.
3
Carrying system
LIFE-BASE
4 Ventilation hoseConducts oxygen from the device to the patient.
5
6 Testing bagUsed to check the functioning of the device.
7 Patient valveSwitches between inspiration and expiration.
8 PEEP valve*Prevents a pressure drop during expiration.
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Mounting plate and the
fastening strap
CPR
Used to secure the device.
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3 Description
No.DesignationDescription
9 Breathing system filter*Cleans and air-conditions the respiratory air.
10 Instructions for UseServe to ensure safe use of the device.
11 Tube*
12 Ventilation mask
13 Compressed gas tube
14 MEDUtriggerManually triggers mechanical breaths.
15 MEDUtrigger cableConnects the MEDUtrigger to the device.
16 Hose protection sleeve
17 Clips
* Third-party accessories, not included in the purchase of the
device.
Connects the patient to be ventilated with the patient
hose system.
Connects the patient to be ventilated with the patient
hose system.
Conducts oxygen from the compressed gas supply to the
device.
Keeps the ventilation hose, pressure measuring tube, and
MEDUtrigger cable together and protects the patient hose
system from soiling.
Keep the ventilation hose and pressure measuring tube
together and secure the MEDUtrigger cable to the patient
hose system.
3.2Function
MEDUMAT Easy
ventilator. Highly compressed medical oxygen is used as the
ventilation gas; this is reduced to the necessary operating pressure
via an external pressure reducer. The oxygen is supplied at the
compressed gas connection.
The ventilation parameters – frequency and tidal volume – are
linked together and can be set using the adjusting knob on the
device.
The ventilation gas is transported to the patient through the
ventilation hose via the patient valve and ventilation mask or via
the tube. The lip membrane in the patient valve guarantees that
the expiration gas can be exhaled via the expiration side. In order
to monitor the patient, the device features continuous
measurement of the airway pressure as well as a visual and audible
alarm system.
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is an automatic emergency and transport
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EN 17
3 Description
2
1
3
5
4
6
The device also features a voice prompt and a metronome,
intended as an aid to users with little experience with the device in
particular. If the voice prompt is not required, it can be switched
off with a key combination (see “6.7 Activating/deactivating the
voice prompt”, page 85). The same applies for the metronome
(see “6.8 Activating/deactivating the metronome”, page 87).
3.3Accessories
3.3.1Patient hose system with patient valve
The patient hose system with patient valve is available as a reusable
hose system with reusable patient valve or a disposable hose
system with disposable patient valve.
3-2 Reusable hose system with reusable patient valve
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3-3 Reusable patient valve
3
2
1
4
6
5
1
2
3
6
5
4
3 Description
3-4 Disposable hose system with disposable patient valve
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EN 19
3 Description
2
1
3
The ventilation gas is delivered to the patient via the patient hose
system with patient valve. The patient hose system comprises a
pressure measuring tube (1) and a ventilation hose (2). Both hoses
are connected to the patient valve and the device. The pressure
measuring tube conducts the pressure on the inspiration side to
the device. The pressure measuring tube, ventilation hose, and the
MEDUtrigger cable are connected together with clips (3) in the
disposable hose system. In the reusable hose system, the hose
protection sleeve (3) keeps the pressure measuring tube, the
ventilation hose, and the MEDUtrigger cable together.
The patient valve is designed so that if the device fails,
spontaneous respiration is possible regardless of the ventilation
mode set. If necessary, fresh air can be inhaled via the spontaneous
respiration side with emergency air membrane (4).
The inspiration side (6) serves to enable a breathing system filter, a
ventilation mask or a tube to be attached to the patient valve or to
connect a testing bag to perform a function check. The expiration
side with disk diaphragm (5) serves to discharge the respiratory air
to the environment during expiration and, if necessary, to connect
a PEEP valve to the patient valve.
3.3.2MEDUtrigger
3-5 MEDUtrigger
The MEDUtrigger serves to trigger individual mechanical breaths
with the set tidal volume. In this way, you determine the respiratory
rate administered yourself. The mechanical breaths are triggered
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by actuating the button (3) on the MEDUtrigger.
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The two LEDs (1 and 2) on the MEDUtrigger show the current
operating status.
3.3.3PEEP valve
3-6 PEEP valve
The PEEP valve enables ventilation with a positive end-expiratory
pressure (PEEP). The PEEP valve prevents the pressure dropping to
the ambient air pressure during expiration.
Attach the PEEP valve to the expiration side of the patient valve.
A PEEP valve is not included in the purchase of the device.
3 Description
3.3.4Tube
3-7 Tube
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3 Description
The tube can be used in addition to the ventilation mask for patient
ventilation. For this, the tube must firstly be inserted into the
patient’s trachea by a medical specialist (intubation). The tube is
not included in the purchase of the device.
3.3.5Ventilation mask
3-8 Ventilation mask
The ventilation mask is used for non-invasive ventilation.
3.3.6Breathing system filter
3-9 Breathing system filter
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Commercially available HME breathing system filters (HME = Heat
2
1
Moisture Exchange) with standard connections (15/22 mm) can be
attached to the inspiration side of the patient valve to filter and aircondition the respiratory air. The breathing system filter is not
included in the purchase of the device.
3.3.7Testing bag
3-10 Testing bag
The testing bag (1) serves to check the functionality of the device
prior to use. During testing, the testing bag simulates the human
lung.
3 Description
The connector (2) is connected to the patient valve for the function
check.
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3 Description
2
1
3
3.3.8Compressed gas tube
3-11 Compressed gas tube
The compressed gas tube connects the device to the oxygen
supply.
3.3.9Mounting set with mounting plate and
fastening strap
3-12 Mounting set with mounting plate and fastening strap
The mounting set serves to temporarily secure the device to the site
of use. It comprises a mounting plate (3), screws (1), and a
fastening strap with a safety lock (2).
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3.4Connections and interfaces
3
4
5
7
1
2
6
3 Description
3-13 Connections and interfaces
No.DesignationDescription
1 Compressed gas connectionConnects the oxygen supply to the device.
2 Battery compartmentHouses the battery.
3 LoudspeakerEmits audible alarms.
4 Connection for MEDUtriggerConnects the MEDUtrigger to the device.
5
Connection for pressure
measuring tube
Connects the pressure measuring tube to the device.
Conducts the airway pressure at the patient valve to
the pressure sensor inside the device.
6 Connection for ventilation hoseConnects the ventilation hose to the device.
7 Pressure relief valveServes to limit the ventilation pressure.
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3 Description
1
2
3
4
5
6
7
8
9
10
11
3.5Control panel
3-14 Control panel
No.DesignationDescription
1 Ventilation pressure displayDisplays the ventilation pressure in mbar.
2 Alarm field
3 LED for alarm muting
Indicates alarm states visually.
• LED is lit: Alarm is active.
• LED is not lit: Alarm is not active.
Indicates the status of alarm muting.
• LED is lit: The alarm is muted for 120 seconds.
• LED is not lit: The alarm is switched on.
4 Alarm mute buttonServes to mute the alarm and switch the audible alarm back on.
5 Color legend
Displays assignment of the ventilation parameters:
•Orange: Child
•Red: Adult
6 Man. button with control LED
Adjusting knob for the
7
ventilation parameters
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Activates and deactivates the manual mode (CPR mode). Shows
readiness for operation.
Serves to set the ventilation rate freq (breaths per minute) and
tidal volume Vt (ml).
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No.DesignationDescription
1
9
2
5
4
3
8
76
10
8 Snap-in position
Switches between continuous mode and the demand flow
mode.
Visually displays the status of the demand flow mode.
9 LED demand flow
• Illuminated: The demand flow mode is switched on.
• Not illuminated: The demand flow mode is switched off.
10 On/Off buttonSwitches the device on or off.
11 pMax button with control LEDs
Switches between the ventilation pressure limit for mask
ventilation (20 mbar) and tube ventilation (45 mbar).
3.6Labels and symbols
3.6.1Labels on the device
3 Description
3-15 Labels on the device
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3 Description
2.7-6 bar/
40-87 psi
>40 l/min STPD
O
2
REF
SN
No.SymbolDescription
1
2
2
IP54
Rx only
Input 2.7-6 bar (40-87 psi) O
2
STPD – Standard Temperature and Pressure, dry
Article number
Serial number
Protection against the ingress of dust and splash water from all
sides
Type BF applied part
Do not dispose of device in household waste
CE mark (confirms that the product complies with the applicable
European directives)
Device only available with prescription as per US legislation
[Code of Federal Regulations (CFR) Title 21]
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Manufacturer with date of manufacture (YYYY-MM-DD)
UDI marking - possible application identifiers:
(01): Global Trade Item Number (GTIN) – globally unique
Identification Number
(10): Batch/Lot number
(11): Date of manufacture in format YYMMDD
(17): Expiration date in format YYMMDD
(21): Serial number
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No.SymbolDescription
pMax
100 mbar/
<
<
1.45 psi
Follow the instructions for use
Do not sit on the device
3
Do not climb on the device
UL marking with certification label (see “13.1 Device”,