Weinmann MEDUMAT Easy CPR User manual

MEDUMAT EasyCPR
Ventilator
Instructions for use for devices from Serial Number 25000 or
software version 29
Read these instructions for use before using this product. Failure to do so
can result in serious injury or death.

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Table of Contents
Table of Contents
1 Information on these instructions for use 5
1.1 Copyright protection ..................................................................... 5
1.2 Customer Service .......................................................................... 6
1.3 Warning notices in these instructions for use ................................. 6
2 Safety 8
2.1 Intended use ................................................................................. 8
2.2 Personnel requirements ................................................................. 9
2.3 Preventing a device failure ........................................................... 10
2.4 Ensuring good hygiene practices .................................................. 11
2.5 Safe use of the device and accessories ......................................... 12
3 Description 17
3.1 Overview of device and accessories ............................................. 17
3.2 Description of device functionality ............................................... 18
3.3 Accessories ................................................................................. 19
3.4 Connections and interfaces .......................................................... 25
3.5 Control panel .............................................................................. 26
3.6 Labels and symbols ..................................................................... 27
3.7 Ventilation modes ....................................................................... 29
4 Preparation 31
4.1 Unpacking the delivery and visual inspection ............................... 31
4.2 Securing the retaining plate with fastening strap to the
device ..........................................................................................31
4.3 Connecting an oxygen supply ...................................................... 34
4.4 Connecting the breathing circuit and MEDUtrigger to the
device ..........................................................................................36
5 Function check 39
5.1 Intervals for function check .......................................................... 39
5.2 Visually checking the device and accessories ................................ 40
5.3 Preparing for the function check .................................................. 41
5.4 Checking the system for leaks ...................................................... 41

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Table of Contents
5.5 Checking device functions ........................................................... 43
6 Operation 53
6.1 Preparing for ventilation .............................................................. 53
6.2 Setting the ventilation parameters ............................................... 58
6.3 Switching the device on ............................................................... 61
6.4 Ventilating the patient ................................................................. 62
6.5 Muting alarms ............................................................................. 68
6.6 Switching the device off .............................................................. 69
7 Disassembly 70
7.1 Disassembling the ventilation mask and tube ............................... 70
7.2 Disassembling the breathing system filter ..................................... 71
7.3 Disassembling the PEEP valve ...................................................... 72
7.4 Disconnecting the breathing circuit and MEDUtrigger from
the device ....................................................................................72
7.5 Removing the oxygen supply ....................................................... 75
7.6 Disconnecting the retaining plate and fastening strap from
the device ....................................................................................76
8 Cleaning and disinfection 79
8.1 Intervals ...................................................................................... 79
8.2 Cleaning and disinfection plan ..................................................... 79
8.3 Performing cleaning and disinfection ........................................... 81
9 Alarms and error messages 90
9.1 Alarms ........................................................................................ 90
9.2 Faults .......................................................................................... 93
10 Maintenance 96
10.1 Intervals ...................................................................................... 96
10.2 Sending the device in for maintenance ......................................... 97
10.3 Changing the battery ................................................................... 97
11 Transport, storage and disposal 99
11.1 Transporting the device ............................................................... 99
11.2 Storing the device ........................................................................ 99
11.3 Disposal .................................................................................... 100

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12 Scope of supply, replacement parts and
accessories 101
12.1 Standard scope of supply ........................................................... 101
12.2 Accessories ............................................................................... 102
12.3 Replacement parts .................................................................... 102
13 Technical data 103
13.1 Device ....................................................................................... 103
13.2 Breathing circuit ........................................................................ 106
13.3 Protective transport bag ............................................................ 106
13.4 Pneumatic system diagram ........................................................ 107
13.5 Correlation between ventilation parameters ............................... 109
14 Appendix 110
14.1 Calculating the operating times ................................................. 110
14.2 Demand flow operating time ..................................................... 111
14.3 Ventilation operating time (min) ................................................ 112
14.4 Height compensation ................................................................ 113
15 Warranty terms and conditions 114

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1 Information on these instructions for use
1 Information on these
instructions for use
These instructions for use are meant to enable the safe and
efficient handling of MEDUMAT EasyCPR (referred to below as the
"device"). These 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.
1.1 Copyright 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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1 Information on these instructions for use
1.2 Customer Service
Should you have any questions, the WEINMANN Emergency LP
Customer Service will be delighted to be of assistance:
1.3 Warning notices in these instructions
for use
Warning notices in actions
Warning notices can relate to individual actions. To avoid
interrupting the reading flow, these warning notices are
embedded in the action. The symbols and signal words described
above are used.
Address
WEINMANN Emergency LP
5126 South Royal Atlanta Drive
Tucker, GA 30084
USA
E-mail [e-mail]
Internet www.weinmann-emergency.com/us
Danger!
DANGER indicates a hazardous situation that, if not avoided, will
result in death or serious injury.
Warning!
WARNING indicates a hazardous situation that, if not avoided,
could result in death or serious injury.
Caution!
CAUTION indicates a hazardous situation that, if not avoided,
could result in minor or moderate injury.
Notice!
NOTICE indicates information considered important, but not
hazard-related (e.g., messages related to damage to property or
the environment).
Designates useful tips relating to a particular action.

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1 Information on these instructions for use
Example of an embedded warning notice:
1. Undo screw.
2. CAUTION!
Risk of pinching on lid!
Carefully close the lid.
3. Tighten the screw.

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2 Safety
2 Safety
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.
2.1 Intended use
MEDUMAT EasyCPR is an electrical, pneumatically operated
emergency and transport ventilator used for ventilation and
oxygen inhalation with either a mask or tube.
Patient groups
Adults and children with a body weight of over 22 lbs (10 kg)
where spontaneous respiration has failed or is inadequate.
Users
Qualified medical personnel only.
Intended environments of use
• Mobile use for emergency medicine and primary care during
emergency deployments
• During land or air transport or transfer between hospital rooms
and departments
Federal law restricts this device to sale by or on the order of
a physician!

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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)
2.1.1 Exclusions 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
(MRI, NMR, NMI)
2.2 Personnel 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
2.3 Preventing a device failure
2.3.1 Pay 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
specified ambient conditions (see "13.1 Device", page 103).
2.3.2 Only 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 39).
Only use devices and accessories that have successfully passed
the function check.
2.3.3 Ensuring 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 96).

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2 Safety
2.3.4 Do 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.
2.3.5 Provide alternative ventilation units
If the device fails or the oxygen supply is interrupted: Provide
alternative ventilation units.
2.3.6 Keep 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.
2.3.7 Note shorter battery life at temperatures
below 0°C (32°F)!
Failure to note that the battery life can be significantly shortened
at temperatures below 0°C (32°F) can result in failure of the device
during the treatment.
Note shorter battery life at temperatures below 0°C (32°F)!
2.4 Ensuring good hygiene practices
2.4.1 Device 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 79).
Wear suitable protective equipment (e.g., gloves) during
cleaning and disinfection.
Only use the specified products for cleaning and disinfection.
2.4.2 Disposable 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
2.5 Safe use of the device and accessories
2.5.1 Preventing 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 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.
With portable RF communication devices, maintain a minimum
distance of 30 cm (approx 12 inches) to the device and
accessories. Examples: Wireless device, cell phone.

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2 Safety
2.5.2 Do not use the device with RF-surgery devices,
electrocautery devices or diathermy devices!
Using the device and its accessories in the vicinity of active RF-
surgery devices, electocautery devices or diathermy devices may
lead to failure of the device or its accessories.
Never use the device and its accessories simultaneously with
RF-surgery devices, electocautery devices or diathermy devices.
2.5.3 Do not use the device close to security systems
(e.g. electronic article surveillance systems and
metal detectors)
Using the device in the vicinity of security systems may cause the
device to malfunction and compromise the treatment.
Never operate the device in close proximity to security systems.
2.5.4 Do 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 (MRI, NMR, NMI).
2.5.5 Use 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.

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2 Safety
2.5.6 Monitoring 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., SpO2or etCO2).
2.5.7 Avoid 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).
2.5.8 Preventing 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 air circulation.
2.5.9 Preventing 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 air circulation.
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.

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2 Safety
Before working on the oxygen supply, wash your hands in
order 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.
2.5.10 Preventing the risk of fire and explosion due to
flammable narcotics or gases
Flammable gases and narcotics may cause explosions.
Do not use the device in combination with flammable gases or
flammable narcotics.
2.5.11 Risk 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.
2.5.12 Risk 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.
2.5.13 Keeping 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.
2.5.14 Batteries
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 at temperatures below 0°C (32°F)!

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2 Safety
Do not open the battery and do not deform 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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3 Description
3 Description
3.1 Overview of device and accessories
3-1 Device and accessories
pMax (cmH
2
O)
45
20
MEDUMAT Easy
CPR
3
1
2
9
or
4
5
7
8
6
11
10
12
15
14
13
or
No. Designation Description
1MEDUMAT EasyCPR The device ventilates the patient.
2Pressure measuring tube Measures the ventilation pressure.
3Mounting set with retaining
plate and fastening strap Serves to secure the device onto a pole or stretcher.
4Ventilation hose Conducts oxygen from the device to the patient.
5Testing bag for function
check Serves to check the functioning of the device.
6PEEP valve* Prevents a pressure drop during expiration.
7Patient valve Switches between inspiration and expiration.

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3 Description
* Third-party accessories, not included in the purchase of the
device.
3.2 Description of device functionality
MEDUMAT EasyCPR is an electrical, pneumatically operated
emergency and transport 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 allows for patient
exhalation of expiration gas. In order to monitor the patient, the
device features continuous measurement of the airway pressure as
well as a visual and audible alarm system.
8Breathing system filter* Cleans and air-conditions the respiratory air.
9Instructions for use Serve to ensure safe use of the device.
10 Tube* Connects the patient to be ventilated with the breathing
circuit.
11 Ventilation mask* Connects the patient to be ventilated with breathing
circuit.
12 Low-pressure hose assembly Conducts oxygen from the compressed gas supply to
the device.
13 MEDUtrigger Manually triggers mechanical breaths.
14 MEDUtrigger cable Connects MEDUtrigger to the device.
15 Clips
Keep the ventilation hose and pressure measuring tube
together and secure the MEDUtrigger cable to the
breathing circuit.
No. Designation Description

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3 Description
3.3 Accessories
3.3.1 Breathing circuit
3-2 Breathing circuit
The ventilation gas is delivered to the patient via the breathing
circuit.The breathing circuit comprises a pressure measuring tube
(1), a ventilation hose (2) and the patient valve. Both hoses are
connected to the patient valve and the device. The breathing
circuit is designed as a disposable system which must be replaced
after each use. The pressure measuring tube conducts the pressure
on the inspiration side to the device. The pressure measuring tube,
the ventilation hose and the MEDUtrigger cable are connected
together with clips (3).
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 (5) serves to discharge the respiratory air to the environment
during expiration and, if necessary, to connect a PEEP valve to the
patient valve.
2
1
3
5
4
6

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3 Description
3.3.2 MEDUtrigger
3-3 MEDUtrigger
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 by
actuating the button (3) on MEDUtrigger.
The two LEDs (1and 2) on MEDUtrigger show the current
operating status.
3.3.3 PEEP valve
3-4 PEEP valve
2
1
3