Weinmann MEDUMAT Easy CPR User manual

MEDUMAT Easy
CPR
Ventilator
Instructions for Use for devices from Serial Number 25000 or
software version 29
Read the instructions for use before using the product. Failure to observe
the instructions for use can result in serious injuries 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
3Description 16
3.1 Overview of device and accessories ............................................. 16
3.2 Function ...................................................................................... 17
3.3 Accessories ................................................................................. 18
3.4 Connections and interfaces .......................................................... 25
3.5 Control panel .............................................................................. 26
3.6 Labels and symbols ..................................................................... 27
3.7 Ventilation modes ....................................................................... 38
4 Preparation 40
4.1 Unpacking the delivery and visual inspection ............................... 40
4.2 Install the device on a carrying system or carrying structures ........ 40
4.3 Securing the mounting plate with fastening strap to the device .... 41
4.4 Connecting an oxygen supply ...................................................... 44
4.5 Assemble reusable hose system ................................................... 46
4.6 Connecting the patient hose system and MEDUtrigger to
the device ................................................................................... 48
5 Function check 51
5.1 Intervals for function check .......................................................... 51
5.2 Visually checking the device and accessories ................................ 51
5.3 Preparing for the function check .................................................. 52

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Table of Contents
5.4 Checking the system for leaks ...................................................... 53
5.5 Checking device functions ........................................................... 54
6 Operation 64
6.1 Preparing for ventilation .............................................................. 64
6.2 Setting the ventilation parameters ............................................... 70
6.3 Switching the device on ............................................................... 72
6.4 Ventilating the patient ................................................................. 73
6.5 Muting alarms ............................................................................. 83
6.6 Switching the device off .............................................................. 84
6.7 Activating/deactivating the voice prompt ..................................... 85
6.8 Activating/deactivating the metronome ........................................ 87
7Disassembly 89
7.1 Disassembling the ventilation mask and tube ............................... 89
7.2 Disassembling the breathing system filter ..................................... 90
7.3 Disassembling the PEEP valve ...................................................... 91
7.4 Disconnecting the patient hose system and MEDUtrigger from
the device ................................................................................... 91
7.5 Disassembly of the reusable hose system ..................................... 94
7.6 Removing the oxygen supply ....................................................... 96
7.7 Disconnecting the mounting plate and fastening strap from
the device ................................................................................... 97
8 Cleaning and disinfection 100
8.1 Intervals .................................................................................... 100
8.2 Cleaning and disinfection plan ................................................... 100
8.3 Performing cleaning and disinfection ......................................... 104
9 Alarms and error messages 118
9.1 Alarms ...................................................................................... 119
9.2 Faults ........................................................................................ 123
10 Maintenance 125
10.1 Intervals .................................................................................... 125
10.2 Sending the device in for maintenance ....................................... 126
10.3 Changing the battery ................................................................. 126

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10.4 Changing the membranes and O-ring in the reusable
patient valve ............................................................................. 128
11 Transport, storage and disposal 130
11.1 Transporting the device ............................................................. 130
11.2 Storing the device ..................................................................... 130
11.3 Disposal .................................................................................... 131
12 Scope of supply, replacement parts and
accessories 132
12.1 Standard scope of supply ........................................................... 132
12.2 Accessories ............................................................................... 132
12.3 Replacement parts .................................................................... 133
13 Technical data 134
13.1 Device ....................................................................................... 134
13.2 Patient hose system .................................................................. 137
13.3 Protective transport bag ............................................................ 137
13.4 Pneumatic system diagram ........................................................ 138
13.5 Correlation between ventilation parameters ............................... 140
14 Appendix 141
14.1 Calculating the operating times ................................................. 141
14.2 Demand flow operating time ..................................................... 142
14.3 Ventilation operating time (min) ................................................ 143
14.4 Height compensation ................................................................ 144
14.5 Voice prompts ........................................................................... 145
15 Warranty terms and conditions 147
15.1 Warranty ................................................................................... 147
15.2 Declaration of Conformity .......................................................... 147

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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 the emergency and transport ventilator
MEDUMAT Easy
CPR
(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
Customer Service will be delighted to be of assistance:
1.3 Warning notices in these instructions
for use
Address
WEINMANN Emergency GmbH + Co. KG
Frohbösestraße 12
22525 Hamburg
Germany
E-mail [e-mail]
Internet www.weinmann-emergency.com
Telephone [phone]
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
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
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 Easy
CPR
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 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)
2.1.1 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
(MRT, 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 134)
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 51).
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 125).