Weinmann MEDUMAT Easy CPR Manuel utilisateur
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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Table of Contents
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 info@weinmann-emergency.com
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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