MEDUMAT - Standard 2 Instructions For Use PDF
MEDUMAT - Standard 2 Instructions For Use PDF
MEDUMAT - Standard 2 Instructions For Use PDF
Ventilator
Table of Contents
1 Introduction 5
1.1 Intended use ................................................................................. 5
1.2 Operator and user qualification ..................................................... 6
1.3 Contraindications .......................................................................... 6
1.4 Side effects ................................................................................... 6
2 Safety 7
2.1 Safety information ......................................................................... 7
2.2 General instructions .................................................................... 14
2.3 Warnings in this document .......................................................... 15
3 Description 16
3.1 Overview ..................................................................................... 16
3.2 Control panel .............................................................................. 17
3.3 Display ........................................................................................ 18
3.4 Symbols on the display ................................................................ 20
3.5 Components ............................................................................... 23
3.6 Accessories ................................................................................. 26
3.7 Optional functions ....................................................................... 27
3.8 Labels and symbols ..................................................................... 27
4 Preparation and operation 33
4.1 Mounting the device ................................................................... 33
4.2 Connecting to a power supply ..................................................... 33
4.3 Using the rechargeable battery .................................................... 34
4.4 Connecting components .............................................................. 37
4.5 Switching on the device ............................................................... 42
4.6 Switching off the device .............................................................. 43
4.7 Ventilating the patient ................................................................. 43
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2 EN MEDUMAT Standard2
Table of Contents
MEDUMAT Standard2 EN 3
Table of Contents
WM 68011a 11/2013
4 EN MEDUMAT Standard2
1 Introduction
1 Introduction
1.1 Intended use
MEDUMAT Standard2 is an automatic oxygen emergency
ventilator with functions for the monitoring of respiratory values.
MEDUMAT Standard2 is used in the treatment of infants, children
and adults where spontaneous respiration has failed or is
inadequate. The device can be used for invasive and non-invasive
ventilation. MEDUMAT Standard2 features ventilation modes for
controlled, assisted, and manual ventilation. In addition, the device
also enables oxygen inhalation and preoxygenation. With volume-
controlled ventilation, ventilation volumes from 50 ml are possible.
The device is not suitable for the ventilation of neonates.
Emergency applications:
MEDUMAT Standard2 EN 5
1 Introduction
As the operator or user, you must be fully familiar with the correct
operation of this medical device. Observe the statutory
requirements for operation and use (in Germany, particularly the
German regulations governing owners/operators of medical
devices (MPBetreibV)).
General recommendation: You should seek instruction on the
correct handling, use and operation of this medical device from a
person authorized by WEINMANN Emergency.
1.3 Contraindications
Possible contraindications for ventilation include:
• Pneumothorax or pneumomediastinum
6 EN MEDUMAT Standard2
2 Safety
2 Safety
2.1 Safety information
Read these instructions for use carefully. They form part of the
devices described, and must be available at all times.
Use the device for the designated purpose only (see "1.1 Intended
use", page 5).
bystanders.
Do not use the device in combination with flammable gases or
anesthetic gases.
MEDUMAT Standard2 EN 7
2 Safety
8 EN MEDUMAT Standard2
2 Safety
MEDUMAT Standard2 EN 9
2 Safety
10 EN MEDUMAT Standard2
2 Safety
2.1.4 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.
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MEDUMAT Standard2 EN 11
2 Safety
12 EN MEDUMAT Standard2
2 Safety
MEDUMAT Standard2 EN 13
2 Safety
• Also observe the respective instructions for use for the device,
the components, and the accessories.
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• Always carry out a function check before using the device (see
"8 Function check", page 98).
14 EN MEDUMAT Standard2
2 Safety
You will find a warning preceding any action that entails a hazard
for persons or equipment.
Warnings consist of
• the warning symbol (pictogram),
Danger!
Designates an extremely dangerous situation. Failure to observe
this warning will lead to serious, irreversible injury or death.
Warning!
Designates an extremely dangerous situation. Failure to observe
this warning may lead to serious, irreversible or fatal injury.
Caution!
Designates a dangerous situation. Failure to observe this warning
may lead to minor or moderately serious injury.
Notice!
Indicates a hazardous situation. Failure to observe this warning
may lead to damage to equipment.
MEDUMAT Standard2 EN 15
3 Description
3 Description
3.1 Overview
1 2 3 4 5 6 7 8
ER
FILT
12 11 10 9
3-1 Device
16 EN MEDUMAT Standard2
3 Description
3-2 Controls
MEDUMAT Standard2 EN 17
3 Description
3.3 Display
3.3.1 Start menu
1 2 3 4
18 EN MEDUMAT Standard2
3 Description
1 2 3 4
13 6
12
11 10
MEDUMAT Standard2 EN 19
3 Description
20 EN MEDUMAT Standard2
3 Description
MEDUMAT Standard2 EN 21
3 Description
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22 EN MEDUMAT Standard2
3 Description
3.5 Components
3.5.1 Overview
1 2 3
6 5 4
3-5 Components
MEDUMAT Standard2 EN 23
3 Description
14 15
13
1 2
12
11 10 9 8 7 6 5 4
24 EN MEDUMAT Standard2
3 Description
MEDUMAT Standard2 EN 25
3 Description
3.6 Accessories
1 2 3
5 4
3-7 Accessories
26 EN MEDUMAT Standard2
3 Description
5 1
ER
FILT
4 3 2
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MEDUMAT Standard2 EN 27
3 Description
Input
1 DC voltage
CE mark (confirms that the product complies with the applicable European
directives)
Other labels and symbols
4 Input
28 EN MEDUMAT Standard2
3 Description
1 2
3
4
5
6
9 8 7
2 Battery status
4 Date of manufacture
5 SN Serial number
6 Manufacturer
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China RoHS label (confirms that the product does not emit toxic substances for
8
the number of years indicated)
MEDUMAT Standard2 EN 29
3 Description
10
1
2
9
4
7 6 5
CE mark (confirms that the product complies with the applicable European
3
directives)
30 EN MEDUMAT Standard2
3 Description
Indicates the date when the next maintenance is due (Position: on the service
9
label).
Symbol Description
Device information label
CE mark (confirms that the product complies with the applicable European directives)
Symbol Description
Device
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MEDUMAT Standard2 EN 31
3 Description
Symbol Description
Fragile
SN Serial number
CE mark (confirms that the product complies with the applicable European directives)
Patient hose system (reusable hose system and disposable hose system)
Latex Latex-free
CE mark (confirms that the product complies with the applicable European directives)
Expiration date
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32 EN MEDUMAT Standard2
4 Preparation and operation
ER
FILT
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MEDUMAT Standard2 EN 33
4 Preparation and operation
4. If necessary:
If operating on the portable system, mount the portable system
on a wall mounting with charging interface.
or
or
or
• The device is connected to the line power via the power supply.
34 EN MEDUMAT Standard2
4 Preparation and operation
Battery
You can see the battery status on the battery itself.
The battery status is indicated by 4 green status LEDs. Simply press
the status button on the battery.
MEDUMAT Standard2 EN 35
4 Preparation and operation
Device
If the device is switched on, you can see the battery status on the
display:
36 EN MEDUMAT Standard2
4 Preparation and operation
1. Switch off the device (see "4.6 Switching off the device", page
43) or connect it to the line power.
or inhalation cannula!
Ventilation with an inhalation mask, tube or inhalation cannula
connected may cause an injury to the patient.
Do not use an inhalation mask, tube or inhalation cannula for
ventilation.
MEDUMAT Standard2 EN 37
4 Preparation and operation
ER
FILT
ER
FILT
38 EN MEDUMAT Standard2
4 Preparation and operation
or
Result The patient hose system is connected to the device and is ready for
use.
MEDUMAT Standard2 EN 39
4 Preparation and operation
Transport
safety
device
3. Push the device input filter with the half-inserted filter cassette
into the filter compartment of the device.
In the process, the filter cassette is pushed all the way into the
device input filter.
4. Press the device input filter into the filter compartment until the
device input filter audibly clicks into place and sits flush with
the device.
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40 EN MEDUMAT Standard2
4 Preparation and operation
MEDUtrigger
The operational readiness of the MEDUtrigger is indicated by
2 green LEDs on the MEDUtrigger. If the MEDUtrigger is connected
to the device and the green LEDs on the MEDUtrigger are lit, you
can trigger mechanical breaths manually by pressing the
MEDUtrigger button.
MEDUtrigger button
LEDs
4-2 MEDUtrigger
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MEDUMAT Standard2 EN 41
4 Preparation and operation
or
Result The MEDUtrigger is connected to the device and is ready for use.
• The alarm light flashes twice and two short test tones are
emitted
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42 EN MEDUMAT Standard2
4 Preparation and operation
MEDUMAT Standard2 EN 43
4 Preparation and operation
• Emergency Pediatric
• Emergency Child
• Emergency Adult
44 EN MEDUMAT Standard2
4 Preparation and operation
or
Result The emergency mode of the patient last ventilated is called up.
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MEDUMAT Standard2 EN 45
4 Preparation and operation
46 EN MEDUMAT Standard2
4 Preparation and operation
or
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Navigate to the field Size and turn the navigation knob further
to select the desired patient group:
MEDUMAT Standard2 EN 47
4 Preparation and operation
• Adult
• Child
• Pediatric
4. Press the navigation knob next.
48 EN MEDUMAT Standard2
4 Preparation and operation
1. Select the field for the emergency mode using the right-hand
navigation knob.
• Emergency Child
• Emergency Adult
MEDUMAT Standard2 EN 49
4 Preparation and operation
50 EN MEDUMAT Standard2
4 Preparation and operation
MEDUMAT Standard2 EN 51
4 Preparation and operation
52 EN MEDUMAT Standard2
4 Preparation and operation
• 30:2
• 15:2
• Continuous
or
If the green LEDs on the MEDUtrigger are lit, briefly press the
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MEDUMAT Standard2 EN 53
4 Preparation and operation
You can adjust the startup behavior of the CPR mode in the
operator menu: Operator menu | Presets patient | CPR mode.
54 EN MEDUMAT Standard2
4 Preparation and operation
MEDUMAT Standard2 EN 55
4 Preparation and operation
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56 EN MEDUMAT Standard2
4 Preparation and operation
In the event that the compliance of the lungs is reduced, the device
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MEDUMAT Standard2 EN 57
4 Preparation and operation
Pmax
30
20
Pinsp
10
0 Time
58 EN MEDUMAT Standard2
4 Preparation and operation
You can transport the device in any of the following three ways:
MEDUMAT Standard2 EN 59
4 Preparation and operation
1. Briefly open and then close the valve of the oxygen cylinder in
order to blow away any particles of dust. WM 68011a 11/2013
60 EN MEDUMAT Standard2
4 Preparation and operation
MEDUMAT Standard2 EN 61
4 Preparation and operation
Oxygen supply l
Time min = ------------------------------------------------------------
-
Vt l * f min – 1 + 0.3l
Example
Oxygen supply 2000 l
Vt 500 ml
f 12 min-1
Time 317 min = 5 h 17 min
Oxygen supply l
Time min = ----------------------------------------------------------------------------
-
Vt l * f min – 1 + 0.3l * 2
Example
Oxygen supply 2000 l
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Vt 500 ml
f 12 min-1
Time 634 min = 10 h 34 min
62 EN MEDUMAT Standard2
4 Preparation and operation
MEDUMAT Standard2 EN 63
4 Preparation and operation
64 EN MEDUMAT Standard2
4 Preparation and operation
6. Place the patient hose system in the hose protection sleeve and
close it.
MEDUMAT Standard2 EN 65
5 Menu settings
5 Menu settings
5.1 Navigating the operator menu
1. Switch on the device.
The start menu appears.
4. Press the navigation knob next to confirm the first digit of the
access code.
5. Enter the other digits of the access code in the same way.
On delivery, the access code for the operator menu is 0000. You
can change the access code: Operator menu | Change access
code.
66 EN MEDUMAT Standard2
5 Menu settings
11. To reset values to their original state, press the menu item
Reset.
12. To leave the menu, press the menu item back until the menu
closes.
MEDUMAT Standard2 EN 67
5 Menu settings
Device information
Battery information
Export log files
Import configuration
Software update
Volume
Brightness
Device configuration
Filter load
Language
Date / Time
PEEP Warning
Patient size
Presets patient
CPR mode
Infant
Child
Adult
Option S-IPPV
Option SIMV
Options
Option Inhalation
Option MEDUtrigger
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Option
O ti RSI
Option Demand
Unlock
U l kO Option
ti
68 EN MEDUMAT Standard2
5 Menu settings
Here you can see the following information about the device:
• Device ID
MEDUMAT Standard2 EN 69
5 Menu settings
Here you can see the following information about the battery:
• Serial number
• Battery capacity
• Cycle count
• Battery status
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70 EN MEDUMAT Standard2
5 Menu settings
5.3.3 Import/export
Exporting a configuration
This function allows you to export all the configuration settings
performed on the device to an SD card.
As a general rule, all the configuration settings are exported, with
the exception of the following values:
• Date and time
• Serial number
• Device runtime
• Filter runtime
• Date of last function check
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MEDUMAT Standard2 EN 71
5 Menu settings
Importing a configuration
This function allows you to import the configuration settings
exported to an SD card from a device onto a second device.
Following the import, the second device is configured in exactly the
same way as the original device.
Configuration imports are saved in the log files. Configurations
can only be transferred between devices with the same software
version. Options subject to a charge are only imported if these
options are already activated.
Inserting an SD card
2. Slide the SD card into the SD card slot until it audibly clicks into
place.
In doing so, note: The beveled corner of the SD card must be
at the front on the right during insertion.
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Result The SD card is inserted in the device and ready for use.
72 EN MEDUMAT Standard2
5 Menu settings
or
5. Remove the SD card (see " Removing the SD card", page 74).
5. Remove the SD card (see " Removing the SD card", page 74).
MEDUMAT Standard2 EN 73
5 Menu settings
4. Close the splash guard to protect the device from the ingress
of moisture or an oxygen-enriched atmosphere.
• The operator menu has been called up (see "5.1 Navigating the
operator menu", page 66).
74 EN MEDUMAT Standard2
5 Menu settings
4. After the end of the update: Press the navigation knob reboot
to restart the device.
The device restarts and the start menu appears on the display.
MEDUMAT Standard2 EN 75
5 Menu settings
Here you can change the access code for the operator menu. On
delivery, the access code for the operator menu is 0000.
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76 EN MEDUMAT Standard2
5 Menu settings
MEDUMAT Standard2 EN 77
5 Menu settings
78 EN MEDUMAT Standard2
5 Menu settings
4 90
5 80
6 70
7 65
8 60
MEDUMAT Standard2 EN 79
5 Menu settings
For the smallest height which can be set, the tidal volume is always
at least 50 ml.
As the operator, you can enable optional functions for the user in
the Options submenu and activate or deactivate the enabled
options:
Requirement The operator menu has been called up (see "5.1 Navigating the
operator menu", page 66).
80 EN MEDUMAT Standard2
5 Menu settings
4. Press the navigation knob next to confirm the first digit of the
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option code.
5. Enter the other digits of the option code in the same way.
MEDUMAT Standard2 EN 81
5 Menu settings
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82 EN MEDUMAT Standard2
6 Description of the modes
Breathing effort
100%
Patient
Ventilator
0%
Assisted
ventilation
Controlled ventilation Spontaneous respiration
MEDUMAT Standard2 EN 83
6 Description of the modes
Ventilation
Unit Description
parameter
Vt ml Tidal volume (breath volume)
Freq. 1/min Ventilation rate
Pmax mbar Maximum inspiratory pressure
PEEP mbar Positive end-expiratory pressure (CPAP)
Ventilation through the addition of
Air Mix -
ambient air
100% oxygen - Ventilation with 100% oxygen
With a set PEEP value > 0 mbar, the patient must create an
underpressure of at least -1.3 mbar below the set PEEP value
through his/her spontaneous respiratory effort in order to initiate
an inspiratory trigger in the device.
If no PEEP value has been set (PEEP value = 0), the patient must
create an underpressure of at least -0.8 mbar in order to initiate
an inspiratory trigger. When using assisted ventilation modes,
ensure that the patient shows sufficient respiratory effort. If this is
not the case, the trigger sensitivity can be increased by setting a
PEEP value > 2 mbar. If the patient is still not able to initiate a
trigger, the mandatory rate must be set accordingly high to ensure
adequate ventilation of the patient.
• When the device switches to CPR mode, the PEEP value is
automatically set to 0 mbar.
• When the device switches from CPR mode to another
ventilation mode, it automatically changes from the preset
Pmax value for CPR to the preset Pmax value for all the other
ventilation modes (see "5.3.7 Presets patient", page 78).
84 EN MEDUMAT Standard2
6 Description of the modes
Description
Abbreviation CPAP
Long form Continuous Positive Airway Pressure
Type Pressure-controlled
Ventilation parameters
Left-hand navigation knob -
Central navigation knob -
• PEEP
Right-hand navigation knob
• Pmax
Pressure CPAP
Pmax
CPAP
CPAP / PEEP
Time
MEDUMAT Standard2 EN 85
6 Description of the modes
Pressure
IPPV
PEEP
Time
86 EN MEDUMAT Standard2
6 Description of the modes
Description
Abbreviation S-IPPV
Synchronized Intermittent Positive
Long form
Pressure Ventilation
Type Volume-controlled
Ventilation parameters
Left-hand navigation knob Vt
Central navigation knob Freq.
• PEEP
Right-hand navigation knob • Pmax
• Emergency mode
Pressure
S-IPPV
Synchronized machine
Machine ventilation ventilation
Pmax
Pplateau
PEEP
Time
1/Freq. (current) ΔT
1/Freq. (set)
Risk of hyperventilation!
Monitor the patient continuously.
MEDUMAT Standard2 EN 87
6 Description of the modes
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88 EN MEDUMAT Standard2
6 Description of the modes
Pmax
Machine ventilation Synchronized machine
ventilation
Spontaneous respiration
Patient
trigger
PEEP
Time
1/Freq. (current) ΔT
1/Freq. (set)
MEDUMAT Standard2 EN 89
6 Description of the modes
Description
Abbreviation CPR
Long form Cardiopulmonary Resuscitation
Type Volume-controlled
Ventilation parameters
Left-hand navigation knob Vt
Central navigation knob Freq.
• PEEP
• Pmax
Right-hand navigation knob
• Metronome
• Rhythm
The CPR mode supports you during cardiopulmonary resuscitation
(according to the Resuscitation Guidelines). MEDUMAT Standard2
emits a metronome sound which dictates the frequency of the
cardiac massage according to the algorithm 15:2 or 30:2 or
continuously (in the case of intubated patients).
90 EN MEDUMAT Standard2
6 Description of the modes
Following the selection of the RSI mode, the device launches the
100% oxygen demand function immediately for the
preoxygenation of a spontaneously breathing patient.
MEDUMAT Standard2 EN 91
7 Hygienic preparation
7 Hygienic preparation
7.1 General instructions
• This product may contain disposable items. Disposable
items are intended to be used only once. So use these
items only once and do not reprocess them. Reprocessing
disposable items may impair the functionality and safety of the
product and lead to unforeseeable reactions as a result of
ageing, embrittlement, wear, thermal load, the effects of
chemical processes, etc.
92 EN MEDUMAT Standard2
7 Hygienic preparation
7.2 Intervals
Clean the device, components and accessories after every use (but
at least once a week).
2. Switch off the device (see "4.6 Switching off the device", page
43).
MEDUMAT Standard2 EN 93
7 Hygienic preparation
Thermal
Part Cleaning Disinfection Sterilization
disinfection
Device
Battery
Not permitted
Power supply
MEDUtrigger
Wipe down with a Steam sterilize at
Wipe disinfection
dry or moist cloth: 134°C (for a
(Recommendation: Not permitted minimum of
Use water or mild
terralin® protect) 5 mins and
soap.
Testing bag maximum of
18 mins with
devices which
comply with
EN 285)
Wipe down with a
Oxygen fittings dry or moist cloth: Not permitted Not permitted Not permitted
Use clean water.
Reusable hose system See "7.4 Hygienic preparation of the reusable hose system", page 95.
Disposable hose system Disposable item, do not reuse
Device input filter Disposable item, do not reuse
Inhalation adapter Disposable item, do not reuse
Steam sterilize at
Rinse at up to
134°C (for a
95°C
Use the immersion minimum of
(Recommendation:
Clean in warm disinfection ® 5 mins and
thermosept
Ventilation masks water with a mild method(2) maximum of
alkaclean forte
cleaning agent(1). (Recommendation: 18 mins with
and
gigasept® FF (new)) devices which
thermosept®
comply with
NKZ)
EN 285)
94 EN MEDUMAT Standard2
7 Hygienic preparation
8. Insert battery.
Thermal
Part Cleaning Disinfection Sterilization
disinfection
Patient valve Use the immersion
Diaphragms disinfection method(2) Steam sterilize at
Rinse at up to
(Recommendation: 134°C (for a
Ventilation hose 95°C
gigasept® FF (new)) minimum of
(Recommendation:
Clean in warm Use the immersion 5 mins and
Measuring tube system: thermosept®
water with a mild disinfection method(2) maximum of
• PEEP control hose alkaclean forte
cleaning agent(1). (Recommendation: 18 mins with
• Pressure- and
gigasept® FF (new)) devices which
measurement hose thermosept®
See "7.5 Disinfecting the comply with
• Measuring hose NKZ)
measuring hose EN 285)
system connector system", page 96.
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MEDUMAT Standard2 EN 95
7 Hygienic preparation
Thermal
Part Cleaning Disinfection Sterilization
disinfection
• Wipe with a • Wash at 30°C in the
damp cloth: washing machine Rinse at up to
Using water (without spinning, 95°C
or mild soap with the addition of (Recommendation:
• Wash at a suitable thermosept®
Hose protection sleeve Not permitted
30°C in the disinfectant) alkaclean forte
washing • Use the immersion and
machine disinfection method thermosept®
(without (Recommendation: NKZ)
spinning) gigasept® FF (new))
(1)
Brush the parts thoroughly inside and outside using a normal
laboratory soft bottle brush.
(2)
Wet all surfaces, free of bubbles, inside and outside. Allow the
full exposure time to elapse. Following disinfection, rinse the parts
off and out thoroughly with distilled water and allow them to dry.
Requirement The measuring hose system is disconnected from the patient hose
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system.
1. Connect a sterile disposable syringe (20 ml) to the free end of
the pressure-measurement hose.
96 EN MEDUMAT Standard2
7 Hygienic preparation
MEDUMAT Standard2 EN 97
8 Function check
8 Function check
8.1 Intervals
Carry out a function check at regular intervals:
5. Check the patient valve of the patient hose system (see "8.6
Checking the reusable hose system", page 106).
If necessary: Replace the patient hose system.
7. Check the system for leaks (see "8.7 Checking the system for
leaks", page 107).
If necessary: Rectify any leaks in the system (see "8.8 Rectifying
leaks in the system", page 107).
98 EN MEDUMAT Standard2
8 Function check
MEDUMAT Standard2 EN 99
8 Function check
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8. In the button test, press all of the controls one after the other
except for the On/Off button .
10. Proceed with the device input filter according to the following
table:
Color Action
Green Continue to use the device input filter.
• Keep a device input filter at the
ready.
Yellow
or
• Order a device input filter.
Red Replace the device input filter.
11. When the device input filter has been replaced: Reset the filter
change indicator using the navigation knob reset.
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Device
ᅛ is ready for use,
+ Function check passed.
Use the device and take action (see
"8.4 Successful function check
Maintenance symbol with maintenance notification",
page 103).
Requirement The function check ended with Device is not ready for use.
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3. If the function check ends with Device is not ready for use
again: Contact your authorized dealer or WEINMANN
Emergency.
2. Check the PEEP control diaphragm and inspect the check valve
diaphragm: If the diaphragm is torn, wavy, distorted or sticky,
replace the diaphragm.
Result The patient valve of the reusable hose system has been checked
and is ready for use.
2. Wet all screw connections and hoses with the soapy solution.
Bubbles will form if a leak is present.
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7. Check the system for leaks once more (see "8.7 Checking the
system for leaks", page 107).
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Alarms are displayed in text format in the alarm line on the display.
Depending on the priority of the alarm, the text is highlighted a
certain color:
9.2.1 Device
9.2.2 Battery
9.2.3 Ventilation
10 Maintenance
10.1 General instructions
Maintenance, safety checks, inspections, and repairs must only be
carried out by the manufacturer or a technician specifically
authorized by the manufacturer.
10.2 Intervals
Result The reusable hose system has been maintained and is ready for
use.
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1. Pull the device input filter out of the filter compartment of the
device.
2. Dispose of the device input filter along with the filter cassette
(see "11.2.4 Device input filter", page 120).
Transport
safety
device
3. Remove the transport safety device from the device input filter.
4. Push the device input filter with the half-inserted filter cassette
into the filter compartment of the device.
In the process, the filter cassette is fully inserted in the device
input filter.
5. Press the device input filter into the filter compartment until the
device input filter audibly clicks into place and sits flush with
the device.
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1. Switch off the device (see "4.6 Switching off the device", page
43).
11.2 Disposal
11.2.1 Electronic waste
Do not dispose of the product in the household waste. Consult an
authorized, certified electronic waste recycling company for proper
disposal. You can find out their address from your environmental
officer or from your local council.
The device packaging (cardboard box and inserts) can be disposed
of as waste paper.
• Device
• Power supply
11.2.2 Battery
Do not dispose of used batteries in the household waste. Contact
WEINMANN Emergency or a public waste disposal authority.
12 Appendix
12.1 Technical data
12.1.1 Technical data on device
Specification Device
Product class according to Directive
IIb
93/42/EEC
Dimensions (W x H x D) 206 mm x 137 mm x 130 mm
Weight:
Without battery Approx. 2 kg
With battery Approx. 2.5 kg
Operation:
Temperature range -18°C to +50°C
Humidity 0% RH to 95% RH without condensation
Air pressure 540 hPa to 1100 hPa
Altitude above sea level -500 m to 5000 m
Storage/Transport:
Temperature range -40°C to +70°C (max. 48 h)
Humidity 0% RH to 95% RH without condensation
Electrical connection (rated voltage) 12 V to 15 V
Max. power consumption 30 W
Current consumption 0.1 to 3 A
Operating time with battery 6h
Vehicle electrical system operation:
Rated voltage 12 V
Max. internal resistance of vehicle
electrical system 500 m
Line operation
Rated voltage 15 V
Pulling out the power plug disconnects the device from line power
Disconnection from line power
on all poles.
Operating mode Continuous operation
Classification acc. to EN 60601-1:
WM 68011a 11/2013
Specification Device
Degree of protection against:
• ingress of solid objects
• ingress of dust IP54
• ingress of water with harmful
effect
Test parameters and limit values can be requested from the
Electromagnetic compatibility (EMC) as manufacturer (WEINMANN Emergency Medical Technology GmbH
per EN 60601-1-2: + Co. KG, Frohboesestrasse 12, 22525 Hamburg, Germany) if
Radio interference suppression required.
Radio interference immunity EN 55011
EN 61000-4 (parts 2 to 6, 8 and 11)
RTCA DO 160 G
5" TFT color display
Display
Resolution: 320 pixels x 240 pixels
Alarm volume 60 dBA to 88 dBA
EN 60601-1
EN 1789
Standards used EN 794-3
ISO 10651-3
RTCA DO-160 G
Control of ventilation modes:
• Volume-controlled IPPV, CPR, SIMV (optional), S-IPPV (optional), RSI, Inhalation
(optional)
• Pressure-controlled CPAP
Inhalation 0 l/min to 10 l/min, in increments of 1 l/min
Operating gas Medical oxygen
Operating pressure range 2.7 bar to 6 bar
4.5 bar (static)
Recommended gas supply
2.7 bar at 80 l/min
At least 80 l/min with an input pressure of 4.5 bar in Air Mix and
Maximum outlet flow
Non-Air Mix mode
I:E 1:1.7 mandatory, otherwise trigger-dependent (±10%)
Ventilation rate 5 min-1 to 50 min-1 (±1 min-1)
At least 0.45 s
Inspiration time
Max. 4.5 s
Tidal volume 50 ml to 2000 ml (±40 ml or ±20%)
WM 68011a 11/2013
At least 0.25 l
Respiratory minute volume
Max. 20 l
Pressure limitation (Pmax) 10 mbar to 65 mbar (±3 mbar or ±15%)
Mechanical safety valve Pressure limitation to a maximum of 100 mbar
PEEP 0 mbar to 20 mbar (±3 mbar or ±15%)
Specification Device
Inspiratory trigger:
-1.3 mbar at PEEP > 0
-0.8 mbar at PEEP = 0
Trigger
Expiratory trigger:
30% of the maximal flow
Oxygen concentration:
• Air Mix mode
See "12.1.6 Oxygen concentration in Air Mix mode", page 129.
100% O2
• Non-Air Mix mode
Pressurized gas thread External thread G 3/8
Ventilation hose connection WEINMANN Emergency-specific
Patient valve connections WEINMANN Emergency-specific
Service life of the device input filter 24 h in Air Mix mode or 6 months
Specification Battery
Type Li-ion
Dimensions (W x H x D) 97 mm x 127 mm x 33 mm
Weight 450 g
Rated capacity 4.3 Ah ( 46.4 Wh)
Rated voltage 10.8 V
Charging time (0% to 95%) 3.5 h
Charging temperature 0°C to +45°C
Temperature range for operation -18°C to +50°C
Transport/Storage:
Temperature range -30°C to +70°C (max. one week at more than
+60°C)
Humidity 0% RH to 95% RH without condensation
Life At least 300 charging cycles
WM 68011a 11/2013
Pressure drop [hPa] over the inspiratory and expiratory flow path at different flow
rates [l/min] as per EN 794-3 (in combination with MEDUMAT Standard2, measuring
point 1: patient connection opening)
Patient
hose system
Patient hose system Patient hose system (disposable),
Flow (reusable), 2 m (disposable), 2 m 2 m, with
[l/min] reduced
dead space
With Without With Without With
elbow elbow elbow elbow elbow
Spontaneous 2.5 0.35 0.26 0.23 0.10 0.13
respiration 15 1.35 1.08 0.15 0.50 1.18
in the event of
power failure,
inspiratory 30 2.82 2.72 2.93 1.30 3.27
(1)
(STP)
Spontaneous 2.5 0.62 0.66 1.17 0.60 0.75
respiration 15 1.52 1.53 1.99 1.00 1.82
in the event of
power failure,
expiratory 30 2.05 2.00 2.60 1.20 3.26
(2)
(BTPS)
Normal 5 0.00 0.00 0.10 0.00 0.00
operation, 30 0.13 0.00 0.26 0.10 0.12
inspiratory
(STP)(1) 60 0.34 0.14 0.93 0.20 0.27
Normal 5 0.85 0.92 1.41 0.70 0.96
operation, 30 2.01 2.01 2.58 1.20 3.24
expiratory
(BTPS)(2) 60 2.80 2.59 3.67 1.70 7.28
WM 68011a 11/2013
Pressure drop [hPa] over the inspiratory and expiratory flow path at different flow
rates [l/min] as per EN 794-3 (in combination with MEDUMAT Standard2, measuring
point 1: patient connection opening)
Patient hose system Patient hose system
Flow (reusable), 3 m (disposable), 3 m
[l/min] With Without With Without
elbow elbow elbow elbow
Spontaneous 2.5 0.35 0.32 0.26 0.27
respiration 15 1.25 1.19 1.23 1.18
in the event of
power failure, 30 2.75 2.68 2.96 2.81
inspiratory (STP)(1)
Spontaneous 2.5 0.54 0.83 1.30 1.15
respiration 15 1.29 1.35 2.03 1.85
in the event of
power failure,
expiratory 30 1.75 1.75 2.63 2.38
(2)
(BTPS)
Normal operation, 5 0.00 0.00 0.00 0.00
inspiratory 30 0.15 0.12 0.18 0.10
(STP)(1) 60 0.40 0.15 0.76 0.21
Normal operation, 5 0.80 1.05 1.50 1.33
expiratory 30 1.75 1.72 2.60 2.36
(BTPS)(2) 60 2.39 2.29 3.86 3.27
(1) STP (Standard Temperature and Pressure): volume at 21°C and 1013 hPa
(2)
BTPS (Body Temperature and Pressure, saturated): volume at
current ambient pressure and 37°C, with 100% saturated gas
Pre ssure
sensors
Safety
Pre ssure Dosage Air Mix Flow Optiona l:
Pressurized gas and emerg ency Patient va lve Patient
redu ce r valve valve sensor HME filter
air valve
Device
Ambient air Injector
inpu t fil ter
WM 68011a 11/2013
0,5
Consumpon [l/min]
0,4
PEEP = 20 mbar
PEEP = 15 mbar
0,3 PEEP = 10 mbar
PEEP = 5 mbar
PEEP = 0 mbar
MEDUMAT Standard2
0,2
0,1
.
0
0 10 20 30 40 50 60 70
12 Appendix
PInsp / mbar
EN
128
12 Appendix
100
O2 in %
50
55
60
65
70
75
80
85
90
95
2
4
6
Respiratory minute volume in l/min
8
10
12
10 mbar counterpressure
15 mbar counterpressure
30 mbar counterpressure
14
16
18
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20
Separation distances
With the aid of the IBW, the tidal volume can be calculated as
follows:
Vt = 80 kg x 6 ml/kg = 450 ml
WM 68011a 11/2013
(1)
Source: TRAUB, S.L.; JOHNSON, C.E.: Comparison of methods of estimating
creatinine clearance in children. In: American journal of hospital pharmacy 37, 1980,
No.2, pp. 195–201
(2)
Source: DEVINE, Ben J. Gentamicin therapy. The Annals of Pharmacotherapy, 1974,
Vol. 8, No. 11, pp. 650-655
tightness
bleeding
pressure
pressure
system
result*
alarm-
fcheck
airmix
input-
#date
time
flow
uid
*In the column result, you will find the result of a function check
(ok = passed, failed = not passed). If a function check has been
failed, the cause of the failure is indicated by the appearance of the
word failed in the columns which follow. In the example given,
the function check was failed due to a leak (tightness column).
WM 68011a 11/2013
Article
Part
number
Basic device with MEDUtrigger socket WM 28710-01
Basic patient hose system, 2 m, reusable WM 28860
Battery WM 45045
MEDUtrigger 2 m WM 28992
Testing bag for MEDUMAT WM 1454
Set of CPAP/NIV disposable masks with air cushion WM 15807
Ventilation mask with self-inflating silicone cushion for
WM 5074
adults, size 5
Device input filter WM 28745
Medical device logbook WM 16430
Delivery record WM 16318
MEDUMAT Standard2 Instructions for Use WM 68011
12.4.2 Accessories
Accessories can be ordered separately, if required. A current list of
accessories is available on the Internet at www.weinmann-
emergency.de or from your authorized dealer.
Article
Part
number
MEDUtrigger 3 m WM 28993
Charging adapter WM 28979
50 W power supply WM 28305
100 W power supply WM 28937
12 V cable WM 28356
WM 68011a 11/2013
Article
Part
number
Set, holding plate for equipment rail WM 15845
Set, wall holder for power supply unit and charger WM 15846
Set, wall holder for rechargeable battery pack WM 15847
Hospital standard rail attachment set WM 15795
Rail bracket attachment set WM 15806
Basic patient hose system, 2 m, disposable WM 28865
Basic patient hose system, 3 m, reusable WM 28861
Basic patient hose system, 3 m, disposable WM 28866
Basic patient hose system, 2 m, disposable, with reduced
WM 28867
dead space
Breathing system filter for MEDUMAT ventilators WM 22162
Inhalation adapter WM 28263
AD22 protective cap WM 28942
2 l oxygen cylinder, full, G 3/4,
WM 1822
max. filling pressure 200 bar
2 l lightweight oxygen cylinder, full, G 3/4,
WM 1814
max. filling pressure 200 bar
Pressure reducer OXYWAY Fix III, G 3/4 WM 30301
Pressure reducer OXYWAY Fast II High Flow, G 3/4 WM 31891
Pressure hose, 10 bar, with connection nozzle G 3/8;
Article number
at the other end, the option of a union nut G 3/8 or oxygen
on request
supply connector
12.5 Warranty
Starting from the date of purchase, WEINMANN Emergency offers
the customer a limited manufacturer’s warranty on a new original
WEINMANN Emergency product or replacement parts installed by
WEINMANN Emergency in accordance with applicable warranty
terms and conditions for the particular product and the warranty
periods listed below. The warranty terms and conditions are
available on the Internet at www.weinmann-emergency.de. On
request, we will send you the warranty terms and conditions by
mail.
If you wish to make a warranty claim, consult your authorized
dealer.
WM 68011a 11/2013 EN
GERMANY
medical technology
made in germany