Weinmann MEDUMAT Standard a User manual
MEDUMAT Standard a
Ventilator
Description and instructions for use
EN
Contents
1. Overview . . . . . . . . . . . . . . . . . . . . 4
1.1 Device . . . . . . . . . . . . . . . . . . . . . . 4
1.2 Symbols used on the ventilator . . . . 7
2. Description of ventilator . . . . . . 10
2.1 Uses . . . . . . . . . . . . . . . . . . . . . . . 10
2.2 Owner/operator and user
qualification . . . . . . . . . . . . . . . . . 11
2.3 Ventilation function . . . . . . . . . . . 11
2.4 Controlled ventilation. . . . . . . . . . 13
2.5 Assisted ventilation. . . . . . . . . . . . 13
2.6 Check ventilation curve . . . . . . . . 14
2.7 Patient valve. . . . . . . . . . . . . . . . . 14
2.8 Modules. . . . . . . . . . . . . . . . . . . . 15
3. Safety instructions . . . . . . . . . . . 16
3.1 Safety regulations. . . . . . . . . . . . . 16
4. Installation . . . . . . . . . . . . . . . . . . 20
4.1 Wall mounting for STATION
MEDUMAT. . . . . . . . . . . . . . . . . . 20
4.2 Installation kit for the wall
mounting . . . . . . . . . . . . . . . . . . . 21
4.3 Connecting up the oxygen
cylinder . . . . . . . . . . . . . . . . . . . . 21
4.4 Ventilation hose . . . . . . . . . . . . . . 22
5. Using the ventilator . . . . . . . . . . 25
5.1 Switching on/self test . . . . . . . . . . 25
5.2 Selecting the ventilation settings. . 26
5.3 Select ventilation method . . . . . . . 28
5.4 Performing ventilation . . . . . . . . . 30
5.5 Monitoring ventilation . . . . . . . . . 30
5.6 Ventilation with PEEP Valve . . . . . 31
5.7 Ventilation with HME filter . . . . . . 32
5.8 Ventilating with bacteria filter. . . . 32
5.9 Terminating ventilation. . . . . . . . . 33
5.10 Alarm signals . . . . . . . . . . . . . . . . 33
5.11 Calculation of oxygen content/
remaining operating time . . . . . . . 37
5.12 Alternative ventilation
procedures . . . . . . . . . . . . . . . . . . 38
6. Hygienic preparation . . . . . . . . . 39
6.1 MEDUMAT Standard a. . . . . . . . . 39
6.2 Patient valve . . . . . . . . . . . . . . . . 40
6.3 Hose system . . . . . . . . . . . . . . . . 41
6.4 Components and accessories . . . . 42
6.5 Fittings . . . . . . . . . . . . . . . . . . . . 43
6.6 Cleaning, disinfecting and
sterilizing . . . . . . . . . . . . . . . . . . . 44
7. Functional checks . . . . . . . . . . . . 45
7.1 Preparation for functional check . 45
7.2 Obligatory checks . . . . . . . . . . . . 46
7.3 Check for leaks in the system. . . . 47
7.4 Check of patient valve . . . . . . . . . 48
7.5 Checking the minute volume . . . . 49
7.6 Check of maximal ventilation
pressure. . . . . . . . . . . . . . . . . . . . 51
7.7 Check assisted ventilation . . . . . . 52
7.8 Check of alarm systems . . . . . . . . 54
8. Troubleshooting . . . . . . . . . . . . . 57
8.1 Batteries . . . . . . . . . . . . . . . . . . . 59
8.2 Cut-out system . . . . . . . . . . . . . . 60
8.3 Adjustment of manometer. . . . . . 61
8.4 Change valve membrane in
patient valve . . . . . . . . . . . . . . . . 61
9. Servicing . . . . . . . . . . . . . . . . . . . . 63
9.1 Intervals. . . . . . . . . . . . . . . . . . . . 63
9.2 Sending in device. . . . . . . . . . . . . 64
9.3 Storage . . . . . . . . . . . . . . . . . . . . 64
9.4 Disposal. . . . . . . . . . . . . . . . . . . . 65
10. Supply schedule . . . . . . . . . . . . . . 66
10.1 Standard supply schedule . . . . . . 66
10.2 Accessories . . . . . . . . . . . . . . . . . 66
10.3 Spare parts . . . . . . . . . . . . . . . . . 67
11. Technical data . . . . . . . . . . . . . . . 68
11.1 Device . . . . . . . . . . . . . . . . . . . . . 68
11.2 Patient’s hose system. . . . . . . . . . 70
11.3 Pneumatics . . . . . . . . . . . . . . . . . 71
11.4 Resistance to interference . . . . . . 72
11.5 O
content when using Air Mix . . 72
2
2 Contents
EN
11.6 Switching from Air Mix to
No Air Mix . . . . . . . . . . . . . . . . . . 73
12. Warranty . . . . . . . . . . . . . . . . . . . . 74
13. Declaration of conformity . . . . . 74
Contents 3
EN
1. Overview
Control panel MEDUMAT Standard a
1 Ventilation pressure gauge
7 Colour code
Toddler (yellow, 10 kg to 30 kg)
Child (orange, 30 kg to 60 kg)
Adult (brown, 60 kg to 110 kg)
4 Air Mix/No Air Mix switch
3 Alarm acknowledgement2 Alarm panel
8 ON/OFF switch
9 Ventilation frequency regulator
5 Minute volume regulator
10 Max. ventilation pressure
regulator
6 On/Off switch,
assisted ventilation
1.1 Device
Stenosis
Disconnection
< 2,7 bar O
2
No assist
MEDUMAT
Standard a
Air Mix
No Air Mix
4 Overview
EN
MEDUMAT Standard a connections
12 Catch for STATION MEDUMAT
wall mounting
11 Pressure gas connection
13 Connection for ventilation tube
14 Pressure gauge hose connection
15 Relief valve
16 Dust cover
17 Mixed air filter
12 Catch for STATION MEDUMAT
wall mounting
I
Overview 5
EN
MEDUMAT Standard a device combinations
19 Ventilation hose
18 Ventilation mask
21 Filter
23 Patient valve
24 PEEP valve
22 Hose casing
25 Tube
or
20 Pressure gauge hose
Disposable hose system
6 Overview
EN
1.2 Symbols used on the ventilator
Position
> PSU< 134°
Patient valve
The symbol on the patient valve indicates that
the lip and valve membranes in the expiration and
spontaneous breathing arms must be changed immediately if they are crinkled, sticky or misshapen.
Under no circumstances continue to use the patient
valve for ventilation in this case, as malfunctions are
likely (note “7.4 Check of patient valve“ on
page 48).
The symbol indicates the correct position for
insertion of the lip membrane.
When connecting the patient valve, take care to
ensure that the direction of respiratory gas flow is
correct.
Overview 7
EN
MEDUMAT Standard a
1
2
3
4567
1 Inlet 2,7 - 6 bar O2.
2 Tube system connection
3 Maximum pressure ≤100mbar
I
4
5 Servicing label: indicates when the next service is due.
8 Overview
Safety check and servicing label
Safety check label: (in Germany only) marks when the next safety
check as per §6 of the German law relating to users of medical
devices is required.
EN
MEDUMAT Standard a device information plate
SN
6
IP24
Serial number of device
Date of manufacture
Direct voltage
3,6 V lithium battery
Do not dispose of device in domestic waste
CE symbol (confirms that the product conforms to the applicable
European directives)
Type BF application part
Degree of protection
– against the ingress of solid particles
– against access to hazardous parts
– against the ingress of water with a harmful effect
Other markings
7 Follow instructions for use
Overview 9
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2. Description of ventilator
2.1 Uses
The MEDUMAT Standard a is an automatic (shortterm) ventilator with the option of assisted ventilation.
You can use MEDUMAT Standard a:
• to revive patients at the site of the emergency
• on a longer term basis in more protracted emergencies, e.g. fires.
You can use MEDUMAT Standard a while transporting patients:
• between the various rooms and departments of
a hospital;
• between the hospital and other premises;
• in emergencies;
• when transport over a considerable distance is
planned.
10 Description of ventilator
MEDUMAT Standard a:
• is designed to provide controlled ventilation to
persons of approx. 10 kg body weight or more,
or in the case of assisted ventilation, of approx.
15 kg body weight or more.
• is used to treat respiratory arrest;
• can be preset to parameters that ensure evenly
balanced ventilation provided that the selected maximum ventilation pressure P
• can be supplied with additional modules for
aspiration and oxygen inhalation. (N.B.
is not exceeded.
max
EN
MEDUMAT Standard a cannot be used as a ventilator simultaneously with these modules.)
2.2 Owner/operator and user qualification
As an owner/operator or user, you must be familiar
with the operation of this medical device. Observe
the legal requirements for operation and use (in Germany, the regulations governing owner/operators of
medical devices apply in particular). Basic recommendation: get a person authorized by Weinmann
to provide you with proper instruction about the
handling, use and operation of this medical device.
2.3 Ventilation function
MEDUMAT Standard a operates within a pressure
range of 2.7 to 6 bar and at a flow rate of not less
than 70 l/min O
It uses high-pressure, medicinal-grade oxygen. An
external pressure reducer brings this down to the required operating pressure. The oxygen supply is fed
in at input valve.
Both the infinitely variable ventilation frequency and
the inspiration/expiration ratio of 1:1.67 in the case
of controlled ventilation are regulated by internal
electronic control mechanisms.
. It has an in-built power pack.
2
The gas for inspiration is routed to the patient
through the ventilation tube via the patient valve
and the ventilation mask or hose. A lip membrane
Description of ventilator 11
EN
Air Mix
No Air Mix
Air Mix
No Air Mix
in the patient valve ensures that the expiration gas
can be exhaled through the expiration arm.
Regardless of the ventilation mode selected, the patient has the option of breathing spontaneously between ventilation strokes via the patient valve. In
this case, the patient draws air for breathing from
the ambient air.
With the Air Mix setting, in the case of mechanical
ventilation, atmospheric air is admixed to give an O
concentration generally of between 55 % and 85 %
at 10 mbar ventilation pressure (note “11.5 O
con-
2
tent when using Air Mix“ on page 72).
In certain indications and in cases where the surrounding atmosphere is contaminated, you can switch to
No Air Mix and ventilate with pure oxygen.
The injector unit is switched off when switching
from
Air Mix to No Air Mix. This increases minute vol-
ume which can result in the set pressure limit being
exceeded and a stenosis alarm (Stenosis) being trig-
gered. In this case, set minute volume correspondingly
lower.
In the opposite instance, in other words when
switching from
No Air Mix to Air Mix, the injector
unit is switched on. This reduces minute volume
which can lead to the set pressure limit being
. In this case, set minute volume correspondingly
shot
higher.
under-
2
12 Description of ventilator
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2.4 Controlled ventilation
Mandatory ventilation
stroke: the device, not the
patient, determines the
time of the next breathing
stroke.
After being switched on, the MEDUMAT Standard a
is automatically in Controlled Ventilation mode. This
administers mandatory ventilation strokes to the intubated patient according to the ventilation values
set on the device.
2.5 Assisted ventilation
In addition to Controlled Ventilation mode, the
MEDUMAT Standard a also has an Assisted Ventilation mode.
After you have switched on Assisted Ventilation
mode by pressing the
LED indicates this mode.
Triggered ventilation
stroke: the patient can trigger a ventilation stroke by
his own breathing efforts.
IPPV: intermittent positive
pressure ventilation (= controlled ventilation).
The patient now has the option of triggering a triggered ventilation stroke within a time window of 40
% of expiration. To do so, the patient must generate
a flow of over 6 l/min. by his own breathing efforts.
If the breathing efforts of the patient are not sufficient to trigger, the patient automatically receives a
mandatory ventilation stroke at the end of the time
window, so that the set minute volume is guaranteed.
With this function, the ventilation strokes of the device can be synchronised with the breathing efforts
of the patient.
Between the mandatory ventilation strokes of the
device, the patient has the option of breathing in air
from the surrounding atmosphere via the patient
valve.
Assist key, a flashing green
Description of ventilator 13
EN
If the patient does not trigger the device, an alarm is
Respiration hose connection
Expiration
tube
Connection
for pressure
gauge tube
Mask/tube connection
Spontaneous
breathing tube
triggered. The patient continues to receive controlled ventilation.
2.6 Check ventilation curve
The ventilation curve is checked at ventilation
pressure gauge.
2.7 Patient valve
The gas for inspiration is channelled into the
patient’s airways through the patient valve.
It is designed so that spontaneous breathing is possible, even if the MEDUMAT Standard a fails, regardless of which ventilation mode you have selected.
14 Description of ventilator
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2.8 Modules
M
OD
UL
O
x
y
g
e
n
O
2
0
5
1
0
1
5
l/min
O
2
MODUL
Combi
O
2
Modules with additional functions can be attached
to MEDUMAT Standard a.
Please refer to the directions for use enclosed with
the modules for exact details of how to fit and operate these. It is essential to read these directions carefully before using the modules. The most important
points are listed below:
Oxygen MODULE
The Oxygen MODULE enables you to apply oxygen
inhalation.
Put the switch marked
O
into the “I“ position. Se-
2
lect the desired oxygen volume by turning the knob
marked
l/min to a setting between 0 and 15 l/min.
You can check this setting on the volume manometer.
Combi MODULE
The Combi MODULE enables you to apply both
oxygen inhalation and suction.
For inhalation put the switch marked
position. Select the desired oxygen volume by turning
the knob marked
l/min to a setting between 0 and
15 l/min. You can check this setting on the volume
manometer.
For suction switch the tumbler marked
position. The suction pressure is locked at -0.5 bar.
O2 into the “I“
Vac to the “I“
Description of ventilator 15
EN
3. Safety instructions
3.1 Safety regulations
For your own safety, the safety of your patients, and
to comply with the requirements of EU Directive 93/
42/EEC, please observe the following points:
General
• Please read the directions for use carefully. They
are an integral part of the ventilator and should
be available for reference at all times.
• Before starting to work with
MEDUMAT Standard a, you must understand
how to operate it.
• Please comply with section “6. Hygienic preparation“ on page 39 to prevent infection or bacterial contamination.
• MEDUMAT Standard a should be used only by
medically qualified personnel who have had
training in ventilation techniques. Incorrect use
can cause severe physical injury.
16 Safety instructions
• It is advisable for you to have servicing and repairs carried out only by the manufacturer,
Weinmann, or by qualified technicians expressly
authorized by Weinmann.
• If third-party items are used, functional failures
may occur and fitness for use may be restricted.
Biocompatibility requirements may also not be
met. Please note that in such cases, any claim
under warranty and liability will be voided if neither the accessories nor genuine replacement
EN
parts recommended in the instructions for use
are used.
• MEDUMAT Standard a should be used only for
the purposes for which it is designed (note “2.1
Uses“ on page 10).
• MEDUMAT Standard a is not designed for use
under hyperbaric conditions (pressure chamber).
• MEDUMAT Standard a should never be used
with flammable anaesthetics.
• In the case of use in poisoned or low-oxygen
atmospheres, do not operate the
MEDUMAT Standard a with the „Air Mix“
setting or in Assist mode.
• A back-up ventilator should always be available
in case of technical failure.
Warning: • Modifications may not be made to the device.
Have modifications to the device carried out only
by the manufacturer, Weinmann, or by specialist
staff expressly authorized by the manufacturer.
Oxygen
Highly-compressed oxygen can lead to spontaneous
explosive reactions in combination with flammable
substances (fat, oil, alcohol, disinfectants, etc.):
• All screw connections and other components of
the ventilator must be kept absolutely free of oil
and grease.
• Always wash your hands before starting to work
on the oxygen supply.
• Smoking and open flames are strictly prohibited
in the vicinity of all fittings containing or transporting oxygen.
• During assembly and when changing the oxygen
cylinder, only hand pressure should be used
Safety instructions 17
EN
when tightening the screw connections to the
cylinder and to the pressure reducer. Never use
tools for this purpose. Excessive tightening damages the screw threads and seals and can cause
leaks.
• Protect oxygen cylinders from accidental falls. If
a cylinder falls, the pressure reducer or the valve
may break off and cause a violent explosion.
Important note • Always open the valve of the oxygen cylinder
slowly to prevent pressure damage to the other
fittings.
• The oxygen cylinder should never be completely
emptied as this may allow moisture-containing
air to enter the cylinder and cause corrosion.
Operation
• Both the patient and the ventilator must be kept
under constant observation during ventilation.
• Make sure that neither the expiration tube nor
the spontaneous breathing tube on the patient
valve is blocked or impeded in any other way,
e.g. by the patient’s position.
18 Safety instructions
• MEDUMAT Standard a must never be used simultaneously with a module as this would make
it impossible to work to the selected parameters.
Note • Disposable hose systems WM 28110 (2 m) and
WM 28188 (3 m) are only intended to be used
once.
Software
• Extensive validation tests have been performed
to minimize risks arising from software errors.
EN
Accessories
• Please protect the silicone and rubber components against UV radiation and prolonged exposure to direct sunlight, as this can make them
brittle and friable.
Safety instructions 19
EN
4. Installation
A permanent mounting is usually necessary only
when MEDUMAT Standard a is installed as a fixture
in rescue vehicles, helicopters or aircraft. In these
cases either the STATION MEDUMAT or installation
kits are available as accessories.
If MEDUMAT Standard a is supplied complete with
carrying platform, it is ready for use and requires no
further installation. Separate directions for use are
supplied with the carrying platform.
Functional tests must be carried out after installation
(note “7. Functional checks“ on page 45).
4.1 Wall mounting for STATION MEDUMAT
The wall mounting for the STATION MEDUMAT
should be installed at an appropriate place, e.g., on
a side panel inside the vehicle. Please refer to the
sheet enclosed with the STATION MEDUMAT for
details of dimensions and the installation procedure.
20 Installation
To place MEDUMAT Standard a in the wall mounting,
first insert the slides on the underside of the ventilator
into the matching grooves in the STATION MEDUMAT
and then press the MEDUMAT Standard a inwards
until the catch snaps into the fastening at the top of
the STATION MEDUMAT.
EN
4.2 Installation kit for the wall mounting
A number of kits are available for installing a wall
mounting, e.g. on a panel inside a vehicle. The kit
size varies according to the number of modules attached to the MEDUMAT Standard a.
Please refer to the sheet enclosed with each installation kit for details of dimensions and installation
procedure.
4.3 Connecting up the oxygen cylinder
Wash your hands thoroughly before any work on the
oxygen supply. Hydrocarbon compounds (e.g. oils,
greases, alcohol for cleaning, disinfectants, hand
cream or sticking plaster) can lead to explosive reactions if they come into contact with highly-compressed oxygen.
Never use wrenches or similar tools to tighten or
loosen the screw connections.
Removal of empty cylinder
1. Close the valve of the oxygen cylinder.
Switch on MEDUMAT Standard a with ON/OFF
switch. This exhausts any residual oxygen and
depressurizes the ventilator. Wait until the pressure gauge on the pressure reducer shows
oxygen content before uncoupling the screw
connection by hand.
2. First switch off MEDUMAT Standard a again.
3. Then loosen the screw connection to the
cylinder.
Installation 21
0 bar
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Connecting up new cylinder
I
1. First open the valve of the new oxygen cylinder
and close it again quickly. This will blow out any
particulate matter.
Keep the valve opening away from the body,
making sure that neither yourself or other persons can be injured by escaping particles!
2. Next couple the pressure reducer to the valve on
the oxygen cylinder with the fluted connecting
nut. Tighten up the nut by hand.
3. If the pressure hose is not already connected to
the exit valve of the pressure reducer, make this
connection with the G 3/8 connecting nut.
4. Screw the other end of the pressure hose on to
pressure gas connection on the
MEDUMAT Standard a if this has not yet been
done.
4.4 Ventilation hose
22 Installation
1. Slide the pressure gauge hose onto the
connection.
2. Slide the ventilation tube onto the connection.
Make sure that the pressure gauge hose already
connected is not kinked. If necessary, turn the
ventilation tube while sliding on as appropriate.
Do solely grasp the ventilation tube by its end (position of arrow in adjacent drawing). Otherwise the
hose may become damaged or tear.
EN
3. Plug the other end of the ventilation tube and the
Po
s
it
i
o
n
>
PS
U
<
1
3
4
°
P
o
s
i
t
io
n
>
P
S
U
<
1
34°
pressure measurement tube onto the patient
valve.
4. If the patient is intubated, insert the patient
valve into the tube,
or
if a mask is being used for ventilation, insert the
patient valve into the connector on the mask.
(This is identical with the connector on the tube.)
HME-Filter
If a heat and moisture exchanger (HME) filter is
required, this should be installed between the patient-side connector on the patient valve and the
tube or mask.
Always follow the manufacturer’s directions for use.
Installation 23
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